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

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

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

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

If you want us to acknowledge receipt of your comments on this proposal, include with your comments a self-addressed, stamped postcard on which you have written the docket number. We will stamp the date on the postcard and mail it back to you.

On September 30, 2009, Electronic Cable Specialists, Inc., applied for a supplemental type certificate for a dual Class 3 EFB system on the Boeing Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes. The EFB system will contain lithium batteries in the EFB electronic display unit (EDU).

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.101, Electronic Cable Specialists, Inc., must show that the Boeing Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in A16WE or the applicable regulations in effect on the date of application for the change.

The regulations incorporated by reference in the type certificate are commonly referred to as the “original type-certification basis.” The certification basis for the Boeing Model 737 airplanes affected by this modification is as follows:

For 737-600, -700, and -800 series airplanes: 14 CFR part 25 as amended by Amendments 25-1 through 25-77, with the exemptions and special conditions listed on type certificate A16WE.

For 737-700C and -900 series airplanes: 14 CFR part 25 as amended by Amendments 25-1 through 25-91, with the exemptions and special conditions listed on type certificate A16WE.

For 737-900ER series airplanes: 14 CFR part 25 as amended by Amendments 25-1 through 25-108, with the exemptions and special conditions listed on type certificate A16WE.

If the Administrator finds that the applicable airworthiness regulations ( i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Boeing Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes modified by Electronic Cable Specialists, Inc., because of a novel or unusual design feature, special conditions are prescribed under the provisions of 14 CFR 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under 14 CFR 21.101.

Special conditions are initially applicable to the model for which they are issued. Should Electronic Cable Specialists, Inc., apply for a supplemental type certificate to modify any other model included on type certificate A16WE to incorporate the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

Electronic Cable Specialists, Inc., proposes to use rechargeable lithium-ion batteries in a dual Class 3 EFB system on Boeing Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes. This type of battery possesses certain failure and operational characteristics, and maintenance requirements differ significantly from that of the nickel-cadmium (Ni-Cd) and lead-acid rechargeable batteries currently approved for installation in large, transport-category airplanes. Small, low-capacity, rechargeable lithium batteries are a novel or unusual design feature in transport-category airplanes, and current regulations in 14 CFR part 25 do not address installation of rechargeable lithium batteries.

The current regulations governing installation of batteries in large, transport-category airplanes were derived from Civil Air Regulations (CAR) part 4b.625(d) as part of the re-codification of CAR 4b that established 14 CFR part 25 in February 1965. The new battery requirements, § 25.1353(c)(1) through (c)(4), basically reworded the CAR requirements.

Increased use of Ni-Cd batteries in small airplanes resulted in increased frequency of battery fires and failures, which led to additional rulemaking affecting large, transport-category airplanes as well as small airplanes. On September 1, 1977, and March 1, 1978, the FAA issued § 25.1353(c)(5) and (c)(6), respectively, which govern Ni-Cd battery installations on large, transport-category airplanes.

The proposed use of rechargeable lithium batteries for equipment on the Boeing Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes has prompted the FAA to review the adequacy of these existing regulations. Our review indicates that the existing regulations do not adequately address several failure, operational, and maintenance characteristics of lithium batteries that could affect the safety and reliability of rechargeable lithium-battery installations on the Boeing Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes.

The use of lithium rechargeable batteries in applications involving commercial aviation has limited history. However, other users of this technology, ranging from wireless-telephone manufacturers to the electric-vehicle industry, have noted safety problems with lithium batteries. These problems include overcharging, over-discharging, and lithium-battery cell-component flammability.

In general, lithium-ion batteries are significantly more susceptible than their Ni-Cd or lead-acid counterparts to internal failures that can result in self-sustaining increases in temperature and pressure ( i.e., thermal runaway). This is especially true for overcharging, which causes heating and destabilization of the components of the lithium-battery cell, which can lead to the formation, by plating, of highly unstable metallic lithium. The metallic lithium can ignite, resulting in a self-sustaining fire or explosion. The severity of thermal runaway due to overcharging increases with increased battery capacity due to the higher amount of electrolyte in large batteries.

Discharge of some versions of the lithium-battery cell, beyond a certain voltage (typically 2.4 volts), can cause corrosion of the electrodes in the cell, resulting in loss of battery capacity that cannot be reversed by recharging. This loss of capacity may not be detected by the simple voltage measurements commonly available to flight crewmembers as a means of checking battery status, a problem shared with Ni-Cd batteries.

Unlike Ni-Cd and lead-acid cells, some types of lithium-battery cells use flammable liquid electrolytes. The electrolyte can serve as a source of fuel for an external fire if the cell container is breached.

The problems that lithium-battery users experience raise concerns about the use of these batteries in commercial aviation. The intent of these special conditions is to establish appropriate airworthiness standards for lithium-battery installations in the Boeing Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes and to ensure, as required by §§ 25.601 and 25.1309, that these battery installations will not result in an unsafe condition.

To address these concerns, these special conditions adopt the following requirements:

• Those sections of § 25.1353 that are applicable to lithium batteries.

• The flammable-fluid fire-protection requirements of § 25.863. In the past, this rule was not applied to batteries in transport-category airplanes because the electrolytes in lead-acid and Ni-Cd batteries are not considered flammable.

• New requirements to address hazards of overcharging and over-discharging that are unique to rechargeable lithium-ion batteries.

• Section 25.1529, Instructions for Continued Airworthiness, must include maintenance requirements to ensure that batteries used as spares are maintained in an appropriate state of charge, and installed lithium batteries are sufficiently charged at appropriate intervals. These instructions must also describe proper repairs, if allowed, and battery part-number configuration control.

In issuing these special conditions, the FAA requires that:

(1) All characteristics of the lithium batteries and their installation that could affect safe operation of the Boeing Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes are addressed, and

(2) Appropriate instructions for continued airworthiness, which include maintenance requirements, are established to ensure the availability of electrical power from the batteries when needed.

As discussed above, these special conditions are applicable to the Boeing Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes. Should Electronic Cable Specialists, Inc., apply at a later date for a supplemental type certificate to modify any other model included on type certificate A16WE to incorporate the same novel or unusual design feature, the special conditions would apply to that model as well.

This action affects only certain novel or unusual design features on Boeing Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes. It is not a rule of general applicability and it affects only the applicant who applied to the FAA for approval of these features on the airplane.

The authority citation for these special conditions is as follows:

On October 3, 2006, Cessna Aircraft Company applied for a change to type certification (TC) T00012WI for installation of lithium-ion batteries in the Model 680.

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.101, Cessna Aircraft Company must show that the Model 680, as changed, continues to meet the applicable provisions of the regulations incorporated by reference in TC T00012WI or the applicable regulations in effect on the date of application for the change. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type-certification basis.” The regulations incorporated by reference in TC T00012WI are as follows:

Title 14, Code of Federal Regulations, part 25, effective February 1, 1965, as amended by amendments 25-1 through 25-98. Refer to TC T00012WI, as applicable, for a complete description of the type-certification basis for this model, including special conditions and exemptions that are not relevant to these special conditions.

If the Administrator finds that the applicable airworthiness regulations ( i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model 680 because of a novel or unusual design feature, special conditions are prescribed under the provisions of 14 CFR 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Model 680 must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34 and the noise-certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under 14 CFR 21.101.

The Model 680 will incorporate the following novel or unusual design features:

Cessna Aircraft Company proposes to use rechargeable lithium-ion main batteries and Auxiliary Power Unit (APU) start batteries on the Model 680, and is also considering the use of this lithium-battery technology in several other auxiliary-battery applications in these airplanes. This type of battery possesses certain failure and operational characteristics, and maintenance requirements differ significantly from that of the nickel-cadmium (Ni-Cd) and lead-acid rechargeable batteries currently approved for installation in transport-category airplanes. Large, high-capacity, rechargeable lithium batteries are a novel or unusual design feature in transport-category airplanes, and current regulations in 14 CFR part 25 do not address installation of rechargeable lithium batteries.

The current regulations governing the installation of batteries in transport-category airplanes were derived from Civil Air Regulation (CAR) 4b.625(d) as part of the re-codification of CAR 4b that established Federal aviation regulations, in 14 CFR part 25, in February 1965. The new battery requirements, § 25.1353(c)(1) through (c)(4), basically reworded the CAR requirements.

Increased use of Ni-Cd batteries in small airplanes resulted in increased frequency of battery fires and failures, which led to additional rulemaking affecting transport-category airplanes as well as small airplanes. On September 1, 1977, and March 1, 1978, the FAA issued § 25.1353(c)(5) and (c)(6), respectively, which govern Ni-Cd battery installations on transport-category airplanes.

The proposed use of rechargeable lithium batteries for equipment and systems on the Model 680 airplane has prompted the FAA to review the adequacy of existing battery regulations. Our review indicates that the existing regulations do not adequately address several failure, operational, and maintenance characteristics of lithium batteries that could affect the safety and reliability of rechargeable lithium-battery installations on the Model 680 airplane.

The use of lithium rechargeable batteries in applications involving commercial aviation has limited history. However, other users of this technology, ranging from wireless-telephone manufacturers to the electric-vehicle industry, have noted safety problems with lithium batteries. These problems include overcharging, over-discharging, and lithium-battery cell-component flammability.

In general, lithium-ion batteries are significantly more susceptible than their Ni-Cd or lead-acid counterparts to internal failures that can result in self-sustaining increases in temperature and pressure ( i.e., thermal runaway). This is especially true for overcharging, which causes heating and destabilization of the components of the lithium-battery cell, which can lead to the formation, by plating, of highly unstable metallic lithium. The metallic lithium can ignite, resulting in a self-sustaining fire or explosion. The severity of thermal runaway due to overcharging increases with increased battery capacity due to the higher amount of electrolyte in large batteries.

Discharge of some versions of the lithium-battery cell, beyond a certain voltage (typically 2.4 volts), can cause corrosion of the electrodes in the cell, resulting in loss of battery capacity that cannot be reversed by recharging. This loss of capacity may not be detected by the simple voltage measurements commonly available to flight crewmembers as a means of checking battery status, a problem shared with Ni-Cd batteries.

Unlike Ni-Cd and lead-acid cells, some types of lithium-battery cells use flammable liquid electrolytes. The electrolyte can serve as a source of fuel for an external fire if the cell container is breached.

The problems that lithium-battery users experience raise concerns about the use of these batteries in commercial aviation. The intent of these special conditions is to establish appropriate airworthiness standards for lithium-battery installations in the Model 680 airplane, and to ensure, as required by §§ 25.601 and 25.1309, that these battery installations will not result in an unsafe condition.

To address these concerns, these special conditions adopt the following requirements:

• Those sections of § 25.1353 that are applicable to lithium batteries.

• The flammable-fluid fire-protection requirements of § 25.863. In the past, this rule was not applied to batteries in transport-category airplanes because the electrolytes in lead-acid and Ni-Cd batteries are not considered flammable.

• New requirements to address hazards of overcharging and over-discharging that are unique to rechargeable lithium-ion batteries.

• Section 25.1529, Instructions for Continued Airworthiness, must include maintenance requirements to ensure that batteries used as spares are maintained in an appropriate state of charge, and installed lithium batteries are sufficiently charged at appropriate intervals. These instructions must also describe proper repairs, if allowed, and battery part-number configuration control.

In issuing these special conditions, the FAA requires that:

(1) All characteristics of the lithium batteries and their installation that could affect safe operation of the Cessna Model 680 airplane are addressed, and

(2) Appropriate Instructions for Continued Airworthiness, which include maintenance requirements, are established to ensure the availability of electrical power from the batteries when needed.

Notice of proposed special conditions no. 25-11-15-SC for the Model 680 airplane was published in the Federal Register on July 1, 2011 (76 FR 41142). No comments were received, and the special conditions are adopted as proposed.

As discussed above, these special conditions are applicable to the Model 680 airplane. Should Cessna Aircraft Company apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the special conditions would apply to that model as well.

This action affects only certain novel or unusual design features on the Cessna Model 680 airplane. It is not a rule of general applicability.

The authority citation for these special conditions is 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 November 8, 2010 (75 FR 68548), and proposed to supersede AD 2009-17-04, Amendment 39-15995 (74 FR 41611, August 18, 2009). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

The corrective actions include replacing any cracked rod eye-end with a serviceable unit and re-adjusting the elevator servo-control. 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. The following presents the comments received on the proposal and the FAA's response to each comment.

US Airways stated that the NPRM (75 FR 68548, November 8, 2010) will help prevent a possible dual servo control disconnection on the same elevator, which would result in an uncontrolled surface.

Delta Air Lines (Delta) recommended that paragraph (g) of the NPRM (75 FR 68548, November 8, 2010) be simplified to accept the compliance specified in Airbus Mandatory Service Bulletin A320-27A1186, Revision 05, dated March 10, 2010. Delta stated that the current NPRM wording is difficult to correlate between service bulletin instructions and the wording of the AD, and as written, it appears the operators are responsible for compliance to both the FAA AD wording and the service bulletin wording. Delta also stated that the FAA AD wording does not give acceptance to the compliance times for OPTION 2 specified in the tables on pages 22 and 23 of Airbus Mandatory Service Bulletin A320-27A186, Revision 05, dated March 10, 2010. Delta stated it has used both options that are allowed under Airbus All Operators Telex (AOT) A320-27A1186 Revision 04, dated April 3, 2009.

We disagree with the request to revise the compliance time specified in paragraph (g) of this AD. This AD allows incorporation of Task 271186-832-803-001, referenced as OPTION 2 in Airbus Mandatory Service Bulletin A320-27A1186, Revision 05, dated March 10, 2010, as a method for doing the inspection of inboard and outboard servo control rod eye-ends required by this AD; however, the task must be done at the compliance time mandated in this AD. In developing an appropriate compliance time for paragraph (g) of this AD, we considered the safety issues as well as the recommendations of EASA. Delta agreed with the FAA position during a teleconference on June 17, 2011. We have not changed the AD in this regard.

Delta requested that we allow Airbus Mandatory Service Bulletin A320-27A1186, Revision 06, dated December 14, 2010, as an acceptable means of compliance with the NPRM (75 FR 68548, November 8, 2010).

We agree. In addition, we have received Airbus Mandatory Service Bulletin A320-27A1186, Revision 07, dated March 2, 2011. We have revised paragraphs (g), (h), (j), and (m), in this final rule to reference Airbus Mandatory Service Bulletin A320-27A1186, Revision 07, dated March 2, 2011. We have also added table 2 of this AD to provide credit for certain actions done before the effective date of this AD in accordance with the Accomplishment Instructions of Airbus Mandatory Service Bulletin A320-27A1186, Revision 05, dated March 10, 2010, which was cited in the NPRM (75 FR 68548, November 8, 2010) as the appropriate source of service information; and Airbus Mandatory Service Bulletin A320-27A1186, Revision 06, dated December 14, 2010.

Delta stated that Airbus Mandatory Service Bulletin A320-27A1186, Revision 05, dated March 10, 2010, as written, is confusing and difficult to comply with. Delta stated that it is poorly written for actual maintenance usage and it intermixes tasks that are accomplished on-wing with tasks that are performed in the shop environment. This makes literal compliance with Airbus Mandatory Service Bulletin A320-27A1186, Revision 05, dated March 10, 2010 (and thus the AD) difficult and unnecessarily places the operator at risk of non-compliance. To support its position, this commenter mentioned that, for example, the instructions in Figure A-FBEAA of Airbus Mandatory Service Bulletin A320-27A1186, Revision 05, dated March 10, 2010, for re-installing the crack-free rod-end using the same number of turns previously recorded when the rod-end was removed is meaningless as the rod-end will be installed on a different aircraft, and the number of turns most likely will be different in order to maintain aircraft rig on the new airplane. Delta wanted us to provide clearer language within the service information or allow operators to deviate from Airbus Mandatory Service Bulletin A320-27A1186, Revision 05, dated March 10, 2010, as written such that the operator can perform the required work without requesting an AMOC.

We disagree with the request. The example given in Figure A-FBEAA of Airbus Mandatory Service Bulletin A320-27A1186, Revision 05, dated March 10, 2010, for re-installing the crack-free rod-end specifies installation of a spare rod eye-end using the same number of turns previously recorded when the rod eye-end was removed. Therefore recording and re-installing using the same number of turns is necessary. We conclude that the service information is adequate and we have not changed this AD in this regard. However, under the provisions of paragraph (l) of this AD, we will consider requests for approval of an AMOC if sufficient data are submitted to substantiate that a deviation from the service information would provide an acceptable level of safety.

Delta, US Airways, and Airbus request the removal of the reporting requirement of paragraph (g)(3) of the NPRM (75 FR 68548, November 8, 2010) because Airbus has announced that it is no longer using the reported data to form a technical solution.

Because Airbus no longer needs the reported data to form a technical solution, we agree it is not necessary for operators to submit a report of inspection findings. We have removed paragraphs (g)(3) and (l)(3) of this AD.

Delta requested we add a statement regarding the servos (and the associated rod-end) that are replaced for failure prior to the 10,000 flight-cycle threshold be placed on the repetitive 5,000 flight-cycle period rather than the “first” inspection period after the aircraft reached the 10,000 flight-cycle initial level. Delta stated that the NPRM (75 FR 68548, November 8, 2010) would require the inspection be delayed for aircraft under/less than the 10,000 flight-cycle threshold. Delta stated as the servo “mean time between removals” is currently about 11,000 flight hours, it makes little sense to inspect a replacement rod-end only a few hundred or 1,000 flight cycles after installation. Delta stated it makes sense to apply the 5,000 flight-cycle limit to the rod-end on the replaced servo.

We disagree. If the servos are replaced before accumulating 10,000 total airplane flight cycles as of September 22, 2009 (the effective date of AD 2009-17-04, Amendment 39-15995 (74 FR 41611, August 18, 2009)), then the first inspection in accordance with paragraph (g)(2) of this AD is required at the later of the times specified in paragraphs (g)(2)(ii)(A) and (g)(2)(ii)(B), i.e., before the airplane accumulates 7,500 total flight cycles, or within 40 months after the effective date of this AD, whichever occurs later, but no later than 13,000 total flight cycles on the airplane, followed by repeat inspection in accordance with paragraph (h) of this AD. Therefore, no foreseeable scenario can necessitate an inspection after a few hundred or 1,000 airplane flight cycles. We have not changed this AD 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 also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

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

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

We estimate that this AD will affect about 770 products of U.S. registry.

The actions that are required by AD 2009-17-04, Amendment 39-15995 (74 FR 41611, August 18, 2009), and retained in this AD, take about 13 work-hours 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 $1,105 per product.

We estimate that it will take about 12 work-hours 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 these AD requirements to the U.S. operators to be $785,400, or $1,020 per product.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (75 FR 68548, November 8, 2010), 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:

On July 15, 2011, the FAA published in the Federal Register a notice of proposed rulemaking to modify controlled airspace at Miles City, MT (76 FR 41725). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6002 and 6005, respectively, of FAA Order 7400.9V dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Class E surface airspace, and Class E airspace extending upward from 700 feet above the surface, at Frank Wiley Field, Miles City, MT, to accommodate IFR aircraft executing new RNAV (GPS) standard instrument approach procedures at the airport. This action also adjusts the geographic coordinates for Frank Wiley Field to coincide with the FAA's aeronautical database. This action is necessary for the safety and management of IFR operations.

The FAA has determined this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies controlled airspace at Frank Wiley Field, Miles City, MT.

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

On July 13, 2011, the FAA published in the Federal Register a notice of proposed rulemaking to establish controlled airspace at Chinle, AZ (76 FR 41147). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005, of FAA Order 7400.9V dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace extending upward from 700 feet above the surface, at Chinle Municipal Airport, to accommodate IFR aircraft executing new RNAV (GPS) standard instrument approach procedures at the airport. This action is necessary for the safety and management of IFR operations.

The FAA has determined this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Chinle Municipal Airport, Chinle, AZ.

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

Background: On May 24, 2011, SEC published notice of three new Privacy Act systems of records entitled Tips, Complaints, and Referrals (TCR) Records (SEC-63)”, “SEC Security in the Workplace Incident Records (SEC-64)”, and “Investor Response Information System (IRIS) (SEC-65)”; and to revise two existing systems of records at Release No. PA-46, (May 18, 2011), 76 FR 30213 (May 24, 2011). In conjunction with publication of the systems of records notice, the SEC published, with invitation to comment, a proposed rule to exempt the new systems of records from 5 U.S.C. 552a(c)(3), (d), (e)(1), (e)(4)(G), (H), and (I), and (f) of the Privacy Act and 17 CFR 200.303, 200.304, and 200.306; and to make technical amendments to its current inventory of exempted systems of records at Release No. PA-45 (May 18, 2011), 76 FR 30048 (May 24, 2011). The TCR Records (SEC-63) system of records contains records related to tips, complaints, referrals of misconduct, or related information about actual or potential violations of the federal securities laws; investor harm; conduct of public companies; securities professionals; regulated entities; and associated persons. This system of records may include investigatory materials that were compiled in connection with the Commission's enforcement responsibilities under the federal securities laws. Such material may consist of unsolicited and often unverified statements concerning individuals, information received from confidential sources, as well as reports from the Commission's investigators and other law enforcement personnel. The disclosure of the existence of investigatory materials could seriously undermine effective enforcement of the federal securities laws by prematurely alerting individuals to the fact that they are under investigation, by giving them access to the evidentiary bases for a Commission enforcement action or seriously hampering the Commission's case in court or before an administrative law judge.

The SEC Security in the Workplace Incident Records (SEC-64) system of records contains records related to reports involving incidents of assault, harassment, intimidation, bullying, weapons possession, or threats at the SEC. This system of records may include investigatory materials that were compiled in connection with inquiries or investigation of potential or actual incidents of violence by and against individuals at an SEC facility. The disclosure of information as it relates to investigatory materials or the identity of sources of information may seriously undermine the safety and security of employees in the workplace. Access to such information could allow the subject of an investigation or inquiry of an actual or potential criminal or civil violation to interfere with and impede the investigation, tamper with witnesses or evidence, and to avoid detection or apprehension.

The IRIS (SEC-65) system of records contains records related to complaints/inquiries/requests from members of the public and others. This system of records may include investigatory materials that were compiled in connection with the Commission's enforcement responsibilities under the federal securities laws. Such material may consist of unsolicited and often unverified statements concerning individuals, information received from confidential sources, as well as reports from the Commission's investigators and other law enforcement personnel. The disclosure of the existence of investigatory materials could seriously undermine effective enforcement of the federal securities laws by prematurely alerting individuals to the fact that they are under investigation, by giving them access to the evidentiary bases for a commission enforcement action or seriously hampering the Commission's case in court or before an administrative law judge.

The Commission is exempting SEC-63, SEC-64 and SEC-65 from 5 U.S.C. 552a(c)(3), (d), (e)(1), (e)(4)(G), (H), and (I), and (f) and 17 CFR 200.303, 200.304, and 200.306, insofar as they contain investigatory materials compiled for law enforcement purposes; and amending its existing inventory of exemptions by modifying the name of SEC 38 from “Office of Personnel Code of Conduct and Employee Performance Files” to “Disciplinary and Adverse Actions, Employee Conduct, and Labor Relations Files” and by deleting reference to “Personnel Security Files”, which was published for deletion at Release No. PA-29 (July 28, 2000), 65 FR 49037(August10, 2000).

Public Comments: The Commission received only one comment on the proposal, but it did not address the specific exemptions; instead, the commenter stated generally that he thought privacy should be preserved and not taken away. We continue to believe the exemptions are consistent with the Privacy Act because the exemptions protect information relating to enforcement investigations from disclosure.

This rule does not contain a “collection of information” requirement within the meaning of the Paperwork Reduction Act of 1995, so the Paperwork Reduction Act is not applicable.

The Commission is sensitive to the costs and benefits imposed by its rules. The Privacy Act of 1974 directs each agency that proposes to establish or make a significant change in a system of records to publish in the Federal Register a notice of the existence and character of the system. Government agencies may exempt certain records from certain provisions of the Privacy Act, but to claim an exemption the agency must issue a rule justifying the exemption.

The new systems of records may include investigatory materials compiled in connection with the Commission's enforcement of the federal securities laws, in connection with potential or actual incidents of workplace violence, or in connections with complaints, inquiries or requests from the public. The Commission and investors will benefit from the amendments, because in their absence the potential access to or disclosure of the investigatory materials in these systems of records could seriously undermine the effective enforcement of the Federal securities laws, and could jeopardize the safety and security of Commission employees in the workplace.

We recognize that the proposed amendments may impose costs on individuals who may wish to obtain access to records that contain investigatory materials in these systems of records. We have no way of estimating the potential number of individuals who might in the future desire such access. Nevertheless, the benefits of exempting those records from public access are compelling, and they clearly justify the costs of the exemption. In addition, Congress was aware of such potential costs when they promulgated the specific exemption in 5 U.S.C. 552a(k)(2). The Commission discussed these costs and benefits in the proposing release and received no comments on them.

Pursuant to the requirements of the Regulatory Flexibility Act, 5 U.S.C. 601-612, SEC certified that these regulations would not significantly affect a substantial number of small entities. The rule imposes no duties or obligations on small entities. Further, in accordance with the provisions of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, SEC has determined that this rule would not impose new recordkeeping, application, reporting, or other types of information collection requirements. The Commission provided this certification in the proposing release and received no comments.

For the reasons set out in the preamble, Title 17, Chapter II, of the Code of Federal Regulations is amended as follows:

CHCBP is the program that provides continued health care coverage for eligible beneficiaries who lose their MHS eligibility. It was initially established by Congress in section 4408 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 1993, Public Law 102-484, which amended title 10 U.S.C., by adding section 1078a. The Department of Defense (DoD) published the initial final rule regarding CHCBP in the Federal Register on September 30, 1994, (59 FR 49817). It is modeled after private sector insurance programs giving some employees the ability to continue health insurance coverage after leaving employment as authorized by the Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1985. “COBRA Coverage” requires the individual to pay up to 100 percent of the program cost plus an amount to cover administrative expenses.

Section 713 of the NDAA for FY 2004 expanded the category of persons authorized coverage to include the uniformed services that are not armed forces. A final rule implementing this change was published in the Federal Register on September 30, 1994. The statute was again amended by Section 705 of the NDAA for FY 2008 which authorized the expansion of persons eligible for the CHCBP under 10 U.S.C. 1078a to include any person specified by regulation prescribed by the Secretary who was authorized coverage under 10 U.S.C. chapter 55 and who loses that eligibility. The proposed rule to implement this change was published in the Federal Register on November 27, 2009. The intent of the proposed rule and this final rule is to specify that any person who is currently authorized coverage under 10 U.S.C. chapter 55 or 10 U.S.C. 1145(a) and any person who may in the future be authorized coverage under chapter 55 of 10 U.S.C. or 10 U.S.C. 1145(a) and who loses that eligibility shall be authorized coverage under the CHCBP.

Currently, CHCBP provides coverage for certain active duty (AD) service members and their family members as well as RC members and their families. The coverage period is up to 36 months after the date on which the person first ceases to be covered under his or her respective program eligibility. However, for RC members the coverage is for 18 months from either separation from AD or when coverage under the Transitional Assistance Management Program (TAMP) (10 U.S.C. 1145(a)) ends.

The 2008 change to 10 U.S.C. 1078a expands CHCBP to all who the Secretary specifies in regulation who lose entitlement or eligibility to health care services under 10 U.S.C. chapter 55 Therefore, members or former members of the RC, such as TRICARE Reserve Select under 10 U.S.C. 1076d or TRICARE Retired Reserve under 10 U.S.C. Section 1076e coverage under CHCBP will now run for 18 months after the date the member ceases to be eligible for benefits under their respective Reserve program's eligibility. The rule also standardizes the number of days that a written election by an eligible beneficiary must be made to sixty (60) days after loss of entitlement or eligibility. Previously, those losing eligibility for TRICARE Reserve Select had only thirty (30) days to elect CHCBP coverage. The rule clarifies that individual locked out of other TRICARE plans per the other TRICARE program rules are not eligible to purchase CHCBP.

The proposed rule was published in the Federal Register on November 27, 2009 (74 FR 62271), for a 60-day comment period. We received comments from one individual. We thank the commenter for his comments. Specific matters raised are summarized below.

Comment: One commenter said the final changes to the CHCBP could be extremely beneficial to current and former service members, but that eligibility for health care for National Guard/RC members after the member ceases to be entitled to care under 10 U.S.C. 1074(a) (AD) or 10 U.S.C. 1145(a) (TAMP) should be extended to at least 24 months to maximize the opportunity for care. The commenter noted many health issues that service members are experiencing in theater need more time to be fully understood by the member and to be officially diagnosed. By extending an additional six months, service members who may be in denial about health issues or who may be having trouble transitioning to “civilian” life would have more time to obtain medical and dental care.

Response: The period of CHCBP eligibility after a period of AD or TAMP is limited by statute to 18 months. However, the 6 months of TAMP plus the 18 months of CHCBP allows the member the opportunity for 24 months of care.

Comment: One comment asked for clarity as to how long a “specific and limited period of time” CHCBP can continue.

Response: Eligibility timeframes for CHCBP vary by beneficiary category and are outlined in 32 CFR 199.20(d)(1).

Comment: One comment asked who would be considered a “certain former spouse” who is eligible for CHCBP.

Response: Eligibility for unremarried former spouses is outlined in 32 CFR 199.20(d)(1)(iii).

This rule expands eligibility to purchase CHCBP coverage for any beneficiary that loses entitlement or eligibility for medical care under 10 U.S.C. chapter 55 or 10 U.S.C. 1145(a), subject to the coverage limits of 10 U.S.C. 1078a.

The final rule incorporates a number of revisions from the proposed rule to clarify the expanded coverage adopted by Congress in section 705 of the NDAA for FY 2008 to ensure that all future beneficiaries under 10 U.S.C. chapter 55 or 10 U.S.C. 1145 who lose eligibility for care under those parts will be eligible to purchase CHCBP. For example in relation to coverage of RC personnel and their family members, the children of RC personnel who are covered dependent children under TRS and who reach the coverage age limit will have the same CHCBP eligibility as their counterparts who are children of AD personnel. As another example, a surviving spouse and child of a RC member who dies and who were covered by TRR will have the opportunity to obtain CHCBP coverage for up to three years after TRR coverage ends.

This final rule provides for improved administration of CHCBP by: Allowing the Department of Defense and the other uniformed services the ability to delegate to a designee the responsibility for notifying persons eligible to receive health benefits under the CHCBP; requiring supporting documentation on any change in status that would make a child eligible for CHCBP; allowing notification of a former spouse's potential eligibility for CHCBP to be made to the CHCBP contractor by the member, former member, or former spouse; establishing a 14-day period within which the CHCBP contractor must advise former spouses of their potential eligibility for CHCBP; and discontinuing the requirement that CHCBP premium rates be published annually but, instead, requiring that the premium rates be published whenever a change in rate occurs. There have been no changes in this final rule from the proposed rule on these administrative matters.

This final rule also makes minor editorial changes in an attempt to improve understanding of CHCBP program requirements and processes, including making grammatical improvements in the text of § 199.20. There have been a few minor changes in this final rule from the proposed rule on these editorial matters. These include reference to the “TRICARE Standard program” vice the TRICARE basic program; reference to the “CHCBP contractor” vice the “Third Party Administrator;” and reference to members of the “uniformed services” where the term “armed forces” was inadvertently used. Finally, the final rule includes a conforming change to § 199.24, deleting the paragraph that addressed the relationship between TRS and the CHCBP. That relationship is not covered by the revised provisions in § 199.20, which governs the CHCBP.

This final rule also contains administrative changes to update information regarding the current CHCBP and TRICARE programs as follows: Updates the “CHAMPUS” (Civilian Health and Medical Program of the Uniformed Services) program name to “TRICARE” when appropriate; updates the Department of Defense agency name from “OCHAMPUS” (the Office of CHAMPUS) to “TRICARE Management Activity” (TMA); replaces the reference “Third Party Administrator” with “CHCBP contractor” to make it consistent with the “contractor” term used for TMA programs; updates “military health services system” with “Military Health System;” and updates information regarding the enrollment process both to require the use of the enrollment applications or DD Form as designated by the Director, TRICARE as well as the documentation required to verify an applicant's eligibility for enrollment.

This final rule contains administrative changes to other paragraphs of Title 32 Code of Federal Regulations, specifically in § 199.20, by: Changing the title of paragraph (n) of this section “Peer Review Organization Program” to “Quality and Utilization Review Peer Review Organization Program;” changing the title of the program in paragraph (p)(2)(ii) from “Active Duty Dependents Dental Plan” to “TRICARE Dental Program;” and by adding to that same paragraph the “TRICARE Retiree Dental Program” under § 199.22 as a special program that is not available to participants in the CHCBP. In addition, this final rule deletes paragraph (p)(3) in its entirety, as that subpart referenced two demonstration projects that are no longer in existence and therefore no longer available to CHCBP participants: The “Home Health Care Demonstration” and the “Home Health Care—Case Management Demonstration.” There have been no changes in this final rule from the proposed rule on these references.

Executive Order 12866 requires that a comprehensive regulatory impact analysis be performed on any economically significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. The Regulatory Flexibility Act (RFA) requires that each Federal agency prepare, and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This rule is not an economically significant regulatory action and will not have a significant impact on a substantial number of small entities for purposes of the RFA, thus this final rule is not subject to any of these requirements.

This rule does not contain unfunded mandates. It does not contain a Federal mandate that may result in the expenditure by State, local, and tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year.

This rule will not impose additional information collection requirements on the public. OMB previously cleared the collection requirements under OMB Control Number 0704-0364.

We have examined the impact(s) of the rule under Executive Order 13132, and it does not have policies that have federalism implications that would 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, consultation with State and local officials is not required.

Accordingly, 32 CFR part 199 is amended as follows:

In the Federal Register of August 6, 2010, (75 FR 47519-47520), the Office of the Secretary of Defense published for public comment a proposed rule to allow coverage for otherwise covered services and supplies required in the treatment of complications (unfortunate sequelae) resulting from a noncovered incident of treatment provided in a Military Treatment Facility (MTF), when the initial noncovered service has been authorized by the MTF Commander and the MTF is unable to provide the necessary treatment of the complications.

In order to support Graduate Medical Education and maintain provider skill levels, MTF providers are frequently required to perform medical procedures that may be excluded from coverage under TRICARE. Unexpected complications (unfortunate sequelae) from these procedures may result and, in those instances where the MTFs are unable to provide the appropriate level of care necessary for the proper treatment of these complications, the MTF Commander must refer beneficiaries for treatment outside the MTF. Under current regulatory provisions, TRICARE is unable to cover treatment of the complications resulting from noncovered procedures. When beneficiaries require treatment outside the MTF for these complications, arising from noncovered procedures, they are responsible for payment for this necessary treatment resulting in significant financial hardship. This final rule will address that unfortunate situation by allowing coverage of treatment for the complications resulting from noncovered treatment provided in an MTF when the original procedure was authorized by the MTF Commander. The specific procedures for approval of this treatment will be addressed in the TRICARE Policy Manual rather than in the regulation to ensure that this information is current and easily accessible. TRICARE manuals may be accessed at http://www.tricare.mil .

We provided a 60-day public comment period following publication of the Proposed Rule in the Federal Register (75 FR 47519-47520) on August 6, 2010. One comment was received in full support of the rule.

Section 801 of title 5, United States Code, and Executive Order 12866 require certain regulatory assessments and procedures for any major rule or significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. It has been certified that this rule is not an economically significant rule, however, it is a regulatory action which has been reviewed by the Office of Management and Budget as required under the provisions of E.O. 12866.

Section 202 of Public Law 104-4, “Unfunded Mandates Reform Act,” requires that an analysis be performed to determine whether any Federal mandate may result in the expenditure by State, local and Tribal governments, in the aggregate, or by the private sector of $100 million in any one year. It has been certified that this rule does not contain a Federal mandate that may result in the expenditure by State, local and Tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year.

The “Regulatory Flexibility Act” (RFA) requires each Federal agency to prepare and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This rule will not significantly impact a substantial number of small entities for purposes of the RFA.

This rule will not impose significant additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3511).

This rule has been examined for its impact under E.O. 13132 and does not contain policies that have federalism implications that would have substantial direct effects on the States, on the relationship between the national government and the States, or in the distribution of power and responsibilities among the various levels of government; therefore, consultation with the State and local officials is not required.

Accordingly, 32 CFR part 199 is amended as follows:

This final rule implements section 704 of the National Defense Authorization Act for Fiscal Year 2010 (NDAA for FY10), Public Law 111-84, as amended by Section 703 of the National Defense Authorization Act for Fiscal Year 2011 (NDAA for FY11), Public Law 111-83.

This final rule expands the survivor eligibility under the TRICARE Dental Program (TDP). The legislation entitles the surviving spouse and child(ren) continuation of eligibility for the TDP regardless of whether they were previously enrolled in the TDP. Prior enrollment in the TDP had been a requirement of the 2010 legislation for both the spouse and children. The period of continued eligibility for spouse will be 3 years beginning on the date of the member's death. The period of continued eligibility for children will be 3 years beginning on the date of the member's death or until age 21 (or age 23 for most full-time students).

The final rule will maintain the government's payment of both the government and dependent's portion of the premium share during the period of continuous enrollment.

The proposed rule was published in the Federal Register on August 18, 2010, for a 60-day comment period. We received one comment expressing support of the extended eligibilities.

Executive Orders 12866 and 13563 require that a comprehensive regulatory impact analysis be performed on any significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. The Regulatory Flexibility Act (RFA) requires that each Federal agency prepare, and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This rule is not a significant regulatory action and will not have a significant impact on a substantial number of small entities for purposes of the RFA, thus this final rule is not subject to any of these requirements.

This rule will not impose additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3511).

We have examined the impact(s) of the final rule under Executive Order 13132 and it does not have policies that have federalism implications that would 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, consultation with State and local officials is not required.

Accordingly, 32 CFR part 199 is amended as follows:

A copy of the current DoD Instruction may be obtained from http://www.dtic.mil/whs/directives/corres/pdf/416557p.pdf .

Direct Final Rule and Significant Adverse Comments

DoD has determined this rulemaking meets the criteria for a direct final rule because it involves nonsubstantive changes dealing with DoD's management of its Privacy Progams. DoD expects no opposition to the changes and no significant adverse comments. However, if DoD receives a significant adverse comment, the Department will withdraw this direct final rule by publishing a notice in the Federal Register . A significant adverse comment is one that explains: (1) Why the direct final rule is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the direct final rule will be ineffective or unacceptable without a change. In determining whether a comment necessitates withdrawal of this direct final rule, DoD will consider whether it warrants a substantive response in a notice and comment process.

It has been determined that Privacy Act rules for the Department of Defense are not significant rules. The rules do not (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 these Executive orders.

It has been determined that this Privacy Act rule for the Department of Defense does not have significant economic impact on a substantial number of small entities because it is concerned only with the administration of Privacy Act systems of records within the Department of Defense.

It has been determined that Privacy Act rules for the Department of Defense impose no additional information collection requirements on the public under the Paperwork Reduction Act of 1995.

It has been determined that this Privacy Act rulemaking for the Department of Defense does not involve a Federal mandate 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 and that such rulemaking will not significantly or uniquely affect small governments.

It has been determined that the Privacy Act rules for the Department of Defense do not have federalism implications. The rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.

Accordingly, 32 CFR part 311 is amended as follows:

In FR Doc. 2011-22919 appearing on page 55561 in the Federal Register of Thursday, September 8, 2011, the following correction is made:

This rule withdraws federal water quality standards, specifically aquatic life criteria for chronic and acute copper and nickel and chronic endrin and selenium for Wisconsin surface waters designated for certain aquatic life uses in the Great Lakes System (described in 40 CFR part 132). As a result of this rule, Wisconsin will implement the following State-revised and EPA-approved aquatic life criteria: chronic and acute copper and nickel for all Wisconsin surface waters designated for aquatic life use; chronic endrin for Wisconsin surface waters designated for aquatic life use except waters designated as Warm Water Forage Fish and Warm Water Sportfish use; chronic selenium for Wisconsin surface waters designated for aquatic life use except waters designated as Limited Forage Fish use. Entities discharging copper, nickel, endrin or selenium to surface waters of Wisconsin could be affected by this rulemaking given that water quality standards are used to determine water quality based effluent limits in National Pollutant Discharge Elimination System (NPDES) permits, and may affect Clean Water Act (CWA) Section 404 dredge and fill permits, and other federal licenses and permits requiring CWA 401 certification. Table 1, below, provides examples of the types of NPDES-regulated entities that may ultimately be affected by the federal rule withdrawal.

If you have any questions regarding the applicability of this action to a particular entity, consult the person identified in the preceding section entitled FOR FURTHER INFORMATION CONTACT .

In 1995, the EPA published the final Water Quality Guidance for the Great Lakes System (Guidance), required by CWA Section 118(c)(2) (33 U.S.C. 1268). Among other provisions, the Guidance identified minimum water quality standards to protect aquatic life as part of a comprehensive plan to restore the health of the Great Lakes System (40 CFR 132.3). Under CWA Section 118(c)(2), within two years of publishing the Guidance, Great Lakes States, including Wisconsin, were required to adopt provisions consistent with the Guidance into their water quality standards and NPDES permit programs. The regulation at 40 CFR 132.5(f) provides that, after review of a State's water quality standards submission, the EPA must either publish a notice of approval of the State's submission in the Federal Register or notify the State that the EPA has determined that all or part of its submission is inconsistent with the CWA and/or the Guidance, and identify any changes needed to obtain EPA approval. If the EPA notified the State of inconsistencies, then the State had 90 days to make the necessary changes. If the State failed to make the necessary changes, the EPA was required to publish a document in the Federal Register identifying the approved and disapproved elements of the submission and a final rule identifying the provisions of the Guidance that apply to the State.

In 1997, Wisconsin adopted revised water quality standards to comply with the Guidance requirements at 40 CFR part 132. In October 2000, the EPA disapproved six of Wisconsin's revised aquatic life criteria including chronic and acute copper and nickel, and chronic endrin and selenium. Subsequently the EPA published a final rule effective February 5, 2001, making the following aquatic life criteria, published at 40 CFR 132.6, effective for waters of the Great Lakes System in the State of Wisconsin: (1) Chronic and acute copper and nickel in Tables 1 and 2 of 40 CFR 132.6(f); (2) chronic endrin in Table 2 of 40 CFR 132.6(f); and (3) chronic selenium in Table 2 of 40 CFR 132.6(g).

In January 2008, Wisconsin began rulemaking to revise its water quality standards to address the EPA's disapproval of these aquatic life criteria. The Wisconsin Natural Resources Board adopted the State's revised criteria on June 24, 2008 and the Wisconsin Attorney General certified these rules on December 22, 2008. On May 4, 2009, EPA Region 5 received a letter from the Wisconsin Department of Natural Resources requesting approval of final revisions to Chapter NR 105 (Surface Water Quality Criteria and Secondary Values for Toxic Substances) of the Wisconsin Administrative Code (WAC).

Pursuant to CWA section 303(c)(3), the EPA is required to review and approve new and revised State water quality standards before such standards become effective for CWA purposes. The EPA found that Wisconsin's revised criteria, with the exception of chronic selenium for waters designated by Wisconsin as Limited Forage Fish use, satisfy the federal requirements for submittal of new or revised water quality standards to the EPA and are consistent with the CWA and the Guidance requirements. Therefore, the EPA approved Wisconsin's revised aquatic life criteria on July 1, 2009, with the exception of the chronic aquatic life criterion for selenium in waters designated by Wisconsin as Limited Forage Fish use.

The EPA's approval of Wisconsin's aquatic life criteria makes the federal criteria no longer necessary for compliance with the CWA and the Guidance. Therefore, the EPA determined that the following federal aquatic life criteria for waters of the Great Lakes System in Wisconsin may be withdrawn: chronic and acute copper and nickel for all aquatic life uses; chronic endrin for all aquatic life uses with the exception of waters designated by Wisconsin as Warm Water Forage Fish and Warm Water Sportfish use; and chronic selenium for all aquatic life uses with the exception of waters designated by Wisconsin as Limited Forage Fish use.

The EPA is not withdrawing the federal chronic endrin aquatic life use criterion for waters of the Great Lakes System in Wisconsin designated as Warm Water Sportfish and Warm Water Forage Fish use, due to a State transcription error. While the EPA approved Wisconsin's revised chronic endrin aquatic life use criteria for all waters in the State of Wisconsin on July 1, 2009, the chronic aquatic life use criterion for endrin for waters designated as Warm Water Forage Fish and Warm Water Sportfish use published in Wisconsin's regulations at NR 105.06 (0.05 μg/L) is not identical to the criterion that Wisconsin submitted and that the EPA had approved (0.036 μg/L). The EPA is not withdrawing the federal chronic endrin criterion for these aquatic life uses until after Wisconsin concludes rulemaking to correct the criterion in the State's regulations.

The EPA is not withdrawing the federal chronic selenium aquatic life use criterion for waters of the Great Lakes System in Wisconsin designated for Limited Forage Fish use because the EPA took no action on Wisconsin's revised chronic selenium criterion for this aquatic life use in its July 1, 2009 action approving the other aquatic life criteria. Therefore, the federal aquatic life use criterion for chronic selenium will continue to apply to waters within the Great Lakes System of Wisconsin, designated as Limited Forage Fish use. Wisconsin calculated the chronic selenium criterion based on water column toxicity studies, rather than through dietary exposure, which currently available data indicates is the appropriate methodology to use. Because Wisconsin does not have an EPA-approved chronic aquatic life selenium criterion for Limited Forage Fish Waters, the EPA is not withdrawing the federal chronic aquatic life selenium criterion for Wisconsin's Limited Forage Fish waters in this rule. Wisconsin may revise their chronic selenium criterion and submit it to the EPA for review and approval at a future date.

The EPA is withdrawing certain federal aquatic life criteria for Wisconsin included in the Guidance at 40 CFR 132.6. Specifically, the EPA is withdrawing the federal aquatic life use criteria for chronic and acute copper and nickel (40 CFR 132.6(f)) applicable to all waters of the Great Lakes System in Wisconsin designated for aquatic life uses. The EPA is also amending the federal chronic aquatic life criterion for endrin (40 CFR 132.6(f)) to apply exclusively to waters designated by Wisconsin as Warm Water Sportfish and Warm Water Forage Fish use, and amending the federal chronic aquatic life criterion for selenium (40 CFR 132.6(g)) to apply exclusively to waters designated by Wisconsin as Limited Forage Fish use. As a result of this final rule withdrawal, Wisconsin will implement the EPA-approved aquatic life criteria under State law.

Wisconsin has tiered aquatic life uses and the State's EPA-approved aquatic life criteria revisions do not affect Wisconsin's designated uses included in Chapter NR 105 of the WAC. Based on the designated uses defined in NR 102.04(3) of the WAC, Wisconsin's aquatic life designated uses of Cold Water, Warm Water Sportfish, and Warm Water Forage Fish are consistent with the requirements of CWA Section 101(a)(2) for the protection and propagation of fish, shellfish, and wildlife. The Limited Forage Fish aquatic life use does not meet this requirement because these surface waters are capable of supporting only a “limited community of forage fish and other aquatic life,” based on “limited capacity and naturally poor water quality or habitat” (WAC, Chapter 102.04(3)(d)). The following section discusses and compares the calculations and criteria included in the EPA's federal regulations and those included in Wisconsin's revised criteria.

Wisconsin adopted and the EPA reviewed and approved an acute copper aquatic life criteria equation applicable to all surface waters in Wisconsin designated for aquatic life use. The equation used by Wisconsin to calculate the acute copper aquatic life criteria results in a slightly higher value than the EPA equation at a given hardness (see Table 2).

The difference between the EPA's and Wisconsin's intercept in the acute copper equation is due to the elimination of one of the most sensitive species from the criteria calculation (northern pikeminnow, genus Ptychocheilus) and inclusion of additional data for three species. Eliminating the Ptychocheilus data from the equation is scientifically defensible because Ptychocheilus is not native to Wisconsin and is not a surrogate for other Wisconsin taxa unrepresented in the data set. The northern pikeminnow is a type of minnow, and other minnows (fathead and bluntnose) found in Wisconsin are well-represented in the copper data set. Wisconsin's slope of 0.9436 is slightly different from the EPA's 0.9422 slope due to Wisconsin's inclusion of additional data on three species ( Daphnia magna, rainbow trout, and bluegill) that were not included in the EPA's 1985 slope calculation used in the Guidance. The EPA included these data in the 1995 criteria update, but did not recalculate the slope used in the 1985 EPA copper criteria document.

Wisconsin's method for deriving the acute copper criteria equation is an acceptable State-specific modification of the EPA's criteria, consistent with Wisconsin's methods for deriving criteria (WAC Chapter NR 105). The equation is scientifically sound and results in criteria that are protective of the use; therefore this equation is consistent with CWA Sections 101(a)(2) and 303(c)(2), and 40 CFR Parts 131 and 132.

Wisconsin adopted and the EPA reviewed and approved a chronic copper aquatic life criteria equation applicable to all surface waters in Wisconsin designated for aquatic life use. The equation used by Wisconsin for calculating chronic aquatic life criteria for copper produces a slightly higher value than the EPA equation at a given hardness (see Table 3).

The difference between the EPA's and Wisconsin's chronic copper equation intercept is primarily due to the elimination of one of the most sensitive species from the federal criteria calculation (northern pikeminnow, genus Ptychocheilus ), which is not native to Wisconsin. Wisconsin's elimination of data for a non-native species that is not a surrogate for taxa that are unrepresented in the data set, is scientifically defensible. The northern pikeminnow is a type of minnow, and other minnows (fathead and bluntnose) found in Wisconsin, are well-represented in the copper data set. Wisconsin's slope of 0.8557 is slightly different from the EPA's 0.8545 slope due to Wisconsin's inclusion of additional data on three species ( Daphnia magna, rainbow trout, and bluegill) that were not included in the EPA's 1985 slope calculation used in the Guidance. The EPA included these data in the 1995 criteria update, but did not recalculate the slope used in the 1985 copper criteria document.

Wisconsin's method for deriving the chronic copper criteria equation is an acceptable State-specific modification of the EPA's criteria, consistent with Wisconsin's methods for deriving criteria (WAC Chapter NR 105). The equation is scientifically sound and results in criteria that are protective of the use, therefore this equation is consistent with CWA Sections 101(a)(2) and 303(c)(2), and 40 CFR parts 131 and 132.

Wisconsin adopted and the EPA reviewed and approved an acute nickel aquatic life criteria equation applicable to all surface waters in Wisconsin designated for aquatic life use. The equation used by Wisconsin to calculate acute aquatic life criteria for nickel is identical to the equation contained in the Great Lakes Water Quality Guidance, 40 CFR part 132 as well as the EPA's CWA Section 304(a) criteria (see Table 4). The equation is scientifically sound and results in criteria that are protective of the use, therefore this equation is consistent with CWA Sections 101(a)(2) and 303(c)(2), and 40 CFR parts 131 and 132.

Wisconsin adopted and the EPA reviewed and approved, two criteria equations for chronic nickel for differing aquatic life uses (see Table 5).

The equation used by Wisconsin for calculating the chronic nickel criteria for Cold Water, Warm Water Sportfish, Warm Water Forage Fish, and Limited Forage Fish designated uses results in a value that is slightly higher than the resulting criterion from the EPA's equation at a given hardness. This difference is due to Wisconsin's use of a slightly different intercept and acute-chronic ratio for the Cladoceran test data. The equation for the Limited Aquatic Life classification has a different value for the intercept because data for the fathead minnow, which are not expected to have a fish community in Limited Aquatic Life use waters, were not included in the calculation.

For the Cold Water, Warm Water Sportfish, Warm Water Forage Fish, and Limited Forage Fish water classifications, Wisconsin's chronic nickel criteria equation is scientifically defensible and results in criteria protective of the use and therefore is consistent with CWA Sections 101(a)(2) and 303(c)(2), and 40 CFR parts 131 and 132. For Wisconsin's equation for Limited Aquatic Life water classification, the elimination of data for a non-resident species is an appropriate State-specific modification of the EPA's equation. Wisconsin's equation is scientifically sound and results in criteria that are protective of the use, and is therefore consistent with CWA Sections 101(a)(2) and 303(c)(2), and 40 CFR parts 131 and 132.

Wisconsin adopted and the EPA reviewed and approved a chronic endrin criterion for Cold Water, Warm Water Forage Fish, and Warm Water Sportfish classifications that is identical to the EPA's criterion in the Guidance (40 CFR part 132). The criterion is scientifically sound and protective of the use, therefore this criterion is consistent with CWA Sections 101(a)(2) and 303(c)(2), and 40 CFR parts 131 and 132 (see Table 6). However, due to a transcription error, the chronic endrin aquatic life use criterion for waters designated as Warm Water Forage Fish and Warm Water Sportfish use published in Wisconsin's regulations NR 105.06 (0.05 µg/L) is not identical to the criterion that Wisconsin submitted to the EPA and which the EPA approved (0.036 µg/L). Therefore, the EPA is not withdrawing the federal chronic endrin criterion for these uses until after Wisconsin concludes rulemaking to correct the criterion in the State's regulations.

Wisconsin's criterion for Limited Forage Fish and Limited Aquatic Life waters is higher than the EPA's criterion because three of the four most sensitive genera used to calculate the EPA's criterion do not exist in these waters in Wisconsin, and were therefore excluded from the State's calculation. These species are Perca (yellow perch), Lepomis (bluegill), and micropterus (largemouth bass). Instead, Wisconsin used data for the following genera for the endrin criterion calculation for Limited Forage Fish Waters: Pteronarcys (stonefly), which was also used by the EPA; Cyprinus (carp); Piemphales (fathead minnow); and Pteronarcella (stonefly). When the fathead minnow data set was removed from the Limited Aquatic Life calculation, the calculated criterion was lower than the calculated criterion for Limited Forage Fish waters. Under Wisconsin's rules NR 105.05(1)(a)(9), when this occurs, the Limited Aquatic Life criterion can be set equal to the Limited Forage Fish criterion if the species used to calculate the Limited Aquatic Life criterion are already included in the database used to calculate the Limited Forage Fish criterion. Therefore, Wisconsin established the Limited Aquatic Life criterion for endrin at a level that provides protection equal to the level for the Limited Forage Fish criterion.

Wisconsin's method for deriving the chronic endrin criterion for Limited Aquatic Life and Limited Forage Fish waters is an acceptable State-specific modification of the EPA's criterion, consistent with Wisconsin's methods for deriving criteria (Chapter NR 105 of the WAC). The criterion is scientifically sound and protective of the use, therefore this criterion is consistent with CWA Sections 101(a)(2) and 303(c)(2), and 40 CFR parts 131 and 132.

The EPA reviewed and approved Wisconsin's revised chronic selenium criterion for Cold Water, Warm Water Sportfish, and Warm Water Forage Fish classifications, which are identical to the EPA's chronic selenium criterion in 40 CFR part 132 (see Table 7). The criterion is scientifically sound and protective of the uses, and is therefore consistent with CWA Section 101(a)(2) and 303(c)(2), and 40 CFR parts 131 and 132.

Wisconsin did not adopt the EPA's chronic aquatic life criterion for selenium, found in 40 CFR Part 132, for Limited Aquatic Life waters. Wisconsin's basis for this decision is that Limited Aquatic Life waters only support an invertebrate community, and the EPA's criterion was based on observed effects of selenium on sportfish (bluegills) in field studies (Belews Lake, North Carolina, and others). Instead, Wisconsin calculated a criterion for Limited Aquatic Life waters based on toxicity studies listed in the EPA's 1987 selenium aquatic life criteria document (selenite, +4). Wisconsin's value of 46.5 µg/L is slightly different than the EPA's calculated criterion of 44.72 µg/L, because Wisconsin removed the data for two saltwater species used in the EPA's calculation.

Wisconsin's chronic aquatic life selenium criterion of 46.5 µg/L for Limited Aquatic Life waters is consistent with the protection provided for aquatic life in Limited Aquatic Life waters, for several reasons. First, two of the three freshwater studies used to calculate the criterion, in accord with the 1985 Guidelines, were conducted on invertebrates ( Daphnia magna and Daphnia pulex ). Wisconsin followed their State procedures for deriving aquatic life criteria, using these toxicity studies (Chapter NR 105 of the WAC). Second, current literature on selenium states: “The most important aspect of selenium residues in aquatic food chains is not direct toxicity to the organisms themselves, but rather the dietary source of selenium they provide to fish and wildlife species that feed on them”. 1 In the case of Limited Aquatic Life waters, there are no fish that feed on the invertebrates, and there is currently no information available to determine effects on wildlife from eating these organisms. No new studies have been conducted with invertebrates that would provide a scientific basis to refute the 1987 invertebrate toxicity studies reported in the EPA's 1987 selenium criteria document.

For the above reasons, the EPA approved Wisconsin's chronic selenium criterion for Limited Aquatic Life waters as an acceptable State-specific modification of the EPA's criterion, consistent with Wisconsin's methods for deriving criteria. The criterion is scientifically sound and protective of the use, therefore this criterion is consistent with CWA Sections 101(a)(2) and 303(c)(2), and 40 CFR Parts 131 and 132.

Wisconsin did not adopt the EPA's chronic aquatic life selenium criterion of 5 µg/L, found in 40 CFR Part 132, for Limited Forage Fish waters. Wisconsin's basis for not adopting the EPA's criterion is that Limited Forage Fish waters only support forage fish and invertebrates, and the EPA's criterion was based on observed effects of selenium on sportfish (bluegill) in field studies. Instead, Wisconsin calculated a chronic selenium criterion for Limited Forage Fish waters based on toxicity studies listed in the EPA's 1987 selenium aquatic life criteria document (selenite, +4). The EPA did not use these laboratory toxicity studies as the final basis for the recommended national selenium criterion of 5 µg/L because these studies were based on water column-only exposure to selenium. Given the available data showing the importance of dietary exposure, the EPA's criteria recommendations are based on field studies that account for bioaccumulation through the food chain as the main route of the exposure. The available data indicate that the primary route of exposure to all fish species is dietary. Consequently, a water column exposure-based criterion, such as the criterion adopted by Wisconsin for Limited Forage Fish waters, may not protect aquatic life in these waters. Therefore, the EPA did not act on Wisconsin's revised chronic selenium criterion for Limited Forage Fish waters in its July 1, 2009 action approving the other aquatic life criteria. Because Wisconsin does not have an EPA-approved chronic aquatic life selenium criterion for Limited Forage Fish Waters, the EPA is not withdrawing the federal chronic aquatic life selenium criterion for these waters. Therefore, the federal criteria for chronic selenium will continue to apply to Wisconsin's Limited Forage Fish waters.

This action withdraws federal requirements applicable to Wisconsin and imposes no regulatory requirements or costs on any person or entity, does not interfere with the action or planned action of another agency, and does not have any budgetary impacts or raise novel legal or policy issues. Thus, it has been determined that this rule is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to Office of Management and Budget (OMB) review.

This action does not impose any new information collection burden because it is administratively withdrawing Federal requirements that are no longer needed in Wisconsin. It does not include any information collection, reporting or recordkeeping requirements. However, the OMB has previously approved the information collection requirements contained in the existing regulations 40 CFR Part 131 under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2040-0049. The OMB control numbers for the EPA's regulations are listed in 40 CFR part 9.

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

For purposes of assessing the impacts of this action on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

This rule imposes no regulatory requirements or costs on any small entity. Therefore, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under UMRA Section 202, the EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, UMRA Section 205 generally requires the EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of UMRA Section 205 do not apply when they are inconsistent with applicable law. Moreover, UMRA Section 205 allows the EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation of why that alternative was not adopted. Before the EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under UMRA Section 203 a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of the EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

This rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, Tribal, or local governments or the private sector because it imposes no enforceable duty on any of these entities. Thus, this rule is not subject to the requirements of UMRA Sections 202 and 205 for a written statement and small government agency plan. Similarly, the EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments and is therefore not subject to UMRA Section 203.

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

This rule imposes no regulatory requirements or costs on any State or local governments; therefore, it does not have federalism implications under Executive Order 13132.

Subject to the Executive Order 13175 (65 FR 67249, November 9, 2000) the EPA may not issue a regulation that has tribal implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal Government provides the funds necessary to pay the direct compliance costs incurred by tribal governments, or the EPA consults with tribal officials early in the process of developing the proposed regulation and develops a tribal summary impact statement.

The EPA has concluded that this action may have tribal implications. However, it will neither impose substantial direct compliance costs on tribal governments, nor preempt Tribal law. Wisconsin's revised and EPA-approved aquatic life criteria are identical to, or only slightly less stringent than, the federal criteria being withdrawn in this rule. In 2009 the EPA determined that Wisconsin's revised criteria, with the exception of the chronic aquatic life criterion for selenium in waters designated as Limited Forage Fish use, adequately protect all waters of the State designated for aquatic life use at a level consistent with the Guidance and CWA requirements. Therefore, tribal consultation on this rule is unnecessary.

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

This rule is not subject to Executive Order 13045 because it is not economically significant and the EPA has no reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because it is not a significant regulatory action under Executive Order 12866.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, 12(d)(15 U.S.C. 272 note) directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs the EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This rulemaking does not involve technical standards. Therefore, the EPA is not considering the use of any voluntary consensus standards.

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

The EPA has determined that this rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations for several reasons. First, this rule pertains to aquatic life use criteria only which, based on current science and the EPA's CWA Section 304(a) recommended criteria, the EPA has previously determined are protective of the applicable aquatic life designated uses. Second, Wisconsin's revised and EPA-approved aquatic life criteria apply to all waters in the State designated for certain aquatic life uses. For these reasons, the EPA believes that this action will not disproportionately affect any one group over another in the State of Wisconsin.

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. The EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A “major rule” cannot take effect until 60 days after it is published in the Federal Register , however this action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will become effective 30 days after publication in the Federal Register as provided under the Administrative Procedure Act.

For the reasons set out in the preamble, 40 CFR part 132 is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

You may access a frequently updated electronic version of 40 CFR part 174 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0609 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 15, 2011. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2009-0609, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov . Follow the on-line instructions for submitting comments.

• Mail: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In the Federal Register of June 8, 2011 (76 FR 33183) (FRL-8874-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 1G7868) by Syngenta Seeds, Inc., P.O. Box 12257, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 174 be amended by extending the effective date of an existing temporary exemption from the requirement of a tolerance for residues of Bacillus thuringiensis eCry3.1Ab protein in corn. This notice referenced a summary of the petition prepared by the petitioner, Syngenta Seeds, Inc., which is available in the docket via http://www.regulations.gov . One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit VII.C.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe ” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance exemption and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.” Additionally, section 408(b)(2)(D) of FFDCA requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] * * * residues and other substances that have a common mechanism of toxicity.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Based on amino acid sequence homology and crystal structures, known Cry proteins have a similar three-dimensional structure comprised of three domains, Domain I, II, and III (Refs. 1, 2, 3, and 4). The toxin portions of Cry proteins are characterized by having five conserved blocks (CB) across their amino acid sequence. These are numbered CB1 to CB5 from the N-terminus to the C-terminus (Ref. 5). The sequences preceding and following these conserved blocks are highly variable and are designated as variable regions V1 to V6.

Syngenta Seeds, Inc. developed Event 5307 maize ( Zea mays ) through Agrobacterium -mediated transformation (via plasmid vector PV-ZMIR245) to express eCry3.1Ab protein for use as a plant-incorporated protectant (PIP). This proposed PIP is a chimeric Bacillus thuringiensis protein, composed of portions of Cry1Ab and modified Cry3A proteins. The eCry3.1Ab protein was genetically engineered via exchanging the variable regions (V1 to V6) between the mCry3A and the Cry1Ab proteins for enhanced toxicity against western corn rootworm (WCR, Diabrotica virgifera ). The eCry3.1Ab protein consists of a fusion between the N-terminus (Domain I, Domain II, and a portion of Domain III) of mCry3A and the C-terminus (a portion of Domain III and variable region 6) of Cry1Ab. The eCry3.1Ab protein is 654 amino acid residues in size and is approximately 73.7 kilodaltons.

Syngenta Seeds, Inc. has submitted acute oral toxicity data demonstrating the lack of mammalian toxicity at high levels of exposure to the pure eCry3.1Ab protein. These data demonstrate the safety of the product at a level well above maximum possible exposure levels that are reasonably anticipated in the crop. Basing this conclusion on acute oral toxicity data without requiring further toxicity testing and residue data is similar to EPA's position regarding toxicity testing and the requirement of residue data for the microbial Bacillus thuringiensis products from which this PIP was derived (see 40 CFR 158.2130(d)(1)(i) and 158.2140(d)(7)). For microbial products, further toxicity testing and residue data are triggered by significant adverse acute effects in studies, such as the mouse oral toxicity study, to verify and quantify the observed adverse effects and clarify the source of these effects (Tiers II & III).

An acute oral toxicity study in mice (Master Record Identification Number (MRID No.) 477539-01) indicated that eCry3.1Ab is nontoxic. Two groups of 10 male and 10 female mice were orally dosed (via gavage) with 2,000 milligrams/kilograms bodyweight (mg/kg bwt) (eCry3.1Ab protein mg/kg bwt) of the eCry3.1Ab-0208 test substance, the microbial-produced eCry3.1Ab protein. All treated animals gained weight and had no test material-related clinical signs and no test material-related findings at necropsy. Since there were no significant differences between the test and control groups related to the oral administration of eCry3.1Ab-0208 test material, the eCry3.1Ab protein does not appear to cause any significant adverse effects at an exposure level of up to 2,000 mg/kg bwt and supports the finding that the eCry3.1Ab protein would be nontoxic to mammals.

When proteins are toxic, they are known to act via acute mechanisms and at very low dose levels (Ref. 6). Therefore, since no acute effects were shown to be caused by eCry3.1Ab, even at relatively high dose levels, the eCry3.1Ab protein is not considered toxic. Further, amino acid sequence comparisons showed no similarities between the eCry3.1Ab protein and known toxic proteins in protein databases that would raise a safety concern.

Since eCry3.1Ab is a protein, allergenic sensitivities were considered. Currently, no definitive tests exist for determining the allergenic potential of novel proteins. Therefore, EPA uses a “weight-of-the-evidence” approach where the following factors are considered: Source of the trait; amino acid sequence similarity with known allergens; prevalence in food; and biochemical properties of the protein, including in vitro digestibility in simulated gastric fluid (SGF) and glycosylation (as recommended by CAC 2003, see Ref. 7). Current scientific knowledge suggests that common food allergens tend to be resistant to degradation by acid and proteases; may be glycosylated; and present at high concentrations in the food.

1. Source of the trait. Bacillus thuringiensis is not considered to be a source of allergenic proteins.

2. Amino acid sequence. A comparison of the amino acid sequence of eCry3.1Ab with known allergens showed no significant overall sequence similarity or identity at the level of eight contiguous amino acid residues. This is the appropriate level of sensitivity to detect possible IgE epitopes without high false positive rates.

3. Prevalence in food. Preliminary expression level analysis shows that the eCry.1Ab protein is present at relatively low levels. Dietary exposure is expected to be correspondingly low. Expression in Event 5307 leaf is 35 parts per million (ppm); root is 6 ppm; and pollen is 0.15 ppm. Thus, the expression has been shown to be in the parts per million range.

4. Digestibility. The eCry3.1Ab protein was rapidly digested in simulated mammalian gastric fluid containing pepsin at a pH of 1.2 at 37 °C. The estimated degradation rate (DT 50 ) is less than 1 minute for eCry3.1Ab protein.

5. Glycosylation. The eCry3.1Ab protein expressed in corn was shown not to be glycosylated.

6. Conclusion. Considering all of the available information, EPA has concluded that the potential for eCry3.1Ab to be a food allergen is minimal.

In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

EPA has considered available information on the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances. First, with respect to other related substances, the eCry3.1Ab protein is a chimeric Bacillus thuringiensis protein, composed of portions of Cry1Ab and mCry3A proteins, both of which are registered PIPs that were previously assessed as having a lack of mammalian toxicity at high levels of exposure. Exemptions from the requirement of a tolerance have been established for Cry1Ab in food and mCry3A in maize (see 40 CFR 174.511 and 40 CFR 174.505, respectively). Second, and specific to the eCry3.1Ab protein, these considerations include dietary exposure under the tolerance exemption and all other tolerances or exemptions in effect for the PIP chemical residue and exposure from non-occupational sources. Exposure via the skin or inhalation is not likely since the PIP is contained within plant cells, which essentially eliminates these exposure routes or reduces these exposure routes to negligible. The amino acid homology assessment included similarity to known aeroallergens. It has been demonstrated that there is no evidence of occupationally related respiratory symptoms, based on a health survey on migrant workers after exposure to Bacillus thuringiensis pesticides (Ref. 8). Exposure via residential or lawn use to infants and children is also not expected because the use sites for the eCry3.1Ab protein are all agricultural for control of insects. Oral exposure, at very low levels, may occur from ingestion of processed corn products and, potentially, drinking water.

However, oral toxicity testing done at a dose of 2 gm/kg showed no adverse effects. Furthermore, the expected dietary exposure from corn is several orders of magnitude lower than the amounts of eCry3.1Ab protein shown to have no toxicity. Therefore, even if negligible aggregate exposure should occur, EPA concludes that such exposure would present no harm due to the lack of mammalian toxicity and the rapid digestibility demonstrated for the eCry3.1Ab protein.

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance exemption, EPA consider “available information concerning the cumulative effects of [a particular pesticide's] * * * residues and other substances that have a common mechanism of toxicity.”

Since eCry3.1Ab is not considered toxic, EPA has not found Bacillus thuringiensis eCry3.1Ab protein in corn to share a common mechanism of toxicity with any other substances, and Bacillus thuringiensis eCry3.1Ab protein in corn does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that Bacillus thuringiensis eCry3.1Ab protein in corn does not have a common mechanism of toxicity with other substances. Following from this, EPA concludes that there are no cumulative effects associated with eCry3.1Ab that need to be considered. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative .

The data submitted and cited regarding potential health effects for the eCry3.1Ab protein include the characterization of the expressed eCry3.1Ab protein in corn, as well as the acute oral toxicity, heat stability, and in vitro digestibility of the protein. The results of these studies were used to evaluate human risk, and the validity, completeness, and reliability of the available data from the studies were also considered.

As discussed more fully in Unit III., the acute oral toxicity data submitted supports the prediction that the eCry3.1Ab protein would be nontoxic to humans. Moreover, eCry3.1Ab showed no sequence similarity to any known toxin. Because of this lack of demonstrated mammalian toxicity, no protein residue chemistry data for eCry3.1Ab were required for a human health effects assessment. Even so, preliminary expression level analysis showed eCry3.1Ab protein is present at relatively low levels. Dietary exposure is expected to be correspondingly low.

In addition, since eCry3.1Ab is a protein, its potential allergenicity was also considered as part of the toxicity assessment. Data considered as part of the allergenicity assessment include that the eCry3.1Ab protein came from Bacillus thuringiensis, which is not a known allergenic source, showed no sequence similarity to known allergens, was readily degraded by pepsin, and was not glycosylated when expressed in the plant. Therefore, there is a reasonable certainty that eCry3.1Ab protein will not be an allergen.

Considered together, the lack of mammalian toxicity at high levels of exposure to the eCry3.1Ab protein and the minimal potential for that protein to be a food allergen demonstrate the safety of the product at levels well above possible maximum exposure levels anticipated in the crop.

Finally, and specifically in regards to infants and children, FFDCA section 408(b)(2)(C) provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database unless EPA determines that a different margin of safety will be safe for infants and children.

Based on its review and consideration of all the available information, as discussed in more detail in this unit, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of the Cry3.1Ab protein and the genetic material necessary for its production in corn. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. EPA has also concluded, again for the reasons discussed in more detail in this unit, that there are no threshold effects of concern and, as a result, that an additional margin of safety for infants and children is unnecessary in this instance.

EPA has determined that an analytical method is not required for enforcement purposes since it is establishing an exemption from the requirement of a tolerance without any numerical limitation. Nonetheless, a method for extraction and two test strip commercial kits to detect eCry3.1Ab protein via enzyme-linked immunosorbent assay analysis in corn have been submitted.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. In this context, EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for Bacillus thuringiensis eCry3.1Ab protein in corn.

One comment was received from an anonymous individual who objected to the use or approval of Bacillus thuringiensis -based corn. The individual further stated that the subject Bt corn was toxic and harmful and that animals eating it would be poisoned. No basis was given for these comments. While EPA understands that some individuals are opposed to all pesticide use and/or biotechnology based products, relevant data discussed in this unit did serve as the basis for EPA's conclusion in this instance that there is a reasonable certainty of no harm from residues of Bacillus thuringiensis eCry3.1Ab protein in corn.

EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Bacillus thuringiensis eCry3.1Ab protein in corn and the genetic material necessary for its production. Therefore, the temporary exemption for residues of Bacillus thuringiensis eCry3.1Ab protein in corn, in or on the food or feed commodities of corn; corn, field; corn, sweet; and corn, pop, when used as a plant-incorporated protectant in accordance with the terms of Experimental Use Permit (EUP) No. 67979-EUP-8 is modified by extending the expiration date to December 31, 2013.

This final rule modifies a tolerance exemption under section 408(d) of FFDCA in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are modified on the basis of a petition under section 408(d) of FFDCA, such as the tolerance exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, EPA has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, EPA has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action does not involve any technical standards that would require EPA consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

In addition to accessing electronically available documents at http://www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the Federal Register listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0360 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 15, 2011.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2011-0360, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg., 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

A detailed summary of the background related to EPA's proposal to extend the time-limited interim tolerances for the combined residues of the insecticide tetrachlorvinphos, including its metabolites, in or on multiple commodities can be found in the Federal Register of June 8, 2011 (76 FR 33184) (FRL-8874-7), by going to http://www.regulations.gov, and is hereby incorporated by reference. The referenced document is available in the docket established by this action, which is described under ADDRESSES . Locate and click on the hyperlink for docket ID number EPA-HQ-OPP-2011-0360. Double-click on the document to view the referenced background summary information on pages 33186-33187. Two anonymous comments were received in response to the referenced proposal. These comments were non-substantive in nature and totally unrelated to EPA's proposal.

Therefore, an extension of the time-limited interim tolerances is established for the combined residues of the insecticide tetrachlorvinphos [(Z)-2-chloro-1-(2,4,5-trichlorophenyl) vinyl dimethyl phosphate], including its metabolites, 1-(2,4,5-trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5-trichloroacetophenone, and 1-(2,4,5-trichlorophenyl)-ethanediol, in or on cattle, fat (of which no more than 0.1 ppm is tetrachlorvinphos per se ) at 0.2 parts per million (ppm); cattle, kidney (of which no more than 0.05 ppm is tetrachlorvinphos per se ) at 1.0 ppm; cattle, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se ) at 0.5 ppm; cattle, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se ) at 2.0 ppm; cattle, meat byproducts, except kidney and liver at 1.0 ppm; egg (of which no more than 0.05 ppm is tetrachlorvinphos per se ) at 0.2 ppm; hog, fat (of which no more than 0.1 ppm is tetrachlorvinphos per se ) at 0.2 ppm; hog, kidney (of which no more than 0.05 ppm is tetrachlorvinphos per se ) at 1.0 ppm; hog, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se ) at 0.5 ppm; hog, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se ) at 2.0 ppm; hog, meat byproducts, except kidney and liver at 1.0 ppm; milk, fat (reflecting negligible residues in whole milk and of which no more than 0.05 ppm is tetrachlorvinphos per se) at 0.05 ppm; poultry, fat (of which no more than 7.0 ppm is tetrachlorvinphos per se ) at 7.0 ppm; poultry, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se ) at 2.0 ppm; poultry, meat (of which no more than 3.0 ppm is tetrachlorvinphos per se ) at 3.0 ppm; and poultry, meat byproducts, except liver at 2.0 ppm, for a period of 18 months following the date of publication of this final rule in the Federal Register. A time-limitation has been imposed in order to provide the Agency with additional time to complete the reviews of the submitted livestock Magnitude of Residue (MOR) data, storage stability data, and the waiver request for the swine MOR data. As a result, these time-limited interim tolerances will expire on March 18, 2013.

This final rule establishes tolerances under section 408(e) of FFDCA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

In addition, under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), the Agency previously assessed whether establishing tolerances, exemptions from tolerances, raising tolerance levels, or expanding exemptions might adversely impact small entities and concluded, as a generic matter, that there is no adverse economic impact. The factual basis for the Agency's generic certification for tolerance actions was published on May 4, 1981 (46 FR 24950), and was provided to the Chief Counsel for Advocacy of the Small Business Administration.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

Section 9004 of the Resource Conservation and Recovery Act (RCRA), 42 U.S.C. 6991c, authorizes EPA to approve underground storage tank programs to operate in the State in lieu of the federal underground storage tank (UST) program. To qualify for final approval, a state's program must be “no less stringent” than the federal program in all eight elements set forth at section 9004(a)(1) through (7) and (9) of RCRA, 42 U.S.C. 6991c(a)(1) through (7) and (9); include the notification requirements of RCRA section 9004(a)(8) and provide for adequate enforcement of compliance with UST standards (section 9004(a) of RCRA, 42 U.S.C. 6991c(a)). Note that the Energy Policy Act of 2005 added state-specific operator training requirements as a state program approval element in section 9004(a)(9). Although, EPA has not yet established performance criteria in 40 CFR Part 281 for making a no-less-stringent determination for the operator training element, EPA finds Oregon's operator training requirements to be consistent with Operator Training Grant Guidelines issued by EPA in 2007 and approves Oregon's operator training requirements in today's approval. Also, note that RCRA sections 9005 (on information-gathering) and 9006 (on Federal enforcement) by their terms apply even in states with programs approved by EPA under RCRA section 9004. Thus, the Agency retains its authority under RCRA sections 9005 and 9006, 42 U.S.C. 6991d and 6991e, and other applicable statutory and regulatory provisions to undertake inspections and enforcement actions in approved states. With respect to such an enforcement action, the Agency will rely on Federal sanctions, Federal inspection authorities, and Federal procedures rather than the State authorized analogues to these provisions.

On July 19, 2010, the State of Oregon submitted an official application to obtain final program approval to administer the underground storage tank program for petroleum and hazardous substances. On March 2, 2011, EPA published a tentative determination announcing its intent to approve the State of Oregon's program. Further background on the tentative decision to grant approval appears in the Federal Register at 76 FR 11404 (March 2, 2011).

Along with the tentative determination, EPA announced the availability of the application for public review and comment and the date of a public hearing on the application. EPA requested advance notice for testimony and reserved the right to cancel the public hearing in the event of insufficient public interest. Since there was no public request for a hearing, the public hearing was cancelled. No public comments were received regarding EPA's tentative approval of Oregon's underground storage tank program.

I conclude that the State of Oregon's application for program approval meets all of the statutory and regulatory requirements established by subtitle I of RCRA and 40 CFR part 281. Accordingly, Oregon is granted final approval to operate its underground storage tank program for petroleum and hazardous substances in lieu of the federal underground storage tank program. Oregon has primary enforcement responsibility for petroleum and hazardous underground storage tanks, although EPA retains the right to conduct enforcement actions for all regulated underground storage tanks under section 9006 of RCRA. This approval is subject to the terms and conditions set forth in the State's application for approval (including, but not limited to, the Memorandum of Agreement) and in the March 2, 2011 Federal Register Oregon: Tentative Approval of State Underground Storage Tank Program. This final determination to approve the Oregon program applies to all areas within the State except for land in Indian Country. This includes all lands within the exterior boundaries of the Grande Ronde, Klamath, Siletz, Umatilla and Warm Springs Reservations; any land held in trust by the United States for an Indian tribe, and any other lands that are Indian Country within the meaning of 18 U.S.C. 1151.

This rule only applies to Oregon's UST Program requirements pursuant to RCRA Section 9004 and imposes no requirements other than those imposed by State law. It complies with applicable EOs and statutory provisions as follows:

The Office of Management and Budget (OMB) has exempted this rule from its review under Executive Order 12866.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., because this rule does not establish or modify any information or recordkeeping requirements for the regulated community and only seeks to authorize the pre-existing requirements under State law and imposes no additional requirements beyond those imposed by State law. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing, and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in Title 40 of the CFR are listed in 40 CFR part 9.

The Regulatory Flexibility Act (RFA) generally requires Federal agencies to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business defined by the Small Business Administration's size regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. I certify that this rule will not have a significant economic impact on a substantial number of small entities because the rule will only have the effect of authorizing pre-existing requirements under State law and imposes no additional requirements beyond those imposed by State law.

This rule does not have any impacts as described in the Unfunded Mandates Reform Act because this rule codifies pre-existing requirements under State law and does not impose any additional enforceable duty beyond that required by State law. It does not contain any unfunded mandates or significantly or uniquely affects small governments.

This rule does not have Federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This rule authorizes pre-existing State rules. Thus, Executive Order 13132 does not apply to this rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (59 FR 22951, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This rule does not have tribal implications, as specified in Executive Order 13175 because EPA retains its authority over Indian Country. Thus, Executive Order 13175 does not apply to this rule.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it approves a state program.

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a “significant regulatory action” as defined under Executive Order 12866.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, 12(d) (15 U.S.C. 272), directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This rulemaking does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards.

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA has determined that this rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations. This rule does not affect the level of protection provided to human health or the environment because this rule authorizes pre-existing State rules which are no less stringent than existing Federal requirements.

Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business Regulatory Enforcement Fairness Act of 1996, EPA submitted a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives and the Comptroller General of the General Accounting Office prior to publication of the rule in today's Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Accordingly, the amendment to Table 1 of Appendix B to CFR part 300 to remove the entry “State Marine of Port Arthur Superfund Site,” “Port Arthur, Texas,” is withdrawn as of September 16, 2011.

This final rule implements the recommendations of the DoD Inspector General (IG) by providing a DFARS clause to use in lieu of the FAR clause at 52.203-14, Display of Hotline Poster(s).

Government Accountability Office (GAO) Report GAO-09-591, entitled “Defense Contracting Integrity: Opportunities Exist to Improve DoD's Oversight of Contractor Ethics Programs,” recommended that the DoD IG determine the need for defense contractors to display the DoD IG's fraud hotline poster.

The DoD IG determined that DoD contractors, including contractors that have an ethics and compliance program that includes a reporting mechanism such as a hotline poster, need to display DoD fraud hotline posters in a common work area within business segments performing work under the contract and at contract work sites.

FAR 52.203-14(c) states that “(i)f the Contractor has implemented a business ethics and conduct awareness program, including a reporting mechanism, such as a hotline poster, then the Contractor need not display any agency fraud hotline posters, other than any required DHS posters.” The DoD IG determined that this exemption has the potential to make the DoD hotline program less effective by ultimately reducing contractor exposure to DoD IG fraud hotline posters and diminishing the means by which fraud, waste, and abuse can be reported under the protection of Federal whistleblower protection laws. According to the DoD IG, some contractors' posters may not be as effective as the DoD poster in advertising the hotline number, which is integral to the fraud program. The DoD IG is also revising the DoD IG fraud hotline poster to inform contractor employees of their Federal whistleblower protections.

Therefore, the prescription for use of the new DFARS clause provides no exception to the use of the DoD hotline poster for contractors that have implemented a business ethics and conduct awareness program, even those that include a reporting mechanism such as a hotline poster.

DoD published a proposed rule at 76 FR 13327 on March 11, 2011, to implement the DoD IG's policy. Nine respondents submitted 25 public comments on the proposed rule. The comments are summarized and discussed in the following paragraphs.

Comments: Four respondents supported the DFARS rule, stating that it would assist employees in reporting fraud, waste, and abuse and might promote qui tam suits. Two respondents recommended expanding the rule's applicability by (1) Lowering the threshold or (2) making it applicable to U.S.-owned and -operated firms that perform overseas.

Response: DoD acknowledges the respondents' support. DoD declines to expand the rule's applicability because the prescription and conditions for the use of the hotline poster in DoD contracts are exactly those prescribed at FAR 3.1004(b) for the inclusion of the FAR clause at 52.203-14, Display of Hotline Poster(s). The respondents did not provide rationale supporting the proposed further expansion of requirements to use the DoD IG hotline poster clause.

Comments: One respondent asked that the DFARS Procedures, Guidance and Information (PGI), include guidance on obtaining relevant information to be inserted in the clause regarding the title of the applicable Department of Homeland Security (DHS) fraud hotline poster and Web site(s) or other contact information. Another respondent, however, stated that the requirement, at 252.203-700X(b)(ii) of the proposed rule, to display the DHS fraud hotline posters, is unnecessary for several reasons. It is unlikely, according to the respondent, that DoD would be awarding DHS contracts for disaster recovery, and the coverage at FAR 52.203-14 relating to the display of DHS fraud hotline posters does not need to be duplicated in the DFARS.

Response: There is a reason to include in the DFARS clause a requirement to use the DHS fraud hotline poster when DHS disaster relief funding is added to a DoD contract. The DoD clause prescription has been expanded (at 203.1004(b)(2)(ii)) to explain that information regarding the DHS hotline poster is needed only when DHS disaster relief funding is added to the DoD contract. In most cases, there is no need to display the DHS hotline poster and, therefore, no need to include in the clause information about where to obtain the DHS poster. Adding this clarification to the DFARS clause prescription removes any need to add PGI guidance on relevant information regarding the applicable DHS fraud hotline poster and Web sites or other contact information.

Comments: Five comments were received on this issue. One respondent remarked that the new requirement will be unnecessarily burdensome with little, if any, commensurate benefit. The respondent called the rule “an example of the stacking of regulations within and across agencies that increases the burden without any apparent benefit to achieving the mission.” Three other respondents made essentially the same point, one suggesting that the rule could be viewed as an unintentional but unfortunate effort by DoD to discourage contractors from implementing rigorous internal mechanisms for dealing with compliance concerns. A respondent suggested that the proposed rule ignored the significant change already made to the FAR that requires mandatory reporting to the agency IG if the contractor has credible evidence of a violation of Federal criminal law involving fraud, conflict of interest, bribery, or gratuity, or a violation of the civil False Claims Act in connection with Government contracts (see FAR 3.1003(b)).

According to one respondent, many company employee hotline reports simply disclose a concern about an activity or behavior without the employee knowing whether it violates only company policy or some Government contract provision or law. Posting the DoD IG hotline poster will confuse employees, asserted the respondent, and will result in company employees not reporting potentially valuable information to anyone.

Response: A requirement to hang a free poster in work areas does not appear to be measurably burdensome. Further, the DoD poster contains a prominent location for inclusion of the contractor's own fraud hotline number and does not preclude or preempt posting of a contractor's separate fraud hotline poster. As to any additional burden on the DoD IG, that office has weighed the potential cost and elected this approach.

Comments: One respondent stated that this change would seriously undermine the role company hotline posters have in internal contractor compliance and ethics programs. The respondent noted that these company programs have a proven track record of inhibiting improper and/or illegal behavior. This respondent and one other respondent expressed concern that, from a purely practical perspective, removing the exemption and requiring the use of the DoD hotline posters will usurp the company's position as the first line of defense against waste and fraud and, instead, place the DoD/IG in that role.

Response: There is no intent to replace the company hotline poster. This rule supplements the Government defense against fraud, waste, and abuse.

Comments: Five comments were received from two respondents. A respondent concluded that posting the DoD IG fraud hotline poster will result in the DoD IG becoming involved in matters of an urgent nature, as well as a significant number of day-to-day issues. Both respondents pointed out that the majority of the matters reported to company hotlines are human resource-related issues that have little or nothing to do with the direct performance and final deliverables under DoD-funded contracts and subcontracts. The respondents were concerned that, if such matters are reported through the DoD IG fraud hotline rather than directly to the contractor, the latter will be left to learn about them from the DoD IG and will be unable to respond quickly, which ultimately will have a negative impact on employee morale. Further, display of the DoD IG fraud hotline posters, according to a respondent, will assuredly result in the DoD IG being quickly drawn into a myriad of personnel and related issues, thus bogging down the system. The respondents considered that result to be against the best interests of both DoD and its contractors.

The respondents also noted that, if employees choose to contact the DoD IG hotline regarding more serious potential workplace-safety or product-quality matters, the contractor may not learn about these matters in a timely manner, thereby increasing the possibility of injury or deficient product quality. The respondents suggested that directly inserting the DoD IG into these matters could potentially result in DoD “taking on some measure of responsibility for failing to respond in a timely manner.” One of the respondents quoted the GAO report as recognizing these potential issues:

Response: This rule provides contractor employees with more than one option for reporting matters of concern. Further, the Office of the DoD IG advises that its fraud hotline is adequately staffed with personnel trained to recognize and react appropriately to reports with the potential to affect safety or quality. They further advise that the staff is trained to distinguish between routine personnel issues and those that impact Government contracts.

Comments: Four respondents raised issues on this subject. One respondent pointed out that contractors already have existing contractual and regulatory duties to notify the Government of certain significant events that occur in connection with contract performance. Another respondent stated that the requirement is likely to lead to confusion as to appropriate reporting channels and mechanisms. The respondents asserted that defense industry and research institutions, as well as other segments of DoD's contracting community, take most seriously the responsibility to self-report or voluntarily disclose violations to the Government. Contractors also take very seriously the need to have open and accessible reporting mechanisms and respond expeditiously and thoroughly to matters raised through those reporting mechanisms. Creating an alternate reporting mechanism without the same level of accountability as the contractor's in-house or external reporting mechanism, according to respondents, adds no value to the process and undermines existing systems, processes, and programs already in place. A respondent took issue with the DoD IG implication, made in the background section of the proposed rule (76 FR 13328, March 11, 2011), that reports made to a contractor hotline diminished the protections available under Federal whistleblower-protection laws. This respondent expressed the strong belief that adequate provisions ensure that employees who in good faith report information to a company hotline, but who are not themselves culpable, have full whistleblower protection for their disclosures.

Response: For those contractors that have existing internal compliance programs with a fraud hotline number, the posting of the DoD IG fraud hotline poster supplements the existing reporting mechanisms. A contractor's existing duty to self-report or voluntarily disclose violations to the Government is not preempted by posting the DoD IG fraud hotline poster.

Comments: One respondent expressed strong support for the $5 million threshold and the exclusions provided for prime contracts that are for commercial items or that will be performed entirely outside the U.S. This respondent also strongly supported the $5 million threshold for flowdown of the requirement to subcontracts, as well as the exclusion from the flowdown requirement for subcontracts that are for commercial items or that will be performed entirely outside the U.S. However, the respondent recommended that the flowdown requirement be further limited to first-tier subcontracts.

Response: DoD has adopted the same criteria for flowdown of the new clause at DFARS 252.203-7004, Display of Fraud Hotline Posters, as is used for the comparable clause at FAR 52.203-14, Display of Hotline Posters. Because DoD is using DFARS 252.203-7004 in lieu of the clause at FAR 52.203-14, DoD has retained the same criteria for flowdown to subcontractors.

Comment: A respondent noted that the nature of the workplace has changed significantly, making the requirement to display the DoD IG hotline poster in traditional office locations less effective than it might have been in the past. The respondent, noting that the clause at FAR 52.203-14 already requires each company to display the hotline poster on the company's Web site, if a Web site is maintained, recommended that the DFARS final rule allow electronic posting to satisfy the regulatory requirement to “display the hotline poster in common work areas.”

Response: The DFARS coverage specifically requires electronic display, if the contractor maintains a Web site, in addition to physical display. These are the same posting rules as are used in the comparable FAR clause, 52.203-14, Display of Fraud Hotline Posters.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all 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). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

DoD does not expect this final rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because the requirement to display posters has minimal economic impact and the rule only applies to contracts and subcontracts that exceed $5 million in value, so few small business concerns are impacted. However, a final regulatory flexibility analysis has been performed and is summarized as follows:

This rule was initiated in response to a Government Accountability Office (GAO-09-591) recommendation that the DoD IG should determine the need for defense contractors to display the DoD IG's fraud hotline poster. The DoD IG subsequently determined that DoD contractors, including contractors with an ethics and compliance program that includes a reporting mechanism such as a hotline poster (currently exempt), need to display DoD fraud hotline posters in a common work area within business segments performing work under the contract and at contract work sites.

The final rule does not include an exemption for DoD contractors to post their own company posters instead of the DoD IG hotline poster and requires all DoD contractors with contracts that exceed $5 million to post the DoD IG fraud hotline poster. The DoD IG determined that this FAR exemption to the posting of an agency's fraud hotline poster had the potential to make the DoD IG hotline program less effective by ultimately reducing contractor exposure to DoD IG fraud hotline posters and diminishing the means by which fraud, waste, and abuse can be reported under the protection of Federal whistleblower protection laws. The DOD IG further determined that some contractors' posters may not be as effective as the DoD poster in advertising the hotline number, which is integral to the DoD fraud program. The legal basis for the rule is 41 U.S.C. 1303 and 48 CFR chapter 1.

The rule applies to all contractors with DoD contracts with a value that exceeds $5 million. Many small businesses, therefore, are not impacted.

Paragraph (c) of the clause at FAR 52.203-14 provides that a contractor need not display any agency fraud hotline posters (other than required DHS posters) if the contractor has implemented a business ethics and conduct awareness program that includes a reporting mechanism such as a hotline poster. The DFARS rule differs only in that it removes this FAR exemption.

There is no reporting or recordkeeping requirement established by this rule. The rule does not duplicate, overlap, or conflict with any other Federal rules. There are no alternatives that would achieve the objectives of the final rule. No comments were received on the small business impact in response to the initial regulatory flexibility analysis.

Interested parties may obtain a copy of the final regulatory flexibility analysis (FRFA) from the point of contact named herein. A copy of the FRFA has been submitted to the Chief Counsel for Advocacy of the Small Business Administration.

The 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. chapter 35).

Therefore, 48 CFR parts 203 and 252 are amended as follows:

An interim rule was published in the Federal Register under DFARS Case 2009-D039, Award-Fee Reductions for Health and Safety Issues, on November 12, 2010, at 75 FR 69360 to implement section 823 of the National Defense Authorization Act for Fiscal Year 2010 (Pub. L. 111-84). This interim rule includes the review of public comments received in response to the Federal Register notice for DFARS Case 2009-D039. DFARS Case 2009-D039 was merged into this case, DFARS Case 2011-D033, after the NDAA for FY 2011 (Pub. L. 111-383) was enacted on January 7, 2011, in order to combine related sections of the NDAAs for FY 2010 and FY 2011 affecting identical sections of the DFARS.

• The NDAA for FY 2011 was enacted on January 7, 2011. Section 834 of the statute added to existing statutory authorities to decrease or eliminate a contractor's award fee for a performance period based on a final determination resulting from a DoD investigation of a serious bodily injury or death of any civilian or military personnel alleged to have been caused by a contractor or subcontractor.

• Section 834 applies only to contractors and subcontractors at any tier that are not subject to the jurisdiction of U.S. courts.

A contractor's award fee is affected if, after the investigation, a determination is made that the serious bodily injury or death was caused by the contractor's or subcontractor's gross negligence or with reckless disregard for the safety of civilian or military personnel of the Government.

Senate Report 111-201, “to accompany S. 3454, the National Defense Authorization Act for Fiscal Year 2011,” associated with section 834, stated that investigations under the provision would be conducted pursuant to existing DoD procedures for administrative fact-finding investigations, such as those provided by Army Regulation 15-6 and the Manual of the Judge Advocate General of the Navy. Defense Criminal Investigative Organizations (DCIOs) have procedures in place currently for conducting criminal investigations of contractor misconduct. In addition, the Military Services have procedures for conducting administrative investigations involving actions related to civilian and military personnel. Findings of criminal misconduct are made at the conclusion of the DCIO investigations.

• The statute also modifies section 872 of the NDAA for FY 2009 (Pub. L. 110-417), and requires that information on the final determination be entered into the Federal Awardee Performance and Integrity Information System (FAPIIS) (see DFARS 209.105-2-70) and will be available to the public.

DoD has added a provision at DFARS 209.105-2-70 to provide for the inclusion of a final determination of contractor fault in the FAPIIS (see FAR 9.104-6 and http://www.ppirs.gov ). In addition, the requirements of section 834 have been included at DFARS 216.405-2-70, Award fee reduction or denial for jeopardizing the health or safety of Government personnel, and added as a fifth cause for reducing or denying a contractor's award fee in the clause at DFARS 252.216-7004.

The related statutory provision, section 823 of the NDAA for FY 2010, currently is addressed at DFARS 216.405-2-70, Award fee reduction for jeopardizing the health or safety of Government personnel, and the clause at DFARS 252.216-7004 (similarly titled), which require the contracting officer to include in the evaluation criteria of any award-fee plan a review of contractor actions that jeopardized the health and safety of Government personnel. As previously discussed, the section 823 requirement was implemented in the DFARS by DFARS Case 2009-D039, published in the Federal Register as an interim rule on November 12, 2010, at 75 FR 69360, prior to its being merged into this case, 2011-D033, Award Fee Reduction or Denial for Health or Safety Issues.

The public comment period for the interim rule issued under DFARS Case 2009-D039 closed January 24, 2011. Two respondents submitted comments on the interim rule. The individual comments are discussed below.

Comment: A respondent recommended that the rule be applied to harm caused to any person (not just Government employees).

Response: Section 823 addresses “serious bodily injury or death to any civilian or military personnel of the Government.” Extension of the application of this rule to any person is outside the scope of the statute.

Comment: The respondent commented that the definition of “covered incident” should be broadened, such that contractors are not encouraged to settle out of court and thus deny any liability or wrong-doing and protect their award fees.

Response: The rule implements the statutory definition of a “covered incident” in section 823 of the NDAA for FY 2010, which provides instructions to the contracting officer to reduce the award fee if the contractor is found at fault for a covered incident. It does not instruct the Government on how to proceed with any investigation or resolve covered incidents. No changes to the statutory definition are determined necessary in response to this comment.

Comment: A respondent called for the contracting officer to be allowed to consider any incident that calls into question a contractor's integrity or responsibility when deciding whether to reduce or deny award fees.

Response: Extension of the application of this rule to any incident that calls into question a contractor's integrity or responsibility is outside the scope of the statute; however, other parts of the FAR, such as FAR parts 3, Improper Business Practices and Personal Conflicts of Interest, and 9, Contractor Qualifications, and the related DFARS parts, provide information on dealing with contractor responsibility and improper business practices.

Comment: A respondent stated that contracting officers should be required to make a written determination regarding decisions to reduce or deny the award fee or decline to do so. The statements should also be made available to the public, according to this respondent.

Response: FAR 16.401(e)(2) states that “(t)he basis for all award-fee determinations shall be documented in the contract file, to include, at a minimum, a determination that overall cost, schedule, and technical performance in the aggregate is or is not at a satisfactory level.” The award-fee determination does not go into FAPIIS. It is the “final determination of contractor fault by the Secretary of Defense” (section 834(d)) that is required to be submitted into FAPIIS. While the latter determination impacts the former determination, they are not the same thing. A requirement for public posting of award-fee determinations is outside the scope of the statute.

Comment: The respondent noted that contractors performing on contracts within Government facilities have little control over the conditions of the facilities, the funding to provide for repairs to facilities, or the priorities of the repairs.

Response: The DFARS clause at 252.216-7004, Award Fee Reduction or Denial for Jeopardizing the Health or Safety of Government Personnel, applies only when a direct, causal connection is found between a contractor's actions and a serious bodily injury to a Government employee.

Comment: The respondent expressed concern that, if a contractor is found partially liable under the Occupational Safety and Health Administration multi-employer worksite policy for a hazardous worksite condition that caused serious injury, then the contractor's future/past award fee could be reduced or denied.

Response: The statute as implemented in DFARS clause 252.216-7004, requires that if a contractor is found liable in a covered incident for causing serious bodily injury to a Government employee, the contracting officer must consider reducing or denying the relevant award fee.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all 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). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is a significant regulatory action and therefore was subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This is not a major rule under 5 U.S.C. 804.

On November 12, 2010, DoD published an interim rule at 75 FR 69360 implementing section 823 of the NDAA for FY 2010. The interim rule was immediately effective upon publication. Section 823 required contracting officers to consider reduction or denial of award fee if the actions of the contractor or a subcontractor at any tier jeopardize the health or safety of Government personnel. DoD did not prepare an initial regulatory flexibility analysis at that time because generally, contracts awarded to small business are not likely to utilize incentive- and award-fee contract structures. No comments were received on the regulatory flexibility section of the notice for the interim rule implementing section 823.

DoD does not expect this interim rule implementing section 834 of the NDAA for FY 2011 to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. This rule does not apply to firms that are subject to the jurisdiction of U.S. courts. By definition, small businesses are U.S. businesses and, therefore, are subject to the jurisdiction of the U.S. courts. Accordingly, this rule will not affect small businesses. An initial regulatory flexibility analysis has not been performed because this rule will apply only to primes and subcontractors at any tier that are not subject to the jurisdiction of the U.S. courts. DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.

DoD will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2011-D033) in correspondence.

The interim 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. chapter 35).

A determination has been made under the authority of the Secretary of Defense (DoD) that urgent and compelling reasons exist to promulgate this interim rule without prior opportunity for public comment. Pursuant to section 823 of the NDAA for FY 2010, contracting officers shall include in the evaluation criteria of any award-fee plan, a review of contractor and subcontractor actions that jeopardize the health and safety of Government personnel, through gross negligence or reckless disregard for the safety of such personnel, as determined through conviction in a criminal proceeding or finding of fault and liability in a civil or administrative proceeding. Additionally, pursuant to section 834 of the NDAA for FY 2011, which became effective on enactment, January 7, 2011, contracting officers are authorized to make a determination of contractor or subcontractor fault where DoD has reason to believe that a contractor or subcontractor may have caused the serious bodily injury or death of civilian or military personnel and the contractor or any subcontractor is not subject to the jurisdiction of the U.S. courts. If DoD finds that a contractor or subcontractor caused the death or serious injury through gross negligence or with reckless disregard for the safety of such personnel, this final determination shall be included in award-fee determinations, thereby providing an important remedy for those situations where a DoD contractor or subcontractor is not otherwise subject to U.S. court jurisdiction. Issuing an interim rule will provide contracting officers with this important remedy immediately upon publication of the rule. However, pursuant to 41 U.S.C. 1707 (formerly 41 U.S.C. 418b) and FAR 1.501-3(b), DoD will consider public comments received in response to this interim rule in the formation of the final rule.

Therefore, 48 CFR parts 209, 216, and 252 are amended as follows:

This DFARS case was initiated to implement an initiative to incentivize productivity and innovation in industry, as set forth in a memorandum from the Under Secretary of Defense for Acquisition, Technology, & Logistics (USD(AT&L)), dated November 3, 2010. The memorandum provided guidance to the secretaries of the military departments and directors of defense agencies on obtaining greater efficiency and productivity in defense spending. In support of this initiative, DoD published a proposed rule in the Federal Register on March 2, 2011 (76 FR 11410). The proposed rule required that contracting officers must—

(1) Give particular consideration to the use of fixed-price incentive (firm target) contracts, especially for acquisitions moving from development to production; and

(2) Pay particular attention to share line and ceiling prices for fixed-price incentive (firm target) contracts, with 120 percent ceiling and a 50/50 share ratio as the default arrangement.

The respondent considered that the incorporation of a broad preference to use a 50/50 share line with a ceiling of 120 percent is a mistake for Government acquisitions for the reasons discussed in the following comments.

Comment: The respondent provided anecdotal evidence that currently acquisition leadership translates this preference as a mandatory requirement.

Response: All of the documentation for this case, and all of the presentations by senior acquisition leaders within DoD, have emphasized that this initiative is to be implemented in a way that makes sense for each individual acquisition. The guidance in the DFARS companion Procedures, Guidance, and Information (PGI) reiterates that each situation must be evaluated in terms of the degree and nature of the risk presented in order to select the proper contract type. The PGI also provides additional guidance on establishing the target cost, share lines, and ceiling price. This regulation is not a “one-size-fits-all” mandate.

However, to make the final rule more consistent with the terminology of the USD(AT&L) memo of November 3, 2010, and to clarify that each contract must be considered on a case-by-case basis, DoD has revised the description of the use of a fixed-price incentive (firm target) contract with a 50/50 share ratio and a 120 percent ceiling from “the default arrangement” to “the point of departure for establishing the incentive arrangement.”

Comment: According to the respondent, the Institute for Defense Analyses (IDA) study, Can Profit Policy and Contract Incentives Improve Defense Contract Outcomes?, makes a strong case for the ineffectiveness of incentive contracts.

Response: The majority of incentive contracts covered by the IDA study were award-fee contracts, not fixed-price incentive (firm target) contracts. Furthermore, DoD is actively taking steps to ensure that incentives are linked to acquisition outcomes and the profits are tied to performance in achieving those outcomes.

Comment: The respondent stated that in order to correct the use of incentives, DoD should mandate that contracting officers use a true pessimistic/optimistic weighted average and ensure that their cost curves do not mirror cost-plus-fixed-fee cost curves.

Response: DoD endorses the respondent's concept that contracting officers should carefully develop a realistic target cost and that an incentive contract should provide adequate incentives. The reason for specifying the 120 percent ceiling and the 50/50 cost sharing arrangement as the point of departure for establishing the incentive arrangement is to promote cost realism and discourage an incentive arrangement that does not provide adequate incentive to the contractor to control costs. An excessively flat share line approaches a cost-plus-fixed-fee arrangement (100/0), thereby providing almost no incentive to the contractor to control costs. A 50/50 share line suggests that the Government and the contractor have a common view of the likely contract execution cost. A 50/50 share line should represent a point where the estimate is deemed equally likely to be too high or too low. However, as already stated, rather than issuing mandates, DoD encourages the evaluation of each situation in terms of the degree and nature of the risk presented in order to select the proper contract type and, if an incentive contract type is selected, the appropriate incentive arrangement.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all 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). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

DoD has prepared a final regulatory flexibility analysis (FRFA) consistent with the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. The FRFA is summarized as follows:

This rule amends the Defense Federal Acquisition Regulation Supplement to implement the initiative on incentivizing productivity and innovation in industry, as presented by the Under Secretary of Defense for Acquisition, Technology, & Logistics in a memorandum dated November 3, 2010. The objective of the rule is to incentivize contractors to control costs. The legal basis is 41 U.S.C. 1303 and 48 CFR chapter 1.

There were no public comments in response to the initial regulatory flexibility analysis.

The final rule will not have much impact on small entities, because the focus of the rule is on development efforts that are moving into early production. Small entities are more likely to receive awards for commercial products, including commercially available off-the-shelf products, for which firm-fixed-price contracts are appropriate. In Fiscal Year 2010, 93 percent of awards to small businesses were firm-fixed-price contracts, and 99.99 percent of awards to small businesses were other than fixed-price incentive contracts.

The final rule imposes no reporting, recordkeeping, or other information collection requirements.

There are no known alternatives to the rule that would adequately implement the DoD policy. There is no significant economic impact on small entities.

There are no other alternatives that will accomplish the objectives of the rule.

The final rule does not contain any information collection requirements that require approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

Therefore, 48 CFR part 216 is amended as follows:

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

NMFS closed directed fishing for shallow-water species by vessels using trawl gear in the GOA under § 679.21(d)(7)(i) on September 3, 2011 (76 FR 55726, September 7, 2011).

As of September 12, 2011, NMFS has determined that approximately 149 metric tons remain in the fourth seasonal apportionment of the 2011 Pacific halibut bycatch allowance specified for the trawl shallow-water species fishery in the GOA. Therefore, in accordance with § 679.25(a)(1)(i), (a)(2)(i)(C) and (a)(2)(iii)(D), and to fully utilize the fourth seasonal apportionment of the 2011 Pacific halibut bycatch allowance specified for the trawl shallow-water species fishery in the GOA, NMFS is terminating the previous closure and is opening directed fishing for trawl shallow-water species by vessels using trawl gear in the GOA. This will enhance the socioeconomic well-being of harvesters dependent upon shallow-water species in this area. The Administrator, Alaska Region (Regional Administrator) considered the following factors in reaching this decision: (1) The current catch of halibut by trawl vessels participating in the shallow-water species fisheries and, (2) the harvest capacity and stated intent on future harvesting patterns of vessels participating in this fishery.

In accordance with § 679.21(d)(7)(i), the Regional Administrator has determined that the fourth seasonal apportionment of the Pacific halibut bycatch allowance specified for the trawl shallow-water species fishery in the GOA will be reached after 48 hours. Consequently, NMFS is prohibiting directed fishing for the shallow-water species fishery by vessels using trawl gear in the GOA. The species and species groups that comprise the shallow-water species fishery are pollock, Pacific cod, shallow-water flatfish, flathead sole, Atka mackerel, skates, and “other species.” This prohibition does not apply to fishing for pollock by vessels using pelagic trawl gear in those portions of the GOA open to directed fishing for pollock. This inseason action does not apply to vessels fishing under a cooperative quota permit in the cooperative fishery in the Rockfish Program for the Central GOA.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the opening of directed fishing for shallow-water species by vessels using trawl gear in the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent and relevant data only became available as of September 12, 2011.

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

Without this inseason adjustment, NMFS could not allow the fishery for shallow-water species by vessels using trawl gear in the GOA to be harvested in an expedient manner and in accordance with the regulatory schedule. Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until September 28, 2011.

This action is required by § 679.20 and § 679.25 and is exempt from review under Executive Order 12866.