Effective July 30, 2008, Division A of the Housing and Economic Recovery Act of 2008 (HERA), Public Law 110-289, 122 Stat. 2654 (2008), titled the Federal Housing Finance Regulatory Reform Act of 2008, amended the Federal Housing Enterprises Financial Safety and Soundness Act of 1992 (12 U.S.C. 4501 et seq. ) (Safety and Soundness Act) and created FHFA as an independent agency of the Federal Government. HERA provided for the abolishment of the Office of Federal Housing Enterprise Oversight (OFHEO) and the Federal Housing Finance Board (Finance Board) one year after the date of enactment. Those agencies, together with the Housing and Urban Development Enterprise mission staff, were combined to establish FHFA. FHFA was established to oversee the prudential operations of the Federal National Mortgage Association (Fannie Mae), the Federal Home Loan Mortgage Corporation (Freddie Mac) (together, Enterprises), and the Federal Home Loan Banks (Banks); and to ensure that they operate in a safe and sound manner, remain adequately capitalized, foster liquid, efficient, competitive and resilient national housing finance markets, comply with the Safety and Soundness Act and their respective authorizing statutes, as well as all rules, regulations, guidelines and orders under those statutes, and carry out their missions through activities that are authorized by their respective statutes and are consistent with the public interest. FHFA also has regulatory authority over the Federal Home Loan Bank System's Office of Finance under section 1311(b)(2) of the Safety and Soundness Act (12 U.S.C. 4511(b)(2)).

The rule sets forth FHFA's business address and hours of operation.

The rule also informs the public about FHFA's organization and structure, including the Office of the Director, the Division of Enterprise Regulation, the Division of Housing Mission and Goals, the Division of Federal Home Loan Bank Regulation, the Office of Inspector General, the Office of General Counsel, the Office of the Ombudsman, and the Office of Minority and Women Inclusion.

The rule describes and depicts FHFA's official logo and seal.

FHFA is removing the comparable regulations of the Finance Board and OFHEO, 12 CFR part 905 of the Finance Board regulations and 12 CFR part 1700 of the OFHEO regulations.

This final rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

Because no notice of proposed rulemaking is required for this regulation, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply. See 5 U.S.C. 601(2) and 603(a).

In promulgating this regulation, FHFA has determined that notice and public comment are not necessary. Section 553(b)(A) of title 5, United States Code, provides that when regulations involve matters of agency organization, procedure or practice, the agency may publish regulations in final form. In addition, FHFA finds, in accordance with 5 U.S.C. 553(d), that a delayed effective date is unnecessary. Accordingly, these regulations are effective upon publication.

Accordingly, for the reasons stated in the Supplementary Information, under the authority of 12 U.S.C. 4526, 12 U.S.C. 4512, and 5 U.S.C. 552, FHFA amends Chapters IX, XII, and XVII of title 12 of the Code of Federal Regulations as follows:

Discussion

On November 26, 2008, at 73 FR 71952, the Federal Register published our notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR part 39 to include an AD that would apply to Erickson Model S-64F helicopters with a transition fitting, part number (P/N) 6420-66341-101, -102, -103, or -104; bulkhead assembly, P/N 6420-66340-041, -043, or -044; or a strap, P/N 6420-66301-119 or -127, installed. That NPRM proposed to require inspecting for cracking or working rivets in each transition fitting, the bulkhead assembly, the strap, and the attaching rotary rudder boom and pylon structure, and repairing or replacing any cracked or damaged part with an airworthy part. The NPRM also proposed to require, for any part where you could not visually determine that a crack does not exist, inspecting using a 10-power or higher magnifying glass. If you could not determine that a crack does not exist in the part after inspecting it with a 10-power or higher magnifying glass, the NPRM proposed to require performing a fluorescent particle inspection (FPI) of any part other than a strap, and performing a magnetic particle inspection (MPI) of any strap. The NPRM also proposed to require replacing any loose or working rivet. The proposed requirements were intended to detect cracking in the rotary rudder boom or pylon due to fatigue, and to prevent failure from static overload and subsequent loss of control of the helicopter.

After our NPRM (73 FR 71952, November 26, 2008) was published, we received comments from one commenter.

A commenter from Erickson Air-Crane asked that we delete the bulkhead assembly, P/N 6420-66340-041, from the applicability and compliance section of the NPRM (73 FR 71952, November 26, 2008) since that P/N is not used on Erickson Model S-64F helicopters. We agree and have revised this AD accordingly.

The commenter also asked that we delete the words “other than a strap” from the requirement to perform an FPI on a part other than a strap if you cannot determine that a crack does not exist, and delete the entire requirement to perform an MPI of the strap if you cannot determine that a crack does not exist. The commenter states that an MPI cannot be performed on the strap when it is installed on a helicopter; instead an FPI of the strap would need to be performed with the other parts. We partially agree. We agree that an MPI cannot be performed on the strap while it is installed on the helicopter because the strap is attached to the aluminum pylon section. An MPI for the strap was initially proposed in the NPRM (73 FR 71952, November 26, 2008) because this would be the type of inspection normally used for a steel part. Instead of changing the MPI on the strap to an FPI as requested, after further review, we determined that deleting this inspection, as well as the magnifying glass inspection and certain FPIs that were proposed in the NPRM, will not impact the overall level of safety. These inspections were included in the event a visual inspection was insufficient to determine whether a crack exists. If any additional inspections are necessary to determine if a crack exists, a qualified individual performing the inspection must make this determination.

We have reviewed the relevant information, considered the comments received, and determined that an unsafe condition exists and is likely to exist or develop on other products of the same type design and that air safety and the public interest require adopting the AD requirements as proposed with the changes described previously and minor editorial changes. We have also revised the estimated costs of complying with this AD to reflect an average labor rate of $85 per work-hour instead of $80 per work-hour. These changes are consistent with the intent of the proposals in the NPRM (73 FR 71952, November 26, 2008) and will not increase the economic burden on any operator nor increase the scope of the AD.

We have reviewed Erickson Service Bulletin (SB) No. 64B20-6, Revision A, dated December 12, 2007, which describes procedures for inspecting the transition fittings, the bulkhead assembly, the strap, and the attaching rotary rudder boom and pylon structure for cracking or working rivets. We have also reviewed Erickson SB No. 64F General-3, Revision C, dated December 12, 2007, which summarizes a listing of a portion of the Model S-64F helicopter components, their part numbers, and the corresponding SBs to use when performing the structural inspections.

We estimate that this AD will affect 7 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. It will take about 0.75 work-hour to visually inspect the transition fittings, skin panels, the bulkhead assembly, strap, and pylon exterior in the strap area; we estimate 30 of these visual inspections per year. It will take about 0.50 work-hour to visually inspect the pylon interior in the strap area; we estimate 4 of these visual inspections per year. It will take about 0.75 work-hour to visually and fluorescent penetrant inspect the skin panels at the transition fitting; we estimate performing these inspections 1 time per year. It will take about 40 work-hours to repair a pylon structural assembly. The average labor rate is $85 per work-hour and the cost for required parts to repair a pylon structural assembly is approximately $50,000. Based on these figures, we estimate the annual cost of the inspections will be $2,146 per helicopter and $15,024 for the fleet on U.S. operators. The estimated cost to repair a pylon structural assembly, including the cost for replacement parts and labor, is $53,400.

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.

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

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

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

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

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

(4) 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 an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

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

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive AD No. 2012-0145, dated August 6, 2012 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

The in-service event engine was assembled at the factory by RR. After the in-service event, RR inspected all LPT bearing housing end cover assemblies they had assembled and found one other assembly with a missing spherical seat. RR estimates that up to 200 LPT bearing housing end cover assemblies assembled using this procedure may have been built without the spherical seat. We are issuing this AD to prevent fracture of the oil transfer tube, which could result in uncontained failure of the engine and damage to the airplane. You may obtain further information by examining the MCAI in the AD docket.

Rolls-Royce has issued Alert Non-Modification Service Bulletin Alert (NMSB) RB.211-72-AH051, dated August 3, 2012, or Revision 1, dated September 11, 2012, and NMSB RB.211-72-H056, dated August 3, 2012, or Revision 1, dated September 11, 2012. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the United Kingdom and is approved for operation in the United States. Pursuant to our bilateral agreement with the European Community, EASA has notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that notice and comment prior to adoption of this rule is unnecessary because no engines are used on U.S. registered airplanes. Therefore, we find that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2012-1117; Directorate Identifier 2012-NE-25-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

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

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.

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 6, 2012 (77 FR 33334), and proposed to supersede AD 2010-11-14, Amendment 39-16319 (75 FR 30277, June 1, 2010). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

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 have considered the comments received.

Embraer requested that we include EMBRAER Temporary Revision (TR) 5-5, dated May 24, 2012; and EMBRAER TR 5-7, dated August 12, 2012; to Appendix A, Part 2, Airworthiness Limitation Inspections (ALI)—Structures, of the EMBRAER 190 MRBR, MRB-1928, in the operators' maintenance programs. Embraer points out that those TRs include additional maintenance tasks that were approved in recent design changes, which identify and mitigate potential premature structural cracks.

We disagree. There have been numerous changes to the structural inspection requirements intended to identify potential premature cracks since the last structural airworthiness limitations (EMBRAER TR 2-5, dated December 6, 2007; and EMBRAER TR 2-6, dated February 12, 2008; to Appendix A, Part 2, Airworthiness Limitation Inspections (ALI) -Structures, of the EMBRAER 190 MRBR, MRB-1928 were mandated in FAA AD 2010-11-14, Amendment 39-16319 (75 FR 30277, June 1, 2010).

The requested changes would alter the actions currently required by this AD, so additional rulemaking would be required. We find that delaying this action would be inappropriate in light of the identified unsafe condition.

In addition, we have contacted the ANAC, the aviation authority for Brazil. ANAC has indicated it intends to mandate the maintenance actions in Appendix A, Parts I, II, and IV of EMBRAER 190 MRBR, MRB-1928, Revision 5, dated November 11, 2010; including EMBRAER TR 5-3, dated November 11, 2010; and EMBRAER TR 5-6, dated November 11, 2010, in addition to the TRs referred to by the commenter. These new maintenance actions include certification maintenance requirements (CMRs) and life-limited parts, in addition to the structural inspections from the TRs referred to by the commenter. As we stated previously, we consider that to delay this AD action would be inappropriate, since we have determined that an unsafe condition exists. When ANAC issues mandatory continued airworthiness instructions that encompass all appropriate airworthiness limitations, including the commenter's recommended action, we might consider additional rulemaking. We have not changed the AD in this regard.

We have deleted Note 1 to paragraph (g)(1) of the NPRM (77 FR 33334, June 6, 2012). Instead, we have added the same information in paragraph (g)(2) of this AD.

We also revised the compliance times specified in table 1 to paragraph (g)(1) of this AD to correctly identify the effective date of AD 2010-11-14, Amendment 39-16319 (75 FR 30277, June 1, 2010).

We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (77 FR 33334, June 6, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (77 FR 33334, June 6, 2012).

We estimate that this AD will affect about 88 products of U.S. registry.

The actions that are required by AD 2010-11-14, Amendment 39-16319 (75 FR 30277, June 1, 2010), and retained in this AD take about 1 work-hour per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the currently required actions is $85 per product.

We estimate that it will take about 1 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 $7,480, 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 that 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);

3. Will not affect intrastate aviation in Alaska; and

4. 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 (77 FR 33334, June 6, 2012), 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:

Comments Invited

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, we invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit them only one time. We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.

On October 23, 2012, we issued Emergency AD 2012-21-52, which requires inspecting the pilot's and co-pilot's collective and cyclic control sticks for correctly installed attaching hardware, and reinstalling the affected stick before further flight if the hardware is not correct. The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, issued EASA AD No. 2012-0213-E, dated October 16, 2012, to correct an unsafe condition for certain Agusta Model AW139 helicopters. EASA advises that an incident of an incorrectly installed pilot's collective stick, pilot's cyclic stick, and co-pilot's cyclic stick was reported. This condition, if not detected and corrected, could lead to in-flight detachment of the cyclic or collective sticks and subsequent loss of control of the helicopter.

These helicopters have been approved by the aviation authority of Italy and are approved for operation in the United States. Pursuant to our bilateral agreement with Italy, EASA, its technical representative, has notified us of the unsafe condition described in the EASA AD. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other helicopters of the same type design.

Agusta has issued Bollettino Tecnico (BT) No. 139-308, dated October 16, 2012. The BT describes procedures to inspect the pilot's and co-pilot's collective and cyclic sticks for the correct installation of bolts, washers, self-locking nuts, cotter pins, ring nuts, and quick-release pins. If any collective or cyclic stick is incorrectly installed, the BT requires reinstalling the affected control stick.

This AD requires, within 5 hours time-in-service (TIS):

• Inspecting the pilot collective and cyclic control sticks for the correct installation of the attachment bolts, washers, self-locking nuts, and cotter pins. If the installed hardware is not as prescribed in this AD, before further flight, reinstalling the pilot collective or cyclic control stick.

• Inspecting the co-pilot collective and cyclic control sticks for the correct installation of the ring nuts and quick-release pins. If the installed hardware is not as prescribed in this AD, before further flight, reinstalling the co-pilot collective or cyclic control stick.

The EASA AD allows compliance within 1 week or 5 flight-hours; this AD requires compliance within 5 hours TIS.

We estimate that this AD will affect 45 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. Inspecting the pilot's and co-pilot's collective and cyclic stick installation will require about 1 work-hour at an average labor rate of $85 per hour, for a cost per helicopter of $85 and a cost to U.S. operators of $3,825.

Reinstalling a cyclic or collective stick will require about 1 work-hour, at an average labor rate of $85 per hour, for a cost per helicopter of $85.

Providing an opportunity for public comments prior to adopting these AD requirements would delay implementing the safety actions needed to correct this known unsafe condition. Therefore, we found and continue to find that the risk to the flying public justifies waiving notice and comment prior to the adoption of this rule because the previously described unsafe condition can adversely affect the controllability of the helicopter and the required corrective actions must be accomplished within 5 hours TIS.

Since it was found that immediate corrective action was required, notice and opportunity for prior public comment before issuing this AD were impracticable and contrary to the public interest and good cause existed to make the AD effective immediately by Emergency AD 2012-21-52, issued on October 23, 2012 to all known U.S. owners and operators of these helicopters. These conditions still exist and the AD is hereby published in the Federal Register as an amendment to section 39.13 of the Federal Aviation Regulations (14 CFR 39.13) to make it effective to all persons.

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, I certify that this AD:

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

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

3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

4. 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 an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

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 27, 2012 (77 FR 38224). That NPRM proposed to correct an unsafe condition for the specified products. The Mandatory Continuing Airworthiness Information (MCAI) states:

We gave the public the opportunity to participate in developing this AD. We considered the comments received. The National Transportation Safety Board stated that it supports the NPRM (77 FR 38224, June 27, 2012).

Saab AB (the commenter) requested that we revise the NPRM (77 FR 38224, June 27, 2012) throughout to change the name of the Saab company referenced in the NPRM from “Saab AB, Saab Aerosystems” to the new company name, “Saab AB, Aeronautics.” The commenter also requested to change the company email address referenced in the NPRM from “ saab2000techsupport@saabgroup.com ” to “ saab340techsupport@saabgroup.com .”

We agree with the intent of the commenter's request. The FAA is in the process of changing the type certificate data sheet (TCDS) to reflect the name change. We will use the name identified in the current TCDS so as not to delay issuance of the final rule. Once the TCDS has been changed, we will use the new name in subsequent ADs. We changed the email address appropriately in paragraph (m) of this AD.

Saab AB requested that we revise the second and third sentences in the Summary section and a related sentence in paragraph (e) of the NPRM (77 FR 38224, June 27, 2012). In the Summary section, the commenter requested that we revise the following text to clarify that the airplane had been certified with natural buffet—as the stall warning—in icing conditions, and explained that replacement of the SWC would increase the safety level by introducing an artificial stall warning for icing conditions.

The commenter suggested the following text.

The commenter also requested that the first sentence in paragraph (e) of the NPRM (77 FR 38224, June 27, 2012) be changed to match the new wording.

We agree with the request for the reasons provided by the commenter. Therefore, we changed the wording in the Summary section and paragraph (e) of this AD as proposed by the commenter.

Saab AB requested that we revise paragraph (i) of the NPRM (77 FR 38224, June 27, 2012), which reads “As of effective date of this AD, do not install any SWC having P/N 0020AK, 0020AK1, 0020AK2, 0020AK4, or 0020AK3 MOD 1 on any airplane,” to “After modification of an airplane as required by paragraph (g) and (h) of this AD, do not install any SWC having P/N 0020AK, 0020AK1, 0020AK2, 0020AK4, or 0020AK3 MOD 1 on any airplane.” The commenter stated that this change would allow an operator, during the compliance time, to install an SWC having the same part number of the failed SWC.

We agree because there is a potential problem with availability of the new part. Therefore, we have changed the wording in paragraph (i) of this AD to match the intent of the commenter's request.

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—except for minor editorial changes. We have determined that these changes:

• Are consistent with the intent that was proposed in the NPRM (77 FR 38224, June 27, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (77 FR 38224, June 27, 2012).

We estimate that this AD will affect 162 products of U.S. registry. We also estimate that it will take about 78 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 $33,000 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 $6,420,060, or $39,630 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 that 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);

3. Will not affect intrastate aviation in Alaska; and

4. 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 (77 FR 38224, June 27, 2012), 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 published in the Federal Register on February 28, 2012 (77 FR 11789). That NPRM proposed to require modifying the anti-icing system for the angle of attack sensor, the total air temperature, and the pitot probes.

Since we issued the NPRM (77 FR 11789, February 28, 2012), we reviewed Boeing Alert Service Bulletin 737-30A1063, Revision 1, dated July 10, 2012. (The NPRM referred to Boeing Alert Service Bulletin 737-30A1063, dated November 16, 2011.) Among other things, Boeing Alert Service Bulletin 737-30A1063, Revision 1, dated July 10, 2012, updates certain information, including part numbers, various accomplishment steps, certain modules, maintenance manuals, and kit information.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal (77 FR 11789, February 28, 2012) and the FAA's response to each comment. Aviation Partners Boeing stated that installation of winglets per STC ST00830SE does not affect the NPRM and stated it would provide supporting data to the FAA upon request.

Seven commenters requested that we revise the 24-month compliance time, as proposed in the NPRM (77 FR 11789, February 28, 2012).

Korean Air Lines (KAL), Air Pacific Limited (APC), Delta Air Lines, Inc. (DAL), American Airlines (AAL), United Airlines (UAL), and Southwest Airlines (SWA) requested we extend the compliance time. UAL and AAL requested we take into account the time needed to obtain modification kits and to modify the panels. SWA and AAL stated that the compliance time will result in unscheduled maintenance outside of a heavy maintenance cycle. SWA stated unscheduled maintenance visits could last up to four days outside of a heavy maintenance cycle. APC noted it would not be able to accomplish the actions during this year's C-checks, which are at 2-year intervals.

Turkish Airlines (THY) stated that the proposed 24-month compliance time may not be enough for fleet-wide retrofit since the P5-9 panel modification restricts the rate of aircraft modification. KAL requested that the compliance time be extend to 30 or more months. DAL requested that the compliance time be extended to 36 months due to several factors. DAL cited the rate at which operators can complete the modification, expected late kit release based on revisions in service information linked to the service bulletin validation process, and “flawed” service information. DAL also compared the modification specified in this NPRM (77 FR 11789, February 28, 2012) with a similar modification that installs warning lights to the P1-3 and P3-1 panels, and stated that this similar modification has a 36-month compliance time.

We disagree with these requests to extend the compliance time. In developing an appropriate compliance time for these actions, we considered the urgency associated with the subject unsafe condition, the practical aspect of accomplishing the required modification and the normal scheduled maintenance times for most affected operators. In consideration of these items, as well as parts availability, we have determined that the 24-month compliance time for the modification is the longest duration allowable that will ensure an acceptable level of safety. According to the provisions of paragraph (i) of this AD, however, we may approve requests to adjust the compliance time if the requests include data substantiating that the new compliance time would provide an acceptable level of safety. We have not changed the final rule regarding this issue.

Air Line Pilots Association International (ALPA) requested that we revise the NPRM (77 FR 11789, February 28, 2012) by including an alerting system as part of the proposed requirements. ALPA stated that any automatic system design must include a crew alerting system to provide the flight crew with an aural and visual indication if the heating system does not automatically activate or is not functioning properly. ALPA further states that human factors principles should be integrated into a warning system design to ensure that factors such as pilot field of view and nuisance warnings due to normal ground operations (e.g., single engine taxi) are fully evaluated. ALPA stated that Boeing Model 747-400 airplanes have an automatic system and this system provides crews with an engine indicating and crew alerting system (EICAS) message if any item in the air data probe suite is not being heated, either due to heating element failure or if the system fails to activate upon engine start. ALPA reasoned that a similar alerting system should be included in the proposed system for Model 737 airplanes.

We agree that if the heating system does not automatically activate or is not functioning properly, the flight crew should receive an alert. We also agree that human factors principles should be considered in an alert system design. These principles are consistent with FAA regulations, policy, and guidance.

However, we disagree with revising this AD to include changes to the flight crew alerting for pitot heat malfunctions on Model 737 airplanes because that model incorporates “CAPT PITOT” and “F/O PITOT” caution lights on the P5-9 overhead panel for the captain's and first officer's probe heat. Both caution lights are tied to a Master Caution light in each pilot's primary field of view and an “Anti-ice” caution light that alerts the pilots to check the overhead panel for the specific condition causing the Master Caution and “Anti-ice” lights to illuminate. The captain's and/or first officer's PITOT light will illuminate whenever a loss of electrical current flow is sensed through the respective pitot probe heater. The practical effect of the change to automatic probe heat activation is that when the probe heat switch is in AUTO, the respective PITOT light should be out when either engine is running. Therefore, if the switch is in AUTO and the corresponding PITOT light remains on with either engine running, a malfunction of the automatic activation system is indicated.

Flight crew procedures for both normal and non-normal operation of the pitot heat system are unaffected by this change. We have determined that the existing flight crew alerting for pitot heat malfunctions provides adequate flight crew alerting for pitot heat malfunctions on Model 737 airplanes, whether the system is manually or automatically activated. Furthermore, since probe heat is activated with the probe heat switch in AUTO when either engine is running, single engine taxi should not generate nuisance warnings; a PITOT light during single engine taxi would indicate a malfunction of the automatic activation system. No change to the final rule is necessary in this regard.

Boeing requested we revise the sentence in the Summary section of the NPRM (77 FR 11789, February 28, 2012) that describes the precipitating event, i.e., “reports of flight crew failure to activate air data probe heat.” Boeing suggested that the phrase “as required by the FAA approved operating procedures” be added to the end of the sentence in question. Boeing reasoned that the suggested text would make it clear that existing Boeing Model 737NG operating procedures are FAA-approved and that the flight crew failed to perform a required action.

We disagree with the commenter's request to revise the language that describes the precipitating event. Regardless of whether the flight crew adhered to prescribed operating procedures, we consider that failure to activate the air data probe heat on the part of the flight crew represents an unacceptable risk to the affected airplanes, as evidenced by the current lack of an automatic probe heat activation system in combination with the demonstrated accident and incident history on the type associated with failure to activate probe heat. In addition, the purpose of this AD is to identify and correct an unsafe condition in the type design of the affected airplanes. We find that the precipitating event statement is accurate as originally worded in the NPRM (77 FR 11789, February 28, 2012). We have not made any change to the final rule in this regard.

Boeing requested we revise the unsafe condition statement in the Summary section, Discussion section, and paragraph (e) of the NPRM (77 FR 11789, February 28, 2012). Boeing stated that the text “* * * which could lead to loss of control of the airplane” should read, “* * * which would not provide the necessary air data instrumentation to safely fly the airplane.” Boeing stated that loss of, or erroneous, airspeed indications do not necessarily lead to loss of control because other indications can be used to safely fly the airplane. Boeing noted that multiple in-service events have occurred without loss of control when the flight crew followed the procedures that mitigate loss of air data.

We disagree with the commenter's request to revise the unsafe condition statement. Although some in-service events might have occurred without loss of control, loss of, or misleading airspeed indication on all airspeed indicating systems can, in fact, lead to an unsafe condition of loss of airplane control. FAA Advisory Circular (AC) 25-11A, “Electronic Flight Deck Displays,” dated June 21, 2007 ( http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgAdvisoryCircular.nsf/0/7d6139991c94e7d9862573080063f84d/$FILE/AC%2025-11A.pdf ), typically classifies loss of all airspeed displays (including the standby display) as a “catastrophic” failure condition. “Catastrophic” is defined in FAA AC 25.1309-1A, “System Design and Analysis,” dated June 21, 1988 ( http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgAdvisoryCircular.nsf/0/50bfe03b65af9ea3862569d100733174/$FILE/AC25.1309-1A.pdf ) as a failure condition which would prevent continued safe flight and landing. FAA AC 25-11A also classifies display of misleading airspeed information on one primary display combined with a standby failure (i.e., loss of airspeed or incorrect airspeed) as a “catastrophic” failure condition. As specified in National Transportation Safety Board (NTSB) Safety Recommendation A-07-56, dated September 13, 2007 ( http://www.ntsb.gov/doclib/recletters/2007/a07_55_56.pdf ), in at least one in-service event on a Boeing Model 737 airplane, it was determined that this condition ultimately resulted in a loss of airplane control with fatal injuries.

In addition, we agree with Boeing's identification of the effects of unreliable air data, as given in the Background section of Boeing Alert Service Bulletin 737-30A1063, dated November 16, 2011; and Revision 1, dated July 10, 2012. For these reasons, we find that the unsafe condition statement is accurate as originally worded in the NPRM (77 FR 11789, February 28, 2012). We have not made any change to the final rule in this regard.

Boeing requested we revise certain text in the Discussion section of the NPRM (77 FR 11789, February 28, 2012):

• To indicate existing compliance of pitot heat alerting with section 25.1326 of the Federal Aviation Regulations (14 CFR 25.1326);

• To indicate failure of the flight crew to respond properly to the amber caution-level indication of a lack of probe heat; and

• To state that the indication is in clear view of a flight crew member. Boeing stated the changes are needed for the following reasons:

• To correctly state that the system provides indication of a lack of probe heat activation, as required by section 25.1326 of the Federal Aviation Regulations (14 CFR 25.1326), rather than a positive indication of heat activation, as stated by the FAA (and which would not be compliant);

• To make it clear that the existing indication is compliant;

• To correct the “blameless” tone of the passive voice used in the first sentence of the Discussion section by making it clear that it is only the flight crew that can fail to activate the probe heat, which is one of the advantages of a manual system; and

• To make it explicit that the unsafe condition is not only a result of flight crew failure to activate the probe heat, but also a result of the flight crew ignoring the caution-level indication that is in plain view.

Since the Discussion section of the NPRM (77 FR 11789, February 28, 2012) is not restated in the final rule, we cannot change that section. However, we find that clarification is necessary.

According to section 39.5 of the Federal Aviation Regulations (14 CFR 39.5), we issue ADs when we find that an unsafe condition exists in the product, and that the unsafe condition is likely to exist or develop in other products of the same type design. We made such a finding with respect to the pitot heat system of the affected airplanes in this AD action. Therefore, it is our responsibility to correct the unsafe condition independent of whether the design was considered compliant to applicable airworthiness standards; an AD is the appropriate vehicle for doing so.

Additionally, we do not make findings for the incidents identified in safety recommendations issued by the National Transportation Safety Board (NTSB). We do not have any information that supports the argument that the flight crews involved in the incidents identified in the NTSB safety recommendation deliberately disregarded a properly functioning pitot heat alert that they had observed. Many possible scenarios associated with pitot heat alerting could contribute to the failure of the flight crew to activate the probe heat; including a malfunction of probe heat alerting resulting in failure to provide an indication of lack of activation, the flight crew not observing or properly identifying the alert due to various factors (even though certain elements of the alerting system are within the pilots' primary field of view), or the flight crew not understanding the meaning of the alert or the proper procedures for responding to it.

We have not made any changes to the final rule in this regard.

AAL, DAL, and SWA requested that we revise the cost estimate of the NPRM (77 FR 11789, February 28, 2012). AAL stated the NPRM and service information underestimate the labor cost by greater than 50 percent. AAL stated that additional out-of-service days and lost opportunity cost should be included in the Cost of Compliance section of the NPRM. DAL stated there is a significant investment in excess of $250,000 in “seed” modules that are necessary to minimize the risk of not accomplishing the proposed changes. DAL concluded that this cost is not represented in the Costs of Compliance of the NPRM. SWA stated the expected labor cost is underestimated by 32 work-hours due to removal and reinstallation of lavatory A and galley #1.

We partially agree with the commenters' request to revise the cost estimate. We do not agree to change the AD to accommodate the investment in “seed” modules, since this appears to be an operator-specific cost associated with individual maintenance scheduling. Also, we disagree that the cost estimate is underestimated by greater than 50 percent. However, we revised the Costs of Compliance section of this AD as follows. We revised the parts cost to match the information presented in Boeing Alert Service Bulletin 737-30A1063, Revision 1, dated July 10, 2012. In addition, we included 30 additional work-hours for removing and reinstalling lavatory and galley monuments that might be necessary to do the modification. This information was coordinated with Boeing.

Several commenters noted that Boeing Alert Service Bulletin 737-30A1063, dated November 16, 2011, is inadequate. That service information is cited in the NPRM (77 FR 11789, February 28, 2012) as the appropriate source of service information for accomplishing the required actions. The commenters requested that the service information be revised to incorporate certain clarifications. One airline, DAL, specifically requested that the final rule not be released until the service information has been validated.

We agree. As explained previously, Boeing Alert Service Bulletin 737-30A1063, Revision 1, dated July 10, 2012, has been issued. This service information has been validated by means of use of an aircraft in maintenance, and is referenced in this final rule as the appropriate source of service information. In addition, we added a new paragraph (h) to this AD (and re-designated subsequent paragraphs) to provide credit for certain actions performed before the effective date of this AD using Boeing Alert Service Bulletin 737-30A1063, dated November 16, 2011.

DAL also requested we specify “revisions to BAE Systems Service Bulletin 233A3201-30-02” as approved service information, and provide contact information for BAE. (The commenter did not specify a revision level or date for the BAE service information.) DAL stated that its review of the BAE Systems service information (which provides instructions on how to modify the P5-9 window/pitot heat module to the required ON and AUTO pitot heat switch configuration) identified discrepancies in the Accomplishment Instructions.

DAL provided examples of the identified discrepancies, including connector identifications and the number of printed wire assemblies on the P5-9 modules. DAL stated it has contacted Boeing and BAE Systems to seek resolution of these discrepancies.

DAL added that BAE concurred that its service information will require revision. DAL indicated that additional revision of the Boeing service information might be required in light of any BAE Systems service information revision. DAL noted that the service information, as currently published, would necessitate that operators request approval of alternative methods of compliance (AMOC) for resolutions to the identified discrepancies in order to comply with the final rule.

We find that clarification is necessary. The intent of this AD is to require installation of a P5-9 module with AUTO and ON pitot heat switch functionality that supports automatic pitot heat activation. As discussed previously, we reviewed Boeing Alert Service Bulletin 737-30A1063, dated November 16, 2011; and Boeing Alert Service Bulletin 737-30A1063, Revision 1, dated July 10, 2012; and determined that this service information provides sufficient instructions to adequately correct the unsafe condition. Operators may use either the original issue or Boeing Alert Service Bulletin 737-30A1063, Revision 1, dated July 10, 2012, to comply with the AD requirements. However, this AD does not require accomplishment of the BAE service information. No change to the final rule is necessary in this regard.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these minor changes:

• Αre consistent with the intent that was proposed in the NPRM (77 FR 11789, February 28, 2012) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (77 FR 11789, February 28, 2012).

We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We estimate that this AD affects 1,025 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

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

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

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

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

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

(3) Will not affect intrastate aviation in Alaska, and

(4) 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.

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

On June 29, 2012, the Commission issued a notice of proposed rulemaking to amend regulations on the CPSC's animal testing methods under 16 CPR part 1500 to clarify alternative test methods that replace, reduce, or refine animal testing. 77 FR 38754. The final rule on the Commission's regulations on animal testing under 16 CFR part 1500 is published elsewhere in this Federal Register . The final rule on revisions to the animal testing regulations is effective 30 days after publication of the rule in the Federal Register .

In addition, on June 29, 2012, the Commission also proposed to codify its statement of policy on animal testing to reflect new methods accepted by the scientific community as replacements, reductions, or refinements to animal tests including recommendations of and test methods of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM; http://iccvam.niehs.nih.gov/home.htm ). 77 FR 38751. Codification at 16 CFR 1500.232 would make the ICCVAM recommendations and Commission's animal testing policy more accessible and transparent to interested parties. Although the Commission proposed to make the animal testing policy effective on the date of publication in the Federal Register , because the animal testing policy references sections of the animal testing regulations in 16 CFR part 1500, we will make the statement of policy effective on the same date, 30 days after publication of the policy in the Federal Register . The Commission has also established a Web page on the CPSC's Web site at http://www.cpsc.gov/library/animaltesting.html regarding the ICCVAM recommendations and new developments in test methods that replace, reduce, or refine animal testing. After consideration of the comments, the Commission codifies its final statement of policy on animal testing.

In the Federal Register of June 29, 2012, we published a proposed statement of policy on animal testing (77 FR 38751). We received two comments on the proposed statement. One commenter was an individual and the other comment was submitted jointly by the Alternatives Research and Development Foundation, American Anti-Vivisection Society, Humane Society of the United States, People for the Ethical Treatment of Animals, and the Physicians Committee for Responsible Medicine. Both commenters support the use of alternative test methods to eliminate or reduce the use of animals.

Comment: One commenter states that alternative test methods approved for testing potentially hazardous substances were too limited as laid out in the Commission's proposal, and requests that the CPSC broaden its recommendations to in vitro and in silico tests beyond those already approved by the Commission through ICCVAM. Specifically, the commenter recommends adding methods that were already approved by other regulatory bodies, such as the Organisation for Economic Cooperation and Development (OECD) or the European Centre for the Validation of Alternative Methods (ECVAM EURL). The commenter further suggests that § 1500.232(b) should include any “scientifically acceptable” non-animal alternative that is “fit for the purpose,” not limited to those expressly approved by the Commission, nor to those that had undergone an official regulatory validation process.

Response: The Commission agrees that alternatives outside of those which ICCVAM has approved may be acceptable for hazard testing. For hazard testing for the purpose of labeling under FHSA, alternative test methods beyond those reviewed and recommended by ICCVAM may be acceptable because ICCVAM's purview is not exhaustive. In addition, data derived from scientifically valid testing methods can be used to make hazard determinations for substances regulated under FHSA, assuming tests are reliable, reproducible, and accurate. The Commission encourages hazard testing that supports the replacement, reduction, and refinement of animal test methods while simultaneously maintaining a high degree of scientific integrity. Therefore, if a manufacturer or other entity performs a hazard test for FHSA labeling purposes that has not been previously approved by the Commission ( i.e., an ICCVAM-recommended test method or one of the tests described in the current version of the FHSA), CPSC staff will consider the data on a case-by-case basis and, upon review, determine whether to post the test method on the animal testing Web site.

In the final statement of policy, we refer to in vitro and in silico methods, in general, as alternative test methods that a manufacturer may wish to consider in lieu of animal testing. We also refer generally to methods that have been deemed acceptable by other national or international organizations, but do not refer to them specifically in the regulations on animal testing under 15 CFR 1500.3, 1500.40-42. The CPSC animal testing Web page at http://www.cpsc.gov/library/animaltesting.html is the platform on which the CPSC will list alternative methods.

Comment: One commenter states that the guidance should explicitly state that “when faced with a decision between a non-animal or animal-based approach, the non-animal approach must be taken.”

Response: Although the Commission is issuing this guidance in part to encourage non-animal alternatives to testing, it cannot require manufacturers to adhere to its guidelines. As stated in the CPSC Chronic Hazard Guidelines (57 FR 46626, October, 9, 1992), the Commission does not enforce guidelines as mandatory requirements for manufacturers. A manufacturer may follow a different but scientifically supportable analysis to determine the potential hazard of a substance as reflected in the alternative test methods posted on the CPSC animal testing Web page at http://www.cpsc.gov/library/animaltesting.html.

Comment: One commenter requests that all details on in vivo testing procedures be deleted from § 1500.232, including the LD50/LC50 assays at 1500.232(b)(1)(i), the method of testing dermally toxic substances at 1500.232(b)(1)(ii), and the ocular irritation assay at 1500.232(b)(1)(iii).

Response: The FHSA currently defines acute hazards based on animal test results and identifies irritation and toxicity tests that use animals. Although they are not superior, these in vivo test methods remain the baseline to which alternative methods are compared and therefore should remain in the text. Furthermore, the in vivo testing described in sections of CFR part 1500 does remain an option to manufacturers performing hazard testing of substances. However, the Commission will emphasize that the use of in vitro and other alternative test methods, including a weight-of-evidence approach, and prior human experience are recommended over in vivo tests whenever possible throughout the statement of policy. Furthermore, the Commission reiterates its preference for reliable human experience over animal test data. These changes are reflected throughout the summary and statement of policy.

Comment: One commenter requests the addition of section 1500.232(b)(1)(iv) on alternative test methods for dermal sensitization testing.

Response: The Commission agrees and will add the following section to the statement of animal testing policy:

Comment: One commenter requests that we reorder the paragraphs in § 1500.232(a) to ensure that manufacturers first consider the most human-relevant data and methods in determining appropriate labeling

Response: The Commission has already stated a preference for human over animal data throughout the statement of policy, and will maintain the current order of the paragraphs in the animal testing policy.

For the reasons given above, the Commission amends 16 CFR part 1500 as follows:

The Federal Hazardous Substances Act (FHSA), 15 U.S.C. 1261-1278, requires appropriate cautionary labeling on certain hazardous household products to alert consumers to the potential hazards that a product may present. Among the hazards addressed by the FHSA are products that are toxic, corrosive, irritants, flammable, combustible, or strong sensitizers. The FHSA and the Commission regulations at 16 CFR part 1500 provide certain definitions and test methods related to testing on animals to determine the existence of the hazards addressed by the FHSA.

On June 29, 2012, the Commission issued a notice of proposed rulemaking to amend and to update regulations on the CPSC's animal testing methods under the FHSA. 77 FR 38754. The Commission proposed amendments to the regulations that interpret, supplement, or provide alternatives to definitions of animal test methods used to aid in the classification of hazardous substances under the FHSA.

In addition, on June 29, 2012, the Commission proposed to codify its statement of policy on animal testing to reflect new methods accepted by the scientific community as replacements, reductions, or refinements to animal tests including recommendations and test methods of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM; http://iccvam.niehs.nih.gov/home.htm ) approved by the Commission. 77 FR 38751. The proposed codification at 16 CFR 1500.232 would make the ICCVAM recommendations and the Commission's animal testing policy more accessible and transparent to interested parties. The Commission has also established a Web page on the CPSC's Web site at http://www.cpsc.gov/library/animaltesting.html regarding the ICCVAM recommendations and new developments in test methods that avoid or further reduce or refine animal testing. The final statement on the CPSC's animal testing policy is published elsewhere in this Federal Register .

In the Federal Register of June 29, 2012, we published a proposed rule on revisions to the animal testing regulations (77 FR 38754). We received three comments on the proposed rule. Two of the comments were from individuals and the third comment was submitted jointly by the Alternatives Research and Development Foundation, American Anti-Vivisection Society, Humane Society of the United States, People for the Ethical Treatment of Animals, and the Physicians Committee for Responsible Medicine.

Comment: All three commenters urge the Commission to more strongly consider non-animal testing alternatives. One commenter suggests that the NPR underemphasizes in vitro and in silico alternatives to animal testing throughout relevant sections of 16 CFR part 1500. The commenter gives examples of in vitro tests to support this assertion.

Response: The Commission agrees that in vitro and in silico tests should be mentioned in the regulation as general options in a testing strategy and the rule has been revised accordingly.

Comment: One commenter notes that the Commission's stated preference for human data/experience over animal testing results is not referenced in the relevant sections of 16 CFR part 1500. The commenter also provides a number of examples where in vivo test methods were detailed while the preference for alternatives was mentioned only briefly.

Response: The FHSA direct that reliable human experience data take precedence over differing results from animal tests. 15 U.S.C. 1261(h)(2). Therefore, the Commission would always consider human experience with products and substances first, when it exists, followed by a thorough examination of the existing animal database. The Commission likewise recommends this approach to manufacturers who are labeling substances to indicate a hazard. Accordingly, the proposed rule has been revised to make the preference for human data clearer in the regulatory text.

Comment: One commenter suggests that the regulations uncouple definitions of toxic effects from specific animal test results and that these animal tests are “enumerated with such detail as part of the definition [as to be] problematic.” The commenter urges the Commission to remove nearly all references to the in vivo tests that comprise the existing text of 16 CFR 1500.3(c)(1-4), 1500.40, 1500.41, and 1500.42.

Response: The Commission disagrees that the hazard definitions using animal test methods are problematic. The test methods currently described in the FHSA and relevant sections of 16 CFR part 1500 are intended to show how the Commission would make a hazard determination in the absence of human experiential data, existing animal data, or another acceptable alternative, and are not mandatory or even necessarily recommended test methods for manufacturers. These methods set a baseline standard for hazard testing against which alternative tests can be compared for validity and reliability. They serve as the baseline because they have been used traditionally in hazard testing, not because they are considered superior to other methods. Therefore, while we understand the need to be clear on the discretionary nature of in vivo testing, these methods cannot be removed from the regulations altogether. However, the proposed rule has been revised to emphasize the use of in vitro and other alternative test methods and prior human experience throughout the relevant sections of 16 CFR part 1500.

Comment: One commenter states that CPSC's animal testing guidelines Web site should not be limited to listing ICCVAM test methods, but should include new methods than can replace animal-based tests. In addition, this commenter requests that the Web site contain a process that would allow the public to propose changes to the test methods on the Web site.

Response: We address these comments in further detail in response to the comments on the Final Statement on Animal Testing Policy published elsewhere in this Federal Register . In that policy statement we indicate that alternative test methods beyond those reviewed and recommended by ICCVAM may be acceptable. If a manufacturer or other entity performs a hazard test for FHSA labeling purposes that has not been previously approved by the Commission ( i.e. an ICCVAM-recommended test method or one of the tests described in the current FHSA), the CPSC staff will review such data on a case-by-case basis before it will post any changes on the animal testing policy Web site. Although the Commission welcomes input from the public regarding new test methods, proposed changes to the test methods will be posted on the animal testing guidelines Web page only after review of the data regarding the proposed test method by CPSC staff.

1. Definition of highly toxic. Currently, the test methods in § 1500.3(c)(1)(ii)(A) through (C), used in the definitions of oral, inhalation, and dermal toxicity, respectively, each describe a method for defining a substance as highly toxic.

Because there are other Commission-approved test methods that may be used by CPSC staff or the public for toxicity testing and defining a substance as highly toxic, as reflected in the ICCVAM recommendations and outlined in the CPSC's statement of policy on animal testing published elsewhere in this Federal Register , the proposed rule added language (in underline) under new § 1500.3(c)(1)(iii) as follows: A substance that produces a result of `highly toxic' in any of the approved test methods described in the CPSC's animal testing policy set forth in 16 CFR 1500.232.

In response to comments that request that the rule contain more references to human experience or in vitro or in silico tests as non-animal testing alternatives, the final rule provides additional language (in underline) to § 1500.3(c)(1) as follows:

2 . Definition of toxic. Currently, the test methods in § 1500.3(c)(2)(i)(A) through (C) used in the definitions of oral, inhalation, and dermal toxicity, respectively, each describe a method for defining a substance as toxic.

Because there are other Commission-approved test methods that may be used by CPSC staff or the public for toxicity testing and defining a substance as toxic, as reflected in the ICCVAM recommendations, and outlined in the CPSC's statement of policy on animal testing, the proposed rule added language (in underline) under new § 1500.3(c)(2)(iii) as follows:

In response to comments that request that the rule contain more references to human experience or in vitro or in silico tests as non-animal testing alternatives, the final rule provides additional language (in underline) to § 1500.3(c)(2) as follows:

In addition, in the final rule, the Commission is moving the text from proposed section (iii) to section (i) to more accurately reflect that the text applies to the section on acute toxicity, rather than to create a separate section. Accordingly, the last sentence in § 1500.3(c)(2)(i) has been revised (in underline) as follows:

3. Definition of corrosive. 16 CFR 1500.3(c)(3) currently states that: Corrosive means “a substance that causes visible destruction or irreversible alterations in the tissue at the site of contact. A test for a corrosive substance is whether, by human experience, such tissue destruction occurs at the site of application. A substance would be considered corrosive to the skin if, when tested on the intact skin of the albino rabbit by the technique described in § 1500.41, the structure of the tissue at the site of contact is destroyed or changed irreversibly in 24 hours or less. Other appropriate tests should be applied when contact of the substance with other than skin tissue is being considered.”

The proposed rule added the following text (in underline) to 16 CFR 1500.3(c)(3):

In response to comments that request that the rule contain more references to human experience or in vitro or in silico tests as non-animal testing alternatives, the final rule provides additional language (in underline) to § 1500.3(c)(3) as follows:

4. Definition of irritant, primary irritant, and eye irritant. Currently, 16 CFR 1500.3(c)(4) provides that the test methods for irritant, primary irritant, and eye irritant reference 16 CFR 1500.41 and 1500.42, which each describe a specific animal test method and outcome. For example, 16 CFR 1500.41 states that primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. A minimum of six subjects are used in the skin tests. To test for eye irritants, 16 CFR 1500.42 requires the use of six albino rabbits. Such tests require the test material be placed in one eye of each animal, while the other eye remains untreated, to serve as a control to assess the grade of ocular reaction.

The proposed rule added the following language (in underline) to § 1500.3(c)(4):

In response to comments that request that the rule contain more references to human experience or in vitro or in silico tests as non-animal testing alternatives, the final rule provides additional language (in underline) to § 1500.3(c)(4) as follows:

5. Method of Testing Toxic Substances

The method of testing toxic substances is set forth under 16 CFR 1500.40. This method details an acute dermal toxicity assay using rabbits. The method is referenced in § 1500.3(c)(1)(ii)(C) and (c)(2)(C). The proposed rule added the following text (in underline) to § 1500.40 immediately after the heading titled, “Method of testing toxic substances”:

In response to comments that request that the rule contain more references to human experience or in vitro or in silico tests as non-animal testing alternatives, the final rule modifies the language (in underline) to § 1500.40 as follows:

6. Method of Testing Primary Irritant Substances

The method of testing primary irritant substances is set forth under 16 CFR 1500.41. This method details an acute dermal toxicity assay using rabbits. The method is referenced in § 1500.3(c)(3) and (4). The proposed rule added the following text (in underline) to § 1500.41 immediately after the heading titled, “Method of testing primary irritant substances”:

In response to comments that request that the rule contain more references to human experience or in vitro or in silico tests as non-animal testing alternatives, the final rule modifies the language (in underline) to § 1500.41 as follows:

7. Test for Eye Irritants

Section 1500.42 of 16 CFR provides a detailed animal test for eye irritation. The method is referenced in § 1500.3(c)(4), which defines irritation. The proposed rule added the following text (in underline) to § 1500.42 immediately after the heading titled, “Test for eye irritants”:

In response to comments that request that the rule contain more references to human experience or in vitro or in silico tests as non-animal testing alternatives, the final rule modifies the language (in underline) to § 1500.42 as follows:

8. Editorial changes

The proposed rule eliminates the reference in § 1500.42(c) to the “Illustrated Guide for Grading Eye Irritation by Hazardous Substances,” and the accompanying note. The referenced guide is out of print, and photocopies are rare. Accordingly, the proposed rule amended § 1500.42(c) to reference guidelines from the U.S. Environmental Protection Agency (EPA) and the Organisation for Economic Co-operation and Development (OECD) as follows:

The only change made to this section was to update the Web page link for the CPSC animal testing guidelines.

The Commission certifies that this rule will not a have a significant impact on a substantial number of small entities under section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 605(b). The Commission's Directorate for Economic Analysis prepared an assessment of the impact of amending the regulations on animal testing. That assessment found that there would be little or no effect on small businesses and other entities because the amendments will not result in product modifications in order to comply, and they will not result in additional testing or recordkeeping burdens.

Generally, CPSC rules are considered to “have little or no potential for affecting the human environment,” and environmental assessments and environmental impact statements are not usually prepared for these rules (see 16 CFR 1021.5(c)(1)). The Commission does not expect the rule to have any adverse impact on the environment under this categorical exclusion.

According to Executive Order 12988 (February 5, 1996), agencies must state in clear language the preemptive effect, if any, of new regulations. The preemptive effect of regulations such as this proposed rule is stated in section 18 of the FHSA. 15 U.S.C. 1261n.

This rule would not impose any information collection requirements. Accordingly, this rule is not subject to the Paperwork Reduction Act, 44 U.S.C. 3501-3520.

The Administrative Procedure Act generally requires that a substantive rule be published not less than 30 days before its effective date, unless the agency finds, for good cause shown, that a lesser time period is required. 5 U.S.C. 553(d)(3). The final rule will take effect 30 days after publication in the Federal Register .

Accordingly, 16 CFR part 1500 is amended as follows:

I. Background A. Relevant Statutory and Regulatory Provisions

The Poison Prevention Packaging Act of 1970 (PPPA), 15 U.S.C. 1471-1476, authorizes the Commission to establish standards for the “special packaging” of any household substance if: (1) The degree or nature of the hazard to children in the availability of such substance, by reason of its packaging, is such that special packaging is required to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting such substance, and (2) the special packaging is technically feasible, practicable, and appropriate for such substance.

Special packaging, also referred to as “child-resistant (CR) packaging,” is: (1) Designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time, and (2) not difficult for “normal adults” to use properly. 15 U.S.C. 1471(4). Household substances for which the Commission may require CR packaging include (among other categories) foods, drugs, or cosmetics, as these terms are defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). 15 U.S.C. 1471(2)(B). The Commission has issued performance requirements for special packaging. 16 CFR 1700.15, 1700.20.

Section 4(a) of the PPPA, 15 U.S.C. 1473(a), allows the manufacturer or packer to package a nonprescription product subject to special packaging standards in one size of non-CR packaging, only if the manufacturer (or packer) also supplies the substance in CR packages of a popular size, and the non-CR packages bear conspicuous labeling stating: “This package for households without young children.” 15 U.S.C. 1473(a), 16 CFR 1700.5.

To protect children younger than 5 years old from serious personal injury following ingestion, the rule requires CR packaging for any over-the-counter (OTC) or prescription product containing the equivalent of 0.08 milligrams or more of an imidazoline (including tetrahydrozoline, naphazoline, oxymetazoline, or xylometazoline) in a single package.

Imidazolines are a family of drugs that are used as decongestants in eye drops and nasal products. Imidazolines are used as topical decongestants because they produce vasoconstriction when administered to the eye or nasal mucosa. In the eye, the imidazolines relieve redness due to minor eye irritations by causing vasoconstriction of the blood vessels on the surface of the eye and eyelid (Facts and Comparisons, Ophthalmic Decongestants, Pharmacology, 2011). The onset of vasoconstriction after topical application is within minutes. As nasal decongestants, imidazolines temporarily relieve nasal congestion or stuffy nose due to the common cold, hay fever, or other upper respiratory allergies (Facts and Comparisons, Nasal Decongestants, Pharmacology 2011). The imidazolines cause vasoconstriction in mucous membranes, which decreases blood flow and leads to shrinking of swollen nasal mucosa and increased drainage of the sinuses.

Topical and nasal administration of imidazolines results in little absorption into the general circulation. Orally ingested imidazolines, however, are absorbed into the general circulation leading to systemic effects. Even though death from ingesting imidazolines is rare, ingestion can result in severe life-threatening consequences, such as central nervous system (CNS) depression and cardiovascular effects. Specific symptoms of CNS depression upon ingestion of imidazolines range from drowsiness to coma, with a concurrent depression of the respiratory system. Other reported CNS side effects include: Headache, lightheadedness, dizziness, tremor, insomnia, nervousness, restlessness, giddiness, psychological disturbances, prolonged psychosis, and weakness. Imidazolines have led to CNS depression and insomnia in different children. Prominent cardiovascular effects in response to overdose include low blood pressure and slowed heart rate. The medical literature and evidence from collected samples demonstrate that despite the danger of ingesting imidazolines, imidazoline-containing products are not manufactured in CR packaging.

Eye drops containing imidazolines are widely available at drug, grocery, and mass market retailers. Imidazoline eye drops generally come in small squeeze bottles. The most common size is the 1/2-ounce (15 milliliters) bottle, and the second most common size appears to be a 1-ounce bottle (30 milliliters). One-quarter ounce (8 milliliters) bottles are also available.

Nasal sprays containing imidazolines are widely available at drug, grocery, and mass market retailers. Some packages are used by rapidly squeezing the bottle to spray the product into a nostril. Other packages have a pump mechanism that activates the spray. As with eye drops, 1/2-ounce containers are the most common container size, and 1-ounce bottles are the second most common size.

We are aware of approximately 45 manufacturers who sell topical decongestant products under about 64 different labels. Because some manufacturers produce both nasal and ophthalmic products, the number of manufacturers within the market for topical decongestants is not the sum of the manufacturers of ophthalmic products, plus the manufacturers of nasal products.

We estimate that approximately 45 million units of ophthalmic decongestants containing imidazolines are sold annually, with estimated annual sales receipts of approximately $180 million. We estimate that approximately 39 million units of nasal products containing imidazolines are sold annually, generating annual sales receipts of approximately $233 million.

Commission staff examined 12 packages—10 eye drops, 1 nasal spray, and 1 nasal drops—of over-the-counter products that contain imidazolines. The 10 eye drop samples were packaged in squeeze-to-dispense plastic dropper bottles. The nasal spray was packaged in a plastic bottle with an attached metered pump sprayer, and the nasal drop was packaged in a squeeze-to-dispense plastic dropper bottle. All of the eye drop product bottles were finished with continuous threads, and the bottle openings were fitted with plastic dropper plugs. The nasal spray bottle was finished with continuous threads onto which a metered pump dispenser was attached. The pump mechanism was not child resistant. The nasal drops were packaged in a squeeze-dropper bottle, finished with continuous threads, and the bottle opening was fitted with a dropper plug. None of the samples of eye drops, nasal spray, or nasal drops was packaged using special packaging.

On January 25, 2012, the Commission issued a notice of proposed rulemaking (NPR) that proposed requiring CR packaging for imidazoline preparations containing 0.08 milligrams or more of imidazolines in a single package. 77 FR 3646.

The Commission received five comments in response to the proposed rule. Two comments address the amount of time necessary to develop, test, and produce CR packaging for imidazolines, and they request additional time beyond the 1-year effective date proposed in the NPR. Two comments pertain to imidazoline nasal and ophthalmic packaging, and one comment concerns the derivation of the proposed regulation level of 0.08 milligrams or more of imidazolines in a single package. We respond to each of these comments below.

Comment: Two commenters indicate that the proposed effective date of 1 year is too short. One commenter concludes: “it is not feasible for manufacturers to comply with the proposed one (1) year effective date” and opines that 2 years would be required at a minimum. Regarding nasal products, the commenter contends that this amount of time is required because it will probably be necessary to replace the commonly used single-piece cap with two-component CR protection caps. The commenter also notes that most ophthalmic finishes  1 are 13mm-15mm; that there are no CR closures available smaller than 18mm; and therefore, new CR packages will also be required for ophthalmic products. The commenter provides a timeline identifying the various steps of the CR packaging development, testing, and approval process, and the time range for the expected completion of each stage. The commenter requests that the Commission consider a 1-year stay of enforcement in addition to the 1-year effective date recommended in the NPR to allow manufacturers 2 years after publication of the rule to comply. This commenter also states that additional time beyond the one year effective date and one year stay of enforcement may be required by some manufacturers, especially if the products in question are subject to U.S. Food and Drug Administration (FDA) requirements for new drug applications (NDAs) or abbreviated new drug applications (ANDAs). This additional approval process, the commenter reports, could require an additional 6 to 12 months. This commenter also requests that manufacturers be granted extended stays of enforcement on a case-by-case basis, if required.

A second commenter states that it manufactures sterile eye drops that require “specialized aseptic processing,” notes that the process for developing CR packages suitable for sterile ophthalmic products is complex and “based upon historical experience with the regulated design and qualification activities required for aseptically filled sterile products,” and requests that the effective date of the rule be extended to 24 months.

Response: We agree with the first commenter's analysis of the steps necessary to comply with a CR packaging requirement and the time frames associated with each step. We also agree with the second commenter's statement that producing sterile products will take 24 months, such that a conditional 12-month stay of enforcement is warranted. We address our assessment of the anticipated duration of each step in the process of developing, testing, and producing CR packaging, and we highlight each step identified in the commenter's submission. The first commenter states that design development will take 2 to 4 months, and we believe that this range is typical for modern computer-assisted design processes. We note that there are several nonpatented designs, and one patented design for CR packaging for imidazoline products that, if purchased or licensed by a manufacturer, could reduce the duration of the design development stage to 1 month or less. The commenter states that prototype tooling will take from 4 to 6 months, and we have been advised by independent sources that mold tool production typically takes 4 to 5 months, with an additional month for production testing to ensure that the mold tool can be used at the intended production rate. The commenter estimates that CR protocol testing will take approximately 3 months, and we have been advised by CR protocol test providers that such testing for child-resistant and senior-friendly packaging typically takes 2 to 4 months, depending on the complexity of the CR system. The commenter states that industrial scale-up for packaging and validation will take from 7 to 11 months because of the possibility that existing filling and capping equipment will need to be replaced, or at least significantly modified, depending on the design of the CR closure. Independent sources have advised us that this work should take less than 6 months if a similar sterile process is already in place and between 6 and 12 months if new equipment must be installed. According to the commenter, adoption and validation of the new filling line will take between 3 and 6 months, which is the time range provided by manufacturers of similar products in connection with previous regulatory activity. The commenter states that stability testing will take between 3 and 12 months, a timeframe that is consistent with FDA Stability Test Guidelines of 1 year for regular stability testing and 6 months for accelerated stability testing, which is intended to increase the rate at which the degradation reactions take place. The commenter states that the FDA review process for an NDA or an ANDA can take from 6 months to a year. The FDA advises that 10 months is the median review time for NDAs, while the ANDA review process typically does not take as long; however, permission must be obtained before filing an ANDA, which can take up to 6 months alone.

Based on the foregoing review and analysis of the steps necessary to develop, test, and produce CR packaging for products that contain imidazolines, as well as the time frames for each of those steps, the Commission agrees that more than 1 year may well be necessary. Thus, the Commission will grant a conditional 1-year stay of enforcement to provide additional time to produce CR packaging for these products. This issue is discussed further in Section VI of the preamble.

Comment —One commenter notes that the NPR failed to consider one type of nasal spray package. The package in question “is a glass bottle which houses the imidazoline drug product, with a crimped seal holding the pump in place and with [a] detachable nozzle.” The metered pump is housed in a metal case, the rim of which is crimped to the glass bottle. A plastic nozzle is placed over the pump, and the overcap is attached to the nozzle. Consumers access the product by squeezing the package between the thumb and first two fingers, causing an aerosolized form of the product to be released from the nozzle's tip.

The commenter believes that this package is inherently child resistant because it is a unit-dose package. The commenter requests that CPSC staff provide clarification “as to what could constitute a pass or failure of such a package.”

Response: We disagree with the commenter's fundamental premise that unit-dose packages are inherently child resistant. In fact, we believe that unit-dose packages are not inherently CR. It is likely that a child can easily access the contents because neither the pumping action, nor the overcap or nozzle attachments are CR, and it is reasonably foreseeable that a child could access more than the regulated quantity of the contents. Either the pump action or the overcap must be child resistant.

Comment —One commenter asks: “for nasal sprays that contain Imidazoline equivalent to 0.08 milligrams or more, is Child-Resistant packaging required for crimp-on pumps?” The commenter acknowledges that continuous thread (CT) closures and squeezable packages permit a child to have access to the entire contents, but states that metered-dose pumps crimped onto a rigid bottle would permit a child access to “only one dose at a time.” In addition, the commenter states: “it is not likely to be ingested due to its aerosol form.”

Response —As stated in the response to the previous comment, unit-dose packaging is not inherently CR. Child-resistant packaging is required for the pump action and/or the overcap. We also disagree that an aerosolized form of the product would not be ingested by a child.

Comment— One commenter asks whether the lowest observed adverse effect level (LOAEL) ( i.e., 0.75 mg) should first be normalized to mg/kg and then extrapolated to a 25-pound child before applying a tenfold safety factor, resulting in a no observable adverse effect level (NOAEL) of 0.18 mg.

Response— The proposed regulated level (0.08 mg imidazoline) was based upon an actual imidazoline case with a safety factor applied to the dose ingested. Notably, ingestions expressed as normalized doses show that adverse effects occurred at levels within about the same range of imidazoline (0.1-0.3 mg/kg). Moreover, another case in the medical literature documents an adolescent who developed persistent cardiovascular and neurological effects after ingestion of approximately 0.07 to 0.1 mg/kg of tetrahydrozoline, which is also consistent with the proposed imidazoline level e.g., 0.07 mg/kg (lower end of range) × 11.4 kg child = ~ 0.8 mg ÷ 10 fold-safety factor = 0.08 mg.

The Commission's Directorate for Health Sciences reviewed the toxicity of imidazolines. Imidazolines are used as topical decongestants because they produce vasoconstriction when administered to the eye or nasal mucosa. In the eye, the imidazolines relieve redness due to minor eye irritations by causing vasoconstriction of the blood vessels on the surface of the eye and eyelid (Facts and Comparisons, Ophthalmic Decongestants, Pharmacology, 2011). The onset of vasoconstriction after topical application is within minutes. As nasal decongestants, imidazolines temporarily relieve nasal congestion or stuffy nose due to the common cold, hay fever, or other upper respiratory allergies (Facts and Comparisons, Nasal Decongestants, Pharmacology 2011). The imidazolines cause vasoconstriction in mucous membranes, which decreases blood flow and leads to shrinking of swollen nasal mucosa and increased drainage of the sinuses.

The therapeutically effective dose of imidazolines occurs within a narrow dose range, with toxic effects occurring at doses close to, or at, therapeutic levels. CNS depression (ranging from drowsiness to deep sedation) may occur after recommended doses in infants. Overdoses (doses not specified) of these medications have caused initial spikes of high blood pressure, leading to slowed heart rate, drowsiness, and rebound low blood pressure in adults. A shock-like syndrome with abnormally low blood pressure and slowed heart rate may also occur. Warnings on tetrahydrozoline- and naphazoline-containing OTC drugs state that their use may cause CNS depression, leading to coma in pediatric patients. Xylometazoline and oxymetazoline symptoms of overdose include: extreme tiredness, sweating, dizziness, a slowed heartbeat, and coma.

When the drug is absorbed, it can act systemically within the body. Topical administration of imidazolines to the eye produces local effects to the blood vessels of the eye, but little is absorbed into the general circulation. (For purposes of this document, we interpret “absorption” as the passage of a drug from its site of administration into the blood plasma.)

Nasal administration of imidazolines causes an intense degree of vasoconstriction, and therefore, negligible absorption of the drug into the general circulation (POISINDEX,® 2011). However, with oral ingestion, imidazolines are absorbed into the general circulation, leading to systemic effects. These drugs are absorbed quickly, and symptoms can occur in as little as 1 hour, peaking at 8 hours, and resolving after 12-36 hours. Even though the symptoms resolve in a relatively short amount of time, ingestion of imidazolines can result in severe life-threatening consequences, including decreased breathing, decreased heart rate, and loss of consciousness, which require hospitalization to ensure recovery.

FDA regulations pertaining to “Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use,” at 21 CFR 341.80(c)(2)(iv), require the product label for products containing naphazoline hydrochloride at a concentration of 0.05 percent to state: “Do not use this product in children under 12 years of age because it may cause sedation if swallowed.” Specific symptoms of CNS depression upon ingestion of imidazolines range from drowsiness to coma, with a concurrent depression of the respiratory system. Other observed CNS side effects include: Headache, lightheadedness, dizziness, tremor, insomnia, nervousness, restlessness, giddiness, psychological disturbances, prolonged psychosis, and weakness. Imidazolines have led to CNS depression and insomnia in different individuals. The insomnia, seen in a few cases, may be an unpredictable, idiosyncratic reaction ( i.e., a drug effect that occurs in a small number of people due to age, genetics, or disease state). Prominent cardiovascular effects in response to overdose include rebound low blood pressure and slowed heart rate.

No specific treatment for imidazoline overexposure exists. Naloxone (an opioid blocker) has been used without consistent success. Gastric lavage is not recommended more than 1 hour after ingestion because the imidazolines are absorbed quickly after ingestion, leading to CNS depression and a greater risk of aspiration into the lungs. Activated charcoal may be used up to 1 hour after ingestion; but again, due to the CNS depression, there is a greater risk of aspiration into the lungs. Therefore, treatment of the clinical effects from imidazolines is supportive, based on symptoms. For example, mechanical respiration would be administered to those with severe respiratory depression.

As discussed more extensively in the NPR, staff reviewed several sources for information on adverse health effects from ingestion of imidazolines. These sources are the National Electronic Injury Surveillance System (NEISS), and the FDA's Adverse Event Reporting System (AERS).

The CPSC's Directorate for Health Sciences maintains the Children and Poisoning (CAP) system, a subset of NEISS records containing additional information obtained through NEISS involving children under 5 years old. NEISS is a statistically valid injury surveillance and follow-back database that the Commission maintains of consumer product-related injuries occurring in the United States. Injury data are gathered from the emergency departments (ED) of approximately 100 hospitals selected as a probability sample of all 5,000+ U.S. hospitals with emergency departments. The system's foundation rests on emergency department surveillance data, but the system also has the flexibility to gather additional data at either the surveillance or the investigation level. Surveillance data enable the Commission to make timely national estimates of the number of injuries associated with (but not necessarily caused by) specific consumer products. This data also provides evidence of the need for further study of particular products. Subsequent follow-back studies yield important clues to the cause and likely prevention of injuries and deaths. For additional information on NEISS, see the CPSC's Web site at: http://www.cpsc.gov/cpscpub/pubs/3002.html.

CAP includes data on each pediatric poisoning, chemical burn, or ingestion case reported from a NEISS hospital, as well as data on some ingestions that could lead to poisoning. We searched the CAP database for incidents between January 1997 and December 2011, involving household products that typically contain imidazolines. During that time, there were an estimated 6,650 emergency room-treated injuries associated with household products containing imidazolines involving children under 5 years old. Table 1 below shows the injury estimates for each of the product groups involved in these incidents. Four-fifths of the estimated injuries (82 percent) involved eye drops.

As set forth in tabular form in the NPR, In-Depth Investigations (IDIs) were assigned in connection with certain NEISS-reported imidazoline ingestion incidents. A selection of these IDIs reveals various scenarios in which children between the ages of 13 months and 4 years gained access to imidazoline products including young children who removed caps from eye drop bottles left within their reach; obtained an eye drop bottle from an older sibling; used a chair to access an eye drop bottle in a medicine cabinet; and took a bottle of eye drops out of his mother's purse. See NPR, Table 2, section III.A (77 FR 3649), for a summary of IDIs of selected incidents.

The AERS is a database of voluntary reports from health care professionals and consumers, along with mandatory reports from manufacturers. AERS is maintained by the FDA and contains reports of adverse events and medication errors for all FDA-approved drugs and therapeutic biologic products. We asked the FDA for all AERS reports mentioning the imidazolines tetrahydrozoline, oxymetazoline, xylometazoline, or naphazoline. FDA provided 1,041 reports for 772 distinct cases for us to review involving both children and adults occurring between October 1968 and August 2010. We checked for cases related to imidazolines, excluded the cases with concomitant drugs, and determined that 67 cases (with 115 total reports) were in scope for consideration in this rulemaking.

Reports through the AERS system show a wide variety of adverse events associated with the use of imidazolines across all ages. The top three system/organ classes with reported adverse events were psychiatric disorders (52 reports); nervous system disorders (47 reports); and respiratory, thoracic, and mediastinal disorders (38 reports). Sixty-two out of 67 in-scope cases (93 percent) reported an adverse event in one of the top three system/organ classes. (Reports can include more than one adverse event, so individual reports may be recorded in more than one system/organ class.) Our review of these cases is contained in the January 11, 2012, Staff Briefing Package: http://www.cpsc.gov/LIBRARY/FOIA/FOIA12/brief/imidazolines.pdf.

The volumes of imidazoline ingestions in children (under the age of 5) that were reported from two sources, the FDA's AERS database (MedWatch reports) and the medical literature, ranged from several drops to a high of 30 mL (2 tablespoons). The volume ingested was unknown in several imidazoline cases. As set forth in Table 3 in the NPR, very serious adverse effects occurred in response to small oral doses of imidazolines. For example, a 2-year-old child who ingested between 1 and 1.5 mg of tetrahydrozoline, experienced decreased blood pressure and respiration, and he was placed on mechanical respiration in the pediatric intensive care unit for 18 hours. Also, a 16-month-old child who ingested between 1.25 and 2.5 mg of tetrahydrozoline experienced decreased heart rate, depressed respiration, and was admitted to the hospital overnight.

In MedWatch reports of adverse events occurring in response to ingestion of imidazolines, 43 cases occurred in children under 5 years old. Tetrahydrozoline ingestions constituted the majority of the cases (88 percent). There were no reported deaths related to imidazoline ingestion. See: http://www.cpsc.gov/LIBRARY/FOIA/FOIA12/brief/imidazolines.pdf: January 11, 2012, Staff Briefing Package, for a complete list of cases.

The most recent imidazoline ingestion case cites the lowest dose of ingestion of which we are aware that caused severe adverse symptoms in a child. The case involved a 25-day-old infant who suffered apnea after being treated with tetrahydrozoline nasal drops (0.05 percent). The mother inadvertently administered the nasal drops by the oral route three times per day with 0.5 ml/day (0.25 mg). The immature kidney and liver function of the newborn caused the drugs to clear the newborn's system more slowly than in an adult. CPSC staff reviewing this case report considered the three doses of nasal drops to be additive and calculated the total dose for this case to be 0.75 mg. After the second dose, the child was not feeding well and had low muscle tone. Two hours after the second dose, he developed apnea. After the third dose was administered, the child was brought to the hospital and admitted with a respiratory rate of four breaths per minute and a slowed heart rate. The infant was treated with naloxone, resolving the apnea and bradycardia. After 2 days, the child was in good condition and was discharged. After follow-up 10 days later, the child was in normal condition (Katar et al. 2010).

Our review of the ingestion data is contained in: http://www.cpsc.gov/LIBRARY/FOIA/FOIA12/brief/imidazolines.pdf: January 11, 2012, Staff Briefing Package.

The Commission is issuing a rule requiring special packaging for any over-the-counter or prescription product containing the equivalent of 0.08 milligrams or more of an imidazoline in a single package. The absorption of imidazolines after oral ingestion can lead to unpredictable and profound CNS depression, including depressed respiration and cardiovascular events. Data indicate that children under 5 years old are accidentally ingesting imidazoline-containing products. Even though death from imidazoline exposure is rare, many of these events result in serious life-threatening consequences requiring hospitalization and intensive care monitoring for recovery. See NPR, Section Table 3, section III.C (77 FR 3650), for a summary of relevant cases of imidazoline ingestion.

Mindlin (1966) reported a case in which a 1-year-old girl ingested 1/2 to 1 teaspoon (2.5-5 mL) of tetrahydrozoline eye drops and suffered CNS depression with slowed respiration and decreased heart rate. Based on this ingestion, recent publications define 2.5 mL tetrahydrozoline (0.05 percent, 1.25 mg) as the dose at which serious toxicity from imidazoline exposure can occur after ingestion (Holmes and Berman, 1999; Eddy and Howell 2000). The preamble to the proposed FDA rule for OTC nasal decongestants reported that the minimum oral dose of oxymetazoline in an adult causing measurable cardiovascular effects (on blood pressure and heart rate) was 1.8 mg of oxymetazoline (41 FR 38312, 38398 (September 9, 1976)). This minimum dose may be lower for children because they appear to be more sensitive to imidazoline effects than adults (Brainerd and Olmstead, 1956). Cases indicate that ingestion of as little as 0.75 mg of imidazolines can result in serious illness in children, requiring supportive therapy (Katar et al., 2010; Summary see Table 3). The most recent case of imidazoline ingestion is reviewed in section III of this preamble. It involved a 25-day-old infant who suffered apnea after being treated with tetrahydrozoline nasal drops (0.05 percent). CPSC staff reviewing this case report calculated the total dose for this case to be 0.75 mg, which is the lowest dose the ingestion of which we are aware, caused severe adverse symptoms in a child.

Because serious effects on the heart and breathing rates occur with the ingestion of as little as 0.75 mg of tetrahydrozoline, we consider this the lowest observed adverse effect level (LOAEL). All of the imidazolines cause potent central and peripheral sympathetic effects, but tetrahydrozoline has the highest potency for CNS sedative/depressive effects and the lowest potency for cardiac effects. Oxymetazoline and naphazoline are the most potent imidazolines for peripheral cardiac effects and have an 8-10 times lower maximum daily dose than tetrahydrozoline (0.4 mg, 0.3 mg and 3.2 mg, respectively). Xylometazoline and oxymetazoline have a longer duration of action than tetrahydrozoline (12 hrs., 10 hrs., and 4-6 hrs., respectively).

Applying a safety factor of 10 to the LOAEL to derive a recommended regulated level of 0.08 mg for all imidazolines is appropriate in order to protect children from serious health effects following ingestion of this family of drugs. The level of 0.08 mg would require all known imidazolines currently on the market to be placed in CR packaging. The assumptions underlying the use of safety factors are that by using these factors, both the public health and sensitive populations are protected. Further assumptions hold that humans are somewhere between 10 and 1,000 times more sensitive to some toxic agents than animals, and adults are less sensitive than children. Hence, a safety assessment can be conducted using the proper toxicological evaluation with different populations to establish the NOAEL (no observable adverse effect level) or its equivalent. We used a tenfold safety factor to divide the LOAEL to reach a NOAEL level.

The regulated dose level is expected reasonably to protect children under 5 years of age from serious personal injury or illness. The Commission proposed this level and received one comment on it, which we addressed in Section I of the preamble.

As noted above, the toxicity data concerning children's oral ingestion of imidazolines demonstrate that they can cause serious illness and injury to children. Moreover, imidazolines are available to children in common household products, such as eye drops and nasal sprays. Products containing imidazolines currently do not use CR packaging. The Commission concludes that a regulation is needed to ensure that products subject to the regulation will be placed in CR packaging by any current, as well as new manufacturers.

Pursuant to Section 3(a) of the PPPA, 15 U.S.C. 1472(a), the Commission finds that the degree and nature of the hazard to children from handling, using, or ingesting imidazolines is such that special packaging is required to protect children from serious illness. The Commission bases this finding on the toxic nature of imidazolines and the accessibility of products containing imidazolines in the home.

In issuing a standard for special packaging under the PPPA, the Commission also is required to find the special packaging is “technically feasible, practicable and appropriate.” 15 U.S.C. 1472 (a)(2). For special packaging to be technically feasible, the technology must be available, or can be readily developed and implemented to produce packaging that conforms to established standards. A package is practicable if the special packaging is adaptable to modern mass production and assembly line techniques. Finally, packaging is appropriate if the packaging will adequately protect the integrity of the substance and will not interfere with its intended storage or use. All three of these conditions must be met before we can require special packaging for a product.

The definition of “packaging” is “the immediate package or wrapping in which any household substance is contained for consumption, use, or storage by individuals in or about the household.” The PPPA defines “special packaging” as packaging that is designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of substance within a reasonable time and not difficult for normal adults to use properly. 15 U.S.C. 1471(4). The child-resistance and adult-use-effectiveness of special packaging are measured by performance, testing packaging with children and senior adults, respectively.

We evaluated packaging representative of OTC products that contain imidazolines. The specimens represent products from all four imidazoline families: naphazoline hydrochloride (HCL), oxymetazoline HCL, tetrahydrozoline HCL, xylometazoline, and a naphazoline HCL combination product. None of the samples used special packaging. The eye drops were packaged in squeeze-to-dispense plastic dropper bottles. The nasal spray was packaged in a plastic bottle with an attached metered-pump sprayer, and the nasal drops were packaged in a squeeze-to-dispense plastic dropper bottle. See January 11, 2012, Staff Briefing Package, for a more detailed discussion of the products: http://www.cpsc.gov/library/foia/foia12/brief/imidazolines.pdf.

With changes to package size and/or type, certain types of packaging, such as ASTM Type IA, ASTM Type ID, and a CR metered-pump sprayer design, are available to the market to replace the non-CR continuously threaded (NCRCT) and the non-CR (NCR) metered-spray pump packages. Product packaging assembly line techniques used for the NCR packages can be adapted for some of the CR packages already in the marketplace. Other product manufacturers may use packages that could require changes in assembly- and filling-line techniques. New package sizes also may need to be designed. These new packages would require new tools to be produced. It could take up to 2 years from initiating tool design to final production of a new package, depending upon the complexity of the package. The Commission did not receive any comments asserting that CR packaging for products containing imidazolines was not technically feasible, practicable, or appropriate; although two comments addressed the amount of time required to develop, test, and produce CR packaging for products containing imidazolines. As will be discussed in further detail in Section VI, we have determined that a 12-month effective date, with an additional 12-month conditional stay of enforcement will provide sufficient time for manufacturers to produce CR packaging in compliance with this rule.

Based on the foregoing, the Commission concludes that available data support the findings that CR packaging for household products containing imidazolines is technically feasible, practicable, and appropriate.

In establishing a special packaging standard under the PPPA, the Commission must consider the following:

The PPPA provides that no regulation shall take effect sooner than 180 days or later than 1 year from the date such final regulation is issued, except that, for good cause, the Commission may establish an earlier effective date if it determines an earlier date to be in the public interest. 15 U.S.C. 1471n.

The Commission stated in the preamble to the NPR that because it could take up to 1 year to produce a new package for some companies, any final rule would become effective 1 year after publication of the final rule in the Federal Register .

As discussed in section I.C. of this preamble, the Commission received comments indicating that more than 12 months would be necessary to design, develop, test, and manufacture CR packaging for many of the products containing imidazolines currently on the market. Two commenters indicated that a design could be modified, tested, and in commercial use in approximately 24 months. The Commission agrees that this time seems reasonable because companies will need to develop custom packaging, and the FDA must approve the packaging for acceptable sterilization and stability qualities.

Because there are more than 60 products manufactured by approximately 45 companies that will be affected by this rule, and because the vast majority of these companies will likely require more than 1 year to comply with this rule, the Commission has determined to grant a 12-month conditional stay of enforcement of the rule for products containing the equivalent of 0.08 milligrams of imidazolines in one package, rather than require each manufacturer to request a stay of enforcement for each affected product. The Commission believes that it is important to establish accountability in meeting the CR requirements for products containing imidazolines within 24 months of the publication of this rule.

Therefore, the Commission sets the following conditions for the 1-year stay of enforcement. First, the manufacturer of an imidazoline product containing the equivalent of 0.08 milligrams of imidazolines or more must notify the Commission prior to the effective date of the final rule of its intent to avail itself of the stay, which notice shall include a detailed time line setting forth the steps necessary to produce CR packaging for its product(s) and the range of time anticipated for completion of each step. Manufacturers should be aware that submitting the required notice on or near the effective date of the rule may not allow Commission staff sufficient time to review their notice for completeness prior to the effective date of the rule. Second, each manufacturer providing notice of its intent to avail itself of the stay must submit quarterly reports to the Commission for each affected product, beginning on the effective date of the rule, and on or before the first day of each subsequent quarter during the one year stay period. The quarterly report must provide the following information: (a) Proposed packaging specifications; (b) estimated initial production date; (c) progress made and/or steps completed during the quarterly reporting period; and (d) reports of any incidents or exposures involving the firm's imidazoline-containing products that are subject to the rule. If a manufacturer fails to provide the above-referenced notice in a timely fashion or timely submit any quarterly report, its imidazoline-containing products will be subject to enforcement of the CR packaging requirement set forth in this rule as of the effective date of the rule.

The rule would add a new paragraph 33 to 16 CFR 1700.14(a), which contains a list of substances requiring special packaging. Pursuant to § 1700.14(a), all substances listed in § 1700.14 must meet the requirements for special packaging contained in § 1700.20(a) (on testing procedures for special packaging). Section 1700.14(a)(33) provides that any over-the-counter or prescription product containing the equivalent of 0.08 milligrams or more of an imidazoline (tetrahydrozoline, naphazoline, oxymetazoline, or xylometazoline) in a single package, must be packaged in accordance with the provisions of § 1700.15(a), (b), and (c). Section 1700.15(a) contains general requirements for special packaging, such as the special packaging must continue to function with the effectiveness specifications set forth in § 1700.15(b). Section 1700.15(b), pertaining to effectiveness specifications, provides criteria that special packaging tested pursuant to § 1700.20 must meet. Finally, § 1700.15(c) provides that special packaging subject to this paragraph (c) may not be reused.

Generally, our regulations are considered to have little or no potential for affecting the human environment, and environmental assessments and impact statements are not usually required. See 16 CFR 1021.5(a). More specifically, requiring CR packaging for certain imidazoline-containing products is not expected to have an adverse impact on the environment. Accordingly, the rule falls within the categorical exclusion in 16 CFR 1021.5(b)(2) for product certification rules and an environmental assessment or environmental impact statement is not required.

According to Executive Order 12988 (February 5, 1996), agencies must state in clear language the preemptive effect, if any, of new regulations. Section 7 of the PPPA provides that, generally, when a special packaging standard issued under the PPPA is in effect, “no State or political subdivision thereof shall have any authority either to establish or continue in effect, with respect to such household substance, any standard for special packaging (and any exemption therefrom and requirement related thereto) which is not identical to the [PPPA] standard.” 15 U.S.C. 1476(a). A state or local standard may be excepted from this preemptive effect if: (1) The state or local standard provides a higher degree of protection from the risk of injury or illness than the PPPA standard; and (2) the state or political subdivision applies to the Commission for an exemption from the PPPA's preemption clause and the Commission grants the exemption through a process specified at 16 CFR part 1061. 15 U.S.C. 1476(c)(1). In addition, the federal government, or a state or local government, may establish and continue in effect a nonidentical special packaging requirement that provides a higher degree of protection than the PPPA requirement for a household substance for the federal, state, or local government's own use. 15 U.S.C. 1476(b).

Thus, with the exceptions noted above, the rule regarding CR packaging for household products containing an imidazoline above the regulated level would preempt nonidentical state or local special packaging standards for such imidazoline-containing products.

When an agency undertakes a rulemaking proceeding, the Regulatory Flexibility Act (RFA) generally requires that agencies review proposed rules for their potential economic impact on small entities, including small businesses. Section 603 of the RFA calls for agencies to prepare, and make available for public comment, an initial regulatory flexibility analysis describing the impact of the proposed rule on small entities and identifying impact-reducing alternatives. 5 U.S.C. 603. Section 605(b) of the RFA, however, states that this requirement does not apply if the head of the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities and the agency provides an explanation for that conclusion.

Nasal and ophthalmic products are classified within the NAICS 325412 Pharmaceutical Preparation Manufacturing industry. According to the U.S. Small Business Administration's Office of Advocacy, a firm classified within NAICS 325412 is considered a small business if the firm has fewer than 750 employees. Based on such classification, out of the approximately 45 firms that manufacture imidazoline-based eye drops and nasal sprays, approximately 20 firms are defined as “small businesses.” There may be more manufacturers, in particular, firms that manufacture under generic labels, which were not identified but that may be small businesses.

As noted in the NPR, the Commission's Directorate of Economic Analysis prepared a preliminary assessment of the impact of a rule to require special packaging for products containing imidazolines equivalent to 0.08 milligrams or more in a single package. Based on this assessment, the Commission concluded that the proposed requirement for products containing imidazolines, if finalized, would not have a significant impact on a substantial number of small businesses. The Commission requested additional information on the possible impact on small businesses, but we received no such comments. Moreover, the preliminary analysis demonstrated that the incremental costs of CR packaging for manufacturers are low, estimated at no more than a few cents per unit for imidazoline products, some of which costs manufacturers are likely to be able to pass on to consumers. The Commission concludes that the rule regarding CR packaging for certain imidazoline products would not have a significant economic impact on a substantial number of small entities.

Please see all citing references in staff's briefing package for the proposed rule, available at: http://www.cpsc.gov/library/foia/foia12/brief/imidazolines.pdf and for the final rule, available at http://www.cpsc.gov/LIBRARY/FOIA/FOIA13/brief/imidazfinal.pdf.

For the reasons given above, the Commission amends 16 CFR part 1700 to read as follows:

On June 28, 2012, the Commission adopted amendments to Rule 19b-4 and Form 19b-4 to define and describe when notices of proposed changes to rules, procedures, or operations are required to be filed by designated financial market utilities in accordance with Section 806(e) of Title VIII of the Dodd-Frank Act  1 (“Advance Notices”), to set forth the process for filing such Advance Notices with the Commission, and to specify the process for a clearing agency's submission for review of any security-based swap, or any group, category, type, or class of security-based swaps that the clearing agency plans to accept for clearing (“Security-Based Swap Submissions”). 2 The effective date for the amendments to Rule 19b-4 was August 13, 2012. The effective date for all amendments to Form 19b-4 and 17 CFR 249.819 is December 10, 2012.

Rule 19b-4(n)(1)(i) requires a DCA  3 for which the Commission is the supervisory agency to provide an Advance Notice to the Commission of any proposed change to its rules, procedures, or operations that could materially affect the nature or level of risks presented by such DCA. 4 Except as provided in Rule 19b-4(n)(1)(ii), a DCA for which the Commission is the supervisory agency is required to submit such Advance Notice to the Commission electronically on Form 19b-4. Rule 19b-4(n)(1)(ii) requires a DCA that files an Advance Notice with the Commission prior to December 10, 2012 to file such Advance Notice in an electronic format to a dedicated email address established by the Commission. 5

Rule 19b-4(o)(2)(i) requires that except as provided in Rule 19b-4(o)(2)(ii), a clearing agency shall submit each Security-Based Swap Submission to the Commission electronically on Form 19b-4. 6 Rule 19b-4(o)(2)(ii) requires a clearing agency that files a Security-Based Swap Submission with the Commission prior to December 10, 2012 to file such Security-Based Swap Submission in electronic format to a dedicated email address established by the Commission. 7

The amendments to Form 19b-4 contained in the Adopting Release provide that, among other things, after December 10, 2012, Advance Notices and Security-Based Swap Submissions, and amendments, extensions, and withdrawals thereto, shall be filed in an electronic format through the Electronic Form 19b-4 Filing System (“EFFS”). 8

The Commission stated in the Adopting Release that it was in the process of designing and implementing EFFS system upgrades that are necessary for Advance Notices and Security-Based Swap Submissions to be filed through EFFS. 9 The Commission anticipated in the Adopting Release that the EFFS system upgrades would be completed no later than December 10, 2012. 10 Prior to December 10, 2012, DCAs for which the Commission is the supervisory agency are required to file Advance Notices and clearing agencies are required to file Security-Based Swap Submissions through dedicated email addresses established by the Commission. 11

Though the Commission has made progress on designing and implementing the EFFS system upgrades since the date of the Adopting Release, the Commission has determined that additional time is required to design, test, and implement the EFFS system upgrades. Therefore, the Commission is amending Rule 19b- 4(n)(1)(ii) and Rule 19b-4(o)(2)(ii) to extend the dates with respect to the requirements that a DCA for which the Commission is the supervisory agency file an Advance Notice and a clearing agency file a Security-Based Swap Submission with the Commission in an electronic format to a dedicated email address established by the Commission to December 10, 2013. Extending the date prevents the scenario that DCAs for which the Commission is the supervisory agency are required to file Advance Notices and clearing agencies are required to file Security-Based Swap Submissions with the Commission through a system that is not yet technologically able to accept such filings. The Commission believes that an extension of the date to December 10, 2013, should provide the time necessary to complete implementation of the EFFS system upgrades.

In considering whether to extend the date with respect to the filing of Advance Notices and Security-Based Swap Submissions in an electronic format to a dedicated email address established by the Commission, the Commission's primary objective is to ensure that DCAs for which the Commission is the supervisory agency desiring to submit Advance Notices and clearing agencies desiring to submit Security-Based Swap Submissions to the Commission have a dependable mechanism with which to do so. As noted above, the Commission has maintained dedicated email addresses to receive Advance Notices and Security-Based Swap Submissions since July 19, 2012, and DCAs for which the Commission is the supervisory agency have developed a familiarity with this temporary mechanism to deliver Advance Notices to the Commission. Furthermore, the dedicated email address for submitting Advance Notices has operated according to design at all times during the period for which it has been in effect and the Commission has not received any complaints regarding the dedicated email address from DCAs for which the Commission is the supervisory agency.

In the Adopting Release, the Commission amended the General Instructions for Form 19b-4 to require, among other things, DCAs for which the Commission is the supervisory agency to submit Advance Notices and clearing agencies to submit Security-Based Swap Submissions to the Commission in an electronic format through EFFS. 12 The effective date of the amendments to Form 19b-4, including the amendments to the General Instructions, is December 10, 2012.

In this release, the Commission is amending the General Instructions for Form 19b-4 to continue the requirement that DCAs for which the Commission is the supervisory agency file Advance Notices and amendments, extensions, or withdrawals thereto, and clearing agencies file Security-Based Swap Submissions, and amendments, extensions, or withdrawals thereto, to the Commission through dedicated email addresses until December 10, 2013. Specifically, the Commission is amending section A, “Use of the Form,” and section F, “Signature and Filing of the Completed Form,” of the General Instructions for Form 19b-4 to require DCAs for which the Commission is the supervisory agency to file Advance Notices and amendments, extensions, and withdrawals thereto, with the Commission by using the dedicated email address AdvanceNoticeFilings@sec.gov and to require clearing agencies to file Security-Based Swap Submissions and amendments, extensions, and withdrawals thereto, with the Commission by using the dedicated email address SBSwapsSubmissions@sec.gov . Finally, to facilitate the filing of Form 19b-4 to the dedicated email addresses, the Commission is also amending section A of the General Instructions for Form 19b-4 to state that blank electronic and PDF versions of Form 19b-4 are available on EFFS and www.sec.gov .

To the extent that EFFS is available for such Advance Notices and Security-Based Swap Submissions before December 10, 2013, the Commission will issue a notice to inform DCAs for which the Commission is the supervisory agency that they may begin voluntarily to submit Advance Notices and clearing agencies that they may begin voluntarily to submit Security-Based Swap Submissions through EFFS.

The Commission finds, for good cause, that notice and solicitation of comment regarding the extension of the dates and the conforming change to the General Instructions for Form 19b-4 set forth herein are impractical, unnecessary, and contrary to the public interest. 13 Notice and solicitation of comment is unnecessary because the extension of the dates and amendment to the General Instructions for Form 19b-4 simply preserve the status quo  14 until the EFFS system upgrade is completed by continuing the mechanism by which DCAs for which the Commission is the supervisory agency file Advance Notices with the Commission and clearing agencies file Security-Based Swap Submissions with the Commission. Notice and solicitation of comment is impractical and contrary to the public interest because it would temporarily create the scenario that DCAs for which the Commission is the supervisory agency are required to file Advance Notices and clearing agencies are required to file Security-Based Swap Submissions with the Commission through a system that is not yet technologically able to accept such filings.

The rule amendments contain “collection of information” requirements as defined by the Paperwork Reduction Act of 1995, as amended (“PRA”), 15 but the Commission believes that these rule amendments will not impose any new burdens or costs upon DCAs or clearing agencies.

The rule amendments further modify recent amendments to Rule 19b-4 under the Exchange Act, by amending Rule 19b-4(n)(1)(ii) to extend the date with respect to the requirement that a DCA shall file an Advance Notice with the Commission in electronic format to a dedicated email address established by the Commission to December 10, 2013, and amending Rule 19b-4(o)(2)(ii) to extend the date with respect to the requirement that a clearing agency file Security-Based Swap Submissions with the Commission in an electronic format to a dedicated email address established by the Commission to December 10, 2013.

The Commission therefore does not believe that these amendments would require any new or additional “collection of information” as such term is defined in the PRA and will not impose any new burdens or costs upon DCAs or clearing agencies.

The Commission is sensitive to the economic effects of the amendments to Rule 19b-4, including its costs and benefits. Section 23(a)  16 of the Exchange Act requires the Commission, when making rules and regulations under the Exchange Act, to consider the impact a new rule would have on competition. Section 23(a)(2) of the Exchange Act prohibits the Commission from adopting any rule that would impose a burden on competition not necessary or appropriate in furtherance of the purposes of the Exchange Act. Section 3(f) of the Exchange Act  17 requires the Commission, when engaging in rulemaking that requires it to consider whether an action is necessary or appropriate in the public interest, to consider, in addition to the protection of investors, whether the action would promote efficiency, competition, and capital formation.

The amendments to Rule 19b-4(n)(1)(ii) and Rule 19b-4(o)(2)(ii) will affect DCAs for which the Commission is the Supervisory Agency and clearing agencies registered with the Commission that clear security-based swaps. Four clearing agencies are DCAs for which the Commission is the supervisory agency (DTC, FICC, NSCC, and OCC) and three clearing agencies registered with the Commission currently clear security-based swaps (CME, ICC, and ICE Clear Europe).

The extension of the dates and amendment to the General Instructions for Form 19b-4 simply preserve the status quo that has operated without complaint  18 by continuing the method by which DCAs for which the Commission is the supervisory agency file Advance Notices and clearing agencies file Security-Based Swap Submissions with the Commission. 19 Though the Commission stated in the Adopting Release that Advance Notices and Security-Based Swap Submissions, and amendments, extensions, and withdrawals thereto, should be filed in an electronic format through EFFS starting on December 10, 2012, because the EFFS system upgrades that are necessary for Advance Notices and Security-Based Swap Submissions to be filed on EFFS were not complete when the Commission adopted Rule 19b-4(n) and Rule 19b-4(o), the Commission mandated through Rules 19b-4(n)(1)(ii) and 19b-4(o)(2)(ii) that a DCA for which the Commission is the supervisory agency that files an Advance Notice or a clearing agency that files a Security-Based Swap Submission with the Commission prior to December 10, 2012 shall file such Advance Notice or Security-Based Swap Submission in electronic format to a dedicated email address established by the Commission. 20 Because the Commission has determined that additional time is required to design, test, and implement the EFFS system upgrades, an extension of the December 10, 2012 date for the use of dedicated email addresses to file Advance Notices or Security-Based Swap Submissions is necessary and appropriate to prevent the scenario that DCAs for which the Commission is the supervisory agency are required to file Advance Notices and clearing agencies are required to file Security-Based Swap Submissions with the Commission through a system that is not yet technologically able to accept such filings and to ensure the Commission continues to obtain the information necessary to meet its statutory obligations in connection with Advance Notices and Security-Based Swap Submissions.

Theoretically, the cost of foregoing the ability to file Advance Notices and Security-Based Swap Submissions through the EFFS system could be incurred by DCAs for which the Commission is the supervisory agency and clearing agencies as a result of the amendments to the rules extending the dates with respect to the filing of Advance Notices and Security-Based Swap Submissions to dedicated email addresses established by the Commission. However, this theoretical cost is not a real cost of the rule because use of the EFFS system is not an option. Instead, the amendments to the rules extending the dates for filing Advance Notices and Security-Based Swap Submissions to dedicated email addresses established by the Commission avoids the cost of eliminating the ability of DCAs for which the Commission is the supervisory agency to file Advance Notices and clearing agencies to file Security-Based Swap Submissions to the Commission through the only method that is currently technologically available. Furthermore, extending the dates also enables the Commission to continue to obtain the information that is necessary to meet its statutory obligations with respect to the enhanced oversight of systemically important financial market utilities and the mandatory clearing of security-based swaps.

The Commission believes that the rule amendments will not lead to any material increase in the costs associated with filing Advance Notices and Security-Based Swap Submissions. The Commission stated in the Adopting Release that it believed that the requirements to file Advance Notices and Security-Based Swap Submissions by email, as well as the temporary nature of such requirements, would impose relatively little additional burden on DCAs for which the Commission is the supervisory agency or clearing agencies, both of which can use their existing email systems to make such filings. 21 The Commission further believes that any additional negligible costs are justified because additional time is required to design, test, and implement the EFFS system upgrades that will facilitate the filing of Advance Notices and Security-Based Swap Submissions with the Commission in accordance with Rule 19b-4(n) and Rule 19b-4(o). As stated above, the Commission's primary objective is to ensure that clearing agencies desiring to submit Advance Notices or Security-Based Swap Submissions to the Commission have a dependable mechanism with which to do so.

Because these rules merely extend the date for the process by which DCAs for which the Commission is the supervisory agency file Advance Notices and clearing agencies file Security-Based Swap Submissions, the Commission believes that the rules being adopted today will have a negligible, if any, impact on efficiency, competition, and capital formation. To the extent that the rule amendments impose a new burden upon market participants, such burden will result from the requirement that DCAs for which the Commission is the supervisory agency filing Advance Notices and clearing agencies filing Security-Based Swap Submissions with the Commission submit Form 19b-4 to a dedicated email address as opposed to submitting it through EFFS. Regardless of whether Form 19b-4 is submitted through EFFS or a dedicated email address, DCAs for which the Commission is the supervisory agency and clearing agencies will still be required to adequately and accurately complete such form. Furthermore, the Commission believes that the interest of gaining additional time to effectively develop, test, and implement the EFFS system upgrades necessary for filing Advance Notices and Security-Based Swaps Submissions in a manner that would be consistent with the requirements and goals of Rule 19b-4(n)(1)(i) and Rule 19b-4(o)(2)(i) justifies the risk of possibly imposing a negligible burden on DCAs for which the Commission is the supervisory agency and clearing agencies.

Pursuant to the Exchange Act, and particularly Sections 3C, 17A, and 19(b) thereof, 15 U.S.C. 78c-3, 78q-1, and 78s(b), and Section 806(e) of the Clearing Supervision Act, 12 U.S.C. 5465(e), the Commission is amending Rule 19b-4 and Form 19b-4 as set forth below.

In accordance with the foregoing, Title 17, chapter II of the Code of Federal Regulations is amended as follows:

Background

It is the policy of U.S. Customs and Border Protection (CBP) to periodically review title 19 of the Code of Federal Regulations (19 CFR) to ensure that it is accurate and up-to-date so that the importing and general public are aware of CBP requirements and procedures regarding import-related activities. As part of this review policy, CBP has determined that certain corrections are necessary affecting parts 4, 24, 101, 102, 127, 159, 161 and 177 of the CBP regulations (19 CFR parts 4, 24, 101, 102, 127, 159, 161 and 177).

Section 4.7 of the CBP regulations (19 CFR 4.7) sets forth requirements regarding vessel manifests. Section 4.21 of the CBP regulations (19 CFR 4.21) concerns exemptions from tonnage taxes. Section 4.83 of the CBP regulations (19 CFR 4.83) governs trade between United States ports on the Great Lakes and other ports of the United States. Sections 4.7, 4.21 and 4.83 each contain references to a Great Lakes license endorsement. The statutory provision providing for a Great Lakes endorsement, formerly found in 46 U.S.C. 12107, was repealed by § 1115(a) of the Coast Guard Authorization Act of 1996, Public Law 104-324 (October 19, 1996). Accordingly, this document makes conforming amendments to 19 CFR Part 4 by removing references to the Great Lakes endorsement in § 4.7; by removing paragraphs (b)(11) and (b)(12) of § 4.21, which pertain to vessels with Great Lakes endorsements, and by removing paragraph (b) of § 4.83, which also pertains to vessels with Great Lakes endorsements. In addition, paragraph (a) of § 4.7 contains a typographical error. As such, paragraph (a) in § 4.7 is amended by replacing the word “Statment” with the word “Statement”. Section 4.85 of the CBP regulations (19 CFR 4.85) concerns vessels with residue cargo for domestic ports. Section 4.85 contains a reference to a Great Lakes license endorsement, which was formally repealed, as discussed above. Accordingly, this document makes conforming amendments to paragraph (a) in § 4.85.

Sections 4.80 and 4.80a of the CBP regulations (19 CFR 4.80 and 4.80a) concern coastwise transportation of passengers or merchandise. Each section contains certain outdated statutory references. Public Law 109-304, titled “To complete the codification of title 46, United States Code, “Shipping”, as positive law” enacted on October 6, 2006, recodified, reorganized and amended title 46, United States Code, including its Appendix. The Jones Act, formerly 46 U.S.C. App. 883, is recodified as 46 U.S.C. 55102. The Passenger Vessel Services Act, formerly 46 U.S.C. App. 289, is now recodified as 46 U.S.C. 55103. Former 46 U.S.C. App. 289c is recodified and now found at 46 U.S.C. 55104. Former 46 U.S.C. 12106(d) is recodified and now found at 46 U.S.C. 12117. Accordingly, this document makes the necessary technical amendments to paragraphs (b), (f) and (h) of § 4.80 and paragraphs (b), (c) and (d) of § 4.80a to conform to the above-referenced statutory changes.

Section 24.5 of the CBP regulations (19 CFR 24.5) contains the legacy agency name and an outdated office name and address for CBP's National Finance Center. Accordingly, § 24.5(f) is amended to remove the outdated information and replace it with the current agency name, office name, and address of the National Finance Center.

Section 24.24 of the CBP regulations (19 CFR 24.24) sets forth CBP's financial and accounting procedures. This section makes reference to the “Office of Finance.” On November 23, 2009, CBP reorganized the “Office of Finance” as the “Office of Administration” and changed its name to better communicate, internally and externally, the scope of the office's responsibilities. The Office of Administration oversees all aspects of financial management and accountability for CBP including: accounting and budget; financial systems; procurement and acquisition; facilities and engineering; asset management and investment management, and oversight of all financial operations within CBP. As appropriate, the term “Office of Finance” is removed wherever it appears and is replaced with the term “Office of Administration”. Accordingly, this document makes non-substantive amendments to §§ 24.24(c)(8)(i), 24.24(e)(1)(ii), 24.24(e)(2)(iii), 24.24(e)(3)(ii), 24.24 (e)(4)(iii) and 24.24(e)(4)(iv)(A) to reflect the correct nomenclature and to § 24.24(e)(4)(iv)(B)(5), to reflect the nomenclature change of “Customs” to “CBP.”

Section 24.26 of the CBP regulations (19 CFR 24.26) contains in various paragraphs an outdated office name, that is, the Financial Management Service Center, and an outdated address for CBP's National Finance Center to where certain applications to participate in a program are to be mailed. Accordingly, paragraphs (b), (c), (d) and (g) of § 24.26 are amended to replace the outdated office name and address with the current office name, Revenue Division, and address of the National Finance Center. Section 24.26 is further amended by replacing the word “Customs” with the term “CBP” in paragraphs (a), (c), (d), (e)(1), and (f).

Section 101.9 of the CBP regulations (19 CFR 101.9) sets forth the test programs or procedures for evaluating the effectiveness of new technologies or operational procedures. Section 101.9 contains a typographical error in the citation of section 411(a)(2) of the Tariff Act of 1930. Section 101.9 is amended by correcting the citation to read “(19 U.S.C. 1411(a)(2)),” in paragraph (b). Section 101.9 is further amended by replacing the words “Commissioner of Customs” with the words “Commissioner of CBP”; by replacing the reference to “Customs Regulations” with a reference to “CBP regulations”; and by replacing the word “shall” with the word “will”.

Section 102.20 of the CBP regulations (19 CFR 102.20) sets forth the specific rules of origin by tariff classification. In paragraph (f) of § 102.20, titled “Section VI: Chapters 28 through 38”, the entry for 2933.11—2934.99 contains duplicative tariff numbers that should appear only in the column headed, “HTSUS.” As such, section 102.20(f) is amended by removing the tariff numbers “2933.11—2934.99:” that are set forth before the sentence that begins with the words, “A change to” in the column headed, “tariff shift and/or other requirements”.

Paragraph (q) of § 102.20, titled “Section XVIII: Chapters 90 through 92” contains a typographical error in the entry for subheading 9001.10, HTSUS, that provides for the tariff shift rule which encompasses optical fibers and optical fiber bundles and cables. As such, section 102.20(q) is amended by removing the typographical error of the word “performs” and replacing it with the word “preforms” in the entry for subheading 9001.90, HTSUS.

Section 127.43 of the CBP regulations (19 CFR 127.43) sets forth regulations regarding establishing title to unclaimed and abandoned merchandise which has vested in the government. This section makes a reference to the outdated “Office of Finance.” Accordingly, this document amends § 127.43(e) to reflect the correct nomenclature.

Sections 159.41 and 159.47 of the CBP regulations (19 CFR 159.41 and 159.47) concern the special duties of antidumping and countervailing, respectively. These sections contain an outdated reference to the Department of Commerce's International Trade Administration (ITA) regulations. ITA promulgated a single new part 351 and removed parts 353 and 355 from 19 CFR chapter III by a final rule published in the Federal Register (62 FR 27296, May 19, 1997). Accordingly, §§ 159.41 and 159.47 are amended to conform the CBP regulations with the ITA regulations by removing the outdated reference to part 353 and replacing it with part 351.

Section 159.63 of the CBP regulations (19 CFR 159.63) pertains to CBP receiving a certification from certain domestic producers to make a distribution of an offset under the antidumping and countervailing laws. This section makes references to the outdated “Office of Finance.” Accordingly, this document amends § 159.63(a) to reflect the correct nomenclature.

Section 161.16 of the CBP regulations (19 CFR 161.16) pertains to filing a claim for informant compensation. This section contains an outdated reference to a Customs form that was abolished and replaced by a DHS form and an outdated reference to an investigative position. Accordingly, § 161.16(b) is amended by replacing the reference to “Customs Form 4623” with the reference to “DHS Form 4623”; by replacing the outdated position in the former Customs Service of “Special Agent in Charge” with the current position of “Special Agent in Charge, U.S. Immigration and Customs Enforcement, Homeland Security Investigations”; and by replacing “Customs Headquarters” with the reference to “CBP Headquarters”. Also, the word “shall” is replaced with either “must” or “will”, as appropriate, in paragraphs (a) and (b) of § 161.16 to conform with the plain English mandate.

Section 177.13 of the CBP regulations (19 CFR 177.13) pertains to inconsistent customs decisions. This section contains an incorrect statutory citation. Accordingly, the first sentence in paragraph (a)(2)(i) of § 177.13 is amended by removing the incorrect reference to “(19 U.S.C. 1514(c) (1))” and replacing it with the reference to “(19 U.S.C. 1514(c)(2))”. Also, section 177.13 is amended by making non-substantive editorial and nomenclature amendments. As appropriate, the word “Customs” is replaced with the term “CBP” in the context of either a CBP official(s), CBP offices or CBP Headquarters in the title of the section, paragraph (a), the first sentence of paragraph (b)(2), and paragraph (d) of § 177.13. The words “Customs Service” are replaced with the term “CBP” in paragraphs (b)(2), (d), and (f) of § 177.13. Additionally, the word “shall” is replaced with the word “will” in paragraphs (a)(2), (c), and (f) of § 177.13. Finally, paragraph (b)(1) of § 177.13 is amended, by replacing the word “shall” with the word “must”.

Because the technical corrections set forth in this document merely conform to existing law and regulation, CBP finds that good cause exists for dispensing with notice and public procedure as unnecessary under 5 U.S.C. 553(b)(B). For this same reason, pursuant to 5 U.S.C. 553(d)(3), CBP finds that good cause exists for dispensing with the requirement for a delayed effective date.

Because this document is not subject to the notice and public procedure requirements of 5 U.S.C. 553, it is not subject to the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ).

These amendments do not meet the criteria for a “significant regulatory action” as specified in Executive Order 12866, as supplemented by Executive Order 13563.

This document is limited to technical corrections of the CBP regulations. Accordingly, it is being signed under the authority of 19 CFR 0.1(b)(1).

Title 19, Part 122, Code of Federal Regulations (CFR), sets forth regulations relating to the entry and clearance of aircraft in international commerce and the transportation of persons and cargo by aircraft in international commerce.

Generally, a civil aircraft arriving from a place outside of the United States is required to land at an airport designated as an international airport. Alternatively, the pilot of a civil aircraft may request permission to land at a specific airport, and, if landing rights are granted, the civil aircraft may land at that landing rights airport.

Section 236 of Public Law 98-573 (the Trade and Tariff Act of 1984), codified at 19 U.S.C. 58b, created an option for civil aircraft desiring to land at an airport other than an international airport or a landing rights airport. A civil aircraft arriving from a place outside of the United States may ask for permission to land at an airport designated by the Secretary of Homeland Security as a user fee airport.

Pursuant to 19 U.S.C. 58b, an airport may be designated as a user fee airport if the Commissioner of CBP as delegated by the Secretary of Homeland Security determines that the volume of business at the airport is insufficient to justify customs services at the airport and the governor of the state in which the airport is located approves the designation. Generally, the type of airport that would seek designation as a user fee airport would be one at which a company, such as an air courier service, has a specialized interest in regularly landing.

As the volume of business anticipated at this type of airport is insufficient to justify its designation as an international or landing rights airport, the availability of customs services is not paid for out of appropriations from the general treasury of the United States. Instead, customs services are provided on a fully reimbursable basis to be paid for by the user fee airport on behalf of the recipients of the services.

The fees which are to be charged at user fee airports shall be paid by each person using the customs services at the airport and shall be in the amount equal to the expenses incurred by the Commissioner of CBP in providing customs services which are rendered to such person at such airport, including the salary and expenses of those employed by the Commissioner of CBP to provide the customs services. To implement this provision, generally, the airport seeking the designation as a user fee airport or that airport's authority agrees to pay a flat fee for which the users of the airport are to reimburse the airport/airport authority. The airport/airport authority agrees to set and periodically review the charges to ensure that they are in accord with the airport's expenses.

The Commissioner of CBP designates airports as user fee airports pursuant to 19 U.S.C. 58b. If the Commissioner decides that the conditions for designation as a user fee airport are satisfied, a Memorandum of Agreement (MOA) is executed between the Commissioner of CBP and the local responsible official signing on behalf of the state, city or municipality in which the airport is located. In this manner, user fee airports are designated on a case-by-case basis. The regulation pertaining to user fee airports is 19 CFR 122.15. It addresses the procedures for obtaining permission to land at a user fee airport, the grounds for withdrawal of a user fee designation and includes the list of user fee airports designated by the Commissioner of CBP in accordance with 19 U.S.C. 58b.

Periodically, CBP updates the list of user fee airports at 19 CFR 122.15(b) to reflect those that have been recently designated by the Commissioner. A MOA approving the designation of user fee status for Bozeman Yellowstone International Airport was signed on March 16, 2012. This document updates the list of user fee airports by adding Bozeman Yellowstone International Airport, in Belgrade, Montana to the list.

Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive the normal notice and comment requirements if it finds, for good cause, that they are impracticable, unnecessary, or contrary to the public interest. The final rule lists an airport already designated by the Commissioner of CBP in accordance with 19 U.S.C. 58b as a user fee airport. This amendment is a conforming change to update the list of user fee airports. Notice and comment for this rule is unnecessary and contrary to the public interest, because the rule merely conforms the regulatory text to reflect the Commissioners' designation of this airport as a user fee airport; it is technical in nature; and it relates only to management, organization, procedure, and practice. For the same reasons, pursuant to 5 U.S.C. 553(d)(3), a delayed effective date is not required.

Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply. This amendment does not meet the criteria for a “significant regulatory action” as specified in Executive Order 12866, as supplemented by Executive Order 13563.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

The rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13123, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This document is limited to technical corrections of CBP regulations. Accordingly, it is being signed under the authority of 19 CFR 0.1(b).

For the reasons set forth above, part 122, Code of Federal Regulations (19 CFR part 122) is amended as set forth below:

On July 17, 2012, the Coast Guard published a temporary final rule regulating the on-water activities associated with the “Louis Vuitton Cup,” “Red Bull Youth America's Cup,” and “America's Cup Finals Match” scheduled to occur in July, August, and September, 2013 (77 FR 41902). Among the regulations established by this temporary final rule was a transit zone created to facilitate the safe transit of vessels needing access to pier space and facilities along the City of San Francisco waterfront and to minimize other traffic that may obstruct the waterfront (33 CFR 100.T11-0551B(d)(6), to become effective July 4, 2013-September 23, 2013). An image illustrating the location of the transit zone is available in the docket.

On August 20, 2012, the Coast Guard became aware of errors in the transit zone coordinates after a member of the Coast Guard plotted the transit zone on vessel traffic management software and found four coordinates positioned on land and out of line with the concept of operations developed by the Coast Guard. All four errors can be attributed to data-entry errors, where a 4 was accidently typed as a 2 in the seconds of one coordinate, and a 2 was accidently typed as a 1 in the degrees of three other coordinates. When plotted, the erroneous coordinates do not reflect the transit zone as described in the temporary final rule and shared with the public in diagrams and presentations. The narrative description of the transit zone in the temporary final rule, and the images distributed during outreach, accurately portray the operational intentions of the Coast Guard and the America's Cup regulated areas. To ensure that members of the public have the correct geographical positioning data to locate the regulated areas and navigate around the dangers associated with the sailing events, the Coast Guard is correcting these coordinates to align with the stated intent of the temporary final rule and the images distributed during public outreach. The location and restrictions of 33 CFR 100.T11-0551B remain as they were described on July 17, 2012, and are not changed by this correction.

In Federal Register document 2012-17305 published on July 17, 2012, (77 FR 41902), make the following correction:

VHA recently revised its organizational structure. Under VHA's new organizational structure, the Secretary of Veterans Affairs has delegated management and operations duties for State Veterans Homes to the Director of the Office of Geriatrics and Extended Care Operations through the Under Secretary for Health. The Secretary had formerly delegated this authority to the Chief Consultant of the Office of Geriatrics and Extended Care through the Under Secretary for Health. Consequently, VHA is revising its regulations to reflect the new delegation.

Sections 53.10, 53.11, 53.30, 53.40, and 53.41 of title 38 of the Code of Federal Regulations will be revised to name the Director of the Office of Geriatrics and Extended Care Operations as the person with the management and operations authority for State Veterans Homes. VA's internal mailbox code will also be removed from §§ 53.20 and 53.40.

This final rule pertains strictly to agency organization. Accordingly, this rule is exempt from the prior notice-and-comment and delayed-effective-date requirements of 5 U.S.C. 553.

Title 38 of the Code of Federal Regulations, as revised by this final rule, represents the exclusive legal authority on this subject. No contrary rules or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible, or, if not possible, such guidance is superseded by this rulemaking.

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). This final rule merely updates references to certain VA personnel referred to under 38 CFR part 53 and will not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

Executive Orders 12866 and 13563 direct agencies to assess the 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 effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action” requiring review by the Office of Management and Budget (OMB) as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”

The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined not to be a significant regulatory action as defined by Executive Order 12866.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any given year. This rule will have no such effect on State, local, and tribal governments, or on the private sector.

The Catalog of Federal Domestic Assistance program numbers and titles are: 64.005, Grants to States for Construction of State Home Facilities; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.016, Veterans State Hospital Care; 64.018, Sharing Specialized Medical Resources; 64.022, Veterans Home Based Primary Care; 64.024, VA Homeless Providers Grant and Per Diem Program; and 64.026, Veterans State Adult Day Health Care.

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. John R. Gingrich, Chief of Staff, Department of Veterans Affairs, approved this document on December 4, 2012 for publication.

For the reasons stated in the preamble, VA amends 38 CFR part 53 as follows:

I. Background II. Summary of SIP Revision III. Final Action IV. Statutory and Executive Order Reviews I. Background

On July 16, 1997, EPA promulgated the 1997 PM 2.5 NAAQS, including an annual standard of 15.0 micrograms per cubic meter (µg/m 3 ) based on a 3-year average of annual mean PM 2.5 concentrations, and a 24-hour (or daily) standard of 65 µg/m 3 based on a 3-year average of the 98th percentile of 24-hour concentrations. 62 FR 38652 (July 18, 1997). EPA established the standards based on significant evidence and numerous health studies demonstrating that serious health effects are associated with exposures to PM 2.5 .

Following promulgation of a new or revised NAAQS, EPA is required by the CAA to designate areas throughout the United States as attaining or not attaining the NAAQS; this designation process is described in section 107(d)(1) of the CAA. In 1999, EPA and state air-quality agencies initiated the monitoring process for the 1997 PM 2.5 NAAQS and, by January 2001, established a complete set of air-quality data. On January 5, 2005, EPA published initial air-quality designations for the 1997 PM 2.5 NAAQS (70 FR 944), which became effective on April 5, 2005, based on air-quality monitoring data for calendar years 2001-03.

On April 14, 2005, EPA promulgated a supplemental rule amending the agency's initial designations (70 FR 19844), with the same effective date (April 5, 2005) as that which was promulgated at 70 FR 944. As a result of this supplemental rule, PM 2.5 nonattainment designations are in effect for 39 areas, comprising 208 counties within 20 states (and the District of Columbia) nationwide, with a combined population of approximately 88 million. The Baltimore Area which is the subject of this rulemaking was included in the list of areas not attaining the 1997 PM 2.5 NAAQS.

On June 6, 2008, the State of Maryland submitted a revision to the Maryland SIP (#08-04) to meet nonattainment requirements for the Baltimore Area. On May 22, 2012 (77 FR 30208), EPA determined that Maryland had attained the 1997 PM 2.5 NAAQS in the Baltimore Area. That determination was based upon quality assured, quality controlled and certified ambient air monitoring data that showed the Area had monitored attainment of the 1997 PM 2.5 NAAQS for the 2007-2009 monitoring period and that continued to show attainment of the 1997 PM 2.5 NAAQS based on the 2008-2010 data. The May 22, 2012 determination suspended the requirements for Maryland to submit an attainment demonstration, associated reasonably available control measures, a reasonable further progress plan, contingency measures, and other planning SIP revisions related to attainment of the standard for so long as the nonattainment area continues to meet the 1997 PM 2.5 NAAQS. On June 21, 2012, MDE withdrew portions of the June 6, 2008 Baltimore, Maryland 1997 PM 2.5 SIP revision including the attainment plan, analysis of reasonably available control measures, attainment demonstration, contingency plans and mobile source budgets. To meet the requirements of CAA section 172(c)(3), MDE did not request the withdrawal of the 2002 base year emission inventory portion of the June 6, 2008 1997 PM 2.5 SIP revision. Section 172(c)(3) of the CAA requires submission and approval of a comprehensive, accurate, and current inventory of actual emissions.

The 2002 base year emission inventory submitted by MDE on June 6, 2008 for Baltimore, Maryland includes emissions estimates that cover the general source categories of stationary point sources, stationary nonpoint sources, nonroad mobile sources and onroad mobile sources. The pollutants that comprise the inventory are nitrogen oxides (NO X ), volatile organic compounds (VOCs), PM 2.5 , coarse particles (PM 10 ), ammonia (NH 3 ), and sulfur dioxide (SO 2 ). EPA has reviewed the results, procedures and methodologies for the 2002 base year emissions inventory submitted by MDE for Baltimore, Maryland. The year 2002 was selected by MDE as the base year for the emissions inventory per 40 CFR 51.1008(b). A discussion of the emissions inventory development as well as the emissions inventory can be found in the June 6, 2008 SIP submittal.

The CAA section 172(c)(3) emissions inventory is developed by the incorporation of data from multiple sources. States were required to develop and submit to EPA a triennial emissions inventory according to the Consolidated Emissions Reporting Rule (CERR) for all source categories (i.e., point, area, nonroad mobile and on-road mobile). The 2002 emissions inventory was based on data developed by MDE. The data were developed according to current EPA emissions inventory guidance, “Emissions Inventory Guidance for Implementation of Ozone and Particulate Matter NAAQS and Regional Haze Regulations,” August 2005. EPA agrees that the process used to develop this emissions inventory is adequate to meet the requirements of CAA section 172(c)(3), the implementing regulations, and EPA guidance for emission inventories. More information regarding the review of the base year inventory can be found in the technical support document (TSD) that is located in this docket.

EPA is approving the 2002 base year emissions inventory portion of the SIP revision submitted by Maryland through MDE on June 6, 2008 for Baltimore, Maryland. EPA is publishing this rule without prior proposal because EPA 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 February 8, 2013 without further notice unless EPA receives adverse comment by January 9, 2013. 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.

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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 8, 2013. 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 pertaining to the PM 2.5 2002 base year emissions inventory portion of the Maryland SIP may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

40 CFR part 52 is amended as follows:

Throughout this document, “we,” “us” and “our” refer to EPA.

Table 1 lists the rules on which we are taking action along with the dates on which they were adopted or amended by the applicable local agency and submitted to EPA by the California Air Resources Board (CARB).

The rule submittals were found to meet the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.

There are no previous versions of these rules in the SIP. However, EKAPCD originally adopted EKAPCD Rule 210.4 on September 9, 1984 and amended it on November 18, 1985, and September 2, 1999. We are only taking action on the currently submitted version of each rule as listed in Table 1.

Section 110(a) of the CAA requires states to adopt and submit regulations for the implementation, maintenance and enforcement of the primary and secondary national ambient air quality standards (NAAQS). Specifically, sections 110(a)(2)(C), 110(a)(2)(D)(i)(II), and 110(a)(2)(J) require such state plans to meet the applicable requirements of section 165 relating to a pre-construction permit program for the prevention of significant deterioration of air quality and visibility protection. The purpose of the rule submittals that are addressed in this action is to establish and implement a pre-construction PSD permit program as required by section 165 of the CAA for certain new and modified major stationary sources located in attainment areas. Because the State of California does not currently have a SIP-approved PSD program within EKAPCD, ICAPCD, PCAPCD, and YSAQMD (referred to hereinafter as the “Districts”), EPA is currently the PSD permitting authority for each District. Inclusion of these rules into the SIP transfers PSD permitting authority from EPA to the Districts. EPA will assume the role of overseeing the PSD permitting program within each District.

The relevant statutory provisions for our review of the submitted rules include CAA sections 110(a), 110(l), and 165 and part 51, section 166 of title 40 of the Code of Federal Regulations (40 CFR 51.166). Section 110(a) requires, among other things, that SIP rules be enforceable, while section 110(l) precludes EPA approval of SIP revisions that would interfere with any applicable requirements concerning attainment and reasonable further progress. Section 165 of the CAA requires states to adopt a pre-construction permitting program for certain new and modified major stationary sources located in attainment or unclassifiable areas. 40 CFR 51.166 establishes the specific requirements for SIP-approved PSD permit programs that must be met to satisfy the requirements of section 165 of the CAA.

With some exclusions and revisions, EKAPCD Rule 210.4, ICAPCD Rule 904, PCAPCD Rule 518, and YSAQMD Rule 3.24 incorporate by reference EPA's PSD permit program at 40 CFR 52.21, as of January 12, 2012, December 20, 2011, February 10, 2011, and July 12, 2012, respectively. We generally consider EPA's PSD permit program to be consistent with the criteria in 40 CFR 51.166. However, we conducted a review of each rule to ensure that all requirements of 40 CFR 51.166 were met. Our evaluations are available as an attachment to the technical support document (TSD) for this rulemaking. We also reviewed the revisions the Districts made to the provisions of 40 CFR 52.21 that were incorporated by reference into each rule, such as revising certain terms and definitions to reflect the fact that the Districts, rather than the EPA, will be the PSD permitting authority. Based on our evaluation we have concluded each rule meets the requirements of 40 CFR 51.166 for a PSD program.

Specifically, EKAPCD Rule 210.4 makes significant revisions to the applicability procedures and definitions for major modification, actual emissions, baseline actual emission, and net emissions increase as incorporated by reference in 40 CFR 52.21(a)(2) and (b). EKAPCD Rule 210.4 also excludes the Actuals Plantwide Applicability Limits (PALs) provisions contained in 40 CFR 52.21(aa). These revisions are intended to implement a PSD program that does not contain the 2002 NSR Reform provisions (see generally 67 FR 80,185 (Dec. 31, 2002)). Based on our evaluation of Rule 210.4 and the EKAPCD's Staff Report, we have concluded that Rule 210.4 is at least as stringent, in all respects, as the requirements of 40 CFR 51.166 for a PSD program. A more detailed discussion of those revisions and our analysis are in the TSD for this rulemaking.

We note that three of the District rules under consideration in this action also rely on existing SIP-approved permit application processing requirements, which are found in EKAPCD Rule 210.1, ICAPCD Rule 206, and PCAPCD Rule 502, for meeting some of the PSD program requirements.

We also reviewed clarifying information provided by the Districts in letters dated July 19, 2012 (EKAPCD), July 10, 2012 (ICAPCD), July 6, 2012 (PCAPCD), and August 7, 2012 (YSAQMD). Based on our review of the Districts' rules as well as these clarification letters, we have determined that the Districts' PSD SIP rules are acceptable under CAA sections 110(a), 110(l) and 165 and 40 CFR 51.166. EPA's TSD for this rulemaking has more information about these rules, including our evaluation and recommendation to approve them into the SIP.

Eastern Kern Rule 210.4, Imperial Rule 904, and Placer Rule 518 incorporate by reference the PM 2.5 significant impact levels (SILs) found in 40 CFR 52.21(k)(2). Yolo-Solano Rule 3.24 does not incorporate these PM 2.5 SILs, by reference or otherwise. Consistent with 40 CFR 51.166(k)(2), these PM 2.5 SILs are an optional portion of the PSD permitting program. However, EPA's authority to implement the PM 2.5 SILs for PSD purposes is currently subject to litigation, Sierra Club v. EPA, Case No. 10-1413 (D.C. Circuit). As a result, EPA has come to recognize that the regulatory text it adopted in 40 CFR 51.166(k)(2) and 40 CFR 52.21(k)(2) does not accurately reflect EPA's intent, because the text does not afford permitting authorities sufficient discretion to deny sources use of the SILs where their use would lead to a new violation of the NAAQS or increment. In our response brief to the Court in this litigation, EPA requested that the Court remand and vacate 40 CFR 51.166(k)(2) and 40 CFR 52.21(k)(2) so that we may initiate a rulemaking to make revisions to the regulatory text.

Paragraph (k)(1) of 40 CFR section 52.21 requires that sources applying for a new PSD permit demonstrate that any allowable emission increases from the proposed source or modification, in conjunction with all other applicable emissions increases or reductions, will not cause or contribute to a violation of any NAAQS or any applicable increment. In the preamble to the 2010 final rule adding the (k)(2) provision to section 52.21, EPA advised that, “notwithstanding the existence of a SIL, permitting authorities should determine when it may be appropriate to conclude that even a de minimis impact will `cause or contribute' to an air quality problem and to seek remedial action from the proposed new source or modification.” Prevention of Significant Deterioration (PSD) for Particulate Matter Less than 2.5 Micrometers (PM 2.5 )—Increments, Significant Impact Levels (SILs) and Significant Monitoring Concentration (SMC), 75 FR 64,864, 64,892 (Oct. 20, 2010). In another passage of the preamble to the 2010 final rule, EPA also observed that “the use of a SIL may not be appropriate when a substantial portion of any NAAQS or increment is known to be consumed.” Id. at 64,894.

We requested clarification from EKAPCD, PCAPCD, and ICAPCD concerning their interpretation of their respective rules that incorporate by reference 40 CFR 52.21(k)(2). Consistent with the statements by EPA in the preamble to the 2010 final rule, EKAPCD, PCAPCD, and ICAPCD confirmed that they do not interpret section 52.21(k)(2) to preclude them from exercising the discretion to determine when it may be appropriate to conclude that even a de minimis impact on air quality (an impact below the PM 2.5 SIL values) will cause or contribute to an air quality problem and to seek remedial action from the proposed new source or modification. See clarification letters from EKAPCD dated August 21, 2012, from ICAPCD dated August 21, 2012, and from PCAPCD dated August 20, 2012. Based on this interpretation, each of these Districts has clarified that it will not read section 52.21(k)(2) as an absolute “safe harbor,” but will exercise discretion to determine whether a particular application of the PM 2.5 SILs is appropriate when a substantial portion of the PM 2.5 NAAQS or increment is known to be consumed. These Districts have also clarified that they retain the discretion to require additional information from a permit applicant as needed to assure that the source will not cause or contribute to a violation of any NAAQS or applicable increment pursuant to section 52.21(k)(1).

Based on these clarifications provided by EKAPCD, PCAPCD, and ICAPCD, we find that these Districts' PSD rules are approvable and consistent with the Act and the requirements for a PSD program.

The Districts have also requested approval to exercise their authority, as applicable, to administer the PSD program with respect to those sources located in the Districts that have existing PSD permits issued by EPA. This would include authority to conduct general administration of these existing permits, authority to process and issue any and all subsequent PSD permit actions relating to such permits (e.g., modifications, amendments, or revisions of any nature), and authority to enforce such permits. Pursuant to the criteria under section 110(a)(2)(E)(i) of the CAA, we have determined that these districts have the authority, personnel, and funding to implement the PSD program within each District for existing EPA-issued permits. Upon the effective date of our approval of the Districts' PSD programs into the SIP, the EPA-issued PSD permits will be transferred to each District, as applicable. A list of these EPA-issued permits is provided as an attachment to the TSD for this action. In addition, any PSD permit applications submitted to EPA for which EPA has not yet proposed a permit decision upon the effective date of this action will also be transferred to the applicable District upon the effective date of this rule.

EPA is finalizing a SIP revision for the Eastern Kern, Imperial County, Placer County, and Yolo-Solano portions of the California SIP. This SIP revision will be codified in 40 CFR 52.220 by incorporating by reference the District PSD rules listed in Table 1. In addition, the letters from the Districts to EPA described elsewhere in this preamble that provide certain clarifications concerning the Districts' rules will be included as additional material in 40 CFR 52.220. The regulatory text addressing this action also makes it clear that EPA is relying, in part, on the clarifications provided in the Districts' clarification letters in taking this final approval action. As such, the Districts' implementation of the PSD program in a manner consistent with these clarifications is a pre-condition of today's final approval of this PSD SIP revision. This SIP revision provides a federally approved and enforceable mechanism for the District to issue pre-construction PSD permits for certain new and modified major stationary sources subject to PSD review within the Districts. The regulatory text at 40 CFR 52.270 will also be revised so that these Districts are no longer a part of California's Federal Implementation Plan for the PSD program.

EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial action and anticipates no adverse comments. As discussed above, this approval action will transfer PSD permitting program responsibility and authority from EPA to the Districts, which will generally continue to implement the PSD program consistent with 40 CFR section 52.21 as incorporated by reference into the Districts' rules. However, in the “Proposed Rules” section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve this SIP revision should relevant adverse comments be filed on this direct final rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document.

This rule will be effective February 8, 2013 without further notice unless the Agency receives relevant adverse comments by January 9, 2013. If EPA receives such comments, then EPA will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. All public comments received would then be addressed in any subsequent final rule based on the proposed rule. Please note that if EPA receives adverse comment on a distinct provision 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. In such case, EPA would publish a timely withdrawal in the Federal Register indicating which provisions we are withdrawing. The provisions that are not withdrawn will become effective on the date set out above, notwithstanding adverse comment on any other provision.

EPA is approving the following CARB submittals into the California SIP to establish a PSD permit program for pre-construction review of certain new and modified major stationary sources in attainment or unclassifiable areas: CARB's 4/25/2012 submittal of EKAPCD Rule 210.4—Prevention of Significant Deterioration; CARB's 2/23/2012 submittal of ICAPCD Rule 904—Prevention of Significant Deterioration (PSD) Permit Program; CARB's 6/21/2011 submittal of PCAPCD Rule 518—Prevention of Significant Deterioration (PSD) Permit Program; and CARB's 7/3/2012 submittal of YSAQMD Rule 3.24—Prevention of Significant Deterioration.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k). 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 proposed 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 of California 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 8, 2013. 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. This action may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2).)

Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

Throughout this document, “we,” “us” and “our” refer to EPA.

On August 29, 2012 (77 FR 52277), EPA proposed to approve the rule listed in Table 1 that was submitted for incorporation into the California SIP.

We proposed to approve this rule because we determined that it complied with the applicable CAA requirements. Our proposed rule and related Technical Support Document (TSD) contain more information on the basis for this rulemaking and our evaluation of the submittal.

EPA's proposed approval action for this SIP revision submittal provided a 30-day public comment period. During this period, we received no comments.

EPA is finalizing a SIP revision for the SCAQMD portion of the California SIP. This SIP revision will be codified in 40 CFR 52.220 by incorporating by reference District Rule 1714 listed in Table 1 above. In addition, the letter from the District to EPA dated August 15, 2012 that provides certain clarifications concerning the District's rule, discussed in EPA's proposed rule for this action, will be included as additional material in 40 CFR 52.220. The regulatory text addressing this action also makes it clear that EPA is relying, in part, on the clarifications provided in the District's clarification letter in taking this final approval action. As such, the District's implementation of the PSD program in a manner consistent with these clarifications is a pre-condition of today's final approval of this PSD SIP revision. District Rule 1714 applies only to sources that trigger the PSD program for GHGs. This SIP revision provides a federally approved and enforceable mechanism for the District to issue pre-construction PSD permits for new and modified major stationary sources of GHGs within the District. The regulatory text at 40 CFR 52.270 is also being revised so that the SCAQMD is no longer subject to the FIP for the PSD program as it pertains to GHGs.

For pollutants other than GHGs that trigger the PSD program, the District will continue to administer the PSD program under the criteria and procedures in 40 CFR 52.21, 40 CFR Part 124 (including the opportunity to petition for review by EPA's Environmental Appeals Board), and the applicable PSD delegation agreement.

Under CAA sections 110(a), 110(l), and 165 and for the reasons set forth in our August 29, 2012 proposed rule, EPA is approving CARB's December 30, 2010 submittal of District Rule 1714—Prevention of Significant Deterioration for Greenhouse Gases—into the California SIP to establish a PSD permit program for pre-construction review of certain new and modified major stationary sources of greenhouse gases.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k). 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 final 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 8, 2013. 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. This action may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2).)

Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

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

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

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

Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988.

Accordingly, 44 CFR part 67 is amended as follows:

Table of Contents for Preamble I. Abbreviations II. Regulatory History III. Basis and Purpose IV. Background V. Discussion of Comments and Changes VI. Regulatory Analyses A. Regulatory Planning and Review B. Small Entities C. Assistance for Small Entities D. Collection of Information E. Federalism F. Unfunded Mandates Reform Act G. Taking of Private Property H. Civil Justice Reform I. Protection of Children J. Indian Tribal Governments K. Energy Effects L. Technical Standards M. Environment I. Abbreviations ABS American Bureau of Shipping APPS Act to Prevent Pollution from Ships CFR Code of Federal Regulations DHS Department of Homeland Security EPA Environmental Protection Agency FR  Federal Register IEE International Energy Efficiency IMO International Maritime Organization MARPOL Protocol International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 MEPC Maritime Environment Protection Committee NMFS National Marine Fisheries Service NPRM Notice of Proposed Rulemaking OMB Office of Management and Budget §  Section U.S.C. United States Code II. Regulatory History

On October 2, 2012, we published a notice of proposed rulemaking (NPRM) entitled “Adding International Energy Efficiency (IEE) Certificate to List of Certificates a Recognized Classification Society May Issue” in the Federal Register (77 FR 60096). We received one written submission on the proposed rule. No public meeting was requested and none was held.

The Coast Guard is amending its Vessel Inspection Alternatives regulations to add the International Energy Efficiency (IEE) Certificate to the list of certificates that a recognized classification society may issue on behalf of the Coast Guard. We are making this change because Annex VI of the International Convention for the Prevention of Pollution by Ships, 1973 (MARPOL), as modified by the Protocol of 1978 (MARPOL Protocol), has been amended to address energy efficiency for ships, and these amendments call for the issuance of IEE Certificates starting January 1, 2013. This rule will enable recognized classification societies to apply to the Coast Guard to issue IEE Certificates to vessel owners and help to ensure that the demand for IEE Certificates is met.

The Act to Prevent Pollution from Ships (APPS), 33 U.S.C. 1901 et seq., implements legislation for the International Convention for the Prevention of Pollution from Ships, 1973 as modified by the Protocol of 1978 (MARPOL Protocol), which includes MARPOL Annex VI: Regulations for the Prevention of Air Pollution from Ships. See 33 U.S.C. 1901(a)(4) and (5). APPS directs the Secretary of Homeland Security to prescribe any necessary or desired regulations to carry out the provisions of the MARPOL Protocol, and it directs the Secretary to designate those persons authorized to issue MARPOL Protocol certificates on behalf of the United States. See 33 U.S.C. 1903(c) and 1904. This authority was delegated to the Coast Guard. See Department of Homeland Security Delegation No. 0170.1. As required by APPS, the Coast Guard has consulted with the U.S. Environmental Protection Agency (EPA) regarding this final rule.

On July 15, 2011, in resolution MEPC.203(62), the International Maritime Organization's (IMO's) Marine Environment Protection Committee (MEPC) adopted amendments to MARPOL Annex VI. Those amendments, which were accepted July 1, 2012, and come into force January 1, 2013, contain energy efficiency provisions for new and existing ships. These amended regulations call for the issuance of an International Energy Efficiency (IEE) Certificate to document a ship's compliance with Annex VI's new Chapter 4, Regulations on Energy Efficiency for Ships. See amended Annex VI Regulations 5.4 and 6.4. Since the mid-1990s, under authority of 46 U.S.C. 3103, 3306, 3316, and 3703, and regulations in 46 CFR part 8—Vessel Inspection Alternatives, the Coast Guard has authorized recognized classification societies to issue international certificates to vessels. The Coast Guard regularly adds to the list of international certificates that classification societies may apply to issue to vessels on the Coast Guard's behalf. This list is located in 46 CFR 8.320(b). Recent additions to the list include the MARPOL 73/78 International Air Pollution Prevention Certificate and the International Anti-Fouling System Certificate. See, respectively, 74 FR 21554, May 8, 2009; and 76 FR 76896, December 9, 2011. The United States currently recognizes seven classification societies for purposes of issuing international certificates: The American Bureau of Shipping (ABS, United States); Det Norske Veritas (DNV, Norway); Lloyd's Register (LR, Great Britain); Germanischer Lloyd (GL, Germany); Bureau Veritas (BV, France); RINA S.p.A. (RINA, Italy), and ClassNK (NKK, Japan).

Recognized classification societies assist the Coast Guard and help to ensure that U.S.-flagged ships that qualify for an international certificate are able to obtain it promptly. As we stated in 1996, to avoid a duplication of effort between the Coast Guard and classification societies that results in extra costs to U.S. vessel owners, it is more efficient to take full advantage of inspections done by classification societies:

Starting January 2013, U.S.-flagged ships that are 400 gross tonnage or more as measured under 46 U.S.C. 14302, Convention Measurement System, (hereafter 400 GT ITC or more) may be subject to detention or delay in foreign ports if they do not have an IEE certificate to document compliance with Annex VI. See amended Annex VI Regulation 19.

Section 8.320 of 46 CFR allows the Coast Guard to delegate issuance of an international convention certificate to a recognized classification society only if the certificate is listed in § 8.320(b). The IEE Certificate is not currently listed in § 8.320(b).

As noted, we published an NPRM on October 2, 2012 (77 FR 60096). We received one written submission containing three comments. See docket USCG-2012-0861.

First, the commenter recommended that the Coast Guard consult with the National Marine Fisheries Service (NMFS) within the Department of Commerce regarding this rulemaking, as we did with the EPA. She wrote that NMFS's expertise is valuable in determining whether adding the IEE Certificate is worth the additional administrative costs it will cause. In response to the first comment, the Coast Guard did contact NMFS and advised them of our rulemaking and this comment. The NMFS had no comments.

Second, regarding the comment on the administrative cost of adding the International Energy Efficiency (IEE) Certificate, we note that APPS requires compliance with Annex VI, which now includes a new chapter, Chapter 4, with energy efficiency requirements for ships, and the IEE Certificate documents compliance with these Chapter 4 requirements. See 33 U.S.C. 1907(a). Annex VI Regulation 6.5 directs that the IEE “certificate shall be issued or endorsed either by the [United States] or any organization duly authorized by it.” APPS directs the Secretary of Homeland Security to designate those persons authorized to issue MARPOL Protocol certificates on behalf of the United States and this final rule does that. See 33 U.S.C. 1904(a).

Third, the commenter recommended that the United States consider creating its own energy efficiency certificate that has greater standards than the IEE Certificate, and that such a certificate could meet the standards of the IEE Certificate, and more. The commenter stated: “This way other areas could require the IEE Certificate as a minimum baseline, while [a U.S.] energy efficiency certificate would not only meet the minimum baseline but also go beyond it.” This third comment is beyond the scope of this rulemaking. This rulemaking is solely intended to identify who may issue a MARPOL Annex VI IEE certificate on behalf of the Coast Guard. We made no changes from the proposed rule based on any of these comments.

In the NPRM, we proposed to insert a statement regarding preemption in § 8.300, of part 8, subpart C, International Convention Certificate Issuance, and to rename that section heading “Purpose and Preemption.” See 77 FR 60098, 60100, October 2, 2012. After another review of Presidential Memorandum of May 20, 2009 titled “Preemption” (74 FR 24693, May 22, 2009) however, we have determined that we should not include our proposed changes to § 8.300 in this final rule. As discussed in our preamble Federalism section, VI.E, below, States may not regulate in an area that is preempted by Federal statute. APPS is the source of preemption regarding the issuance of MARPOL certificates, not this regulatory action. Therefore, our only change to the CFR in this final rule is to add the IEE certificate to § 8.320.

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

Executive Orders 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, 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. This final rule has not been designated a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, this final rule has not been reviewed by the Office of Management and Budget. A final regulatory assessment follows:

Under the authority of 33 U.S.C. 1903, 1904, and 46 U.S.C. 3103, 3306, 3316, and 3703, the Coast Guard is amending 46 CFR 8.320, to enable the Coast Guard to delegate the activity of issuing IEE Certificates to a recognized classification society that would act on behalf of the Coast Guard. The intent of this rule is to allow for the delegation of IEE Certification to recognized class societies and thus create options for industry in obtaining these certificates. This rule does not impose mandatory actions on the U.S. maritime industry.

Although requesting the delegation of authority to conduct IEE surveys, inspections, and certifications is voluntary, classification societies may incur minor costs associated with this process. The Coast Guard may incur costs associated with the evaluation of these requests and the issuance of delegations of authority to recognized classification societies.

The Coast Guard estimates that this rule would potentially affect seven classification societies that may request a delegation of authority to issue IEE Certificates. The Coast Guard used an Office of Management and Budget (OMB)-approved collection of information (1625-0041) to estimate the costs and burden.

The Coast Guard estimates that it will take classification society employees 5.25 hours to review the rulemaking requirements and prepare the delegation request, at an average one-time cost of $428.75 per classification society (3.5 hours at $112 per hour  1 for a director and 1.75 hours at $21 per hour for an administrative assistant). The total one-time cost for all seven classification societies is estimated to be $3,000 (rounded).

In addition, the Coast Guard estimates that it will incur a one-time cost to review and approve the requests for delegation. Based on the OMB-approved collections of information discussed above, the Coast Guard estimates that it will take about 5 hours to review, approve, and issue an order to delegate authority, at an average cost of $360 per event (3.5 hours for reviewing/approving and 1.5 hours for issuing at $72 per hour for a lieutenant (O-3)). The Coast Guard estimates a total one-time Government cost of $2,500 (rounded) based on OMB-approved collection of information estimates.

The Coast Guard estimates the total one-time cost of this rule for classification societies and the Government combined to be approximately $5,500 (non-discounted) for classification societies and the Government combined.

This rule may result in several benefits to the U.S. maritime industry. First, it may result in a reduction of potential wait time for IEE certificates. In the absence of delegation of authority to classification societies, vessel owners and operators may experience delays while the Coast Guard processes and issues IEE Certificates. The Coast Guard also might have to redirect resources that could be used for other missions, resulting in a less efficient use of Government resources. Finally, this rule may mitigate potential consequences to U.S.-flagged vessels due to non-compliance with the Convention, including costly vessel detentions in foreign ports.

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.

Affected classification societies are classified under one of the following North American Industry Classification System codes for water transportation: 488330—Navigational Services to Shipping, 488390—Other Support Activities for Water Transportation, or 541611—Administrative Management and General Management Consulting Services.

The only predominate U.S. classification society is the American Bureau of Shipping (ABS). ABS is a privately owned non-profit organization that is dominant in its field (Source: 2011 Hoovers, http://www.hoovers.com/company/American Bureau of Shipping Inc/rfsksji-1.html). Based on publicly available information, ABS has more than 3,000 employees and annual revenues of more than $800 million. 2 We do not consider ABS to be a small entity using the Small Business Act definitions of a small entity.

The Coast Guard expects that this rule will not have a significant economic impact on a substantial number of small entities. As described in section VI.A. of this preamble, “Regulatory Planning and Review,” the anticipated cost of this proposed rule, per class society, would be less than $500. This rule is not mandatory, and classification societies, regardless of size, would choose to participate only if the benefits are greater than the costs.

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

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. If this rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult Mr. Wayne Lundy, Systems Engineering Division, Coast Guard, telephone 202-372-1379 or email Wayne.M.Lundy@uscg.mil . 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) because the Coast Guard expects that the number of applications would be fewer than 10 in any given year.

A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

As noted above, APPS implements the MARPOL Protocol. APPS also directs the Secretary to “designate those persons authorized to issue on behalf of the United States the certificates required by the MARPOL Protocol.” See 33 U.S.C. 1904. By enacting this specific provision, it was the intent of Congress to give the Coast Guard, as delegated by the Secretary, the exclusive authority to regulate within this field.

A State may not regulate in an area such as this one which is field preempted by Federal statute. Because the exclusive authority to issue certificates under APPS was given to the DHS Secretary by law, and further delegated to the Coast Guard, this rule does not substantially affect the States, the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Therefore, we have determined that this rule does not have implications for federalism because the States are preempted from issuing certificates evincing compliance with APPS.

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 would 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 a risk to safety that might 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 Tribal governments, on the relationship between the Federal Government and Tribal governments, or on the distribution of power and responsibilities between the Federal Government and Tribal governments.

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, supplemented by Executive Order 13563, 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 OMB, 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 (42 U.S.C. 4321-4370f), and have concluded that 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 section 2.B.2, figure 2-1, paragraphs (34)(b) and (d), of the Instruction, and under section 6(b) of the “Appendix to National Environmental Policy Act: Coast Guard Procedures for Categorical Exclusions, Notice of Final Agency Policy” (67 FR 48243, July 23, 2002). This rule involves the delegation of authority, the inspection and documentation of vessels, and congressionally-mandated regulations designed to improve or protect the environment. 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 46 CFR part 8 as follows:

The snapper-grouper fishery of the South Atlantic is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). Blue runner in the South Atlantic are managed under this FMP. The FMP was prepared by the South Atlantic Fishery Management Council and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act by regulations at 50 CFR part 622.

The commercial ACL for blue runner in the South Atlantic is 188,329 lb (85,425 kg), round weight, as specified in 50 CFR 622.49(b)(19)(i)(A).

In accordance with regulations at 50 CFR 622.49(b)(19)(i)(A), NMFS is required to close the commercial sector for blue runner when the commercial ACL for blue runner has been reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined that the commercial ACL for South Atlantic blue runner has been met. Accordingly, the commercial sector for South Atlantic blue runner is closed effective 12:01 a.m., local time, December 10, 2012, until 12:01 a.m., local time, January 1, 2013.

The operator of a vessel with a valid commercial vessel permit for South Atlantic snapper-grouper having blue runner onboard must have landed and bartered, traded, or sold such blue runner prior to 12:01 a.m., local time, December 10, 2012. During this commercial closure, the sale or purchase of blue runner taken from the EEZ is prohibited. The prohibition on sale or purchase does not apply to the sale or purchase of blue runner that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, December 10, 2012, and were held in cold storage by a dealer or processor. For a person on board a vessel for which a Federal commercial permit for the South Atlantic snapper-grouper fishery has been issued, the sale and purchase provisions of the commercial closure for blue runner would apply regardless of where the fish are harvested, i.e., in state or Federal waters, as specified in 50 CFR 622.49(b)(19)(i)(A).

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of South Atlantic blue runner and is consistent with the Magnuson-Stevens Act and other applicable laws.

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

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds that the need to immediately implement this action to close the commercial sector for blue runner constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures would be unnecessary and contrary to the public interest. Such procedures would be unnecessary because the rule itself has been subject to notice and comment, and all that remains is to notify the public of the closure. Allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action to protect the blue runner resource. The capacity of the fishing fleet allows for rapid harvest of the ACL and prior notice and opportunity for public comment would result in a harvest well in excess of the established commercial ACL.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).