Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on April 6, 2011 (76 FR 18960), and proposed to supersede AD 2008-03-04, Amendment 39-15353 (73 FR 5731, January 31, 2008). That NPRM (76 FR 18960, April 6, 2011) proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We considered the comments received.

UPS and FedEx requested an extension to the 8-month compliance time specified in the NPRM (76 FR 18960, dated April 6, 2011) in order to accomplish the additional actions. FedEx requested that the compliance time for the additional actions be at the latest of the 40-month compliance time specified in AD 2008-03-04, Amendment 39-15353 (73 FR 5731, January 31, 2008), any alternative methods of compliance that extend that compliance time or within 12 months after the effective date of the new AD. UPS requested that the compliance time be extended to 60 months. UPS stated that the two additional bonding points specified in the NPRM are no more unsafe than the original 264 bonding points required in AD 2008-03-04. UPS noted that it schedules tank entry checks at 60 months and that the original issue of the service information allowed for a 60-month compliance time.

We agree with extending the compliance time and have determined that extending the compliance time to 30 months is appropriate. In developing an appropriate compliance time for this action, we considered the safety implications, parts availability, and normal maintenance schedules for the timely accomplishment of the modification. In consideration of these items, we have determined that a 30-month compliance time will ensure an acceptable level of safety and allow the modifications to be done during scheduled maintenance intervals for most affected operators. We have also coordinated with European Aviation Safety Agency (EASA) on this issue. We have changed the compliance time in paragraph (h) of this AD to “within 30 months after the effective date of this AD.”

FedEx stated that they averaged 800 work-hours versus the 632 work-hours listed in the NPRM (76 FR 18960, dated April 6, 2011) to accomplish the existing modifications. FedEx also stated that 9 work-hours, as specified for the additional actions, may be adequate if done in conjunction with the other modifications; however, additional work-hours will be required for airplanes that have been previously been modified.

We infer that FedEx is requesting that we increase the work-hours estimate to accomplish the existing and new modifications. We do not agree to revise the work-hours. Work-hours may vary among operators. Our estimate is based on the information provided in the relevant service information. We have not changed this AD in this regard.

FedEx requested that we add wording to the NPRM (76 FR 18960, dated April 6, 2011) that material substitutions supplied by Airbus are approved for use and do not require an alternative method of compliance (AMOC). FedEx stated that the kits specified in Airbus Service Bulletins A300-28-6064, Revision 01, dated April 3, 2007; A300-28-6068, dated July 20, 2005; and A300-28-6077, Revision 01, dated October 26, 2006; might contain parts that are not listed in the kit description specified in the service information.

We do not agree with the request to revise the AD to include wording that material substitutions are approved for use. Airbus Service Bulletins A300-28-6064, Revision 01, dated April 3, 2007; A300-28-6068, dated July 20, 2005; and A300-28-6077, Revision 01, dated October 26, 2006; contain language in the “Standard Practices” section of paragraph 3.A. “General” of the Accomplishment Instructions that specifies which alternative materials are allowed. We have not changed this AD in this regard.

FedEx stated that Airbus has issued Mandatory Service Bulletin A300-28-6064, Revision 05, dated September 27, 2010, and requested that we update our references in the NPRM (76 FR 18960, dated April 6, 2011).

We agree with the request and have updated the references in paragraphs (c)(1), (g)(4), and (h) of this AD to include Airbus Mandatory Service Bulletin A300-28-6064, Revision 05, dated September 27, 2010. Airbus Mandatory Service Bulletin A300-28-6064, Revision 05, dated September 27, 2010, provides clarifications of the actions and materials but contains no substantive changes.

We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect about 125 products of U.S. registry.

The actions that are required by AD 2008-03-04 Amendment 39-15353 (73 FR 5731, January 31, 2008) and retained in this AD take about 632 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost about $6,870 per product. Based on these figures, the estimated cost of the currently required actions is $60,590 per product.

We estimate that it will take about 9 work-hours per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $100 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $108,125, or $865 per product.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (76 FR 18960, dated April 6, 2011), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on April 19, 2011 (76 FR 21822). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We considered the comments received.

EMBRAER and ExpressJet Airlines requested that we reference EMBRAER Service Bulletin 145-53-0062, Revision 07, dated May 27, 2011, in the NPRM (76 FR 21822, April 19, 2011) as it is the most current.

We agree that the latest service information should be referenced in this AD. We have changed references in paragraphs (h) and (l) of this AD to include EMBRAER Service Bulletin 145-53-0062, Revision 07, dated May 27, 2011. The effectivity of Revision 07 was changed to add serial numbers that were inadvertently omitted in EMBRAER Service Bulletin 145-53-0062, Revision 06, dated August 11, 2010. (The applicability of this final rule remains unchanged.) In addition, we have added EMBRAER Service Bulletin 145-53-0062, Revision 06, dated August 11, 2010, to “Table 1—Credit Service Bulletins” of this AD.

American Eagle Airlines requested that we remove the date and revision level of the AMM specified in paragraph (g) of the NPRM (76 FR 21822, April 19, 2011), or allow for future revisions to the AMM. The commenter noted that if either of the AMM sections is updated by the manufacturer, the operators would be required to accomplish an obsolete task.

We disagree with removing the date and revision level of the AMM because all documents incorporated by reference are required to have the date and revision level in accordance with the Office of the Federal Register regulations for approval of materials “incorporated by reference” in rules. See 1 CFR 51.1(f). We also disagree with allowing the use of “future” revisions to the AMM. When referring to a specific service document in an AD, using the phrase, “or later FAA-approved revisions,” violates Office of the Federal Register regulations for approval of materials “incorporated by reference” in rules. See 1 CFR 51.1(f). In general terms, we are required by these OFR regulations to either publish the service document contents as part of the actual AD language; or submit the service document to the OFR for approval as “referenced” material, in which case we may only refer to such material in the text of an AD. The AD may refer to the service document only if the OFR approved it for “incorporation by reference.” See 1 CFR part 51.

However, because a later revision of the AMM has been issued since the NPRM (76 FR 21822, April 19, 2011) was published, we have revised paragraphs (g) and (l), and Note 2 of this AD to refer to EMBRAER EMB145 Aircraft Maintenance Manual, Part II, AMM-145/1124, Revision 54, dated April 28, 2011. We have also added new paragraph (i) (and re-identified subsequent paragraphs accordingly) to this AD to give credit for EMBRAER EMB145 Aircraft Maintenance Manual, Part II, AMM-145/1124, Revision 53, dated October 28, 2010, which was referenced as the appropriate source of service information for certain actions specified in the NPRM. However, operators may request approval of an AMOC to use later revisions of this AMM under the provisions of paragraph (k) of this AD. No changes have been made to the AD in this regard.

ExpressJet Airlines requested that we change the initial compliance time from 3,300 flight hours to “5,000 flight hours or at the next heavy maintenance visit.” The commenter stated that its experience with repairing and replacing APU firewalls can be a very time consuming process which would be better suited for a heavy check.

We disagree with the commenter's request to extend the compliance time. In developing an appropriate compliance time for this action, we considered the safety implications, parts availability, and normal maintenance schedules for the timely accomplishment of the inspection. In consideration of these items, as well as the reports of cracking in the firewall of the APU, we have determined that the initial compliance time of 3,300 flight hours will ensure an acceptable level of safety. However, operators may request approval of an AMOC under the provisions of paragraph (k) of this AD. No changes have been made to the AD in this regard.

We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 668 products of U.S. registry. We also estimate that it will take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $113,560, or $170 per product.

In addition, we estimate that any necessary follow-on actions would take about 10 work-hours and require parts costing $10,060 for a cost of $10,910 per product. We have no way of determining the number of products that may need these actions.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (76 FR 21822, April 19, 2011), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on April 8, 2011 (76 FR 19716), and proposed to supersede AD 2009-10-02, Amendment 39-15897 (74 FR 21246, May 7, 2009). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (76 FR 19716, April 8, 2011) or on the determination of the cost to the public.

Since issuance of the NPRM (76 FR 19716, April 8, 2011), we have reviewed Subjects 05-10-10, “Airworthiness Limitations”; 05-10-20, “Certification Maintenance Requirements”; and 05-10-30, “Critical Design Configuration Control Limitations (CDCCL)—Fuel System”; of Chapter 05, “Airworthiness Limitations”, of the BAE Systems (Operations) Limited Jetstream Series 4100 AMM, Revision 35, dated February 15, 2011. We have revised paragraph (i) of this AD to reference this revision.

We have also added paragraph (j) to this AD to give credit for Subjects 05-10-10, “Airworthiness Limitations”; 05-10-20, “Certification Maintenance Requirements”; and 05-10-30, “Critical Design Configuration Control Limitations (CDCCL)—Fuel System”; of Chapter 05 “Airworthiness Limitations,” of the BAE Systems (Operations) Limited Jetstream Series 4100 AMM, Revision 33, dated February 15, 2010.

We reviewed the available data, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect about 3 products of U.S. registry.

The actions that are required by AD 2009-10-02 (74 FR 21246, May 7, 2009) and retained in this AD take about 1 work-hour per product, at an average labor rate of $85 per work-hour. Required parts cost about $85 per product. Based on these figures, the estimated cost of the currently required actions is $85 per product.

We estimate that it will take about 1 additional work-hour per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $255, or $85 per product.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (76 FR 19716, April 8, 2011), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on July 5, 2011 (76 FR 39033). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states that:

You may obtain further information by examining the MCAI in the AD docket.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM.

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

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are described in a separate paragraph of the AD, and take precedence over the actions copied from the MCAI.

Based on the service information, we estimate that this AD would affect about 1,052 products of U.S. registry. We also estimate that it would take about 1 work-hour per product to comply with this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of the AD on U.S. operators to be $89,420.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office ( phone: 800-647-5527) is provided in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on August 8, 2011 (76 FR 48047). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (76 FR 48047, August 8, 2011) or on the determination of the cost to the public.

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

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 9 products of U.S. registry. We also estimate that it will take about 4.5 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will about $172 per product.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $4,990.50, or $554.50 per product.

In addition, we estimate that any necessary follow-on actions will take about 5 work-hours and require parts costing $275, for a cost of $700 per product. We have no way of determining the number of products that may need these actions.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD Docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (76 FR 48047, August 8, 2011), the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

We issued a supplemental notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That supplemental NPRM was published in the Federal Register on April 25, 2011 (76 FR 22830). That supplemental NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We considered the comments received.

Boeing concurs with content of the supplemental NPRM (76 FR 22830, April 25, 2011).

Airbus stated that the Model A330-200 and -300 series airplanes that were included in table 1 of the supplemental NPRM (76 FR 22830, April 25, 2011) were delivered with 16G-rated seats, not the 9G-rated seats affected by the proposed AD. Airbus requested that Model A330-200 and -300 series airplanes be removed from the supplemental NPRM applicability.

We agree with the comment because it correctly updates table 1 of this AD by removing airplanes that do not have the affected seats. We have changed table 1 of this AD accordingly.

We have corrected the issue number and date for Annex 1 of Sicma Aero Seat Service Bulletin 90-25-013, Issue 3, dated December 19, 2001, to be Annex 1, Issue 1, dated June 26, 2001 (referenced in paragraph (f)(6) of this AD).

We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect about 611 seats on 4 products of U.S. registry. We also estimate that it will take about 1 work-hour per seat to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $0 per seat. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $51,935, or $85 per seat.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (75 FR 2826, January 19, 2010), the supplemental NPRM (76 FR 22830, April 25, 2011), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on June 8, 2011 (76 FR 33176), and proposed to supersede AD 2007-25-15, Amendment 39-15297 (72 FR 69601, December 10, 2007). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We considered the comment received.

The Air Line Pilots Association, International (ALPA) stated it supports the intent and language of the subject NPRM (76 FR 33176, June 8, 2011), but requested the compliance time be changed in paragraph (g) of the NPRM to “not to exceed 1000 flight hours or 12 months, whichever occurs first, under any circumstances.”

We disagree with this request because the unsafe condition is flight-cycle dependent, and the commenter did not provide any supporting data to justify a change in the compliance time. We have not changed the AD in this regard.

We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD as proposed.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 3 products of U.S. registry. We also estimate that it will take about 6 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $1,530, or $510 per product.

In addition, we estimate that any necessary follow-on actions would take about 6 work-hours and require parts costing $0, for a cost of $510 per product. We have no way of determining the number of products that may need these actions.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (76 FR 33176, June 8, 2011), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on June 9, 2011 (76 FR 33658). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We considered the comments received.

Mesa Airlines requested we revise the NPRM (76 FR 33658, June 9, 2011) to change the maintenance program to reduce the repetitive inspection intervals for the water accumulator as an option to installing the enlarged drain tubes. Mesa stated that the main pitot-static drain assemblies on its fleet are inspected for moisture every 500 or 600 flight hours (depending on the model).

We disagree because the pitot static tubing/water accumulator has a design deficiency that may cause it to become partially or completely blocked by water. This pitot static tubing/water accumulator design must be replaced with a new pitot static water accumulator design to eliminate this unsafe condition. Inspecting the pitot static water accumulator more frequently will not meet the intent of this AD. Once we issue this AD, any operator may request approval of an alternative method of compliance (AMOC) under the provisions of paragraph (k)(1) of this AD. Sufficient data must be submitted to substantiate that repetitive inspections would provide an acceptable level of safety. We have not changed the AD in this regard.

American Eagle Airlines requested that paragraph (c) of the NPRM (76 FR 33658, June 9, 2011) be changed from including all serial numbers of the specified airplanes to only those serial numbers called out in Bombardier Service Bulletin 601R-34-147, Revision B, dated March 8, 2011; and Bombardier Service Bulletin 670BA-34-030, Revision B, dated March 23, 2010. American Eagle stated as justification that the requirements of the NPRM were incorporated on airplanes going forward in production, and the illustrated parts catalog applicability has been updated for the affected part as well.

We disagree. Transport Canada Civil Aviation (TCCA), which is the airworthiness authority for Canada, has determined that all serial numbers of the specified airplane models need to be called out in its AD in order to prevent unsafe parts from being installed in any airplane. We agree with TCCA that all serial numbers need to be included in this AD, and also have included in paragraph (h) of the AD a prohibition against installing certain unsafe water accumulator assemblies on the pitot and static lines of the air data computer on any airplane.

We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD as proposed.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable in a U.S. court of law. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are described in a separate paragraph of the AD. These requirements, if any, take precedence over the actions copied from the MCAI.

We estimate that this AD will affect 1,041 products of U.S. registry. We also estimate that it will take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $1,200 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $1,426,170, or $1,370 per product.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (76 FR 33658, June 9, 2011), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Section 335 of the Tariff Act of 1930 (19 U.S.C. 1335) authorizes the Commission to adopt such reasonable procedures, rules, and regulations as it deems necessary to carry out its functions and duties. This rulemaking seeks to update certain provisions of the Commission's existing Rules of Practice and Procedure. The Commission is amending its rules covering investigations under Section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) (“Section 337”) in order to increase the efficiency of its Section 337 investigations. Specifically, the changes to the Commission's Rules are for the purpose of improving the Commission's procedures and ensuring the completeness of the record with respect to the required analysis concerning the public interest under Sections 337(d)(1) and (f)(1). There is no change in the Commission's substantive practice with respect to its consideration of the public interest factors in its determinations relating to the appropriate remedy.

The Commission published a notice of proposed rulemaking (“NOPR”) in the Federal Register at 75 FR 60671 (Oct. 1, 2010), proposing to amend the Commission's Rules of Practice and Procedure to gather more information on public interest issues. Consistent with its ordinary practice, the Commission invited the public to comment on all the proposed rules amendments. This practice entails the following steps: (1) Publication of an NOPR; (2) solicitation of public comments on the proposed amendments; (3) Commission review of public comments on the proposed amendments; and (4) publication of final amendments at least thirty days prior to their effective date.

The NOPR requested public comment on the proposed rules within 60 days of publication of the NOPR. In response to requests from the American Intellectual Property Law Association (“AIPLA”) and the Intellectual Property Owners Association (“IPO”), the Chairman granted an extension by letter of December 2, 2010, to allow those entities to submit comments until January 7, 2011. The Commission received a total of eight sets of comments from corporations or organizations, including one each from the ITC Trial Lawyers Association (“ITCTLA”); Microsoft Corp. (“Microsoft”); Intellectual Ventures, LLC (“Intellectual Ventures”); the Ministry of Commerce of the People's Republic of China (“MOFCOM”); the China Chamber of Commerce for Light Industrial Products & Arts-Crafts (“CCCLA”); the Computer & Communications Industry Association (“CCIA”), and the IPO. In addition, the law firm of Adduci, Mastriani & Schaumberg LLP (“AMS”) filed a set of comments. Three sets of comments were received from persons writing in their individual capacities, viz., Ms. Mary White, Mr. Steven Beard, and a group of economists including Messrs. Fei Deng, Greg Leonard, and Mario Lopez. The IPO's comments were filed one week late on January 14, 2011. The AIPLA did not submit comments.

The Commission has carefully considered all comments that it received. The Commission's response is provided below in a section-by-section analysis. The Commission appreciates the time and effort of the commentators in preparing their submissions.

As required by the Regulatory Flexibility Act, the Commission certifies that these regulatory amendments will not have a significant impact on small business entities.

The final regulations contain eleven (11) changes from those proposed in the NOPR. These changes are summarized here.

First, with regard to rule 210.12, relating to the complaint, the Commission has determined that it will not require complainants to include public interest allegations in the complaint. Second, the Commission has determined to add final rule 210.8(b) to require complainants to file a separate statement of public interest concurrently with the complaint. Final rule 210.8(b) contains a list of the issues that a complainant should address in its public interest statement, which is similar to the list contained in proposed rule 210.12(a)(12). Third, the Commission has determined to add final rule 210.8(c)(1) to provide for the responses to a Commission pre-institution Federal Register notice that will solicit comments regarding the public interest, including addressing complainant's filing under rule 210.8(b), from proposed respondents and the public upon receipt of a complaint. Included in this section is a requirement that public interest submissions are due eight (8) calendar days after publication of the pre-institution notice in the Federal Register . Fourth, the Commission has added final rule 210.8(c)(2) to provide that complainants may file reply submissions to responses submitted by the public and proposed respondents in response to the Commission's pre-institution Federal Register notice under final rule 210.8(c)(1). Any such replies are due within three (3) calendar days following the filing of submissions by proposed respondents and the public. Fifth, current rule 210.8(b) is redesignated 210.8(d).

Sixth, with regard to proposed rule 210.13(b), the Commission has determined that respondents will likewise not be required to address the public interest in their response to the complaint. Therefore, proposed rule 210.13(b) will not appear in the final rules. Seventh, the Commission has determined to add final rule 210.14(f) to require respondents to submit a statement of public interest in response to complainants' filings under § 210.8(b) and (c)(2) when the Commission has delegated the matter of public interest to the presiding administrative law judge (“ALJ”).

Eighth, the Commission has determined to amend proposed rule 210.50(a)(4) to clarify that the parties are requested, but not required, to file comments on the public interest thirty (30) days after issuance of the presiding ALJ's recommended determination (“RD”) on remedy, bonding, and where ordered, the public interest. These comments may include any information relating to the public interest, including any updates to the information provided pursuant to sections 210.8(b) and (c) and 210.14(f), and are limited to five (5) pages, inclusive of attachments. Members of the public will be given an opportunity to comment on the RD in response to a Federal Register notice that will be issued by the Commission after issuance of the presiding ALJ's RD. Ninth, the Commission has determined to redesignate the currently undesignated paragraph following current rule 210.50(a)(4) as final rules 210.50(a)(4)(i), (ii), (iii), and (iv).

Tenth, the Commission has determined to amend rule 210.10(b) to indicate that the comments received during the pre-institution period—under final rules 210.8(b) and (c)—are the general basis for the Commission's determination as to whether to delegate the issue of public interest to the ALJ. Rule 210.10(b) is also amended to clarify the limits on discovery when the Commission orders the ALJ to consider the public interest. Eleventh, the Commission has determined to add final rule 210.42(a)(1)(ii)(C) to clarify that, when ordered to take evidence on the public interest, the ALJ shall include analysis of the public interest in his RD.

A comprehensive explanation of the rule changes is provided in the section-by-section analysis below. The section-by-section analysis includes a discussion of all modifications suggested by the commentators. As a result of some of the comments, the Commission has determined to modify several of the proposed amendments and to add several new sections to the final rule as summarized above. The section-by-section analysis will refer to the rules as they appeared in the NOPR. Any new rules will be discussed with respect to the previously proposed rules.

The NOPR proposed to amend § 210.12 by adding a subsection (12) to § 210.12(a) to require that the complainant provide in its complaint specific information regarding how issuance of an exclusion order and/or a cease and desist order in an investigation could affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.

The NOPR further proposed adding a paragraph (k) to § 210.12 to provide that, when a complaint is filed, the Secretary to the Commission will publish a notice in the Federal Register soliciting comments from the public and the proposed respondents on any public interest issues arising from the complaint. Under the proposed rules, these comments would be limited to five pages and would be required to be filed within five days of publication of the notice. The purpose of the proposed amendments to 210.12 was to gather information for the Commission to consider in deciding whether to refer the public interest issues to the ALJ.

Microsoft, Intellectual Ventures, and AMS contend that if the Commission seeks more information on the public interest, it would be sufficient to allow the parties and the public to comment in response to a pre-institution Federal Register notice published immediately after the filing of the complaint. Microsoft, Intellectual Ventures, and AMS are of the view that it would be unnecessary and burdensome to require the complaint and the respondents' responses to the complaint to include information on the public interest in addition to any submissions the parties might file in response to the pre-institution Federal Register notice.

AMS states that the Commission's recent practice of soliciting comments at the beginning of the investigation is a good one and should be made a permanent part of Section 337 procedure. AMS notes that many parties and members of the public have taken advantage of the opportunity to file such comments since the Commission began soliciting them in 2010. AMS states that “[i]t would not be consistent with the remedial purpose of Section 337 if potential complainants were deterred from coming to the ITC due to concerns about the burdens associated with addressing public interest issues before there has been any adjudication of violation or the scope of the remedy.”

Microsoft states that requiring information on the public interest in the complaint and responses thereto would be unduly burdensome in light of the rare instances where the public interest has been a factor in deciding whether to issue relief. Microsoft states that to the extent the Commission believes amendment to its rules is necessary, the pre-institution Federal Register notice alone would identify to the Commission the few instances warranting early development of public interest information. Microsoft, however, urges the Commission to make clear that the Commission is not expanding the breadth of the statutory public interest factors with any amendment. It believes that open-ended and undefined submissions regarding “competitive conditions in the United States economy” would provide little guidance to the Commission.

According to Intellectual Ventures, the public interest information required in the complaint under the proposed rules may not be in the possession of many complainants and determining the potential public interest impact of a hypothetical remedy is a highly speculative endeavor, particularly at the outset of an investigation. Moreover, the proposed rules could place a burden upon potential complainants to conduct extensive research on subjects far outside their businesses and expertise. Intellectual Ventures believes a pleading requirement would not only burden the parties, but would run the risk of reintroducing at least the perception that the Commission is making a determination of injury as part of the determination of violation, which is in direct opposition to the Congressional mandate that there is no longer an injury requirement in Section 337 investigations. Intellectual Ventures is particularly concerned about domestic industries that are based on the exploitation of intellectual property through engineering, research and development, and licensing. Intellectual Ventures also states that “by placing a de facto burden on complainant to deny the existence of public interest concerns—a burden which the statute does not require them to meet—this proposal may deter some complainants from coming to the ITC at all, which would be contrary to the purpose and intent of Section 337 to protect domestic industries from unfair import competition.” While Intellectual Ventures is opposed to any change in the current rules, it states that it is better to solicit comments through the Federal Register during the pre-institution stage of the investigation than to require the information in the pleadings.

Although not part of the official comments, on January 19, 2011, during the Third Annual Live at the ITC—Forum on Section 337 of the Tariff Act of 1930, panelists expressed concerns that ordering a complainant to act against its own interest by listing public interest issues in the complaint is essentially unfair because the statute directs the issuance of an exclusion order unless, upon consideration of the public interest, the Commission decides not to do so. Another concern was the burden such a requirement would place on non-practicing entities (NPEs) which might not actually know what their licensees are doing with the asserted patented technology. One panelist raised the possibility that NPEs might be subject to sanctions if they could not truthfully answer the public interest questions in the complaint.

On the other hand, the ITCTLA does not object to requiring public interest information in the complaint.

The Commission has determined that it will not require complainants to include public interest allegations in the complaint. Instead, the Commission will obtain public interest information from the parties early in the investigation in a format different from that which was proposed in the NOPR. Specifically, instead of including public interest information in the complaint, complainants will be required to file a separate statement of public interest concurrently with the filing of the complaint. If a complainant includes information which it deems confidential in the submission, it will be required to also file a nonconfidential version concurrently with its complaint. This final rule will be designated as 210.8(b). Current rule 210.8(b) will be redesignated as 210.8(d), as discussed below.

The ITCTLA suggests that the Commission solicit even more specific information concerning the public interest. In particular, the ITCTLA suggests that the complainant identify, to the best of its knowledge, the “like or directly competitive articles,” and how the complainant's requested relief would affect consumers in the United States. The ITCTLA also suggests different language for some of the Commission's final rules. For instance, it suggests that the amendments be more consistent with the statutory public interest factors and proposes that a fifth provision be included that would require a statement as to how a company's requested relief would affect consumers in the United States. The ITCTLA also suggests that the comments be directed to the “requested” exclusion order and cease and desist order rather than to a generic exclusion order and cease and desist order.

MOFCOM suggests that the public interest considerations be expanded to include the sales of upstream and downstream products of the subject articles, and the operation condition of the importer, exporter, and retailer of the subject articles. The CCCLA suggests that the public interest factors include market conditions and the competitiveness of importers, distributors and retailers in the upstream and downstream industry related to the subject articles.

Economists Deng, Leonard, and Lopez suggest that the Commission refrain from seeking information on an exhaustive list and instead lay out general types of information that might prove fruitful. Some examples of information they deem relevant in evaluating the impact of an exclusion order, are as follows: (1) The costs and time it would take a consumer to switch to substitute products, (2) the loss in consumer welfare due to reduction in product variety in differentiated product industries, (3) the potential for a price increase from the reduction in competition, (4) the ability of non-infringing firms to offer close substitutes and the time required to do so, (5) potential entrants, i.e., potential new suppliers of substitute goods, and (6) the potential profit lost by vertically-related firms versus the potential profit gained by competitors and competitors' vertically-related firms.

The CCIA suggests that the Commission adopt for its public interest rules the standard for obtaining a permanent injunction in a federal district court laid out by the Supreme Court in eBay Inc v. MercExchange, L.L.C., 547 U.S. 388 (2006) (“ eBay” ). The CCIA suggested that the Commission would need to do so in order to comply with United States obligations under Article III: 4 of the GATT, specifically, a GATT decision, United States—Section 337 of the Tariff Act of 1930 (Nov. 7, 1989).

The Commission has determined that complainants' statement concerning the public interest under final rule 210.8(b) should be focused as follows: (a) Explain how the articles potentially subject to the order are used in the United States; (b) identify any public health, safety, or welfare concerns relating to the requested remedial orders; (c) identify like or directly competitive articles that complainant, its licensees, or third parties make which could replace the subject articles if they were to be excluded; (d) indicate whether the complainant, its licensees, and/or third parties have the capacity to replace the volume of articles subject to the potential orders in a commercially reasonable time in the United States; and (e) state how the requested relief would impact consumers. These topics will replace those currently listed in proposed rule 210.12(a)(12). The Commission has determined that the final rules will not adopt the test for permanent injunctions articulated in eBay.

Several parties (Mary White, the ITCTLA, AMS, MOFCOM, and the CCCLA) state that five days is too short a time for proposed respondents and the public to respond to the pre-institution Federal Register notice soliciting comments. The ITCTLA suggests extending this time period to seven business days; MOFCOM suggests 10 calendar days; and AMS and the CCCLA suggest 15 calendar days. ITCTLA suggests that an additional period of seven (7) business days be allowed for responses to these early comments.

The Commission has determined to provide more time for public comment beyond what was proposed in the NOPR (rule 210.12(k)). Specifically, the Commission will require that public interest submissions be due eight (8) calendar days after publication of the pre-institution notice in the Federal Register . If any such submission includes information which the submitting entity deems confidential, it will be required to also file a nonconfidential version concurrently with its confidential submission. This requirement will appear in final rule 210.8(c)(1).

Steven Beard suggests that public comments in response to the pre-institution Federal Register notice should be forwarded to the parties in the adjudicative proceeding.

The Commission has determined that public interest comments should not be forwarded by the Commission to the complainant and proposed respondents, since the Commission's Electronic Document Information System (EDIS) is available to allow access to any comments that are filed. No amendments to the final rules will be made in this regard.

MOFCOM criticizes the “and/or” language of the proposed amendment to § 210.12(k), which it believes suggests that in some cases either, but not both, the public or the proposed respondents will have the right to comment on the public interest.

This is not the intent of the amendments, so to address this comment, final rule 210.8(c)(1) states that both proposed respondents and the public may respond to complainants' filings under 210.8(b).

The ITCTLA points out that under the proposed amendment to rule 210.13, respondents are permitted to submit a formal response to any public interest submissions made by members of the general public pursuant to proposed rules 210.12(k), but that no such opportunity exists as a matter of right for the complainant to do so. The ITCTLA proposes that Rule 210.12(a)(13) be added to afford a complainant an opportunity to file a reply to any comments received from the general public and respondents.

The Commission has determined that the complainant will be allowed under final rule 210.8(c)(2) to file a reply submission to responses submitted by the public and proposed respondents to the Commission's pre-institution notice. Any such replies are due within three (3) calendar days of the filings under final rule 210.8(c)(1) and are limited to five (5) pages, inclusive of attachments. If a complainant includes information that it deems confidential in the submission, it will be required to also file a nonconfidential version concurrently with its confidential submission.

The NOPR proposed adding a subsection (4) to section 210.13(b) to require respondents' response to the complaint to address the public interest statements made in the complaint and any comments received from the public with respect to the public interest.

The ITCTLA proposes that the respondent be allowed to amend or supplement the public interest statement contained in its response to the complaint and notice of investigation to respond to any replies that might be filed by complainants. The ITCTLA recommends that since this submission is made early in the investigation, the respondent be permitted to supplement its public interest submission under proposed Rule 210.13(b)(4), where necessary and with good cause shown.

Since the Commission has determined that complainants will not be required to include public interest information in the complaint, respondents will likewise not be required to address the public interest in the response to the complaint. The Commission has, however, determined that respondents must submit a mandatory statement of public interest if the Commission has delegated the matter of public interest to the ALJ, as discussed below in conjunction with proposed amendments to rule 210.50. This provision is reflected in final rule 210.14(f).

The NOPR further proposed to add language to section 210.50(a)(4) to provide that, after the service of the presiding ALJ's RD on remedy and bonding, the parties are instructed to submit to the Commission within thirty (30) days any information relating to the public interest, including any updates to the information provided in the complaint and response, as required by the proposed amendments to §§ 210.12 and 210.13. Members of the public would also be permitted to submit information with respect to the public interest under the proposed rule.

The NOPR further proposed to amend section 210.50(b)(1) to provide that unless the Commission orders otherwise, an ALJ shall not take evidence on the issue of the public interest for purposes of the RD under § 210.42(a)(1)(ii). If the Commission orders the ALJ to take evidence on the public interest, the extent of the taking of discovery by the parties shall be at the discretion of the presiding ALJ.

The ITCTLA, IPO, Microsoft, and Intellectual Ventures are concerned that, by requiring public interest submissions subsequent to the issuance of the RD but prior to the issuance of the Commission's notice of review, a misperception may be created that the Commission is weighing public interest information as part of its threshold merits inquiry on review. The ITCTLA further points out that at this stage of the investigation, it is not known what, if any, portions of the final initial determination (“ID”) the Commission has taken under review. Thus, if the Commission determines not to review a final ID finding no violation, or determines to review and remand issues to the ALJ, any submissions on the public interest at this time would be irrelevant or untimely.

The Commission has determined to implement in its final regulations its current practice of requesting party comments on the public interest within thirty (30) days after the RD issues, under final rule 210.50(a)(4). Solicitation of these comments is not limited to cases in which the Commission has delegated the public interest issue to the ALJ. Final rule 210.50(a)(4) has been amended to clarify that the parties are requested, but not required, to file comments under this provision. Such submissions are limited to five (5) pages, inclusive of attachments. The final rule does not allow members of the public to submit similar comments. Rather, the Commission will issue a Federal Register notice soliciting comments from the public after an RD issues. Additionally, the Commission has determined to amend rule 210.50(a)(4) to clarify that the undesignated paragraph following current rule 210.50(a)(4) will be preserved as rule § 210.50(a)(4)(i), (ii), (iii), and (iv) in compliance with Federal Register requirements.

With respect to the proposed amendments to rule 210.50(b)(1), while generally supporting the Commission's efforts to develop a better record on the public interest, the ITCTLA states that it expects that the Commission will rarely refer the public interest issue to the ALJ and that the proposed rules will not change the Commission's practice substantively. The ITCTLA believes the proposed rules balance the interests of complainants, respondents, and the public by giving each a fair opportunity to present public interest issues early in the investigation and to update information at each stage of the investigation. The ITCTLA warns that delegation of the issue of public interest to the ALJ has the “potential for a significant expansion of the scope of discovery in Section 337 investigations, particularly with respect to third-party discovery.” The ITCTLA and Intellectual Ventures state that discovery regarding the public interest may lead to significant party and non-party costs, and the ITCTLA notes that discovery could lead to an extension of the time required to complete investigations. In this connection, the ITCTLA suggests that the Commission limit the scope of the public interest issue that it may delegate to the ALJ in a given case based on the complainant's statement of what articles are like or directly competitive. Specifically, the ITCTLA suggests that the Commission include a preamble stating that it expects ALJs to limit such discovery appropriately, with particular consideration for the interests of third parties, and to ensure that public interest discovery does not delay the investigation and is not used improperly.

Intellectual Ventures, Microsoft, and AMS state that the current rules, which solicit comments on the public interest and analysis of public interest evidence only after a final ID and RD is issued by the presiding ALJ, are adequate. Intellectual Ventures believes that consideration of the public interest as implemented in the NOPR would have a detrimental effect on Section 337 by increasing the burdens on Commission resources, particularly those of the ALJs, and on the parties. Intellectual Ventures submits that Section 337's statutory framework puts the public interest in issue only near the end of an investigation, after a violation is found and an appropriate remedy is determined. It argues that, given the infrequency with which genuine public interest concerns have been implicated in Section 337 investigations, early consideration of the factors is neither necessary nor appropriate in most investigations. It points out that consideration of the public interest at an early stage may encompass investigations where public interest considerations are non-existent, or will not have an impact by the time the Commission reaches a determination on violation, e.g., some issues could be mooted if patents are found not infringed or invalid.

Intellectual Ventures suggests that the final version of rule 210.50 provide for the Commission to delegate only the gathering of evidence to the ALJ, such that the ALJ would collect information and forward it to the Commission without analyzing or addressing the issue himself. Intellectual Ventures expresses concern that allowing the ALJ to both take evidence on the public interest and analyze that evidence would run afoul of Congress's decision, reflected in the 1988 amendments to the Trade Act, to eliminate the injury requirement in Section 337 investigations. Intellectual Ventures also notes that the costs associated with public interest discovery could potentially discourage potential complainants from making use of Section 337 proceedings particularly due to the broad nature of the public interest factors addressed in § 337(d) and (f). Intellectual Ventures expresses concern at the implication that the public will not have any input on the public interest issue during discovery, while also questioning the feasibility of having non-parties present evidence concerning the public interest during discovery. Intellectual Ventures further submits that leaving discovery on the public interest to the ALJs' discretion will lead to inconsistent practices among the ALJs, and ostensibly, inconsistent results in the analysis of public interest evidence.

The IPO supports the Commission's intent of furthering its efforts under the statute to consider the effect of any remedial relief granted in Section 337 investigations. It is concerned, however, that the proposed rule delegates a new obligation to the ALJs, who are already faced with challenging time lines. According to the IPO, delegating the collection of evidence to the ALJs places a significant, and in the vast majority of cases, a needless burden on them at a time when caseloads are growing and target dates have lengthened. It is also concerned that the new rules interject the public interest consideration into the investigation too early, creating a situation where the violation determination would be improperly influenced by the public interest considerations.

Microsoft is concerned that the proposed amendments will unnecessarily interject “additional (and potentially burdensome) factual, contention, and expert discovery in the name of `public policy' ” that does not truly correspond with the purpose of the statute. It notes that the public interest has overridden a Commission order in only a few cases, and states that the application of any new rules should be correspondingly limited to the narrow instances in which public interest concerns are truly relevant. Microsoft asserts that information received at the beginning of the investigation may be out of date or otherwise irrelevant by the time any exclusion order would issue.

AMS states that, historically, the public interest rarely has been relevant in the administration of Section 337. It asserts that referring the public interest issue to the ALJ would, in most cases, be superfluous and premature, noting that a large percentage of cases settle or result in a determination of no violation. The IPO and Intellectual Ventures comment that referring the public interest issue to the ALJ will increase the instances of discovery abuse, particularly in regard to third parties. The ITCTLA also warns that the proposed rules could have the unintended consequence of discovery abuse, particularly in regard to third parties. Intellectual Ventures and Microsoft believe that the proposed rules amendments could overwhelm the Commission process at all stages, particularly by overburdening the ALJ, and lead to longer target dates for the completion of investigations.

Mary White suggests that the Commission clarify that the ALJ would not be allowed to take public interest evidence, or consider the public interest comments, unless ordered to do so by the Commission.

On the other hand, Steven Beard suggests that an ALJ should be able to take evidence on the issue of the public interest, without restrictions, in all investigations and should be mandated to address the substantive issues raised in the public comments when writing their decisions. MOFCOM also believes the ALJ should always be empowered to take evidence on and to address the public interest without reliance on a Commission order.

Rule 210.10(b) has been amended to indicate that the comments received during the pre-institution period—under final rules 210.8(b) and (b)—are the general basis for the Commission's determination as to whether to delegate the issue of public interest to the ALJ. Since proposed rule 210.50(b)(1) clearly states that “[u]nless the Commission orders otherwise, an ALJ shall not take evidence on the issue of the public interest * * *[,]” the final rule will not be amended in that respect. The amendment to rule 210.10(b), however, makes clear that, when directed to consider the public interest, the ALJ is expected to limit public interest discovery appropriately, with particular consideration for third parties, and not allow such discovery to delay the investigation or be used improperly. The Commission notes that, when the ALJ is not directed to consider the public interest, the proposed amendments do not expand scope of discovery beyond the issues bearing upon violation. Furthermore, the Commission has amended current rule 210.42(a)(1)(ii) to include § 210.42(a)(1)(ii)(C), which provides that, when ordered to take evidence on the public interest, the ALJ shall include analysis of the public interest in his RD.

The Commission has determined that the final rules do not meet the criteria described in section 3(f) of Executive Order 12866 (58 FR 51735, Oct. 4, 1993) and thus do not constitute a significant regulatory action for purposes of the Executive Order.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) is inapplicable to this rulemaking because it is not one for which a notice of final rulemaking is required under 5 U.S.C. 553(b) or any other statute. Although the Commission chose to publish a notice of proposed rulemaking, these regulations are “agency rules of procedure and practice,” and thus are exempt from the notice requirement imposed by 5 U.S.C. 553(b).

These final rules do not contain federalism implications warranting the preparation of a federalism summary impact statement pursuant to Executive Order 13132 (64 FR 43255, Aug. 4, 1999).

No actions are necessary under the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq. ) because the final rules will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and will not significantly or uniquely affect small governments.

The final rules are not major rules as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ). Moreover, they are exempt from the reporting requirements of the Contract With America Advancement Act of 1996 (Pub. L. 104-121) because they concern rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties.

The amendments are not subject to section 3504(h) of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ), because it is part of an administrative action or investigation against specific individuals or entities. 44 U.S.C. 3518(c)(1)(B)(ii).

For the reasons stated in the preamble, 19 CFR part 210 is amended as set forth below:

In the Federal Register of August 4, 1993 (58 FR 41612), FDA published a proposal (“the 1993 proposed rule”) to revise the bottled water quality standard regulations in 21 CFR part 103 (now 21 CFR 165.110(b)) to establish or modify the allowable levels in bottled water for 5 inorganic chemicals and 18 synthetic organic chemicals, and to maintain the existing allowable level for the inorganic chemical sulfate. As required under Section 410 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA proposed these revisions in response to the publication by EPA of a final rule (57 FR 31776; July 17, 1992) that established national primary drinking water regulations (NPDWRs) consisting of maximum contaminant levels (MCLs) for the same 23 chemicals and establishing an MCL for sulfate in public drinking water under the Safe Drinking Water Act (SDWA). In a final rule published March 26, 1996 (61 FR 13258), FDA maintained its existing allowable level for sulfate and adopted the proposed allowable levels for the 5 inorganic chemicals and 17 of the synthetic organic chemicals. FDA deferred final action on the proposed allowable level of 0.006 milligrams/liter (mg/L) for the chemical DEHP, in response to a comment stating that the proposed allowable level conflicted with an existing prior sanction for this substance in § 181.27 (21 CFR 181.27).

In the Federal Register of April 1, 2010 (75 FR 16363), FDA announced that it was reopening the comment period for the 1993 proposed rule to seek further comment on finalizing the allowable level for DEHP in the bottled water quality standard. At the same time, FDA addressed the issue of the prior sanction for the use of DEHP under § 181.27, which resulted in deferral of final action in 1996. FDA also provided updates on the use of DEHP in bottled water bottles and lid gaskets, and on international standards for DEHP in bottled water. Finally, FDA provided information on analytical methods for measuring DEHP that were adopted by EPA after the 1993 proposed rule and sought comment on the possible inclusion of these methods in a final regulation.

The agency received 10 responses, each containing one or more comments, to the April 1, 2010, Federal Register document reopening the comment period for the 1993 proposed rule. The agency previously received 13 responses, each containing one or more comments, to the 1993 proposed rule. Some comments addressed issues that are outside the scope of this final rule ( e.g., monitoring requirements, other chemicals, and food labeling), and thus will not be discussed here.

Most comments supported adoption of an allowable level for DEHP. As noted previously, one comment received in response to the 1993 proposed rule stated that the proposed allowable level for DEHP conflicted with an existing prior sanction for this substance in § 181.27. This comment also stated that DEHP is routinely used as a plasticizer in gaskets, and that such gaskets are permitted for use under relevant European national regulations. FDA responded to this comment in the April 1, 2010, Federal Register document. Briefly, FDA stated that the prior sanction for the use of DEHP in § 181.27 does not preclude the agency from establishing an allowable level for DEHP in the bottled water quality standard under § 165.110(b). FDA also stated that it appears that DEHP currently is not used in caps or closures for bottled water in the United States (Ref. 1), and that DEHP use is not permitted under European Commission regulations for plastic caps or plastic lid gaskets in metal caps (Ref. 2). Finally, FDA stated that several international organizations have adopted standards for DEHP that are the same or similar to the proposed allowable level of 0.006 mg/L, and that the International Bottled Water Association (IBWA), a trade association representing a large segment of the U.S. bottled water industry, adopted EPA's 0.006 mg/L standard for DEHP (40 CFR 141.61(c)) in its Model Code by 1995, suggesting that U.S. manufacturers already are able to meet the proposed level (Refs. 3 and 4). FDA did not receive any comments disagreeing with FDA's conclusions.

Two comments received in response to the April 1, 2010, Federal Register document opposed action related to DEHP in bottled water. The first comment stated that there was no reason to change current standards for plastic water bottles because evidence from two studies puts previous concerns to rest concerning the effects of DEHP consumption in humans. In response, FDA notes that it is establishing an allowable level for DEHP in bottled water, not changing standards for plastic bottles. Furthermore, FDA does not agree that the comment provided sufficient evidence to challenge EPA's finding that long-term, chronic exposure to DEHP above the MCL of 0.006 mg/L may have the potential to cause health effects in humans including damage to liver and testes, reproductive effects, and cancer (Ref. 5). Therefore, FDA continues to believe that it is appropriate to base its allowable level for DEHP in bottled water upon the MCL established by EPA for public drinking water.

A second comment received in response to the April 1, 2010, Federal Register document stated that DEHP does not leach into water in appreciable amounts and that prohibiting the use of DEHP would increase costs for consumers for beverages packaged in plastic bottles. However, this rule does not prohibit the use of DEHP; rather, it sets an allowable level for DEHP in bottled water. The allowable level for DEHP in bottled water is intended to address the potential presence of DEHP in water for any reason, not just leaching from bottles or caps. Furthermore, the comment did not provide any evidence to support or quantify its statement that DEHP does not leach into water in appreciable amounts. Finally, FDA disagrees that the regulation would increase costs for consumers. Many U.S. manufacturers already appear to be meeting the allowable level for DEHP in bottled water (Refs. 3 and 4). In fact, information from industry suggests that DEHP currently is not used in bottled water caps or bottles in the United States (Refs. 1 and 6). Therefore, FDA does not agree with the comment's assertion that the rule prohibits the use of DEHP or its assertion that the rule would increase costs for consumers for beverages packaged in plastic bottles.

In the April 1, 2010, Federal Register document, FDA noted that EPA had updated its methods for DEHP analysis after FDA published the 1993 proposal. FDA made available the updated methods (Refs. 7 and 8) for comment on their possible inclusion in the final regulation. FDA did not receive any comments disagreeing with adoption of the updated methods.

The agency is adopting the allowable level for DEHP in the bottled water quality standard as proposed (58 FR 41612). Therefore, FDA is establishing in § 165.110(b)(4)(iii)(C) (21 CFR 165.110(b)(4)(iii)(C)), which includes allowable levels for pesticides and other synthetic organic chemicals, an allowable level for DEHP at 0.006 mg/L.

As a consequence, in accordance with FDA's current good manufacturing practice (CGMP) regulations for bottled water (21 CFR part 129), bottled water manufacturers will be required to monitor their source water and finished bottled water products for DEHP. Bottled water manufacturers will be required to monitor their source water for DEHP as often as necessary, but at a minimum frequency of once each year (21 CFR 129.35(a)(3)), unless they meet the criteria for source water monitoring exemptions under the CGMP regulations (21 CFR 129.35(a)(4)). Bottled water manufacturers will be required to monitor their finished products for DEHP at least once a year (21 CFR 129.80(g)(2)).

With respect to analytical methods for the determination of chemical contaminants, FDA is making the following changes in § 165.110(b)(4)(iii). In the revised § 165.110(b)(4)(iii)(F) introductory text and in new § 165.110(b)(4)(iii)(F)( 21 ) and (b)(4)(iii)(F)( 22 ), FDA is incorporating by reference EPA-approved analytical methods for determining compliance with the quality standard for DEHP in bottled water. FDA believes that these methods are sufficient to use for determining the level of DEHP in bottled water. These methods are contained in the manual entitled “Methods for the Determination of Organic Compounds in Drinking Water, Supplement III,” EPA National Exposure Research Laboratory, EPA/600/R-95/131, August 1995.

Therefore, upon the effective date of this rule, any bottled water that contains DEHP at a level that exceeds the applicable allowable level will be deemed misbranded under section 403(h)(1) of the FD&C Act (21 U.S.C. 343(h)(1)) unless it bears a statement of substandard quality as provided by § 165.110(c)(3).

The agency has previously considered the environmental effects of this rule as announced in the proposed rule. No new information or comments have been received that would affect the agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required.

FDA has examined the impacts of this final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The agency concludes that this final rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the costs per entity of this rule are small, the agency also concludes that this 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 (Pub. L. 104-4) 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 $136 million, using the most current (2010) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

The Economic Impact Analysis of the 1996 final rule (61 FR 13258) revised the analysis set forth in the 1993 proposed rule (58 FR 41612) in response to comments received. Likewise, this final Economic Impact Analysis revises the analysis set forth in the 1993 proposed rule in response to comments received.

Section 410 of the FD&C Act (21 U.S.C. 349)  1 requires that, whenever EPA prescribes interim or revised NPDWRs under section 1412 of the Public Health Service Act (The SDWA, 42 U.S.C. 300f through 300j-9), FDA consult with EPA and either amend its regulations for bottled drinking water in § 165.110 (21 CFR 165.110) or publish in the Federal Register its reasons for not making such amendments. In accordance with section 410 of the FD&C Act, FDA published in the Federal Register of August 4, 1993 (58 FR 41612), a proposal to adopt EPA's MCL for DEHP as an allowable level in the bottled water quality standard. This action was in response to EPA's issuance of an NPDWR establishing an MCL for DEHP in public drinking water on July 17, 1992 (57 FR 31776). As described above, FDA deferred final action on the proposed allowable level for DEHP on March 26, 1996 (61 FR 13258). By finalizing the allowable level for DEHP in the bottled water quality standard, FDA is meeting the requirement in the FD&C Act to amend its regulations for bottled drinking water in response to EPA's establishment of an MCL for DEHP.

Although DEHP is not expected to be found in bottled water in levels above the standard, FDA concludes that this rule is protective of public health because it will ensure that, should current conditions change, such as new sources of water or new manufacturing practices, the level of DEHP will remain low.

In the 1993 proposed rule, FDA stated that a single test can be used to analyze 23 contaminants, including DEHP, with costs of up to $3,000 per sample. Comments submitted by IBWA in response to the 1993 proposed rule stated that a single test can be used for 14 contaminants, including DEHP and certain previously regulated contaminants, and that no additional testing costs would be required (Ref. 9). Although FDA is adopting new methods for DEHP analysis in this final rule (EPA Method 506, Rev. 1-1, and EPA Method 525.2, Rev. 2.0), EPA Method 525.2 tests for multiple currently regulated chemicals, including all the chemicals that were detected by the previously proposed method, EPA Method 525.1, Rev. 2.2. Since no additional testing is needed for DEHP, and since the costs of testing for DEHP have already been estimated in the 1993 proposed rule, FDA expects no additional testing costs resulting from the adoption of an allowable level for DEHP.

As discussed above, many U.S. manufacturers already appear to be meeting the allowable level (Refs. 3 and 4). Further, information from industry suggests that DEHP currently is not used in bottled water caps or bottles in the United States (Refs. 1 and 6). Thus, no reformulation costs are expected because DEHP is not expected to be found in bottled water in levels above the standard.

In the Economic Impact Analysis of the 1993 proposed rule, FDA determined that, because none of the 23 contaminants including DEHP are expected to be found in bottled water above the levels of the standards, the benefits of the proposed rule were expected to be zero. Because the 23 contaminants, including DEHP, still are not expected to be found in bottled water at levels above the standards, benefits of this final rule continue to be zero. However, as stated in the Economic Impact Analysis in the 1996 final rule for the other contaminants (61 FR 13258), this rule continues to ensure that, should current conditions change, such as new sources of water or new manufacturing practices, the level of DEHP and other contaminants will remain low.

FDA examined the economic implications of this final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires us to analyze regulatory options that would lessen the economic effect of the rule on small entities.

FDA finds that this final rule is not a significant regulatory action as defined by Executive Order 12866. In compliance with the Regulatory Flexibility Act, the 1996 Economic Impact Analysis found that the final rule will not have a significant impact on a substantial number of small businesses.

As stated in the analysis of impacts, information from industry suggests that DEHP currently is not used in bottled water caps or bottles in the United States (Refs. 1 and 6). Furthermore, many U.S. manufacturers already appear to be meeting the allowable level (Refs. 3 and 4). Thus, no reformulation costs are expected because DEHP is not expected to be found in bottled water above the levels of the standard.

For the reasons stated above, we do not classify as costs of this final rule any voluntary expenses that some small firms may incur because they already chose to meet the new standards for DEHP set forth in this rule.

FDA concludes that the provisions of this final rule are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3220).

FDA has analyzed this 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.”

Section 403A of the FD&C Act (21 U.S.C. 343-1) is an express preemption provision. Section 403A(a) of the FD&C Act provides that: “* * * no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce—(1) Any requirement for a food which is the subject of a standard of identity established under section 401 that is not identical to such standard of identity or that is not identical to the requirement of section 403(g) * * *.” FDA has interpreted this provision to apply to standards of quality (21 CFR 100.1(c)(4)).

The express preemption provision of section 403A(a) of the FD&C Act does not preempt any State or local requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food (section 6(c)(2) of the Nutrition Labeling and Education Act of 1990, Pub. L. 101-535, 104 Stat. 2353, 2364 (1990)).

This final rule creates requirements that fall within the scope of section 403A(a) of the FD&C Act.

The following references have been placed on display in the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register .)

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 165 is amended as follows:

Background

The Drug Enforcement Administration (DEA) is a component of the Department of Justice and is the primary agency responsible for coordinating the drug law enforcement activities of the United States. DEA also assists in the implementation of the President's National Drug Control Strategy. The diversion control program (DCP) is a strategic component of the DEA's law enforcement mission. It is primarily the DCP within DEA that implements and enforces Titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA) and the Controlled Substances Import and Export Act (CSIEA) (21 U.S.C. 801-971), as amended (hereinafter, “CSA”). 1 DEA drafts and publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), parts 1300 to 1321. The CSA together with these regulations are designed to establish a closed system for controlled substances and to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while ensuring a sufficient supply of controlled substances and listed chemicals for legitimate medical, scientific, research, and industrial purposes.

The CSA and DEA's implementing regulations establish the legal requirements for possession and dispensing of controlled substances, most notably pursuant to a prescription issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. “The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.” 21 CFR 1306.04(a). A prescription serves both as a record of the practitioner's determination of the legitimate medical need for the drug to be dispensed, and as a record of the dispensing, providing the pharmacy with the legal justification and authority to dispense the medication prescribed by the practitioner. The prescription also provides a record of the actual dispensing of the controlled substance to the ultimate user (the patient) and, therefore, is critical to documenting that controlled substances held by a pharmacy have been dispensed legally. The maintenance by pharmacies of complete and accurate prescription records is an essential part of the overall CSA regulatory scheme established by Congress.

Historically, where federal law required that a prescription for a controlled substance be issued in writing, that requirement could only be satisfied through the issuance of a paper prescription. Given advancements in technology and security capabilities for electronic applications, DEA recently amended its regulations to provide practitioners with the option of issuing electronic prescriptions for controlled substances (EPCS) in lieu of paper prescriptions. Efforts to develop EPCS have been underway for a number of years. DEA's Interim Final Rule for Electronic Prescriptions for Controlled Substances was published on March 31, 2010 at 75 FR 16236-16319 and became effective on June 1, 2010. While these regulations have paved the way for controlled substance prescriptions to be issued electronically, not all States have authorized electronic prescriptions for controlled substances, particularly Schedule II controlled substances which have a significant potential for abuse.

The information technology industry is currently in the process of developing and testing applications to implement the requirements set forth in the Interim Final Rule. As this process continues, DEA believes it prudent to issue the following clarifications, recommendation, and update to help ensure that the requirements of the Interim Final Rule are properly implemented. Specifically, DEA is clarifying that third-party audits must be conducted by qualified persons and must determine that an application meets all of the applicable requirements in 21 CFR part 1311 as well as other requirements referenced in Part 1311. “Processing integrity” must be addressed in audits of EPCS applications. DEA recommends that federal guidelines as set forth by the National Institute of Standards and Technology (NIST), including NIST Special Publication 800-53A, be consulted where questions arise. DEA has also announced an approved certification process for EPCS applications and has posted this information on its Web site. DEA notes its concern that proposed EPCS applications receive careful review prior to being used to create, sign, transmit or process controlled substance prescriptions so as to ensure the closed system for controlled substances established by the CSA. Secure and safe dispensing of controlled substances is necessary to protect the public interest and prevent diversion of controlled substances to illicit purposes. As with any violations of the CSA or DEA's implementing regulations, if diversion occurs in the EPCS environment, or if controlled substances are otherwise dispensed in violation of the EPCS regulations, those responsible may be subject to administrative and/or judicial action, to include civil injunction.

Implementation of electronic prescriptions for controlled substances is occurring at the same time the President has declared current prescription drug misuse and abuse as an epidemic constituting a major public health and public safety crisis. 2 The non-medical use of prescription drugs is on the rise in the United States. Drug induced deaths now exceed motor vehicle accident deaths in the United States. 3 According to the “Drug Abuse Warning Network (DAWN), 2009: National Estimates of Drug-Related Emergency Department Visits,” the Substance Abuse and Mental Health Services Administration (SAMHSA), 4 emergency department visits involving non-medical use of pharmaceuticals (misuse or abuse) almost doubled between 2004 and 2009 from 627,291 in 2004 to 1,244,679 visits in 2009 (a 98.4 percent increase). 5 About half of the 2009 emergency department visits related to abuse or misuse of pharmaceuticals involved painkillers and more than one-third involved drugs to treat insomnia and anxiety. 6

The 2009 National Survey on Drug Use and Health (NSDUH)  7 estimated that 7.0 million persons used prescription-type psychotherapeutic drugs—pain relievers, anti-anxiety medications, stimulants, and sedatives—non-medically. This represents 2.8 percent of the population aged twelve or older. These estimates were 13 percent higher than those from the 2008 Survey. In 2009, 2.2 million persons aged twelve or older used pain relievers non-medically for the first time; that averages to over 6,000 new users per day. Teenagers (grades 9-12) believe that prescription drugs are easier to obtain than illegal drugs. There is a concern that young people may perceive prescription and/or over-the-counter drugs as “safer” than illegal drugs because of their intended, legitimate medical use. 8

Cyber attacks are growing in frequency, size and complexity and are of concern as EPCS goes online. Responses by 583 U.S. businesses of all sizes to a recent independent survey conducted by the Ponemon Institute released June 22, 2011 found that 90 percent had at least one cyber security breach in the past 12 months. This survey found that the top two endpoints from which these security breaches occurred are employees' laptop computers and employee's mobile devices. 9 Numerous recent news articles describe incidents of major security breaches or hacking incidents into major U.S. private and government computer systems, including incidents involving electronic health records. 10 These incidents occur for many reasons, but access to controlled substances has not been cited as an objective because such substances have not been communicated via an electronic system. With the impending implementation of electronic prescriptions for controlled substances, DEA wishes to reiterate that adequate security of EPCS has been and continues to be a primary consideration in any electronic system used to communicate a legitimate controlled substance prescription for the purpose of dispensing to an ultimate user.

DEA wishes to provide the following clarifications.

EPCS, as with paper prescriptions, requires the individual practitioner be responsible for ensuring the prescription conforms to all legal requirements and the pharmacist, acting under the authority of the DEA-registered pharmacy, has a corresponding responsibility to ensure the prescription is valid and meets all legal requirements. Review of an EPCS application must be thorough in order to provide the prescriber and pharmacist the level of assurance needed in order to use the application.

Before any application may be used for electronic prescriptions for controlled substances, it must be reviewed, tested and determined by a third party to meet all of the requirements of 21 CFR part 1311. See 21 CFR 1311.300(a). There are two alternative processes for review of EPCS applications: (1) A third-party audit conducted by a person qualified to conduct a SysTrust, WebTrust or SAS 70 audit or a Certified Information System Auditor as stated in 21 CFR 1311.300(b), which comports with the requirements of paragraphs (c) and (d) of 21 CFR 1300.300 or (2) A certification by a certifying organization whose certification process has been approved by DEA as stated in 21 CFR 1311.300(e), which certification verifies that the application meets all of the requirements of 21 CFR part 1311.

21 CFR 1311.300(c) and 21 CFR 1311.300(d) state respectively that an audit for installed applications and application service providers must, among other things, determine that the application meets all of the applicable requirements in Part 1311. This includes all of Part 1311 and references to Parts 1300, 1304 and 1306.

Some individuals may be misinterpreting 21 CFR 1311.300(c) and (d), which state that audits “for installed applications must address processing integrity and determine that the application meets the requirements of this part ,” and audits “for application service providers must address processing integrity and physical security and determine that the application meets the requirements of this part .” (emphasis added). To further clarify, the Code of Federal Regulations is organized by title, chapter, part, subpart, section and paragraph. Any audit must include all of the applicable requirements for electronic prescriptions of controlled substances found in 21 CFR part 1311 and not just section 1311.300 of part 1311. Part 1311 also cross-references Parts 1300, 1304 and 1306 which establish specific requirements that must be the subject of any audit. Thorough review and testing of all requirements is both required by the regulations and necessary to ensure secure and effective electronic prescribing and dispensing of controlled substances in the interests of public health and safety.

“Processing Integrity” must be addressed in audits of EPCS prescriber and pharmacy applications.

EPCS applications must address security to prevent insider threats and outsider attacks on any system. Careful review by an independent, qualified third-party of the “processing integrity” of any application is required to determine whether an application or application service provider has adequate protection against the range of potential security threats.

Person qualified to conduct a third-party audit.

DEA notes that 21 CFR 1311.300(b)(1) and (2) require that a third-party audit be conducted by a person qualified to conduct a SysTrust, WebTrust or SAS 70 audit or by a Certified Information System Auditor. The regulations do not require one of these types of audits, but rather that the person conducting the audit must have specified qualifications. As provided in 21 CFR 1311.300(c) and (d), any audit must address processing integrity and determine that the application meets the requirements of DEA's regulations. DEA is reviewing the fact that the American Institute of Certified Public Accountants has replaced SAS 70 audits referenced in 21 CFR 1311.300(b)(1) and will necessarily address this issue in the final rule on EPCS.

Where questions arise in reviewing a particular EPCS prescriber or pharmacy application, DEA recommends that federal guidelines as set forth by the National Institute of Standards and Technology (NIST), specifically NIST Special Publication 800-53A, be consulted. Other NIST standards and publications are incorporated by reference in the Interim Final Rule and must be complied with as stated in the Interim Final Rule.

Some of the questions surrounding interpretation of DEA's EPCS regulations as applied to specific applications are addressed by federal guidelines articulated by the National Institute of Standards and Technology in NIST Special Publication (SP) 800-53A, as revised. Federal computer systems must comply with federal guidelines as outlined in NIST SP 800-53A. 11 As NIST SP 800-53A states, the publication may be used by nongovernmental organizations on a voluntary basis. Although the Interim Final Rule does not require compliance with NIST SP 800-53A, DEA believes this publication provides useful guidance and that it is advisable for private sector entities to consult the publication when reviewing security requirements for EPCS applications. In addition, EPCS will be used on federal systems in the military, the Department of Veterans Affairs and elsewhere where such systems must comply with federal guidelines.

DEA notes that the Notice of Proposed Rulemaking (NPRM) in June 27, 2008 discussed NIST SP 800-53A and whether or not it should be the basis for security requirements. 73 FR 36746-47 (June 27, 2008). DEA did not require application of NIST SP 800-53A in the Interim Final Rule due to the perceived need for flexibility and because security would be ensured by review of “processing integrity.” In light of developments since that time, DEA will be revisiting this issue as it is clear that a mechanism must be established in the EPCS regulations to keep EPCS applications current with technology, particularly security requirements.

All certifying organizations with a certification process approved by DEA pursuant to 21 CFR 1311.300(e) are posted on DEA's Web site once approved.

As noted above, the Interim Final Rule provides that, as an alternative to the audit requirements of 21 CFR 1311(b) through (d), an electronic prescription or pharmacy application may be verified and certified as meeting the requirements of 21 CFR Part 1311 by a certifying organization whose certification process has been approved by DEA. The preamble to the Interim Final Rule further indicated that, once a qualified certifying organization's certification process has been approved by DEA in accordance with 21 CFR 1311.300(e), such information will be posted on DEA's Web site. 75 FR 16243, March 31, 2010. On September 22, 2011, DEA approved the certification process developed by InfoGard Laboratories, Inc. and relevant information has been posted on DEA's Web site at http://www.DEAdiversion.usdoj.gov under electronic prescriptions.

This document contains amendments to 26 CFR part 1 to provide regulations under section 181 of the Internal Revenue Code of 1986 (Code). Section 181 permits the deduction of certain production costs by the producer of a qualified film or television production.

Section 181 was added to the Code by section 244 of the American Jobs Creation Act of 2004, Public Law 108-357 (118 Stat. 1418) (October 22, 2004), and was modified by section 403(e) of the Gulf Opportunity Zone Act of 2005, Public Law 109-135 (119 Stat. 2577) (December 21, 2005). Section 502 of the Tax Extenders and Alternative Minimum Tax Relief Act of 2008, Public Law 110-343 (122 Stat. 3765) (October 3, 2008) further modified section 181 for film and television productions commencing after December 31, 2007, and extended section 181 to film and television productions commencing before January 1, 2010. Section 181 was extended again to film and television productions commencing before January 1, 2012, by section 744 of the Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010, Public Law 111-312 (December 17, 2010).

On September 30, 2011, the IRS and the Treasury Department published in the Federal Register (TD 9551, 76 FR 60721) final regulations relating to deductions for the cost of producing film and television productions under section 181 as enacted by the American Jobs Creation Act of 2004 and modified by the Gulf Opportunity Zone Act of 2005.

Section 181 permits an owner of a qualified film or television production to elect to deduct production costs paid or incurred by that owner for the year the costs are paid or incurred, in lieu of capitalizing the costs and recovering them through depreciation allowances. For a qualified film or television production that commenced before January 1, 2008 (a “pre-amendment production”), this deduction is available only if the aggregate production costs paid or incurred by all owners do not exceed $15 million ($20 million if a significant amount of the production costs are paid or incurred in certain designated areas) for each qualified production (the “aggregate production costs limit”). For productions commencing on or after January 1, 2008, the aggregate production costs limit does not apply; instead, the aggregate deduction under section 181 for production costs paid or incurred by all owners of a qualified film or television production is limited to $15 million ($20 million if a significant amount of the production costs are incurred in certain designated areas) for each qualified production (the “deduction limit”). A film or television production (“production”) is a qualified film or television production if at least 75 percent of the total compensation of the production is compensation for services performed in the United States by actors, directors, producers, and other production personnel.

These temporary regulations amend § 1.181-1 to define the term “post-amendment production” and specify that the aggregate deduction under section 181 (rather than the amount of aggregate production costs) is subject to the dollar limits imposed under § 1.181-1(b). The temporary regulations also amend §§ 1.181-0 (table of contents) and 1.181-6 (effective date provisions).

These temporary regulations apply to qualified film and television productions for which principal photography or, for an animated production, in-between animation, commenced on or after October 18, 2011. An owner may choose to apply these temporary regulations to qualified film or television productions commencing on or after January 1, 2008, and before October 18, 2011.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) and (d) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. For applicability of the Regulatory Flexibility Act (5 U.S.C. chapter 6), please refer to the Special Analyses section of the preamble to the cross-reference notice of proposed rulemaking published in the Proposed Rules section in this issue of the Federal Register . Pursuant to section 7805(f) of the Code, these temporary regulations have been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

The principal author of these regulations is Bernard P. Harvey, Office of Associate Chief Counsel (Income Tax and Accounting). However, other personnel from the IRS and the Treasury Department participated in their development.

Accordingly, 26 CFR part 1 is amended as follows:

Regulatory Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when an agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under U.S.C. 553 (b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because waiting for a notice and comment period to run would be impracticable and contrary to the public interest in that it would prevent the Coast Guard from protecting the public and vessels on navigable waters from the hazards associated with the alteration of the Elgin Joliet & Eastern Railroad Drawbridge, as discussed in detail below.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . For the reasons discussed in the preceding paragraph and due to the Captain of the Port Sector Lake Michigan not receiving notice of the need for a safety zone, a 30-day notice period would be impracticable and contrary to the public interest.

The Truman-Hobbs alteration of the Elgin Joliet & Eastern Railroad Drawbridge, which consists of the removal of the bridges old piers and pier protection cells, will begin on October 13, 2011. This temporary safety zone is necessary to protect vessels from the hazards associated with those alteration efforts. The falling debris associated with the removal of the bridge's piers and protection cells poses a serious risk of injury to persons and property. As such, the Captain of the Port, Sector Lake Michigan, has determined that the alteration project of the Elgin Joliet & Eastern Railroad Drawbridge poses significant risks to public safety and property and that a safety zone is necessary.

The safety zone will encompass all U.S. navigable waters of the Illinois River in the vicinity of the Elgin Joliet & Eastern Railroad Drawbridge between Mile Marker 270.1 and Mile Marker 271.5 of the Illinois River in Morris, IL. [DATUM: NAD 83].

All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port, Sector Lake Michigan, or his or her designated representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port, Sector Lake Michigan, or his or her designated representative. The Captain of the Port, Sector Lake Michigan, or his or her designated representative may be contacted via VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under that Order. We conclude that this rule is not a significant regulatory action because we anticipate that it will have a minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone around the bridge project will be relatively small and exist for a relatively short duration. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule, if promulgated, will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor on a portion of the Illinois River between Mile Marker 270.1 and Mile Marker 271.5 at various times between 7 a.m. on October 13, 2011 and 7 a.m. on November 16, 2011.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will only be enforced while unsafe conditions exist. Vessel traffic will be minimal due to the public and commercial outreach that has been made the by D8 Bridge Branch over the last several months.

In the event that this temporary safety zone affects shipping, commercial vessels may request permission from the Captain of The Port, Sector Lake Michigan, or his or her designated representative to transit through the safety zone. The Coast Guard will give notice to the public via a Broadcast to Mariners that the regulation is in effect.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves the establishment of a safety zone and is therefore categorically excluded under paragraph 34(g) of the Instruction.

A final environmental analysis checklist and categorical exclusion determination are available in the docket where indicated under ADDRESSES .

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this fireworks display were not received in sufficient time for the Coast Guard to solicit public comments before the start of the event. Thus, waiting for a notice and comment period to run would be impracticable and contrary to the public interest because to do so would inhibit the Coast Guard's ability to protect the public and vessels from the hazards associated with fireworks displays on navigable waters.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable and contrary to the public interest because to do so would inhibit the Coast Guard's ability to protect the public and vessels from the hazards associated with fireworks displays on navigable waters.

Between 9 p.m. and 9:15 p.m. on October 22, 2011, a fireworks display will be held on the waters of Lake Erie near Lakewood, OH. The Captain of the Port Buffalo has determined that fireworks launched in proximity to watercraft pose a significant risk to the boating public. Such hazards include premature detonations, dangerous detonations, dangerous projectiles, and falling or burning debris that may cause death, serious bodily injury or property damage.

Because of the aforementioned hazards, the Captain of the Port Buffalo has determined that a temporary safety zone is necessary to ensure the safety of spectators and vessels during the setup, loading, and launching of the Mainardi/Kinsey wedding fireworks display. The safety zone will be in effect on October 22, 2011 from 8:30 p.m. to 9:45 p.m. The safety zone will encompass all waters of Lake Erie in Lakewood, OH within a 700 foot radius of position 41°29′34″ N and 81°49′39″ W (NAD 83).

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his on-scene representative. The Captain of the Port or his on-scene representative may be contacted via VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). The safety zone will be enforced for a relatively short time, vessels may pass around the zone, and vessels may still pass through the zone with permission of the Captain of the Port. Thus, we conclude that this rule is not a significant regulatory action because we anticipate that during the short time this zone will be in effect, it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel or legal policy issue.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in a portion of Lake Erie in Lakewood, OH on October 22, 2011 from 8:30 p.m. until 9:45 p.m.

This rule will not have a significant economic impact on a substantial number of small entities because of the minimal amount of time in which the safety zone will be enforced. This safety zone will only be enforced for one hour and fifteen minutes in a low vessel traffic area. Plus, vessel traffic can pass safely around the zone. Before the effective period, maritime advisories will be issued, which include a Broadcast Notice to Mariners.

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

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

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

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

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

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction because this rule involves the establishment of a temporary safety zone. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES .

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

I. Background

Transportation conformity is required under section 176(c) of the CAA to ensure that Federally supported highway, transit projects, and other activities are consistent with (conform to) the purpose of the SIP. Conformity currently applies to areas that are designated nonattainment and those redesignated to attainment after 1990 (maintenance areas), with plans developed under section 175A of the CAA for the following transportation related criteria pollutants: Ozone, particulate matter (PM 2.5 and PM 10 ), carbon monoxide (CO), and nitrogen dioxide (NO 2 ).

Conformity to the purpose of the SIP means that transportation activities will not cause new air quality violations, worsen existing violations, or delay timely attainment of the relevant national ambient air quality standards (NAAQS).

On October 17, 2006 (71 FR 61144), EPA promulgated a final rule that strengthened the 24-hour PM 2.5 NAAQS and revoked the annual PM 10 NAAQS. As a result of this rulemaking, EPA promulgated amendments to the transportation conformity rule in order to provide regulations for implementing conformity for the revisions to the PM 2.5 and PM 10 NAAQS and to address hot-spot analyses as a result of a remand from the Court of Appeals for the District of Columbia Circuit (March 24, 2010, 75 FR 14260).

On June 13, 2011, the Virginia Department of Environmental Quality (VADEQ) submitted a revision to its SIP for Transportation Conformity purposes. The SIP revision consists of amendments to the Commonwealth Regulation for Transportation Conformity (9VAC5 Chapter 151). This SIP revision addresses provisions of the EPA Conformity Rule required under 40 CFR part 93. The revision amends 9VAC5-151-40, entitled “General,” in order to change the date of the specific version of the provisions incorporated by reference from Code of Federal Regulations (CFR) (2008) in effect July 1, 2008 to CFR (2010) in effect July 1, 2010. The SIP revision also amends 9VAC5-151-70, entitled “Consultation,” in order to change conformity tests and methodologies for isolated rural nonattainment and maintenance areas as required by 40 CFR 93.109(1)(2)(iii) to as required by 40 CFR 93.109(n)(2)(iii).

EPA's review of Virginia's SIP revisions indicates that it is consistent with EPA's Conformity Rule. Virginia met the requirements under 40 CFR 51.390 to establish conformity criteria and procedures consistent with the transportation conformity regulation promulgated by EPA under 40 CFR part 93. In order to implement the federal transportation conformity requirements, Virginia's regulation must reflect the most recent rulemaking promulgated by EPA on March 24, 2010 (75 FR 14260).

In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information (1) That are generated or developed before the commencement of a voluntary environmental assessment; (2) that are prepared independently of the assessment process; (3) that demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) that are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege Law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by Federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce Federally authorized environmental programs in a manner that is no less stringent than their Federal counterparts. * * *” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by Federal law to maintain program delegation, authorization or approval.”

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any Federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity.”

Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the CAA is likewise unaffected by this, or any, state audit privilege or immunity law.

EPA is approving the Virginia SIP revision for transportation conformity, which was submitted on June 13, 2011. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the Proposed Rules section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on December 19, 2011 without further notice unless EPA receives adverse comment by November 18, 2011. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA 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 action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this 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).

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.

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 19, 2011. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking.

This action to approve the Virginia Transportation Conformity Regulation may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2).)

40 CFR part 52 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

EPA has previously determined that the entire Cincinnati-Hamilton area is attaining the 1997 annual PM 2.5 standard and that the Ohio and Indiana portions of the area have met the requirements for redesignation under section 107(d)(3)(E) of the CAA through a final determination made on September 29, 2011. EPA is thus approving the requests from the states of Ohio and Indiana to change the legal designation of their portions of the Cincinnati-Hamilton area from nonattainment to attainment for the 1997 annual PM 2.5 NAAQS. This action does not address the Kentucky portion of the Cincinnati-Hamilton area. EPA is also taking several additional actions related to Ohio and Indiana's PM 2.5 redesignation requests, as discussed below.

EPA is approving Indiana's and Ohio's PM 2.5 maintenance plans for the Cincinnati-Hamilton area as revisions to the Ohio and Indiana SIP (such approval being one of the CAA criteria for redesignation to attainment status). The maintenance plans are designed to keep the Cincinnati-Hamilton area in attainment of the 1997 annual PM 2.5 NAAQS through 2021.

EPA is approving 2005 emissions inventories for primary PM 2.5 , 1 NO X , and sulfur dioxide (SO 2 ), 2 documented in Ohio and Indiana's PM 2.5 redesignation request supplemental submittal. These emissions inventories satisfy the requirement in section 172(c)(3) of the CAA for a comprehensive, current emission inventory.

Finally, EPA finds adequate and is approving Ohio's and Indiana's 2015 and 2021 primary PM 2.5 and NO X MVEBs for the Cincinnati-Hamilton area. These MVEBs will be used in future transportation conformity analyses for the area. Further discussion of the basis for these actions is provided below.

The first air quality standards for PM 2.5 were promulgated on July 18, 1997, at 62 FR 38652. EPA promulgated an annual standard at a level of 15 micrograms per cubic meter (µg/m 3 ) of ambient air, based on a three-year average of the annual mean PM 2.5 concentrations at each monitoring site. In the same rulemaking, EPA promulgated a 24-hour PM 2.5 standard at 65 µg/m 3 , based on a three-year average of the annual 98th percentile of 24-hour PM 2.5 concentrations at each monitoring site.

On January 5, 2005, at 70 FR 944, EPA published air quality area designations for the 1997 annual PM 2.5 standard based on air quality data for calendar years 2001-2003. In that rulemaking, EPA designated the Cincinnati-Hamilton, area as nonattainment (for Ohio: Butler, Clermont, Hamilton, and Warren Counties, Ohio; for IN: a portion of Dearborn County, and for Kentucky: Boone, Campbell, and Kenton Counties) for the 1997 annual PM 2.5 standard.

On October 17, 2006, at 71 FR 61144, EPA retained the annual PM 2.5 standard at 15 µg/m 3 (2006 annual PM 2.5 standard), but revised the 24-hour standard to 35 µg/m 3 , based again on the three-year average of the annual 98th percentile of the 24-hour PM 2.5 concentrations. In response to legal challenges to the 2006 annual PM 2.5 standard, the U.S. Court of Appeals for District of Columbia Circuit (DC Circuit) remanded this standard to EPA for further consideration. See American Farm Bureau Federation and National Pork Producers Council, et al. v. EPA, 559 F.3d 512 (DC Cir. 2009). However, given that the 1997 and 2006 annual PM 2.5 standards are essentially identical, attainment of the 1997 annual PM 2.5 standard would also indicate attainment of the remanded 2006 annual standard. Since the Cincinnati-Hamilton area is designated as nonattainment for the 1997 annual PM 2.5 standard, today's proposed action addresses redesignation to attainment only for this standard.

Fine particulate pollution can be emitted directly from a source (primary PM 2.5 ) or formed secondarily through chemical reactions in the atmosphere involving precursor pollutants emitted from a variety of sources. Sulfates are a type of secondary particulate formed from SO 2 emissions from power plants and industrial facilities. Nitrates, another common type of secondary particulate, are formed from combustion emissions of NO X from power plants, mobile sources, and other combustion sources.

The CAA sets forth the requirements for redesignating a nonattainment area to attainment. Specifically, section 107(d)(3)(E) of the CAA allows redesignation provided that: (1) The Administrator determines that the area has attained the applicable NAAQS; (2) the Administrator has fully approved the applicable SIP for the area under section 110(k) of the CAA; (3) the Administrator determines that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from the implementation of the applicable SIP, Federal emission control regulations, and other permanent and enforceable emission reductions; (4) the Administrator has fully approved a maintenance plan for the area meeting the requirements of section 175A of the CAA; and, (5) the state containing the area has met all requirements applicable to the area for purposes of redesignation under section 110 and part D of the CAA.

EPA has determined that the entire Cincinnati-Hamilton area has attained the 1997 annual PM 2.5 standard and that the Ohio and Indiana portions of the area have met all other applicable redesignation criteria under CAA section 107(d)(3)(E). The basis for EPA's approvals of the redesignation requests is as follows:

On June 3, 2011, EPA proposed to determine that the entire Cincinnati-Hamilton area has attained the 1997 annual PM 2.5 NAAQS (76 FR 32110). No adverse comments were received and EPA's Region 4 and Region 5 Regional Administrators signed the final determination of attainment for the Cincinnati-Hamilton area on August 18, 2011 and September 12, 2011, respectively and published in the Federal Register on September 29, 2011. Relevant discussion of the monitored concentrations and sites can be found in the notices for the proposed and final determinations that are referenced above. EPA's September 29, 2011 final determination that the Cincinnati-Hamilton area has attained the 1997 annual PM 2.5 standard fulfills the requirement set forth in CAA section 107(d)(3)(E)(i).

We have determined that Ohio and Indiana have met all currently applicable SIP requirements for purposes of redesignation of the Ohio and Indiana portions of the Cincinnati-Hamilton area under section 110 of the CAA (general SIP requirements). We are also finding that the Ohio and Indiana SIPs meet all SIP requirements currently applicable for purposes of redesignation under part D of title I of the CAA, in accordance with section 107(d)(3)(E)(v). In addition, with the exception of the emissions inventory under section 172(c)(3), we have approved all applicable requirements of the Ohio and Indiana SIPs for purposes of redesignation, in accordance with section 107(d)(3)(E)(ii). As discussed below, in this action EPA is approving Ohio and Indiana's 2005 emissions inventories as meeting the section 172(c)(3) comprehensive emissions inventory requirement.

In making these determinations, we have ascertained which SIP requirements are applicable for purposes of redesignation, and have determined that there are SIP measures meeting those requirements and that they are fully approved under section 110(k) of the CAA.

Section 110(a) of title I of the CAA contains the general requirements for a SIP. Section 110(a)(2) provides that the implementation plan submitted by a state must have been adopted by the state after reasonable public notice and hearing, and, among other things, must: include enforceable emission limitations and other control measures, means or techniques necessary to meet the requirements of the CAA; provide for establishment and operation of appropriate devices, methods, systems, and procedures necessary to monitor ambient air quality; provide for implementation of a source permit program to regulate the modification and construction of any stationary source within the areas covered by the plan; include provisions for the implementation of part C, Prevention of Significant Deterioration (PSD) and part D, New Source Review (NSR) permit programs; include criteria for stationary source emission control measures, monitoring, and reporting; include provisions for air quality modeling; and provide for public and local agency participation in planning and emission control rule development.

Section 110(a)(2)(D) of the CAA requires that SIPs contain measures to prevent sources in a state from significantly contributing to air quality problems in another state. EPA believes that the requirements linked with a particular nonattainment area's designation are the relevant measures to evaluate in reviewing a redesignation request. The transport SIP submittal requirements, where applicable, continue to apply to a state regardless of the designation of any one particular area in the state. Thus, we believe that these requirements should not be construed to be applicable requirements for purposes of redesignation.

Further, we believe that the other section 110 elements described above that are not connected with nonattainment plan submissions and not linked with an area's attainment status are also not applicable requirements for purposes of redesignation. A state remains subject to these requirements after an area is redesignated to attainment. We conclude that only the section 110 and part D requirements that are linked with a particular area's designation are the relevant measures which we may consider in evaluating a redesignation request. This approach is consistent with EPA's existing policy on applicability of conformity and oxygenated fuels requirements for redesignation purposes, as well as with section 184 ozone transport requirements. See Reading, Pennsylvania, proposed and final rulemakings (61 FR 53174-53176, October 10, 1996, and 62 FR 24826, May 7, 1997); Cleveland-Akron-Lorain, Ohio, final rulemaking (61 FR 20458, May 7, 1996); and Tampa, Florida, final rulemaking (60 FR 62748, December 7, 1995). See also the discussion on this issue in the Cincinnati, Ohio 1-hour ozone redesignation (65 FR 37890, June 19, 2000), and in the Pittsburgh, Pennsylvania 1-hour ozone redesignation (66 FR 50399, October 19, 2001).

We have reviewed Ohio and Indiana's SIPs and have concluded that they meet the general SIP requirements under section 110 of the CAA to the extent they are applicable for purposes of redesignation. EPA has previously approved provisions of Ohio and Indiana's SIPs addressing section 110 requirements (including provisions addressing particulate matter, at 40 CFR 52.770 and 40 CFR 52.1870, respectively).

On December 7, 2007, September 9, 2008, March 23, 2011, and April 7, 2011, Indiana made submittals addressing “infrastructure SIP” elements required by section 110(a)(2) of the CAA. EPA approved elements of Indiana's submittals on July 13, 2011, at 76 FR 41075.

On December 5, 2007, and September 4, 2009, Ohio made submittals addressing “infrastructure SIP” elements required under CAA section 110(a)(2). EPA proposed approval of the December 5, 2007, submittal on April 28, 2011, at 76 FR 23757 and published final approval on July 13, 2011, at 76 FR 41075. EPA disapproved the element of the September 4, 2009, submittal that addresses section 110(a)(2)(D)(i) on July 20, 2011, at 76 FR 43175, but has not taken rulemaking action on the remainder of the submittal.

The remaining parts of the infrastructure SIPs required by section 110(a)(2) are not relevant to this redesignation, and are statewide requirements that are not linked to the PM 2.5 nonattainment status of the Cincinnati-Hamilton area. Therefore, EPA believes that these SIP elements are not applicable requirements for purposes of review of the state's PM 2.5 redesignation request.

EPA has determined that, upon approval of the base year emissions inventories discussed in section IV.C. of this rulemaking, the Ohio and Indiana SIPs will meet the SIP requirements for the Cincinnati-Hamilton area applicable for purposes of redesignation under part D of the CAA. Subpart 1 of part D, found in sections 172-176 of the CAA, sets forth the basic nonattainment requirements applicable to all nonattainment areas.

Subpart 1—Section 172 Requirements.

For purposes of evaluating these redesignation requests, the applicable section 172 SIP requirements for the Ohio and Indiana portions of the Cincinnati-Hamilton area are contained in sections 172(c)(1)-(9). A thorough discussion of the requirements contained in section 172 can be found in the General Preamble for Implementation of Title I (57 FR 13498, April 16, 1992).

Section 172(c)(1) requires the plans for all nonattainment areas to provide for the implementation of all Reasonably Available Control Measures (RACM) as expeditiously as practicable and to provide for attainment of the primary NAAQS. EPA interprets this requirement to impose a duty on all nonattainment areas to consider all available control measures and to adopt and implement such measures as are reasonably available for implementation in each area as components of the area's attainment demonstration. Because attainment has been reached, no additional measures are needed to provide for attainment, and section 172(c)(1) requirements are no longer considered to be applicable as long as the area continues to attain the standard until redesignation. (40 CFR 51.1004(c)).

The Reasonable Further Progress (RFP) requirement under section 172(c)(2) is defined as progress that must be made toward attainment. This requirement is not relevant for purposes of redesignation because the Cincinnati-Hamilton area has monitored attainment of the 1997 annual PM 2.5 NAAQS. (General Preamble, 57 FR 13564). See also 40 CFR 51.918. In addition, because the Cincinnati-Hamilton area has attained the 1997 annual PM 2.5 NAAQS and is no longer subject to an RFP requirement, the requirement to submit the section 172(c)(9) contingency measures is not applicable for purposes of redesignation. Id.

Section 172(c)(3) requires submission and approval of a comprehensive, accurate and current inventory of actual emissions. Ohio and Indiana submitted 2005 base year emissions inventories along with their redesignation requests. As discussed below in section IV.C., EPA is approving the 2005 base year inventories as meeting the section 172(c)(3) emissions inventory requirement for the Cincinnati-Hamilton area.

Section 172(c)(4) requires the identification and quantification of allowable emissions for major new and modified stationary sources in an area, and section 172(c)(5) requires source permits for the construction and operation of new and modified major stationary sources anywhere in the nonattainment area. EPA approved Ohio's current NSR program on January 10, 2003 (68 FR 1366). EPA approved Indiana's current NSR program on October 7, 1994 (59 FR 51108). Nonetheless, since PSD requirements will apply after redesignation, the area need not have a fully-approved NSR program for purposes of redesignation, provided that the area demonstrates maintenance of the NAAQS without part D NSR. A detailed rationale for this view is described in a memorandum from Mary Nichols, Assistant Administrator for Air and Radiation, dated October 14, 1994, entitled, “Part D New Source Review Requirements for Areas Requesting Redesignation to Attainment.” Indiana has demonstrated that the Indianapolis area will be able to maintain the standard without part D NSR in effect; therefore, the state need not have a fully approved part D NSR program prior to approval of the redesignation request. The state's PSD program will become effective in the Indianapolis area upon redesignation to attainment. See rulemakings for Detroit, Michigan (60 FR 12467-12468, March 7, 1995); Cleveland-Akron-Lorain, Ohio (61 FR 20458, 20469-20470, May 7, 1996); Louisville, Kentucky (66 FR 53665, October 23, 2001); and Grand Rapids, Michigan (61 FR 31834-31837, June 21, 1996).

Section 172(c)(6) requires the SIP to contain control measures necessary to provide for attainment of the standard. Because attainment has been reached, no additional measures are needed to provide for attainment.

Section 172(c)(7) requires the SIP to meet the applicable provisions of section 110(a)(2). As noted above, we believe the Ohio and Indiana SIPs meet the requirements of section 110(a)(2) applicable for purposes of redesignation.

Subpart 1—Section 176(c)(4)(D) Conformity SIP Requirements.

The requirement to determine conformity applies to transportation plans, programs and projects developed, funded or approved under title 23 of the U.S. Code and the Federal Transit Act (transportation conformity) as well as to all other Federally-supported or funded projects (general conformity).

Section 176(c) of the CAA was amended by provisions contained in the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), which was signed into law on August 10, 2005 (Public Law 109-59). Among the changes Congress made to this section of the CAA were streamlined requirements for state transportation conformity SIPs. State transportation conformity regulations must be consistent with Federal conformity regulations and address three specific requirements related to consultation, enforcement, and enforceability.

EPA believes that it is reasonable to interpret the transportation conformity SIP requirements as not applying for purposes of evaluating the redesignation request under section 107(d) for two reasons. First, the requirement to submit SIP revisions to comply with the transportation conformity provisions of the CAA continues to apply to areas after redesignation to attainment since such areas would be subject to a section 175A maintenance plan. Second, EPA's Federal conformity rules require the performance of conformity analyses in the absence of Federally-approved state rules. Therefore, because areas are subject to the transportation conformity requirements regardless of whether they are redesignated to attainment and, because they must implement conformity under Federal rules if state rules are not yet approved, EPA believes it is reasonable to view these requirements as not applying for purposes of evaluating a redesignation request. See Wall v. EPA, 265 F.3d 426 (6th Cir. 2001), upholding this interpretation. See also 60 FR 62748, 62749-62750 (Dec. 7, 1995) (Tampa, Florida).

Ohio and Indiana both have approved transportation conformity SIPs (72 FR 20945 (Ohio) and 75 FR 50708 (Indiana)). Ohio and Indiana are in the process of updating their approved transportation conformity SIPs, and EPA will review these when they are submitted.

Upon final approval of Ohio and Indiana's comprehensive 2005 emissions inventories, EPA will have fully approved the Ohio and Indiana SIP for the Cincinnati-Hamilton area under section 110(k) of the CAA for all requirements applicable for purposes of redesignation. EPA may rely on prior SIP approvals in approving a redesignation request ( See page 3 of the September 4, 1992, memorandum from John Calcagni, entitled “Procedures for Processing Requests to Redesignate Areas to Attainment,”; Southwestern Pennsylvania Growth Alliance v. Browner, 144 F.3d 984, 989-990 (6th Cir. 1998); Wall v. EPA, 265 F.3d 426 (6th Cir. 2001)) plus any additional measures it may approve in conjunction with a redesignation action. See 68 FR 25413, 25426 (May 12, 2003). Since the passage of the CAA of 1970, Ohio and Indiana have adopted and submitted, and EPA has fully approved, provisions addressing various required SIP elements under particulate matter standards. In this action, EPA is approving Ohio and Indiana's 2005 base year emissions inventory for the Cincinnati-Hamilton area as meeting the requirement of section 172(c)(3) of the CAA.

EPA finds that Ohio and Indiana have demonstrated that the observed air quality improvement in the Cincinnati-Hamilton area is due to permanent and enforceable reductions in emissions resulting from implementation of the SIPs, Federal measures, and other state-adopted measures.

In making this demonstration, Ohio and Indiana have calculated the change in emissions between 2005, one of the years used to designate the Cincinnati-Hamilton area as nonattainment, and 2008, one of the years the Cincinnati-Hamilton area monitored attainment. The reduction in emissions and the corresponding improvement in air quality over this time period can be attributed to a number of regulatory control measures that the Cincinnati-Hamilton area and upwind areas have implemented in recent years.

The following is a discussion of permanent and enforceable measures that have been implemented in the areas:

Reductions in fine particle precursor emissions have occurred statewide and in upwind areas as a result of Federal emission control measures, with additional emission reductions expected to occur in the future. Federal emission control measures include the following.

Tier 2 Emission Standards for Vehicles and Gasoline Sulfur Standards. These emission control and fuel requirements result in lower NO X emissions from new cars and light duty trucks, including sport utility vehicles. The Federal rules were phased in between 2004 and 2009. The EPA has estimated that, by the end of the phase-in period, NO X emissions will be reduced by 77 percent from new passenger cars (light-duty vehicles), 86 percent from new light duty trucks, minivans, and sports utility vehicles and, 69 to 95 percent from new larger sports utility vehicles, vans, and heavier trucks. EPA expects fleet wide average NO X emissions to decline as new vehicles replace older vehicles each year. The Tier 2 standards included the requirement to reduce the sulfur content of gasoline to 30 parts per million (ppm) by January 2006 primarily to improve the durability and effectiveness of vehicle emission control technology so that new vehicles could comply with these more stringent NO X emissions standards.

The 2007 Heavy-Duty Highway Rule. EPA issued this rule in December 2000. This rule took effect in 2007. It reduced fine particle and NO X emissions from heavy-duty highway engines and included requirements to reduce the sulfur content of diesel fuel used by highway vehicles to 15 ppm beginning in mid-2006 in order to avoid damage to the advanced PM and NO X controls that are necessary to comply with stringent emissions standards. The total program is estimated to achieve a 90 percent reduction in direct PM 2.5 emissions and a 95 percent reduction in NO X emissions for these new engines using low sulfur diesel, compared to existing engines using higher sulfur content diesel.

Nonroad Diesel Rule. In May 2004 EPA promulgated a new rule for large nonroad diesel engines, such as those used construction, agriculture, and mining equipment, to be phased in between 2008 and 2014. The rule establishes stringent emissions standards for NO X and PM for these types of equipment and establishes limits for the sulfur content of the diesel fuel that they use. The requirement to reduce sulfur levels in the nonroad diesel fuel by as much 99 percent allows advanced emission-control systems to be used for the first time on the engines used in these types of equipment. The combined engine and fuel rules will reduce NO X and PM emissions from large nonroad diesel engines by over 90 percent, compared to current nonroad engines using higher sulfur content diesel. This rule achieved some emission reductions by 2008 and was fully implemented by 2010.

Given the significance of sulfates and nitrates in the Cincinnati-Hamilton area, the area's air quality is strongly affected by regulation of SO 2 and NO X emissions from power plants.

NO X SIP Call . On October 27, 1998 (63 FR 57356), EPA issued a NO X SIP Call requiring the District of Columbia and 22 states to reduce emissions of NO X. Affected states were required to comply with Phase I of the SIP Call beginning in 2004, and Phase II beginning in 2007. Emission reductions resulting from regulations developed in response to the NO X SIP Call are permanent and enforceable.

Clean Air Interstate Rule (CAIR). EPA proposed CAIR on January 30, 2004, at 69 FR 4566, promulgated CAIR on May 12, 2005, at 70 FR 25162, and promulgated associated Federal Implementation Plans (FIPs) on April 28, 2006, at 71 FR 25328, in order to reduce SO 2 and NO X emissions and improve air quality in many areas across the Eastern United States. However, on July 11, 2008, the United States Court of Appeals for the District of Columbia Circuit (DC Circuit or Court) issued its decision to vacate and remand both CAIR and the associated CAIR FIPs in their entirety ( North Carolina v. EPA, 531 F.3d 836 (DC Cir. 2008)). EPA petitioned for a rehearing, and the Court issued an order remanding CAIR and the CAIR FIPs to EPA without vacatur ( North Carolina v. EPA, 550 F.3d 1176 (DC Cir. 2008)). The Court, thereby, left CAIR in place in order to “temporarily preserve the environmental values covered by CAIR” until EPA replaced it with a rule consistent with the Court's opinion ( id. at 1178). The Court directed EPA to “remedy CAIR's flaws” consistent with the July 11, 2008, opinion, but declined to impose a schedule on EPA for completing this action ( id ).

On August 8, 2011, at 76 FR 48208, EPA promulgated the Cross-State Air Pollution Rule (CSAPR) to address interstate transport of emissions and resulting secondary air pollutants and to replace CAIR. CAIR, among other things, required NO X and SO 2 emission reductions that contributed to the air quality improvement in the Cincinnati-Hamilton nonattainment area. CAIR emission reduction requirements limit emissions through 2011; CSAPR requires similar or greater emission reductions in the relevant areas in 2012 and beyond. CSAPR requires substantial reductions of SO 2 and NO X emissions from Electric Generating Units (EGUs or power plants) across most of Eastern United States, with implementation beginning on January 1, 2012. In particular, this rule requires reduction of these emissions to levels well below the levels that led to attainment of the 1997 annual PM 2.5 standard in the Cincinnati-Hamilton nonattainment area. Because the emission reduction requirements of CAIR are enforceable through the 2011 control period, and because CSAPR has now been promulgated to address the requirements previously addressed by CAIR and gets similar or greater reductions in the relevant areas in 2012 and beyond, EPA has determined that the EGU emission reductions that helped lead to attainment in the Cincinnati-Hamilton area can now be considered permanent and enforceable and that the requirement of CAA section 107(d)(3)(E)(iii) has now been met.

Ohio and Indiana developed emissions inventories for NO X , direct PM 2.5 , and SO 2 for 2005, one of the years used to designate the areas as nonattainment, and 2008, one of the years the Cincinnati-Hamilton area monitored attainment of the standard.

EGU SO 2 and NO X emissions were derived from EPA's Clean Air Market's acid rain database. These emissions reflect Ohio and Indiana's NO X emission budgets resulting from EPA's NO X SIP call. The 2008 emissions from EGUs reflect Ohio and Indiana's emission caps under CAIR. All other point source emissions were obtained from Ohio and Indiana's source facility emissions reporting.

Area source emissions for the Cincinnati-Hamilton area for 2005 were taken from Ohio and Indiana's 2005 periodic emissions inventories. 3 These 2005 area source emission estimates were extrapolated to 2008. Source growth factors were supplied by the Lake Michigan Air Directors Consortium (LADCO).

Nonroad mobile source emissions were extrapolated from nonroad mobile source emissions reported in EPA's 2005 National Emissions Inventory (NEI). Contractors were employed by LADCO to estimate emissions for commercial marine vessels and railroads.

On-road mobile source emissions were calculated using EPA's mobile source emission factor model, MOVES2010a, in conjunction with transportation model results developed by the Ohio-Kentucky-Indiana Regional Council of Governments (OKI).

All emissions estimates discussed below were documented in the submittals and Appendices of Ohio and Indiana's redesignation request submittal from January 25, 2011, and December 9, 2010, respectively. For these data and additional emissions inventory data, the reader is referred to EPA's digital docket for this rule, http://www.regulations.gov , for docket numbers EPA-R05-OAR-2011-0106 (Indiana) or EPA-R05-OAR-2011-0017 (Ohio), which include digital copies of Ohio and Indiana's submittals.

Emissions data for the entire Cincinnati-Hamilton area (OH-IN-KY) are shown in Tables 1 through 4 below.

Table 1 shows that the entire Cincinnati-Hamilton area reduced NO X emissions by 18,869.14 tpy between 2005 and 2008. Table 2 shows that the Cincinnati-Hamilton area reduced direct PM 2.5 emissions by 1,080.46 tpy between 2005 and 2008. Table 3 shows that the Cincinnati-Hamilton area reduced SO 2 emissions by 152,837.88 tpy between 2005 and 2008.

Because PM 2.5 concentrations in the Cincinnati-Hamilton area are significantly impacted by the transport of sulfates and nitrates, the area's air quality is strongly affected by regulation of SO 2 and NO X emissions from power plants. Table 4, below, presents statewide EGU emissions data compiled by EPA's Clean Air Markets Division for the years 2002 and 2008. Emissions for 2008 reflect implementation of CAIR.

Table 4 shows that states impacting the Cincinnati-Hamilton area reduced NO X and SO 2 emissions from EGUs by 701,175 tons per year (tpy) and 1,409,011 tpy, respectively, between 2002 and 2008.

Based on the information summarized above, Ohio and Indiana have adequately demonstrated that the improvement in air quality is due to permanent and enforceable emissions reductions.

In conjunction with Ohio and Indiana's requests to redesignate the Cincinnati-Hamilton nonattainment area to attainment status, Ohio and Indiana have submitted SIP revisions to provide for maintenance of the 1997 annual PM 2.5 NAAQS in the area through 2021.

Section 175A of the CAA sets forth the required elements of a maintenance plan for areas seeking redesignation from nonattainment to attainment. Under section 175A, the plan must demonstrate continued attainment of the applicable NAAQS for at least ten years after EPA approves a redesignation to attainment. Eight years after redesignation, the state must submit a revised maintenance plan which demonstrates that attainment will continue to be maintained for ten years following the initial ten-year maintenance period. To address the possibility of future NAAQS violations, the maintenance plan must contain contingency measures with a schedule for implementation as EPA deems necessary to assure prompt correction of any future annual PM 2.5 violations.

The September 4, 1992, John Calcagni memorandum provides additional guidance on the content of a maintenance plan. The memorandum states that a maintenance plan should address the following items: The attainment emissions inventories, a maintenance demonstration showing maintenance for the ten years of the maintenance period, a commitment to maintain the existing monitoring network, factors and procedures to be used for verification of continued attainment of the NAAQS, and a contingency plan to prevent or correct future violations of the NAAQS.

The states developed emissions inventories for NO X , direct PM 2.5 , and SO 2 for 2008, one of the years used to demonstrate monitored attainment of the 1997 annual PM 2.5 standard, as described in section IV.A.3.b., above. The attainment level of emissions is summarized in Tables 1 through 4, above.

Along with the redesignation request, the two states submitted revisions to their PM 2.5 SIPs to include maintenance plans for the Cincinnati-Hamilton area, as required by section 175A of the CAA. These demonstrations show maintenance of the annual PM 2.5 standard through 2021 by showing that current and future emissions of NO X , directly emitted PM 2.5 and SO 2 for the area remain at or below attainment year emission levels. A maintenance demonstration need not be based on modeling. See Wall v. EPA, 265 F.3d 426 (6th Cir. 2001), Sierra Club v. EPA, 375 F. 3d 537 (7th Cir. 2004). See also 66 FR 53094, 53099-53100 (October 19, 2001), 68 FR 25413, 25430-25432 (May 12, 2003).

Ohio and Indiana are using emissions inventory projections for the years 2015, and 2021 to demonstrate maintenance. The projected emissions were estimated by Ohio and Indiana, with assistance from LADCO, and the local Metropolitan Planning Organization (MPO), OKI using the MOVES2010a model. Emissions data are shown in Table 5, below.

Table 5 shows that the NO X emissions in the Cincinnati-Hamilton area are 69.887.02 tpy less in 2021, the outermost year of the maintenance plan, than in attainment year 2008. Direct PM 2.5 emissions are 702.01 tpy lower in 2021 than in 2008, and SO 2 emissions are 28,505.87 tpy lower in 2021 than in 2008.

Because the PM 2.5 concentrations in the Cincinnati-Hamilton area are significantly impacted by the transport of sulfates and nitrates, the area's air quality is strongly affected by regulation of SO 2 and NO X emissions from power plants. Table 6, below, presents statewide EGU emissions data compiled for 2008 and 2014 and beyond. Emissions for 2008 reflect implementation of CAIR and an attainment year, while 2014 emissions reflect budgets established in the CSAPR.

Table 6 shows that NO X emissions from EGUs are projected to decrease by 693,590 tpy from 2008 to 2014 and beyond in states impacting the Cincinnati-Hamilton area. Over that same time period, SO 2 emissions from EGUs are projected to decrease by 2,818,746 in states impacting the Cincinnati-Hamilton area.

Based on the information summarized above, Ohio and Indiana have adequately demonstrated maintenance of the PM 2.5 standard in this area for a period extending in excess of ten years from the date that EPA is completing rulemaking on the state's redesignation request.

Ohio currently operates nine monitors for purposes of determining attainment with the annual PM 2.5 standard in the Cincinnati-Hamilton area. Kentucky currently operates one monitor for the area. Currently, Indiana operates no monitors for the Cincinnati-Hamilton area since the state makes up only a small portion of the non-attainment area, and EPA has determined that the monitors maintained by both Ohio and Kentucky constitute an adequate monitoring network. Ohio has committed to continue to operate and maintain its monitors and will consult with EPA prior to making any changes to the existing monitoring network. Ohio remains obligated to continue to quality-assure monitoring data in accordance with 40 CFR part 58 and enter all data into EPA's Air Quality System (AQS) database in accordance with Federal guidelines.

Continued attainment of the annual PM 2.5 NAAQS in the Cincinnati-Hamilton area depends, in part, on the state's efforts toward tracking indicators of continued attainment during the maintenance period. Ohio and Indiana's plan for verifying continued attainment of the annual PM 2.5 standard in the Cincinnati-Hamilton area consists of continued ambient PM 2.5 monitoring in accordance with the requirements of 40 CFR part 58. The two states will also continue to develop and submit periodic emission inventories as required by the Federal Consolidated Emissions Reporting Rule (codified at 40 CFR 51 Subpart A) to track future levels of emissions.

The contingency plan provisions are designed to promptly correct or prevent a violation of the NAAQS that might occur after redesignation of an area to attainment. Section 175A of the CAA requires that a maintenance plan include such contingency measures as EPA deems necessary to assure that the state will promptly correct a violation of the NAAQS that occurs after redesignation. The maintenance plan should identify the contingency measures to be adopted, a schedule and procedure for adoption and implementation of the contingency measures, and a time limit for action by the state. The state should also identify specific indicators to be used to determine when the contingency measures need to be adopted and implemented. The maintenance plan must include a requirement that the state will implement all measures with respect to control of the pollutant(s) that were contained in the SIP before redesignation of the area to attainment. See section 175A(d) of the CAA.

As required by section 175A of the CAA, Ohio and Indiana have adopted contingency plans for the Cincinnati-Hamilton area to address possible future annual PM 2.5 air quality problems.

Under Indiana's plan, if a violation of the 1997 annual PM 2.5 standard occurs, Indiana will implement an “Action Level Response”. Unless the violation is due to an atypical unfavorable meteorological condition, exceptional event, malfunction or noncompliance with a permit condition or rule requirement, Indiana will adopt and implement one or more of its contingency measures. Indiana has provided clarification that the state considers the term “an atypical unfavorable meteorological condition” to mean an exceptional event as determined by EPA. EPA agrees with and relies upon this clarification in approving Indiana's contingency measures provisions. (See docket EPA-R05-OAR-2011-0106 for clarification communications).

If a violation occurs, it will trigger an Action Level Response; that is, Indiana will adopt and implement one or more control measures from its list of candidate measures within 18 months from the end of the year in which monitored air quality triggering the response occurs. Indiana's candidate contingency measures include the following:

i. Alternative fuel and diesel retrofit programs for fleet vehicle operations;

ii. NO X or SO 2 controls on new minor sources;

iii. Wood stove change out program;

iv. Idle restrictions; and

v. Broader geographic applicability of existing measures.

Ohio's contingency measures include a Warning Level Response and an Action Level Response. An initial Warning Level Response is triggered when the average weighted annual mean for one year exceeds 15.5 μg/m 3 . In that case, a study will be conducted to determine if the emissions trends show increases; if action is necessary to reverse emissions increases, Ohio will follow the same procedures for control selection and implementation as for an Action Level Response.

The Action Level Response will be prompted by any one of the following: A Warning Level Response study that shows emissions increases, a weighted annual mean over a two-year average that exceeds the standard, or a violation of the standard. If an Action Level Response is triggered, Ohio will adopt and implement appropriate control measures within 18 months from the end of the year in which monitored air quality triggering a response occurs.

Ohio's candidate contingency measures include the following:

i. ICI Boilers—SO 2 and NO X controls;

ii. Process heaters;

iii. EGUS;

iv. Internal combustion engines;

v. Combustion turbines;

vi. Other sources > 100 TPY;

vii. Fleet vehicles;

viii. Concrete manufacturers and;

ix. Aggregate processing plants.

Ohio and Indiana further commit to conduct ongoing review of their data, and if monitored concentrations or emissions are trending upward, Ohio and Indiana commit to take appropriate steps to avoid a violation if possible. Ohio and Indiana commit to continue implementing SIP requirements upon and after redesignation.

EPA believes that both Ohio and Indiana's contingency plans, as well as the commitment to continue implementing any SIP requirements, satisfy the pertinent requirements of section 175A(d).

As required by section 175A(b) of the CAA, Ohio and Indiana have each committed to submit to the EPA an updated maintenance plan eight years after redesignation of the Cincinnati-Hamilton area to attainment of the 1997 annual PM 2.5 standard to cover an additional ten-year period beyond the initial ten-year maintenance period. As required by section 175A of the CAA, Ohio and Indiana have committed to retain the control measures contained in the SIP prior to redesignation, or submit to EPA, as a SIP revision, any changes to its rules or emission limits applicable to SO 2 , NO X or direct PM 2.5 sources as required for maintenance of the annual PM 2.5 standard in the Cincinnati-Hamilton area.

EPA has concluded that the maintenance plans adequately address the requisite five basic components: Attainment inventory, maintenance demonstration, monitoring network, verification of continued attainment, and a contingency plan. Thus EPA is fully approving the maintenance plan SIP revisions submitted by Ohio and Indiana for the Cincinnati-Hamilton area as meeting the requirements of section 175A of the CAA.

Under the CAA, states are required to submit, at various times, control strategy SIP revisions and maintenance plans for PM 2.5 nonattainment areas and for areas seeking redesignations to attainment of the PM 2.5 standard. These emission control strategy SIP revisions ( e.g., RFP and attainment demonstration SIP revisions) and maintenance plans create MVEBs based on on-road mobile source emissions for criteria pollutants and/or their precursors to address pollution from on-road transportation sources. The MVEBs are the portions of the total allowable emissions that are allocated to highway and transit vehicle use that, together with emissions from other sources in the area, will provide for attainment, RFP or maintenance, as applicable.

Under 40 CFR part 93, a MVEB for an area seeking a redesignation to attainment is established for the last year of the maintenance plan and could also be established for an interim year or years. The MVEB serves as a ceiling on emissions from an area's planned transportation system. The MVEB concept is further explained in the preamble to the November 24, 1993, transportation conformity rule (58 FR 62188).

Under section 176(c) of the CAA, new transportation plans and transportation improvement programs (TIPs) must be evaluated to determine if they conform to the purpose of the area's SIP. Conformity to the SIP means that transportation activities will not cause new air quality violations, worsen existing air quality violations, or delay timely attainment of the NAAQS or any required interim milestone. If a transportation plan or TIP does not conform, most new transportation projects that would expand the capacity of roadways cannot go forward. Regulations at 40 CFR part 93 set forth EPA policy, criteria, and procedures for demonstrating and assuring conformity of such transportation activities to a SIP.

When reviewing SIP revisions containing MVEBs, including attainment strategies, rate-of-progress plans, and maintenance plans, EPA must affirmatively find adequate and/or approve the MVEBs for use in determining transportation conformity before the MVEBs can be used. Once EPA affirmatively approves and/or finds the submitted MVEBs to be adequate for transportation conformity purposes, the MVEBs must be used by state and Federal agencies in determining whether proposed transportation plans and TIPs conform to the SIP as required by section 176(c) of the CAA. EPA's substantive criteria for determining the adequacy of MVEBs are set out in 40 CFR 93.118(e)(4). Additionally, to approve a motor vehicle emissions budget EPA must complete a thorough review of the SIP, in this case the PM 2.5 maintenance plans, and conclude that the SIP will achieve its overall purpose, in this case providing for maintenance of the 1997 annual PM 2.5 standard in the Indiana and Ohio portions of the Cincinnati area.

EPA's process for determining adequacy of a MVEB consists of three basic steps: (1) Providing public notification of a SIP submission; (2) providing the public the opportunity to comment on the MVEB during a public comment period; and, (3) EPA taking action on the MVEB. The process for determining the adequacy of submitted SIP MVEBs is codified at 40 CFR 93.118.

The maintenance plans submitted by Ohio and Indiana for the Cincinnati-Hamilton area contain new primary PM 2.5 and NO X MVEBs for the area for the years 2015 and 2021. The motor vehicle emissions budgets were calculated using MOVES2010(a). After the adequacy finding and approval of the budgets become effective, the budgets will have to be used in future conformity determinations and regional emissions analyses prepared by the OKI, will have to be based on the use of MOVES2010a or the most recent version of MOVES required to be used in transportation conformity determinations. 4 The states have determined the 2015 MVEBs for the combined Ohio and Indiana portions of Cincinnati-Hamilton area to be 1,678.60 tpy for primary PM 2.5 and 35,723.83 tpy for NO X . Ohio and Indiana have determined the 2021 MVEBs for their combined portions of the Cincinnati-Hamilton area to be 1,241.19 tpy for primary PM 2.5 and 21,747.71 tpy for NO X . These MVEBs exceed the on-road mobile source primary PM 2.5 and NO X emissions projected by the states for 2015 and 2021. Ohio and Indiana have decided to include “safety margins” as provided for in 40 CFR 93.124(a) (described below) of 79.93 tpy and 112.84 tpy for primary PM 2.5 and 4,659.63 tpy and 2,836.65 tpy for NO X in the 2015 and 2021 MVEBs, respectively, to provide for on-road mobile source growth. Ohio and Indiana did not provide emission budgets for SO 2 , VOCs, and ammonia because it concluded, consistent with EPA's presumptions regarding these precursors, that emissions of these precursors from on-road motor vehicles are not significant contributors to the area's PM 2.5 air quality problem.

In the Ohio and Indiana portions of the Cincinnati-Hamilton area, the motor vehicle budgets including the safety margins and motor vehicle emission projections for both NO X and PM 2.5 are lower than the levels in the attainment year.

EPA has reviewed the submitted budgets for 2015 and 2021 including the added safety margins using the conformity rule's adequacy criteria found at 40 CFR 93.118(e)(4) and the conformity rule's requirements for safety margins found at 40 CFR 93.124(a). EPA has also completed a thorough review of the maintenance plan for the Ohio and Indiana portions of the Cincinnati-Hamilton area. Based on the results of this review of the budgets and the maintenance plans EPA is approving the 2015 and 2021 direct PM 2.5 and NO X budgets including the requested safety margins for the Ohio and Indiana portions of the Cincinnati-Hamilton area. Additionally, EPA, through this rulemaking, has found the submitted budgets to be adequate for use to determine transportation conformity in the Indiana and Ohio portions of the area, because EPA has determined that the area can maintain the 1997 annual PM 2.5 NAAQS for the relevant maintenance period with on-road mobile source emissions at the levels of the MVEBs including the requested safety margins. These budgets must be used in conformity determinations made on or after the effective date of this direct final rulemaking (40 CFR 93.118(f)(iii)). Additionally, transportation conformity determinations made after the effective date of this notice must be based on regional emissions analyses using MOVES2010a or a more recent version of MOVES that has been approved for use in conformity determinations. 5

A “safety margin” is the difference between the attainment level of emissions (from all sources) and the projected level of emissions (from all sources) in the maintenance plan. As shown in Table 5, the combination of the Ohio and Indiana portions of the Cincinnati-Hamilton area is projected to have safety margins for NO X and direct PM 2.5 of 42,994.13 tpy and 270.09 tpy in 2015, and 69,887.02 tpy and 702.01 tpy for NO X and PM 2.5 in 2021 (the difference between the attainment year, 2008, emissions and the projected years of 2015 and 2021 emissions for all sources in the Cincinnati-Hamilton area). Even if emissions exceeded expectations by the full level of the safety margin, the area would still demonstrate maintenance since emission levels would equal those in the attainment year.

The transportation conformity rule allows areas to allocate all or a portion of a “safety margin” to the area's motor vehicle emissions budgets (40 CFR 92.124(a)). The MVEBs requested by Ohio and Indiana contain NO X safety margins for mobile sources in 2015 and 2021 and PM 2.5 safety margins for mobile sources in 2015 and 2021 are much smaller than the allowable safety margins reflected in the total emissions for the Cincinnati-Hamilton area. The state is not requesting allocation to the MVEBs of the entire available safety margins reflected in the demonstration of maintenance. Therefore, even though the state is requesting MVEBs that exceed the projected on-road mobile source emissions for 2015 and 2021 contained in the demonstration of maintenance, the increase in on-road mobile source emissions that can be considered for transportation conformity purposes is well within the safety margins of the overall PM 2.5 maintenance demonstration.

Therefore, EPA believes that the requested budgets, including the requested portion of the safety margins, provide for a quantity of mobile source emissions that would be expected to maintain the PM 2.5 standard. Once allocated to mobile sources, these portions of the safety margins will not be available for use by other sources.

EPA, through this rulemaking, has found adequate and is approving the MVEBs for use to determine transportation conformity in the Ohio and Indiana portions of the Cincinnati-Hamilton area, because EPA has determined that the area can maintain attainment of the 1997 annual PM 2.5 NAAQS for the relevant maintenance period with mobile source emissions at the levels of the MVEBs including the requested safety margins. These budgets must be used in conformity determinations made on or after the effective date of this direct final rulemaking, December 19, 2011. (40 CFR 93.118(f)(iii)) Additionally, the determinations made after the effective date of this notice must be based on regional emissions analyses using MOVES2010a or a more recent version of MOVES that has been approved for use in conformity determinations. 6

As discussed above in section IV.A.2.a.ii., section 172(c)(3) of the CAA requires areas to submit a comprehensive emissions inventory. Ohio and Indiana submitted 2005 base year emissions inventories that meet this requirement. Emissions contained in the submittals cover the general source categories of point sources, area sources, on-road mobile sources, and nonroad mobile sources.

For the point source sector, EGU SO 2 and NO X emissions were derived from EPA's Clean Air Market's database. All other point source emissions were obtained from Ohio and Indiana's source facility emissions reporting.

Area source emissions were extrapolated from Ohio and Indiana's 2005 periodic emissions inventories. Source growth factors were supplied by LADCO.

Nonroad mobile source emissions were extrapolated from nonroad mobile source emissions reported in EPA's 2005 NEI. LADCO estimated emissions for commercial marine vessels and railroads.

On-road mobile source emissions were calculated using EPA's mobile source emission factor model, MOVES2010a, in conjunction with roadway network traffic information prepared by OKI.

All emissions discussed in Table 1 were documented in the submittal and the Appendices of Ohio and Indiana's redesignation request submittals. EPA has reviewed Ohio and Indiana's documentation of the emissions inventory techniques and data sources used for the derivation of the 2005 emissions estimates and has found that Ohio and Indiana have thoroughly documented the derivation of these emissions inventories. The submittals for both the Ohio and Indiana state that the 2005 emissions inventories are currently the most complete emissions inventories for PM 2.5 and PM 2.5 precursors in the Cincinnati-Hamilton area. Based upon EPA's review, we conclude that the 2005 emissions inventories areas complete and accurate as possible given the input data available to the states.

EPA has previously made the determination that the Cincinnati-Hamilton area has attained the 1997 annual PM 2.5 standard. EPA is determining that the area continues to attain the standard and that the Ohio and Indiana portions of the area meet the requirements for redesignation to attainment of that standard under section 107(d)(3)(E) of the CAA. EPA is thus approving the requests from Ohio and Indiana to change the legal designation of their portions of the Cincinnati-Hamilton area from nonattainment to attainment for the 1997 annual PM 2.5 NAAQS. EPA is approving Ohio and Indiana's 1997 annual PM 2.5 maintenance plans for the Cincinnati-Hamilton area as revisions to the respective SIPs because the plans meet the requirements of section 175A of the CAA. EPA is approving the 2005 emissions inventories for primary PM 2.5 , NO X , and SO 2 , documented in Indiana's and Ohio's December 9, 2010, and January 25, 2011, submittals as satisfying the requirement in section 172(c)(3) of the CAA for a comprehensive, current emission inventory. Finally, EPA finds adequate and is approving 2015 and 2021 primary PM 2.5 and NO X MVEBs submitted from each state for the Ohio and Indiana portions of the Cincinnati-Hamilton area. These MVEBs will be used in future transportation conformity analyses for the area after the effective date for the adequacy finding and approval.

Under the CAA, redesignation of an area to attainment and the accompanying approval of a maintenance plan under section 107(d)(3)(E) are actions that affect the status of a geographical area and do not impose any additional regulatory requirements on sources beyond those imposed by state law. A redesignation to attainment does not in and of itself create any new requirements, but rather results in the applicability of requirements contained in the CAA for areas that have been redesignated to attainment. Moreover, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA 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 action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, these actions:

• Are 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);

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

• Are 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. );

• Do 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);

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

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

• Are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Are 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 Clean Air Act; and

• Do 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.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 19, 2011. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of these actions for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw these direct final rules and address the comment in the proposed rulemaking. These actions may not be challenged later in proceedings to enforce their requirements. (See section 307(b)(2).)

40 CFR Parts 52 and 81 are amended as follows: