On August 13, 2004, FSIS published a proposal in the Federal Register (69 FR 50086-50088) to add San Marino to the list of countries eligible to export meat and meat products to the United States. As discussed in that proposed rulemaking, in 1997 the government of San Marino requested approval to export meat and meat products to the United States. In response to this request, FSIS conducted a thorough review of the San Marino meat processing inspection system to determine whether it is equivalent to the U.S. meat inspection system. San Marino did not ask FSIS to review its slaughter system for equivalency to the U.S. meat inspection system. FSIS concluded that the requirements contained in San Marino's meat inspection laws and regulations pertaining to its meat processing system are equivalent to those mandated by the FMIA and implementing regulations. FSIS then conducted an on-site review of the San Marino meat processing inspection system in operation. The FSIS review team concluded that San Marino's implementation of meat processing standards and procedures is equivalent to that of the United States.

The government of San Marino will certify to FSIS establishments eligible to export products to the United States. FSIS will retain the right to verify that establishments certified by the San Marino government are meeting requirements equivalent to those of FSIS. This will be done through annual on-site reviews of the establishments while they are in operation.

Products from a country eligible to export meat and meat products must also comply with all other U.S. requirements, including those of the U.S. Customs Service and the restrictions under Title 9, part 94 of the Animal and Plant Health Inspection Service (APHIS) regulations that relate to the importation of meat and meat products from foreign countries into the United States. APHIS is responsible for keeping foreign animal diseases out of the United States. APHIS restricts the importation of any fresh, frozen, and chilled meat, meat products, and edible products from countries in which certain animal diseases exist. Those products that APHIS has restricted from entering the United States are refused entry. FSIS works closely with APHIS in coordinating its import inspection system so as to allow into the United States only meat products that APHIS has found to pose no animal health risk. At present, San Marino has certified only one establishment wishing to export processed pork products as eligible to export meat food products into the United States.

FSIS received no comments on the proposed rule.

This rule has been reviewed under Executive Order 12866. It has been determined to be not significant for purposes of E.O. 12866 and therefore has not been reviewed by the Office of Management and Budget (OMB).

There is only one establishment in San Marino that has applied to export meat products to the United States. This establishment will export non-shelf stable cooked pork products. U.S. imports from this establishment are expected to total approximately 500,000 pounds per year.

Adoption of this rule will continue to open trade between the U.S. and San Marino, which over the past decade has consisted of U.S. firms occasionally exporting small amounts of pork and poultry products to San Marino. This rule will also increase the U.S. food supply.

The impact of this rule on U.S. consumers is voluntary in that consumers will not be required to purchase meat products produced and processed in San Marino, although they may choose to do so. Expected benefits from this type of rule would accrue primarily to consumers in the form of competitive prices due to a larger market variety of meat products. The volume of trade stimulated by this rule, however, will likely be so small as to have little effect on supply and prices. Consumers, apart from any change in prices, would benefit from increased choices in the marketplace.

The costs of this rule will accrue primarily to producers in the form of greater competition from San Marino. Again, it must be noted that the volume of trade stimulated by this rule will be very small, likely having little effect on supply and prices. Nonetheless, it is possible that U.S. firms that produce products that would compete with San Marino imports could face short-term difficulty. In the long run, however, such firms could adjust their product mix in order to compete effectively.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. When this final rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

The Administrator, FSIS, has made a determination that this rule will not have a significant impact on a substantial number of small entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601). This rule will add San Marino to the list of countries eligible to export meat products into the United States. Currently, only one San Marino establishment has applied to export product to the United States. This establishment is planning to export approximately 500,000 pounds of non-shelf stable cooked pork products to the United States per year. The volume of trade stimulated by this rule would be very small, likely having little effect on supply and prices. Therefore, this rule is not expected to have a significant impact on small entities that produce these types of products domestically.

No new paperwork requirements are associated with this rule. A foreign country wanting to export livestock products to the United States is required to provide information to FSIS certifying that its inspection system provides standards equivalent to those of the United States and that the legal authority for the system and its implementing regulations are equivalent to those of the United States before it may start exporting such product to the United States. FSIS collects this information one time only. FSIS gave San Marino questionnaires asking for detailed information about the country's inspection practices and procedures to assist the country in organizing its materials. This information collection was approved under OMB number 0583-0094. The proposed rule contains no other paperwork requirements.

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that the public and in particular minorities, women, and persons with disabilities are aware of this final rule, FSIS will announce it on-line through the FSIS Web page at http://www.fsis.usda.gov/regulations/2005_Proposed _Rules_Index/.

The Regulations.gov Web site is the central online rulemaking portal of the United States government. It is being offered as a public service to increase participation in the Federal government's regulatory activities. FSIS participates in Regulations.gov and will accept comments on documents published on the site. The site allows visitors to search by keyword or Department or Agency for rulemakings that allow for public comment. Each entry provides a quick link to a comment form so that visitors can type in their comments and submit them to FSIS. The Web site is located at http://www.regulations.gov.

FSIS also will make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and other types of information that could affect or would be of interest to our constituents and stakeholders. The update is communicated via Listserv, a free e-mail subscription service consisting of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. The update also is available on the FSIS web page. Through Listserv and the web page, FSIS is able to provide information to a much broader, more diverse audience.

In addition, FSIS offers an electronic mail subscription service that provides an automatic and customized notification when popular pages are updated, including Federal Register publications and related documents. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/ and allows FSIS customers to sign up for subscription options in eight categories. Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves and have the option to password protect their accounts.

The FAA has determined that notice and opportunity for prior public comment hereon is unnecessary, as 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, the FAA invites interested persons to participate in this rulemaking by submitting 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. The docket is available for public inspection 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 in light of the comments received.

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 July 5, 2005, Flight Test Associates, Inc., of Mojave, California, applied to the FAA, Los Angeles Aircraft Certification Office for a supplemental type certificate (STC) to modify a Boeing Model 720B airplane. The proposed modification incorporates the installation of dual Honeywell AM-250 digital altimeters as primary instruments. The information presented is flight critical. The altimeter installed in the airplane has the potential to be vulnerable to high-intensity radiated fields (HIRF) external to the airplane.

Under the provisions of 14 CFR 21.101, Flight Test Associates, Inc., must show that the Boeing Model 720B airplane, as changed, continues to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. 4A28, 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 regulations incorporated by reference in Type Certificate No. 4A28 include Civil Aeronautics Manual 4b, as amended by Amendments 4b-1 through 4b-6.

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 modified Boeing Model 720B airplane, because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 720B airplane must comply with the fuel vent and exhaust emission requirements of 14 CFR part 24 and the noise certification requirements of 14 CFR part 36.

Special conditions, as defined in 14 CFR 11.19, are issued in accordance with § 11.38 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 Flight Test Associates, Inc., apply at a later date for an STC to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under the provisions of § 21.101.

As noted earlier, the Boeing Model 720B airplane modified by Flight Test Associates, Inc., will incorporate new dual primary altimeters that will perform critical functions. These systems may be vulnerable to HIRF 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 the Boeing Model 720B airplane modified by Flight Test Associates, Inc. These special conditions require that new primary altimeters 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, plus the advent of space and satellite communications coupled with electronic command and control of the airplane, the immunity of critical digital 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 indicated in the following table 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 Boeing Model 720B airplane, modified by Flight Test Associates, Inc. Should Flight Test Associates, Inc., apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well as under the provisions of 14 CFR 21.101.

This action affects only certain design features on the Boeing Model 720B airplane modified by Flight Test Associates, Inc. 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 the special conditions for these airplanes 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 immediately. 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 Boeing Model 720B airplane, modified by Flight Test Associates, Inc:

1. Protection from Unwanted Effects of High-Intensity Radiated Fields (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.

The FAA has determined that notice and opportunity for prior public comment hereon is unnecessary, as 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, the FAA invites interested persons to participate in this rulemaking by submitting 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. The docket is available for public inspection 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 in light of the comments received.

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 February 17, 2005, Flight Test Associates, Inc., of Mojave, California, applied to the FAA, Los Angeles Aircraft Certification Office for a supplemental type certificate (STC) to modify Raytheon Model BH125 Series 400A and 600A airplanes. The proposed modification incorporates the installation of dual Honeywell Model AM-250 digital altimeters as primary instruments. The information presented is flight critical. The altimeters installed in the airplanes have the potential to be vulnerable to high-intensity radiated fields (HIRF) external to the airplanes.

Under the provisions of 14 CFR 21.101, Flight Test Associates, Inc., must show that the airplanes 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 regulations incorporated by reference in Type Certificate No. A3EU include Civil Aeronautics Manual 4b, as amended by Amendments 4b-1 through 4b-11.

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 modified Raytheon Model BH125 Series 400A and 600A airplanes, because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Raytheon Model BH125 Series 400A and 600A airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 24 and the noise certification requirements of 14 CFR part 36.

Special conditions, as defined in 14 CFR 11.19, are issued in accordance with § 11.38 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 Flight Test Associates, Inc., apply at a later date for an STC to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under the provisions of § 21.101.

As noted earlier, the Raytheon Model BH125 Series 400A and 600A airplanes modified by Flight Test Associates, Inc., will incorporate new dual primary altimeters that will perform critical functions. These systems may be vulnerable to HIRF 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 the Raytheon Model BH125 Series 400A and 600A airplanes. These special conditions require that new primary altimeters 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, plus the advent of space and satellite communications coupled with electronic command and control of the airplane, the immunity of critical digital 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 indicated in the following table 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 Raytheon Model BH125 Series 400A and 600A airplanes, modified by Flight Test Associates, Inc. Should Flight Test Associates, Inc., apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well as under the provisions of 14 CFR 21.101.

This action affects only certain design features on the Raytheon Model BH125 Series 400A and 600A airplanes modified by Flight Test Associates, Inc. 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 the special conditions for these airplanes 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 immediately. 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 modified Raytheon Model BH125 Series 400A and 600A airplanes, modified by Flight Test Associates, Inc.:

1. Protection from Unwanted Effects of High-Intensity Radiated Fields (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.

Comments Invited

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, the FAA invites interested persons to participate in this rulemaking by submitting 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. The docket is available for public inspection 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 4:00 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 May 26, 2005, Premier Air Center, 18 Terminal Drive, East Alton, Illinois, 62024, applied for a supplemental type certificate (STC) to modify Dassault-Aviation Mystere-Falcon 50 airplanes. This model is currently approved under Type Certificate No. A46EU. The Dassault-Aviation Mystere-Falcon 50 airplanes are transport category airplanes powered by three Allied Signal TFE-731-3-1C turbine engines with maximum takeoff weights of up to 40,780 pounds. These airplanes operate with a 2-pilot crew and can seat up to 19 passengers. The modification incorporates the installation of Universal Avionics EFI-890 Electronic Flight Displays and Rockwell Collins AHS-3000A Attitude Heading Reference Systems (AHRS). These systems perform critical functions whose failure would prevent the continued safe flight and landing of the airplane. The display and attitude systems that will be 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, Premier Air Center must show that the Dassault-Aviation Mystere-Falcon 50 airplanes, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A46EU, 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 Dassault-Aviation Mystere-Falcon 50 airplanes includes applicable sections of 14 CFR part 25 as amended by Amendment 25-1 through Amendment 25-34, Special Conditions No. 25-86-EU-24, and SFAR 27 as amended by Amendment 27-1. In addition, the certification basis includes certain special conditions, exemptions, equivalent levels of safety, or later amended sections of the applicable part 25 that are not relevant to these special conditions.

If the Administrator finds that the applicable airworthiness regulations (i.e., part 25, as amended) do not contain adequate or appropriate safety standards for Dassault-Aviation Mystere-Falcon 50 airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Dassault-Aviation Mystere-Falcon 50 airplanes 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 in accordance with § 11.38 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 Premier Air Center apply at a later date for a STC to modify any other model included on Type Certificate No. A46EU to incorporate the same or similar novel or unusual design feature, these special conditions would also apply to the other model under the provisions of § 21.101.

As noted earlier, the Dassault-Aviation Mystere-Falcon 50 airplanes modified by Premier Air Center will incorporate Universal Avionics EFI-809 Electronic Flight Displays and Rockwell Collins AHS-3000A AHRS that will perform critical functions. These systems may be vulnerable to high-intensity radiated fields (HIRF) 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 the Dassault-Aviation Mystere-Falcon 50 airplanes modified by Premier Air Center. 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 Dassault-Aviation Mystere-Falcon 50 airplanes modified by Premier Air Center. Should Premier Air Center apply at a later date for a STC to modify any other model included on Type Certificate No. A46EU to incorporate the same or similar novel or unusual design feature, these 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 Dassault-Aviation Mystere-Falcon 50 airplanes modified by Premier Air Center. 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 Dassault-Aviation Mystere-Falcon 50 airplanes modified by Premier Air Center.

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.

Although this is a final rule that was not preceded by notice and an opportunity for public comment, we invite you to submit any relevant written data, views, or arguments regarding this AD. Include “Docket No. FAA-2005-22539; Directorate Identifier 2004-NM-08-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the AD. We will consider all comments received by the closing date and may amend the AD in light of those comments.

We will post all comments we receive, without change, to http://dms.dot.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of that web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78), or you may visit http://dms.dot.gov.

You may examine the AD docket on the Internet at http://dms.dot.gov, or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them.

The Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, notified us that an unsafe condition may exist on certain Airbus Model A330-300 series airplanes. The DGAC advises that, during fatigue tests of the fuselage, cracks initiated and grew at the circumferential joint of frame (FR) 53.3. This condition, if not corrected, could result in reduced structural integrity of the fuselage.

Airbus has issued Service Bulletin A330-53-3127, including Appendix 01, Revision 01, dated November 21, 2003. The service bulletin describes procedures for reinforcing the structure of the center fuselage by installing external doublers (butt straps) at FR53.3 on the fuselage skin between left- and right-hand stringer 13. The installation of the three butt straps includes removing fasteners and doing the related investigative action of rototesting the holes where the fasteners were removed. If a crack is found during a rototest, the service bulletin specifies contacting Airbus for repair instructions. If no crack is found, the installation includes counter-drilling the fastener holes in the butt straps, cold-expanding the matching holes in the fuselage, reaming and deburring the holes, shimming, and applying sealant around the butt straps. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. The DGAC mandated the service information and issued French airworthiness directive F-2003-415, dated November 12, 2003, to ensure the continued airworthiness of these airplanes in France.

These airplane models are manufactured in France and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept the FAA informed of the situation described above. We have examined the DGAC's findings, evaluated all pertinent information, and determined that we need to issue an AD for products of this type design that are certificated for operation in the United States.

Therefore, we are issuing this AD to prevent fatigue cracking of the fuselage, which could result in reduced structural integrity of the fuselage. This AD requires accomplishing the actions specified in the service information described previously.

The applicability of French airworthiness directive F-2003-415, dated November 12, 2003, excludes airplanes on which Airbus Service Bulletin A330-53-3127, Revision 01, has been accomplished in service. However, we have not excluded those airplanes in the applicability of this proposed AD; rather, this proposed AD includes a requirement to accomplish the actions specified in that service bulletin. This requirement would ensure that the actions specified in the service bulletin and required by this proposed AD are accomplished on all affected airplanes. Operators must continue to operate the airplane in the configuration required by this proposed AD unless an alternative method of compliance is approved.

None of the airplanes affected by this action are on the U.S. Register. All airplanes affected by this AD are currently operated by non-U.S. operators under foreign registry; therefore, they are not directly affected by this AD action. However, we consider this AD necessary to ensure that the unsafe condition is addressed if any affected airplane is imported and placed on the U.S. Register in the future.

The following table provides the estimated costs to comply with this AD for any affected airplane that might be imported and placed on the U.S. Register in the future.

No airplane affected by this AD is currently on the U.S. Register. Therefore, providing notice and opportunity for public comment is unnecessary before this AD is issued, and this AD may be made effective in less than 30 days after it is published in the Federal Register .

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that the regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

The Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, notified us that an unsafe condition may exist on all Airbus Model A330-243, -341, -342, and -343 airplanes. The DGAC advises that it has received reports of engine damage to the blades of the first stage of the intermediate pressure compressor (IPC) due to ice accumulation. In one case, an engine shutdown in flight, prompting the flightcrew to divert to the nearest available airport. The other cases resulted in two unplanned engine removals. Investigations have revealed that the engines were damaged due to ground operations in severe ice conditions like extended running times at idle in very low outside air temperature (OAT) and freezing fog. During subsequent take-off, heat transfer combines with variable inlet guide vanes movements and tends to remove ice, which then impacts and damages the blades of the first stage of the IPC. Engine damage due to ice accumulation, if not corrected, could result in an engine shutdown and cause the flightcrew to divert to the nearest available airport.

Airbus has issued Temporary Revision (TR) 4.03.00/24, dated April 2, 2004, to the A330 Airplane Flight Manual (AFM). The TR revises the Normal Procedures section of the AFM to provide the flightcrew with new, ground ice-shedding procedures during long taxi periods in very low OAT and freezing fog. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. The DGAC mandated the service information and issued French airworthiness directive F-2004-081, dated June 9, 2004, to ensure the continued airworthiness of these airplanes in France.

These airplane models are manufactured in France and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept the FAA informed of the situation described above. We have examined the DGAC's findings, evaluated all pertinent information, and determined that we need to issue an AD for products of this type design that are certificated for operation in the United States. Therefore, we are issuing this AD to prevent engine damage due to ice accumulation, which could result in an engine shutdown and cause the flightcrew to divert to the nearest available airport. This AD requires revising the AFM to provide the flightcrew with new, ground ice-shedding procedures specified in the service information described previously.

None of the airplanes affected by this action are on the U.S. Register. All airplanes affected by this AD are currently operated by non-U.S. operators under foreign registry; therefore, they are not directly affected by this AD action. However, we consider this AD necessary to ensure that the unsafe condition is addressed if any affected airplane is imported and placed on the U.S. Register in the future.

If an affected airplane is imported and placed on the U.S. Register in the future, the required actions would take about 1 work hour per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the AD would be $65 per airplane.

No airplane affected by this AD is currently on the U.S. Register. Therefore, providing notice and opportunity for public comment is unnecessary before this AD is issued, and this AD may be made effective in less than 30 days after it is published in the Federal Register .

This AD is a final rule that involves requirements that affect flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any relevant written data, views, or arguments regarding this AD. Send your comments to an address listed in the ADDRESSES section. Include “Docket No. FAA-2005-22563; Directorate Identifier 2004-NM-177-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the AD that might suggest a need to modify it.

We will post all comments we receive, without change, to http://dms.dot.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78), or you may visit http://dms.dot.gov.

You may examine the AD docket on the Internet at http://dms.dot.gov, or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that the regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

The Civil Aviation Authority (CAA), which is the airworthiness authority for the United Kingdom, notified us that an unsafe condition may exist on certain BAE Systems (Operations) Limited Model ATP airplanes. The CAA advises that in-service failures of the bolts attaching the aft isolators to the engine subframe have been reported. Testing has demonstrated that reduced torque loading has an adverse effect on the fatigue life of the bolts attaching the aft isolators to the engine subframe. Failure of all bolts in the bolt group will affect the ability of the engine subframe to control the effects of resonance and whirl flutter. This condition, if not corrected, could result in an engine separating from an airplane.

BAE Systems (Operations) Limited has issued Service Bulletin ATP-54-20, dated July 29, 2003. The service bulletin describes procedures for performing a visual inspection for missing or failed bolts that attach aft isolator brackets to both engine subframes, replacing all four bolts on an engine subframe if any bolt is missing or failed on that engine subframe, and reporting results. The replacement includes doing a torque check of each bolt, checking the dimensions of the bolt holes, and contacting the manufacturer if the holes are not within tolerance. The service bulletin also notes that quick engine change unit subframes should be inspected prior to installation.

The CAA mandated the service information and issued British airworthiness directive G-2004-0001, dated January 22, 2004, to ensure the continued airworthiness of these airplanes in the United Kingdom.

This airplane model is manufactured in the United Kingdom and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the CAA has kept the FAA informed of the situation described above. We have examined the CAA's findings, evaluated all pertinent information, and determined that we need to issue an AD for products of this type design that are certificated for operation in the United States.

Therefore, we are issuing this AD to prevent failure of the bolts attaching the aft isolators to the engine subframe, which may result in an engine separating from the airplane. This AD requires accomplishing the actions specified in the service information described previously, except as discussed under “Differences Among the AD, the Service Bulletin, and the British Airworthiness Directive.”

The service bulletin specifies to contact the manufacturer for instructions if holes are not within tolerance, but this AD would require repairing those conditions using a method that we or the CAA (or its delegated agent) approve. In light of the type of repair that would be required to address the unsafe condition, and consistent with existing bilateral airworthiness agreements, we have determined that, for this AD, a repair we or the CAA approve would be acceptable for compliance with this AD.

The service bulletin refers only to a “visual inspection.” We have determined that the procedures in the service bulletin should be described as a “detailed inspection.” Note 1 has been included in this AD to define this type of inspection.

We consider this AD interim action. If final action is later identified, we may consider further rulemaking then.

None of the airplanes affected by this action are on the U.S. Register. All airplanes affected by this AD are currently operated by non-U.S. operators under foreign registry; therefore, they are not directly affected by this AD action. However, we consider this AD necessary to ensure that the unsafe condition is addressed if any affected airplane is imported and placed on the U.S. Register in the future.

The following table provides the estimated costs to comply with this AD for any affected airplane that might be imported and placed on the U.S. Register in the future.

No airplane affected by this AD is currently on the U.S. Register. Therefore, providing notice and opportunity for public comment is unnecessary before this AD is issued, and this AD may be made effective in less than 30 days after it is published in the Federal Register .

This AD is a final rule that involves requirements that affect flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any relevant written data, views, or arguments regarding this AD. Send your comments to an address listed in the ADDRESSES section. Include “Docket No. FAA-2005-22562; Directorate Identifier 2004-NM-60-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the AD that might suggest a need to modify it.

We will post all comments we receive, without change, to http://dms.dot.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of that web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78), or you may visit http://dms.dot.gov.

You may examine the AD docket on the Internet at http://dms.dot.gov , or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that the regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

The FAA proposed to amend 14 CFR Part 39 with a proposed airworthiness directive (AD). The proposed AD applies to RR RB211 Trent 875, 877, 884, 892, 892B, and 895 series turbofan engines with LPC fan blade P/Ns: FK 30838, FK30840, FK30842, FW12960, FW12961, FW12962, FW13175, FW18548, or FW23552. We published the proposed AD in the Federal Register on February 18, 2005 (70 FR 8303). That action proposed to require repetitive application of DFL to LPC fan blade roots at more frequent intervals than the existing AD. That action also proposed to add the Trent 884B engine to the applicability, to add a fan blade P/N to the affected list of fan blades, and to relax the initial DFL repetitive application compliance time for certain fan blades that have never been removed from the disk.

You may examine the AD Docket (including any comments and service information), by appointment, between 8 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. See ADDRESSES for the location.

We provided the public the opportunity to participate in the development of this AD. We received one comment on the proposal and it was favorable.

We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

There are approximately 388 RR RB211 Trent 875, 877, 884, 884B, 892, 892B, and 895 series turbofan engines of the affected design in the worldwide fleet. We estimate that 106 engines installed on airplanes of U.S. registry will be affected by this AD. We also estimate that it will take approximately six work hours per engine to perform the DFL application, and that the average labor rate is $65 per work hour. Based on these figures, we estimate the total cost of the AD to U.S. operators to perform one repetitive application of DFL to the affected engines to be $41,340.

Paragraph (d) of the current AD, AD 2002-10-15, contains a paragraph pertaining to special flight permits. Even though this final rule does not contain a similar paragraph, we have made no changes with regard to the use of special flight permits to operate the airplane to a repair facility to do the work required by this AD. In July 2002, we published a new Part 39 that contains a general authority regarding special flight permits and airworthiness directives; see Docket No. FAA-2004-8460, Amendment 39-9474 (69 FR 47998, July 22, 2002). Thus, when we now supersede ADs we will not include a specific paragraph on special flight permits unless we want to limit the use of that general authority granted in section 39.23.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866;

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary by sending a request to us at the address listed under ADDRESSES. Include “AD Docket No. 2001-NE-12-AD” in your request.

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that supersedes AD 2001-13-12, amendment 39-12292 (66 FR 34526, June 29, 2001), and AD 2003-08-11, amendment 39-13124 (68 FR 19937, April 23, 2003). AD 2001-13-12 applies to certain Boeing Model 747 series airplanes. AD 2003-08-11 applies to all Boeing Model 747-100, -200B, -200F, -200C, -100B, -300, -100B SUD, -400, -400D, and -400F series airplanes; and Model 747SR series airplanes. That NPRM was published in the Federal Register on April 13, 2005 (70 FR 19345). That NPRM proposed to continue to require the existing requirements of ADs 2001-13-12, and 2003-08-11. For certain airplanes, that NPRM also proposed to require new inspections for discrepancies of the actuator attach fittings of the flaps, and follow-on and corrective actions if necessary, which ends the repetitive inspections of both existing ADs. For all airplanes, that NPRM also proposed to require repetitive overhaul/replacements of the fittings of both the inboard and outboard flaps.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments received.

One commenter, the airplane manufacturer, requests that paragraph (r) of the NPRM be revised to apply to “fittings” instead of “airplanes.” The commenter states that some operators may have complied with paragraph (o)(2) of the NPRM for some fittings, but not others. The commenter also states that the proposed actions in paragraph (r) are not necessary if the proposed actions in paragraph (o)(2) have been done. The commenter also requests that paragraph (r) be revised to clarify this point.

We partially agree. We agree with the commenter to refer to “fittings” rather than “airplanes” in paragraph (r) and have revised the final rule accordingly. However, we do not agree that paragraph (r) needs to be clarified regarding paragraph (o)(2). Although the actions specified in paragraph (o)(2) (refers to Parts 2 through 5 of the Accomplishment Instructions of Boeing Alert Service Bulletin 747-57A2316, dated December 19, 2002) are identical to those in paragraphs (r) and (s), the affected fittings and compliance times in those paragraphs are different.

Paragraph (r) states, “For [fittings] on which * * * the inspections required by [paragraph] (m), (n), or (o)(1) of this AD are being done as of the effective date of this AD.” The actions specified in paragraphs (m), (n), and (o)(1) are done in accordance with Part 1 of the Accomplishment Instructions of the referenced service bulletin. Paragraph (r) does not apply to fittings on which the actions specified in paragraph (o)(2) ( i.e. , Parts 2 through 5) are being done. Operators doing the actions specified in paragraph (o)(2) instead of the actions specified in paragraph (o)(1), must continue to do those actions at the specified times in paragraph (o)(2). Operators doing the actions in paragraph (o)(1) of this AD as of the effective date of this AD, must do the requirements of paragraph (r). We have made no change to the final rule in this regard.

The same commenter notes that paragraph (t) of the NPRM states, “at the applicable time specified in Figures 1 and 2 of the service bulletin.” The commenter requests that the reference to Figure 2 in that paragraph be deleted, because Figure 2 does not specify compliance times.

We agree and have revised paragraph (t) accordingly.

Based on the comment above that fittings may be overhauled at different times, we have clarified the terminating action in paragraphs (j)(1) and (j)(2) of the NPRM. Overhauling an actuator attach fitting on an applicable flap constitutes terminating action for the repetitive inspection requirements for that fitting. The remaining fittings that are not being repetitively overhauled must be repetitively inspected. Therefore, we have revised paragraphs (j)(1) and (j)(2) of this AD accordingly.

Paragraph (r) of the NPRM applies to fittings on which the repetitive borescopic, detailed, “or” ultrasonic (as applicable) inspections required by paragraph (m), (n), or (o)(1) of this AD are being done as of the effective date of this AD. Paragraph (m) of the NPRM proposed to require both borescopic and detailed inspections. Paragraph (n) of the NPRM proposed to require borescopic, detailed, and ultrasonic inspections. Paragraph (o)(1) of the NPRM proposed to require applicable inspections specified in paragraphs (m) and (n). It was our intent that paragraph (r) apply to fittings on which the repetitive borescopic, detailed, “and” ultrasonic (as applicable) inspections required by paragraph (m), (n), or (o)(1) of this AD are being done as of the effective date of this AD. Therefore, we have revised paragraph (r) accordingly.

Boeing Commercial Airplanes has received a Delegation Option Authorization (DOA). We have revised this AD to delegate the authority to approve an alternative method of compliance for any repair required by this AD to an Authorized Representative for the Boeing Commercial Airplanes DOA rather than a Designated Engineering Representative.

Although paragraph (s) of the NPRM states, “except as provided by paragraph (u) of this AD,” paragraph (u) does not refer to paragraph (s). We have corrected this mistake in this AD.

Although paragraph (t) of the NPRM states, “except as provided by paragraph (v) of this AD,” paragraph (v) incorrectly refers to paragraph (s) rather than paragraph (t). In addition, paragraph (t) states, “If any discrepancy is detected during any inspection required by paragraph (r) * * *” The requirements of paragraph (t) also are required if any discrepancy is detected during an inspection required by paragraph (s), as specified in Boeing Alert Service Bulletin 747-57A2316, described in the preamble of the NPRM. We have corrected these mistakes in this AD.

We have added a new paragraph (y)(2) and renumbered subsequent paragraphs to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies.

We have carefully reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

This AD will affect about 1,000 Model 747-100, -200B, -200F, -200C, -100B, -300, -100B SUD, -400, -400D, and -400F series airplanes; and Model 747SR series airplanes worldwide. There are about 181 airplanes on the U.S. registry. The average labor rate is $65 per hour. The following two tables provide the estimated costs for U.S. operators to comply with this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866;

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

On August 3, 2005, the FAA proposed to amend 14 CFR parts 71 by modifying the Class E airspace area at Hana Airport, HI (05 FR 15314). Additional controlled airspace extending upward from 700 feet or more above the surface is needed to contain aircraft executing the RNAV (GPS) (RWY) 26 IAP and RNAV DP at Hana Airport, Hana, HI. This action will provide adequate controlled airspace for aircraft executing the RNAV (GPS) (RWY) 26 IAP and RNAV DP at Hana Airport, Hana, HI.

Interested parties were invited to participate in this rulemaking, proceeding by submitting written comments on the proposal to the FAA. No comments to the proposal were received. Class E airspace designations for airspace extending from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9N, dated August September 1, 2005, and effective September 16, 2005, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This amendment to 14 CFR part 71 modifies the Class E airspace area at Hana Airport, HI. The establishment of a RNAV (GPS) (RWY) 26 IAP and RNAV DP at Hana Airport has made this action necessary. The effect of this action will provide adequate airspace for aircraft executing the RNAV (GPS) (RWY) 26 IAP and RNAV DP at Hana Airport, Hana, HI.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976 (the amendments), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR part 807 of FDA's regulations.

Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing such classification (section 513(f)(2) of the act).

In accordance with section 513(f)(1) of the act, FDA issued an order on April 1, 2005, classifying the Wako LBA (liquid-phase binding assay) AFP-L3 in class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device that was subsequently reclassified into class I or class II. On April 6, 2005, Wako Chemical USA, Inc., submitted a petition requesting classification of the Wako AFP-L3 Test System under section 513(f)(2) of the act. The manufacturer recommended that the device be classified into class II.

In accordance with 513(f)(2) of the act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in 513(a)(1) of the act. Devices are to be classified into class II if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA determined that the Wako LBA AFP-L3 Test System can be classified into class II with the establishment of special controls. FDA believes these special controls will provide reasonable assurance of the safety and effectiveness of the device.

The device is assigned the generic name AFP-L3% immunological test system and it is identified as an in vitro device that consists of reagents and an automated instrument used to quantitatively measure, by immunochemical techniques, AFP and AFP-L3 subfraction in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma, in conjunction with other laboratory findings, imaging studies, and clinical assessment.

FDA has identified the risks to health associated with this type of device as inappropriate risk assessment and improper patient management. Failure of the system to perform as indicated, or error in interpretation of results, could lead to inappropriate risk assessment and improper management of patients with chronic liver diseases. Specifically, a falsely low AFP-L3% could result in a determination that the patient is at a lower risk of developing hepatocellular carcinoma, which could delay appropriate monitoring and treatment. A falsely high AFP-L3% could result in a determination that the patient is at a higher risk for hepatocellular carcinoma, which could lead to unnecessary evaluation and testing, or inappropriate treatment decisions. Use of assay results without consideration of other laboratory findings, imaging studies, and clinical assessment could also pose a risk.

The class II special controls guidance document aids in mitigating potential risks by providing recommendations on validation of performance characteristics, including software validation, control methods, reproducibility, and clinical studies. The guidance document also provides information on how to meet premarket (510(k)) submission requirements for the device. FDA believes that following the recommendations in the class II special controls guidance document generally addresses the risks to health identified in the previous paragraph.

Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for an AFP-L3% immunological test system will need to address the issues covered in the special controls guidance. However, the firm need only show that its device meets the recommendations of the guidance, or in some other way provides equivalent assurance of safety and effectiveness.

Section 510(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under 510(k) of the act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device and, therefore, the type of device is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the AFP-L3% immunological test system they intend to market.

The agency has determined under 21 CFR 25.34(b) that this action is of type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action as defined by the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because classification of this device into class II will relieve manufacturers of the device of the cost of complying with the premarket approval requirements of section 515 of the act (21 U.S.C. 360e), and may permit small potential competitors to enter the marketplace by lowering their costs, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202 (a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $115 million, using the most current (2003) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies 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. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

FDA tentatively concludes that this proposed rule contains no collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3502) is not required.

FDA also tentatively concludes that the special controls guidance document identified by this rule contains information collection provisions that are subject to review and clearance by OMB under the PRA. Elsewhere in this issue of the Federal Register , FDA is publishing a notice announcing the availability of the draft guidance document entitled “Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems.”

The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

The final regulations (TD 9223) that are the subject of this correction are under sections 402(a), 79 and 83 of the Internal Revenue Code.

As published, TD 9223 contains an error that may prove to be misleading and is in need of clarification.

Accordingly, the publication of the final regulations (TD 9223) which was the subject of FR Doc. 05-17046, is corrected as follows:

On page 50969, column 2, in the preamble, under the paragraph heading “ B. The 2004 Proposed Regulations ”, line 2 from the top of the column, the language “§ 1.79-(d) to replace the term “cash” is corrected read “§ 1.79-1(d) to replace the term “cash”.

Throughout this document wherever “we,” “us,” or “our” are used we mean the EPA.

Section 129 of the CAA requires us to develop new source performance standards (NSPS) and emission guidelines (EG) for the control of certain designated pollutants which includes these categories addressed in today's action: sulfuric acid mist emissions from sulfuric acid plants, fluoride emissions from phosphate fertilizer plants and total reduced sulfur emissions from kraft pulp mills. Such standards shall include emissions limitations and other requirements applicable to new units and guidelines required by section 111(d) of the CAA.

Section 111(d) of the CAA requires states to submit plans to control certain pollutants (designated pollutants) at existing facilities (designated facilities) whenever standards of performance have been established under section 111(b) for new sources of the same type, and EPA has established emission guidelines for such existing sources. A designated pollutant is “any air pollutant, emissions of which are subject to a standard of performance for new stationary sources but for which air quality criteria have not been issued, and which is not included on a list published under section 108(a) or section 112(b)(1)(A) of the CAA.” 40 CFR 60.21(a).

Section 129(b) of the CAA also requires us to develop an EG for the control of certain designated pollutants. Under section 129 of the CAA, the EG is not federally enforceable. Section 129(b)(2) requires states to submit State Plans to EPA for approval. State Plans must be at least as protective as the EG, and they become federally enforceable upon EPA approval.

The status of our approvals of State plans for designated facilities (often referred to as “111(d) plans” or “111(d)/129 plans”) is given in separate subparts in 40 CFR part 62, “Approval and Promulgation of State Plans for Designated Facilities and Pollutants.” The Federal plan requirements for the control of certain designated pollutants are also codified in separate subparts at the end of part 62.

Procedures and requirements for development and submission of state plans for controlling designated pollutants are given in 40 CFR part 60, “Standards of Performance for New Stationary Sources,” subpart B, “Adoption and Submittal of State Plans for Designated Facilities” and in 40 CFR part 62, subpart A, “General Provisions.” If a State does not have any existing sources of a designated pollutant located within its boundaries, 40 CFR 62.06 provides that the State may submit a letter of certification to that effect, or negative declaration, in lieu of a plan. The negative declaration exempts the State from the requirements of 40 CFR part 60, subpart B, for that designated facility. In the event that a designated facility is located in a State after a negative declaration has been approved by EPA, 40 CFR 62.13 requires that the Federal plan for the designated facility, as required by section 129 of the CAA and 40 CFR 62.02(g), will automatically apply to the facility.

This Federal Register action approves negative declarations submitted by the City of Albuquerque (Bernalillo County), New Mexico for the following: sulfuric acid mist emissions from sulfuric acid plants, fluoride emissions from phosphate fertilizer plants and total reduced sulfur emissions from kraft pulp mills.

The Albuquerque Environmental Health Department submitted letters dated November 23, 2004, certifying that there are no existing sulfuric acid mist emissions from sulfuric acid plants, no existing fluoride emissions from phosphate fertilizer plants and no existing total reduced sulfur emissions from kraft pulp mills, under its jurisdiction in the City of Albuquerque and Bernalillo County, New Mexico (excluding tribal lands). These negative declarations meet the requirements of 40 CFR 62.06.

We are removing the 40 CFR 62.7881, “Identification of sources—negative declaration” and the centered heading “Emissions From Existing Commercial and Industrial Solid Waste Incineration Units” immediately before § 62.7881, because this is a duplicate of the negative declaration in §62.7890(b).

The EPA published in the Federal Register on January 10, 2005 (70 FR 1668), a document approving a negative declaration submitted by the City of Albuquerque (Bernalillo County), New Mexico, which certified that there are no existing commercial and industrial solid waste incineration units in Bernalillo County. The January 10, 2005, Federal Register action added a new undesignated center heading “Emissions From Existing Commercial and Industrial Solid Waste Incineration (CISWI) Units” followed by a new § 62.7881, “Identification of sources—negative declaration.” We later discovered that there was already a centered heading in Subpart GG entitled “Emissions From Existing Commercial and Industrial Solid Waste Incineration (CISWI) Units” that had been added when we approved the CISWI negative declaration for the State of New Mexico in § 62.7890 on June 13, 2003 (68 FR 35299). On June 27, 2005 (70 FR 36849) we partially corrected the error by revising § 62.7890 to include the Bernalillo County CISWI negative declaration codified in § 62.7881. However the June 27, 2005, correction failed to remove § 62.7881 and the centered heading immediately before it. This Federal Register action corrects this oversight by removing § 62.7881 and the centered heading “Emissions From Existing Commercial and Industrial Solid Waste Incineration (CISWI) Units” immediately before § 62.7881.

We are approving negative declarations submitted by the City of Albuquerque Environmental Health Department certifying that there are no existing sulfuric acid mist emissions from sulfuric acid plants, no existing fluoride emissions from phosphate fertilizer plants, and no existing total reduced sulfur emissions from kraft pulp mills, under its jurisdiction in the City of Albuquerque/Bernalillo County (excluding tribal lands).

If a designated facility is later found within any noted jurisdiction after publication of this Federal Register action, then the overlooked facility will become subject to the requirements of the Federal plan for that designated facility, including the compliance schedule. The Federal plan will no longer apply, if we subsequently receive and approve the 111(d)/129 plan from the jurisdiction with the overlooked facility.

Since the City of Albuquerque has not submitted a demonstration of authority over “Indian Country,” (as defined in 18 U.S.C. 1151) we are limiting our approval to those areas that do not constitute Indian Country. Under this definition, EPA treats as reservations, trust lands validly set aside for the use of a tribe even if the trust lands have not been formally designated as a reservation. Any existing designated facility that may exist on “Indian Country” is subject to the Federal plan for the designated facility. See 40 CFR 62.13.

The EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial action and anticipates no adverse comments. However, in the “Proposed Rules” section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve these rules should relevant adverse comments be filed. This action will be effective December 5, 2005 unless EPA receives adverse written comments by November 3, 2005.

If EPA receives such comments, then it will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. All public comments received will then be addressed in a subsequent direct final rule based on the proposed rule. The EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on December 5, 2005 and no further action will be taken on the proposed rule.

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 5, 2005. Filing a petition for reconsideration by the Administrator of this direct final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (See 42 U.S.C. 7607(b)(2)).

Throughout this document wherever “we,” “us,” or “our” are used we mean the EPA.

The Environmental Protection Agency (EPA) is approving sections 111(d) and 129 of the State Plan submitted by the Oklahoma Department of Environmental Quality (ODEQ) on June 29, 2005. The State Plan establishes emission limits, monitoring, operating, and recordkeeping requirements for commercial and industrial solid waste incinerator (CISWI) units for which construction commenced on or before November 30, 1999. This State Plan implements and enforces provisions at least as protective as the Federal Emission Guidelines (EGs) applicable to existing CISWIs. The State Plan becomes federally enforceable upon EPA's approval.

Sections 111(d) and 129 of the Clean Air Act (CAA) require states to submit plans to control certain pollutants (designated pollutants) at existing solid waste combustor facilities (designated facilities) whenever standards of performance have been established under section 111(b) for new sources of the same type, and EPA has established emission guidelines (EG) for such existing sources. A designated pollutant is any pollutant for which no air quality criteria have been issued, and which is not included on a list published under section 108(a) or section 112(b)(1)(A) of the CAA, but emissions of which are subject to a standard of performance for new stationary sources. However, section 129 of the CAA, also requires EPA to promulgate EG for commercial and industrial solid waste incineration (CISWI) units that emit a mixture of air pollutants. These pollutants include organics (dioxins/furans), carbon monoxide, metals (cadmium, lead, mercury), acid gases (hydrogen chloride, sulfur dioxide, and nitrogen oxides) and particulate matter (including opacity). On December 1, 2000 (65 FR 75338), EPA promulgated CISWI unit new source performance standards and the EG, 40 CFR part 60, subparts CCCC and DDDD, respectively. The designated facility to which the EGs apply is each existing CISWI unit, as defined in subpart DDDD, that commenced construction on or before November 30, 1999.

Section 111(d) of the Clean Air Act (CAA) requires that “designated” pollutants, regulated under standards of performance for new stationary sources by section 111(b) of the CAA, must also be controlled at existing sources in the same source category to a level stipulated in an emission guideline (EG) document. Section 129 of the CAA specifically addresses solid waste combustion and emissions controls based on what is commonly referred to as “maximum achievable control technology” (MACT). Section 129 requires EPA to promulgate a MACT based emission guidelines document for CISWI units, and then requires states to develop plans that implement the EG requirements.

The CISWI EG under 40 CFR part 60, subpart DDDD, establishes emission and operating requirements under the authority of the sections 111(d) and 129 of the CAA. States must also include in their State Plans other elements, such as inventories, legal authority, and public participation documentation, to demonstrate their ability to enforce the State Plans. These requirements must be incorporated into a State plan that is “at least as protective” as the EG, and is federally enforceable upon approval by EPA. The procedures for adoption and submittal of State plans are codified in 40 CFR part 60, subpart B.

When burned, commercial and industrial solid wastes emit various air pollutants, including hydrochloric acid, dioxin/furan, toxic metals (lead, cadmium, and mercury) and particulate matter. Mercury is highly hazardous and is of particular concern because it persists in the environment and bioaccumulates through the food web. Serious developmental and adult effects in humans, primarily damage to the nervous system, have been associated with exposures to mercury. Harmful effects in wildlife have also been reported; these include nervous system damage and behavioral and reproductive deficits. Human and wildlife exposure to mercury occur mainly through eating of fish. When inhaled, mercury vapor attacks also the lung tissue and is a cumulative poison. Short-term exposure to mercury in certain forms can cause hallucinations and impair consciousness. Long-term exposure to mercury in certain forms can affect the central nervous system and cause kidney damage.

Exposure to particulate matter can aggravate existing respiratory and cardiovascular disease and increase risk of premature death. Hydrochloric acid is a clear colorless gas. Chronic exposure to hydrochloric acid has been reported to cause gastritis, chronic bronchitis, dermatitis, and photosensitization. Acute exposure to high levels of chlorine in humans may result in chest pain, vomiting, toxic pneumonitis, pulmonary edema, and death. At lower levels, chlorine is a potent irritant to the eyes, the upper respiratory tract, and lungs.

Exposure to dioxin and furan can cause skin disorders, cancer, and reproductive effects such as endometriosis. These pollutants can also affect the immune system.

The EPA proposed the EGs in the Federal Register on November 30, 1999. (64 FR 67092). On December 1, 2000, EPA finalized the EGs at 65 FR 75338. The EGs are also found at 40 CFR part 60, subpart DDDD.

EGs are not federally enforceable. Section 129(b)(2) of the CAA requires states to submit State Plans to EPA for approval. Each state must show that its State Plan will carry out and enforce the EGs. State Plans must be at least as protective as the EGs, and they become federally enforceable upon EPA's approval. The procedures for adopting and submitting State Plans are in 40 CFR part 60, subpart B.

The State of Oklahoma submitted its sections 111(d) and 129 State Plan to EPA for approval on June 29, 2005. The State adopted the EG requirements of 40 CFR part 60, subpart DDDD by incorporation by reference (IBR) into the Oklahoma Administrative Code (OAC 252:100-17, Part 9) on April 21, 2003. The State Plan also included a demonstration of the State's legal authority to carry out the plan, inventory of sources and emissions, evidence of a public hearing on the State Plan, and provisions for submission of progress reports to EPA.

EPA has evaluated the CISWI State Plan submitted by Oklahoma for consistency with the Act, EPA guidelines and policy. EPA has determined that Oklahoma's State Plan meets all requirements and therefore, EPA is approving Oklahoma's Plan to implement and enforce the EGs as it applies to existing CISWIs.

EPA's approval of Oklahoma's State Plan is based on our findings that: (1) ODEQ provided adequate public notice of public hearings for the proposed rulemaking that allows Oklahoma to carry out and enforce provisions that are at least as protective as the EGs for CISWIs; and (2) ODEQ demonstrated legal authority to: adopt emission standards and compliance schedules applicable to the designated facilities; enforce applicable laws, regulations, standards and compliance schedules; seek injunctive relief; obtain information necessary to determine compliance; require recordkeeping; conduct inspections and tests; require the use of monitors; require emission reports of owners and operators; and make emission data publicly available.

A detailed discussion of EPA's evaluation of the State Plan is included in the technical support document (TSD) located in the public rulemaking file for this action and available from the EPA contact listed in the Public Participation section of this document.

All CISWIs that commenced construction on or before November 30, 1999 must comply with these requirements.

The following incinerator source categories are exempt from the federal requirements for CISWIs:

(1) Pathological waste incineration units;

(2) Agricultural waste incineration units;

(3) Municipal waste combustion units;

(4) Hospital/medical/infectious waste incineration units;

(5) Small power production facilities;

(6) Cogeneration facilities;

(7) Hazardous waste combustion units;

(8) Materials recovery units;

(9) Air curtain incinerators;

(10) Cyclonic barrel burners;

(11) Rack, part, and drum reclamation units;

(12) Cement kilns;

(13) Sewage sludge incinerators;

(14) Chemical recovery units; and

(15) Laboratory analysis units.

Please refer to 40 CFR 60.2555 for specific definitions of these incinerator source categories, and any recordkeeping or other requirements that still may need to be met.

A state's section 111(d) plan must include a compliance schedule that owners and operators of affected CISWI units must meet in complying with the requirements of the plan. 40 CFR 60.2535 indicates that final compliance should be achieved as expeditiously as practicable after EPA approval of the state plan but no later than December 1, 2005 or three years after the effective date of the state plan approval, whichever is sooner. If the owner or operator of a CISWI unit plans to achieve compliance more than one year following the effective date of the state plan approval, then two increments of progress must be met, which are; submit a final control plan; and achieve final compliance. Section 252:100-17-75 of the Oklahoma Administrative Code includes the increments of progress and the dates by which those increments must be met, which are, submit a final control plan by January 1, 2004 and achieve final compliance with the emission limitations and other requirements by December 1, 2005.

EPA has evaluated the CISWI plan submitted by the state of Oklahoma for consistency with the CAA, EPA emission guidelines and policy. EPA has determined that Oklahoma's Plan meets all requirements and, therefore, EPA is approving Oklahoma's Plan to implement and enforce subpart DDDD, as promulgated on December 1, 2000, applicable to existing CISWI units that have commenced construction on or before November 30, 1999. EPA is also approving revisions to OAC 252:100-17, Part 9 Regulations for the Control of Atmospheric Pollution, entitled, “Definitions” and “Incineration,” respectively.

EPA is publishing this approval action without prior proposal because the Agency views this as a noncontroversial action and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the State Plan should relevant adverse comments be filed. If EPA receives no significant, material, and adverse comments by November 3, 2005, this action will be effective on December 5, 2005.

If we receive adverse comments, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

EPA is committed to ensuring public access to the information that is used to inform the Agency's decisions regarding the environment and human health and to ensuring that the public has an opportunity to participate in the Agency's decision process. The official public rulemaking file consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. The public rulemaking file does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute, although such information is a part of the administrative record for this action. The public rulemaking file is the collection of materials that is available for public viewing at the Regional Office. The administrative record is the collection of material used to inform the Agency's decision on this rulemaking action.

1. An official public rulemaking file available for inspection at the Regional Office. The Regional Office has established an official public rulemaking file for this action under R06-OAR-2005-OK-0004. The public rulemaking file is available for viewing at the Air Planning Section, U.S. Environmental Protection Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733. EPA requests that, if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section two working days in advance to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4 p.m. excluding federal Holidays.

2. Copies of the State submittal. Copies of the State submittal is also available for public inspection during official business hours, by appointment at the Oklahoma Department of Environmental Quality, 707 N. Robinson, Oklahoma City, Oklahoma 73101-1677.

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

The E Government Act of 2002 states that to “to the extent practicable” agencies shall accept electronic comments and establish electronic dockets. Also, President Bush's management plan for government includes a government-wide electronic rulemaking system. The first phase of the eRulemaking initiative was the development a federal portal that displays all Federal Register notices and proposed rules open for comment. The URL for this site is http://www.regulations.gov . The site also provides the public with the ability to submit electronic comments that then can be transferred to the Agency responsible for the rule.

EPA's policy is to make all comments it receives, whether submitted electronically or on paper, available for public viewing at the Regional Office as EPA receives them and without change. However, those portions of a comment that contain properly identified and claimed CBI or other information whose disclosure is restricted by statute will be excluded from the public rulemaking file. The entire comment, including publicly restricted information, will be included in the administrative record for this action.

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Section I.D, below. Do not use e-mail to submit CBI or information protected by statute.

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

i. E-mail. Comments may be sent by electronic mail (e-mail) to boyce.kenneth@epa.gov , Attention “Public comment on proposed rulemaking R06-OAR-2005-OK-0004”. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the Docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

ii. Regulations.gov. As an alternative to email, you may submit comments electronically to EPA by using the federal Web-based portal that displays all Federal Register notices and proposed rules open for comment. To use this method, access the Regulations.gov Web site at http://www.regulations.gov , then select “Environmental Protection Agency” at the top of the page and click on the “Go” button. The list of current EPA actions available for comment will be displayed. Select the appropriate action and please follow the online instructions for submitting comments. Unlike EPA's e-mail system, the Regulations.gov Web site is an “anonymous” system, which means EPA will not know your identity, e-mail address, or other contact information, unless you provide it in the text of your comment.

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

2. By Mail. Send your comments to: Kenneth Boyce, Air Planning Section (6PD-L), Multimedia Planning and Permitting Division, U.S. Environmental Protection Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733. Please include the text “Public comment on proposed rulemaking R06-OAR-2005-OK-0004” in the subject line of the first page of your comments.

3. By Hand Delivery or Courier. Deliver your written comments or comments on a disk or CD ROM to: Kenneth Boyce, Air Planning Section (6PD-L), Multimedia Planning and Permitting Division, U.S. Environmental Protection Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733, Attention “Public comment on proposed rulemaking R06-OAR-2005-OK-0004”. Such deliveries are only accepted during official hours of business, which are Monday through Friday, 8:30 a.m. to 4 p.m., excluding federal Holidays.

For comments submitted to the Agency by mail or hand delivery, in either paper or electronic format, you may assert a business confidentiality claim covering confidential business information (CBI) included in your comment by clearly marking any part or all of the information as CBI at the time the comment is submitted to EPA. CBI should be submitted separately, if possible, to facilitate handling by EPA. Submit one complete version of the comment that includes the properly labeled CBI for EPA's official docket and one copy that does not contain the CBI to be included in the public docket. If you submit CBI on a disk or CD ROM, mark on the outside of the disk or the CD ROM that it contains CBI and then identify the CBI within the disk or CD ROM. Also submit a non-CBI version if possible. Information which is properly labeled as CBI and submitted by mail or hand delivered will be disclosed only in accordance with procedures set forth in 40 CFR part 2. For comments submitted by EPA's e-mail system or through Regulations.gov, no CBI claim may be asserted. Do not submit CBI to Regulations.gov or via EPA's e-mail system. Any claim of CBI will be waived for comments received through Regulations.gov or EPA's e-mail system. For further advice on submitting CBI to the Agency, contact the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice.

It is important to note that the comments you provide to EPA will be publicly disclosed in a rulemaking docket or on the internet. The comments are made available for public viewing as EPA receives them and without change. Any personal information you choose to include in your comment will be included in the docket. However, EPA will exclude from the public docket any information labeled confidential business information (CBI), copyrighted material or other information restricted from disclosure by statute.

Comments submitted via Regulations.gov will not collect any personal information, e-mail addresses, or contact information unless they are included in the body of the comment. Comments submitted via Regulations.gov will be submitted anonymously unless you include personal information in the body of the comment. Please be advised that EPA cannot contact you for any necessary clarification if technical difficulties arise unless your contact information is included in the body of comments submitted through Regulations.gov. However, EPA's e-mail system is not an anonymous system. E-mail addresses are automatically captured by EPA's e-mail system and included as part of your comment that is placed in the public rulemaking docket.

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

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

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

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

5. Provide specific examples to illustrate your concerns.

6. Offer alternatives.

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

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

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 5, 2005. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Entities potentially affected by this action are generators of industrial hazardous waste, and entities that treat, store, transport and/or dispose of these wastes. The table below is not intended to be exhaustive, but rather provides a guide for readers regarding the types of entities likely to be affected by this action.

This table lists the types of entities that EPA believes could be affected by this action, based on industrial sectors identified in the “Economics Background Document” in support of this rule. A total of about 3,266 to 10,446 entities are expected to benefit from the revisions to 40 CFR 261.3 in the 32 industrial sectors listed above, but primarily in the chemicals and allied products sector ( i.e. , SIC code 28, or NAICS code 325). Other entities not listed in the table also could be affected. To determine whether your facility is covered by this action, you should examine 40 CFR part 261 carefully in concert with the final rules found at the end of this Federal Register announcement. If you have questions regarding the applicability of the action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

The information in this preamble is organized as follows:

These rules are promulgated under the authority of Sections 2002(a), 3001, 3002, 3004 and 3006 of the Solid Waste Disposal Act of 1970, as amended by the Resource Conservation and Recovery Act of 1976 (RCRA), 42 U.S.C. 6912(a), 6921, 6922, 6924, 6938.

The current wastewater treatment exemptions (“headworks rule”) under 40 CFR 261.3(a)(2)(iv)(A)-(G) exempt from the mixture rule spent solvents, commercial chemical products, lab wastes, and certain additional listed wastes which are a minuscule and treatable part of the mix in wastewaters. The “mixture rule” dictates that a solid waste becomes regulated as a hazardous waste if it is mixed with one or more listed hazardous waste (40 CFR 261.3(a)(2)(iv)). The rationale for these exemptions is the risk to the environment would be negligible because wastewater treatment systems are capable of easily and effectively handling small volumes of these organic constituents. After the promulgation of the original headworks rule (46 FR 56582, November 17, 1981), the Agency listed four additional solvents (1,1,2-trichloroethane, benzene, 2-nitropropane, and 2-ethoxyethanol) in the F002 and F005 categories (51 FR 6537, February 25, 1986). However, at the time, the Agency did not determine whether or not to add these solvents to the headworks rule exemptions.

In August 1999, EPA received a request from the American Chemistry Council (ACC, formerly the Chemical Manufacturers Association) to add 1,1,2-trichloroethane, benzene, 2-nitropropane, and 2-ethoxyethanol to the headworks exemption. ACC also asked the Agency to allow direct monitoring as an alternative method for determining compliance with the headworks rule. Other ACC-requested headworks rule changes included allowing those wastes listed in 40 CFR 261.31 and 261.32 to be added to the de minimis exemption and expanding the headworks rule to include certain landfill leachates. EPA included a request for comment in the November 19, 1999, proposed Hazardous Waste Identification Rule (HWIR) (64 FR 63382) on these and other ACC-suggested exemptions to the mixture and derived-from rules. Many of the changes in the April 8, 2003, proposed rule (68 FR 17234) are an outgrowth of ACC's suggested revisions and the public comments that EPA received in response to the discussion of these suggested revisions in the 1999 HWIR proposal.

These final regulations will become effective November 3, 2005.

On April 8, 2003, we proposed to add to the headworks exemption two of the four solvents that were listed in 1986 (68 FR 17234). Benzene was proposed to be added at the level of 1 part per million (ppm) with these conditions: wastewaters containing benzene are managed in aerated biological waste management units; and, surface impoundments used prior to secondary clarification are lined (40 CFR 261.3(a)(2)(iv)(A)). The addition of these contingent management practices was supported by data from the groundwater pathway human health risk analysis which demonstrated that non-aerated treatment scenarios resulted in exposures above the level of concern for all components of the treatment scenario and that aerated biological treatment scenarios resulted in exposures above the level of concern only when primary clarifier wastewaters were managed in an unlined surface impoundment. (See Risk Assessment to Support the Wastewater Treatment Exemptions (Headworks Exemptions) Proposed Rule, U.S. EPA 2003).

In addition, we proposed to add 2-ethoxyethanol to the headworks exemption at the level of 25 ppm (40 CFR 261.3(a)(2)(iv)(B)). Data from the groundwater pathway human health risk analysis supported this proposed addition of 2-ethoxyethanol at 25 ppm in the headworks as it posed no significant human health risk at this level. (See Risk Assessment to Support the Wastewater Treatment Exemptions (Headworks Exemptions) Proposed Rule, U.S. EPA 2003).

The Agency did not take any action to add 2-nitropropane and 1,1,2-trichloroethane to the exemption due to the lack of available risk information and the failures in the groundwater pathway human health risk analysis, respectively.

The Agency proposed to add an additional approach for facilities to demonstrate compliance with 40 CFR 261.3(a)(2)(iv)(A), (B), (F) and (G) of the wastewater treatment exemptions. The additional method is an option to directly measure solvent chemical levels at the headworks of the wastewater treatment system in lieu of performing mass balance calculations. Direct monitoring will be an option for those facilities subject to Clean Air Act (CAA) regulations that minimize fugitive process or wastewater emissions ( e.g. , MACT standards under 40 CFR part 61 or 63 or NSPS requirements under 40 CFR part 60). Facilities taking advantage of the proposed direct monitoring approach will be required to report the entire concentration of the chemical in question if any of it was used as a solvent.

The proposed addition of direct monitoring as a headworks compliance monitoring method required the Agency to address a number of implementation issues not associated with the mass balance approach. To ensure facilities utilizing the direct monitoring method will understand where in the wastewater treatment train sampling is to occur, the Agency provided guidance describing the headworks location in the proposal (67 FR 17242, April 8, 2003). This guidance mirrors the language in the 1981 preamble and provides maximum flexibility by accommodating the numerous facility configurations present in the regulated community.

The Agency also proposed that facilities taking advantage of the direct monitoring approach are to develop a site-specific sampling and analysis plan that demonstrates compliance with the weekly average standards set for the appropriate solvent(s). The sampling and analysis plan must include the monitoring point location, the sampling frequency and methodology, and a list of appropriate constituents to be monitored. The Agency proposed that facilities file a copy of the sampling and analysis plan with the overseeing agency. However, no approval of the plan is required prior to the commencement of the direct monitoring method; nevertheless, the facility must have confirmation of the plan's receipt ( e.g. , a certified mail return receipt or written confirmation of delivery from a commercial delivery service) by the overseeing agency prior to implementation of the direct monitoring scheme.

The Agency proposed to add those scrubber waters derived-from the combustion of spent solvents that are then subsequently sent to a facility's wastewater treatment system to the headworks exemption. The Agency believes that the scrubber waters derived-from combustion of spent solvent wastes will be comparable in expected constituents and concentration levels with spent solvent wastewaters.

The Agency discussed the ACC request to consider adding leachate from landfills that accept only F001-F005 spent solvent wastes to the headworks exemption. Because we lacked sufficient data concerning the variability, the Agency did not propose an exemption but considered the discussion of the issue as an Advanced Notice of Proposed Rulemaking.

The Agency also discussed and sought comment regarding a possible future addition of leachate from captive, on-site hazardous waste landfills to the headworks exemption. Again, because EPA lacked adequate information to determine if the levels of constituents present in the leachate pose an unacceptable risk, it did not propose an exemption for non-solvent leachate.

The Agency proposed to broaden the scope of the de minimis exemption (40 CFR 261.3(a)(2)(iv)(D)) in two ways: (1) By expanding the eligibility for the exemption beyond manufacturing facilities to include non-manufacturing sites such as raw material storage terminals and hazardous waste facilities; and, (2) by expanding the types of waste eligible for the exemption to include the F- and K-listed wastes (§§ 261.31 and 261.32). To qualify for the newly expanded portions of the de minimis exemption, we also proposed that either the manufacturing facilities claiming a de minimis loss of F- or K-listed wastes or non-manufacturing facilities claiming a de minimis loss of waste listed in §§ 261.31 through 261.33 would need to have limits for the Appendix VII and Land Disposal Restrictions (LDR) constituents associated with their wastes included in their Clean Water Act (CWA) permits or that the facilities had to have eliminated the discharge of wastewater altogether.

In addition, the Agency proposed that the words “unscheduled,” “uncontrollable,” “inadvertent,” and “insignificant” be added to the regulatory definition. The reasoning behind the addition of these words was to provide a clearer understanding of what a de minimis release is for all the listed wastes.

In the April 8, 2003, notice, EPA proposed to include in the exemption under § 261.3(a)(2)(iv)(A) and (B) those scrubber waters derived-from the combustion of spent solvents that then are sent to a facility's wastewater treatment system. However, specific regulatory language for the inclusion of these scrubber waters in the headworks exemption was not included in the proposal. Based on the comments received, the final rule includes such language.

As discussed in the preamble of the proposed rule, scrubber waters derived-from the combustion of spent solvents previously were not considered eligible for the headworks exemption because they are derived-from residuals of spent solvents and their release into the wastewater treatment system is not incidental (68 FR 17243, April 8, 2003). However, in the carbamates rule (60 FR 7824-7859, February 9, 1995), the Agency allowed scrubber waters derived-from the incineration of carbamate production wastes to be eligible for the headworks exemption because the scrubber waters would be comparable in the expected constituents and concentration levels with the already-exempted wastewaters. Following the rationale in the carbamates rule, the Agency decided to propose in the April 8, 2003 notice that scrubber waters derived-from spent solvent combustion which are then sent to a facility's wastewater treatment system will be eligible for the headworks exemption under § 261.3(a)(2)(iv)(A) and (B). Similar to the carbamate scrubber waters, the Agency believes that the scrubber waters derived-from such combustion will be comparable in expected constituents and concentration levels with spent solvent wastewaters.

Regulatory language has been included under § 261.3(a)(2)(iv)(A) and (B). The Agency notes the requirement that the scrubber waters must be solely derived-from the combustion of the listed spent solvents remains unchanged from the proposal.

The proposed rule contained a new requirement for those facilities taking advantage of the expanded de minimis exemption. Under this proposed requirement, a manufacturing facility claiming a de minimis loss of F- or K-listed wastes or a non-manufacturing facility claiming any de minimis loss of waste listed in §§ 261.31 through 261.33 would have needed limits for the Appendix VII and LDR constituents associated with its wastes included in its CWA permit.

However, commenters noted that permit writers usually do not set specific permit limits for every constituent that may be present in the effluent. In response to this comment, the Agency instead is requiring any facility that would like to claim any part of the expanded exemption to list all expected Appendix VII and LDR constituents in the CWA permit application. Alerting the permit writers of all expected Appendix VII and LDR constituents by listing them in the CWA permit application will allow the permit writers to ensure that the permit is sufficiently protective of human health and the environment. Similarly, facilities that discharge to publicly owned treatment works (POTW) must disclose every Appendix VII and LDR constituent that may be released to the POTW, as this will alert the POTW of any potential chemicals that may pass through or interfere with its operation or cause a permit violation. This notification to the permit writer or control authority must occur before the facility claims the newly expanded portions of the de minimis exemption. EPA has promulgated updated regulatory language under § 261.3(a)(2)(iv)(D) in response to these comments.

In the proposed rule, the words “unscheduled,” “uncontrollable,” “insignificant” and “inadvertent” were added to the regulatory definition of de minimis (§ 261.3(a)(2)(iv)(D)). Numerous commenters were opposed to the addition of these four words and requested that they be removed from the regulatory text because the words would cause confusion to the regulated community and narrow the scope of the exemption. The Agency agrees that these descriptors are not necessary and is removing the words “unscheduled,” “uncontrollable,” and “insignificant” from the regulatory text of de minimis . However, the word “inadvertent” will remain in the regulatory language. The purpose for the addition of “inadvertent” in the regulatory definition of de minimis is to reinforce the concept that the losses must not be a result of neglectful or careless facility management. Rather, de minimis refers to small losses that occur during normal operating procedures at well-maintained facilities. The Agency believes that it is imperative that this concept be conveyed due to the exemption being expanded to include the F- and K-listed wastes (§ 231.31 and § 231.32), as well as to non-manufacturing facilities. Please see Section IV.D.3. for further discussion regarding the addition of the word “inadvertent” to the regulatory definition.

The Agency summarizes below the responses to the most significant comments received in response to the proposal. All comments received by the Agency are addressed in the Response to Comments Background Document that is available in the docket associated with this rulemaking.

Many commenters supported the addition of benzene and 2-ethoxyethanol as proposed stating that their inclusion in the exemption will add consistency to the current regulatory scheme. Several commenters emphasized that the spent solvents will remain a very small and treatable part of the wastewater mixture. In addition, one commenter stated that the contingent management practices placed on the addition of benzene to the exemption were very reasonable.

While there was strong support for the inclusion of the two solvents, one commenter disagreed with the addition of benzene and 2-ethoxyethanol to the exemption at the current concentration levels of 1 ppm and 25 ppm, respectively. The commenter stated that these levels are not protective of human health and the environment and that the calculated and direct measurement concentrations need to be reduced. In addition, the commenter suggested that the current weekly averaging period be decreased to daily or to some other shorter-term averaging period; however, the commenter did not submit data to support the reduction of the calculated and direct measurement concentrations, nor was data submitted to support a reduction in the averaging period.

The Agency disagrees that the concentration limits of 1 ppm and 25 ppm for benzene and 2-ethoxyethanol, respectively, are not protective. The environmentally conservative risk assessment performed on benzene demonstrated that the 1 ppm standard is protective when groundwater is indirectly exposed to the wastewater treatment sludge and when groundwater is directly exposed to wastewaters and sludge from aerated treatment trains (after secondary clarification). Scenarios from non-aerated systems and primary clarifier sludge from the aerated treatment scenario did result in some risks of concern. As a result, we are requiring that wastewaters containing benzene be managed in an aerated biological treatment unit and that surface impoundments used prior to secondary clarification be lined to be eligible for the exemption. The risk assessment performed on 2-ethoxyethanol demonstrated it does not pose a risk of concern for direct air exposure or for indirect and direct groundwater exposures at the concentration limit of 25 ppm. (See Risk Assessment to Support the Wastewater Treatment Exemptions (Headworks Exemptions) Proposed Rule, U.S. EPA 2003). In regards to the commenter's statement that the weekly average be reduced ( i.e. , that the compliance standard be changed), decreasing the averaging period from weekly to daily or to some other shorter averaging time addresses a provision in the current rule not identified specifically in the proposal as subject to possible amendment. EPA stated in the proposed rule that it would not respond to comments addressing such provisions (68 FR 17241, April 8, 2003).

One commenter supported the addition of benzene but not the conditional management practices. The commenter requested that we reconsider our proposed conditions and allow benzene to be discharged into wastewater treatment systems in the same manner that the other solvents listed in § 261.3(a)(2)(iv)(A) are allowed. In the commenter's opinion, the conditional management practices are too restrictive and inflexible for the addition of benzene to the exemption to be of any use to facilities.

EPA disagrees that the exemption for benzene be unrestricted. Due to the exemption being based on the concentration level of benzene entering the wastewater treatment system and not wastewater and/or sludge waste leaving a facility, evaluation of the risks associated with benzene at this level required assuming various treatment methods and determining the risks from managing effluents from each interim point in a given treatment method (for further discussion, please see Risk Assessment to Support the Wastewater Treatment Exemptions (Headworks Exemptions) Proposed Rule, U.S. EPA 2003). Aerated and non-aerated biological treatment, the two methods evaluated during the risk assessment, are understood by EPA to be the treatment methods used by the vast majority of facilities potentially affected by this rule. The conditional requirements on benzene are based directly on the results of the risk assessment for benzene (see above). If a facility using a method other than aerated biological treatment wishes to exempt their wastewater, they can apply for a site-specific delisting for their wastewater under § 260.22.

One commenter requested that we include benzene still bottoms in the headworks exemption. This commenter argued that there is no regulatory relief for facilities recycling benzene in a still since the still bottoms must be managed as a hazardous waste (F005). The commenter stated that if the facility's wastewater treatment system has the capability of treating the impurities that can be found in still bottoms, then the facility should be able to benefit from the exemption as well.

EPA did not consider benzene still bottoms or still bottoms resulting from the distillation of other F-listed solvents within the scope of the proposed headworks rule. Therefore, still bottoms were not included in the risk assessment we performed in support of the addition of the spent solvents to § 261.3(a)(2)(iv)(A) and (B). Due to concerns regarding constituents, such as metals, which can be found in still bottoms, EPA does not believe that it is appropriate to include benzene still bottoms in the wastewater treatment exemption without having performed a risk assessment. EPA notes that if a facility recycling benzene wishes to exempt their benzene still bottoms, they can apply for a site-specific delisting for their still bottoms under § 260.22.

Most commenters supported the addition of direct monitoring as a compliance option. Several cited the complexity for some sites to perform the mass balance calculations and commended the Agency for proposing to allow direct monitoring at the headworks location as an alternative compliance option. No commenters opposed the addition of direct monitoring, although several commenters did raise a number of issues related to direct monitoring. Separate sections discuss commenters' issues and the Agency's responses regarding the informal definition of headworks, eliminating the requirement to submit the sampling and analysis plan, and allowing performance-based reductions in sampling frequency.

In addition to the issues listed above, many commenters expressed support for the requirement that a facility wanting to use direct monitoring be subject to CAA rules that minimize fugitive emissions. One commenter, however, questioned the eligibility status of those facilities that have adopted voluntary limits or controls as part of a federally enforceable permit. The Agency agrees that those facilities having federally enforceable permits that limit fugitive emissions in the facility prior to the headworks are eligible for the exemption as these federally enforceable permits are equivalent to a facility being subjected to CAA regulations that minimize fugitive emissions. Therefore, regulatory language explicitly allowing those facilities that have adopted limits or controls for fugitive emissions as part of a federally enforceable permit has been added in § 261.3(a)(2)(iv)(A), (B), (F), and (G).

Another commenter expressed confusion about whether the CAA rule had to apply to the entire facility or just to the wastewater treatment unit specifically. The purpose of the requirement is to ensure that volatilization of solvents are minimized, and thereby preventing fugitive emissions from lowering spent solvent concentration levels, prior to the monitoring point at the headworks. EPA considered volatilization from the wastewater treatment unit after the headworks point (such as from the activated sludge unit or primary clarifier) in the Agency's risk assessment and did not find volatilization to be an unacceptable source of risk as long as the solvent concentrations at the headworks did not exceed the specified levels. Because the intention of the requirement is to minimize volatilization prior to the headworks point and the risk assessment found that volatilization from the wastewater treatment unit did not present an unacceptable risk, it is not necessary for the receiving wastewater treatment unit itself to be subject to CAA regulations. However, EPA stresses that the process streams and wastewater streams that lead up to the headworks point must be subject to CAA regulations, or an enforceable limit federal operating permit, that minimizes fugitive emissions.

One commenter objected to the requirement that, under the direct monitoring alternative, the generator must count the total amount of the chemical in the waste stream, even if some portion of it was from a non-solvent source. In addition, another commenter stated that only allowing the sampling to occur at the headworks location is unnecessarily limiting because the chemical not being used for its solvent purposes will be included in the measured level. They asserted that these requirements are overly conservative and should be modified, suggesting that facilities be allowed to reduce the measured concentration by the fraction known to be from non-solvent sources and that facilities be allowed to sample wastewaters closer to the point of generation. The Agency disagrees. The risk assessment performed by the Agency demonstrated that the 1 ppm and 25 ppm standards were protective for the total amount of the chemicals (benzene and 2-ethoxyethanol, respectively) introduced at the headworks. The source of these chemicals is irrelevant for the purposes of determining risk. If the solvent fraction of the chemical in the waste stream contributed to the total chemical concentration in the wastestream which exceeds the 1 ppm or 25 ppm threshold, then that constituent is posing an unacceptable risk to human health. Therefore, facilities cannot use a hybrid of the results from the mass balance and direct monitoring methods to discount the non-solvent source from the total measured concentration, nor can facilities sample at alternate locations in lieu of sampling at the headworks point. The Agency notes that facilities continue to have the option of using mass balance.

Another issue of concern by a commenter is the possibility of the overseeing agency finding a facility to have exceeded the exemption levels on the basis of a compliance method different than the one the facility chose to use ( e.g. , the facility using mass balance and the agency using sampling). The overseeing agency will not be bound to use the same compliance method chosen by the facility; however, the procedures utilized by the overseeing agency when investigating a potential violation will be comprehensive enough to determine if the facility has exceeded the exemption levels before being found in violation.

Lastly, a commenter requested that we clarify our intent with regards to allowing facilities to alternate between the two compliance methods or to use a combination of the two methods to demonstrate compliance. Facilities will have the option to alternate between the two methods or to concurrently use both methods and report the result of either method. However, as discussed above, facilities cannot use a hybrid of the two methods to demonstrate compliance ( e.g. , apply the solvent percentage to measured concentrations to discount the non-solvent use). EPA encourages facilities to notify the overseeing agency via the sampling and analysis plan that alternating between the compliance methods may occur. EPA also encourages facilities to provide examples of when a facility may switch from one method to the other. EPA notes that facilities may switch monitoring methods even if their submitted sampling and analysis plan did not discuss examples of when such an occurrence would happen.

Several commenters supported the Agency's approach of not proposing a formal regulatory definition for the term “headworks,” but rather providing guidance on what it considers to be the “headworks” location. In the preamble to the proposed rule, EPA stated that for purposes of this rule, “headworks can include a central catch basin for industrial wastewaters, a pump station outfall, equalization tank, or some other main wastewater collection area that exists in which transport of process wastewaters stops and chemical or biological treatment begins” (68 FR 17242). The Agency did solicit comments on this non-regulatory description. Supporters for the informal description stated that the description of the term “headworks” in the preamble to the proposal is flexible enough to accommodate a myriad of different facilities within the regulated community. In addition, commenters agreed that creating a regulatory definition for “headworks” would result in the loss of this flexibility.

However, one commenter believed that confusion might result from EPA's headworks description because it assumes that no pretreatment is occurring prior to the wastewaters' arrival at the headworks. The commenter explained that pretreatment frequently occurs upstream to the headworks location, and typically there is no one central location where all wastewaters come together prior to pretreatment. Therefore, the headworks location should be the point where the exemption is claimed regardless of whether or not pretreatment has occurred. The commenter also stated that the definition of headworks should be codified; however, as an alternative to incorporating the definition into the regulatory code, the commenter suggested that clarification of the location be provided in the preamble of the final rule.

First, EPA disagrees with the commenter's statement that a definition of headworks should be codified. The Agency believes that it would be difficult to develop a regulatory definition of the term “headworks” that could apply at all or even most facilities given the varied nature of facility configurations. The guidance approach to identifying the headworks location accommodates a range of facility configurations, thereby providing maximum flexibility. However, EPA does agree that the in-process pre-treatment of wastewaters prior to their arrival at the headworks location occurs and is allowable under this provision. Therefore, EPA is modifying its guidance regarding the informal description of the term “headworks” so that the headworks location can now be described as the point at which final combination of raw or pre-treated process wastewater streams typically takes place.

Many supporters of the direct monitoring option commented that it was too burdensome to submit the sampling and analysis plan and to obtain confirmation of its receipt before direct monitoring can begin. One commenter, who misunderstood the proposed requirement, objected to explicit approval having to be obtained by the overseeing agency prior to starting direct monitoring. However, the Agency is not requiring that the facility obtain explicit approval from their overseeing agency prior to the start of direct monitoring. The facility simply is required to obtain confirmation of receipt ( e.g. , a certified mail return receipt or written confirmation of delivery from a commercial delivery service) prior to starting direct monitoring.

The Agency disagrees that submittal of the sampling and analysis plan is overly burdensome. Submittal of the sampling and analysis plan will provide notification to the overseeing agency that a change in compliance methodology is planned. This notification is a one-time event, unless there is a change in the facility's operations that causes a change in monitoring that renders the SAP obsolete. The majority of the burden in this requirement is the preparation of the sampling and analysis plan, and no commenter objected to developing the sampling and analysis plan, correctly recognizing that it is the foundation for any rigorous monitoring program.

Several commenters asserted that requiring the facility to submit their sampling and analysis plan ran counter to EPA's recently proposed RCRA Burden Reduction Initiative (67 FR 2518, Jan. 17, 2002). In addition, commenters noted that in 1997, the Agency specifically eliminated the requirement that generators managing and treating prohibited waste in tanks, containers and containment buildings under 40 CFR 262.34 submit sampling and analysis plans to its overseeing Agency under 268.7(a)(5). These commenters also pointed out that neither the chlorinated aliphatics final rule (65 FR 67068) nor the paint production proposed rule (66 FR 10060) required facilities to submit their sampling and analysis plans to the overseeing agency, instead allowing the facilities to keep their plans on-site.

EPA believes that it is inappropriate to compare the proposed chlorinated aliphatics rule  1 (64 FR 46476; August 25, 1999) and the proposed paints rule  2 to the headworks rule. While it is true that the proposed chlorinated aliphatics rule and the proposed paint production rule required sampling and analysis plans to be developed but not submitted, there are two significant differences between these listing rules and the headworks exemption. First, the testing required under the two listing rules is on currently non-hazardous waste to document that the waste should continue to be out of the hazardous waste regulatory system. In contrast, the testing required under the headworks rule is on currently hazardous waste to determine whether or not it can safely exit the hazardous waste regulatory system. The Agency has generally taken a different approach for determining whether a waste is hazardous, as opposed to demonstrating that hazardous waste in fact is not hazardous. Second, direct monitoring is not a requirement to qualify for the headworks exemption; it is an option. If the facility determines that submitting the sampling and analysis plan is too burdensome, then the facility can opt not to use the direct monitoring method to demonstrate compliance but can continue to use the mass balance approach.

EPA also disagrees that submitting the sampling and analysis plan is contradictory to the proposed RCRA Burden Reduction Initiative (67 FR 2518, Jan. 17, 2002) and the removal in 1997 of the LDR requirement to submit the facility's sampling and analysis plan. The purpose of the proposed burden reduction rule is to eliminate reports that are found to be duplicative or not used by state or regional agencies to protect human health and the environment. In today's rule, submitting the sampling and analysis plan serves as a notification to the overseeing agency that the facility will be using direct monitoring to demonstrate compliance with the headworks exemption. The sampling and analysis plan also will provide important information on key sampling parameters that the facility intends to use. EPA notes that the facility has a wide latitude to design the sampling and analysis plan, and the facility initially will set the conditions with which they intend to comply. As the sampling and analysis plan is not duplicative of any other requirement and serves as notification to the overseeing agency, EPA believes retaining the requirement to submit the sampling and analysis plan is reasonable and consistent with the proposed burden reduction rule.

In addition, while it is true that in 1997 EPA removed the requirement of submitting waste analysis plans for generators managing and treating prohibited waste in tanks, containers and containment buildings, the purpose of removing this requirement was to streamline the LDR process (60 FR 43678, August 22, 1995). This streamlining was in response to the Burden Reduction Initiative set forth in the President's report on “Reinventing Environmental Regulations,” March 16, 1995. EPA stated that due to the growth of the LDR program and the regulated community's better understanding of the program, it was unnecessary to maintain all of the reporting and recordkeeping requirements. Thus, certain LDR paperwork requirements were eliminated to reduce the regulatory burden (61 FR 2363, January 25, 1996). EPA notes several key differences between the headworks rule and the LDR Phase IV rule. First, while the headworks exemption is not a new exemption, the addition of direct monitoring as a compliance method is a new option. Second, submitting the sampling and analysis plan is not a requirement to qualify for the exemption; it is a requirement for the use of the direct monitoring option. Therefore, EPA is requiring submittal of sampling and analysis plans to provide the overseeing agency the opportunity to ensure that facilities are utilizing the newly instituted compliance method properly.

Two commenters requested further clarification regarding the rejection of the sampling and analysis plan. One commenter stated that if a sampling and analysis plan is submitted in good faith, but only exhibits minor flaws, then that facility should be able to continue to use the direct monitoring method while the minor inadequacies are being addressed. The other commenter requested more explanation regarding the actions that need to be taken in order for a facility to restart direct monitoring if the sampling and analysis plan is rejected.

The Agency notes that the parameters of the sampling and analysis plan must enable the facility to accurately calculate the weekly average concentration, and the plan must include the monitoring point location, the sampling frequency and methodology, and a list of the constituents to be monitored. Therefore, the Agency maintains that if the sampling and analysis plan is rejected for major deficiencies ( e.g. , fails to include the above information or does not enable the facility to accurately calculate the weekly average) or if the facility is found not to be following the plan, then the facility can no longer use the direct monitoring option until the bases for rejection are corrected. Even if the overseeing agency does reject the sampling and analysis plan, the facility continues to have the option to demonstrate compliance using the mass balance method, while the facility is addressing the sampling and analysis plan issues. The Agency does support the continued use of direct monitoring while deficiencies are being corrected if the sampling and analysis plan is submitted in good faith and the deficiencies are minor. However, it is left to the discretion of the overseeing agency to determine the severity of the deficiencies and whether or not direct monitoring may continue while the facility addresses such minor deficiencies.

It is the facility's responsibility to determine from the overseeing agency the reason for the rejection and the steps that need to be taken to rectify the insufficiencies. The overseeing agency will determine whether the facility is to resubmit the entire sampling and analysis plan or just the amended sections once the facility corrects the bases for the rejection. Once the facility has received confirmation that the overseeing agency no longer has concerns with the amended sections of the plan, the facility may begin using the direct monitoring option.

Several commenters offered detailed suggestions of how the proposed site-specific sampling and analysis plan could establish a sampling schedule that would allow a reduced sampling frequency once compliance with the 1 ppm and 25 ppm thresholds was established. The commenters stated that this approach would be analogous to those taken historically in RCRA Waste Analysis Plans (WAP) and in CWA NPDES permits.

The Agency is interested in the possibility of allowing a facility's sampling and analysis plan to include a provision to reduce sampling frequency based on performance as long as the current compliance standards under 261.3(a)(2)(iv)(A) and (B) are maintained and the facility's provisions for reduced sampling frequency are thoroughly discussed in the plan. However, EPA would first need to propose the specific requirements of such a provision in order to allow for adequate notice and comment.

In addition, a number of commenters suggested that EPA increase the length of the current compliance period in order to reduce the costs associated with direct monitoring. The commenters' suggestion to increase the averaging period from weekly to monthly ( i.e. , the compliance period) addresses a provision in the current rule not specifically identified in the proposal as subject to possible amendment. EPA stated in the proposed rule that it would not respond to comments addressing such provisions (68 FR 17241, April 8, 2003).

Numerous commenters supported the proposed addition of scrubber waters derived-from the incineration of F-listed solvents to the headworks exemption. Several supporters stated that the rationales used by EPA to advocate the addition of these scrubber waters are both accurate and justifiable. However, many commenters were concerned over the Agency reinterpreting the current regulatory language and requested that the exemption be incorporated into the regulatory text. Even though specific regulatory text for this provision was not proposed, we expressly stated in the preamble that the “Agency is proposing that scrubber waters derived from the combustion of spent solvents and sent to a facility's wastewater treatment system qualify for the exemption under 40 CFR 261.3(a)(2)(iv)(A) and (B)” (68 FR 17243; April 8, 2003). Nevertheless, based on the rational set forth in the preamble to the proposal, EPA is promulgating regulatory text to implement the proposed addition to the headworks exemption.

Many commenters stated that limiting the exemption to only scrubber waters derived-from the incineration of F-listed solvents was too narrow in scope and that the exemption as proposed would not be of much benefit to the regulated community. For the exemption to be useful, commenters requested that the exemption also apply to scrubber waters derived-from the incineration of other F-, K-, P-, and U-listed wastes. The commenters claimed that the rationales used to exempt the scrubber waters derived-from the F-listed solvents and to exempt the de minimis quantities of P- and U-listed wastes could be used to support the exemption of the scrubber waters derived-from the incineration of other listed wastes in the headworks exemption. As an alternative, some commenters stated that the other F-, K-, P-, and U-listed wastes in the scrubber waters are analogous to the de minimis quantities of the same chemicals. Therefore, the rationale used to exempt the release of de minimis quantities of these listed wastes can be applied to justify the addition of these scrubber waters into the de minimis exemption (§ 261.3(a)(2)(iv)(D)).

The Agency disagrees that scrubber waters derived-from the incineration of other listed wastes should be included in the headworks exemption. Scrubber waters derived-from the incineration of F-listed solvents are eligible for the exemption because these scrubber waters would be comparable in expected constituents and concentration levels with the already exempted F-listed solvents (§ 261.3(a)(2)(iv)(A) & (B)). This rationale cannot be applied universally to the scrubber waters derived-from the incineration of the other listed wastes because not all of these listed wastes are currently exempted in § 261.3(a)(2)(iv)(A) & (B). Therefore, if the listed wastes themselves are not exempt, then the scrubber waters derived-from their incineration cannot be exempt using this rationale.

The Agency also will not be including scrubber waters derived-from the incineration of U-, P-, K- and other F-listed wastes in the de minimis exemption (§ 261.3(a)(2)(iv)(D)). EPA's proposal discussed expanding the de minimis exemption to facilities other than manufacturing facilities and discussed expanding the type of wastes that could qualify for the exemption. The proposal did not discuss expanding the de minimis exemption to systematic discharges of small amounts of waste to a wastewater treatment system. Since originally adopted in 1981, the de minimis exemption has removed from regulation small amounts of listed wastes that are inadvertently and often unavoidably lost under normal material handling operations at well-maintained facilities. The systematic release of scrubber waters into the wastewater treatment system advocated by some of the commenters would neither be inadvertent or unavoidable as the scrubber water is a segregated wastewater stream at its point of generation. Allowing systematic releases to come within the de minimis exemption would be a fundamental change in how the de minimis exemption operates and arguably would require additional notice and comment to adopt.

All who commented on the proposed de minimis expansion generally supported it, but many commenters raised specific issues. Separate sections discuss commenters' issues and the Agency's responses regarding the CWA permit requirement, the inclusion of “unscheduled,” “uncontrollable,” “insignificant” and “inadvertent” in the regulatory language and the removal of “rinsates from empty container” from the regulatory language.

In addition to the issues listed above, one commenter stated that they were interpreting the de minimis exemption expansions to include facilities that have eliminated the discharge of wastewaters using permitted Class I injection wells. The Agency agrees with this interpretation. As explained in the preamble of the original headworks rule, the exemptions not only apply to wastewaters that are managed in wastewater treatment systems whose discharges are subject to regulation under Section 402 or 307(b) of the CWA, but also apply to “those facilities (known as “zero dischargers”) that have eliminated the discharge of wastewater as a result of, or by exceeding, NPDES or pretreatment program requirements” (46 FR 56584, November 17, 1981). These wastewater management requirements remain unchanged by the amendments to the final headworks rule.

In addition, EPA continues to believe that underground injection wells can meet the headworks' definition of zero discharge if the injection well is being used for the purposes of complying with a NPDES permit, other applicable effluent guideline, or pretreatment program requirements. See discussion in Third Third Rule (55 FR 22672, June 1, 1990). Wastewaters disposed of via injection well usually are not considered discharges under the CWA. However, if underground injection of wastewaters occurs for reasons other than to comply with a NPDES permit, other applicable effluent guideline or pretreatment program requirements, then those wastewaters are not eligible for the wastewater treatment (headworks) exemptions (in 40 CFR 261.3(a)(2)(iv)).

The Agency proposed that for manufacturing facilities claiming a de minimis loss of F- or K-listed wastes or non-manufacturing facilities claiming a de minimis loss of wastes listed in §§ 261.31 through 261.33, the CWA permit must include limits for the Appendix VII hazardous constituents and the LDR constituents associated with the listed wastes. Many commenters objected to this proposed requirement. Several of these commenters argued that it usually is not the permit writer's practice to set specific permit limits for every constituent that may be present in the facility's effluent. Rather, they argued that listing the waste streams or constituents of concern in the CWA permit application will provide the permit writer or control authority with the necessary information to decide whether or not a specified level or method of treatment is necessary in the permit for the various constituents.

The rationale for requiring a facility's CWA permit to contain limits for Appendix VII and LDR constituents associated with the specific wastes was due to the de minimis eligibility being expanded to include F- and K-listed wastes. At the time of the proposal, the Agency wanted to ensure that the releases of F- and K-listed wastes would be minimized so that these wastes would not have a significant effect upon wastewater treatment systems, the quality of effluent discharges, solid wastes generated, occupational safety and health, and human health and the environment (67 FR 17244, April 8, 2003). However, the Agency recognizes that it usually is not the permit writer's practice to set specific permit limits for every constituent that may be present in a facility's effluent. For instance, some constituents are controlled through the use of limits on conventional pollutants (such as biochemical oxygen demand, total suspended solids, or pH), or through limits on other bulk parameters (such as chemical oxygen demand or total organic carbon), while other constituents may require limitations on whole effluent toxicity or special monitoring procedures to be performed, or may be present at such low levels that no permit limit is necessary. Therefore, we agree with the commenters that it is sufficiently protective for direct discharging facilities to list all expected Appendix VII and LDR constituents in their CWA permit application (or for indirect dischargers to POTWs, in their submission to their control authority) and to rely on the permit writer's (or control authority's) judgment to determine if specific permit limits are needed. Further, as discussed in the preamble of the proposed rule, the toxicity characteristics and CERCLA's reportable quantities will remain as additional protective mechanisms (68 FR 17244). Therefore, in the final rule, facilities only will be required to list all Appendix VII and LDR constituents in the CWA permit application or POTW submission which will allow the permit writer or control authority to determine if specific permit limits are needed. In addition, facilities will be required to keep a copy of the CWA permit application or POTW submission on-site as an alert to inspectors that the permit writer or control authority was notified of the possible de minimis releases of constituents of concern. Finally, the Agency notes that alerting the permit writer or control authority must occur before the facility claims the newly expanded portions of the de minimis exemption.

In addition, several commenters stated that facilities that discharge to POTWs should be allowed to take advantage of the exemption, and if allowed, they should not be required to have pretreatment limits for each constituent that may be released. Further, the POTW's CWA permit should not be required to have specific limits for each of the constituents managed at the indirect discharger's facility.

Indirect dischargers are eligible for the de minimis exemption if the POTWs they discharge to have valid CWA permits that include an approved pretreatment program as a condition of the POTW's permit. As discussed above, the rationale for requiring all constituents to have pretreatment limits was to ensure the protection of human health and the environment and to minimize the incentive to “dispose of” F- and K-listed wastes into the wastewater treatment system. However, EPA believes indirect dischargers can qualify for the de minimis exemption using mechanisms other than requiring pretreatment limits for each constituent potentially released and still be protective of human health and the environment. The disclosure of each Appendix VII and LDR constituent that may be released to the POTW by the indirect discharger will sufficiently protect human health and the environment by alerting the POTW of any potential chemicals that may pass through or interfere with its operation or cause a permit violation of the POTW's discharge permit. The control authority ( i.e. , POTW, state, or EPA Region) can determine if specific pretreatment limits are necessary once all potential Appendix VII and LDR constituents are disclosed. In addition, as with the direct dischargers, POTWs do not need to have specific limits listed for each constituent in the indirect discharger's permit (or control mechanism) but must have received a list of all Appendix VII and LDR constituents from the indirect discharger in order for the discharger to use the exemption.

Commenters also objected to the proposed addition of the words “unscheduled,” “uncontrollable,” “insignificant,” and “inadvertent” which were used to describe de minimis releases to a wastewater treatment system (§ 261.3(a)(2)(iv)(D)). Commenters expressed concern that EPA did not adequately announce or explain these qualifiers and that the qualifiers would cause confusion to the regulated community as well as narrow the scope of the exemption.

Because the expansion of the de minimis exemption includes the F- and K-listed wastes for which there is no economic incentive to prevent their loss into the wastestream, the Agency believed that it was necessary to reaffirm its understanding of what is meant by a de minimis release. However, EPA has been persuaded by commenters that the intended meanings of “unscheduled” and “uncontrollable” can be misinterpreted and that they should not be included in this final rule. EPA also recognizes the redundancy of including “insignificant” in the regulatory definition of de minimis . Therefore, in today's final rule, “insignificant” also will not be included in the regulatory language. However, EPA disagrees that facilities will be confused over the meaning of “inadvertent.” The inclusion of “inadvertent” in the regulatory definition of de minimis reinforces that these losses, no matter if a F-, K-, P- or U-listed waste, must be minor and must result from normal operating procedures at well-maintained facilities.

The commenters also state that EPA failed to explain how these words would effect the current interpretation of the de minimis exemption. Regarding the remaining additional term “inadvertent,” it is not the Agency's intent to alter the interpretation of the exemption. It is clearly illustrated in the preamble of the original rule that the de minimis exemption was intended for minor losses resulting from normal operating procedures, such as when small amounts of raw material are lost in various unloading or material transfer operations, or when small losses occur as a result from purgings and relief valve discharges. In addition, the original preamble states that it was not the Agency's intention for the exemption to include losses from normal operating procedures occurring at facilities that use neglectful or careless management practices. In fact, the preamble states that the Agency will use its listing authority to list the wastewaters from those facilities whose neglectful or careless management practices cause such high losses of § 261.33 hazardous wastes (46 FR 56586, November 17, 1981). Therefore, “inadvertent” is not altering the interpretation of de minimis but is reinforcing the Agency's original intent that the exemption apply only to those minor losses resulting from normal operating procedures at well-maintained facilities. The Agency believes that it is imperative to reinforce that the minor losses of waste must be inadvertent because the expanded exemption includes listed wastes that are not commercial chemical products. As is discussed in the 1981 preamble, facilities have an economical incentive to minimize the loss of commercial chemical products during normal operating procedures. Id. This economic incentive does not exist for the F- and K-listed wastes being added to the de minimis exemption. Therefore, it is imperative that there is an understanding that any large intentional losses of these wastes will not be considered as de minimis and accordingly, will not be exempted under § 261.3(a)(2)(iv)(D).

Commenters stated that the inclusion of the four new terms in the regulatory language would narrow the scope of the exemption. However, the Agency disagrees that the inclusion of the remaining term “inadvertent” in the regulatory language will narrow the scope of the exemption. Our use of the term “inadvertent” implies that the de minimis loss must not be a result of neglect or carelessness. As stated in the 1981 preamble, small losses of listed wastes do occur during normal operating procedures at well-maintained facilities because it is exceedingly expensive to prevent such losses. In addition, EPA recognized that the segregation and separate management of these losses would also be exceedingly expensive as well as unnecessary because wastewater treatment systems would be capable of efficiently treating these small quantities of listed wastes. Id. Our inclusion of the word “inadvertent” in the regulatory language is not intended to alter the original scope of the exemption, as these small losses that are occurring during normal operating procedures at well-maintained facilities will remain in the exemption. Inclusion of the term “inadvertent” only reinforces that losses, which result from mismanagement, neglectfulness or carelessness during normal operating procedures, are not (and have never been) included in the exemption.

The commenters also suggest that “inadvertent” is not consistent with the examples provided in the existing regulatory language, as the examples describe losses that are “predictable,” not “inadvertent.” As acknowledged in the 1981 preamble, well-maintained facilities will have predictable losses that can be prevented but only at a considerable cost. Id. The Agency recognizes these “predictable” losses as “inadvertent” as long as they are occurring during normal operating procedures at a facility that is not managed in a neglectful or careless manner.

Finally, some commenters suggested applying the qualifying terms “unscheduled,” “uncontrollable,” “insignificant,” and “inadvertent” to only F- and K-listed wastes. As we have decided not to include the first three of those terms in the final rule, we will address the comment with respect to the remaining term “inadvertent.” We disagree with the comments requesting the qualifiers apply to only F- and K-listed wastes. The universe of the de minimis exemption is being expanded to include both the listed wastes in § 261.31 and § 261.32 and non-manufacturing facilities. Therefore, it is imperative that those facilities that do not have a history with the exemption have a clear understanding of what a de minimis release is for all the listed wastes.

Two commenters raise what they believe is an inconsistency between two existing regulatory provisions. The commenters believe that the phrase “rinsates from empty containers” in 40 CFR 261.3(a)(2)(iv)(D) conflicts with language found in 40 CFR 261.7, which excludes “residues of hazardous waste in empty containers” from regulation under part 261. As argued by the commenters, “rinsates from empty containers” are “residues of hazardous waste in empty containers,” and since “residues of hazardous waste in empty containers” are not considered hazardous wastes, it is inconsistent for EPA to retain the “rinsates from empty containers” phrase in the de minimis regulatory language. Because the de minimis regulatory language is being amended to include the new expansions to the exemption, the commenters claim that the Agency now has the opportunity to fix the apparently inconsistent language.

EPA notes that this comment raises an issue that is outside the scope of the proposed rulemaking. As stated in the preamble, the Agency made clear that it would not respond to any comments addressing any provisions of the headworks rule not specifically identified as subject to possible amendment (68 FR 17233, April 8, 2003).

However, EPA would like to take this opportunity to clarify how the existing “empty container” exemption operates. Under 40 CFR 261.7, a container can contain a small amount of non-acute hazardous waste and still be considered “empty” for the purpose of hazardous waste regulation. (40 CFR 261.7 includes very specific definitions on how much waste can remain in an “empty container.”) The waste remaining in this “empty” container is not subject to hazardous waste regulation (including the mixture rule).

However, even though rinse water from an “empty” container may often times be non-hazardous, 40 CFR 261.7 does not directly exempt rinse water from Subtitle C regulation. Specifically, rinse water is not a waste “remaining in” an “empty” container. Indeed, while 40 CFR 261.7 clearly exempts residue remaining in an “empty” container from Subtitle C regulation, the Agency has made it clear that when the residue is removed from an “empty” container, the residue is subject to full regulation under Subtitle C if the removal or subsequent management of the residue generates a new hazardous waste that exhibits any of the characteristics identified in Part 261, Subpart C (see 45 FR 78529, November 25, 1980, where it states “[C]ontainer cleaning facilities which handle only “empty” containers are not currently subject to regulation unless they generate a waste that meets one of the characteristics in Subpart D.”). (See also April 12, 2004 letter from Robert Springer, Director, Office of Solid Waste to Casey Coles, Hogan and Hartson, LLP).

Finally, it also should be noted that if the rinsing agent includes a solvent (or other chemical) that would be a listed hazardous waste when discarded, then the rinsate from an “empty” container would be considered a listed hazardous waste. This is not due to the nature of the waste being rinsed from the “empty” container, but rather, because of the nature of the rinsing agent. In this scenario, the rinsate still may be eligible for the exemptions from the mixture rule found in 40 CFR 261.3(a)(2)(iv) ( i.e. , headworks exemptions) if it meets the conditions of those exemptions ( e.g. , solvent levels at the headworks below those in 40 CFR 261.3(a)(2)(iv)(A) and (B)).

Commenters generally supported potential exemptions of solvent waste and non-solvent waste leachates and urged EPA to continue developing a future proposal addressing such exemptions. One commenter stated that exempting such leachates would provide facilities flexibility in waste management that currently is not available to them. The commenter also added that if exempted, leachates could be treated in a biological wastewater treatment unit without the facility having to manage the resulting treatment residue as a listed hazardous waste.

While very supportive of a potential rulemaking addressing leachates, several commenters objected to our use of the most recent EPA study of landfill leachate characteristics (65 FR 3007, January 19, 2000) as a factor in our decision to not exempt non-solvent leachates during this rulemaking. This study, which was conducted as part of data collected to establish technology-based effluent limitations guidelines and standards for landfills, determined that leachates from hazardous waste landfills had a greater number of constituents than leachates from non-hazardous landfills. In addition, the study concluded that the constituents present in the leachates from hazardous waste landfills were an order of magnitude greater than their counterparts in non-hazardous waste landfills. 3 The commenters argued that the results of the study might be biased for two reasons. First, the commenters stated that leachates from hazardous waste landfills are analyzed for more constituents as well as analyzed more frequently than leachates from non-hazardous landfills. Therefore, the lack of data resulting from non-hazardous waste landfill leachates not being routinely analyzed cannot be an indicator for the absence of constituents in those leachates. Second, commenters were concerned that the contents of the non-hazardous landfill database may have been skewed towards landfills that do not accept hazardous wastes from households, conditionally exempt small quantity generators, or other wastes that do not require pretreatment, such as construction/demolition types of landfills. Therefore, the commenters question whether or not the comparison made between leachates from hazardous waste and non-hazardous waste landfills is based upon equivalent data. Finally, due to the concern that our decision was based upon an insufficient analysis, one commenter submitted analytical data from their facilities on leachate composition.

The Agency disagrees that it is inappropriate to base the decision not to include leachates in the exemption, in part, on the study of landfill leachate characteristics. The results of the study are based on data gathered to support the final effluent guidelines for the landfill point source category (65 FR 3007, January 19, 2000) and was therefore designed to be comparable. The Agency analyzed all wastewater samples that it collected for the study for the same list of constituents regardless of whether the landfill was considered a hazardous or non-hazardous waste landfill. While the Agency disagrees with the commenters regarding the appropriateness of utilizing the landfill leachate characteristics study as a decision factor to not include leachates in the exemption at this time, we do believe, as stated in the preamble to the proposed rule, that the results of the study indicate that further analysis is needed before an exemption is considered.

Under section 3006 of RCRA, EPA may authorize a qualified state to administer and enforce a hazardous waste program within the state in lieu of the Federal program, and to issue and enforce permits in the state. Following authorization, the state requirements authorized by EPA apply in lieu of equivalent Federal requirements and become federally enforceable as requirements of RCRA. EPA maintains independent authority to bring enforcement actions under RCRA sections 3007, 3008, 3013, and 7003. Authorized states also have independent authority to bring enforcement actions under state law.

A state may receive authorization by following the approval process described in 40 CFR part 271. Part 271 of 40 CFR also describes the overall standards and requirements for authorization. After a state receives initial authorization, new federal regulatory requirements promulgated under the authority in the RCRA statute which existed prior to the 1984 Hazardous and Solid Waste Amendments (HSWA) do not apply in that state until the state adopts and receives authorization for equivalent state requirements. The state must adopt such requirements to maintain authorization. In contrast, under RCRA section 3006(g), (42 U.S.C. 6926(g)), new federal requirements and prohibitions imposed pursuant to HSWA provisions take effect in authorized states at the same time that they take effect in unauthorized states. Although authorized states still are required to update their hazardous waste programs to remain equivalent to the federal program, EPA carries out HSWA requirements and prohibitions in authorized states, including the issuance of new permits implementing those requirements, until EPA authorizes the state to do so. Authorized states are required to modify their programs only when EPA promulgates federal requirements that are more stringent or broader in scope than existing federal requirements.

RCRA section 3009 allows the states to impose standards more stringent than those in the federal program. See also 40 CFR 271.1(i). Therefore, authorized states are not required to adopt federal regulations, either HSWA or non-HSWA, that are considered less stringent.

Today's rule is finalized pursuant to non-HSWA authority. The finalized changes in the conditional exemptions from the definition of hazardous waste under the headworks rule are less stringent than the current federal requirements. Therefore, states will not be required to adopt and seek authorization for the finalized changes. EPA will implement the changes to the exemptions only in those states which are not authorized for the RCRA program. Nevertheless, EPA believes that this rulemaking has considerable merit, and we thus strongly encourage states to amend their programs and become federally-authorized to implement these rules.

Under Executive Order 12866, [58 Federal Register 51,735 (October 4, 1993)] the Agency must determine whether the regulatory action is “significant” and therefore subject to OMB review and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

Pursuant to the terms of Executive Order 12866, it has been determined that this rule is a “significant regulatory action” because this rule contains novel policy issues. As such, this action was submitted to OMB for review. Changes made in response to OMB suggestions or recommendations will be documented in the public record. EPA's economic analysis suggests that this rule is not economically significant under Executive Order 12866, because EPA estimates that the overall national economic effect of the rule is $11.4 million to $48.6 million in average annual potential cost savings for RCRA regulatory compliance. The following table presents an itemization of EPA's estimated count of affected facilities, affected annual RCRA waste quantities, and estimated annual cost savings for each of the five main features of this final rule.

A detailed presentation of EPA's methodology, data sources, and computations applied for estimating the number of affected entities (industrial facilities) and economic impacts attributable to today's final rule is provided in the “Economic Background Document.”

The information collection requirements in this rule have been submitted for approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The information collection requirements are not enforceable until OMB approves them.

The rule requires generators wanting to demonstrate compliance with the RCRA headworks exemptions through direct monitoring (rather than by the mass balance computation method as required before this rule), to submit a one-time copy of their wastewater headworks sampling and analysis plan (SAP), to the EPA Regional Administrator (or to the State Director in an authorized State), and to maintain in on-site files, all direct monitoring records for a minimum of three years. The SAP requirements for direct monitoring shall be site-specific. As with all other exemptions and exclusions from EPA's RCRA definition of hazardous waste, a facility is required under 40 CFR 268.7(a)(7) to place a one-time notice concerning RCRA hazardous waste generation, subsequent exclusion from the RCRA definition of hazardous waste, or RCRA definition of solid waste, or exemption from RCRA Subtitle C regulation, and the disposition of the waste, in the facility's on-site files. Generally, such notification, as well as certifications, waste analysis data, and other documentation must be kept in on-site files for a period of three years, unless an enforcement action by the Agency extends the record retention period (40 CFR 268.7(a)(8)).

EPA estimates that the incremental, three-year average annualized respondent burden for the new paperwork requirements in the rule, including initial burden to exemption claimants for reading the rule, is 45,900 hours per year, and the three-year annualized respondent cost for the new paperwork requirements in the rule is $8.56 million per year. However, in addition to the new paperwork requirements in the rule, EPA also estimated the burden and cost that generators could expect as a result of complying with the existing RCRA hazardous waste information collection requirements for the excluded materials. Because the addition of benzene and 2-ethoxyethanol would increase the number of facilities that participate in the existing headworks exemptions (and the greater possibility of using direct monitoring), EPA expects there would be both a reduction in some RCRA paperwork requirements ( i.e. , preparation of RCRA hazardous waste manifests and RCRA Biennial Reports), and an increase in other RCRA paperwork requirements ( i.e. , demonstrating compliance by using mass balance and submitting a one-time LDR notification under 40 CFR 268.7(a)(7)). Taking both revised and existing RCRA requirements into account, EPA expects the rule's revisions to the headworks exemption, would result in a net annualized burden of about 46,200 hours per year at a cost of $8.53 million per year. EPA expects this net additional paperwork cost to be offset by annual costs savings to respondents from reduced waste management costs, resulting in a net cost savings of $11.4 to $48.6 million per year. In addition to respondent burden, EPA estimates the paperwork burden cost to RCRA-authorized State agencies of administering the rule at about 370 hours per year at a cost of $13,800 per year. Because of the fact that some of the rule's paperwork requirements are one-time only ( e.g., sampling and analysis plan) rather than annually-recurring burden, the actual annual burden hours and burden costs after the first-year in which the rule takes effect, will be lower than the three-year average annual values summarized above. 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. When this ICR is approved by OMB, the Agency will publish a technical amendment to 40 CFR part 9 in the Federal Register to display the OMB control number for the approved information collection requirements contained in this final rule.

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

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 Administration's (SBA) 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, I certify 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. 603 and 604. Thus, an agency may certify 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.

Because this final rule expands the existing wastewater treatment exemptions, the Agency believes that the hazardous waste management costs for both small and large entities will be reduced. In addition, these new exemptions are non-mandatory; therefore, the exemptions do not need to be claimed unless it is cost-effective. The net cost savings for affected entities has been estimated to be $11.4-48.6 million (please refer to the economic background document to this final rule for more information). We have 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 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 this 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 one year. This is because this final rule imposes no enforceable duty on any state, local or tribal governments. EPA also has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. In addition, as discussed above, the private sector is not expected to incur costs exceeding $100 million. Thus, today's rule is not subject to the requirements of sections 202 and 205 of the UMRA.

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

This final rule does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This rule directly affects primarily generators of hazardous wastewaters containing spent solvents, generators of scrubber waters derived-from the incineration of spent solvents, and generators releasing de minimis amounts of listed wastes under certain conditions. There are no state and local government bodies that incur direct compliance costs by this rulemaking. State and local government implementation expenditures are expected to be less than $500,000 in any one year. Thus, Executive Order 13132 does not apply to this rule.

In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and state and local governments, EPA specifically solicited comment on the proposed rule from state and local officials.

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. Today's rule does not significantly or uniquely affect the communities of Indian tribal governments, nor would it impose substantial direct compliance costs on them. Thus, Executive Order 13175 does not apply to this rule.

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

This final rule is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.

This rule is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This final rule reduces regulatory burden. It thus should not adversely affect energy supply, distribution or use.

As noted in the proposed rule, Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This rulemaking involves environmental monitoring or measurement. Consistent with the Agency's Performance Based Measurement System (“PBMS”), EPA has decided not to require the use of specific, prescribed analytic methods. Rather, the rule will allow the use of any method that meets the prescribed performance criteria. The PBMS approach is intended to be more flexible and cost-effective for the regulated community; it is also intended to encourage innovation in analytical technology and improved data quality. EPA is not precluding the use of any method, whether it constitutes a voluntary consensus standard or not, as long as it meets the performance criteria specified.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A Major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective November 3, 2005.

Environmental protection, Hazardous waste, Recycling, Waste treatment and disposal.

I. Background and Summary of Errors

In FR Doc. 05-15406 (70 FR 47278), the final rule entitled “Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2006 Rates” (hereinafter referred to as the FY 2006 final rule), there were technical errors that are identified and corrected in the regulations text of this correcting amendment. The provisions of this correcting amendment are effective August 12, 2005.

On page 47487 of the FY 2006 final rule, we made technical errors in the regulation text of § 412.230(d)(2)(iii). In this paragraph, we inadvertently omitted qualifying language related to our reclassification policy. Accordingly, we are revising § 412.230(d)(2)(iii) to accurately reflect our policy on reclassification of a campus of a multicampus hospital. Therefore, on page 47487 first column, lines 23 through 25, the phrase “may seek reclassification to a CBSA in which another campus(es) is located” would be corrected to read “may seek reclassification only to a CBSA in which another campus(es) is located” and on lines 29 and 30, the phrase “may submit” would be corrected to read “must submit.”

We ordinarily publish a notice of proposed rulemaking in the Federal Register to provide a period for public comment before the provisions of a rule take effect in accordance with section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we can waive the notice and comment procedures if the Secretary finds, for good cause, that the notice and comment process is impracticable, unnecessary or contrary to the public interest, and incorporates a statement of the finding and the reasons therefore in the rule. We can also waive the 30-day delay in effective date under the APA (5 U.S.C. 553(d)) when there is good cause to do so and we publish in the rule an explanation of our good cause.

Our policy on reclassification of a campus of a multicampus hospital in the FY 2006 final rule has previously been subjected to notice and comment procedures. These corrections are consistent with the discussion of this policy in the FY2006 final rule and do not make substantive changes to this policy. This correcting amendment merely corrects technical errors in the regulations text of the FY 2006 final rule. As a result, this correcting amendment is intended to ensure that the FY 2006 final rule accurately reflects the policy adopted in the final rule. Therefore, we find that undertaking further notice and comment procedures to incorporate these corrections into the final rule is unnecessary and contrary to the public interest.

For the same reasons, we are also waiving the 30-day delay in effective date for this correcting amendment. We believe that it is in the public interest to ensure that the FY 2006 final rule accurately states our policy on reclassification of a campus of a multicampus hospital. Thus delaying the effective date of these corrections would be contrary to the public interest. Therefore, we also find good cause to waive the 30-day delay in effective date.

Given the errors summarized in section I of this correcting amendment, we are making the following correcting amendments to 42 CFR Part 412:

The modified BFEs are not listed for each community in this interim rule. However, the address of the Chief Executive Officer of the community where the modified BFE determinations are available for inspection is provided.

Any request for reconsideration must be based on knowledge of changed conditions or new scientific or technical data.

The modifications are made pursuant to Section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR Part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified BFEs are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities.

The changes in BFEs are in accordance with 44 CFR 65.4.

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

Regulatory Flexibility Act. The Mitigation Division Director of the Emergency Preparedness and Response Directorate certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are required to maintain community eligibility in the NFIP. No regulatory flexibility analysis has been prepared.

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

Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

Executive Order 12778, Civil Justice Reform. This rule meets the applicable standards of Section 2(b)(2) of Executive Order 12778.

The Federal Emergency Management Agency makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Mitigation Division Director of the Emergency Preparedness and Response Directorate has resolved any appeals resulting from this notification.

The modified BFEs are not listed for each community in this notice. However, this rule includes the address of the Chief Executive Officer of the community where the modified BFE determinations are available for inspection.

The modifications are made pursuant to Section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR Part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The modified BFEs are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).

These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities.

These modified BFEs are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings.

The changes in BFEs are in accordance with 44 CFR 65.4.

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

Regulatory Flexibility Act. The Mitigation Division Director of the Emergency Preparedness and Response Directorate certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are required to maintain community eligibility in the NFIP. No regulatory flexibility analysis has been prepared.

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

Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

Executive Order 12778, Civil Justice Reform. This rule meets the applicable standards of Section 2(b)(2) of Executive Order 12778.

The Federal Emergency Management Agency makes the final determinations listed below for the BFEs and modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Mitigation Division Director of the Emergency Preparedness and Response Directorate has resolved any appeals resulting from this notification.

This final rule is issued in accordance with Section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and 44 CFR Part 67.

The Federal Emergency Management Agency has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR Part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community.

The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

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

Regulatory Flexibility Act. The Mitigation Division Director of the Emergency Preparedness and Response Directorate certifies that this rule is exempt from the requirements of the Regulatory Flexibility Act because modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are required to establish and maintain community eligibility in the NFIP. No regulatory flexibility analysis has been prepared.

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

Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

Executive Order 12778, Civil Justice Reform. This rule meets the applicable standards of Section 2(b)(2) of Executive Order 12778.

On August 24, 2004, NHTSA published (69 FR 52070) a final rule amending the agency's regulations that pertain to the importation by RIs of motor vehicles that were not originally manufactured to comply with all applicable Federal motor vehicle safety, bumper, and theft prevention standards. The agency noted that some RIs have engaged in conduct that, while not expressly prohibited by the RI regulations previously in effect, was nevertheless in need of scrutiny. See 69 FR at 52073. To address concerns about this conduct, the amendments require, among other things, that RIs and applicants for RI status submit additional information beyond what they had previously been required to submit to acquire and maintain their registrations.

One of the information items that each RI and applicant for RI status is required to submit under the final rule is the social security number of each of its principals or partners and each person authorized to sign statements certifying to NHTSA that vehicles the RI has imported or modified conform to all applicable Federal motor vehicle safety and bumper standards. As stated in the final rule at 52074, the agency decided to require this information so that it could determine whether any person associated with an applicant has ever been convicted of a misdemeanor or felony involving motor vehicles or the motor vehicle business.

The final rule also identified and proscribed certain practices of RIs that were not specifically addressed by the previously existing RI regulations because they were not contemplated at the time those regulations were adopted in 1989. Among these were efforts on the part of some RIs to import heavily damaged motor vehicles both before and after their repair (referred to as “salvage vehicles”), or vehicles comprised of the body of one vehicle and the chassis and frame of another (referred to as “reconstructed vehicles”). The agency noted that there can be no assurance that a salvage or reconstructed motor vehicle can be restored to a condition in which it complies or can be brought into compliance with the Federal motor vehicle safety standards (FMVSS). See 69 FR at 52089. As a consequence, the agency adopted a requirement in the final rule (49 CFR 591.5(f)(3)) for the importer to declare at the time of entry that the “vehicle is not a salvage motor vehicle or a reconstructed motor vehicle.”

The agency also adopted definitions for each of these terms, which were added to those in 49 CFR 591.4. Under those definitions, a “reconstructed motor vehicle means a motor vehicle whose body is less than 25 years old and which is mounted on a chassis or frame that is not its original chassis or frame and that is less than 25 years old.” A “salvage motor vehicle” means:

A motor vehicle, whether or not repaired, which has been:

The agency observed in the preamble to the final rule that an RI may license or register an imported motor vehicle for use on public roads, or release custody of a motor vehicle to a person for license or registration for use on public roads “only after 30 days after the registered importer certifies [to NHTSA] that the motor vehicle complies [with applicable FMVSS].” See 69 FR at 52082, quoting 49 U.S.C. 30146(a)(1). An RI performs this function by submitting to the agency a statement certifying that the vehicle complies with all applicable standards in effect on its date of manufacture, supported by documentary and photographic evidence of the modifications that it made to the vehicle to achieve conformity with those standards. This submission is commonly referred to as a “conformity package.” The agency noted in the final rule that it has construed 49 U.S.C. 30146(a)(1) as allowing an RI to license or register a vehicle, or release custody of a vehicle for use on public roads less than 30 days after receipt of the conformity package if NHTSA has notified the RI that the DOT Conformance bond furnished for the vehicle at the time of importation has been released. Id. The agency further noted that it has attempted to accommodate RIs by expediting the process for releasing Conformance bonds, and had been able in 2002 to achieve a reduction in the processing time to an average of five days from the receipt of the conformity package. Id. Despite these efforts to reduce the processing time for the release of Conformance bonds, the agency noted that “in some instances vehicles imported from Canada have been shipped directly to auction houses or dealers and sold very soon after entry, before bonds were released, and in some instances, even before we had received a certification of conformity from the RI.” Id.

To curtail these practices, in the final rule the agency adopted certain measures to better ensure that RIs retain imported nonconforming vehicles for the requisite period before they are released for use on public roads. Among these is a provision (added to 49 CFR 592.6(e)(5)) stating that an RI may not “release custody of [a motor vehicle it imports] to a person for sale, or for license or registration for use on public streets, roads, and highways, or for titling in a name other than that of the Registered Importer who imported the vehicle” until the DOT Conformance bond furnished for the vehicle at the time of importation has been released or until 30 days have elapsed from the date the RI submits a conformity package covering the vehicle to NHTSA. As part of the final rule, NHTSA also amended the provision on bond forfeiture at 49 CFR 592.9(e) to state that a bond may be forfeited if an RI “licenses or registers the vehicle, including titling the vehicle in the name of another person, unless 30 calendar days have elapsed after the Registered Importer has filed a complete certification [of conformity].”

The final rule amended 49 CFR 592.6, which specifies the duties of a registered importer, to address specific problematic activities by some RIs and to clarify the duties of an RI. One of the amendments to 49 CFR 592.6 requires an RI to certify, at the time it submits a conformity package for a nonconforming vehicle it has imported, either that the vehicle is not required to comply with the parts marking requirements of the Theft Prevention Standard at 49 CFR Part 541, or that the vehicle complied with those requirements as originally manufactured. See 49 CFR 592.6(d)(1)(i) and (ii). Another new requirement, specified at 49 CFR 592.6(d)(7), is for the RI to submit to the agency, as part of the conformity data for the second and each subsequent vehicle of a particular make, model, and model year that it brings into conformity with all applicable standards, information including a description of the modifications performed (§ 592.6(d)(1)(ii)), unaltered front, side, and rear photographs of the vehicle (§ 592.6(d)(1)(vi)), and unaltered photographs and documentation sufficient to demonstrate conformity with all applicable Federal motor vehicle safety and bumper standards to which the vehicle was not originally manufactured to conform (§ 592.6(d)(1)(viii)). A third requirement, specified at 49 CFR 592.6(j)(1), is for the RI to allow representatives of NHTSA, upon demand and the presentation of credentials, to inspect facilities where a vehicle for which the RI has submitted a certificate of conformity to the agency is being modified, repaired, or stored, and any facility where any record or other document relating to the modification, repair, testing or storage of such a vehicle is kept. A fourth requirement, at 49 CFR 592.6(e)(1), prohibits an RI, prior to the release of the DOT Conformance bond furnished for a vehicle at the time of importation, from operating the vehicle on the public streets, roads, and highways for a purpose other than transportation to and from a franchised dealership of the vehicle's original manufacturer for remedying a noncompliance or a safety-related defect.

The final rule also amended 49 CFR 592.7, which specifies the acts and omissions that may result in the suspension or revocation of an RI's registration, as well as the process for taking such action and the conditions for reinstating a suspended registration. One provision of that section (§ 592.7(a)(2)) states that NHTSA may automatically suspend an RI's registration if the Administrator decides that the RI has knowingly filed a false or misleading certification with the agency.

In response to the final rule, the agency received one petition for reconsideration. This was submitted by Mr. Philip Trupiano of Auto Enterprises, Inc., an RI located in Warren, Michigan. The petition offered various objections and suggestions. In the petition, Mr. Trupiano takes exception to some aspects of the requirement in the final rule that bars RIs from importing salvage vehicles. The petition also challenges NHTSA's authority to seek forfeiture of a DOT conformance bond if an RI licenses or titles the vehicle covered by the bond less than 30 days after submitting to NHTSA conformance certification data on that vehicle. The petition further seeks the amendment of the provision in the final rule requiring an RI to divulge to the agency the social security numbers of its principals. The requested amendment would restrict access to that information and ensure that it is used only for the purpose of carrying out the vehicle safety laws administered by NHTSA. In addition, the petition seeks amendments to a provision of the final rule enumerating the responsibilities of an RI. The requested amendments would permit RIs to import motor vehicles that have been modified to comply with the Theft Prevention Standard, would waive the requirement for an RI to submit information and photographs to document the modifications that it makes to a nonconforming vehicle, would require the agency to provide an RI with at least 48 hours advance notice before inspecting one of its facilities, and would allow an RI who is also an Independent Commercial Importer (ICI) licensed by the Environmental Protection Agency (EPA) to operate a vehicle on public roads to conduct testing required by that agency. Lastly, the petition seeks the amendment of provisions specifying the acts and omissions that may result in the revocation or suspension of an RI's registration. The requested amendment would make an RI's registration subject to automatic suspension for knowingly filing “a fraudulent certification” instead of a “false or misleading certification.” Each of these issues is addressed below:

The final rule includes a requirement for the importer of a motor vehicle to declare at the time of entry that the “vehicle is not a salvage motor vehicle or a reconstructed motor vehicle. See 49 CFR 591.5(f)(3). The petitioner agrees with the principle that salvage vehicles should be prohibited from entry and that vehicles that are not capable of being repaired to comply with the FMVSS should not be allowed on American roads. He contends, however, than an RI may lack knowledge that any given vehicle it is importing is a repaired salvage vehicle if the repairs to that vehicle were properly done. As a consequence, the petitioner asserts that the prohibition upon the importation of salvage vehicles is not practical, is overly restrictive, and wrongly assumes that RIs are capable of determining whether any vehicle they import is a repaired salvage vehicle. Moreover, the petitioner contends that this prohibition has no clear statutory basis and could subject to civil liability an RI who unknowingly imports a salvage vehicle.

The petitioner observes that there are providers of vehicle history information who can identify whether a particular vehicle had been assigned a previous salvage or rebuilt brand. In view of the availability of this information, the petitioner asks NHTSA to require the RI to perform a computer database search of Canadian motor vehicle registration records covering every Canadian province or territory to determine whether the vehicle has ever had a salvage or rebuilt brand, and to provide a copy of the search confirming no prior salvage history as part of the documentation it submits to the agency to certify that the vehicle conforms to all applicable standards. In addition to, or as an alternative to this requirement, the petitioner states that the agency should require the RI to employ on a full-time basis a licensed collision repair mechanic, or where such licensing is not required, a mechanic holding an Automotive Service Excellence (“ASE”) certification in collision repair to inspect vehicles for evidence of repaired damage. If the agency chooses not to adopt either of the above suggestions, the petitioner asks that it change the operative language of 49 CFR 591.5(f)(3) to restrict the importation of repaired salvage vehicles only when the RI has knowledge of that status.

Agency response: The agency is denying petitioner's request. The rationale for adopting the prohibition on the importation of salvage or reconstructed vehicles was stated in the notice of proposed rulemaking (NPRM) that preceded the final rule. There, the agency stated that “when a vehicle has been heavily damaged or reconstructed, we have no assurance that it can be restored to a condition in which it complies, or can be brought into compliance with, the Federal motor vehicle safety standards.” See 65 FR at 69824. An RI would face a significant burden in proving, to the agency's satisfaction, that a vehicle that has been heavily damaged or reconstructed has been brought into compliance with all applicable FMVSS. Absent such proof, there would be no basis on which the agency could release the DOT Conformance bond furnished for the vehicle at the time of entry.

To avoid these problems, the provision adopted in the final rule requires RIs to file a declaration, at the time of entry, stating that the vehicle is not a salvage motor vehicle or a reconstructed motor vehicle. This declaration is to be made on the HS-7 Declaration form, which is the official NHTSA form required to import a motor vehicle. To make such a declaration, it is incumbent upon the RI to determine that the vehicle to be imported is not a salvage motor vehicle or a reconstructed motor vehicle. There are various ways to assure that the vehicle has not been salvaged or rebuilt.

The petitioner suggests two alternative methods to determine whether the vehicle is a salvage or a reconstructed vehicle—a computer database search of registration records or an inspection by a certified collision specialist. The petitioner specifically recommends that RIs be required to perform a computer database search of Canadian motor vehicle registration records covering every Canadian province or territory to determine whether the vehicle has ever had a salvage or a rebuilt brand. The agency notes that it rejected a similar request, made in response to the NPRM. The request there in issue sought an amendment requiring RIs to conduct lien searches across Canada and then to provide a statement regarding this research on each vehicle they import, to ensure that there are no outstanding Canadian liens on the vehicle. See 69 FR at 52075.

NHTSA's regulation imposes a requirement to preclude the importation of salvage motor vehicles and rebuilt motor vehicles. The agency will not delete this requirement and substitute in its place steps that may be taken to achieve this end result. While it recognizes that the computer database search recommended by the petitioner may be helpful in certain circumstances, NHTSA is not requiring that such a search be performed. RIs are nevertheless free to perform the computer database search the petitioner suggests to assess whether a particular vehicle is a salvage or a reconstructed motor vehicle.

The agency also rejected a comment to the NPRM requesting an amendment similar to the petitioner's other alternative—to require the RI to employ on a full-time basis a licensed collision repair mechanic, or where such licensing is not required, an ASE certification in collision repair to inspect vehicles for evidence of repaired damage. The comment addressed in the final rule recommended that NHTSA require that an RI be specifically licensed to operate as a motor vehicle repair facility and to have at least one employee who is a licensed mechanic in the State where the RI is located. See 69 FR at 52076. In rejecting this comment, the agency stated that it is not conversant with the laws of the various States that relate to this issue, and observed that there may be some that do not require the licensing of auto repair mechanics. Id . For the same reason, the agency is unwilling to accept the petitioner's suggestion that it require RIs to employ full-time mechanics licensed in collision repair to inspect vehicles for evidence of repaired damage. However, the agency recognizes that inspection of the vehicle by a repair specialist would often be a reasonable approach for RIs to take. Any such inspection would have to occur following the vehicle's importation into the United States, and therefore could not provide the basis for the importer's declaration at the time of entry that the vehicle is not a salvage motor vehicle or a reconstructed motor vehicle.

The petitioner expressed concern that the provision at issue could subject to civil liability an RI that unknowingly imports a salvage or a reconstructed motor vehicle. The agency recognizes that sanctions, such as civil penalties or the suspension or revocation of an RI registration, could be brought against an RI that files a false declaration, i.e. , one that declares that a vehicle is not a salvage or a reconstructed vehicle if it is discovered after importation that the vehicle is, in fact, such a vehicle. In these circumstances, the agency gives consideration to the circumstances of the violation. See e.g., 49 U.S.C. 30165(b) (“In determining the amount of a civil penalty or compromise, the appropriateness of the penalty or compromise to the * * * gravity of the violation shall be considered.”). See also 49 CFR 592.7(b), affording an RI that is notified that its registration may be suspended or revoked “an opportunity to present data, views, and arguments * * * as to whether the violation occurred, why the registration ought not be suspended or revoked, or whether the suspension should be shorter than proposed.”). An RI that faced civil penalties or the revocation or suspension of its registration for improperly declaring a salvage or reconstructed vehicle could therefore raise its documented due diligence as a factor that may mitigate a penalty or other sanction.

In view of these considerations, the agency will not amend the language of 49 CFR 591.5(f)(3) to qualify the declaration in the manner the petitioner has suggested.

The petitioner also takes issue with provisions in the final rule (49 CFR 591.8(d)(3) and 592.9(e)) that prohibit an RI from releasing custody of an imported nonconforming motor vehicle to any person for license or registration for use on public roads, streets, or highways, or from licensing or registering the vehicle from the date of entry until 30 calendar days after it has certified compliance of the vehicle to the Administrator, unless the RI is sooner notified that the Administrator has accepted its certification of the vehicle's compliance and permits the bond to be released. As amended, section 592.9(e) states that the bond may be forfeited if the RI releases custody of the vehicle to any person for license or registration for use on public roads, streets, or highways, or licenses or registers the vehicle, including titling the vehicle in the name of another person, unless 30 calendar days have passed from the date the RI files a certificate of conformity with the agency and the RI has not received written notice from the agency to hold the vehicle for the agency's inspection.

The petitioner specifically contends that NHTSA lacks statutory authority to adopt the above provisions and observes that if those provisions are allowed to stand, as amended, there will be fewer surety bond companies that issue conformance bonds and huge increases in the cost of such bonds to importers. The petitioner notes that the amount of the conformance bond has been set by the agency at 150% of the dutiable value of the vehicle. Observing that the average new car today can cost in excess of twenty thousand dollars, the petitioner states that an RI can face a penalty of up to thirty thousand dollars for failing to bring a single vehicle into compliance with all applicable standards. The petitioner questions why a penalty of such magnitude should be imposed on an RI when it has only defaulted on the bond conditions by titling or registering the vehicle within thirty days, or by releasing the vehicle after the RI has modified it to conform to all applicable standards and submitted a statement of conformity to the Administrator.

The petitioner asserts that almost all titles obtained for vehicles imported for resale are “Resale” titles that specifically prohibit the licensing or registration of the vehicle on the public roads. The petitioner further observes that the act of titling does not place the vehicle on public roads, and that only the issuance of a license plate to the end user can accomplish that. Observing that the only purpose of the challenged provisions can be to further delay the importation process, the petitioner finds them out of character with the agency's earlier attempt in this rulemaking proceeding to entirely relax the bonding requirement for Canadian market vehicles.

The petitioner contends that under the controlling statute (49 U.S.C. 30141(d)(1)), the purpose of the conformance bond is to ensure that the vehicle will comply with applicable FMVSS within a reasonable time after importation or will be exported at no cost to the Government or exported from the United States. The petitioner asserts that there is nothing in the controlling statute that confers, or appears to confer on the Administrator the authority to declare the default of a conformance bond under the circumstances described above. According to the petitioner, a more appropriate means for the agency to address violations that do not involve issues of compliance with the FMVSS is by taking civil penalty action against the violator.

The petitioner requests that the language prohibiting titling of the vehicle be stricken from the provisions at issue, and that the agency issue clarification to the RI community and surety companies that reinforces the statutory language that the conformance bond is for the purpose of ensuring that a nonconforming vehicle is brought into compliance with applicable standards by an RI or is exported from, or abandoned to, the United States.

Agency response: The agency is denying the petitioner's request for these changes. Contrary to the petitioner's assertions, the agency finds the provisions at issue to be amply supported by the statute that controls the vehicle importation process. For example, 49 U.S.C. 30146(a)(1) explicitly provides that an RI

Consistent with this statutory provision, one of the conditions of the DOT Conformance bond, in existence since the regulations governing those instruments were first issued on March 28, 1990 (55 FR 11375, 11379), has been as follows:

From the outset of the RI program, some fifteen years ago, the DOT Conformance bond has been subject to forfeiture if the RI releases custody of a nonconforming vehicle to any person for license or registration for use on public roads, streets, or highways, or licenses or registers the vehicle from the date of entry until 30 calendar days after it has certified compliance of the vehicle to the Administrator, unless the Administrator earlier releases the bond. The final rule has not amended this requirement in any respect, except to add titling of a vehicle in the name of another entity as an unlawful act. As noted in the NPRM (65 FR 69810, 69820), we added this prohibition to ensure that the RI retains the ability to export the vehicle, or abandon it to the United States, upon demand, for its failure to conform the vehicle within the requisite period, as required by 49 U.S.C. 30141(d)(1)(B) and 49 CFR 591.7(d)(6).

Long before he submitted the instant petition, Mr. Trupiano had written to the agency, on November 11, 1999, asking whether an RI may obtain a title for resale purposes for a vehicle that it has imported, prior to the time the conformance bond covering the vehicle is released by the agency. The agency responded by letter dated April 17, 2000 (accessible on the agency's Web site at http://www.nhtsa.dot.gov/cars/rules/interps/files/title.ztv.html ). We noted in this response that we do not construe 49 U.S.C. 30146(a)(1) “as prohibiting an RI from obtaining a title in its own name to a vehicle it has imported for resale, while the vehicle is still bound by its [Conformance] bond, in order to expedite the subsequent licensing or registration of that vehicle for on-road use after the bond has been released.” Id. The agency stated, however, that the title could not be in the name of the customer on whose behalf the vehicle is imported, as that would be inconsistent with the bond condition requiring the vehicle to be exported or abandoned to the United States in the event that an insufficient showing of conformity is made and the bond is not released. Id. See 49 U.S.C. 30141(d)(1)(B). The agency further noted that “if the RI has transferred or reassigned title to the vehicle to the “customer on whose behalf the vehicle is imported” before the bond has been released, the RI could not fulfill its duty to export or abandon the nonconforming vehicle because it would no longer own the vehicle.” Id. The agency observed that in this instance, its only recourse would be to foreclose on the bond, which would be “insufficient to fulfill the safety purpose of the statute and the bond which is to ensure that imported noncomplying vehicles be brought into compliance before being licensed for use, and used, on the public roads.” Id. There have been no changes in the underlying statute or in the RI program itself that would cause the agency to reassess the validity of this position.

For the same reasons cited in its letter to Mr. Trupiano, the agency denies his request that it strike from the regulation language prohibiting the titling of an imported nonconforming vehicle in the name of a person other than the RI prior to bond release. The agency notes that with the exception of the two instances in which Mr. Trupiano has raised issues regarding this requirement, no other RI has identified it as posing any problem.

The petitioner seeks the amendment of provisions in the final rule (49 CFR 592.5(a)(4)(ii) and (iii)) requiring an RI or an applicant for RI status to submit to the agency, among other information items needed to acquire or retain an RI registration, the social security numbers of its principals. The petitioner states that he understands that NHTSA officials reviewing RI applications or renewals have appropriate reasons to request social security numbers, especially to determine the applicant's or incumbent's financial ability to conduct recall campaigns to remedy safety-related defects or noncompliances with safety standards in the vehicles it imports. The petitioner expresses concern, however, that “other NHTSA employees who have no valid reason to have access to this private information may make it public with obvious breach of privacy and potential identity theft and other related problems.” To guard against such an eventuality, the petitioner asks the agency to amend the provisions in question to restrict access to that information and to ensure that it is used only for the purpose of carrying out the vehicle safety laws administered by NHTSA.

Agency response: Since receiving the petition, the agency has reassessed the need for an applicant for RI status to submit to the agency the social security numbers of its principals. As previously noted, the agency sought this information so that it could determine whether any person associated with an applicant has been convicted of a misdemeanor or felony involving motor vehicles or the motor vehicle business, such as title fraud, odometer fraud, auto theft, or the sale of stolen vehicles. See 69 FR at 52074. The agency has since learned that a social security number is not an information element that is needed for the purpose of conducting a background check on an applicant for a Federal license. Accordingly, the agency is amending sections 592.5(a)(4)(ii) and (iii) to eliminate the requirement for applicants for RI status to submit this information.

The petitioner requests the agency to make certain amendments to 49 CFR 592.6, which enumerates the responsibilities of an RI. Each of these requests, and the agency's response thereto, is set forth below.

The petitioner first requests the agency to amend section 592.6(d)(1) to expressly permit the importation of a motor vehicle modified prior to importation by any entity to comply with the Theft Prevention Standard at 49 CFR part 541. The provision currently requires an RI to certify to the Administrator, upon the completion of modifications necessary to conform the vehicle to applicable standards, that either “(1) the vehicle is not required to comply with the parts marking requirements of the theft prevention standard, or (2) the vehicle complies as manufactured with those parts marking requirements.”

Agency response: In the final rule, the agency precluded an RI from conforming a motor vehicle to comply with the Theft Prevention Standard following importation. The agency took this position after considering a comment in response to the NPRM (65 FR at 69810), which noted that the statute authorizing the Theft Prevention Standard (49 U.S.C. 33114), unlike the statutes authorizing the Safety and the Bumper Standards (49 U.S.C. 30112, 30146, and 32506), has no provision to allow a vehicle that does not comply with that standard to be brought into conformity following importation. See 69 FR at 52079. Although it recognized that it could not allow conforming modifications to be performed following importation, the agency did not intend to preclude the importation of vehicles that are modified to comply with the Theft Prevention Standard prior to importation. However, the text of the provision adopted by the agency in 49 CFR 592.6(d)(1) inadvertently went beyond this intent by prohibiting the importation of a vehicle that was not originally manufactured to comply with the parts marking requirements of the Theft Prevention Standard. Because we did not intend to preclude the importation of vehicles that are modified to comply with the Theft Prevention Standard prior to importation, we are amending section 592.6(d)(1). As amended, the section excludes vehicles that do not comply with the Theft Prevention Standard at the time of importation, as opposed to those that were not originally manufactured to comply with that standard.

The petitioner next requests the agency to amend 49 CFR 592.6(d)(7) to waive the requirement for an RI to submit, with second and subsequent certification submissions that it makes to the agency for a given make, model, and model year vehicle, unaltered front, side, and rear photographs of the vehicle, as required by 49 CFR 592.6(d)(6)(vi); unaltered photographs and documentation sufficient to demonstrate conformity with all applicable Federal motor vehicle safety and bumper standards to which the vehicle was not originally manufactured to conform, as required by 49 CFR 592.6(d)(6)(viii); as well as a statement that it has brought the vehicle into conformity with all Federal motor vehicle safety and bumper standards that apply to the vehicle, and a description, with respect to each standard for which modifications were needed, of the modifications performed, as required by 49 CFR 592.6(d)(6)(ii). The petitioner contends that the information and photographs required by these sections would be redundant, superfluous, and create unnecessary additional burdens on the RI without providing any safety benefit to the public. In particular, the petitioner asserts that pictures of the outside of a car do not show any distinguishable differences relevant to a compliance evaluation, especially in the case of a vehicle originally manufactured for sale in Canada. In lieu of furnishing this evidence to NHTSA, the petitioner suggests that RIs making modifications to vehicles, such as the replacement of instrument clusters on Canadian market vehicles or more extensive modifications in the case of non-Canadian vehicles, should be required to maintain in their records evidence, including written invoices of parts purchases and labor operations that can be requested by NHTSA on an individual basis or viewed during an agency inspection visit, as contemplated under 49 CFR 592.6(j).

Agency response: The agency notes that if it were to grant this request, it would essentially relieve the RI from any obligation to establish to the agency's satisfaction, upon the completion of conformance modifications, that it has brought a nonconforming vehicle into compliance with all applicable standards. The agency would thereby relinquish the principal tool at its disposal to ensure that nonconforming vehicles offered for importation into the United States are successfully modified to comply with all applicable safety and bumper standards.

The agency will not eliminate the need for an RI to submit documentation to verify the conformity status of nonconforming vehicle it has imported or modified. For one thing, the governing statute (49 U.S.C. 30146(a)) contemplates that a certification of compliance be made to the Secretary of Transportation, in the manner the Secretary prescribes, to permit the release of a conformance bond furnished at the time of entry. The agency further notes that the alternative to the submission of conformity data that the petitioner recommends ( i.e. , that NHTSA conduct periodic inspections at RI facilities of records, including written invoices of parts purchases and labor operations) is simply not workable since it is dependent on the existence of human and financial resources that are not available to the agency. The petitioner takes issue particularly with the requirement in 49 CFR 592.6(d)(6)(vi) for the submission of unaltered front, side, and rear photographs of the vehicle. The agency requires these photographs so that it can confirm that the vehicle is of the make, model, and model year that it was declared to be at the time of importation, and that it is equipped with all required turn signal lamps, sidemarkers, and other lighting equipment. For those reasons, the agency has decided to deny this request.

The petitioner asks the agency to amend 49 CFR 592.6(j), which requires an RI to allow representatives of NHTSA, “upon demand and upon presentation of credentials,” to inspect any facility identified by the RI as one in which a nonconforming vehicle is being modified, repaired, tested, or stored, and any facility where any record or other document relating to the modification, repair, testing, or storage of these vehicles is kept. The requested amendment would require the agency to provide an RI with at least 48 hours advance notice before inspecting one of its facilities. In support of this request, the petitioner observes that RIs are small businesses with limited resources and employees. The petitioner contends that sufficient notice is necessary for these entities to be able to ensure that the appropriate personnel are on hand to respond to the agency official's questions and to prepare to make available any records that may be requested.

Agency response: As a general matter, regulatory agencies need to be able to conduct inspections without notice to obtain a true picture of whether the regulated entity is complying with applicable requirements. In contrast, advance notice would provide time for the regulated entity to undertake corrective actions between the time of the notice and the inspection. In these circumstances, the inspection does not provide a representative picture of the degree to which the regulated entity is adhering to the requirements it must meet. Moreover, limiting inspections to those preceded by advance notice encourages some level of noncompliance because the regulated entity knows that it will have time to undertake corrective measures before the inspection is conducted.

The agency does periodically conduct inspections at RI facilities to ensure the adequacy of those facilities for vehicle modification and storage, to assess the state of the records the RI is required to maintain on the vehicles it modifies, and to ensure that the RI has sufficient personnel on hand to perform its responsibilities. The periodic inspections also allow the agency to ascertain whether the RI is properly holding vehicles prior to bond release. Advance notice of a pending inspection would significantly undermine the agency's ability to ensure that these and other obligations of an RI are being carried out. As a consequence, the agency denies this request.

The petitioner requests an amendment to 49 CFR 592.6(e)(1), which prohibits an RI from operating on public streets, roads, and highways a nonconforming vehicle that has not been bond released, “for a purpose other than transportation to and from a franchised dealership of the vehicle's original manufacturer for remedying a noncompliance or safety-related defect.” The requested amendment would allow an RI that is also an Independent Commercial Importer (ICI) recognized by the Environmental Protection Agency (EPA) to operate a nonconforming vehicle on public roads prior to bond release “for the purpose of mileage accumulation to operate and stabilize the emissions control systems in the vehicle, as required by EPA prior to emissions laboratory testing.” The petitioner notes that this mileage is set by the EPA to be between 2,000 and 10,000 miles, depending on the type of vehicle and the engine displacement. The petitioner observes that otherwise, the ICI could not begin the emissions development program until after the safety certification process is complete.

Agency response: The agency contacted the EPA with regard to this matter. The EPA stated that mileage accumulation is needed to stabilize a new vehicle's catalyst and emissions control systems before pre-certification testing is conducted to obtain an EPA certificate of conformity. The EPA stated that it prefers the mileage accumulation to be performed on a closed test track, but that it will grant permission for the mileage accumulation to be performed on public roads when the use of a test track is not feasible. This permission must be granted in writing and that permission will only be granted to an ICI that holds a current certificate of conformity from the EPA, and the ICI has imported the vehicle under an EPA Declaration form 3520-1 on which Code J is checked. The EPA further indicated that the amount of mileage accumulated is generally in the range of 2,000 miles, plus or minus 250 miles.

Based on the information that it obtained from the EPA, the agency is amending the provision at issue to allow an imported nonconforming vehicle to be operated on public roads prior to bond release for the purpose of mileage accumulation to stabilize the vehicle's catalyst and emissions control systems in preparation for pre-certification testing to obtain an Environmental Protection Agency (EPA) certificate of conformity, but only insofar as the vehicle has been imported by an Independent Commercial Importer (ICI) that holds a current certificate of conformity from the EPA, the ICI has imported the vehicle under an EPA Declaration form 3520-1 on which Code J is checked, and the EPA has granted the ICI written permission to operate the vehicle on public roads for that purpose.

The petitioner requests an amendment to 49 CFR 592.7(a)(2), which states: “If the Administrator decides that a Registered Importer has knowingly filed a false or misleading certification, (s)he shall promptly notify the Registered Importer in writing that its registration is automatically suspended.” The requested amendment would make an RI's registration subject to automatic suspension for knowingly filing “a fraudulent certification” instead of a “false or misleading certification.” In support of this request, the petitioner contends that “such a drastic enforcement measure, which could cause irreversible harm to the RI, must be made only on the basis that the violation poses genuine harm to the safety of the motoring public.” The petitioner observes that even though “automatic suspension should obviously not be used to punish clerical error,” use of the terminology “false or misleading” in the section at issue “could be misconstrued and used by an overzealous official as the basis for automatically suspending an RI's license.” For the petitioner, the basis for an automatic suspension should therefore be the filing of a “fraudulent certification” instead of a “false or misleading” one.

Agency response: The agency notes that the language of § 592.7(a)(2) is derived from the controlling statute, 49 U.S.C. 30141(c)(4)(B), which directs the Secretary of Transportation to establish procedures for “automatically suspending a registration for not paying a fee under subsection (a)(3) of this section in a timely manner or for knowingly filing a false or misleading certification under section 30146 of this title.” In light of this requirement, the agency will not amend the provision at issue in the manner petitioner has requested. The agency also notes that it disagrees with the petitioner's contention that the only violations that can result in the suspension of an RI registration are those that pose genuine harm to the safety of the motoring public.

The agency is also revising the text of 49 CFR 592.5(f) to correct two erroneous citations to other regulations that appear in that section. As presently written, section 592.5(f) states that an RI “must affirm in its annual statement that all information provided in its application or pursuant to § 592.6(r), or as may have been changed in any notification that it has provided to the Administrator in compliance with § 592.6(m), remains correct.” Sections 592.6(q) and 592.6(l) are substituted for the two provisions cited in this text, to correctly identify the provisions in which the described requirements are found.

Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), provides for making determinations whether a regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and to the requirements of the Executive Order. The Order defines a “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.

NHTSA has considered the impact of this rulemaking under Executive Order 12866 and the Department of Transportation's regulatory policies and procedures, and for the following reasons has determined that it is not a “significant regulatory action” within the meaning of Sec. 3 of E.O. 12866 and is not “significant” within the meaning of the Department of Transportation's regulatory policies and procedures. The three non-technical amendments adopted in this rulemaking, which permit RIs to import motor vehicles that have been modified to comply with the Theft Prevention Standard, allow an RI who is also an ICI to operate an imported nonconforming motor vehicle on public roads prior to bond release solely for the purpose of conducting required EPA testing, and relieve an applicant for RI status of the need to disclose to the agency the social security numbers of its principals, can only benefit entities that stand to be affected and have no adverse consequences, financial or otherwise, for any party. This document was not reviewed by the Office of Management and Budget under E.O. 12866, “Regulatory Planning and Review.”

For the following reasons, NHTSA concludes that this final rule will not have any quantifiable cost effect on motor vehicle manufacturers or motor vehicle equipment manufacturers. The three non-technical amendments adopted in this final rule pertain only to RIs and applicants for RI registration. They have no bearing on motor vehicle manufacturers or motor vehicle equipment manufacturers, and therefore have no quantifiable cost effect on those entities.

Because the economic effects of this final rule are so minimal, no further regulatory evaluation is necessary.

Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq. , as amended by the Small Business Regulatory Enforcement Fairness Act (SBFEFA) of 1996), whenever an agency is required to publish a notice of proposed rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small governmental jurisdictions). The Small Business Administration's regulations at 13 CFR part 121 define a small business, in part, as a business entity “which operates primarily within the United States.” (13 CFR 121.105(a)). No regulatory flexibility analysis is required if the head of an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities.

The Deputy Administrator has considered the effects of this rulemaking action under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) and certifies that this final rule will not have a significant economic impact on a substantial number of small entities. The statement of the factual basis for the certification is that this final rule, formulated in response to a petition for reconsideration, makes three non-technical amendments to the agency's regulations to allow RIs to import motor vehicles that have been modified to comply with the Theft Prevention Standard, to allow an RI that is also an ICI to operate a nonconforming motor vehicle on public roads prior to bond solely release for the purpose of conducting required EPA testing, and to relieve applicants for RI status of the need to disclose to the agency the social security numbers of their principals. As such, the amendments can only have a beneficial economic impact on the entities that stand to be effected, and imposes no adverse economic impact on any party.

For these reasons, and for the reasons described in our discussion on Executive Order 12866 and DOT Regulatory Policies and Procedures, NHTSA concludes that this final rule will not have a significant economic impact on a substantial number of small entities.

NHTSA has analyzed these amendments for the purposes of the National Environmental Policy Act and determined that they will not have any significant impact on the quality of the human environment.

Executive Order 13132 requires NHTSA 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.” The Executive Order defines “policies that have federalism implications” 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.” Under Executive Order 13132, NHTSA may not issue a regulation with Federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or the agency consults with State and local officials early in the process of developing the regulation. NHTSA also may not issue a regulation with Federalism implications and that preempts State law unless the agency consults with State and local officials early in the process of developing the regulation.

NHTSA has analyzed this rulemaking action in accordance with the principles and criteria set forth in Executive Order 13132. The agency has determined that this rule will not have sufficient federalism implications to warrant consultation with State and local officials or the preparation of a federalism summary impact statement. This rule will not have any substantial effects on the States, or on the current Federal-State relationship, or on the current distribution of power and responsibilities among the various local officials. Thus, the requirements of Section 6 of the Executive Order do not apply.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires federal agencies to prepare a written assessment of the costs, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted for inflation with base year of 1995). Before promulgating a rule for which a written assessment is needed, Section 205 of the UMRA generally requires NHTSA to identify and consider a reasonable number of regulatory alternatives and to 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 NHTSA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the agency publishes with the final rule an explanation as to why that alternative was not adopted.

This rule will not result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually. Accordingly, this rule is not subject to the requirements of Sections 202 and 205 of the UMRA.

Pursuant to Executive Order 12988 “Civil Justice Reform,” this agency has considered whether this final rule would have any retroactive effect. NHTSA concludes that this final rule will not have any retroactive effect. Judicial review of the rule may be obtainable under 5 U.S.C. 702. That section does not require submission of a petition for reconsideration or other administrative proceedings before parties may file suit in court.

Under the Paperwork Reduction Act of 1995 (PRA), a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid OMB control number. This final rule eliminates an existing requirement for an applicant for RI status to submit to the agency the social security number of each of its principals, and does not impose any new information collection requirements for which a 5 CFR part 1320 clearance must be obtained.

Executive Order 13045 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 NHTSA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, we 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 us.

This rulemaking does not involve any environmental, health, or safety risks that disproportionately affect children.

Anyone is able to search the electronic form of all submissions received into any of our dockets by the name of the individual submitting the comment or petition (or signing the comment or petition, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit http://dms.dot.gov.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Pub. L. 104-113, section 12(d) (15 U.S.C. 272) directs NHTSA to use voluntary consensus standards in its regulatory activities unless doing 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, such as the Society of Automotive Engineers (SAE). The NTTAA directs the agency to provide Congress, through the OMB, explanations when we decide not to use available and applicable voluntary consensus standards.

After conducting a search of available sources, we have concluded that there are no voluntary consensus standards applicable to this final rule.

The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.

The reef fish fishery of the Gulf of Mexico is managed under the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP). The FMP was prepared by the Gulf of Mexico Fishery Management Council and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. Those regulations set the commercial quota for red grouper in the Gulf of Mexico at 5.31 million lb (2,413,636 kg) for the current fishing year, January 1 through December 31, 2005. Those regulations also require closure of the entire shallow-water grouper commercial fishery when either the red grouper quota or the shallow-water grouper quota is reached.

Under 50 CFR 622.43(a), NMFS is required to close the commercial fishery for a species or species group when the quota for that species or species group is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register . Based on current statistics, NMFS has determined the available commercial quota of 5.31 million lb (2,413,636 kg) for red grouper will be reached on or before October 10, 2005. Accordingly, NMFS is closing the commercial shallow-water grouper fishery in the Gulf of Mexico EEZ from 12:01 a.m., local time, on October 10, 2005, until 12:01 a.m., local time, on January 1, 2006. The operator of a vessel with a valid reef fish permit having shallow-water grouper aboard must have landed and bartered, traded, or sold such shallow-water grouper prior to 12:01 a.m., local time, October 10, 2005.

During the closure: (1) the sale or purchase of shallow-water grouper taken from the EEZ is prohibited; (2) when the recreational grouper fishery is open, the bag and possession limits specified in 50 CFR 622.39(b) apply to all harvest or possession of red grouper and shallow-water grouper in or from the Gulf of Mexico EEZ; and (3) when the recreational grouper fishery is closed, all harvest or possession of grouper in or from the Gulf EEZ is prohibited. The prohibition on sale or purchase does not apply to sale or purchase of red grouper or shallow-water grouper that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, October 10, 2005, and were held in cold storage by a dealer or processor.

This action is required under 50 CFR 622.43(a) and is exempt from review under Executive Order 12866.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, finds the need to immediately implement this action to close the fishery constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures would be unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule itself has been subject to notice and comment, and all that remains is to notify the public of the closure. Allowing prior notice and opportunity for public comment is contrary to the public interest because it requires time during which harvest would likely exceed the quota. Similarly, there is a need to implement this measure in a timely fashion to prevent an overage of the commercial quota of Gulf red grouper, given the capacity of the fishing fleet to exceed the quota quickly. Any delay in implementing this action would be impractical and contrary to the Magnuson-Stevens Act, the FMP, and the public interest. For these reasons, NMFS finds good cause that the implementation of this action cannot be delayed for 30 days. Accordingly, under 5 U.S.C. 553(d)(3), a delay in the effective date is waived.

NMFS published a final rule in the Federal Register on November 3, 2003 (68 FR 62250) implementing a process for years in which the full Winter I commercial scup quota is not harvested, to: allow unused quota from the Winter I period to be added to the quota for the Winter II period, and allow adjustment of the commercial possession limits for the Winter II period commensurate with the amount of quota rolled over from the Winter I period. Table 5 of the final 2005 quota specifications for summer flounder, scup, and black sea bass (70 FR 303, January 4, 2005) presented detailed information regarding Winter II possession limits, based on the amount of scup to be rolled over from Winter I to Winter II.

On August 2, 2005 (70 FR 44291), NMFS published a temporary rule in the Federal Register, transferring 2,223,502 lb (1,008,564 kg) of unused 2005 Winter I scup commercial quota to the 2005 Winter II period, resulting in an adjusted 2005 Winter II commercial scup quota and possession limit of 4,173,464 lb (1,893,051 kg) and 3,500 lb (1,588 kg), respectively. Since then, NMFS has determined that 291,135 lb (132,057 kg) of scup landed during the 2005 Winter I period were misreported as unclassified porgies or red porgies via the Electronic Dealer Reporting System, and has properly accounted for those landings as scup. The initial 2005 Winter II quota, as established in the final 2005 quota specifications (70 FR 303, January 4, 2005) is 1,949,962 lb (884,488 kg). Including updates in addition to those described above, the best available landings information as of September 18, 2005, indicates that 1,835,953 lb (832,774 kg) remain of the Winter I quota of 5,518,367 lb (2,503,089 kg). Consistent with the final rule to implement Framework Adjustment 3 to the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (68 FR 62250, November 3, 2003), the full amount of unused 2005 Winter I quota is transferred to Winter II, resulting in a revised 2005 Winter II quota of 3,785,915 lb (1,717,262 kg). Consistent with the rollover specifications established in the 2005 final specifications (70 FR 303, January 4, 2005), the 2005 Winter II possession limit is adjusted to 3,000 lb (1,361 kg) per trip to provide an appropriate opportunity for fishing vessels to obtain the adjusted Winter II quota.

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

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2005 Pacific halibut PSC limit for vessels using trawl gear is 2,000 metric tons as established by the 2005 and 2006 harvest specifications for groundfish of the GOA (70 FR 8958, February 24, 2005).

The Administrator, Alaska Region, has determined, in accordance with § 679.21(d)(7)(i), that vessels engaged in directed fishing for groundfish with trawl gear in the GOA have caught the 2005 Pacific halibut PSC limit. Therefore, NMFS is closing directed fishing for groundfish by vessels using trawl gear in the GOA, except for directed fishing for pollock by vessels using pelagic trawl gear in those portions of the GOA that remain open to directed fishing for pollock.

After the effective date of this closure the maximum retainable amounts at §§ 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for groundfish with trawl gear in the GOA. NMFS was unable to publish an action providing time for public comment because the most recent, relevant data only became available as of September 26, 2005.

The AA also finds good cause to waive the 30 day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.21 and is exempt from review under Executive Order 12866.