Discussion

We proposed to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) with a second supplemental notice of proposed rulemaking (NPRM) for a new AD for all Airbus Model A330-200, A330-300, A340-200, and A340-300 series airplanes; and Model A340-541 and A340-642 airplanes. That second supplemental NPRM was published in the Federal Register on June 26, 2008 (73 FR 36288). That second supplemental NPRM would have required revising the Airworthiness Limitations section (ALS), for all affected airplanes, by adding new Airworthiness Limitations Items to incorporate service life limits for certain items and inspections to detect fatigue cracking, accidental damage or corrosion in certain structures, in accordance with the revised ALS of the Instructions for Continued Airworthiness. That second supplemental NPRM was prompted by the issuance of new and more restrictive service life limits and structural inspections based on fatigue testing and in-service findings. The proposed actions were intended to detect and correct fatigue cracking, accidental damage, or corrosion in principal structural elements, and to prevent failure of certain life-limited parts, which could result in reduced structural integrity of the airplane.

Since the second supplemental NPRM was issued, we have published new NPRMs to propose to mandate the most recent airworthiness limitations for Model A330-200 and -300 series airplanes; and new ADs to mandate the most recent airworthiness limitations for Model A340-200 and -300 series airplanes; and Model A340-541 and -642 airplanes, as follows:

• NPRM 2010-NM-210-AD was published on March 22, 2011 (76 FR 15867) for Model A330-200 and -300 series airplanes. That NPRM proposes to revise the airplane maintenance program by incorporating “A330 Airworthiness Limitation Items,” Issue 17.

• NPRM 2010-NM-211-AD was published on March 22, 2011 (76 FR 15872) for Model A330-200 and -300 series airplanes. That NPRM proposes to revise the maintenance program by incorporating Airbus A330 ALS Part 1, “Safe Life Airworthiness Limitation Items,” Revision 05.

• AD 2011-04-05, Amendment 39-16605 was published on February 15, 2011 (76 FR 8612) for Model A340-200, -300, -500, and -600 series airplanes. That AD requires revising the maintenance program by incorporating Airbus A340 ALS Part 1—Safe Life Airworthiness Limitation Items, Revision 05.

• AD 2011-04-06, Amendment 39-16606 was published on February 15, 2011 (76 FR 8610) for Model A340-200, -300, -500, and -600 series airplanes. That AD requires revising the maintenance program by incorporating Airbus A340 Airworthiness Limitation Items, Issue 11.

Upon further consideration, we have determined that the actions required by the second supplemental NPRM are required by other ADs that were published after issuance of the second supplemental NPRM. Accordingly, the supplemental NPRM is withdrawn.

Withdrawal of the second supplemental NPRM does not preclude the FAA from issuing another related action or commit the FAA to any course of action in the future.

Since this action only withdraws a supplemental NPRM, it is neither a proposed nor a final rule and therefore is not covered under Executive Order 12866, the Regulatory Flexibility Act, or DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979).

Accordingly, we withdraw the second supplemental NPRM, Docket No. FAA-2007-27715; Directorate Identifier 2006-NM-140-AD, which was published in the Federal Register on June 26, 2008 (73 FR 36288).

Comments Invited

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2010-1327/Airspace Docket No. 10-ASW-19.” The postcard will be date/time stamped and returned to the commenter.

An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see ADDRESSES section for address and phone number) between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Central Service Center, 2601 Meacham Blvd., Fort Worth, TX 76137.

Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

This action proposes to amend Title 14, Code of Federal Regulations (14 CFR), part 71 by amending Class D airspace extending upward from the surface up to but not including 2,500 feet for standard instrument approach procedures at Denton Municipal Airport, Denton, TX. Controlled airspace is needed for the safety and management of IFR operations at the airport.

Class D airspace areas are published in Paragraph 5000 of FAA Order 7400.9U, dated August 18, 2010 and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class D airspace designation listed in this document would be published subsequently in the Order.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (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, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend controlled airspace at Denton Municipal Airport, Denton, TX.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2011-0046/Airspace Docket No. 11-ACE-1.” The postcard will be date/time stamped and returned to the commenter.

An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see ADDRESSES section for address and phone number) between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Central Service Center, 2601 Meacham Blvd., Fort Worth, TX 76137.

Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

This action proposes to amend Title 14, Code of Federal Regulations (14 CFR), part 71 by modifying Class E airspace extending upward from 700 feet above the surface for standard instrument approach procedures at Hannibal Regional Airport, Hannibal, MO. Airspace reconfiguration is necessary due to the decommissioning of the Hannibal NDB and cancellation of the NDB approach. This action would also update the airport name from “Hannibal Municipal Airport” to “Hannibal Regional Airport” and adjust the geographic coordinates to coincide with the FAA's aeronautical database. Controlled airspace is necessary for the safety and management of IFR operations at the airport.

Class E airspace areas are published in Paragraph 6005 of FAA Order 7400.9U, dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subsequently in the Order.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (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, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify controlled airspace at Hannibal Regional Airport, Hannibal, MO.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

Comments Invited

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2011-0427/Airspace Docket No. 11-AGL-7.” The postcard will be date/time stamped and returned to the commenter.

An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see ADDRESSES section for address and phone number) between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Central Service Center, 2601 Meacham Blvd, Fort Worth, TX 76137.

Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

This action proposes to amend Title 14, Code of Federal Regulations (14 CFR), Part 71 by amending Class E airspace extending upward from 700 feet above the surface to accommodate new standard instrument approach procedures at Gary/Chicago International Airport, Gary, IN. Controlled airspace is needed for the safety and management of IFR operations at the airport. Also, this action would update the airport name from Gary Regional Airport to Gary/Chicago International Airport, Gary IN.

Class E airspace areas are published in Paragraph 6005 of FAA Order 7400.9U, dated August 18, 2010 and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subsequently in the Order.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (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, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend controlled airspace at Gary/Chicago International Airport, Gary, IN.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2011-0047/Airspace Docket No. 11-AGL-1.” The postcard will be date/time stamped and returned to the commenter.

An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov . Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see ADDRESSES section for address and phone number) between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Central Service Center, 2601 Meacham Blvd., Fort Worth, TX 76137.

Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

This action proposes to amend Title 14, Code of Federal Regulations (14 CFR), Part 71 by amending Class E airspace extending upward from 700 feet above the surface for standard instrument approach procedures at Grand Marais/Cook County Airport, Grand Marais, MN. Controlled airspace is needed for the safety and management of IFR operations at the airport.

Class E airspace areas are published in Paragraph 6005 of FAA Order 7400.9U, dated August 18, 2010 and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subsequently in the Order.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (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, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend controlled airspace at Grand Marais/Cook County Airport, Grand Marais, MN.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

I. Background

This draft special controls guidance document was developed to support the proposed classification of in vitro diagnostic devices for Bacillus spp. detection, a previously unclassified preamendments device, into class II (special controls). On March 7, 2002, the Microbiology Devices Panel (the Panel) recommended that in vitro diagnostic devices for Bacillus spp. detection be classified into class II. The Panel believed that class II with the special controls (guidance document and limitations on the distribution) would provide reasonable assurance of the safety and effectiveness of the device.

After the panel meeting, FDA found three additional in vitro diagnostic devices for Bacillus spp. detection to be substantially equivalent to another device within that type. This device has the same intended use as its predicate device but makes use of newer nucleic acid amplification technology (NAAT). While NAAT detection devices exhibit technological differences from the preamendments Bacillus spp. detection devices, FDA has determined that they are as safe and effective as, and do not raise different questions of safety and effectiveness than, their predicates. (See section 513(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(i)).)

This draft guidance document identifies the proposed classification regulation and product code and issues of safety and effectiveness that require special controls. Elsewhere in this Federal Register , in its publication of the proposed classification regulation, FDA is including proposed distribution limitations as another special control. FDA believes that the special controls described in the draft guidance and the proposed regulation when combined with general controls will be sufficient to provide reasonable assurance of the safety and effectiveness of these devices.

FDA believes that adherence to the recommendations described in this guidance document, if finalized, in addition to general controls, and the special control in the proposed rule, if finalized, will provide reasonable assurance of the safety and effectiveness of in vitro diagnostic devices for Bacillus spp. detection classified under § 866.3045 (21 CFR 866.3045). If classified as a class II device under § 866.3045, an in vitro diagnostic device for Bacillus spp. detection will need to comply with the requirement for special controls; manufacturers will need to address the issues requiring special controls as identified in the guidance document or by some other means that provides equivalent assurances of safety and effectiveness as well as comply with any additional controls specified in the classification regulation itself.

Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. To receive “Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection,” you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number 1667 to identify the guidance you are requesting.

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, and 21 CFR 809.10 have been approved under OMB control number 0910-0485.

The labeling requirement listed in Section 8A, “Intended Use,” is not subject to review under the PRA because it is a public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public (5 CFR 1320.3(c)(2) and 21 CFR 1040.10(g)).

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ), either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

I. Background A. Legal Authority

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq. ), as amended by the Medical Device Amendments of 1976 (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), and the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85), establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under section 513 of the FD&C Act, FDA refers to devices that were in commercial distribution before May 28, 1976 (the date of enactment of the 1976 amendments), as “preamendments devices.” FDA classifies these devices after it: (1) Receives a recommendation from a device classification panel (an FDA advisory committee); (2) publishes the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) publishes a final regulation classifying the device. (See also section 513(d) (21 U.S.C. 360c(d)). FDA has classified most preamendments devices under these procedures.

FDA refers to devices that were not in commercial distribution before May 28, 1976, as “postamendments devices.” These devices are classified automatically by statute (section 513(f)) of the FD&C Act (21 U.S.C. 360c(f)) into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless and until: (1) FDA reclassifies the device into class I or II; (2) FDA issues an order classifying the device into class I or class II in accordance with section 513(f)(2) of the FD&C Act (21 U.S.C. 360(f)(2)), as amended by FDAMA; or (3) FDA issues an order finding the device to be substantially equivalent, under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)), to a predicate device that does not require premarket approval. The Agency determines whether a postamendments device is substantially equivalent to a predicate device by means of premarket notification procedures described in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 807.

A person may market a preamendments device that has been classified into class III through premarket notification procedures, without submission of a premarket approval application (PMA) until FDA issues a final regulation under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval. Consistent with the FD&C Act and the regulations, FDA consulted with the Panel, regarding the classification of this device.

After the enactment of the Medical Device Amendments of 1976, FDA undertook to identify and classify all preamendments devices, in accordance with section 513(b) of the FD&C Act (21 U.S.C. 360c(b)). However, in vitro diagnostic devices for Bacillus spp. detection were not identified and classified in this initial effort. FDA subsequently identified several preamendments devices for Bacillus spp. detection, including Bacillus spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to presumptively identify bacillus-like organisms in clinical specimens, antigens used to identify antibodies to B. anthracis (anti-toxin and anti-capsular) in serum, and bacteriophage used for differentiating B. anthracis from other Bacillus spp. based on susceptibility to lysis by the phage.

Consistent with the FD&C Act and the regulations, FDA held a Panel meeting on March 7, 2002, regarding the classification of the preamendments in vitro diagnostic devices for Bacillus spp. detection. After the Panel meeting, FDA found three additional in vitro diagnostic devices for Bacillus spp. detection to be substantially equivalent to another device within that type. These three devices have the same intended use as their predicate devices, but make use of newer nucleic acid amplification technology (NAAT). While they exhibit technological differences from the preamendments Bacillus spp. detection devices, FDA has determined that they are as safe and effective as, and do not raise different questions of safety and effectiveness than, their predicates. (See section 513(i) of the FD&C Act (21 U.S.C. 360c(i).)

During a public meeting held on March 7, 2002, the Panel made the following recommendation regarding the classification of in vitro diagnostic devices for Bacillus spp. detection (Ref. 1).

FDA is proposing the following identification based on the Panel's recommendation and the available information. An in vitro diagnostic device for Bacillus spp. detection is used to detect and differentiate among Bacillus spp. and presumptively identify B. anthracis ( B. anthracis ) and other Bacillus spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. This device may consist of Bacillus spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to presumptively identify bacillus-like organisms in clinical specimens; or bacteriophage used for differentiating B. anthracis from other Bacillus spp. based on susceptibility to lysis by the phage; or antigens used to identify antibodies to B. anthracis (anti-toxin and anti-capsular) in serum. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused by B. anthracis, and gastrointestinal disease and non-gastrointestinal infections caused by Bacillus cereus ( B. cereus ).

The Panel recommended that in vitro diagnostic devices for Bacillus spp. Detection be classified into class II. The Panel believed that class II with the special controls (special controls guidance document and distribution limitations) would provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as a special control for this device.

At the March 7, 2002, meeting, the Panel considered information from the literature presented by FDA (Refs. 2 to 5), information presented at the meeting by representatives from the United States Army Medical Research Institute for Infectious Diseases (USAMRIID) who shared the historical perspective on their institution's use of devices for the detection of B. anthracis and their personal experience using these devices, and the Panel's personal knowledge and experience.

Evidence presented to the Panel addressed how the preamendments devices of this type work and some of their limitations. Bacteriophage tests are used for differentiating B. anthracis from other Bacillus spp. based on susceptibility to lysis by the phage. They have been shown to specifically lyse vegetative B. anthracis and not B. cereus strains, although the phage can fail to lyse rare strains of B. anthracis. Bacillus spp. antisera tests conjugated with a fluorescent dye (immunofluorescent reagents) are used to microscopically visualize specific binding with cultured bacteria. Gram positive rods with capsules that fluoresce is presumptive evidence for identification of B. anthracis and must be confirmed with further testing. Antigen tests are used to identify antibodies to B. anthracis (anti-toxin and anti-capsular) in serum. They can be used for confirmation of anthrax if the patient survives the disease, because early antibiotic treatment does not abrogate antibody expression. However, such serological testing is most useful for monitoring responses to anthrax vaccines and for epidemiological investigations.

The Panel recommended prescription use of the device, with the added restrictions that use of these devices be limited to persons with specific training or experience in the applicable testing methods, and only in facilities under the oversight of public health laboratories, so that the laboratories would coordinate and communicate with state and local public health directors and that performance of the device in the laboratory hands might be systematically collated for interagency review (including FDA).

The Panel believes that in vitro diagnostic devices for Bacillus spp. should be classified into class II because special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls to provide such assurance.

Based on the Panel's discussion and recommendations, and FDA's experience with these devices, we believe the following are risks to health associated with the use of the device type.

Failure of in vitro diagnostic devices for Bacillus spp. detection to perform as indicated or an error in interpretation of results may lead to misdiagnosis and improper patient management or inaccurate epidemiological information that may contribute to inappropriate public health responses. FDA believes that this type of device presents risks associated with a false negative test result, and a false positive test result, as explained below. In addition, there may be risks to laboratory workers resulting from handling cultures and control materials.

A false positive result may lead to a medical decision causing a patient to undergo unnecessary or ineffective treatment, as well as inaccurate epidemiological information on the presence of anthrax disease in a community. A false negative result may lead to delayed recognition by the physician of the presence or progression of disease and inaccurate epidemiological information to control and prevent additional infections. A false negative result could potentially delay diagnosis and treatment of infection caused by B. anthracis or other Bacillus spp.

Because handling the quality control organisms and those potentially present in the specimen may pose a risk to laboratory workers, use of these products and the needed laboratory control materials would be restricted to laboratories with the appropriate biosafety facilities and training.

The Panel suggested the following special controls: (1) That FDA partner with the Centers for Disease Control and Prevention (CDC), USAMRIID, and other appropriate Agencies involved in laboratory performance issues to develop practical ways to evaluate the performance of these devices; (2) that appropriate biosafety handling of the diagnostic specimens be followed; and (3) that FDA develop testing guidelines to include recommendations on specimen selection, procedures, interpretation of results, and possibly public health notification.

Based on the Panel's discussion and recommendations, FDA believes that, in addition to general controls, the special controls discussed in the following paragraphs are adequate to address the risks to health.

FDA believes that the draft guidance document entitled “Class II Special Controls Guidance Document: “In Vitro Diagnostic Devices for Bacillus spp. Detection” and limitations on distribution of these devices, set forth in the proposed classification regulation, will help to address the issues identified previously and provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability for comment of the draft of the guidance document that is proposed to serve as a special control for this device. The class II special controls guidance provides information on how to meet premarket (510(k)) submission requirements for the assays in the sections that discuss performance characteristics and labeling. The performance characteristics section describes studies to demonstrate appropriate performance and control against assays that may otherwise fail to perform to acceptable standards. The labeling section addresses factors such as directions for use, quality control and precautions for use and interpretation.

In addition, FDA proposes to require as a special control in the proposed classification regulation that distribution of the device be limited to laboratories with experienced personnel who have training in principles and use of microbiological culture identification methods and infectious disease diagnostics, and with appropriate biosafety equipment and containment. As noted, the Panel was concerned that these devices be used by personnel sufficiently skilled to maximize their performance and to appropriately interpret and make use of test results. FDA believes that this proposed distribution limitation will appropriately help assure the safe and effective use of these devices, and that it is consistent with the intent of the Panel in its discussion of limitations on the use of the devices and on monitoring of test results.

FDA agrees with the Panel's recommendation that in vitro diagnostic devices for Bacillus spp. detection should be classified into class II because special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls to provide such assurance.

FDA proposes that any final regulation based on this proposal become effective 30 days after its date of publication in the Federal Register .

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

FDA has examined the impacts of the proposed rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 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 proposed 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 of the minor impact expected from this proposed rule, the Agency proposes to certify 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 $135 million, using the most current (2009) Implicit Price Deflator for the Gross National Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount.

The objective of the proposed regulation is to ensure the continued safety and effectiveness of in vitro diagnostic test kits for the identification of potential Bacillus ( Bacillus spp.) infections.

Since the 1950s, diagnostic tests have been used to detect Bacillus spp., differentiate between species, and identify B. anthracis from culture isolates or clinical specimens. Over the 10-year period 1999 to 2009, there have been approximately 8,000 such tests (using the estimated annual testing rate), the vast majority of which were for the purposes of proficiency testing and training. No accidents have been reported associated with these tests.

There are currently five diagnostic test kits cleared from different manufacturers, as well as devices developed by CDC and Department of Defense. The CDC test kits have been distributed to approximately 114 laboratories that belong to the national LRN (Laboratory Response Network). Kits are able to test between 10 and 100 samples depending on the testing capability of the different test kits. The alternative to using in vitro diagnostic test kits to identify potential exposure to B. anthracis is to use blood, fluid, and tissue specimens to grow cultures that may be used to identify the bacillus. This method is more time-consuming and presents risks that the disease (if present) will progress and be more difficult to treat when identified. It also means increased patient anxiety while the culture is growing, whether the patient has been exposed or not. A patient that may have contracted inhalational anthrax would be expected to have high levels of anxiety while awaiting diagnosis. The diagnostic test kits offer significant public health benefits by providing rapid diagnosis that can both save lives by identifying patients with anthrax and rapidly beginning treatment as well as avoiding unnecessary prophylactic treatments for patients that are found to not have the bacillus.

Currently most marketed diagnostic test kits have extremely high predictive values. Sensitivities of these devices (proportion of positive patients correctly identified by the test) have been tested to be over 99 percent and specificities (proportion of negative patients correctly identified by the test) approach 100 percent.

However, after the 2001 incident of inhalational anthrax exposures, there was an increased public awareness of the risk of contracting anthrax due to the media publicity that surrounded the event. Fourteen manufacturers reacted to this increased public attention by submitting inquiries to FDA about obtaining marketing clearance for additional products that would diagnose the presence of the bacillus. Two of the 14 inquiries have resulted in diagnostic products getting cleared through the Premarket Notification (510(k)) process and one manufacturer submitting an Investigational Device Exemption (IDE). The remaining manufacturers expressed interest but decided not to conduct the necessary investigations to ensure the safety and effectiveness of the test kits.

The increased level of public attention and concern towards potential inhalational anthrax exposures that result from any incident (such as in 2001) is likely to have similar responses from potential manufacturers in the future. In the absence of this proposed rule, there will continue to be ambiguity as to the specific testing criteria for the device to be cleared for marketing. In addition, FDA resources will be spent responding to these inquiries for potential products that are not destined to be marketed.

We are proposing to classify anthrax diagnostic test kits as Class II, and designate special controls. The special controls include limitations of distribution for all Bacillus spp. detection devices and the special controls guidance will include recommendations for the performance data, quality control information, and labeling. This guidance document will be unlikely to affect the number of laboratory tests for Bacillus spp. or the number of tests used for training purposes. Generally, these recommendations are already being practiced. The document is also not likely to result in any procedural changes in how laboratories handle the diagnostic test kits because we have been interacting with manufacturers individually to ensure safety and effectiveness and the guidance document is designed to clearly articulate the best current practices. The proposed rule will ensure that information provided to manufacturers and users of these diagnostic test kits is consistent and appropriate and limit distribution to laboratories that have experienced personnel and appropriate biosafety equipment.

If the proposed regulation is implemented, potential marketers of these kits would clearly know what criteria and what evidence would be needed to ensure clearance of their devices. In addition, laboratory personnel would have assurance that they were handling the test kits appropriately, thus both ensuring the predictive value of the test kits were maximized and any potential risk of exposure to pathogens due to careless handling of the test kits remain minimized. That being said, we do not expect any change from current conditions that would result from the proposed regulation. The current predictive values of the test kits are already extremely high. Of the five products currently cleared, there were no reports of false positive (specificity of 100 percent) and few reports of false negatives (estimated sensitivity of 99.6 percent combining all products). Therefore, we do not expect any change in either use of the test kits by laboratories or in the predictive value of the test kits in patients. The proposed rule will, however, provide additional levels of assurance that the test kits will provide accurate and timely diagnosis and the proper laboratory procedures will maintain the safe and effective use of the test kits.

The costs of the proposed rule are due to manufacturers' ensuring that product labeling will be consistent with the language suggested in the guidance document as well as likely periodic quality control testing to ensure that marketed test kits maintain levels of safety and effectiveness. The costs associated with ensuring consistent labeling are expected to be minor. The labeling recommendation is based on the labeling of the currently cleared devices and little or no change from current conditions is expected. Nevertheless, we have estimated that manufacturers may incur minor revisions to their labels in response to the new guidance after regulatory staff review and compare current labeling language and design to the language and design recommendations (including photographs or diagrams) proposed in the guidance document. To account for these reviews and any possible labeling revisions, we have estimated that typical label changes for typical medical devices or diagnostic products would cost manufacturers approximately $2,200 per label change per brand. This estimate is based on market driven label revisions and was derived from estimates for a variety of devices similar to test kits (Cost Analysis of the Labeling and Related Testing Requirements for Medical Glove Manufacturers, Eastern Research Group (ERG), 2002) and account for only simple language and design alterations. We have further estimated that changes of this sort typically occur about every 5 years in response to market changes and improvements to the specific product. The manufacturers of each of the 4 currently marketed test kits are likely to review and perhaps revise labels for a total cost of $8,800. Over an expected 5-year evaluation period (based on a typical labeling cycle), the annualized cost of reviewing and revising labels is only $1,900 (3-percent annual discount rate) or $2,100 (7-percent annual discount rate).

In addition, the draft guidance document will include a description of the quality control tests recommended to ensure the safety and effectiveness of the diagnostics. While these tests are currently used to develop marketed products, it is possible that the frequency of testing to ensure continued quality may increase as a result of the proposed rule. We have estimated that additional quality control testing may require expenditures of as much as $100 per product per year for each brand. This cost is based on a sampling of typical laboratory control tests (including ELISHA, Lowry, and other ASTM (American Society for Testing of Materials) recommended tests) for devices (ERG, 2002). Therefore, for the duration of a 5-year evaluation period, we expect the industry may incur additional quality control testing costs of about $400 per year.

The proposed rule is designed to articulate current practices for the currently marketed test kits. However, because of this regulatory classification, it is possible that these additional activities will result in minor cost increases. We have estimated that the proposed rule could result in, at most, annualized costs of approximately $2,300 (3 percent) or $2,500 (7 percent).

There are unlikely to be any direct public health benefits of the proposed rule, because the rule articulates current industry practice and does not change the expected use of the diagnostic product. However, the proposed regulation is designed to ensure continued quality of this important diagnostic tool. The Bacillus spp. test kit provides important public health benefits through rapid diagnosis and thus, rapid treatment of a fatal disease, or rapid identification that treatment is not necessary. The absence of this diagnostic test kit, or even a decrease in the performance of the kit, would increase the negative outcomes of any future anthrax event, including increases in potential mortalities. The proposed regulation will provide additional assurance that the current level of public health protection is maintained.

In addition, it is possible that any slight label revisions or standardization of information in the labeling, as well as an increased emphasis on laboratory training, may decrease the likelihood of potential mishandling of either the diagnostic test kits or the test medium. There is currently no way to quantify this effect because there has been no reported exposure or risk associated with these diagnostic tests or the test medium in this country. We acknowledge that it is possible that mishandling could occur in the future and it is possible that clear, consistent instructions may avoid some potential future mishandling, but cannot quantify any benefit based on this eventuality.

However, the response of potential marketers of Bacillus spp. test kits to the publicity that surrounded the 2001 anthrax event indicates that a potential benefit could be derived from clearly articulating the tests needed to provide sufficient data to ensure adequate safety and effectiveness of these products. By having consistent and easily available criteria, potential marketers will easily be able to ascertain whether or not to pursue market clearance. The availability of this information is expected to result in better, and perhaps fewer, potential marketing applications that may arise in response to future incidents of public inhalation anthrax exposure. Of course we hope that future events do not occur; however, there is a low level of probability that an incident could occur in the future. We have estimated the annual probability of a public inhalational anthrax incident to be approximately between 2 percent and 5 percent based on historical occurrences. We received 14 inquiries in regards to obtaining clearances which have resulted in 3 applications and 2 clearances. Using the success rate of 14 percent (2 successes from 14 inquiries), we expect a reduction of approximately 0.24 to 0.6 unsuccessful inquiries or applications each year. (Twelve unsuccessful inquiries or applications multiplied by the annual probability of an incident). The estimated effort to potential marketers of contacting FDA, obtaining advice concerning the clearance process, and preliminarily preparing a marketing application is estimated to take approximately 5 days of review, market research, and internal decisionmaking. The mean salary for employees within NAICS 325413 (In Vitro Diagnostic Substance Manufacturing) is approximately $80,000 (Census, 2007). A week of FTE (full-time employee) time would thus have an average cost to manufacturers of about $1,500. By avoiding unnecessary (and ultimately unsuccessful) inquiries for potential marketing applications, we expect the proposed rule to result in savings of between $400 and $900 per year. ($1,500 multiplied by 0.24 and 0.6 avoided inquiries each year).

In addition, FDA resources will not be spent responding to inquiries or reviewing unsuccessful applications that would not be submitted with the clear information that would be the result of the proposed rule. The average FDA full-time equivalent employee is valued at approximately $130,000, including salary, benefits, overhead, and support). Responding to inquiries concerning a potential application may consume a few hours of resources per inquiry while reviewing an application may consume as much as 2 weeks of review time. On average, we expect each avoided inquiry or application to save approximately 8 hours of FDA resources. Thus, with the clear information available as a result of the proposed rule, FDA is expected to save between $100 and $300 per year ($130,000 divided by 235 days times 0.24 and 0.6 annual inquiries avoided).

Thus, we estimate the proposed regulation will result in quantifiable benefits of avoiding unnecessary inquiries and potential applications to be between $500 and $1,200 per year. We believe that the unquantified benefits of providing an additional level of quality assurance, maintaining the predictive value of the marketed test kits, and avoiding any potential future laboratory errors cannot be estimated, but represent real benefits to the public health.

We identified four plausible alternatives to the proposed rule.

1. Continue to regulate as an unclassified device. This alternative would not provide an assurance of safety and effectiveness and would continue the current level of inconsistent information for potential new marketers.

2. Regulate this diagnostic test as a Class I device. Because sufficient information was available to develop special controls for this device, this alternative, which would require general controls only, was not considered sufficient for the potential risks of this device.

3. Regulate this diagnostic test as a Class III device. Premarket approval and clinical data collection are not appropriate for the potential risks of this device, which are more appropriately dealt with using the proposed special controls. Classifying the test as Class III would increase the cost of marketing the devices without an increase in assurances of safety and effectiveness.

4. Regulate this diagnostic test as a Class II device with alternative special controls. The proposed guidance document is sufficient to provide assurances of safety and effectiveness. Other potential special controls were deemed to not be cost-effective and not provide additional assurances of safety and effectiveness.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because of the minor costs to manufacturing entities attributable to the proposed rule, the Agency believes the proposed rule will not have a significant economic impact on a substantial number of small manufacturing entities. In addition, the proposed rule will not affect testing laboratories because we do not expect any change in current use of the diagnostic test kit.

There are currently five cleared diagnostic kits for the identification of Bacillus spp. marketed by five companies. These companies are classified in the In Vitro Diagnostic Substance Manufacturing Industry (NAICS 325413) by the Census of Manufacturers. This industry is typified by small entities. For this industry, the Small Business Administration classifies any establishment with 500 or fewer employees as small. The typical establishment in this industry employs only about 120 employees, so virtually every company is small. Value of shipments for this industry is approximately $50,000,000 per establishment. The expected annualized cost per affected establishment ($800) represents less than 0.002 percent of annual shipments.

Testing Laboratories (NAICS 541380) are considered small by the Small Business Administration if they generate $12,000,000 or less in annual revenue. There is no change in activity expected by this industry from the proposed rule, so we do not expect any impact on laboratories.

FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain state requirements “different from or in addition to” certain Federal requirements applicable to devices. 21 U.S.C. 360k; See Medtronic v. Lohr 518 U.S. 470 (1996); Riegel v. Medtronic, 552 U.S. 312 (2008). The special control regarding limited distribution set out in the proposed regulation, if finalized, would create a requirement. The other special controls, if finalized, would create “requirements” to address each identified risk to health presented by these specific medical devices under 21 U.S.C. 360k, even though product sponsors may have flexibility in how they meet those requirements. Cf. Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997).

FDA concludes that this proposed rule contains no new collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520) is not required.

The proposed rule would establish as special control a draft guidance document that refers to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control no. 0910-0120. The collections of information in 21 CFR part 801 and 21 CFR 809.10, regarding labeling, have been approved under OMB control no. 0910-0485.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) electronic or written comments regarding this proposed rule. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. We have verified all Web site addresses, but we are not responsible for subsequent changes to the Web sites after this document publishes in the Federal Register .

1. Transcript of the FDA Microbiology Devices Panel meeting, March 7, 2002, at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=348.

2. Abshire, T.G. et al., “Validation of the use of gamma phage for identifying Bacillus anthracis,” 102nd American Society for Microbiology Annual Meeting poster #C122, 2001.

3. Brown, Eric R. and William B. Cherry, “Specific identification of Bacillus anthracis by means of a variant bacteriophage,” vol. 96, Journal of Infectious Disease, p. 34, 2001.

4. Brown, Eric R. et al., “Differential diagnosis of Bacillus cereus, Bacillus anthracis and Bacillus cereus var. mycoides,” vol. 75, Journal of Bacteriology, p. 499, 1957.

5. Buck C.A. et al., “Phage isolated from lysogenic Bacillus anthracis,” vol. 85, Journal of Bacteriology, p. 423, 1963.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 866 be amended as follows:

On May 10, 2011, the Postal Service filed a petition pursuant to 39 CFR 3050.11 asking the Commission to initiate an informal rulemaking proceeding to consider changes in the analytical principles approved for use in periodic reporting. 1 Proposal Two is a set of four changes that the Postal Service first presented in its FY 2010 Annual Compliance Report (ACR) modifying the cost models that are used to evaluate Negotiated Service Agreements (NSAs) for competitive products. These cost models were included in USPS-FY10-NP27 in that docket.

The Petition notes that in its FY 2010 Annual Compliance Determination, the Commission made a preliminary determination that these four changes constitute changes to analytical principles that require prior Commission approval before being incorporated in an ACR. 2 The Postal Service notes that the purpose of its Petition is to obtain the Commission's approval of the referenced changes for use in future ACRs, even though some of the changes could be viewed as corrections to its models not requiring advance Commission approval. Petition at 1.

The four changes for which the Postal Service seeks approval are:

1. The addition of a cost avoidance for Priority mailpieces;

2. The inclusion of D-Report adjustments;  3

3. The incorporation of the CRA adjustment for Alaska Air Priority transportation; and

4. Changes in the distribution of other costs for Parcel Select and Parcel Return Service.

In the material supporting these changes, the Postal Service asserts that including them in the NSA cost models better matches the characteristics of the mail volume for the NSAs in question. It characterizes inclusion of the D-Report and the Alaska Air adjustments as rectifying previous omissions from these models. It notes that the change in the distribution of “Other” costs for Parcel Select is made necessary by the inclusion of the D-Report adjustment.

The Postal Service explains that if the D-Report adjustment is made, it will comprise the majority of “Other” costs. Since the D-Report adjustment is computed as a cost per piece, it contends, “Other” costs should be distributed on a per-piece basis, rather than treated as proportionate to mail processing, transportation, and delivery costs. It says that for consistency, a similar adjustment should be made to the costs of Parcel Return Service. Id. at 4.

More detailed descriptions of the proposed changes can be found in USPS-RM2011-10/NP1, which is filed under seal.

It is ordered:

1. The Petition of the United States Postal Service Requesting Initiation of a Proceeding to Consider a Proposed Change in Analytical Principles (Proposal Two), filed May 10, 2011, is granted.

2. The Commission establishes Docket No. RM2011-10 to consider the matters raised by the Postal Service's Petition.

3. Interested persons may submit comments on Proposal Two no later than June 13, 2011.

4. The Commission will determine the need for reply comments after review of the initial comments.

5. John P. Klingenberg is appointed to serve as the Public Representative to represent the interests of the general public in this proceeding.

6. The Secretary shall arrange for publication of this notice in the Federal Register.

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

EPA is proposing to determine that California is no longer required to submit or implement Clean Air Act (CAA or the Act) section 185 fee program SIP revisions for the Sacramento Metro 1-hour ozone nonattainment area (Sacramento Metro Area) to satisfy anti-backsliding requirements associated with the transition from the 1-hour ozone standard (1-hour standard or 1-hour) to the 1997 8-hour ozone standard (8-hour standard or 8-hour). This proposed Termination Determination is based on EPA's belief that the area is attaining the 1-hour ozone standard due to permanent and enforceable emission reductions implemented in the area. In addition, EPA proposes to exclude from use in determining the area has attained the 1-hour ozone standard certain air quality monitoring data because they meet the criteria for ozone exceptional events that are caused by wildfires. If finalized, the effect of EPA's determination that the area has attained the 1-hour ozone standard due to permanent and enforceable emission reductions would be to terminate the area's obligations with respect to section 185 fee program requirements for the 1-hour ozone standard. In a separate interim final action, published in the Rules section in today's Federal Register , we are deferring sanctions that would otherwise apply to the entire Sacramento Metro Area with the exception of Sacramento County, that is, the entirety of Yolo County and the Sacramento Metro Area portions of Solano, Sutter, Placer and El Dorado counties. This action addresses only the CAA section 185 requirements for the 1-hour ozone standard for the Sacramento Metro Area, and not for the 1997 8-hour ozone standard.

The Act requires us to establish NAAQS for certain widespread pollutants that cause or contribute to air pollution that is reasonably anticipated to endanger public health or welfare (sections 108 and 109 of the Act). In 1979, we promulgated the revised 1-hour ozone standard of 0.12 parts per million (ppm) (44 FR 8202, February 8, 1979). 1

An area is considered to have attained the 1-hour ozone NAAQS if there are no violations of the standard, as determined in accordance with the regulation codified at 40 CFR section 50.9, based on three consecutive calendar years of complete, quality-assured and certified monitoring data. A violation occurs when the ambient ozone air quality monitoring data show greater than one (1.0) “expected number” of exceedances per year at any site in the area, when averaged over three consecutive calendar years. 2 An exceedance occurs when the maximum hourly ozone concentration during any day exceeds 0.124 ppm. For more information, please see “National 1-hour primary and secondary ambient air quality standards for ozone” (40 CFR 50.9) and “Interpretation of the 1-Hour Primary and Secondary National Ambient Air Quality Standards for Ozone” (40 CFR part 50, Appendix H).

The Act, as amended in 1990, required EPA to designate as nonattainment any area that was violating the 1-hour ozone standard, generally based on air quality monitoring data from the 1987 through 1989 period (section 107(d)(4) of the Act; 56 FR 56694, November 6, 1991). The Act further classified these areas, based on the severity of their nonattainment problem, as Marginal, Moderate, Serious, Severe, or Extreme.

The control requirements and date by which attainment of the 1-hour ozone standard was to be achieved varied with an area's classification. Marginal areas were subject to the fewest mandated control requirements and had the earliest attainment date, November 15, 1993, while Severe and Extreme areas were subject to more stringent planning requirements and were provided more time to attain the standard.

On November 6, 1991, EPA designated the Sacramento Metro Area as Serious nonattainment for the 1-hour ozone standard, with an attainment date no later than November 15, 1999 (56 FR 56694). The Sacramento Metro Area consists of the entirety of both Sacramento and Yolo counties and portions of four adjacent counties (El Dorado, Placer, Solano and Sutter counties) (see 40 CFR section 81.305). Sacramento County is under the jurisdiction of the Sacramento Metropolitan Air Quality Management District (SMAQMD). Yolo County and the eastern portion of Solano County comprise the Yolo-Solano Air Quality Management District. The southern portion of Sutter County is part of the Feather River Air Quality Management District. The western portion of Placer County is part of the Placer County Air Pollution Control District. Lastly, the western portion of El Dorado County is part of the El Dorado County Air Quality Management District. Under California law, each air district is responsible for adopting and implementing stationary source rules, such as the rules required under CAA section 185, while the California Air Resources Board (CARB) adopts and implements consumer products and mobile source rules. The district and state rules are submitted to EPA by CARB.

In 1995, EPA granted the State's request to reclassify the Sacramento Metro Area as Severe. 60 FR 20237 (April 25, 1995). The reclassification of the area as Severe required the State to adopt a SIP revision creating a penalty fee program under CAA section 185 that would apply if the area failed to meet the November 15, 2005 attainment date that applies to Severe 1-hour ozone areas and to submit that SIP revision to EPA by December 31, 2000 (CAA section 182(d)(3)). On September 26, 2002, SMAQMD adopted Rule 307 (”Clean Air Act Fees”). CARB submitted Rule 307 to EPA as a SIP revision for the Sacramento County portion of the area on December 12, 2002 and EPA approved Rule 307 on August 26, 2003 (68 FR 51184). The other affected air districts in the Sacramento Metro Area did not submit 1-hour section 185 SIP revisions for their portions of the nonattainment area. EPA published findings of failure to submit on January 5, 2010 (75 FR 232). 3 These findings started sanctions clocks for imposition of offset sanctions 18 months after January 5, 2010 and highway sanctions six months after the offset sanctions, pursuant to section 179 of the CAA and our regulations at 40 CFR section 52.31.

In 1997, EPA promulgated a new, more protective standard for ozone based on an 8-hour average concentration (the 1997 8-hour ozone standard). In 2004, EPA published the 1997 8-hour ozone designations and classifications and a rule governing certain facets of implementation of the 8-hour ozone standard (Phase 1 Rule) (69 FR 23858 and 69 FR 23951, respectively, April 30, 2004).

By the Sacramento Metro Area's 1-hour ozone 2005 attainment deadline, EPA had revoked the 1-hour standard and designated the area as nonattainment for the 1997 8-hour ozone NAAQS. See 40 CFR 81.305. The area's initial classification for 8-hour ozone was Serious, but EPA subsequently granted CARB's request to reclassify the area to Severe for the 8-hour ozone standard. See 75 FR 24409, May 5, 2010. On July 7, 2010, and in an update on April 13, 2011, CARB requested that EPA find that the Sacramento Metro Area had attained the 1-hour ozone standard due to permanent and enforceable emission reductions, and that EPA terminate 1-hour ozone CAA section 185 requirements for the area. See letters from James Goldstene, CARB Executive Officer, to Jared Blumenfeld, Regional Administrator, U.S. EPA Region IX, with enclosures, dated July 7, 2010 and April 13, 2011.

Although EPA revoked the 1-hour ozone standard (effective June 15, 2005), during the transition from the 1-hour ozone to the 8-hour ozone standard, 1-hour nonattainment areas remain subject to certain requirements based on their 1-hour ozone classification. The section 185 fee program requirement applies to any ozone nonattainment area classified as Severe or Extreme, including any area that was classified Severe or Extreme under the 1-hour ozone NAAQS as of the effective date of the area's 8-hour designation (see 40 CFR part 81).

Initially, in our rules to address the transition from the 1-hour to the 8-hour ozone standard, EPA did not include the section 185 fee penalty requirement as one of the measures necessary to meet Clean Air Act anti-backsliding requirements. 4 However, on December 23, 2006, the United States Court of Appeals for the District of Columbia Circuit determined that EPA should not have removed from its anti-backsliding requirements the application of the section 185 fee provision for Severe and Extreme nonattainment areas that failed to attain the 1-hour ozone standard by their attainment date. South Coast Air Quality Management District v. EPA, 472 F.3d 882 (DC Cir. 2006). In light of the Court's decision, on January 5, 2010 EPA issued guidance on the application of the section 185 1-hour anti-backsliding requirement. 5 EPA's guidance addressed, among other matters, alternative methods of satisfying the section 185 1-hour anti-backsliding requirement, and the circumstances under which EPA would determine that the obligation was terminated.

After the 1-hour ozone standard was revoked, and in accordance with anti-backsliding regulations that remain unchallenged, EPA was no longer obligated to find that an area attained by its 1-hour attainment date, nor to reclassify 1-hour areas under CAA Sections 181(b)(2) or 179(c) (40 CFR 51.905(e)). (69 FR 23951, April 30, 2004).

As a result of the court decision in South Coast Air Quality Management District v. EPA, 472 F.3d 882 (DC Cir. 2006), states with areas classified as Severe or Extreme nonattainment for the 1-hour ozone standard at the time of the area's initial nonattainment designation for the 1997 8-hour standard are no longer categorically exempt from the anti-backsliding requirements imposed by section 185. EPA has issued guidance for states related to developing 1-hour ozone section 185 fee programs. 6 As set forth in this guidance, EPA believes that states can meet the 1-hour ozone section 185 obligation through a SIP revision containing either the fee program prescribed in section 185 of the Act, or an equivalent alternative program, as further explained below. EPA believes that an alternative program may be acceptable if EPA determines, through notice-and-comment rulemaking, that it is consistent with the principles of section 172(e) of the CAA.

Section 172(e) is an anti-backsliding provision of the CAA that requires EPA to develop regulations to ensure that controls in a nonattainment area are “no less stringent” than those that applied to the area before EPA revised a NAAQS to make it less stringent. In the Phase 1 ozone implementation rule for the 1997 ozone NAAQS published on April 30, 2004 (69 FR 23951), EPA determined that although section 172(e) does not directly apply where EPA has strengthened the NAAQS, as it did in 1997, it was reasonable to apply the same anti-backsliding principle that would apply to the relaxation of a standard for the transition from the 1-hour NAAQS to the more stringent 1997 8-hour NAAQS. As part of applying the principle in section 172(e) for purposes of the transition from the 1-hour standard to the 1997 8-hour standard, EPA can either require states to retain programs that applied for purposes of the 1-hour standard, or alternatively can allow states to adopt alternative programs, but only if such alternatives are determined through notice-and-comment rulemaking to be “no less stringent” than the mandated program.

EPA is electing to consider alternative programs to satisfy the 1-hour ozone section 185 fee program SIP revision requirement. States choosing to adopt an alternative program to the section 185 fee program must demonstrate that the alternative program is no less stringent than the otherwise applicable section 185 fee program and EPA can only approve such demonstration after notice-and-comment rulemaking.

As set forth in EPA's January 5, 2010 guidance, EPA believes that for an area that we determine is attaining either the 1-hour ozone or 1997 8-hour ozone NAAQS, based on permanent and enforceable emission reductions, the area would no longer be obligated to satisfy the section 185 anti-backsliding requirements associated with the transition from the 1-hour ozone standard to the 1997 8-hour ozone standard. In such cases, an area's existing SIP could be considered an adequate alternative program. Our reasoning follows from the fact that an area's existing SIP measures, in conjunction with other enforceable Federal measures, are adequate for the area to achieve attainment, which is the purpose of the section 185 program. The section 185 fee program is an element of an area's attainment demonstration and its objective is to bring about attainment after a failure of an area to attain by its attainment date. Thus, areas that have attained the 1-hour ozone standard, the standard for which the fee program was originally required, as a result of permanent and enforceable emission reductions, would have a SIP that is no less stringent than the SIP required under section 185. Therefore, EPA concludes that the obligation to submit a rule or to collect fees terminates once EPA determines that the area has attained the 1-hour ozone standard based on permanent and enforceable emission reductions.

There is also an additional, independent basis for EPA's approach to determining that the anti-backsliding requirements associated with section 185 have been satisfied. Although section 185 provides that fees are to continue until the area is redesignated to attainment for ozone, EPA no longer promulgates redesignations for the 1-hour ozone standard because that standard has been revoked. Therefore, relief from the 1-hour section 185 fee program requirements under the terms of the statute is an impossibility, since the conditions the statute envisioned for relieving an area of its fee program obligation no longer can exist. There is thus a gap in the statute which must be filled by EPA. We believe that under these circumstances we must exercise our discretion under Chevron USA, Inc. v. Natural Resources Defense Council, 467 U.S. 837 (1984), to fill this gap, so as to carry out Congressional intent in the unique context of anti-backsliding requirements for a revoked standard. We believe that it is reasonable for the fee program obligation that applies for purposes of anti-backsliding to cease upon a determination, based on notice-and-comment rulemaking, that an area has attained the 1-hour ozone standard due to permanent and enforceable measures. This determination centers on the core criteria for redesignations under CAA section 107(d)(3). We believe these criteria provide reasonable assurance that the purpose of the 1-hour anti-backsliding fee program obligation has been fulfilled in the context of a regulatory regime where the area remains subject to other applicable 1-hour anti-backsliding and 8-hour nonattainment measures. Under these circumstances, retention of the fee program under the anti-backsliding rule is no longer necessary for the purpose of achieving attainment of the 8-hour standard. See EPA's January 5, 2010 guidance (footnote 5, above).

If this proposed determination to terminate the section 185 fee anti-backsliding requirement for the 1-hour ozone standard is finalized, the requirement for the State of California to submit section 185 penalty fee program SIP revisions for the portions of the area for which we made findings of failure to submit, which would require major stationary sources under the Sacramento Metro Area 1-hour ozone Severe nonattainment classification to pay fees as a penalty for the area's failure to attain the 1-hour ozone standard by the area's 1-hour ozone attainment date, as well as the requirement for the Sacramento Metropolitan Air Quality Management District portion of the area to implement its 1-hour ozone section 185 fee program, would be removed.

A final Termination Determination for the 1-hour standard section 185 measures will not be rescinded based on subsequent nonattainment of the 1-hour ozone standard. After EPA has determined that an area has attained the 1-hour standard due to permanent and enforceable emission reductions, EPA believes that it would be unduly punitive, confusing, and potentially destabilizing to re-impose the years-old penalty requirements if at some point in the future the area lapses back into 1-hour nonattainment. Moreover, EPA believes that under current circumstances, it would not be in keeping with the intent of Congress. First, we note that had the area attained the 1-hour ozone standard prior to its attainment date, no penalties at all would have been imposed even if the area subsequently lapsed into nonattainment. Second, the statute provides that penalties for failure to attain by an area's attainment date would be terminated by redesignation of the area. Now that the 1-hour ozone standard has been revoked and EPA is no longer promulgating redesignations for that standard, relief from the 1-hour section 185 fee program requirements under the terms of the statute is an impossibility—the mechanism the statute envisioned for relief no longer exists. As EPA explains in its January 5, 2010 guidance, we have reasonably concluded in these circumstances that a determination of attainment due to permanent and enforceable emission reductions, along with the area's existing SIP and its continuing obligations to meet ever more stringent ozone standards, are a reasonable alternative means for terminating these unique anti-backsliding penalty provisions. EPA believes that, given the gap in the statute, and the intent of Congress as expressed in quite different regulatory circumstances, it would be counterproductive and in conflict with that intent for EPA's determination to merely suspend rather than permanently terminate the 1-hour anti-backsliding penalty fees. Requiring areas to remain subject to the threat of reviving stale penalty fees for an old revoked standard, when these areas and the sources subject to the penalties must now muster their resources to focus on meeting newer more stringent standards, would be at odds with the purposes of the Act and in conflict with the principle that penalty provisions should be narrowly construed. This is also true because the area is subject to a host of ongoing obligations for the 1997 8-hour ozone standard as well as the future anticipated new 8-hour ozone standard, 7 when it has already shown great improvement towards meeting the 1-hour and 1997 8-hour ozone standards.

EPA's proposed Termination Determination is based upon EPA's belief that the area is attaining the 1-hour ozone standard due to permanent and enforceable emission reductions implemented in the area. In its January 5, 2010 guidance, EPA set forth its views as to potential rationales for terminating section 185 obligations for 1-hour ozone. This notice formally sets forth EPA's legal interpretation concerning the basis for terminating those obligations.

As explained above, EPA set forth our belief in our January 5, 2010 guidance that for an area that we determine is attaining either the 1-hour ozone or 1997 8-hour ozone NAAQS, based on permanent and enforceable emission reductions, that the area would no longer be obligated to satisfy the anti-backsliding requirements associated with the transition from the 1-hour ozone standard to the 1997 8-hour ozone standard.

A determination of whether an area's air quality meets the 1-hour ozone NAAQS is generally based upon the most recent three years of complete, quality-assured and certified air quality monitoring data gathered at established National Air Monitoring Stations (“NAMS”) or State and Local Air Monitoring Stations (“SLAMS”) in the nonattainment area and entered into the EPA's Air Quality System (AQS) database. Data from air monitors operated by state/local agencies in compliance with EPA monitoring requirements must be submitted to the AQS database. Monitoring agencies annually certify that these data are accurate to the best of their knowledge. Accordingly, EPA relies primarily on data in its AQS database when determining the attainment status of an area. See 40 CFR 50.9; 40 CFR part 50, Appendix H; 40 CFR part 53; 40 CFR part 58, Appendices A, C, D and E. All data are reviewed to determine the area's air quality status in accordance with 40 CFR part 50, Appendix H.

Under EPA regulations at 40 CFR 50.9, the 1-hour ozone standard is attained at a monitoring site when the expected number of days per calendar year with maximum hourly average concentrations above 0.12 parts per million (235 micrograms per cubic meter) is equal to or less than 1, as determined by 40 CFR part 50, Appendix H.

EPA proposes to determine that the Sacramento Metro Area has attained the 1-hour ozone standard; that is, the number of expected exceedances at any site in the nonattainment area is not greater than one per year. 8 This proposed determination is based on three years of complete, quality-assured and certified ambient air quality monitoring data in AQS showing attainment of the 1-hour ozone standard for the 2007-2009 monitoring period, and complete, quality-assured data in AQS for 2008-2010 that show continued attainment. As explained below, in determining the area's attainment of the 1-hour ozone standard, EPA is also proposing to exclude from consideration exceedances that occurred on three days in 2008, because they are due to wildfire exceptional events.

In the Sacramento Metro Area, the agencies responsible for assuring that the area meets air quality monitoring requirements include CARB, Sacramento Metropolitan Air Quality Management District (SMAQMD), Placer County Air Pollution Control District (PCAPCD) and Yolo-Solano Air Quality Management District (YSAQMD). Both CARB and SMAQMD submit annual monitoring network plans to EPA. SMAQMD Network Plans describe the monitoring network the district operates; CARB's Network Plans describe the monitoring sites CARB operates, in addition to monitoring sites operated by smaller air districts, namely, for the Sacramento Metro Area, PCAPCD and YSAQMD. These plans discuss the status of the air monitoring network, as required under 40 CFR 58.10.

Since 2007, EPA regularly reviews these annual plans for compliance with the applicable reporting requirements in 40 CFR part 58. With respect to ozone, EPA has found that the area's network plans meet the applicable requirements under 40 CFR part 58. See EPA letters to CARB and SMAQMD approving their annual network plans for years 2007, 2009 and 2010. 9 Furthermore, we concluded in our Technical System Audit of the CARB Primary Quality Assurance Organization (PQAO), 10 conducted during Summer 2007, that the combined ambient air monitoring network operated by CARB and the local air districts in their PQAO currently meets or exceeds the requirements for the minimum number of SLAMS monitoring sites for all criteria pollutants, and that all of the monitoring sites are properly located with respect to monitoring objectives, spatial scales and other site criteria, as required by 40 CFR part 58, Appendix D. See letter from Deborah Jordan, Director, Air Division, U.S. EPA Region IX, to James Goldstene, Executive Officer, CARB, transmitting “Technical System Audit of the California Environmental Protection Agency Air Resources Board: 2007,” with enclosure, August 18, 2008. Also, CARB annually certifies that the data it submits to AQS are complete and quality-assured. See, e.g. , letter from Karen Magliano, Chief, Air Quality Data Branch, Planning and Technical Support Division, CARB, to Jared Blumenfeld, Regional Administrator, U.S. EPA Region IX, certifying calendar year 2009 ambient air quality data and quality assurance data, May 19, 2010.

There were 16 ozone monitoring sites located throughout the Sacramento Metro Area in calendar years 2007, 2008, 2009 and 2010. 11 Sacramento Metro AQMD operates six ozone monitors in Sacramento County: Elk Grove (southwest Sacramento County), Del Paso Manor (northeast City of Sacramento), Folsom (City of Folsom), Sacramento-Goldenland Court  12 (northwest City of Sacramento), North Highlands (north Sacramento County) and Sloughhouse Road (west Sacramento County). CARB operates six ozone monitors in the Sacramento Metro Area: Sacramento-T Street (City of Sacramento) in Sacramento County; Cool (City of Cool), Echo Summit (in the Sierra Nevada Mountains) and Placerville (City of Placerville) in El Dorado County; Roseville (City of Roseville) in Placer County; and Davis (City of Davis) in Yolo County. Placer County APCD operates two ozone monitors in the Sacramento Metro Area: Colfax (City of Colfax) and Auburn (City of Auburn). Yolo-Solano AQMD operates two ozone monitors in the Sacramento Metro Area: Vacaville (City of Vacaville) in Solano County, and Woodland (City of Woodland) in Yolo County.

All Sacramento Metro Area sites monitor ozone concentrations on a continuous basis using ultraviolet absorption monitors. 13 EPA defines specific monitoring site types and spatial scales of representativeness to characterize the nature and location of required monitors. See 40 CFR part 58, Appendix D, § 1. Table 1 below lists the site types and spatial scale for each ozone monitoring site in the Sacramento Metro Area. Due to ozone precursor source distribution and general meteorological patterns in the area, the highest ozone concentrations for the past several years have typically occurred at the Folsom and Sloughhouse Road sites.

On March 22, 2007, EPA adopted a final rule, “Treatment of Data Influenced by Exceptional Events,” also known as the Exceptional Events Rule (EER), to govern the review and handling of certain air quality monitoring data for which the normal planning and regulatory processes are not appropriate (72 FR 13560). Under the EER, EPA may exclude data from use in determinations of NAAQS exceedances and violations if a state demonstrates that an “exceptional event” caused the exceedance or exceedances. 40 CFR 50.1, 50.14. Before EPA can exclude data from these regulatory determinations, the state must flag the data in EPA's AQS database and, after public notice and opportunity for comment, submit a demonstration to EPA to justify the exclusion. EPA considers the demonstration and concurs or nonconcurs with the state's flag. After notice-and-comment rulemaking, EPA determines whether to exclude the data from use when making a determination of attainment.

In submittals dated September 17, 2009 and March 30, 2011, CARB provided documentation for ozone exceedances that occurred at the Folsom monitor on three days in Summer 2008 which the state had flagged as due to wildfire exceptional events. EPA reviewed the documentation and concurred with the June 23, June 27 and July 10, 2008 flags in a letter from Jared Blumenfeld, Regional Administrator, U.S. EPA Region IX, to Mary D. Nichols, Chairman, CARB, dated April 13, 2011. EPA included with the letter a document setting forth in detail the bases for EPA's concurrences. See “Review of Exceptional Events Request: Folsom, CA; 1-hour ozone; June 23, June 27 and July 10, 2008,” dated April 13, 2011 (in the docket for this proposed rulemaking). For the reasons set forth in the concurrence letter and its enclosure, EPA is proposing to exclude from regulatory consideration data showing exceedances at the Folsom monitoring site on June 23, June 27 and July 10, 2008.

EPA's proposal to exclude ozone exceedances monitored at the Folsom site on June 23, June 27 and July 10, 2008, if finalized, would result in a revision of the number of exceedances (as determined by 40 CFR part 50, Appendix H and described in section II of this notice) for 2008 and, therefore, the average number of expected exceedances for the 2007-2009 period. With the exclusion of the data for these three days, the highest three-year average of expected exceedances at any site in the Sacramento Metro Area for 2007-2009 is 1.0, which shows attainment of the 1-hour ozone standard (a three-year average of expected exceedances less than or equal to 1). For more information, please see “National 1-hour primary and secondary ambient air quality standards for ozone” (40 CFR section 50.9) and “Interpretation of the 1-Hour Primary and Secondary National Ambient Air Quality Standards for Ozone” (40 CFR part 50, Appendix H). Consistent with 40 CFR part 50, Appendix H, Tables 2 and 3 set forth the 1-hour ozone data for the Sacramento Metro Area monitors that show that the area is currently attaining the 1-hour ozone NAAQS.

The data in Table 2 indicate a long-term trend observed in the Sacramento Metro Area. As described in CARB's July 7, 2010 letter requesting a Termination Determination, the monitoring sites that historically experienced exceedances of the 1-hour ozone standard are the Cool, Sloughhouse, Folsom and Del Paso Manor sites. For example, in 1998 five exceedances were monitored at Cool and ten at Folsom. In 2009, by contrast, there were no exceedances at any monitor in the entire Sacramento Metro Area.

In sum, EPA believes that, if the exceedances resulting from wildfire exceptional events on three days in 2008 are excluded from consideration, the 2007-2009 ambient air monitoring data for the Sacramento Metro Area show attainment of the 1-hour ozone NAAQS. In addition, if EPA's proposal to exclude exceedances on three days due to wildfire exceptional events is finalized, the data for 2010 (complete and quality-assured but not yet certified), shown in Table 3 for the 2008-2010 monitoring period, show continued attainment. Preliminary data available for 2011 are also consistent with continued attainment.

EPA believes that the State has demonstrated that the observed air quality improvements in the Sacramento Metro Area with respect to the 1-hour ozone standard are due to permanent and enforceable emission reductions through the implementation of state and district emission controls contained in the SIP and not due to favorable meteorology or temporary reductions in emission rates, such as temporary adverse economic conditions. See letter and accompanying documentation (Enclosure 2, Sacramento Metropolitan Air Quality Management District 1-Hour Ozone Attainment Demonstration Request for the Sacramento Federal Ozone Nonattainment Area) from James Goldstene, CARB Executive Officer, to Jared Blumenfeld, Regional Administrator, U.S. EPA Region IX, dated July 7, 2010, requesting termination of CAA section 185 requirements as they pertain to the Sacramento Metro Area (July 7, 2010 request).

In 1994, California submitted a comprehensive ozone plan for all ozone nonattainment areas in California including the Sacramento Metro Area (1994 SIP), which EPA approved on January 8, 1997 (62 FR 1150). The plan provided a blueprint for attaining the 1-hour ozone standard that relied on a combination of stationary and mobile source measures by the districts, and state and Federal governments. In addition, California air districts in the Sacramento Metro Area adopted and implemented emission control rules requiring many existing sources of oxides of nitrogen (NO X ) and volatile organic compounds (VOCs)  14 to meet, at minimum, Reasonably Available Control Technology (RACT). These requirements apply to sources in categories covered by Control Technology Guidelines (CTGs) and major non-CTG sources.

In its July 7, 2010 request (Enclosure 2, Sacramento Metropolitan Air Quality Management District 1-Hour Ozone Attainment Demonstration Request for the Sacramento Federal Ozone Nonattainment Area), CARB provided documentation that the improvement in air quality in the Sacramento Metro Area is not due to favorable meteorology. CARB showed that the weather patterns in the last decade have not been unusually favorable. For example, looking at days equal to or over 95 degrees Fahrenheit in each of the last thirteen years (1997 to 2009) as an indicator of conditions conducive to ozone formation, the area had an annual average of 37 such “high temperature” days, while in the last four years (2006-2009), the area also had an annual average of 37 high temperature days.

The State provided documentation showing that the improvement in air quality leading to 1-hour ozone attainment in the Sacramento Metro Area is not due to a temporary economic downturn. See July 7, 2010 request (Enclosure 2, Sacramento Metropolitan Air Quality Management District 1-Hour Ozone Attainment Demonstration Request for the Sacramento Federal Ozone Nonattainment Area). As an indicator of economic activity, this analysis presented information on gasoline and diesel sales in California from 2000 to 2009. Fuel sales are an indicator of economic activity, and represent an indicator of emissions trends of both VOCs and NO X as well. The Sacramento Metro Area's emissions inventory is dominated by mobile sources. See Table 7 below and Table 4.1 of Enclosure 2 of July 7, 2010 request. Although fuel sales have decreased in the last several years, perhaps coinciding with an overall economic downturn in California and nationally, we note that the decrease has been slight and that the last year presented, 2009, still had a higher level (14.8 billion gallons of fuel sold) than the first year presented (2001, at 14.5 billion gallons). Between those years, fuel sales increased gradually to a peak between 2005 and 2006 (both at 15.9 billion gallons sold per year), before gradually declining.

Given that the earliest years in that ten-year period were years when the area was not attaining the 1-hour ozone standard, EPA believes that any temporary emission reductions due to the more recent economic downturn in 2008 and later are relatively small and not a significant factor in the attainment of the 1-hour standard. Therefore, we conclude that economic conditions are not a source of temporary reductions in emission rates. On the contrary, EPA believes that the steady decline of emissions of NO X and VOCs during the same ten-year period is attributable to fleet turnover with newer vehicles having lower evaporative and tailpipe emissions, as well as greater fuel economy. Additionally, EPA notes that CARB's emissions database ( http://www.arb.ca.gov/ei/emissiondata.htm ) shows that during 2006 through 2009, the vehicle miles traveled (VMT) have increased from approximately 68 million miles per day to 72 million miles per day in the Sacramento Valley Air Basin. See CEPAM: 2009 Almanac—Population and Vehicle Trends Tool, Sacramento Valley Air Basin, Daily Vehicle Miles Traveled, All Vehicles.

Since 1990, the Districts have adopted, implemented and submitted for EPA approval dozens of stationary source rules which achieve NO X and VOC emission reductions and have thus helped reduce ozone levels. Tables 4 through 7 below summarize the local air district rules adopted since 1990 and approved into the California SIP. 15 16

Source categories for which CARB has primary responsibility for reducing emissions in California include most new and existing on- and off-road engines and vehicles, motor vehicle fuels, and consumer products. In addition, California has unique authority under CAA section 209 (subject to a waiver by EPA) to adopt and implement new emission standards for many categories of on-road vehicles and engines, and new and in-use off-road vehicles and engines. California has been a leader in the development of some of the most stringent control measures nationwide for on-road and off-road mobile sources and the fuels that power them. These measures have helped reduce ozone levels in the Sacramento Metro Area and throughout the state.

CARB's 2007 State Strategy provides a recent summary of the measures adopted and implemented by the state. See “Air Resources Board's Proposed State Strategy for California's 2007 State Implementation Plan,” release date: April 26, 2007. From 1994 to 2006, the state has taken more than 45 rulemaking actions which have achieved significant emission reductions needed for the state's nonattainment areas such as the Sacramento Metro Area. See 2007 State Strategy, p. 38. 17 These measures include new emission standards and in-use requirements and have resulted in significant reductions in VOC and NO X emissions from categories such as passenger cars, trucks, buses, motorcycles, locomotives, recreational boats, lawn and garden equipment and consumer products. EPA has generally approved all of the State's measures that are not subject to the CAA section 209 waiver process. See EPA's proposed approval of the San Joaquin Valley 1-hour ozone plan at 74 FR 33933, 33938 (July 14, 2009) and final approval at 75 FR 10420 (March 8, 2010). See also, EPA's proposed partial approval/partial disapproval of the San Joaquin Valley PM2.5 plan at 75 FR 74518, 74526-7 (November 30, 2010) and EPA's proposed partial approval/partial disapproval of the South Coast PM2.5 plan at 75 FR 71294, 71302-3 (November 22, 2010).

Finally, in addition to the local district and state rules discussed above, the Sacramento Metro Area has also benefited from Federal mobile source measures such as emissions standards for new locomotive Tier 1 and Tier 2 engines, nationwide heavy-duty on-highway trucks, and new emission standards for pre-empted farm and construction equipment.

Based on the above discussion, EPA believes that the progress made to reduce emissions in the Sacramento Metro Area during the 1990-2009 timeframe resulting in achieving attainment of the 1-hour ozone standard is from permanent and enforceable measures which achieved significant reductions as summarized in Table 8 below:

The emission reduction trends shown in Table 8 are not only expected to be maintained at current levels, but are expected to continue in the next several decades, in spite of increasing population in the area, due to the continued replacement of older vehicles and engines with newer units subject to more stringent California and Federal emission control requirements. The exception is that there is projected to be a slight (1% annually) growth in VOC emissions starting in 2020, as activity growth overcomes emission reductions. See Letter from James Goldstene, CARB Executive Officer, to Jared Blumenfeld, Regional Administrator, U.S. EPA Region IX, dated July 7, 2010, Section 4.2 of Enclosure 2, “1-Hour Ozone Attainment Determination Request for the Sacramento Federal Ozone Nonattainment Area,” April 26, 2010, prepared by: Sacramento Metropolitan Air Quality Management District.

EPA believes the preceding discussion demonstrates that permanent and enforceable emission reduction measures adopted and implemented by the state have been effective in reaching attainment of the 1-hour ozone standard, and that the improvement in the Sacramento Metro Area's air quality is due to permanent and enforceable emission reductions.

EPA is proposing to make a determination to terminate the 1-hour ozone section 185 penalty fee requirement (Termination Determination) for the Sacramento Metro Area. Our proposed determination is based on our finding that the Sacramento Metro Area is attaining the 1-hour ozone NAAQS due to permanent and enforceable reductions in emissions. In proposing this determination, EPA is also proposing to exclude 1-hour ozone NAAQS exceedances that occurred at the Folsom monitor on three days in 2008 because they were caused by wildfire exceptional events. For the reasons set forth in this notice, EPA's proposed 1-hour ozone section 185 Termination Determination is based on EPA's determination that the area has attained and continues to attain the 1-hour ozone standard due to permanent and enforceable emission reductions.

This action proposes to make a determination of attainment and a determination of termination of the CAA section 185 penalty fee requirements based on attainment of the 1-hour ozone standard due to permanent and enforceable emission reductions, and would, if finalized, result in the termination of the section 185 fee requirements for the 1-hour standard, and would not impose any additional requirements. For that reason, this proposed action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• 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);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to the requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this rule does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on Tribal governments or preempt Tribal law.

For the purpose of this document, we are giving meaning to certain words or initials as follows:

(i) The words or initials Act or CAA mean or refer to the Clean Air Act, unless the context indicates otherwise.

(ii) The words EPA, we, us or our mean or refer to the United States Environmental Protection Agency.

(iii) The initials SIP mean or refer to State Implementation Plan.

1. Submitting Confidential Business Information (CBI). Do not submit CBI to EPA through http://www.regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register , date, and page number);

Follow directions and organize your comments;

Explain why you agree or disagree;

Suggest alternatives and substitute language for your requested changes;

Describe any assumptions and provide any technical information and/or data that you used;

If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced;

Provide specific examples to illustrate your concerns, and suggest alternatives;

Explain your views as clearly as possible, avoiding the use of profanity or personal threats; and,

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

On July 18, 1997, EPA promulgated new NAAQS for ozone based on 8-hour average concentrations. The 8-hour averaging period replaced the previous 1-hour averaging period, and the level of the NAAQS was changed from 0.12 parts per million (ppm) to 0.08 ppm (62 FR 38856). By statute, SIPs meeting the requirements of sections 110(a)(1) and (2) are to be submitted by states within three years after promulgation of a new or revised standard. Section 110(a)(2) provides basic requirements for SIPs, including emissions inventories, monitoring, and modeling, to assure attainment and maintenance of the standards. These requirements are set out in several “infrastructure elements,” listed in section 110(a)(2).

Section 110(a) imposes the obligation upon states to make a SIP submission to EPA for a new or revised NAAQS, and the contents of that submission may vary depending upon the facts and circumstances. In particular, the data and analytical tools available at the time the state develops and submits the SIP for a new or revised NAAQS affects the content of the submission. The contents of such SIP submissions may also vary depending upon what provisions the state's existing SIP already contains. In the case of the 1997 ozone NAAQS, states typically have met the basic program elements required in section 110(a)(2) through earlier SIP submissions in connection with previous NAAQS. In a guidance issued on October 2, 2007, EPA noted that, to the extent an existing SIP already meets the section 110(a)(2) requirements, states need only to certify that fact via a letter to EPA. 1

On March 27, 2008, EPA published a final rule entitled, “Completeness Findings for Section 110(a) State Implementation Plans for the 8-hour Ozone NAAQS” (73 FR 16205). In the rule, EPA made a finding for each state that it had submitted or had failed to submit a complete SIP that provided the basic program elements of section 110(a)(2) necessary to implement the 1997 8-hour ozone NAAQS. In particular, EPA found that Colorado had submitted a complete SIP to meet these requirements.

Section 110(a)(1) provides the procedural and timing requirements for SIP submissions after a new or revised NAAQS is promulgated. Section 110(a)(2) lists specific elements the SIP must contain or satisfy. These infrastructure elements include requirements, such as modeling, monitoring, and emissions inventories, that are designed to assure attainment and maintenance of the NAAQS. The elements that are the subject of this action are listed below.

• 110(a)(2)(A): Emission limits and other control measures.

• 110(a)(2)(B): Ambient air quality monitoring/data system.

• 110(a)(2)(C): Program for enforcement of control measures.

• 110(a)(2)(D)(ii): Interstate and international pollution.

• 110(a)(2)(E): Adequate resources and authority.

• 110(a)(2)(F): Stationary source monitoring and reporting.

• 110(a)(2)(G): Emergency powers.

• 110(a)(2)(H): Future SIP revisions.

• 110(a)(2)(J): Consultation with government officials; public notification; and prevention of significant deterioration (PSD) and visibility protection.

• 110(a)(2)(K): Air quality modeling/data.

• 110(a)(2)(L): Permitting fees.

• 110(a)(2)(M): Consultation/participation by affected local entities.

Two elements identified in section 110(a)(2) are not governed by the three year submission deadline of section 110(a)(1) and are therefore not addressed in this action. These elements relate to part D of Title I of the CAA, and submissions to satisfy them are not due within three years after promulgation of a new or revised NAAQS, but rather are due at the same time nonattainment area plan requirements are due under section 172. The two elements are: (i) Section 110(a)(2)(C) to the extent it refers to permit programs (known as “nonattainment new source review (NSR)”) required under part D, and (ii) section 110(a)(2)(I), pertaining to the nonattainment planning requirements of part D. As a result, this action does not address infrastructure elements related to the nonattainment NSR portion of section 110(a)(2)(C) or related to 110(a)(2)(I).

This action also does not address the “interstate transport” requirements of element 110(a)(2)(D)(i). EPA approved portions of the State's 110(a)(2)(D)(i) interstate transport SIP for the 1997 ozone NAAQS in separate actions (75 FR 31306; 75 FR 71029; 76 FR 22036), and has proposed approval of the remaining portion to meet the requirement of 110(a)(2)(D)(i) regarding interference with measures to prevent significant deterioration (76 FR 21835).

1. Emission limits and other control measures: Section 110(a)(2)(A) requires SIPs to include enforceable emission limitations and other control measures, means, or techniques (including economic incentives such as fees, marketable permits, and auctions of emissions rights), as well as schedules and timetables for compliance as may be necessary or appropriate to meet the applicable requirements of this Act.

a. Colorado's Response to this requirement: Enforceable emission limits and control measures are detailed in the various Colorado Air Quality Control Commission (AQCC) regulations for all sources of criteria pollutants as well as hazardous air pollutants, volatile organic compounds (VOCs), chlorofluorocarbons (CFCs), smoke and odors. A summary of the regulations is found below under section 110(a)(2)(C).

b. EPA analysis: Colorado's SIP meets the requirements of CAA Section 110(a)(2)(A), subject to the following clarifications. First, EPA does not consider SIP requirements triggered by the nonattainment area mandates in part D of Title I of the CAA to be governed by the submission deadline of section 110(a)(1). Nevertheless, Colorado has included some SIP provisions originally submitted in response to part D requirements in its certification for the infrastructure requirements of section 110(a)(1) and (2). For the purposes of this action, EPA is reviewing any rules originally submitted in response to part D requirements solely for the purposes of determining whether they support a finding that the State has met the basic infrastructure requirements of section 110(a)(2). For example, in response to the requirement to have enforceable emission limitations under section 110(a)(2)(A), Colorado cited to rules in Regulation Number 7 that were submitted to meet the reasonably available control technology (RACT) requirements of part D. EPA is here approving those rules as meeting the requirement to have enforceable emission limitations on ozone precursors; any judgment about whether those emission limitations discharge the State's obligation to impose RACT under part D was or will be made separately, in an action reviewing those rules pursuant to the requirements of part D.

Second, in this action, EPA is not proposing to approve or disapprove any existing state rules with regard to director's discretion or variance provisions. A number of States have such provisions which are contrary to the CAA and existing EPA guidance (52 FR 45109, Nov. 24, 1987), and the Agency plans to take action in the future to address such state regulations. In the meantime, EPA encourages any State having a director's discretion or variance provision which is contrary to the CAA and EPA guidance to take steps to correct the deficiency as soon as possible.

Finally, in this action, EPA is also not proposing to approve or disapprove any existing state provisions with regard to excess emissions during startup, shutdown, or malfunction (SSM) of operations at a facility. A number of states have SSM provisions which are contrary to the CAA and existing EPA guidance  2 and the Agency plans to address such state regulations in the future. In the meantime, EPA encourages any state having a deficient SSM provision to take steps to correct it as soon as possible.

2. Ambient air quality monitoring/data system: Section 110(a)(2)(B) requires SIPs to provide for establishment and operation of appropriate devices, methods, systems, and procedures necessary to (i) monitor, compile, and analyze data on ambient air quality, and (ii) upon request, make such data available to the Administrator.

a. Colorado's response to this requirement: The provisions for episodic monitoring, data compilation and reporting, public availability of information, and annual network reviews are found in the statewide monitoring SIP which was approved by EPA on 7/9/80 (45 FR 46073) and 8/11/80 (45 FR 53147). The State has since revised the monitoring SIP to include all new federal requirements. The revised SIP includes a commitment to operate a particulate monitoring network in accordance with EPA regulations (40 CFR Part 58.20 and Appendices A through G). The AQCC adopted monitoring SIP revisions on 3/18/93. The Colorado Air Pollution Control Division periodically submits a Quality Management Plan and a Quality Assurance Project Plan to EPA Region 8. These plans cover procedures to monitor, analyze, and report data to an EPA central database. As such the State of Colorado has an approved monitoring SIP, a plan and authority for monitoring, and the ability to properly handle all related data.

b. EPA analysis: Colorado's air monitoring programs and data systems meet the requirements of CAA Section 110(a)(2)(B) for the 1997 ozone NAAQS. The Colorado 2010 Annual Monitoring Network Plan (AMNP) was approved by EPA Region 8 on August 26, 2010.

3. Program for enforcement of control measures: Section 110(a)(2)(C) requires SIPs to include a program to provide for the enforcement of the measures described in subparagraph (A), and regulation of the modification and construction of any stationary source within the areas covered by the plan as necessary to assure that NAAQS are achieved, including a permit program as required in parts C and D.

a. Colorado's response to this requirement: Colorado has an approved SIP regulating the construction and modification of stationary sources as necessary to assure that the NAAQS are achieved (Colorado Air Quality Control Commission Regulation 3), including a permit program as required in Parts C and D of the federal CAA. Colorado has an approved SIP which provides for the enforcement of the control measures required by CAA Section llO (a)(2)(C).

Many of the Colorado AQCC Regulations address in some manner the programs for enforcement of control measures. Some of these AQCC regulations and other relevant Colorado- specific programs that are in the SIP are described below:

• Regulation 1, “Particulates, Smokes, Carbon Monoxide, and Sulfur Dioxides”—Regulation 1 sets forth emissions limitations, equipment requirements, and work practices (abatement and control measures) intended to control the emissions of particulates, smoke and sulfur oxides from new and existing stationary sources. Control measures specified in this regulation are designed to limit emissions into the atmosphere and thereby minimize the ambient concentrations of particulates and sulfur dioxides.

• Regulation 3, “Air Pollution Emission Notices—Permits”—Regulation 3 provides for a procedural permitting program and requires air pollution sources to file Air Pollution Emissions Notices (APENs). The regulation also requires that new or modified sources of air pollution with certain exemptions-obtain preconstruction permits.

• Regulation 4, “Woodburning Controls”—Regulation 4 requires new stove and fireplace inserts meet the federal certification requirements in specified areas of Colorado.

• Regulation 7, “Volatile Organic Compounds Control”—Regulation 7 controls the emissions of volatile organic compounds, primarily in the Denver-metro area. It sets standards and mandates controls for specific types of volatile organic compound sources.

• Regulation 10, “Transportation Conformity”—Regulation 10 defines the criteria the Colorado Air Quality Control Commission uses to evaluate the consistency between state air quality standards/objectives, and transportation planning and major construction activities across the State, as defined in state implementation plans.

• Regulation 11, “Motor Vehicle Inspection”—Regulation 11 requires automobile emission inspection and maintenance programs to be implemented in specified areas of the State for gasoline-powered on-road vehicles. These programs apply to businesses, industry, and the general public. In addition, the State's Automobile Inspection and Readjustment (AIR) program's purpose is to reduce motor vehicle-related pollution through the inspection and emissions-related repair of automobiles. The program, as defined in Regulation 11, works in specific areas of the State and requires motor vehicles to meet emission standards through periodic maintenance and/or repair.

• Regulation 13, “Oxygenated Fuels”—Regulation 13 addresses the issue of motor vehicle related pollution and requires the use of oxygenated fuels in gasoline-powered motor vehicles in Colorado's Automobile Inspection and Readjustment program.

• Regulation 16, “Street Sanding and Sweeping”—Regulation 16 sets specification standards for street sanding material and street sweeping practices in the Automobile Inspection and Readjustment program area and Denver-metro particulate attainment/maintenance area.

b. EPA analysis: To generally meet the requirements of section 110(a)(2)(C), the State is required to have SIP-approved prevention of significant deterioration (PSD), nonattainment New Source Review (NSR), and minor NSR permitting programs adequate to implement the 1997 8-hour ozone NAAQS. As explained above, in this action EPA is not evaluating nonattainment related provisions, such as the nonattainment NSR program required by part D of the Act. Also, in this action, EPA is not proposing to approve or disapprove any state rules with regard to NSR Reform requirements. EPA will act on SIP submittals that are made for purposes of addressing NSR Reform through a separate rulemaking process. In this action, EPA is evaluating the State's PSD program as required by part C of the Act, and the State's minor NSR program as required by 110(a)(2)(C).

Colorado has a SIP-approved PSD program that meets the general requirements of part C of the Act (51 FR 31125). Below, EPA considers requirements for the PSD program specific to the 1997 ozone NAAQS, but first considers the effects of recent rules regulating greenhouse gases on Colorado's PSD program.

EPA notes a potential inconsistency between Colorado's January 7, 2008 infrastructure SIP certification and EPA's recently promulgated rule, “Limitation of Approval of Prevention of Significant Deterioration Provisions Concerning Greenhouse Gas Emitting-Sources in State Implementation Plans” (“PSD SIP Narrowing Rule”), 75 FR 82536 (Dec. 30, 2010). In the PSD SIP Narrowing Rule, EPA withdrew its previous approval of Colorado's PSD program to the extent that it applied PSD permitting to greenhouse gas (GHG) emissions increases from GHG-emitting sources below thresholds set in EPA's June 3, 2010 “Prevention of Significant Deterioration and Title V Greenhouse Gas Tailoring Rule” (“Tailoring Rule”), 75 FR 31514. EPA withdrew its approval on the basis that the State lacked sufficient resources to issue PSD permits to such sources at the statutory thresholds in effect in the previously-approved PSD program. After the PSD SIP Narrowing Rule, the portion of Colorado's PSD SIP from which EPA withdrew its approval had the status of having been submitted to EPA but not yet acted upon. In its January 7, 2008 certification, Colorado relied on its PSD program as approved at that date—which was before December 30, 2010, the effective date of the PSD SIP Narrowing Rule—to satisfy the requirements of infrastructure element 110(a)(2)(C). Given EPA's basis for the PSD SIP Narrowing Rule, EPA proposes approval of the Colorado infrastructure SIP for infrastructure element (C) if either the State clarifies (or modifies) its certification to make clear that the State relies only on the portion of the PSD program that remains approved after the PSD SIP Narrowing Rule issued on December 30, 2010, and for which the State has sufficient resources to implement, or the State acts to withdraw from EPA consideration the remaining portion of its PSD program submission that would have applied PSD permitting to GHG sources below the Tailoring Rule thresholds. In the alternative, if Colorado does not take either action, EPA proposes to disapprove the infrastructure SIP to the extent it incorporates that portion of the previously-approved PSD program from which EPA withdrew its approval in the PSD SIP Narrowing Rule, which is the portion which would have applied PSD permitting requirements to GHG emissions increases from GHG-emitting sources below the Tailoring Rule thresholds. Such disapproval, if finalized, would not result in a need for Colorado to resubmit a SIP revision, sanctions, or a federal implementation plan (FIP).

In order for the State's SIP-approved PSD program to satisfy the requirements of section 110(a)(2)(C) for the 1997 ozone NAAQS, the program must properly regulate ozone precursors. On November 29, 2005, EPA promulgated the phase 2 implementation rule for the 1997 ozone NAAQS (Phase 2 Rule), which includes requirements for PSD programs to treat nitrogen oxides (NO X ) as a precursor for ozone (72 FR 71612). On August 1, 2007, the State submitted to EPA revisions to AQCC Regulation No. 3, Part D (PSD) which incorporate EPA's Phase 2 Rule. On April 19, 2011, EPA proposed approval of the portions of the August 1, 2007 revisions which adopt language treating NO X as a precursor for ozone (76 FR 21835). We anticipate finalizing the approval of the portions in the April 19, 2011 proposal that satisfy the requirements of the Phase 2 Rule before finalizing approval of Colorado's infrastructure SIP. Contingent on that approval, Colorado's PSD program meets the requirements of section 110(a)(2)(C) for the 1997 ozone NAAQS.

The State has a SIP-approved minor NSR program, adopted under section 110(a)(2)(C) of the Act, which regulates emissions of ozone and its precursors. On April 30, 1981, EPA approved the State's minor NSR program for incorporation into the SIP, and there was at the time no objection to the provisions of this program (46 FR 24180). Since then, the State and EPA have relied on the approved minor NSR program to assure that new and modified sources not captured by the major NSR permitting programs do not interfere with attainment and maintenance of the NAAQS.

In this action, EPA is proposing to approve Colorado's infrastructure SIP for the 1997 ozone NAAQS with respect to the general requirement in section 110(a)(2)(C) to include a program in the SIP that regulates the modification and construction of any stationary source as necessary to assure that the NAAQS are achieved. EPA is not proposing to approve or disapprove the State's existing minor NSR program itself to the extent that it is inconsistent with EPA's regulations governing this program. A number of states may have minor NSR provisions that are contrary to the existing EPA regulations for this program. EPA intends to work with states to reconcile state minor NSR programs with EPA's regulatory provisions for the program. The statutory requirements of section 110(a)(2)(C) provide for considerable flexibility in designing minor NSR programs, and it may be time to revisit the regulatory requirements for this program to give the states an appropriate level of flexibility to design a program that meets their particular air quality concerns, while assuring reasonable consistency across the country in protecting the NAAQS with respect to new and modified minor sources.

4. Interstate transport: Section 110(a)(2)(D)(i) requires SIPs to contain adequate provisions prohibiting, consistent with the provisions of this title, any source or other type of emissions activity within the state from emitting any air pollutant in amounts which will (I) contribute significantly to nonattainment in, or interfere with maintenance by, any other state, with respect to any such national primary or secondary ambient air quality standard, or (II) interfere with measures required to be included in the applicable implementation plan for any other state under part C to prevent significant deterioration of air quality or to protect visibility.

a. Colorado's response to this requirement: An Interstate Transport SIP revision was approved by the AQCC on February 15, 2007 that demonstrates pollutants from Colorado, including ozone and PM 2.5, do not contribute to a NAAQS problem in neighboring states. The SIP revision utilized both monitoring data and modeling to show that neither ozone nor particulate matter originating in Colorado contributes to NAAQS problems outside of Colorado. The SIP revision will be forwarded to EPA after review and approval from the Colorado Legislature and the Governor's Office.

Specific issues of interstate transport are addressed within Colorado Regulation 3, “Air Pollution Emission Notices.” Regulation 3, Part B, Section IV.C.4 requires the Colorado Air Pollution Control Division to notify any state that may be affected by emissions from that source or from a modification to that source as related to the prevention of significant deterioration. Colorado also has a regulation requiring installation of Best Achievable Retrofit Technology (BART) on stationary sources if visibility impairment in any Class I Area is reasonably attributed to such stationary source (Colorado Air Quality Control Commission Regulation 3, Part B.XI.D).

The AQCC has a directive regarding interstate transport of pollutants that prohibits Colorado sources from causing a violation of the NAAQS in a neighboring state with reciprocal provisions as found in the AQCC Common Provisions, Part 2, Section A (5CCR 1001-2).

b. EPA Analysis: Colorado did not submit its interstate transport SIP to meet the requirements of section 110(a)(2)(D)(i) with the January 7, 2008 Infrastructure SIP. Colorado has since submitted an interstate transport SIP and revisions to EPA for the 1997 ozone NAAQS. EPA approved portions of the State's 110(a)(2)(D)(i) interstate transport SIP for the 1997 ozone NAAQS in separate actions (75 FR 31306; 75 FR 71029; 76 FR 22036), and has proposed approval of the remaining portion to meet the requirement of 110(a)(2)(D)(i)(II) regarding interference with measures to prevent significant deterioration (76 FR 21835). EPA is taking no action relevant to section 110(a)(2)(D)(i) in this proposal.

5. Interstate and international transport provisions: Section 110(a)(2)(D)(ii) requires that each SIP shall contain adequate provisions insuring compliance with applicable requirements of sections 126 and 115 (relating to interstate and international pollution abatement).

a. Colorado's response to this requirement: Colorado did not specifically address this requirement, but rather addressed 110(a)(2)(D) as a whole. See Colorado's response to requirement 110(a)(2)(D)(i), in particular the State's citation of Regulation 3, Part B, Section IV.C.4.

b. EPA Analysis: Section 126(a) requires notification to affected, nearby states of major proposed new (or modified) sources. Sections 126(b) and (c) pertain to petitions by affected states to the Administrator regarding sources violating the “interstate transport” provisions of section 110(a)(2)(D)(i). Section 115 similarly pertains to international transport of air pollution.

Colorado meets the requirement of section 126(a) through AQCC Regulation No. 3 Part B, Section IV.C.4. This provision requires notification to states whose lands may be affected by the construction or modification of a stationary source. In addition to satisfying the requirements of 40 CFR 51.166(q)(2)(iv), the provision meets the requirements of section 126(a). Final approval of the AQCC Regulation No. 3 Part B, Section IV.C.4 became effective February 20, 1997 (62 FR 2910). 3

Colorado has no pending obligations under sections 126(c) or 115(b); therefore, Colorado's SIP currently meets the requirements of those sections. The SIP therefore meets the requirements of 110(a)(2)(D)(ii) for the 1997 ozone NAAQS.

6. Adequate resources and authority: Section 110(a)(2)(E) requires states to provide (i) necessary assurances that the state will have adequate personnel, funding, and authority under state law to carry out the SIP (and is not prohibited by any provision of federal or state law from carrying out the SIP or portion thereof), (ii) requires that the state comply with the requirements respecting state boards under section 128, and (iii) necessary assurances that, where the state has relied on a local or regional government, agency, or instrumentality for the implementation of any SIP provision, the state has responsibility for ensuring adequate implementation of such SIP provision.

a. Colorado's response to this requirement:

There are no state or federal provisions prohibiting the implementation of any provision of the Colorado SIP. In general, Colorado provides the necessary assurances that funding, personnel, and authority exist and that the State of Colorado has responsibility for implementing local provisions. All of the regulatory provisions in the SIP were adopted by the AQCC pursuant to authority delegated to it by statute. The AQCC's general authority to adopt the rules and regulations necessary to implement the SIP is set out in the Colorado Air Pollution Prevention and Control Act Section 25-7-105 of the Colorado Revised Statutes (C.R.S.). The general authority for the Air Pollution Control Division to administer and enforce the program is set out at 25-7-111, C.R.S. Additional authority to regulate air pollution and implement provisions in the SIP is set out elsewhere in the Colorado Air Pollution Prevention and Control Act, Article 7 of Title 25. In addition, the AQCC and the Division have the authority delegated to them in Sections 42-4-301 to 42-4-316, C.R.S. (concerning motor vehicle emissions) and 42-4-414 (concerning emissions from diesel-powered vehicles).

The AQCC's authority includes the authority to regulate particulate emissions, regardless of size (C.R.S. Section 25-7-109 (2)(b)).

The Colorado Air Pollution Control Division has staff and an annual budget to operate its six programs (Stationary Sources, Mobile Sources, Indoor Air, Technical Services, Planning and Policy, Administrative Services). The Division employs 154 people and has a budget of $16.5 million for fiscal year 2006-2007.

Of the total budget, 21 percent was derived from federal grants, 38 percent from mobile source fees, and 41 percent from stationary source fees.

Section 128 of the CAA indicates Colorado's SIP must contain requirements that anybody that approves permits or enforcement orders under the CAA must have a majority of members who represent the public interest and do not derive any significant portion of their income from persons subject to permits or enforcement orders.

The Commission's Air Quality Commission Procedural Rules section 1.11.0 state that “The Commission shall have at least a majority of members who represent the public interest and do not derive a significant portion of their income from persons subject to permits or enforcement orders under this article or under the federal act. The members of the Commission shall disclose any potential conflicts of interest that arise during their terms of membership to the other Commissioners in a public meeting of the Commission.”

The Colorado Air Pollution Control Division contracts with local governments in two distinct ways:

1. Colorado grants monies to local health departments to endow them as agents of the State to provide inspections of some local stationary sources, asbestos abatement jobs, and CFC sources. Some local health departments also operate gaseous and particulate monitors under contract for the state. These efforts must comply with federal and state regulations.

2. Colorado grants monies to local governments to help pay for their support of SIP elements via public and private partnerships, education and informational campaigns. Most of these agencies create their own work plan that consists of programs they feel will help enhance air quality in their communities in accordance with general SIP directives.

Colorado has adopted specific regulations for local attainment/maintenance areas to assure these areas meet requirements of the SIP. These regulations include The Colorado Air Quality Control Commission SIP-specific regulations, 5 CCR 1001-20. These regulations provide the necessary authority for the Colorado Air Pollution Control Division to adequately enforce the provisions of the SIP elements in local attainment/maintenance areas.

b. EPA Analysis: Colorado's SIP meets the requirements of section 110(a)(2)(E) for the 1997 ozone NAAQS. The State cites the Colorado Revised Statutes, specifically Air Pollution Prevention and Control Act Sections 25-7-105, 25-7-111, 42-4-301 to 42-4-316, 42-4-414 and Article 7 of Title 25 to demonstrate that the APCD and AQCC have adequate authority to carry out Colorado's SIP obligations with respect to the 1997 ozone NAAQS and revise its SIP as necessary. The State receives sections 103 and 105 grant funds through its Performance Partnership Grant along with required state matching funds to provide funding necessary to carry out Colorado's SIP requirements. Finally, section IV of Colorado's Common Provisions contains requirements for members of the AQCC to disclose potential conflicts of interest.

7. Stationary source monitoring system: Section 110(a)(2)(F) requires (i) the installation, maintenance, and replacement of equipment, and the implementation of other necessary steps, by owners or operators of stationary sources to monitor emissions from such sources, (ii) period reports on the nature and amounts of emissions and emissions-related data from such sources, and (iii) correlation of such reports by the state agency with any emission limitations or standards established pursuant to the Act, which reports shall be available at reasonable times for public inspection.

a. Colorado's response to this requirement: Colorado AQCC Regulations 1, 3, and 6 address the issue of stationary source monitoring. Colorado Regulation 1 sets forth emission limitations, equipment requirements and work practices (abatement and control measures) intended to control the emissions of particulates, smoke, and sulfur dioxides from new and existing stationary sources. Colorado Regulation 3 requires stationary sources to report their emissions on a regular basis through APENs. This air pollutant inventory program is described in the Colorado Pollution Prevention and Control Act Section 25-7-114.1 (C.R.S.) and in Colorado Regulation 3, Part I.VIII that allows for monitoring and record keeping of air pollutants. Colorado Regulation 6 sets standards for performance of new stationary sources in the state and establishes monitoring system requirements.

The Colorado Air Pollution Control Division may require owners and operators of stationary air pollution sources to install, maintain, and use instrumentation to monitor and record emission data as a basis for periodic reports to the Division under the Colorado AQCC Common Provisions.

b. EPA Analysis: The regulations cited by Colorado, including APEN reporting requirements and requirements in Regulation No. 8. I.VIII, meet the requirements of section 110(a)(2)(F) for the 1997 ozone NAAQS.

8. Emergency powers: Section 110(a)(2)(G) requires states to provide for authority to address activities causing imminent and substantial endangerment to public health, including contingency plans to implement the emergency episode provisions in their SIPs.

a. Colorado's response to this requirement: The SIP includes contingency plans to implement emergency powers similar to Section 303 of the CAA. Such contingency plans, called Denver Emergency Episode Plans, address ozone, particulate matter, and carbon monoxide. The Colorado Pollution Prevention and Control Act Sections 25-7-112 and 25-7-113, which have various sections similar to 42 U.S.C. 7603, generally describe Colorado's authority regarding Emergency Episodes. For example, 25-7-112 (2) provides the Colorado Air Pollution Control Division with authority to implement the Emergency Plan through the Governor of Colorado issuing an order in regard to emergency power.

b. EPA analysis: Colorado Pollution Prevention and Control Act Sections 25-7-112 and 25-7-113 provide APCD with general emergency authority comparable to that in section 303 of the Act. In addition, the Denver Emergency Episode Plan, applicable to the Denver metropolitan area, satisfies the requirements of 40 CFR part 51, subpart H (See 74 FR 47888). The SIP therefore meets the requirements of 110(a)(2)(G) for the 1997 ozone NAAQS.

9. Future SIP revisions: Section 110(a)(2)(H) requires that SIPs provide for revision of such plan (i) from time to time as may be necessary to take account of revisions of such national primary or secondary ambient air quality standard or the availability of improved or more expeditious methods of attaining such standard, and (ii), except as provided in paragraph 110(a)(3)(C), whenever the Administrator finds on the basis of information available to the Administrator that the SIP is substantially inadequate to attain the NAAQS which it implements or to otherwise comply with any additional requirements under this Act.

a. Colorado's response to this requirement: The State of Colorado has the ability and authority to address and revise the SIP due to changes in the NAAQS or due to findings of inadequacies.

The Colorado AQCC has the authority and the duty to adopt and revise a State Implementation Plan as necessary to comply with the federal requirements. Colorado Air Pollution Prevention and Control Act Section 25-7-105(1)(a)(I) (C.R.S.) directs the Colorado Air Quality Control Commission to promulgate rules and regulations as related to a comprehensive SIP which will assure attainment and maintenance of the NAAQS and which will prevent significant deterioration of air quality in the State of Colorado.

Colorado Air Pollution Prevention and Control Act Section 25-7-109 (C.R.S.) also gives the Colorado Air Quality Control Commission the authority to promulgate emission control regulations.

b. EPA analysis: Colorado's statutory provision at Colorado Air Pollution Prevention and Control Act Section 25-7-105(1)(a)(I) gives the AQCC sufficient authority to meet the requirements of 110(a)(2)(H).

10. Nonattainment Area Plan or Plan Revision under Part D: Section 110(a)(2)(I) requires that a SIP or SIP revision for an area designated as a nonattainment area must meet the applicable requirements of Part D of this subchapter (relating to nonattainment areas).

a. EPA analysis for Section 110(a)(2)(I): As noted above, the specific nonattainment area plan requirements of Section 110(a)(2)(I) are subject to the timing requirement of section 172, not the timing requirement of section 110(a)(1). This element is therefore not applicable to this action. EPA will take action on part D attainment plans through a separate process.

11. Consultation with government officials, public notification, PSD and visibility protection: Section 110(a)(2)(J) requires that each SIP meet the applicable requirements of section 121 of this title (relating to consultation), section 127 of this title (relating to public notification), and part C of this subchapter (relating to prevention of significant deterioration of air quality and visibility protection).

a. Colorado's response to this requirement: Engineering and meteorological consultation is provided by the State to local agencies. The State assists local agencies in planning air management programs for their respective areas. Colorado holds public meetings and hearings on all SIP revisions in accordance with the AQCC Procedural Rules. Public comment is solicited and accepted at Colorado AQCC meetings and hearings. Colorado's Transportation Conformity Rule, Regulation 10, specifies consultation procedures for SIP revisions in Section IV.F.

Also, as part of the State of Colorado's Visibility SIP, the Colorado Air Pollution Control Division consults with the Federal Land Managers as necessary and required.

b. EPA Analysis: The State has demonstrated that it has the authority and rules in place to provide a process of consultation with general purpose local governments, designated organizations of elected officials of local governments and any Federal Land Manager having authority over federal land to which the SIP applies, consistent with the requirements of CAA section 121. Furthermore, EPA previously approved Colorado's SIP submission to meet the requirements of CAA section 127 (45 FR 53147, Aug. 11, 1980).

Colorado's SIP regulations for its PSD program were federally-approved and made part of the SIP on September 2, 1986 (51 FR 31125). EPA has further evaluated the State's SIP-approved PSD program in this proposed action in section IV.3, element 110(a)(2)(C).

Finally, with regard to the applicable requirements for visibility protection, EPA recognizes that states are subject to visibility and regional haze program requirements under part C of the act. In the event of the establishment of a new NAAQS, however, the visibility and regional haze program requirements under part C do not change. Thus we find that there is no new visibility obligation “triggered” under section 110(a)(2)(J) when a new NAAQS becomes effective. In conclusion, the Colorado SIP meets the requirements of section 110(a)(2)(J) for the 1997 ozone NAAQS.

12. Air quality and modeling/data: Section 110(a)(2)(K) requires that each SIP provide for (i) the performance of such air quality modeling as the Administrator may prescribe for the purpose of predicting the effect on ambient air quality of any emissions of any air pollutant for which the Administrator has established a NAAQS, and (ii) the submission, upon request, of data related to such air quality modeling to the Administrator.

a. Colorado's response to this requirement: Colorado has the authority and resources to model for criteria pollutants. Air quality modeling is done for SIP revisions and for transportation conformity. Colorado Regulation 3 (Air Pollution Emissions Notices, Construction Permits and Fees, Operating Permits, and Prevention of Significant Deterioration) requires stationary sources to predict the effect of air pollutants in attainment areas. Regulation 3 also details the State of Colorado's program regarding permitting as related to air quality modeling and data handling in predicting the effect of emissions of a pollutant with an established NAAQS. Regulatory requirements for Air Quality Related Values as related to modeling are described within Colorado Regulation 3, Part B subsection X and XI. A permit modification for purposes of the acid rain portion of a permit shall be governed by regulations promulgated under Title IV of the federal act, found in 40 CFR part 72 as described under Colorado Regulation 3, Part C, subsection X.K.

The Modeling, Meteorology, and Emission Inventory Unit within the Colorado Air Pollution Control Division performs and reviews air quality impact analyses for a variety of programs, including SIP revisions, transportation conformity determinations, stationary source permitting, environmental impact statements, and hazardous waste site studies. The analyses include modeling, meteorological analysis, and emission inventory development for mobile sources and area stationary sources such as woodburning. The Unit also performs air quality forecasting for the Denver-area High Pollution Season, open burning, and for special air quality studies. Additional information regarding these programs and authority is provided below. Some of these programs are found in the SIP. For example, both Colorado AQCC Regulation 4 (Woodburning) and the Denver PM 10 SIP address State air quality modeling programs.

PSD and Increment Consumption: Colorado's PSD program includes a requirement that the State periodically assess the adequacy of its plan to prevent significant deterioration of air quality. This is presented in Regulation 3, Part B, Section VII. In addition, Regulation 3, Part A, Section VIII “Technical Modeling and Monitoring Requirements” states that all estimates of ambient concentrations required under Regulation 3 shall be based on the applicable air quality models, data bases, and other requirements generally approved by EPA and specifically approved by the Division.

SIP development: Modeling is performed in the development and revision of SIPs, as needed, to ensure that specific areas of the state will maintain compliance with the NAAQS in light of development and increased population and traffic.

Permits: The primary Colorado regulation for air quality permits is Colorado AQCC Regulation No.3. Certain new/modified air pollution sources are subject to the regulatory modeling requirements in Regulation 3. Regulation 3, Part A, subsection VIII describes Colorado's technical modeling and monitoring requirements. Modeling is often required to obtain a construction permit. While modeling is not required to obtain an operating permit, it may be required if the operating permit is modified (in Regulation 3, Part C, subsection X-Minor Permit Modification Procedures). Operating permits may also be subject to modeling if the application is for a combined construction/operating permit (in Regulation 3, Part C, subsection III.C.12.d).

b. EPA Analysis: Colorado's SIP meets the requirements of CAA Section 110(a)(2)(K) for the 1997 ozone NAAQS. In particular, Colorado's Regulation 3 Part A.VIII requires estimates of ambient air concentrations be based on applicable air quality models approved by EPA. Final approval for Regulation 3 Part A.VIII became effective February 20, 1997 (62 FR 2910). As a result, the SIP provides for such air quality modeling as the Administrator has prescribed.

13. Permitting fees: Section 110(a)(2)(L) requires SIPs to require the owner or operator of each major stationary source to pay to the permitting authority, as a condition of any permit required under this act, a fee sufficient to cover (i) the reasonable costs of reviewing and acting upon any application for such a permit, and (ii) if the owner or operator receives a permit for such source, the reasonable costs of implementing and enforcing the terms and conditions of any such permit (not including any court costs or other costs associated with any enforcement action), until such fee requirement is superseded with respect to such sources by the Administrator's approval of a fee program under title V.

a. Colorado's response to this requirement: The State of Colorado requires the owner or operator of a major stationary source to pay the Colorado Air Pollution Control Division any fee necessary to cover the reasonable costs of reviewing and acting upon any permit applications. The collection of fees is described in Colorado AQCC Regulation 3. Specifically, Regulation 3, Part A.VI describes how each applicant required to obtain a permit must pay a fee, including the cost of permit review and relevant actions. Also, stationary source owners or operators must pay an annual fee based on total emissions. The funds are used by the State to administer programs for the control of air pollution from stationary sources.

b. EPA analysis: Colorado's approved title V operating permit program meets the requirements of CAA section 111(a)(2)(L) for the 1997 ozone NAAQS. Final approval of the title V operating permit program became effective October 16, 2000 (65 FR 49919). Interim approval of Colorado's title V operating permit program became effective February 23, 1995 (60 FR 4563). As discussed in the proposed interim approval of the title V program (59 FR 52123, Oct. 14, 1994), the State demonstrated that the fees collected were sufficient to administer the program.

14. Consultation/participation by affected local entities: Section 110(a)(2)(M) requires states to provide for consultation and participation in SIP development by local political subdivisions affected by the SIP.

a. Colorado's response to this requirement: Colorado AQCC Regulation 10, “Transportation Conformity,” defines the criteria the Colorado AQCC uses for transportation conformity determination to develop SIP revisions in non-attainment areas.

Colorado AQCC Regulation 3 also provides for consultation and participation by local entities. Local governments receive notice and have the opportunity to comment on and participate in construction permit review procedures and operating permit application procedures.

The Colorado AQCC holds a public hearing before adopting any regulatory revisions to the SIP. Local political subdivisions may participate in the hearing.

b. EPA Analysis: Colorado's submittal meets the requirements of CAA Section 110(a)(2)(M) for the 1997 ozone NAAQS.

In this action, EPA is proposing to approve in full the following section 110(a)(2) infrastructure elements for Colorado for the 1997 ozone NAAQS: (A), (B), (D)(ii), (E), (F), (G), (H), (J), (K), (L), (M). EPA proposes to approve the section 110(a)(2)(C) infrastructure element in full for the 1997 ozone NAAQS in the event that Colorado takes one of the actions described in the discussion of that element. In the alternative, EPA proposes to disapprove the section 110(a)(2)(C) element to the extent described and to otherwise approve this element. EPA is taking no action on infrastructure elements (D)(i) and (I) for the 1997 ozone NAAQS.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations (42 U.S.C 7410(k), 40 CFR 52.02(a)). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this proposed action merely approves some state law as meeting Federal requirements and disapproves other state law because it does not meet Federal requirements; this proposed action does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• 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);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and,

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

Context

On March 25, 1999, NMFS listed the Middle Columbia River (MCR) steelhead distinct population segment (DPS) as threatened under the Endangered Species Act (ESA) (16 U.S.C. 1531-1544) (64 FR 14517). The MCR steelhead DPS range covers approximately 35,000 square miles (90,650 sq km) of the Columbia plateau of eastern Oregon and eastern Washington. The Deschutes River in central Oregon is one of six major river basins supporting steelhead in this DPS. Since 1968, the Pelton Round Butte Hydroelectric Project (Pelton Round Butte) on the Deschutes River has blocked steelhead from accessing nearly 200 miles (322 km) of historical spawning and rearing habitat.

In this rulemaking, we are proposing to designate as an experimental population the MCR steelhead currently being reintroduced to the upper Deschutes River basin. This reintroduction is a requirement of the new hydropower license for the Pelton Round Butte Hydroelectric Project in Oregon, and thus will continue regardless of whether we designate the steelhead population in the upper Deschutes River basin as experimental. The licensees, Portland General Electric Company and the Confederated Tribes of the Warm Springs Reservation of Oregon, are conducting the reintroduction program in cooperation with the State of Oregon, NMFS, the U.S. Forest Service, the U.S. Fish and Wildlife Service, U.S. Bureau of Land Management, Jefferson and Deschutes Counties, Oregon, and 10 other stakeholder groups. This reintroduction is one of many recovery actions being implemented by NMFS, Federal and state agencies, and other partners throughout the threatened species' historical range. While passage and reintroduction are occurring under the authority of the Federal Power Act, we would be designating the reintroduced steelhead as a NEP, and providing special protective measures for the NEP, under the authority of the ESA. The purpose of this proposed designation is to temporarily lift certain ESA liability and consultation requirements to allow time to develop conservation measures to support the reintroduction effort in the Upper Deschutes River basin. The conservation measures would benefit from information gained during the early stages of the reintroduction effort to focus the conservation measures on the areas needing support.

The specific stock chosen to initiate steelhead reintroduction is from the Round Butte Hatchery. After the new license was issued in June 2005 and reintroduction planning was largely completed, we included the Round Butte Hatchery steelhead stock as part of the threatened group of steelhead (71 FR 834; January 5, 2007).

We are proposing to have the NEP designation set by this action expire after three successive generations of steelhead have been passed over Round Butte Dam. Specifically, the NEP designation would expire 12 years after the first generation of adults return to the NEP area. Some local landowners and one municipality are working to develop a Habitat Conservation Plan (HCP) for certain activities that may impact steelhead reintroduced above Round Butte Dam. This HCP is likely to be completed sooner than the proposed expiration date for the NEP designation. However, the HCP covers only a subset of the activities and area impacted by the reintroduction. Thus, other local entities may consider developing conservation measures to address potential ESA liability. We expect that the fixed-duration NEP designation will incentivize local landowners and municipalities to develop such conservation measures in a timely manner, since full ESA protections will once again apply to the steelhead after the experimental population designation expires. In addition, we expect that information developed during the NEP designation period will help inform conservation measures, either as they are being developed or through adaptive management mechanisms.

The proposed NEP would occur in portions of Deschutes, Jefferson, and Crook Counties, Oregon. The geographic boundaries of the NEP would extend upstream from Round Butte Dam on the Deschutes River to Big Falls (river mile 132, or kilometer 212) and all accessible reaches of its tributary, Whychus Creek; on the Crooked River from its confluence with the Deschutes River upstream to Bowman Dam (river mile 70, or rkm 113) and all accessible tributaries between these points; and on the Metolius River from its confluence with the Deschutes River upstream to all accessible areas. While this area is part of its historical range, it is outside the current range of the Middle Columbia River steelhead DPS. The DPS boundary is located at the Reregulating Dam, the furthest downstream dam of the Pelton Round Butte Hydroelectric Project, on the Deschutes River downstream of the NEP area.

Section 10(j) of the Endangered Species Act (16 U.S.C.S. 1539(j)) allows the Secretary of Commerce (Secretary) to authorize the release of an experimental population of an endangered or threatened species outside the current range of such species if the Secretary determines that such release will further the conservation of such species. The Secretary may designate an experimental population when, and at such times as, the population is wholly separate geographically from nonexperimental populations. In this action, NMFS proposes to designate an experimental population that is geographically separate from the non-experimental ESA-listed MCR steelhead population, due to the dams that block access for the species to the area where the species is being reintroduced. The MCR steelhead will only be considered experimental when they are above the Round Butte Dam. The proposed designation will further the conservation of the species because it will build support for the reintroduction effort among local landowners, incentivize those landowners and municipalities to complete conservation measures within the set time-period, and ensure that the conservation measures are informed by information gathered during the NEP designation, i.e., the first three generations of returning adults. We will provide notice in the Federal Register when the NEP designation is set to expire.

We would like the final rule to be as effective and accurate as possible, and the final EA to evaluate the potential issues and reasonable range of alternatives. Therefore, we invite the public, tribal and government agencies, the scientific community, environmental groups, industry, local landowners, and all other interested parties to provide comments on the proposed rule and EA. We request that you keep your comments relevant to the proposed experimental population designation, bearing in mind that the reintroduction is required by the Pelton Round Butte hydropower license. Your comments should be as specific as possible, provide suggested changes, explain the basis for them, and include supporting information where appropriate.

Prior to issuing a final rule, we will consider the comments and supporting materials we receive. The final rule may differ from the proposed rule based on this information and other considerations.

We are interested in all public comments, and have specific questions we are interested in hearing public comments on:

(1) Use of a specific expiration date: We chose to state up front that the designation would expire at a certain time to encourage completion of conservation measures rather than leaving their development more open ended. Other experimental population designations indicate that the designation may be removed for certain reasons, but do not include a specific expiration date in the designation. Please comment on the use of an expiration date.

(2) Twelve-year time frame: We propose that the NEP designation expire 12 years after the first generation of adults return to the NEP area, in part because useful information will be gained during that timeframe because this 12-year period should allow three generations of the reintroduced steelhead to return. Three generations allows for consideration of variability between generations, including the year-to-year variability in environmental conditions, so is expected to provide useful information for developing and tailoring conservation measures. After this time, we will know where adults are spawning and young are rearing, and whether there are certain needs of the steelhead in specific areas that can be addressed through conservation measures. If the HCP or other conservation measures are completed prior to the 12-year expiration, information from the NEP designation could nevertheless be used to inform those measures through adaptive management mechanisms.

As indicated, the time limit is also designed to incentivize completion of conservation measures—both in the HCP and otherwise. For the HCP, however, a 12-year limit could reduce the incentive to complete the HCP on its current projected timeframe, which is less than 12 years. Yet, if we used a shorter time-frame, the quality of information from the NEP would be significantly diminished.

Please comment on the use of 12 years as a fixed time period for the NEP designation.

(3) The extent to which the experimental population would be affected by current or future Federal, state, or private actions within or adjacent to the experimental population area.

(4) Current programs within the experimental population area that protect fish or aquatic habitats.

(5) Any necessary management restrictions, protective measures, or other management measures that we have not considered.

The Deschutes River basin above the Pelton Round Butte Hydroelectric Project was once home to native runs of summer steelhead, Chinook salmon, sockeye salmon, and Pacific lamprey. Before hydroelectric and irrigation development, steelhead used the Deschutes River up to Big Falls, Whychus Creek (a Deschutes River tributary above the Pelton Round Butte Hydroelectric Project), and the Crooked River watershed. Within the Crooked River watershed, steelhead were documented in McKay, Ochoco, Horseheaven, Newsome, Drake, Twelvemile, and Beaver Creeks, and the North Fork Crooked River (Nehlsen, 1995). The completion of Ochoco Dam east of Prineville in 1920 blocked steelhead access into most of the Ochoco Creek watershed, and the completion of Bowman Dam on the Crooked River in 1961 stopped fish passage into the upper Crooked River watershed. On the Deschutes River, the Pelton and Reregulating Dams were completed in 1958. Even though these dams had fish passage, steelhead numbers in the upper Deschutes River basin, though still significant, had declined by that time (Nehlsen, 1995). Available information suggests peak annual escapements in the 1950s were at least 1,600 adult summer steelhead and 800-900 (Montgomery, 1955) adult spring Chinook salmon (with perhaps twice this number harvested downstream). After completion of Round Butte Dam (the most upstream dam) in 1964, fish passage decreased dramatically, and, by 1968, was abandoned in favor of a hatchery program to mitigate for lost passage and habitat. The runs could not be sustained primarily because deceptive surface currents confused smolts attempting to migrate seaward through Lake Billy Chinook, the project's upper-most reservoir. Most of the smolts failed to find their way from the head of the reservoir downstream to a fish collector installed at Round Butte Dam (Korn et al., 1967). As a result of this decline, and following a comprehensive study of west coast steelhead, we subsequently listed the MCR as a DPS (64 FR 14517, March 25, 1999).

There has long been an interest in reestablishing anadromous fish runs in the upper Deschutes River subbasin. This interest strengthened in recent years as technological innovations advanced and hydrodynamic modeling suggested that surface currents could be altered to favor the downstream passage of smolts. The relicensing of the Pelton Round Butte Project provided the opportunity to implement these innovations in order to attempt to reestablish anadromous fish runs upstream.

The Federal Energy Regulatory Commission issued a new license for the Pelton Round Butte Project (project number P-2030) on June 21, 2005, to Portland General Electric Company (PGE) and the Confederated Tribes of the Warm Springs Reservation of Oregon (CTWSRO), who are joint licensees (Licensees). The license requires fish passage over the Pelton Round Butte Project and incorporates the terms of a Settlement Agreement entered into by the Licensees and 20 other parties. The license establishes a Fish Committee, which is made up of the Licensees, NMFS, Oregon Department of Fish and Wildlife (ODFW), the US Fish and Wildlife Service (FWS), and other agencies and entities. Details regarding the responsibilities of the Licensees with respect to fish passage and reintroduction are in the Fish Passage Plan, included as Exhibit D to the Settlement Agreement. These responsibilities include fish passage improvements at the Pelton Round Butte Project, a wide variety of test and verification studies, and longer term monitoring efforts. The license includes a schedule for meeting those obligations.

Because the Pelton Round Butte Hydroelectric Project does not provide volitional passage, the central element of the Fish Passage Plan is a Selective Water Withdrawal structure now in place and operating at Round Butte Dam to improve water quality in the lower Deschutes River, create currents in the reservoir that should help guide smolts to an associated fish screening and collection facility, and provide downstream passage for juveniles. It is currently envisioned that returning adult steelhead in the experimental population will be collected below the Reregulating Dam and transported for release above Round Butte Dam. This new facility will protect fish in Lake Billy Chinook from being entrained into turbines, and is the centerpiece of a multi-faceted effort to reestablish runs of steelhead that have been absent from the upper basin for more than 42 years. Recognizing the fish reintroduction opportunity, the Oregon Fish and Wildlife Commission adopted Oregon Administrative Rules in December 2003 that direct ODFW to restore anadromous fish, including MCR summer steelhead, into portions of their historical range upstream from the Pelton Round Butte Project. Specific areas targeted for reintroduction include the Deschutes River from Round Butte Dam upstream to Big Falls, Whychus Creek, and the Crooked River and tributaries upstream to Bowman and Ochoco Dams. The Metolius River was not targeted for steelhead reintroduction as it is believed that this subbasin is better suited to resident steelhead (i.e., rainbow trout or redband trout).

Individuals that are used to establish an experimental population may come from a donor population, provided their removal will not create adverse impacts upon the parent population, and provided appropriate permits are issued in accordance with our regulations (50 CFR 222.301) prior to removal. In this case, the donor steelhead are from a captive bred population, which is propagated to mitigate for lost fisheries due to failed fish passage after the Pelton Round Butte Project was originally constructed. The hatchery fish being used for the reintroduction are excess stock. In addition, it is possible that some wild adult stock could also be released into the NEP area before the designation expires.

Congress made significant changes to the ESA in 1982, including the addition of section 10(j), which provides for the designation of reintroduced populations of listed species as “experimental populations.” Previously, we had authority to reintroduce populations into unoccupied portions of a listed species' historical range. However, local citizens often opposed these reintroductions because they were concerned about potential liability for harming these animals, and the placement of restrictions and prohibitions on Federal and private activities. Under section 10(j) of the ESA, the Secretary can authorize the release of an “experimental” population outside the species' current range, but within its historical range, where: (1) The experimental population is geographically separate from the non-experimental population; and (2) the designation will further the conservation of the listed species. The determination of whether experimental populations are “essential” or “nonessential” to the continued existence of the species must be based on the best scientific and commercial data available.

The ESA provides that species listed as endangered or threatened are afforded protection primarily through the prohibitions of section 9 and the consultation requirements of section 7. Section 9 of the ESA prohibits the take of an endangered species. The term “take” is defined by the ESA as “to harass, harm, pursue, hunt, shoot, wound, trap, capture, or collect, or attempt to engage in any such conduct.” 15 U.S.C. 1532(19). Section 7 of the ESA provides procedures for Federal interagency cooperation and consultation to conserve federally listed species, ensure the survival and help in recovery of these species, and to protect designated critical habitat necessary for the listed species' survival. It also mandates that all Federal agencies determine how to use their existing authorities to further the purposes of the ESA to aid in recovering listed species. It also states that Federal agencies will, in consultation with NMFS, ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species, or result in the destruction or adverse modification of designated critical habitat. Section 7 of the ESA does not apply to activities undertaken on private land unless they are authorized, funded, or carried out by a Federal agency.

For the purposes of section 7 of the ESA, section 10(j) requires that we treat NEPs as a species proposed to be listed, unless they are located within a National Wildlife Refuge or National Park, in which case they are treated as threatened, and section 7 consultation requirements apply. When NEPs are located outside a National Wildlife Refuge or National Park, only two provisions of section 7 apply—section 7(a)(1) and section 7(a)(4). In these instances, NEP designations provide additional flexibility in developing conservation and management measures, because they allow NMFS to work with the action agency early to develop conservation measures, instead of analyzing an already well-developed proposed action provided by the agency in the framework of a section 7(a)(2) consultation. Additionally, for populations of listed species that are designated as nonessential, section 7(a)(4) of the ESA only requires that other agencies confer (rather than consult) with NMFS on actions that are likely to jeopardize the continued existence of a species proposed to be listed. These conferences are advisory in nature, and their findings do not restrict agencies from carrying out, funding, or authorizing activities.

Section 10(j) of the ESA (16 U.S.C. 1539(j)) also provides the Secretary of Commerce with authority to designate populations of listed species as experimental, and includes criteria for the designation. Experimental population designations must be done through a rulemaking that identifies the population, and state whether the population is essential or nonessential to the continued existence of the species. For purposes of section 9 of the ESA, a population designated as experimental is treated as threatened regardless of the species' designation elsewhere in its range. Through section 4(d) of the ESA, a threatened designation allows the Services greater discretion in devising management programs and special regulations for such a population. Section 4(d) of the ESA allows us to adopt regulations necessary to provide for the conservation of a threatened species. MCR steelhead are currently included in NMFS' 4(d) rule that imposes section 9 take liability for threatened anadromous fish, at 50 CFR 203. Through this rulemaking, we propose to use our authority under section 4(d) to create a different set of protective regulations, specific to the experimental steelhead population above Round Butte Dam. In effect, we would be modifying the current 4(d) rule as it applies to MCR steelhead. For this nonessential experimental population only, we would allow take if the take is incidental to a lawful activity, such as agricultural activities.

The FWS has regulations for experimental population designation, 50 CFR 17 subpart H, that provide definitions, considerations in finding that the designation would further the conservation of the species, and information to be included in the designation. These regulations state that, in making the determination that the designation would further the conservation of the species, the Secretary must consider the effect of taking the eggs or young from another population, the likelihood that the experimental population will become established, the effect the designation would have on the species' overall recovery, and the extent to which the experimental population would be affected by activities in the area. A regulation designating the experimental population must include: A clear means to identify the experimental population; a finding based on the best available science indicating whether the population is essential to the continued existence of the species; management restrictions, protective measures, or other management concerns; and a periodic review of the success of the release and its effect on the conservation and recovery of the species. The FWS regulations also state that any experimental population shall be treated as threatened for purposes of establishing protective regulations under ESA section 4(d), and the protective regulations for the experimental population will contain applicable prohibitions and exceptions for that population.

While we do not have regulations regarding designation of experimental populations, many of the considerations in FWS's regulation are generally applicable to this designation. Where applicable, we will include the same considerations in our decision regarding designation, and provide that rationale in the preamble. These considerations are in addition to the statutory requirements that are also explained in the preamble.

“Steelhead” is the name commonly applied to the anadromous (migratory) form of the biological species O. mykiss. The common names of the non-anadromous, or resident, form are rainbow trout and redband trout. The species O. mykiss exhibits perhaps the most complex suite of life history traits of any species of Pacific salmonid. These fish can be anadromous or freshwater residents, and under some circumstances yield offspring of the opposite form. Steelhead can spawn more than once, whereas all other Oncorhynchus except cutthroat trout ( O. clarki ) spawn once and then die.

When we originally listed the MCR steelhead as threatened on March 25, 1999 (64 FR 14517), it was classified as an evolutionarily significant unit (ESU) of salmonids that included both the anadromous and resident forms, but not hatchery fish. Since then, we revised our species determinations for West Coast steelhead under the ESA, delineating anadromous, steelhead-only distinct population segments (DPS). We listed the MCR steelhead DPS as threatened on January 5, 2006 (71 FR 834). Rainbow trout and redband trout are not listed under the ESA, and are under the jurisdiction of the states unless they are listed, when they come under the jurisdiction of the FWS. We published a final Critical Habitat designation for MCR steelhead on September 2, 2005, with an effective date of January 2, 2006 (70 FR 52630).

As noted previously, the MCR steelhead DPS extends over an area of about 35,000 square miles (90,650 square km) in the Columbia plateau of eastern Washington and eastern Oregon. The DPS includes all naturally spawned populations of steelhead in drainages upstream of the Wind River, Washington, and the Hood River, Oregon (exclusive), up to, and including, the Yakima River, Washington, excluding steelhead from the Snake River Basin (64 FR 14517, March 24, 1999; 71 FR 834, January 5, 2006). Major drainages that support steelhead in this DPS are the Deschutes, John Day, Umatilla, Walla Walla, Yakima, and Klickitat river systems. Most of the region is privately owned (64 percent), with the remaining area under Federal (23 percent), tribal (10 percent), and state (3 percent) ownership. Most of the landscape consists of rangeland and timberland, with significant concentrations of dryland agriculture in parts of the range. Irrigated agriculture and urban development are generally concentrated in valley bottoms. Human populations in these regions are growing.

Steelhead produced in seven artificial propagation programs are considered part of the DPS, and were given a listing status of threatened in 2006 (71 FR 834, January 5, 2006). These programs are the Touchet River Endemic Summer Steelhead Program, the Yakima River Kelt Reconditioning Program (in Satus Creek, Toppenish Creek, Naches River, and Upper Yakima River), and the Umatilla River and Deschutes River steelhead hatchery programs.

Within the range of West Coast steelhead, spawning migrations occur throughout the year, with seasonal peaks of activity. The runs are usually named for the season in which the peak occurs. Most steelhead can be categorized as one of two run types, based on their sexual maturity when they re-enter freshwater and how far they go to spawn. In the Pacific Northwest, summer steelhead enter freshwater between May and October, and require several months to mature before spawning; winter steelhead enter freshwater between November and April with well-developed gonads and spawn shortly thereafter. Summer steelhead usually spawn farther upstream than winter steelhead (Withler, 1966; Roelofs, 1983; Behnke, 1992).

The steelhead that occur in the Deschutes Basin are summer run. Spawning occurs from late winter through spring, and juveniles typically rear in freshwater for 2 years (may range 1-4 years) before migrating to the Pacific Ocean. About half of the adults return after 1 year in the ocean and the other half returns after 2 years.

Throughout much of its historical range, the decline of steelhead has been attributed to habitat degradation and fragmentation, the blockage of migratory corridors, poor water quality, angler harvest, entrainment (the incidental withdrawal of fish and other aquatic organisms in water diverted out-of-stream for various purposes) into diversion channels and dams, and introduced nonnative species. Specific land and water management activities that may negatively impact steelhead populations and habitat, if not implemented in accordance with best management practices, include the operation of dams and other diversion structures, forest management practices, livestock grazing, agriculture, agricultural diversions, road construction and maintenance, mining, and urban and rural development.

Section 4(a)(1) of the ESA and NMFS implementing regulations (50 CFR part 424) establish procedures for listing species as threatened or endangered. According to this direction, the Secretary must determine if a species is endangered or threatened based on any one or a combination of the following factors: (1) The present or threatened destruction, modification, or curtailment of its habitat or range; (2) overutilization for commercial, recreational, scientific, or educational purposes; (3) disease or predation; (4) inadequacy of existing regulatory mechanisms; or (5) other natural or human-made factors affecting its continued existence (Busby et al., 1996; NMFS, 1999).

In our initial determination to list the MCR steelhead species, we found that all five section 4(a)(1) factors had played a role in the decline of the West Coast salmon and steelhead ESUs. These factors may or may not still be limiting recovery in the future when we reevaluate the status of the species to determine whether the protections of the ESA are no longer warranted and the species may be delisted. Findings leading to the listing of West Coast salmon and steelhead, including MCR steelhead, include: