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. The FAA therefore finds that good cause exists for making these special conditions effective upon publication in the Federal Register .

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 will consider all comments we receive on or before the closing date for comments. We may change these special conditions based on the comments we receive.

On November 30, 2011, Dassault Aviation applied for a change to Type Certificate No. A50NM for the installation of removable storage lockers of two possible sizes (approximately 6.9 and 8.1 cubic feet in volume) in the forward servicing compartment (FSC) of the Falcon 2000/2000EX series airplanes. The Falcon 2000/2000EX are business-class airplanes powered by two turbofan engines, designed for a maximum of 21 occupants, with a maximum takeoff weight of 36,500 pounds for the Falcon 2000 and 42,800 pounds for the Falcon 2000EX.

The FSC is an un-pressurized compartment that is not accessible in flight. It is accessible on the ground from a lockable external door located in the lower aft fuselage. The removable storage lockers (fire containment containers) that will be installed in the FSC will be used mainly for stowage of items to support airplane operations such as the tow bar, ladder, fly-away kit/Electronic Control Unit cover, tool box, and limited passenger items (i.e., golf clubs/golf bags, skis/ski bags). The existing regulations do not adequately address small, inaccessible cargo compartments of this type and function. These special conditions are necessary to ensure a level of safety equivalent to that provided by existing regulations.

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.101, Dassault Aviation must show that the Falcon 2000/2000EX series airplanes, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A50NM or the applicable regulations in effect on the date of application for the change. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” The regulations incorporated by reference in Type Certification No. A50NM are as follows: 14 CFR part 25, as amended by Amendments 25-1 through 25-69 for the Falcon 2000 and 25-1 through 25-98 for the Falcon 2000EX, and 14 CFR part 26, as amended by Amendments 26-1 through 26-6. Dassault Aviation also elects to comply with §§ 25.855, 25.857, and 25.601 through Amendment 25-123, effective December 10, 2007.

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 Falcon 2000/2000EX series airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 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 novel or unusual design feature, the special conditions would also apply to the other model.

In addition to the applicable airworthiness regulations and special conditions, the Falcon 2000/2000EX 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 § 21.101.

The Falcon 2000/2000EX series airplanes will incorporate the following novel or unusual design feature: Removable storage lockers (fire containment containers) installed in the forward servicing compartment (FSC). The FSC is un-pressurized and not accessible in flight; it is accessible on the ground from a lockable, external door located in the lower aft fuselage. The FSC area is designed to host several critical systems; therefore, considering past experience on cargo loading, appropriate design and procedures must be in place to ensure safe installation.

Sections 25.855 provides the design and test requirements for cargo compartments, and § 25.857 describes cargo compartment classifications. The removable storage lockers to be installed in the Falcon 2000/2000EX do not meet any of the existing FAA cargo compartment classifications of cargo compartments and, therefore, would not meet all of the requirements of §§ 25.855 and 25.857.

The European Aviation Safety Agency (EASA) determined that the installation of removable storage lockers in the FSC, except the tow bar and the maintenance ladder stowage, is not compliant with their corresponding Joint Aviation Regulations (JAR) 25.855 and 25.857. EASA's position is that the proposed design and configuration corresponds most closely to, but does not fully meet, a Class F cargo compartment classification defined in their Certification Specifications (CS) 25.857(f) at Amendment 11 in the Fire Containment Container (FCC) option. Class F cargo compartments are further detailed in their Acceptable Means of Compliance (AMC) to CS 25.857(f). FAA is in the rulemaking process of incorporating similar regulations into 14 CFR part 25, and we concur with EASA findings.

EASA proposed special conditions for the approval of these installations. The FAA reviewed the proposed special conditions and determined that they are functionally equivalent to what we would have issued, and that they provide an acceptable level of safety as related to fire containment containers and the requirements of §§ 25.601, 25.855, and 25.857. The FAA finding was based in part on consideration that the proposed containers are not intended to be used for “cargo for hire” or carriage of oxygen or oxygen producing equipment; the container is not intended to be used for carriage of flammable fluids; and, the container is not intended to be used for carriage of more typical passenger/crew baggage, only for the carriage of passenger ski and golf equipment.

As discussed above, these special conditions are applicable to the Dassault Aviation Falcon 2000/2000EX series airplanes. Should Dassault Aviation 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 two model series of airplanes. It is not a rule of general applicability.

Under standard practice, the effective date of final special conditions would be 30 days after the date of publication in the Federal Register ; however, as the certification date for the Dassault Falcon 2000/2000EX series airplanes is imminent, the FAA finds that good cause exists to make these special conditions effective upon publication in the Federal Register .

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Dassault Aviation Falcon 2000/2000EX series airplanes.

1. In order to be acceptable, a container to be placed in the aft unpressurized compartment must comply with the following:

a. The container must be constructed of materials compliant with 14 CFR part 25, appendix F, part III and be sufficiently durable to withstand in-service conditions.

b. It must be demonstrated by test that the container is capable of containing a wide range of internal fire threats, for any period of time, while ensuring that adjacent systems, structure, and occupied areas are protected from the effects of smoke, flames, extinguishing agent, heat, or any other adverse effect. It must also be demonstrated that damage to the airplane's systems or structure cannot be caused by the use of the container.

c. The Operating Limitations section of the Airplane Flight Manual must contain a content limitation, approved by the FAA and justified on the base of operational need and demonstrated low-fire risk. The content limitation must:

• Require that any fire containment container be clearly identified with placards on the container and in the compartment hosting the container;

• Be reflected on any weight and balance or other document used to load the airplane; and

• Include easy-to-follow procedures for loading, installation, and de-installation of the container, e.g., airplane flight crew verification of content before every flight, installation/de-installation only by qualified personnel, etc.

Background

On December 10, 2009, Bombardier Aerospace applied for a type certificate for their new Models BD-500-1A10 and BD-500-1A11 series airplanes (hereafter collectively referred to as “CSeries”). The CSeries airplanes are swept-wing monoplanes with an aluminum alloy fuselage sized for 5-abreast seating. Passenger capacity is designated as 110 for the Model BD-500-1A10 and 125 for the Model BD-500-1A11. Maximum takeoff weight is 131,000 pounds for the Model BD-500-1A10 and 144,000 pounds for the Model BD-500-1A11.

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.17, Bombardier Aerospace must show that the CSeries airplanes meet the applicable provisions of 14 CFR part 25 as amended by Amendments 25-1 through 25-129 thereto.

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 CSeries airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 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, the special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the CSeries 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, and the FAA must issue a finding of regulatory adequacy under § 611 of Public Law 92-574, the “Noise Control Act of 1972.”

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 § 21.17(a)(2).

The CSeries airplanes will incorporate the following novel or unusual design features: A fly-by-wire electronic flight control system (EFCS) and no direct coupling from the flightdeck controller to the control surface. As a result, the pilot is not aware of the actual control surface position as envisioned under current airworthiness standards.

These special conditions require that the flightcrew receive a suitable flight control position annunciation when a flight condition exists in which nearly full surface authority (not crew-commanded) is being used. Suitability of such a display must take into account that some pilot-demanded maneuvers (e.g., rapid roll) are necessarily associated with intended full performance, which may saturate the surface. Therefore, simple alerting systems function in both intended and unexpected control-limiting situations. As a result, they must be properly balanced between providing necessary crew awareness and being a potential nuisance to the flightcrew. A monitoring system that compares airplane motion and surface deflection with the demand of the pilot side stick controller could help reduce nuisance alerting.

These special conditions also address flight control system mode annunciation. Suitable mode annunciation must be provided to the flightcrew for events that significantly change the operating mode of the system but do not merit the classic “failure warning.”

These special conditions establish a level of safety equivalent to that provided by a conventional flight control system and existing regulations.

Notice of proposed special conditions No. 25-13-40-SC for the Bombardier CSeries airplanes was published in the Federal Register on December 12, 2013 (78 FR 75511). No comments were received, and the special conditions are adopted as proposed.

As discussed above, these special conditions are applicable to the Models BD-500-1A10 and BD-500-1A11 series airplanes. Should Bombardier Aerospace 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 two model series of airplanes. It is not a rule of general applicability.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Bombardier Aerospace Models BD-500-1A10 and BD-500-1A11 series airplanes.

Background

On December 10, 2009, Bombardier Aerospace applied for a type certificate for their new Models BD-500-1A10 and BD-500-1A11 series airplanes (hereafter collectively referred to as “CSeries”). The CSeries airplanes are swept-wing monoplanes with an aluminum alloy fuselage sized for 5-abreast seating. Passenger capacity is designated as 110 for the Model BD-500-1A10 and 125 for the Model BD-500-1A11. Maximum takeoff weight is 131,000 pounds for the Model BD-500-1A10 and 144,000 pounds for the Model BD-500-1A11.

The design of the electronic flight control system for the CSeries airplanes incorporates normal load factor limiting on a full time basis that prevents the flightcrew from inadvertently or intentionally exceeding the positive or negative airplane limit load factor. This feature is considered novel and unusual in that the current regulations do not provide standards for maneuverability and controllability evaluations for such systems.

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.17, Bombardier Aerospace must show that the CSeries airplanes meet the applicable provisions of part 25 as amended by Amendments 25-1 through 25-129 thereto.

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 CSeries airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 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, the special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the CSeries 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, and the FAA must issue a finding of regulatory adequacy under § 611 of Public Law 92-574, the “Noise Control Act of 1972.”

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 § 21.17(a)(2).

The CSeries airplanes will use a fly-by-wire electronic flight control system (EFCS). This system provides an electronic interface between the pilot's flight controls and the flight control surfaces for both normal and failure states; and it generates the actual surface commands that provide for stability augmentation and control about all three airplane axes.

The design of the EFCS incorporates the following novel or unusual design feature: Normal load factor limiting on a full-time basis that will prevent the flight crew from inadvertently or intentionally exceeding the positive or negative airplane limit load factor. This feature is considered novel or unusual because the current regulations do not provide standards for maneuverability and controllability evaluations for such systems. Therefore, special conditions are needed to ensure adequate maneuverability and controllability when using this design feature.

Title 14, Code of Federal Regulations, part 25 does not specify requirements or policy for demonstrating maneuver control that impose any handling qualities requirements beyond the design limit structural loads. Nevertheless, some pilots have become accustomed to the availability of this excess maneuver capacity in case of extreme emergency such as upset recoveries or collision avoidance.

As with previous fly-by-wire airplanes, the FAA has no regulatory or safety reason to prohibit a design for an electronic flight control system with load factor limiting. It is possible that pilots accustomed to this feature feel more freedom in commanding full-stick displacement maneuvers because of the following:

• Knowledge that the limit system will protect the structure,

• Low stick force/displacement gradients,

• Smooth transition from pilot elevator control to limit control.

These special conditions will ensure adequate maneuverability and controllability when using this design feature.

The normal load factor limit on the CSeries airplanes is unique in that traditional airplanes with conventional flight control systems (mechanical linkages) are limited in the pitch axis only by the elevator surface area and deflection limit. The elevator control power is normally derived for adequate controllability and maneuverability at the most critical longitudinal pitching moment. The result is that traditional airplanes have a significant portion of the flight envelope wherein maneuverability in excess of limit structural design values is possible.

These special conditions for the CSeries airplanes supplement the applicable regulations, including § 25.143, to accommodate the unique features of the flight envelope limiting systems, and establish an equivalent level of safety to the existing regulations.

Notice of proposed special conditions No. 25-13-38-SC for the Bombardier CSeries airplanes was published in the Federal Register on December 11, 2013 (78 FR 75285). No comments were received, and the special conditions are adopted as proposed.

As discussed above, these special conditions are applicable to the Models BD-500-1A10 and BD-500-1A11 series airplanes. Should Bombardier Aerospace 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 two model series of airplanes. It is not a rule of general applicability.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Bombardier Aerospace Models BD-500-1A10 and BD-500-1A11 series airplanes.

On December 10, 2009, Bombardier Aerospace applied for a type certificate for their new Models BD-500-1A10 and BD-500-1A11 series airplanes (hereafter collectively referred to as “CSeries”). The CSeries airplanes are swept-wing monoplanes with an aluminum alloy fuselage sized for 5-abreast seating. Passenger capacity is designated as 110 for the Model BD-500-1A10 and 125 for the Model BD-500-1A11. Maximum takeoff weight is 131,000 pounds for the Model BD-500-1A10 and 144,000 pounds for the Model BD-500-1A11.

Bombardier has developed comprehensive flight envelope protection features integral to the CSeries electronic flight control system (EFCS) design. These flight envelope protection features include limitations on angle-of-attack, normal load factor, bank angle, pitch angle, and speed. To accomplish this flight envelope limiting, a significant change (or multiple changes) occurs in the EFCS control laws as the limit is approached or exceeded. When EFCS failure states occur, flight envelope protection features can likewise either be modified, or in some cases, eliminated. The current regulations were not written with these comprehensive flight envelope limiting systems in mind.

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.17, Bombardier Aerospace must show that the CSeries airplanes meet the applicable provisions of part 25 as amended by Amendments 25-1 through 25-129 thereto.

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 CSeries airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 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, the special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the CSeries 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, and the FAA must issue a finding of regulatory adequacy under § 611 of Public Law 92-574, the “Noise Control Act of 1972.”

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 § 21.17(a)(2).

The CSeries airplanes will incorporate the following novel or unusual design features: New control architecture and a full digital flight control system that provides comprehensive flight envelope protections.

The applicable airworthiness regulation is 14 CFR 25.143. The purpose of § 25.143 is to verify that any operational maneuvers conducted within the operational envelope can be accomplished smoothly with average piloting skill and without exceeding any structural limits. The pilot should be able to predict the airplane response to any control input. During the course of the flight test program, the pilot determines compliance with § 25.143 primarily through qualitative methods. During flight test, the pilot should evaluate all of the following:

• The interface between each protection function;

• Transitions from one mode to another;

• Airplane response to intentional dynamic maneuvering, whenever applicable, through dedicated maneuvers;

• General controllability assessment;

• High speed characteristics; and

• High angle-of-attack.

Section 25.143, however, does not adequately ensure that the novel or unusual features of the CSeries airplanes will have a level of safety equivalent to that of existing standards. These special conditions are therefore required to accommodate the flight envelope limiting systems in the CSeries airplanes. The additional safety standards in these special conditions will ensure a level of safety equivalent to that of existing standards.

Notice of proposed special conditions No. 25-13-39-SC for the Bombardier CSeries airplanes was published in the Federal Register on December 11, 2013 (78 FR 75287). No comments were received, and the special conditions are adopted as proposed.

As discussed above, these special conditions are applicable to the Models BD-500-1A10 and BD-500-1A11 series airplanes. Should Bombardier Aerospace 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 two model series of airplanes. It is not a rule of general applicability.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Bombardier Aerospace Models BD-500-1A10 and BD-500-1A11 series airplanes.

1. General Limiting Requirements:

a. Onset characteristics of each envelope protection feature must be smooth, appropriate to the phase of flight and type of maneuver, and not in conflict with the ability of the pilot to satisfactorily change airplane flight path, speed, or attitude as needed.

b. Limit values of protected flight parameters (and, if applicable, associated warning thresholds) must be compatible with the following:

i. Airplane structural limits;

ii. Required safe and controllable maneuvering of the airplane; and

iii. Margins to critical conditions. Unsafe flight characteristics/conditions must not result if dynamic maneuvering, airframe and system tolerances (both manufacturing and in-service), and non-steady atmospheric conditions, in any appropriate combination and phase of flight, can produce a limited flight parameter beyond the nominal design limit value.

c. The airplane must be responsive to intentional dynamic maneuvering to within a suitable range of the parameter limit. Dynamic characteristics such as damping and overshoot must also be appropriate for the flight maneuver and limit parameter in question.

d. When simultaneous envelope limiting is engaged, adverse coupling or adverse priority must not result.

2. Failure States: Electronic flight control system failures (including sensor) must not result in a condition where a parameter is limited to such a reduced value that safe and controllable maneuvering is no longer available. The crew must be alerted by suitable means if any change in envelope limiting or maneuverability is produced by single or multiple failures of the electronic flight control system not shown to be extremely improbable.

On December 10, 2009, Bombardier Aerospace applied for a type certificate for their new Models BD-500-1A10 and BD-500-1A11 series airplanes (hereafter collectively referred to as “CSeries”). The CSeries airplanes are swept-wing monoplanes with an aluminum alloy fuselage sized for 5-abreast seating. Passenger capacity is designated as 110 for the Model BD-500-1A10 and 125 for the Model BD-500-1A11. Maximum takeoff weight is 131,000 pounds for the Model BD-500-1A10 and 144,000 pounds for the Model BD-500-1A11.

The longitudinal control law design of the Bombardier CSeries airplanes incorporates an overspeed protection system in the normal mode. This mode prevents the pilot from inadvertently or intentionally exceeding a speed approximately equivalent to the maximum speed for stability characteristics (V FC ) or attaining demonstrated flight diving speed (V DF ). Current Title 14, Code of Federal Regulations (14 CFR) part 25 standards did not envision a high-speed limiter that might preclude or modify flying qualities assessments in the overspeed region.

Under the provisions of 14 CFR 21.17, Bombardier Aerospace must show that the CSeries airplanes meet the applicable provisions of part 25 as amended by Amendments 25-1 through 25-129 thereto.

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 CSeries airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 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, the special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the CSeries 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, and the FAA must issue a finding of regulatory adequacy under § 611 of Public Law 92-574, the “Noise Control Act of 1972.”

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 § 21.17(a)(2).

The CSeries airplanes will incorporate the following novel or unusual design features: An electronic flight control system that contains fly-by-wire control laws, including envelope protections, for the overspeed protection and roll-limiting function. Current part 25 requirements do not contain appropriate standards for high-speed protection systems.

The overspeed protection functionality includes multifunction spoilers (MFS) that will automatically deploy as speed brakes once the airspeed exceeds a small tolerance above maximum operating limit speed (V mo /M mo ); the MFS will retract automatically when speed is subsequently reduced. Special conditions are necessary in addition to the requirements of § 25.143 for the operation of the high-speed protection. The general intent is that the overspeed protection does not impede normal maneuvering and speed control, and that the overspeed protection does not restrict or prevent emergency maneuvering.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

Notice of proposed special conditions No. 25-13-38-SC for the Bombardier CSeries airplanes was published in the Federal Register on December 11, 2013 (78 FR 75284). We received one comment in favor of the proposed special conditions as written.

As discussed above, these special conditions are applicable to the Models BD-500-1A10 and BD-500-1A11 series airplanes. Should Bombardier Aerospace 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 two model series of airplanes. It is not a rule of general applicability.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Bombardier Aerospace Models BD-500-1A10 and BD-500-1A11 series airplanes.

The FAA has determined that notice of, and opportunity for prior public comment on, these special conditions is 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 publication in the Federal Register .

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 will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

On January 27, 2012, the Boeing Company applied for an amendment to Type Certificate No. A16WE to include new minor models, 737-7, -8, and -9. The Models 737-7, -8, and -9, which are derivatives of the 737-700, -800, -900ER currently approved under Type Certificate No. A16WE, are passenger series airplanes designed to substantially reduce fuel burn and community noise. In addition, the design will include a new CFM LEAP-1B engine with a 68.4-inch diameter fan, 8-inch longer nose gear to accommodate the larger engine, a relofted tailcone (which requires the elevator to be trimmed and the elevator tab to be relocated outboard to accommodate the new contours), new horizontal stabilizer strakelets, a retractable auxiliary power unit inlet door, fly-by-wire spoilers, strengthened flight deck bulkhead, and a new winglet design.

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.101, The Boeing Company must show that the Models 737-700, -700C, -800, -900ER, -7, -8, and -9 series airplanes meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A16WE or the applicable regulations in effect on the date of application for the change to the type certificate. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” In addition, the certification basis includes certain special conditions, exemptions, or later amended sections of the applicable part 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 737-700, -700C, -800, -900ER, -7, -8, and -9 because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 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 novel or unusual design feature, the special conditions would also apply to the other model.

In addition to the applicable airworthiness regulations and special conditions, the 737-700, -700C, -800, -900ER, -7, -8, and -9 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 § 21.101.

The Boeing Models 737-700, -700C, -800, -900ER, -7, -8, and -9 series airplanes will incorporate the following novel or unusual design features: Digital systems architecture composed of several connected networks. This network architecture and network configuration may be used for or interfaced with a diverse set of functions, including:

• Flight safety related control, communication, and navigation systems (aircraft control domain);

• Operator business and administrative support (operator information domain); and

• Passenger information and entertainment systems (passenger entertainment domain), and the capability to allow access to or by external network sources.

The proposed architecture and network configuration of the Models 737-700, -700C, -800, -900ER, -7, -8, and -9 series airplanes may allow increased connectivity to and access from external network sources and operations and maintenance networks to the aircraft control domain and operator information domain. The airplane control domain and operator information domain perform functions required for the safe operation and maintenance of the airplane. Previously these domains had very limited connectivity with external network sources.

The architecture and network configuration may allow the exploitation of network security vulnerabilities resulting in intentional or unintentional destruction, disruption, degradation, or exploitation of data, systems, and networks critical to the safety and maintenance of the airplane.

The existing regulations and guidance material did not anticipate these types of airplane system architectures. Furthermore, 14 CFR regulations and current system safety assessment policy and techniques do not address potential security vulnerabilities, which could be exploited by unauthorized access to airplane networks, data buses, and servers. Therefore, these special conditions and a means of compliance are proposed to ensure that the security (i.e., confidentiality, integrity, and availability) of airplane systems is not compromised by unauthorized wired or wireless electronic connections.

As discussed above, these special conditions are applicable to the Models 737-700, -700C, -800, -900ER, -7, -8, and -9 series airplanes. Should The Boeing 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 certain model series of airplanes. It is not a rule of general applicability.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, because a delay would significantly affect the certification of the airplane, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for The Boeing Company Models 737-700, -700C, -800, -900ER, -7, -8, and -9 series airplanes.

1. The applicant must ensure that the airplanes' electronic systems are protected from access by unauthorized sources external to the airplane, including those possibly caused by maintenance activity.

2. The applicant must ensure that electronic system security threats are identified and assessed, and that effective electronic system security protection strategies are implemented to protect the airplane from all adverse impacts on safety, functionality, and continued airworthiness.

3. The applicant must establish appropriate procedures to allow the operator to ensure that continued airworthiness of the airplane is maintained, including all post type certification modifications that may have an impact on the approved electronic system security safeguards.

The FAA has determined that notice of, and opportunity for prior public comment on, these special conditions is 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 publication in the Federal Register .

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 will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

On January 27, 2012, The Boeing Company applied for an amendment to Type Certificate No. A16WE to include new minor models, 737-7, -8, and -9. The Models 737-7, -8, and -9, which are derivatives of the 737-700, -800, -900ER currently approved under Type Certificate No. A16WE, are passenger series airplanes designed to substantially reduce fuel burn and community noise. In addition, the design will include a new CFM LEAP-1B engine with a 68.4-inch diameter fan, 8-inch longer nose gear to accommodate the larger engine, a relofted tailcone (which requires the elevator to be trimmed and the elevator tab to be relocated outboard to accommodate the new contours), new horizontal stabilizer strakelets, a retractable auxiliary power unit (APU) inlet door, fly-by-wire spoilers, strengthened flight deck bulkhead, and a new winglet design.

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.101, The Boeing Company must show that the Models 737-700, -700C, -800, -900ER, -7, -8, and -9 series airplanes meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A16WE or the applicable regulations in effect on the date of application for the change to the type certificate. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” In addition the certification basis includes certain special conditions, exemptions, or later amended sections of the applicable part 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 737-700, -700C, -800, -900ER, -7, -8, and -9 because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 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 novel or unusual design feature, the special conditions would also apply to the other model.

In addition to the applicable airworthiness regulations and special conditions, the 737-700, -700C, -800, -900ER, -7, -8, and -9 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 § 21.101.

The Boeing Models 737-700, -700C, -800, -900ER, -7, -8, and -9 series airplanes will incorporate the following novel or unusual design features: Digital systems architecture composed of several connected networks. This network architecture and network configuration may be used for or interfaced with a diverse set of functions, including:

• Flight safety related control, communication, and navigation systems (aircraft control domain);

• Operation and administrative support (operator information services domain); and

• Passenger information and entertainment systems (passenger entertainment domain), and the capability to allow access to or by external network sources.

The proposed integrated network configuration on the Models 737-700, -700C, -800, -900ER, -7, -8, and -9 may allow increased connectivity with external network sources and will have more interconnected networks and systems, such as passenger entertainment and information services, than previous 737 airplane models. This may allow the exploitation of network security vulnerabilities resulting in intentional or unintentional destruction, disruption, degradation, or exploitation of data and systems critical to the safety and maintenance of the airplane, which could result in unsafe conditions for the airplane and its occupants.

The existing regulations and guidance material did not anticipate these types of system architectures or access to airplane systems. Furthermore, 14 CFR regulations and current system safety assessment policy and techniques do not address potential security vulnerabilities that could be caused by unauthorized access to airplane data busses and servers. Therefore, these special conditions are issued to ensure that the security (i.e., confidentiality, integrity, and availability) of airplane systems are not compromised by unauthorized wired or wireless electronic connections between airplane operation systems and networks and the passenger domain.

As discussed above, these special conditions are applicable to the Models 737-700, -700C, -800, -900ER, -7, -8, and -9 series airplanes. Should The Boeing 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 certain model series of airplanes. It is not a rule of general applicability.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, because a delay would significantly affect the certification of the airplane, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

In the Federal Register of February 3, 2014 (79 FR 6088), FDA published the direct final rule Maximum Civil Money Penalty Amounts; Civil Money Penalty Complaints. The direct final rule revises the table in 21 CFR 17.2 to adjust the preceding maximum CMP amounts for inflation as prescribed by FCPIAA. The adjusted CMPs have been updated to account for the inflation as prescribed by FCPIAA. The direct final rule also revises 21 CFR 17.5(a) to provide authority for the Chief Counsel to delegate the responsibility for initiating a CMP administrative action against a tobacco retailer.

FDA also solicited comments concerning the changes for a 75-day period ending April 21, 2014, in a proposed rule that published in the Federal Register of February 3, 2014 (79 FR 6112). FDA stated that the effective date of the direct final rule would be June 18, 2014, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments.

Background

On June 10, 2011, the IRS and the Treasury Department published temporary regulations and a notice of proposed rulemaking by cross-reference to the temporary regulations in the Federal Register (76 FR 33997, TD 9529, 2011-30 IRB 57; REG-101352-11, 76 FR 34019) (2011 regulations) under sections 6038A and 6038C of the Internal Revenue Code (Code). The 2011 regulations amended final regulations under § 1.6038A-2 to provide that duplicate filing of Form 5472 generally would no longer be required regardless of whether the filer files a paper or an electronic income tax return. As a result, the regulations' only remaining provision for filing a Form 5472 separately from the filer's income tax return applies to cases in which the filer's income tax return is not timely filed.

No comments were received on the 2011 regulations, and no public hearing was requested or held. Accordingly, this Treasury decision adopts the 2011 regulations without substantive change as final regulations and removes the corresponding temporary regulations.

However, contemporaneous with these final regulations, the IRS and the Treasury Department are proposing the removal of § 1.6038A-2(e), which provides for a filer to timely file a Form 5472 separately from the filer's income tax return if the income tax return is untimely filed. As a result, the proposed regulations would require that Form 5472 be filed in all cases only with the filer's income tax return for the taxable year by the due date (including extensions) of that return. For further information, see the proposed regulations set forth in the Proposed Rules section in this issue of the Federal Register .

It has been determined that this final regulation is not a significant regulatory action as defined in Executive Order 12866, as supplemented by Executive Order 13653. Therefore, a regulatory assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulation does not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking preceding this regulation was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

The principal author of these regulations is Anand Desai, Office of Associate Chief Counsel (International). However, other personnel from the IRS and the Treasury Department participated in their development.

Accordingly, 26 CFR part 1 is amended as follows:

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act . . .; and rules and regulations consistent with regulations issued by the Secretary pursuant to this Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the North Dakota program on December 15, 1980. You can find background information on the North Dakota program, including the Secretary's findings, the disposition of comments, and conditions of approval in the December 15, 1980, Federal Register (45 FR 82214). You can also find later actions concerning North Dakota's program and program amendments at 30 CFR 934.15, 934.16, and 934.30.

By letter dated February 2, 2012, North Dakota sent us an amendment to its program (SATS number: ND-053-FOR, Administrative Record Document ID. OSM-2012-0006-0002) under SMCRA (30 U.S.C. 1201 et seq. ). North Dakota submitted the amendment to include changes made at its own initiative.

North Dakota proposed to change the letter of credit provisions in its collateral bond rule at NDAC 69-5.2-12-04 which addresses the financial information that banks issuing a letter of credit must provide to the Commission. Specifically, North Dakota proposed to revise its rules by adding an option that allows banks to provide a certified copy of financial reports that are required by a Federal banking agency rather than submit a balance sheet that is certified by a certified public accountant (CPA). North Dakota also proposed a change that affects the provision requiring banks to give the Commission notice of actions alleging insolvency or bankruptcy. North Dakota is proposing these changes both in order to avoid conflict with Federal and State banking regulations and to assist banks that may have difficulty submitting CPA certified balance sheets.

We announced receipt of the proposed amendment in the April 25, 2012, Federal Register (Vol. 77, No. 80 FR page number 24661). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the amendment's adequacy (Administrative Record Docket ID OSM-2012-0006).

We did not hold a public hearing or meeting because no one requested one. The public comment period ended on May 25, 2012. We did not receive any comments.

30 CFR 732.17(h)(10) requires that State program amendments meet the criteria for approval of State programs set forth in 30 CFR 732.15, including that the State's laws and regulations are in accordance with the provisions of the Act and consistent with the requirements of 30 CFR Part 700. In 30 CFR 730.5, OSMRE defines “consistent with” and “in accordance with” to mean (a) with regard to SMCRA, the State laws and regulations are no less stringent than, meet the minimum requirements of, and include all applicable provisions of the Act and (b) with regard to the Federal regulations, the State laws and regulations are no less effective than the Federal regulations in meeting the requirements of SMCRA.

Following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment as described below.

North Dakota proposed changes to existing language in subsections (d) and (f) of NDAC Section 69-05.2-12-04. The proposed changes include additional conditions that banks must meet in order for the Commission to approve a coal operator's collateral bond pledging a letter of credit. The proposed rule changes are intended to ensure that banks issuing letters of credit to the North Dakota Public Service Commission (hereinafter, “the Commission”) maintain a certain degree of fiscal health and provide notice to the Commission and permittee of insolvency, bankruptcy, or regulatory requirement violations.

North Dakota proposed to revise NDAC Section 69-05.2-12-04(2)(d), which deals with notifications of the fiscal health of banks that issue letters of credit to the Commission. As previously written, the rules required that letters of credit submitted to the Commission be accompanied by a balance sheet and that updated balance sheets must be submitted regularly every year. North Dakota's proposed rule change provides banks with an alternative to submit certified copies of financial reports that are already required under Federal banking regulations. The Federal regulations governing collateral bonds pledging letters of credit are found at 30 CFR 800.21(b). The currently-approved State rules provide specific conditions for letters of credit that were found to be no less effective than Federal regulations [69 FR 2663]. Similarly, the proposed revision to NDAC 69-05.2-12-04(2)(d), although relaxing currently-approved State requirements, adds specificity to Federal requirements. Therefore, we find that the proposed change to NDAC 69-05.2-12-04(2)(d) is no less effective than the Federal regulations. Accordingly, we approve it.

North Dakota also proposed to revise NDAC Section 69-05.2-12-04(2)(f), which states that banks shall give prompt notice to the permittee and the Commission of notices received or actions filed alleging insolvency, bankruptcy, or banking regulatory requirement violations that could result in suspension or revocation of the bank's charter or license to do business. The proposed amendment contains language that limits the amount of information provided in the notice to what is permitted by State and Federal banking laws. North Dakota proposed this rule change to avoid conflict with various Federal and State banking regulations. The counterpart Federal regulations to subsection (f) are found at 30 CFR 800.16(e). 30 CFR 800.16(e)(1) requires that the bond shall “provide a mechanism” for a bank to notify the regulatory authority, or in this case the Commission, of actions filed alleging insolvency, bankruptcy, or banking regulatory requirement violations that could result in suspension or revocation of the bank's charter or license to do business. Furthermore, 30 CFR 800.16(e)(2) requires that the permitee shall promptly notify the regulatory authority of the aforementioned actions. Since North Dakota's proposed rule change does not weaken the requirement that a “mechanism” exists for banks to notify the Commission of alleged insolvency, bankruptcy, or banking regulatory requirement violations, we find that the proposed change to NDAC 69-05.2-12-04(2)(f) is no less effective than the counterpart Federal regulations at 30 CFR 800.16(e) and we approve it.

We asked for public comments on the amendment (Administrative Record Document ID No. OSM-2012-0006-0002), but did not receive any.

Under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various State and Federal agencies with an actual or potential interest in the North Dakota program (Administrative Record Docket ID No. OSM-2012-0006).

We received responses from both the Bureau of Land Management (BLM) and the Mine Safety and Health Administration (MSHA). BLM stated in a letter dated February 17, 2012, that they had no comments on North Dakota Amendment XXXIX (Administrative Record Document ID No. OSM-2012-0006-0004). MSHA stated in a letter dated March 5, 2012, that they concurred with the proposed revisions and had no further comment (Administrative Record Document ID No. OSM-2012-0006-0006).

Under 30 CFR 732.17(h)(11)(ii), we are required to obtain concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) and the Clean Air Act (42 U.S.C. 7401 et seq. ).

None of the revisions that North Dakota proposed to make in this amendment pertain to air or water quality standards. Although OSM did not ask EPA to concur on the amendment, we did request EPA to comment on the amendment (Administrative Record ID No. OSM-2012-0006-0005). EPA did not respond to our request.

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On February 7, 2012, we requested comments on North Dakota's amendment (Administrative Record Document ID No.OSM-2012-0006-0005), but neither responded to our request.

Based on the above finding, we approve North Dakota's February 1, 2012 amendment.

To implement this decision, we are amending the Federal regulations at 30 CFR Part 934, which codify decisions concerning the North Dakota program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrates that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this regulation effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.

This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866 (Regulatory Planning and Review).

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR Parts 730, 731, and 732 have been met.

This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally recognized Indian Tribes and have determined that the rule does not have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal government and Indian Tribes, or on the distribution of power and responsibilities between the Federal government and Indian Tribes. The rule does not involve or affect Indian Tribes in any way.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rule does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C) et seq ).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), of the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Does not have an annual effect on the economy of $100 million.

b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

This determination is based upon the fact that the State submittal which is the subject of this rule is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose an unfunded Mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the federal regulation did not impose an unfunded mandate.

For the reasons set out in the preamble, 30 CFR part 934 is amended as set forth below:

I. Background on the Utah Program II. Submission of the Proposed Amendment III. Office of Surface Mining Reclamation and Enforcement's (OSM's) Findings IV. Summary and Disposition of Comments V. OSM's Decision VI. Procedural Determinations I. Background on the Utah Program

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its State program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act . . . and rules and regulations consistent with regulations issued by the Secretary pursuant to this Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Utah program on January 21, 1981. You can find background information on the Utah program, including the Secretary's findings, the disposition of comments, and conditions of approval of the Utah program in the January 21, 1981, Federal Register (46 FR 5899). You can also find later actions concerning Utah's program and program amendments at 30 CFR 944.15 and 944.30.

By letter dated June 25, 2012, Utah sent us an amendment to its program (Administrative Record Number OSM-2012-0015-0002) under SMCRA (30 U.S.C. 1201 et seq. ). Utah sent the amendment in response to an October 2, 2009 letter (Administrative Record No. OSM-2012-0015-0003) we sent to Utah in accordance with 30 CFR 732.17(c).

We announced receipt of the proposed amendment in the September 5, 2012 Federal Register (77 FR 54491). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the amendment's adequacy (Administrative Record No. OSM-2012-0015-0001). We did not hold a public hearing or meeting because no one requested one. The public comment period ended on October 5, 2012. We received comments from three Federal agencies.

By letter dated November 2, 2012, Utah sent us a supplemental to the June 25, 2012 amendment proposal (Administrative Record No. OSM-2012-0015-0008). Utah sent the supplemental amendment to address two minor revisions that were inadvertently omitted from the June 25th submittal.

We announced receipt of the supplemental proposed amendment in the December 12, 2012 Federal Register (77 FR 73966). In the same document, we reopened the public comment period on the amendment's adequacy (Administrative Record No. OSM-2012-0015-0010). That public comment period ended on December 27, 2012. We did not receive any additional comments during the second comment period.

Following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment.

Utah proposed revisions to the following rules containing language that is the same as or similar to the corresponding sections of the Federal regulations.

R643-874-160 corresponding to 30 CFR 874.16, AML contractor eligibility (general);

R643-875-200 corresponding to 30 CFR 875.20, AML contractor eligibility (noncoal);

R645-100-200 corresponding to 30 CFR 701.5, Definitions of “Applicant/Violator System,” “Control or Controller,” “Knowingly” (deleted), “Knowing or Knowingly,” “ `Owned or controlled' and `Owns or Controls' ” (deleted), “Own, Owner, or Ownership,” “Transfer, Assignment or Sale of Permit Rights,” “Violation,” “Violation, Failure, or Refusal,” “Violation Notice,” “Willful or Willfully,” and “Willful Violation;”

R645-300-132 corresponding to 30 CFR 773.8, Review of compliance and entry of information into the AVS;

R645-300-132.100 corresponding to 30 CFR 773.9 through 773.11, Review of applicant, operator and ownership and control information, permit history, and compliance history;

R645-300-132.120 through -132.121 corresponding to 30 CFR 773.14(3) & (4), Challenging ownership and control listings;

R645-300-132.150 through -132.150.11 corresponding to 30 CFR 773.25 through 773.28, Challenging ownership and control listings;

R645-300-132.200 corresponding to 30 CFR 773.14, Provisionally issued permits;

R645-300-132.400 corresponding to 30 CFR 773.12, Permit eligibility determinations;

R645-300-132.500 corresponding to 30 CFR 773.13, Unanticipated events or conditions at remining sites;

R645-300-133 corresponding to 30 CFR 773.15, Written findings for permit application approval;

R645-300-148 corresponding to 30 CFR 774.12(c), Updating ownership and control information;

R645-300-160 through -162 corresponding to 30 CFR 773.21, Improvidently issued permits;

R645-300-164 corresponding to 30 CFR 773.22 and 773.23, Improvidently issued permit rescission procedures;

R645-300-171 through -173 corresponding to 30 CFR 778.9, Certifying and updating permit application information;

R645-300-180 though -183.2 corresponding to 30 CFR 774.11, Post-permit issuance requirements based on ownership and control information;

R645-301-111 corresponding to 30 CFR 778.11, Minimum requirements for legal, financial, compliance, and related information;

R645-301-112.200 through -112.420 corresponding to 30 CFR 778.11 and 778.12, Providing permit history information;

R645-301-113 corresponding to 30 CFR 778.14, Providing violation information;

R645-302-240 corresponding to 30 CFR 785.25, Remining;

R645-303-310 corresponding to 30 CFR 774.17(a), Transfer, assignment, or sale of permit rights;

R645-400-319 corresponding to 30 CFR 843.11, Notices in the event of a cessation order; and

R645-403 corresponding to 30 CFR 847; Alternative enforcement.

Utah revised the listed provisions to closely mirror Federal counterpart language and requirements. These revisions encompass all required program amendments identified through our October 2, 2009 letter. Because the proposed rules contain language that is the same as or similar to the corresponding Federal regulations, we find that they are no less effective than the corresponding Federal regulations.

We asked for public comments on the amendment (Administrative Record Document ID No. OSM-2012-0015-0001), but did not receive any.

Under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Utah program (Administrative Record Document ID No. OSM-2012-00015-0007).

On August 1, 2012 we received an email comment from the United States Department of Agriculture Forest Service, Intermountain Region (Administrative Record No. OSM-2012-0015-0006). The Forest Service stated that it did not have specific comments on the proposed amendment.

By letter dated August 3, 2012 we received a comment from the Bureau of Land Management (BLM) (Administrative Record No. OSM-2012-0015-0004). The BLM stated that the changes appear to provide clarification of the definition of responsible parties and certain procedural steps. The BLM understands that the changes will continue to be implemented by the Utah Coal Regulatory Program. We agree with the BLM comments and are approving the amendment.

Under 30 CFR 732.17(h)(11)(i) and (ii), we are required to get concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ).

None of the revisions that Utah proposed to make in this amendment pertains to air or water quality standards. Therefore, we did not ask EPA to concur on the amendment. However, under 30 CFR 732.17(h)(11)(i), OSM requested comments on the amendment from EPA (Administrative Record Document ID No. OSM-2012-0015-0007. EPA responded on August 7, 2012, by stating it has no substantive comments on the proposed amendment (Administrative Record Document ID No. OSM-2012-0015-0005).

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On July 2, 2012 we requested comments on Utah's amendment (Administrative Record Document ID No. OSM-2012-0015-0007), but neither responded to our request.

Based on the above findings, we approve Utah's June 25, 2012 amendment as supplemented November 2, 2012.

To implement this decision, we are amending the Federal regulations at 30 CFR Part 944, which codify decisions concerning the Utah program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrates that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this regulation effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards.

Section 503 of SMCRA provides that a State may not exercise jurisdiction under SMCRA unless the State program is approved by the Secretary. Similarly, 30 CFR 732.17(a) requires that any change of an approved State program be submitted to OSM for review as a program amendment. The Federal regulations at 30 CFR 732.17(g) prohibit any changes to approved State programs that are not approved by OSM. In the oversight of the Utah program, we will recognize only the statutes, regulations and other materials we have approved, together with any consistent implementing policies, directives and other materials. We will require Utah to enforce only approved provisions.

This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.

This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866 (Regulatory Planning and Review).

The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of subsections (a) and (b) of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments because each program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR Parts 730, 731, and 732 have been met.

This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA, and section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA.

In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally recognized Indian Tribes and have determined that the rule does not have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal government and Indian Tribes, or on the distribution of power and responsibilities between the Federal government and Indian Tribes. The rule does not involve or affect Indian Tribes in any way.

On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.

This rule does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C) et seq ).

This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), of the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Does not have an annual effect on the economy of $100 million.

b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.

This determination is based upon the fact that the State submittal which is the subject of this rule is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.

This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate.

For the reasons set out in the preamble, 30 CFR part 944 is amended as set forth below:

Purpose of Program: The LRC Program provides grants to institutions of higher education or consortia of these institutions for establishing, strengthening, and operating centers that serve as resources for improving the Nation's capacity for teaching and learning foreign languages through teacher training, research, materials development, and dissemination projects.

Applicable Program Regulations: 34 CFR parts 655 and 669.

We published a notice of proposed priority for this program in the Federal Register on March 18, 2014 (79 FR 15074). That notice contained background information and our reasons for proposing this particular priority.

There are differences between the proposed priority and this final priority as discussed in the Analysis of Comments and Changes section elsewhere in this notice.

Public Comment: In response to our invitation in the notice of proposed priority, three parties submitted comments on the proposed priority.

Generally, we do not address technical and other minor changes.

Analysis of Comments and Changes: An analysis of the comments and any changes in the priority since publication of the notice of proposed priority follows.

Comment: A commenter endorsed the proposed priorities and expressed appreciation for the Department of Education's efforts to facilitate stronger participation of MSIs. In addition, the commenter urged us to use these priorities as absolute or competitive preference priorities.

Discussion: We appreciate the commenter's support. However, it is our practice to specify the priority types for each competition in the notice inviting applications, not in an NFP.

Changes: None.

Comment: One commenter suggested that we include a priority for applications that include collaboration activities with MSIs to enhance access to international activities and foreign language learning.

Discussion: We agree with the commenter and believe that the final priority, consistent with the proposed priority, clearly accomplishes this goal.

Change: None.

Comment: One commenter suggested that it would be helpful if we provide a list of institutions eligible under Title III, part A; Title III, part B; and Title V of the Higher Education Act of 1965, as amended (HEA).

Discussion: We agree that making this information readily available to applicants will help them in addressing and meeting this priority.

Change: None. We will provide the information on the institutions that currently meet this definition in the Federal Register notice inviting applications (NIA).

Comment: One commenter recommended that we remove the singular modifier before minority-serving institutions (MSIs) and before community college to clarify that collaborative activities may be proposed with more than one MSI or more than one community college.

Discussion: We agree with the commenter's suggestion and are making this change to ensure we do not limit the number of entities that are able to collaborate under this priority.

Change: We have revised this priority to make it clear that an institution can collaborate with multiple MSIs or community colleges.

Comment: One commenter encouraged the Department to consider as broad a definition of MSI as possible so as to provide the greatest opportunities for applicant institutions to positively influence students and instructors alike at these underserved institutions.

Discussion: We believe that the definition of an MSI to be used with this priority will serve a wide range of institutions and fulfill the Department's intention of addressing the gap in the types of institutions, faculty, and students that have historically benefitted from the instruction, training, and outreach available at LRCs. Institutions that are eligible to receive assistance under Title III, part A; Title III part B; and Title V of the HEA include MSIs, Historically Black Colleges and Universities (HBCUs), predominately black institutions, Hispanic-serving institutions, and tribal colleges, among others. This range of institutional types provides sufficient options to language resource center institutions in terms of collaboration. Considering, too, that community colleges are included in this priority, there is flexibility, opportunity, and latitude for the Language Resource Center institutions to meet the intended outcomes of this priority. We, therefore, do not agree that the definition of an MSI for the purposes of this proposed priority is too narrow.

Change: None.

Comment: None.

Discussion: Based on internal deliberation, and consistent with a change made to a similar priority for the National Resource Centers program in response to a comment, we have revised the final priority to allow an applicant that itself is an MSI or community college to propose to meet the priority by conducting intra-campus collaborative activities instead of, or in addition to, collaborative activities with other MSIs or community colleges. An example of an intra-campus collaborative activity would be a project involving the faculty in the Department of Social Sciences and the Yoruba language instructors to develop a language across the curriculum course about human rights issues in Africa.

Changes: We have revised the priority language to permit institutions that are MSIs or community colleges to propose intra-campus collaborative activities instead of, or in addition to, collaborative activities with other MSIs or community colleges.

Applications that propose significant and sustained collaborative activities with one or more Minority-Serving Institutions (MSIs) (as defined in this notice) or with one or more community colleges (as defined in this notice).

These activities must be designed to incorporate foreign languages into the curriculum at the MSI(s) or community college(s), and to improve foreign language instruction at the MSI(s) or community college(s). If an applicant institution is an MSI or a community college (as defined in this notice), that institution can meet the intent of this priority by proposing intra-campus collaborative activities instead of, or in addition to, collaborative activities with other MSIs and/or community colleges.

For the purpose of this priority:

Community college means an institution that meets the definition in section 312(f) of the Higher Education Act of 1965, as amended (HEA) (20 U.S.C. 1058(f)); or an institution of higher education (as defined in section 101 of the HEA (20 U.S.C. 1001)) that awards degrees and certificates, more than 50 percent of which are not bachelor's degrees (or an equivalent) or master's, professional, or other advanced degrees.

Minority-Serving Institution means an institution that is eligible to receive assistance under sections 316 through 320 of part A of Title III, under part B of Title III, or under Title V of the HEA.

When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register . The effect of each type of priority follows:

Absolute priority: Under an absolute priority, we consider only applications that meet the priority (34 CFR 75.105(c)(3)).

Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (34 CFR 75.105(c)(2)(ii)).

Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the priority a preference over other applications (34 CFR 75.105(c)(1)).

This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);

(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impacts of entitlement 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 stated in the Executive order.

This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

We have also reviewed this final regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

We are issuing these final priorities only on a reasoned determination that their benefits justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.

We also have determined that this regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive Order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.

This document provides early notification of our specific plans and actions for this program.

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT .

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.gpo.gov/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

In a document published in the Federal Register on December 18, 2013 (78 FR 76574), VA proposed revising its regulations governing eligibility for and payment of monetary burial benefits. The 30-day public comment period ended on January 17, 2014. VA received nine comments from interested individuals and organizations. The comments generally concerned priority of payments and who is a proper claimant for burial benefits. The comments are discussed below. Based on the rationale described in this document and in the notice of proposed rulemaking (NPRM), VA adopts the proposed rule as revised in this document.

In proposed § 3.1700(b), we defined “burial” for purposes of describing the types of services that VA has authority to pay for as a burial benefit. VA liberally defined burial as including, but not limited to, all legal methods for disposing of a deceased person's remains. One commenter recommended that VA include alkaline hydrolysis within the proposed definition of burial. According to the commenter, alkaline hydrolysis is a water-based dissolution process for human remains that uses alkaline chemicals to accelerate natural decomposition. To the extent that alkaline hydrolysis is a lawful method for disposing of human remains in a particular State, the broad language in proposed § 3.1700(b), “all the legal methods,” would necessarily include this method of disposition in VA's definition of burial. Because alkaline hydrolysis, where lawful, is a service that VA would pay for as a burial benefit under the language of proposed § 3.1700(b), we make no change to the proposed rule because it is unnecessary.

One commenter supported the cross-references in proposed § 3.1700(c) to other benefits and services related to memorialization or interment because they reflect the options available to families. The commenter also approved of the specific reference to both “memorialization” and “interment,” which are two distinct concepts, as discussed in the preamble of the proposed rule. VA appreciates the commenter's support for these changes.

Under 38 CFR 3.1601, VA accepted a claim for burial benefits from the funeral director, any person who used his or her funds to pay burial or funeral expenses, or the executor or administrator of the estate of the veteran. Those rules did not allow VA to automate or expedite the payment of these small, one-time benefit payments to survivors who generally have an immediate need for supplemental financial assistance after the veteran's death. To facilitate efficient processing of claims, we proposed in§ 3.1702(a) to automate certain payments to surviving spouses based upon information in VA systems as a first priority and in § 3.1702(b) to establish a priority of payments for other eligible individuals.

We received several comments regarding the payment priority in proposed § 3.1702, whereby VA would automatically pay the burial allowance to an eligible surviving spouse in conjunction with the month-of-death benefit in 38 CFR 3.20, without the need for a separate claim, and regardless of a claim for the same benefit made by other claimants. If there were no surviving spouse, child, or parent, we stated that VA would pay an executor or administrator of the veteran's estate based upon the executor's or administrator's claim, or in the case of an unclaimed veteran, a funeral service provider based upon the provider's claim. As a result of this revised priority of payment, VA would no longer prioritize payment to funeral directors or other service providers.

One commenter stated that benefits should not be paid to funeral homes and recommended that VA pay burial benefits directly to beneficiaries for use in paying for the burial. The commenter went on to state that, “once the process is automated and simplified, funeral homes will be natural beneficiaries of faster benefit payment.” Another commenter stated that the benefit “should be paid upfront so the family can use it right away.”

Two commenters, both funeral service trade and business associations, advocated that VA rewrite § 3.1702 in order to prioritize payment to funeral service providers. The commenters recommended that funeral homes be given priority because they are the actual providers of burial services. One of the trade groups suggested an alternate approach whereby VA would first pay burial providers where services have been rendered or previously contracted. Both commenters reasoned that proposed § 3.1702 would further delay funeral service providers being paid for the goods and services they have already provided. VA disagrees.

As we mentioned in the NPRM, the priority of payment provisions will enable VA to automatically pay annually the basic burial allowance ($300 or $2,000) to approximately 62,000 eligible surviving spouses shortly after being notified of a veteran's death. In order to establish an automatic payment process, VA needs to use existing data of record, which would be a veteran's dependent information. Although this policy change will reduce those instances in which a funeral service provider will be a proper claimant for VA burial benefits, it will ultimately place the survivors and estates of deceased veterans in a better financial position to pay funeral service providers in a timely manner. VA also notes that its monetary burial benefits generally do not cover the entire cost of a burial and funeral, which means that funeral service providers' current business model already includes collection of charges from survivors and other individuals who pay for the services. Further, the NPRM and effective date provisions of this final rule provide service providers with notice that they will no longer be afforded priority of payment and they may change their business practices accordingly. Finally, in cases where the deceased veteran has neither survivors nor an estate, such as when a deceased veteran's remains are unclaimed, § 3.1702(b)(3) provides that the person or entity that provided burial services is a proper claimant. In those circumstances, if a funeral service provider incurred costs for the funeral and burial of the remains of an unclaimed and intestate veteran, VA would pay that funeral service provider as a proper claimant. Therefore, we make no changes to § 3.1702 based on comments regarding priority of payment.

As to a comment that VA should permit the assignment of benefits by funeral homes to third-party providers, federal law precludes assignment of VA benefits. Section 5301(a)(1) of title 38, United States Code, provides in part that “[p]ayments of benefits due or to become due under any law administered by the Secretary [of Veterans Affairs] shall not be assignable except to the extent specifically authorized by law.” No statutory authority currently exists permitting the assignment of VA burial benefits. Accordingly, VA makes no change based on this comment.

As to one commenter's concerns about the timeliness of reimbursement for burial services already provided, VA anticipates that the proposed rules as a whole will increase the timeliness of all burial claims by reducing the evidentiary requirements for deciding all claims pending on the effective date of the final rule. Under proposed § 3.1703(b), apart from proof of death and a claim filed on a VA form, VA will generally require from a claimant only a statement that he/she incurred burial, plot or interment, or transportation costs rather than the itemized receipts and bills required under the current rule. VA will apply these reduced evidentiary requirements to all claims pending on the effective date of the final rule, which will decrease processing time to the benefit of all claimants for monetary burial benefits. VA makes no change based on this comment.

One commenter recommended that VA recognize all legal marriages for purposes of burial benefits and urged VA to incorporate in § 3.1702 “a place of celebration rule” for burial benefits only. Citing language in the NPRM that “[t]he law provides VA with discretion to prescribe who may be properly paid burial benefits,” the commenter asserted that VA's burial statutes do not restrict nor require payment to a specific person or group but rather to “such person as the Secretary prescribes.” Although sections 101 and 103 of title 38, United States Code, limit the definition of the term “spouse,” the commenter asserts that the broad authority in section 2302 “permits a more expansive determination of eligible recipients here.” The commenter also noted that a place of celebration rule would be consistent with other definitions adopted by other agencies following the Supreme Court's decision in United States v. Windsor, No. 12-307, 133 S. Ct. 2675 (2013).

The same commenter also recommended that VA further revise proposed § 3.1702(b)(1) to allow living veterans to designate any beneficiary of their choice for burial benefits. By permitting designation of such a beneficiary, the commenter states that VA would enable veterans to appoint a representative that “more closely matches the reality of their relational ties.”

The same commenter recommended that VA revise proposed § 3.1702(b) to include a “legally recognized domestic partner or civil union partner.” According to the commenter, states such as Colorado, Oregon and Nevada do not allow same-sex marriages, but do recognize civil unions or domestic partnerships. The commenter asserts that VA can, with minor revisions to § 3.1702(b), permit payment of burial benefits to a deceased veteran's survivor from a civil union or domestic partnership.

Current section 101(3) and (31) of title 38, U.S.C., limits the definitions of “surviving spouse” and “spouse” for purposes of title 38 to only a person of the opposite sex of the veteran. The language in these provisions is substantively identical to the language in section 3 of the Defense of Marriage Act (DOMA), 1 U.S.C. 7, which the Supreme Court in Windsor declared to be unconstitutional because it discriminates against legally-married, same-sex couples. On September 4, 2013, the United States Attorney General informed Congress that the President had directed the Executive Branch to cease enforcement of sections 101(3) and (31) of title 38, U.S.C., to the extent that those provisions preclude the recognition of legally-valid marriages of same-sex couples. Pursuant to the President's direction, VA is no longer enforcing the section 101(3) and (31) provisions to the extent that they require a “spouse” or a “surviving spouse” to be a person of the opposite sex. Unlike most other Federal agencies, VA is required by statute to use a place-of-residency rule to determine whether a veteran's marriage is recognized for the purpose of veterans' benefits. Specifically, 38 U.S.C. 103(c) requires that “[i]n determining whether or not a person is or was the spouse of a veteran, their marriage shall be proven as valid for the purposes of all laws administered by the Secretary according to the law of the place where the parties resided at the time of the marriage or the law of the place where the parties resided when the right to benefits accrued.” Thus, VA would recognize a surviving spouse, including a same-sex surviving spouse, whose marriage to a veteran is recognized under the section 103(c) provision. VA is working with the Department of Justice to address this statutory provision in light of recent legal developments.

As explained previously, in order to establish an automatic payment process, VA needs to use existing data of record, which would be a veteran's spouse of record. To make automatic payments to any other individual would require VA to create a pre-death designation process as suggested by the commenter. The commenter's proposed pre-death designation of burial benefits would complicate rather than simplify and streamline adjudication of these benefits. To implement the suggestion would require that VA establish and maintain a process for documenting a pre-death benefits designation and, in the case of a conflict, for adjudicating a deceased veteran's designation of beneficiary. In the context of a program that makes, on average in a particular year, over 139,000 relatively small one-time payments, the burden associated with establishing and maintaining such a process is inconsistent with the purpose of this regulation.

With respect to the commenter's suggestion to include individuals in relationships that are recognized under state law but not recognized by VA under section 103(c), such as domestic partnerships, civil unions, and other formal relationships, within the priority of payment list under § 3.1702(b), we agree with the commenter that VA has authority under section 2302 to expand the class of eligible recipients. Accordingly, to clarify that we do not intend to exclude individuals who had meaningful relationships with veterans but do not meet the requirements of section 103(c), we have revised § 3.1702(b) to also prescribe payment of burial benefits to the survivor of a legal union between the deceased veteran and the survivor that is not otherwise covered by § 3.1702(b)(1)(i) regarding surviving spouses. We define “legal union” to mean a formal relationship between the decedent and the survivor that existed on the date of the veteran's death, was recognized under the law of the State in which the couple formalized the relationship, and was evidenced by the State's issuance of documentation memorializing the relationship.

Consistent with the goal of streamlining adjudication, we have also revised the rule to provide that, except for automatic payments to surviving spouses under § 3.1702(a), which take precedence over all other categories of individuals, VA will pay the first-to-file of the individuals listed in § 3.1702(b). In the proposed rule, the first-to-file rule applied only within a specific priority category. By implementing a first-to-file rule across categories of individuals, the individual who takes initiative to file the claim and certify that he or she incurred burial, plot or interment, or transportation costs of the veteran (see § 3.1703(b)(1)(iii)), will be paid. In addition, such a rule will aid in streamlining adjudication because when VA receives a claim VA will not need to determine whether any individuals in a higher priority group exist.

In the course of reviewing the priority of payments under § 3.1702(b), we noticed that the use of the term “child” would not include an adult child of a deceased veteran given the statutory definition of “child” at 38 U.S.C. 101(4), which includes only minor children, children who became permanently incapable of self-support before the age of eighteen, or children under the age of twenty-three if pursuing a course of instruction at an approved educational institution. Therefore, we add the phrase “regardless of age,” after the word “child” in § 3.1702(b)(1)(ii).

Finally, regarding the priority provisions in § 3.1702(b), VA does not intend to apply the provisions to invalidate claims that are pending on the effective date of this final rule, such as those that VA received from funeral homes. Accordingly, we revise paragraphs (a) and (b) to make it clear that automatic payments to surviving spouses and the priority of payments provision apply to claims VA receives on or after the effective date of the final rule, July 7, 2014. In addition, we revise § 3.1702 to add paragraph (c), which, with two minor reference changes, restates current § 3.1601(a)(1) and (a)(2) for claims VA received before July 7, 2014.

Finally, regarding § 3.1702, a commenter pointed out that the proposed regulation did not expressly address the possibility of a surviving spouse receiving an automatic non-service-connected burial allowance under § 3.1702(a) but later establishing eligibility for the more generous service-connected burial allowance provided under § 3.1704. To remedy this, the commenter recommended that VA insert clarifying language in § 3.1702(a). VA analyzed available data prior to initiating this rulemaking and determined that the largest portion of deaths that are ultimately determined to be service-connected, are those in which the Veteran had a total service-connected disability rating at the time of death. The surviving spouses of those Veterans will receive the automated service-connected burial allowance payment. In proposing this regulation, it was VA's intent that a surviving spouse who received an automatic non-service-connected burial allowance could claim, and if eligible receive, the difference between the non-service-connected and the service-connected burial allowances. We agree with the commenter and revise § 3.1702(a) to include a reference to “the service-connected burial allowance under § 3.1704”.

In proposed § 3.1703(a)(2), we specified that claims for the non-service connected burial allowance based on a corrected character of discharge must be filed within two years of the date that the service department corrected the discharge record. One commenter expressed support for VA's decision to provide burial payments to survivors of veterans whose character of discharge had changed. VA makes no change based on this comment.

One commenter, citing preamble language from the NPRM describing the additional State plot or interment allowances VA pays based on service-connected death, suggested that VA modify proposed § 3.1707 and § 3.1704(c)(2) (referring to § 3.1707(a)) to permit VA to pay tribal cemeteries the plot or interment allowance when veterans eligible for burial in a national cemetery are buried in tribal cemeteries. Proposed § 3.1707(c) implements 38 U.S.C. 2303(b)(2), which provides for a plot or interment allowance for burials in other than State veterans cemeteries. This would include otherwise eligible burials in tribal cemeteries. Proposed § 3.1704 implements 38 U.S.C. 2307, which specifically provides that payments of service-connected death burial and funeral expenses under that section are “in lieu of” the plot or interment allowance for burial in other than a State veterans cemetery under 38 U.S.C. 2303(b)(2). However, as expressed in proposed § 3.1704(c)(2), VA has authority to pay the plot or interment allowance for burial in a State cemetery under 38 U.S.C. 2303(b)(1). For this reason, proposed § 3.1704(c)(2) accurately reflects the statutory authority found in 38 U.S.C. 2307. Therefore, we make no changes based on this comment.

One commenter recommended that VA rewrite § 3.1707(b)(3)(ii) because paragraphs (A) and (B) appear to grant eligibility for plot or interment allowance based on reserve component service on a less stringent basis than National Cemetery Administration (NCA) Directive 3210/1, “Eligibility Requirements,” which provides guidance for determining eligibility for burial in a VA national cemetery as authorized under 38 U.S.C. 2402. The commenter misreads the proposed rule. VA derived § 3.1707(b)(3)(ii)(A) and (B) from current 38 CFR 3.1604(d)(1)(ii), which it published in 2001 (66 FR 48558, 48559) to implement section 333 of Public Law 106-419, the Veterans Benefits and Health Care Improvement Act of 2000 (the Act). The allowance under 38 U.S.C. 2303(b) was previously payable only if the cemetery, or section of the cemetery, was used solely for the interment of persons who were eligible for burial in a national cemetery. Section 333 of the Act amended 38 U.S.C. 2303(b) to include cemeteries, or sections of cemeteries, that are also used for the interment of persons who were members of a reserve component of the Armed Forces not otherwise eligible for burial in a national cemetery or who were former members of such a reserve component not otherwise eligible for burial in a national cemetery who were discharged or released from service under conditions other than dishonorable. The reference to reserve members in proposed § 3.1707(b)(3)(ii)(A) and (B) relates to the criteria for the cemetery or section of a cemetery in which the individual is buried, and is substantively a repetition of the corresponding statutory provision in 38 U.S.C. 2303(b)(1)(A) and (B). This plot or interment allowance remains available only to individuals eligible for burial in a national cemetery under 38 U.S.C. 2402, as specified in proposed § 3.1707(a), General eligibility, which provides that VA will pay the allowances described in that section “[f]or a veteran who was eligible for burial in a national cemetery under 38 U.S.C. 2402, but was not buried in a national cemetery or other cemetery under the jurisdiction of the U.S.” Because proposed § 3.1707 accurately reflects the eligibility criteria established in 38 U.S.C. 2303(b), VA makes no changes based on this comment.

We received three comments about proposed § 3.1708, which would govern burial benefits for veterans whose remains are unclaimed. One commenter expressed concern with § 3.1708(d), which assigns responsibility for making burial arrangements for unclaimed veterans with the Director of the VA Regional Office in the area in which the veteran died. The commenter stated that regional offices did not have enough experience in such matters and needed training in this area. We will not make any changes to the rule at this time based upon the comments. However, we will carefully consider whether regional office directors need additional training regarding burial arrangements for unclaimed veterans in connection with the implementation of the final rule.

Another commenter supported the provisions in proposed § 3.1708, which do not include the wartime service and discharge due to disability requirements in current § 3.1600(b)(3). As mentioned in the preamble, VA eliminated these requirements based on amendments to 38 U.S.C. 2302(a) enacted in section 104 of Public Law 112-260. The same commenter also expressed concern as to whether proposed § 3.1708 would make funeral homes that provided funeral services for unclaimed veterans eligible claimants for purposes of reimbursement of funeral, burial, and transportation expenses. Proposed § 3.1702(b)(2) provided that VA will pay the “person or entity” that provided burial services for the remains of an unclaimed veteran. To the extent that a funeral home provided burial services for the remains of an unclaimed veteran, it is an eligible “entity” under § 3.1702(b)(2). However, VA agrees that the rule should be revised to clarify that VA will also pay transportation expenses in such cases. Therefore, we revise § 3.1702(b)(3) to expressly include “transportation subject to the limitations prescribed in §§ 3.1708 and 3.1709.”

Another commenter suggested that VA revise proposed § 3.1708(c) to include transportation to a State veterans cemetery or tribal cemetery. Proposed § 3.1708(c) provided that VA may reimburse a claimant under § 3.1709 for the expenses of transporting the unclaimed remains of a veteran to a national cemetery. VA's authority to reimburse a claimant for transportation expenses associated with unclaimed remains is limited by law to “the cost of transportation of the deceased veteran . . . for burial in a national cemetery.” 38 U.S.C. 2308(a). Further, “[s]uch payment shall not exceed the cost of transportation to the national cemetery nearest the veteran's last place of residence in which burial space is available.” Id. Because 38 U.S.C. 2308 limits reimbursement authority to transportation costs for burial in a national cemetery, VA is unable to expand through rulemaking reimbursement eligibility for transportation to State veterans and tribal cemeteries. Accordingly, VA makes no changes based on this comment.

Proposed § 3.1708(d) provided that when VA determines that a veteran's remains are unclaimed, the regional office director in the area in which the veteran died is responsible for making arrangements for burial in a national cemetery or cemetery satisfying the requirements of “paragraph (a) of § 3.1707.” The citation to “paragraph (a)” in proposed § 3.1708(d) is incorrect because paragraph (b) of proposed § 3.1708(d) is the paragraph containing the cemetery requirements. Accordingly, we revise § 3.1707(d) to correct this error. In addition, we note that under § 3.1708(d), as revised, a regional office director may make burial arrangements for the unclaimed remains of a veteran at a cemetery satisfying the requirements of § 3.1707(b), which would include a State veterans cemetery. The statutory authority for a burial allowance under proposed § 3.1708 is 38 U.S.C. 2302, which provides for “a sum not exceeding $300 . . . to cover the burial and funeral expenses of the deceased veteran and the expense of preparing the body and transporting it to the place of burial.” For the reasons explained above, VA would not be authorized to pay for transportation under 38 U.S.C. 2308 when transportation is not to a national cemetery.

We received two comments regarding proposed § 3.1709, which implements VA's authority to reimburse transportation expenses associated with burial in a national cemetery. As discussed in the NPRM, except for new provisions authorizing VA to reimburse claimants for the transportation of unclaimed veterans remains to national cemeteries, proposed § 3.1709 was largely unchanged from current burial regulations.

One commenter “strongly supported” the simplified language in proposed § 3.1709(d)(2) stating that VA would reimburse any reasonable transportation expense.

Another commenter suggested that VA consider amending proposed § 3.1709(a), (b), and (c) to include State and tribal veterans cemeteries. Again, VA's authority to reimburse a claimant for transportation expenses associated with unclaimed remains is limited by law to “the cost of transportation of the deceased veteran . . . for burial in a national cemetery” and such payment “shall not exceed the cost of transportation to the national cemetery nearest the veteran's last place of residence in which burial space is available.” 38 U.S.C. 2308(a). Accordingly, paragraph (a) of § 3.1709 provides that VA will, subject to limits, reimburse the costs of transportation of veterans' remains to a national cemetery. Paragraph (b) prescribes specific eligibility criteria for transportation expenses, and paragraph (c) establishes a maximum amount for reimbursement by providing that the amount payable will not exceed the costs of transporting the remains to the national cemetery nearest the veteran's last place of residence in which burial space is available. Because section 2308 limits reimbursement authority to transportation costs for burial in a national cemetery, VA is unable to use this rulemaking to expand its reimbursement authority to cover the cost of transportation of a veteran's remains to a State or tribal cemetery. VA makes no changes based on this comment.

In the course of considering comments regarding proposed § 3.1709, VA noticed that the reference in proposed § 3.1709(c) to “paragraph (e) of this section” should be to “paragraph (d) of this section,” because § 3.1709 contains no paragraph (e). We therefore revised § 3.1709 accordingly.

In the background section of the preamble to the proposed rule, we explained that, for purposes of efficiency, we proposed to adopt a flat-rate payment process where permitted by law based on a presumption that the expenses incurred were at least equal to the statutory maximum, unless VA has evidence to the contrary on the date it receives notice of the veteran's death. One commenter agreed with the flat-rate principle and suggested that VA “just come up with two different dollar amounts.” However, the statutory maximum burial rates are prescribed in statutes, e.g., 38 U.S.C. 2302 prescribes a $300 maximum payment. As a result, VA cannot through regulations establish new maximum rates. We make no changes based on this comment.

Another commenter, “strongly support[ed] the ability of the VA to authorize and automate the payment of burial benefits at the statutory maximum.” Recognizing that survivors face both emotional and economic loss, the same commenter also stated that the proposed rule “would allow more eligible survivors to receive the burial benefits efficiently and painlessly.”

One commenter, a funeral services trade association, expressed concern with the effects of 1990 legislation amending the National Cemeteries Act of 1973, which limited plot and marker allowances for veterans who preferred interment in non-governmental cemeteries. The commenter stated that the “pre-1990 plot and marker allowances were a win/win benefit that should be restored.” As the commenter acknowledged, such a comment is beyond the scope of this rulemaking. Accordingly, we make no changes to the proposed rule.

The Office of Management and Budget (OMB) assigns a control number for each collection of information it approves. Except for emergency approvals under 44 U.S.C. 3507(j), VA 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. In the proposed rule, we stated that proposed § 3.1703 constitutes a collection of information under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). Specifically, except for automated burial benefit payments under § 3.1702(a), it requires an individual seeking burial benefits to file a claim with VA that includes proof of the veteran's death and a statement certifying that the individual incurred burial, plot or interment, or transportation costs of the deceased veteran. The collection of information is currently approved by OMB and assigned OMB control number 2900-0003. We display the control number under the applicable regulation text in this final rule. However, because VA determined that provisions in the proposed rule, including automated burial payments and reduced evidentiary requirements, would reduce the information collection burden, VA submitted a copy of the proposed rule to OMB for its review of the collection of information, and requested public comments on the collection of information provisions contained in § 3.1703.

We received one comment on the proposed collection of information. One commenter stated that “[f]or such as [sic] small monetary benefit, the application should be very simple.” We read this as an endorsement of our elimination of the application for certain burial claims, our elimination of several questions on the application, and the reduced collection burden for applicants. We make no changes to the collection based on this comment.

Summary of collection of information: The proposed rule at § 3.1703 contains collections of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521) concerning applications for VA burial benefits.

Description of the need for information and proposed use of information: This information is needed to determine eligibility for VA monetary burial benefits.

Estimated number of respondents per year: 150,000.

Estimated frequency of responses per year: On occasion.

Estimated total annual reporting and recordkeeping burden: 37,500 hours.

VA has sent OMB the modified information collection requirement for this final rule under the previously assigned OMB control number, 2900-0003.

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). Although this final rule will affect some small entities, specifically funeral homes, it will not have a significant economic impact on those entities. Under current regulations, the funeral home engaged by a deceased veteran's survivor to handle the veteran's burial may seek direct reimbursement from VA for certain expenses in lieu of collecting payment from the survivor. To facilitate automation of VA's burial benefit payments, this final rule will discontinue direct payment of a survivor's burial benefits to a funeral home. While this change might create some additional administrative burden for funeral homes, it will not have a significant economic impact under the Regulatory Flexibility Act.

VA's monetary burial benefits generally do not cover the full cost of a burial and funeral. Accordingly, under current regulations, funeral homes collect a small portion of the total charges to the veteran's survivor from VA and the remainder directly from the survivor. Under this final rule, funeral homes will use the same general business model but collect the total charges for the services they provide from the survivor. Also, surviving spouses will have VA burial benefits available for payment to funeral homes shortly after notifying VA of the veteran's death. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

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

The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined to be a significant regulatory action under the Executive Order because it is likely to result in a rule that may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's Web site at http://www1.va.gov/orpm/, by following the link for “VA Regulations Published.”

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

The Catalog of Federal Domestic Assistance program numbers and titles for the programs affected by this document are 64.100, Automobiles and Adaptive Equipment for Certain Disabled Veterans and Members of the Armed Forces; 64.101, Burial Expenses Allowance for Veterans; 64.102, Compensation for Service-Connected Deaths for Veterans' Dependents; 64.104, Pension for Non-Service-Connected Disability for Veterans; 64.105, Pension to Veterans Surviving Spouses, and Children; 64.106, Specially Adapted Housing for Disabled Veterans; 64.109, Veterans Compensation for Service-Connected Disability; 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death; 64.115, Veterans Information and Assistance; and 64.127, Monthly Allowance for Children of Vietnam Veterans Born with Spina Bifida.

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Mr. Jose D. Riojas, Chief of Staff, Department of Veterans Affairs, approved this document on June 2, 2014, for publication.

For the reasons set out in the preamble, the Department of Veterans Affairs amends 38 CFR part 3 as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 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. 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-2012-0922 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 August 5, 2014. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0922, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

In the Federal Register of January 16, 2013 (78 FR 3377) (FRL-9375-4), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition ( PP IN-10526) by Ecolab, Inc., 370 N. Wabasha Street, St. Paul, MN 55102. The petition requested that 40 CFR 180.940(a) be amended by establishing an exemption from the requirement of a tolerance for residues of sodium bisulfate (CAS Reg. No. 7681-38-1) when used as an inert ingredient in antimicrobial pesticide formulations applied to food contact surfaces in public eating places, dairy processing equipment and food processing equipment and utensils at no more than 2,000 ppm in final formulation. That document referenced a summary of the petition prepared by Exponent, 1150 Connecticut Ave. NW., Suite 1100, Washington, DC 20036, the petitioner, which is available in the docket, http://www.regulations.gov.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

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 tolerance is “safe.” Section 408(b)(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. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance 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. . . .”

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for sodium bisulfate including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with sodium bisulfate follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies 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. Specific information on the studies received and the nature of the adverse effects caused by sodium bisulfate as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

The acute oral toxicity of sodium bisulfate is low. The acute oral LD 50 in male rats was 2,800 mg/kg. It was minimally irritating to the rabbit's skin and mildly irritating to the eyes. An acute inhalation study was available with sodium sulfate. Inhalation toxicity was not observed at 0.01 mg/l (the only dose tested). No dermal toxicity or dermal sanitization studies were available in the database.

Due to the lack of data for sodium bisulfate, both human metabolic processes and toxicity data for sodium sulfate were used for the risk characterization. Both sodium bisulfate and sodium sulfate readily undergo hydrolysis and dissociate to sodium ions and sulfate ions in the body.

Sodium sulfate was administered to male Sprague-Dawley rats at a dietary concentration of 0.84% (approximately 320-400 mg/kg/day) for 27 and 44 weeks. There was no mortality, tumors, body weight change or significant changes in food and/or water consumption. The NOAEL was ~320-400 mg/kg/day. In another study, male Sprague-dawley rats were given in diet 0.0, 0.125, 0.250, 0.5, 1 and 2% sodium sulfate (approximately 0, 125, 250, 500, 1,000 and 2,000 mg/kg/day) for 4 weeks. No changes in food and water consumption, body weight gain, food conversion efficiency, urine production or diarrhea. Blood hemoglobin, white blood count, serum alkaline phosphatase, inorganic phosphate and gross organ pathology were also unaffected. The NOAEL was 2,000 mg/kg/day (highest dose tested). A LOAEL was not observed in this study.

Sodium sulfate showed no mutagenic effect in the Ames test using various strains of S. typhimurium (TA1535, TA1537, TA100, TA98) both with and without S9 activation.

No carcinogenicity studies were available in the database. The National Toxicology Program (NTP), International Agency for Research on Cancer (IARC), and Occupational Safety & Health Administration (OSHA) have not listed sodium bisulfate as a carcinogen. A DEREK analysis was performed on sodium bisulfate and no structural alerts were detected. EPA concluded that sodium bisulfate is unlikely to pose a carcinogenic risk to humans based on lack of mutagenicity concerns for sodium sulfate, lack of any structural alerts for carcinogenicity, lack of any systemic toxicity at doses up to 2,800 mg/kg/day, and its metabolism to form a sulfate which is natural constituent present in the body.

Sodium sulfate was included in a test of a method for rapid assessment of teratogenicity. Pregnant ICR/SIM mice were given a saturated aqueous solution of sodium sulfate orally by gavage to deliver a dose of 2,800 mg/kg/day on days 8-12 of gestation. No maternal deaths occurred and the average maternal weight gain during the treatment period was not significantly different from that of water-treated controls. Twenty-four litters were delivered alive, and none were resorbed. The mean numbers of neonates delivered alive and dead in each litter and the survival of neonates on day 3 were not statistically significantly different from those of controls. Only body weight on day 1 was statistically significantly greater than that of controls. The maternal and developmental NOAEL = 2,800 mg/kg bw, the only dose tested.

No immunotoxicity, neurotoxicity or reproductive toxicity studies were available in the database.

Sodium bisulfate mammalian metabolism is essentially that of the sodium cation and sulfate anion. As previously noted, when sodium bisulfate is added to food products containing water or after ingestion of sodium bisulfate it ionizes to sodium ions, hydrogen ions and sulfate ions. Following ingestion, sulfate anions are predominantly not absorbed from the gastrointestinal tract and are excreted unchanged in urine. However, the sulfate anion is a normal constituent in the body, predominantly resulting from the body's metabolism of sulfur-containing food sources such as foods containing the essential amino acids cysteine and methionine. Sulfate anions are vital components in a number of human biosynthetic pathways such as cartilage production and the formation of pancreatic digestive enzymes. Additionally, the sulfate anion is also an important conjugate in the Phase II conjugation/elimination of oxidized (OH) aromatic ring metabolites and for hydroxyl steroid hormones, such as estrogen, where it acts as a transport agent to target organ tissue receptors.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

There was no hazard identified in repeat dose developmental studies at the limit dose of 2,800 mg/kg/day of sodium sulfate to either parental animals or their offspring. No effects were seen in two subchronic oral toxicity up to approximately 2,000 mg/kg/day of sodium sulfate. Based on the metabolism of sodium bisulfate to sulfate and sodium ions, both of which are essential components in the human metabolic processes, there is a lack of toxicological concern. Thus, due to its low potential hazard and lack of hazard endpoint, the Agency has determined that a quantitative risk assessment using safety factors applied to a point of departure protective of an identified hazard endpoint is not appropriate.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to sodium bisulfate, EPA considered exposure under the proposed exemption from the requirement of a tolerance (40 CFR 180.940(a)) such as food in contact with sanitized counters in public eating places, utensils, dairy processing equipment and food processing equipment as well as other uses which may result in dietary exposure.

However, because no hazard was identified for the acute and chronic dietary assessment (food and drinking water), or for the short-, intermediate-, and long-term residential assessments, no quantitative aggregate exposure assessments were performed.

2. Dietary exposure from drinking water. Residues of sodium bisuflate from uses in food contact sanitizing solutions, utensil, dairy processing equipment and food processing equipment may enter drinking water. However, because no hazard was identified for the acute and chronic dietary assessment, or for the short-, intermediate-, and long-term residential assessments as listed in this unit, no quantitative aggregate exposure assessments were performed.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

Residential (dermal and inhalation) exposure from food contact surface sanitizing solutions for public eating places, dairy-processing equipment, food-processing equipment and utensils are possible. Since an endpoint for risk assessment was not identified, a quantitative residential exposure assessment for sodium bisulfate was not conducted.

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

EPA has not found sodium bisulfate to share a common mechanism of toxicity with any other substances, and sodium bisulfate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that sodium bisulfate does not have a common mechanism of toxicity with other substances. 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 toxicity database for sodium bisulfate is adequate for assessment of risks to infants and children and the potential exposure is adequately characterized given the low toxicity of the chemical and formation of sulfate ion. No hazard was identified and there is no residual uncertainty regarding prenatal and/or postnatal toxicity. No acute or subchronic neurotoxicity studies are available, but there were no clinical signs of neurotoxicity or any systemic toxicity observed in the available database at doses up to 2,800 mg/kg/day. No developmental, reproductive, or teratogenic effects were seen in the available studies at doses up to and including 2,800 mg/kg/day.

Based on this information, there is no concern at this time for increased sensitivity to infants and children to sodium bisulfate when used as an inert ingredient in pesticide formulations for food contact surface sanitizing applications and a safety factor analysis has not been used to assess risk. For the same reason, EPA has determined that an additional safety factor is not needed to protect the safety of infants and children.

Taking into consideration all available information on sodium bisulfate, EPA has determined that there is a reasonable certainty that no harm to any population subgroup, including infants and children, will result from aggregate exposure to sodium bisulfate under reasonable foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.940(a) for residues of sodium bisulfate when used as an inert ingredient in pesticide formulations applied to food contact surface sanitizing solutions for public eating places, dairy processing equipment, food processing equipment and utensils at no more than 2,000 ppm in formulation, is safe under FFDCA section 408.

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of sodium bisulfate in or on any food commodities. EPA is establishing a limitation on the amount of sodium bisulfate that may be used in pesticide formulations. The limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will not register any pesticide for sale or distribution that contains greater than 2,000 ppm of sodium bisulfate in the pesticide formulation.

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. 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 United Nation 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 sodium bisulfate.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.940(a) for sodium bisulfate (CAS Reg. No. 7681-38-1) when used as an inert ingredient in antimicrobial pesticide formulations applied to food contact surface sanitizing solutions for public eating places, dairy processing equipment, food processing equipment and utensils at no more than 2,000 ppm in formulation.

This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. 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 established on the basis of a petition under FFDCA section 408(d), such as the tolerance 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, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq. ).

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) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), 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 . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 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. 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 the appropriate docket ID number, EPA-HQ-OPP-2013-0654 and/or EPA-HQ-OPP-2013-0655, for the pesticide petition of interest 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 August 5, 2014. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing request, identified by the appropriate docket ID number, EPA-HQ-OPP-2013-0654 and/or EPA-HQ-OPP-2013-0655, for the pesticide petition of interest by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

In the Federal Register of October 25, 2013 (78 FR 63938) (FRL-9901-96), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions ( PP 3F8156; EPA-HQ-OPP-2013-0654) and ( PP 3F8174; EPA-HQ-OPP-2013-0655) by Cheminova A/S, c/o Cheminova, Inc., 1600 Wilson Blvd., Suite 700, Arlington, VA 22209-2510. The petitions requested that 40 CFR 180.629 amend the current established tolerances for residues of the fungicide flutriafol, including its metabolites and degradates, in or on corn, field, forage to 5 parts per million (ppm); corn, field, stover to 15 ppm; corn, pop, stover to 15 ppm (PP 3F8156). The petitions also requested that the 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide flutriafol, including its metabolites and degradates, in or on cattle, liver at 1.0 ppm; cattle, meat byproducts, except liver at 0. 10 ppm; cattle, muscle at 0.03 ppm; goat, liver at 1.0 ppm; goat, meat byproducts, except liver at 0.10 ppm; goat, muscle at 0.03 ppm; horse, liver at 1.0 ppm; horse, meat byproducts, except liver at 0.10 ppm; horse, muscle at 0.03 ppm; milk at 0.01 ppm; sheep, liver at 1.0 ppm; sheep, meat byproducts, except liver at 0.10 ppm; sheep, muscle at 0.03 ppm ( PP 3F8156); african tree nut at 0.015 ppm; almond, nutmeat at 0.6 ppm; almond, hulls at 15 ppm; brazil nut at 0.015 ppm; bur oak at 0.015 ppm; butternut at 0.015 ppm; cajon at 0.015 ppm; cashew at 0.015 ppm; castanha-do-maranhao at 0.015 ppm; coconut at 0.015 ppm; coquito nut at 0.015 ppm; dika nut at 0.015 ppm; guiana chestnut at 0.015 ppm; hazelnut at 0.015 ppm; heartnut at 0.015 ppm; hickory nut at 0.015 ppm; Japanese horse-chestnut at 0.015 ppm; macadamia nut at 0.015 ppm; mongongo nut at 0.015 ppm; monkey-pot at 0.015 ppm; pachira nut at 0.015 ppm; peanut, hay at 15 ppm; pecan at 0.015 ppm; sapucaia nut at 0.015 ppm; strawberry at 1.5 ppm; tomato, paste at 1.5 ppm; triticale, grain at 0.10 ppm; vegetable, cucurbit, Group 9 at 0.20 ppm; vegetable, fruiting, Group 8-10 at 0.60 ppm; walnut, black at 0.015 ppm; walnut, English at 0.015 ppm; wheat, forage at 30 ppm; wheat, grain at 0.10 ppm; wheat, hay at 15 ppm; and wheat, straw at 9 ppm ( PP 3F8174). The documents referenced a summary of the petitions prepared by Cheminova, Inc., the registrant, which is available in the docket, http://www.regulations.gov. There was one comment received in response to the notice of filings and is discussed in Unit IV.D.

Based upon review of the data supporting the petitions, proposed tolerances for cattle, liver; cattle, meat by products, except liver; goat, liver; goat, meat by products, except liver; horse, liver; horse, meat by products, except liver; sheep, liver; and sheep, meat by products, except liver were lowered. The proposed tolerances for wheat, grain; pecan; african tree nut; brazil nut; bur oak, butternut, cajou; cashew; castanha-do-maranhao; coconut; coquito nut; dika nut; guiana chestnut; hazelnut; heartnut; hickory nut; japanese horse-chestnut; macadamia nut; mongongo nut; monkey-pot; pachira nut; sapucaia nut; walnut, black; walnut, english; vegetable, cucurbit, group 9; vegetable, fruiting, group 8-10; cattle, muscle; goat, muscle; horse, muscle; and sheep, muscle were increased. A tolerance for triticale, grain is not needed and so is not being established. On the other hand, EPA has determined that tolerances are needed for hog, fat and hog, muscle and accordingly are being established. The established tolerances for cattle, meat by products; goat, meat by products; horse, meat by products; and sheep, meat by products are being removed. The reasons for these changes are explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(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. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance 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. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for flutriafol including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with flutriafol follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies 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.

Flutriafol has high oral acute toxicity in the mouse. It has low acute toxicity via the oral, dermal, and inhalation routes in rats. Flutriafol is minimally irritating to the eyes and is not a dermal irritant. Flutriafol was not shown to be a skin sensitizer when tested in guinea pigs.

Short-term, subchronic, and chronic toxicity studies in rats, mice, and dogs identified the liver as the primary target organ of flutriafol. Hepatotoxicity was first evident in the subchronic studies (rats and dogs) in the form of increases in liver enzyme release (alkaline phosphatase), and liver weights, and histopathology findings ranging from hepatocyte vacuolization to centrilobular hypertrophy and slight increases in hemosiderin-laden Kupffer cells. It is noteworthy that with chronic exposures there are no indications of progression of liver toxicity in any of the species tested. After over 1 year of exposure, hepatotoxicity in rats, dogs, and mice took the form of minimal to severe fatty changes; bile duct proliferation/cholangiolarfibrosis; hemosiderin accumulation in Kupffer cells; centrilobular hypertrophy, and increases in alkaline phosphatase release. Slight indications of effects in the hematopoietic system are sporadically seen in the database. These effects were manifested in the form of slight anemia (rats and dogs) and increased platelet, white blood cell, neutrophil, and lymphocyte counts (mice). These effects, however, were minimal in severity.

Flutriafol is considered to be “Not likely to be Carcinogenic to Humans” based on the results of the carcinogenicity studies in rats and mice. The results of the rat chronic toxicity/carcinogenicity study and the mouse carcinogenicity study are negative for carcinogenicity. All genotoxicity studies on flutriafol showed no evidence of clastogenicity or mutagenicity.

Specific information on the studies received and the nature of the adverse effects caused by flutriafol as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the most recent risk assessment, “Flutriafol: Human-Health Risk Assessment for Tolerances in/on Field Corn, Popcorn, Peanut, Wheat, Strawberries, Cucurbit, Vegetables, Fruiting Vegetables, and Tree Nuts,” which can be found at http://www.regulations.gov, under document ID number EPA-HQ-OPP-2013-0654-0005 and EPA-HQ-2013-0655-0007.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for flutriafol used for human risk assessment is shown in the following table.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to flutriafol, EPA considered exposure under the petitioned-for tolerances as well as all existing flutriafol tolerances in 40 CFR 180.629. EPA assessed dietary exposures from flutriafol in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for flutriafol. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture's (USDA) National Health and Nutrition Examination Survey, What We Eat In America (NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food, EPA made the following assumptions for the acute exposure assessment: Tolerance-level residues or tolerance-level residues adjusted to account for the residues of concern for risk assessment and 100 percent crop treated (PCT). Since adequate processing studies have been submitted which indicate that tolerances for residues in/on apple juice, grape juice, dried prunes, and tomato puree are unnecessary and since tolerances for residues in/on raisin and tomato paste tolerances are established/recommended, the default processing factors for these commodities were reduced to 1. The default processing factors were retained for the remaining relevant commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA's (NHANES/WWEIA) conducted from 2003-2008 as well. As to the residue levels in food, EPA made the following assumptions for the chronic exposure assessment: Tolerance-level residues or tolerance-level residues adjusted to account for the residues of concern for risk assessment and 100 PCT. Since adequate processing studies have been submitted which indicate that tolerances for residues in/on apple juice, dried prunes, grape juice, and tomato puree are unnecessary and since tolerances for residues in/on raisin and tomato paste tolerances are established/recommended, the default processing factors for these commodities were reduced to 1. The default processing factors were retained for the remaining relevant commodities.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that flutriafol does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and PCT information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for flutriafol. Tolerance level residues and/or 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the flutriafol dietary exposure analysis and risk assessment. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of flutriafol. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Food Quality Protection Act (FQPA), First Index Reservoir Screening Tool (FIRST), Pesticide Root Zone Model/Ground Water (PRZM/GW), the estimated drinking water concentrations (EDWCs) of flutriafol for acute exposures are estimated to be 40.55 parts per billion (ppb) for surface water and 310 ppb for ground water.

For chronic exposures for cancer assessments the EDWC's are estimated to be 4.03 ppb for surface water and 202 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute and chronic dietary risk assessment, the water concentration value of 310 ppb and 202 ppb, respectively, were used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Flutriafol is not registered for any specific use patterns that would result in residential exposure.

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

Flutriafol is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events. In conazoles, however, a variable pattern of toxicological responses is found; some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

Triazole-derived pesticides can form the metabolite 1,2,4-triazole (T) and two triazole conjugates triazolylalanine (TA) and triazolylacetic acid (TAA). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides, EPA conducted an initial human-health risk assessment for exposure to T, TA, and TAA resulting from the use of all current and pending uses of any triazole-derived fungicide as of September 1, 2005. The risk assessment was a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors (UFs)) and potential dietary and non-dietary exposures (i.e., high-end estimates of both dietary and non-dietary exposures). In addition, the Agency retained the additional 10X Food Quality Protection Act (FQPA) safety factor (SF) for the protection of infants and children. The assessment included evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment can be found in the propiconazole reregistration docket at http://www.regulations.gov, docket ID number EPA-HQ-OPP-2005-0497 and an update to the aggregate human health risk assessment for free triazoles and its conjugates may be found in this current docket, docket ID number EPA-HQ-OPP-2013-0295 entitled “Common Triazole Metabolites: Updated Dietary (Food + Water) Exposure and Risk Assessment to Address the Revised Tolerance for Residues of Fenbuconazole in Peppers.” Based on the triazole residue estimates resulting from the proposed uses for flutriafol, a revised triazole risk assessment is unnecessary.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. The potential impact of in utero and perinatal flutriafol exposure was investigated in three developmental toxicity studies (two in rats, one in rabbits) and two multi-generation reproduction toxicity studies in rats. In the first of two rat developmental toxicity studies, a quantitative susceptibility was observed (delayed ossification or non-ossification of the skeleton in the fetuses) at a lower dose than maternal effects. In the second rat developmental study, a qualitative susceptibility was noted. Although the developmental toxicity occurred at the same dose level that elicited maternal toxicity, the developmental effects (external, visceral, and skeletal malformations; embryo lethality variations; a generalized delay in fetal development; and fewer live fetuses) were more severe than the decreased food consumption and body-weight gains observed in the dams. For rabbits, intrauterine deaths occurred at a dose level that also caused adverse effects in maternal animals. In the 2-generation reproduction studies, a qualitative susceptibility was also seen. Effects in the offspring (decreased litter size and percentage of live births, increased pup mortality, and liver toxicity) can be attributed to the systemic toxicity of the parental animals (decreased body weight and food consumption and liver toxicity.)

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for flutriafol is complete.

ii. There is no indication that flutriafol is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. Signs of neurotoxicity were reported in the acute and subchronic neurotoxicity studies at the highest dose only; however, these effects were primarily seen in animals that were agonal (at the point of death) and, thus, are not indicative of neurotoxicity. In addition, there was no evidence of neurotoxicity in any additional short-term studies in rats, mice, and dogs, or in the long-term toxicity studies in rats, mice, and dogs.

iii. There are no concerns or residual uncertainties for prenatal and/or postnatal toxicity. Although there is evidence for increased quantitative and qualitative susceptibility in the prenatal study in rats and rabbits and the 2-generation reproduction study in rats, there are no concerns for the offspring toxicity observed in the developmental and reproductive toxicity studies for the following reasons:

• Clear NOAELs and LOAELs were established in the fetuses/offspring for each of these studies.

• The dose-response for these effects are well-defined and characterized.

• Developmental endpoints are used for assessing acute dietary risks to the most sensitive population (females 13-49 years old) as well as all other short- and intermediate-term exposure scenarios.

• The chronic reference dose is greater than 300-fold lower than the dose at which the offspring effects were observed in the 2-generation reproduction studies.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to flutriafol in drinking water. These assessments will not underestimate the exposure and risks posed by flutriafol.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to flutriafol will occupy 31% of the aPAD for females 13-49 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to flutriafol from food and water will utilize 51% of the cPAD for children (1-2 years old the population group receiving the greatest exposure. Because there are no residential uses for flutriafol, the chronic aggregate risk includes food and drinking water only.

3. Short-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Since flutriafol is not registered for any use patterns that would result in residential exposure, the short- and intermediate-term aggregate risk is the sum of the risk from exposure to flutriafol through food and water and will not be greater than the chronic aggregate risk.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, flutriafol is classified as “not likely to be carcinogenic to humans.” EPA does not expect flutriafol to pose a cancer risk.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to flutriafol residues.

Adequate enforcement methodology (Gas Chromatography/Nitrogen/Phosphorus detector (GC/NPD) for proposed tolerances) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

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. 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 United Nations 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.

There are no Canadian or Mexican MRLs for flutriafol in/on the proposed commodities with the exception for peanut hay; dried chili peppers; sweet peppers; wheat straw; wheat grain and wheat bran. The Codex has established MRLs for flutriafol in or on dried chili peppers at 10 ppm; peanut, hay at 20 ppm; sweet peppers at 1 ppm; wheat, bran at 0.3 ppm; wheat, grain at 0.15 ppm; and wheat, straw at 8 ppm. Wheat, bran and wheat, grain MRLs are the same as the tolerances being established for flutriafol in the United States. The Agency is establishing tolerances for vegetable, fruiting, group 8-10 at 1.0 ppm to harmonize with the Codex sweet pepper MRL.

Harmonization of the peanut, hay and wheat, straw tolerances were determined to be unnecessary as these commodities do not normally enter international commerce.

Based on an analysis of feeding studies and on the livestock maximum reasonable dietary burdens, EPA is establishing tolerances for hog, fat and hog, muscle and establishing lower tolerances than those proposed by the petitioner for cattle, liver; cattle, meat by products, except liver; goat, liver; goat, meat by products, except liver; horse, liver; horse, meat by products, except liver; sheep, liver; and sheep, meat by products, except liver. For the same reason EPA is establishing higher tolerance than those proposed by the petitioner for cattle, muscle; goat, muscle; horse, muscle; and sheep, muscle.

EPA established higher tolerance than those proposed by the petitioner for African tree nut; brazil nut; bur oak, butternut, cajou; cashew; castanha-do-maranhao; coconut; coquito nut; dika nut; guiana chestnut; hazelnut; heartnut; hickory nut; Japanese horse-chestnut; macadamia nut; mongongo nut; monkey-pot; pachira nut; sapucaia nut; vegetable, cucurbit, group 9; walnut, black; walnut, english and wheat, grain based upon the analysis of residue levels from crop field trial data and the Organization for Economic Cooperation Development (OECD) tolerance calculation procedure. The proposed tolerance for triticale is unnecessary because triticale is covered by the wheat tolerances. As the petitioned for tolerances for liver and meat byproducts of cattle, goat, horse, and sheep, replace meat byproducts tolerances for cattle, goat, horse, and sheep, the latter tolerances are being removed.

EPA received one comment to the Notice of Filing that stated, in part, that no residues or increase in residues should be allowed for flutriafol. No additional data was provided by the commenter for Agency review. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by FFDCA section 408 states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework. As is the case with almost all conventional pesticides, numerous tests have been performed to study the toxicological effects of flutriafol. The various tests use doses that range from quite low to many times higher than virtually any member of the population of the United States could ever be exposed to. The highest doses are, in fact, deliberately chosen to try to elicit toxicological symptoms because a description of these symptoms and the dose levels at which they occur is one of the desired outcomes of the studies. Virtually any chemical (vitamins, for example) is toxic if taken in excessively large doses. Risk, however, is a function of the exposure levels that actually occur in the population in comparison to the threshold exposure level at which adverse symptoms begin to be elicited. For a toxicologically average person, if actual exposure is less than the adverse symptom exposure threshold, no such symptoms are expected to be seen. However, in order to make the reasonable certainty of no harm determination the Agency requires more assurance than this that the use of animals (instead of humans) for testing, variations in susceptibility among members of the U.S. population, greater sensitivity of infants and children, etc., has been accounted for in the risk assessment process. Therefore, safety factors are used in conjunction with dosing levels at which no or only the first symptoms of exposure to the pesticide were seen to provide a substantial additional margin of safety. This mechanism helps assure that toxicological symptoms will not be elicited in members of the U.S. population by beneficial, labeled uses of the pesticide. The fact that very high doses of a pesticide cause toxicological symptoms is not, by itself, enough to make approval of uses of that pesticide unreasonable.

Therefore, tolerances are established for residues of flutriafol, in or on African tree nut at 0.02 ppm; Almond at 0.60 ppm; Almond hull at 15 ppm; Brazil nut at 0.02 ppm; Butternut at 0.02 ppm; Bur oak at 0.02 ppm; Cajou at 0.02 ppm; Cashew at 0.02 ppm; Castanha-Do-Maranhao at 0.02 ppm; Cattle, fat at 0.05 ppm; Cattle, liver at 0.80 ppm; Cattle, meat by products, except liver at 0.05 ppm; Cattle, muscle at 0.05 ppm; Coconut at 0.02 ppm; Coquito nut at 0.02 ppm; Corn, field, forage at 5.0 ppm; Corn, field, stover to 15 ppm; Corn, pop, stover to 15 ppm; Dika nut at 0.02 ppm; Guiana chestnut at 0.02 ppm; Goat, fat at 0.05 ppm; Goat liver at 0.80 ppm; Goat, meat byproducts, except liver at 0.05 ppm; Goat, muscle at 0.05 ppm; Hazelnut at 0.02 ppm; Heartnut at 0.02 ppm; Hickory nut at 0.02 ppm; Hog, fat at 0.01 ppm; Hog, muscle at 0.01 ppm; Horse, fat at 0.05 ppm; Horse, liver at 0.80 ppm; Horse, meat byproducts, except liver at 0.05 ppm; Horse, muscle at 0.05 ppm; Japanese horse-chestnut at 0.02 ppm; Macadamia nut at 0.02 ppm; Milk at 0.01 ppm; Mongongo nut at 0.02 ppm; Monkey-pot at 0.02 ppm; Pachira nut at 0.02 ppm; Peanut, hay at 15 ppm; Pecan at 0.02 ppm; Sapucaia nut at 0.02 ppm; Sheep, fat at 0.05 ppm; Sheep, liver at 0.80 ppm; Sheep, meat byproducts, except liver at 0.05 ppm; Sheep, muscle at 0.05 ppm; Strawberry at 1.5ppm; Tomato, paste at 1.5 ppm; Vegetable, cucurbit, group 9 at 0.30 ppm; Vegetable, fruiting, group 8-10 at 1.0 ppm; Walnut, black at 0.02 ppm; Walnut, English at 0.02 ppm; Wheat, bran at 0.30 ppm; Wheat, forage at 30 ppm; Wheat, germ at 0.25 ppm; Wheat, grain at 0.15 ppm; Wheat, hay at 15 ppm; and Wheat, straw at 9.0 ppm.

This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. 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 established on the basis of a petition under FFDCA section 408(d), such as the tolerance 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, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq. ).

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) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), 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 . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

EPA Region 4 is publishing this direct final Notice of Deletion of the B&B Chemical Co., Inc. Superfund Site from the NPL. The NPL constitutes Appendix B of 40 CFR part 300 which is the NCP, which EPA promulgated pursuant to section 105 of the CERCLA of 1980, as amended. EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). As described in the Section 300.425(e)(3) of the NCP, sites deleted from the NPL remain eligible for Fund-financed remedial actions if conditions at a deleted site warrant such actions.

Because EPA considers this action to be noncontroversial and routine, this action will be effective August 5, 2014 unless EPA receives adverse comments by July 7, 2014. Along with this direct final Notice of Deletion, EPA is co-publishing a Notice of Intent to Delete in the “Proposed Rules” section of the Federal Register . If adverse comments are received within the 30-day public comment period on this deletion action, EPA will publish a timely withdrawal of this direct final Notice of Deletion before the effective date of the deletion, and the deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent to Delete and the comments already received. There will be no additional opportunity to comment.

Section II of this document explains the criteria to delete sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the B&B Chemicals Superfund Site and demonstrates how it meets the deletion criteria. Section V discusses EPA's action to delete the Site from the NPL unless adverse comments are received during the public comment period.

The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate. In making such a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the State, whether any of the following criteria have been met:

i. Responsible parties or other persons have implemented all appropriate response actions required;

ii. all appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

iii. the remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures is not appropriate.

Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-year reviews to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants, or contaminants remain at a site above levels that allow for unlimited use and unrestricted exposure. EPA conducts such five-year reviews even if a site is deleted from the NPL. EPA may initiate further action to ensure continued protectiveness at a deleted site if new information becomes available that indicates it is appropriate. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the Hazard Ranking System.

The following procedures apply to deletion of the site:

(1) EPA consulted with the State of Florida before developing this direct final Notice of Deletion and the Notice of Intent to Delete co-published today in the “Proposed Rules” section of the Federal Register

(2) EPA has provided the state 30 working days for review of this notice and the parallel Notice of Intent to Delete prior to their publication today, and the state, through the FDEP, has concurred on the deletion of the site from the NPL.

(3) Concurrently with the publication of this direct final Notice of Deletion, a notice of the availability of the parallel Notice of Intent to Delete is being published in a major local newspaper, Miami Today. The newspaper notice announces the 30-day public comment period concerning the Notice of Intent to Delete the Site from the NPL.

(4) The EPA placed copies of documents supporting the proposed deletion in the deletion docket and made these items available for public inspection and copying at the Site information repositories identified above.

(5) If adverse comments are received within the 30-day public comment period on this deletion action, EPA will publish a timely notice of withdrawal of this direct final Notice of Deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent to Delete and the comments already received.

Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions, should future conditions warrant such actions.

The following information provides EPA's rationale for deleting the Site from the NPL:

B & B Chemical Co., Inc. Superfund Site, (EPA ID: FLD004574190) is located at 875 West 20th Street, Hialeah, Florida 33010. The B&B Chemical Co., Inc. Superfund Site (the Site) is still operational and occupies 5 acres in the industrial area of Hialeah, Miami-Dade County, Florida. B&B Tritech, Inc., formerly B&B Chemical Co., Inc. (B&B) manufactured industrial cleaning compounds at the Site since 1958. The Site is bounded to the north by Highway 934 (Hialeah Expressway), to the east by West 8th Avenue, to the south by West 20th Street, and to the west by the Dade County Metrorail Okeechobee Station and parking garage. Chemicals and products used by the facility include a variety of solvents, polishes, detergents, oxidizing agents, corrosive inhibitors and metal cleaners. In the mid-1970s, inspectors from the Miami-Dade County Department of Environmental Resource Management (DERM) documented wastewater residues in soakage pits at the Site, and subsequently issued a Cease and Desist Order related to wastewater discharge to the soakage pits. In May 1976, B&B put a wastewater pre-treatment system into operation. During a 1979 area-wide ground water study conducted for DERM, two samples were collected from irrigation wells located on the Site. Analytical data from these samples indicated the presence of trans-1,2-dichloroethlyene, tetrachloroethylene, chlorobenzene, 1,1-dichloroethane, vinyl chloride and trichloroethylene. In September 1981, construction workers installing a potable water line immediately south of the B&B site experienced skin irritation. Analytical data from a ground water sample collected in the ditch indicated the presence of phenol, trichoroethylene, tetrachloroethlyene, vinyl chloride, trans-1,2 dichloroethlyene and cis-1,2 dichloroethylene. In June 1982, during the construction of the Metrorail track immediately south of the Site, workers also complained of skin bums while working in the trenches.

In August 1985, at the request of DERM, EPA conducted an investigation at the Site and found benzene, chlorobenzene, vinyl chloride and chromium in the ground water. Results of the 1986 EPA-funded investigation were used to compute a Hazard Ranking System (HRS) score for ground water at the Site. The HRS score exceeded the threshold at which sites would normally be placed on the National Priorities List (NPL). The primary contaminants of concern at the Site include, but are not limited to, benzene, chlorobenzene, vinyl chloride and chromium in the ground water. The Site was proposed for the NPL June 24, 1988 (53 FR 23988) and finalized on the NPL August 30, 1990 (55 FR 35502).

In 1987, B&B completed a Remedial Investigation/Feasibility Study (RI/FS) to determine the type and extent of contamination at the Site. Starting in August 1988, B&B operated a ground-water treatment system on site, in accordance with a Court Order of Stipulated Settlement with DERM. The treatment system operated, with some periods of interruption, until 1993. The B&B RI/FS was determined inadequate based on NCP requirements and thus EPA conducted another investigation. The EPA Remedial Investigation (RI) and Feasibility Study (FS) were conducted between September 13, 1989 and September 12, 1994.

Analytical results of the RI sampling identified at the Site were constituents commonly associated with chemical manufacturing operations that posed a threat to human health and the environment. The primary contaminants of concern (COCs) identified in the 1994 RI/FS included benzene, chlorobenzene, chromium and vinyl chloride in ground water and were selected based on exceedences of State of Florida and federal MCLs for contaminants in the 1992 to 1994 ground-water monitoring period. The feasibility study at the site was focused on the validity of monitored natural attenuation for the ground-water remediation. Ground-water monitoring results revealed a downward trend in the contaminant concentrations which supported the natural attenuation as a viable remedy.

EPA's Record of Decision (ROD) was signed on September 12, 1994, and the State of Florida concurred with the selected remedy. The selected alternative included the following:

• Natural attenuation of ground-water contaminants;

• Ground-water monitoring to verify natural attenuation;

• Implementation of institutional controls in the form of a notification agreement between EPA and the landowner to ensure continued integrity of the asphalt cover;

The remedy involves the natural attenuation of groundwater contaminants to levels below MCLs. Decreasing trends of groundwater contaminant concentrations were observed during the 1992 through 1994 monitoring period. These trends gave evidence that natural attenuation would be protective of human health and the environment.

Ground-water monitoring was conducted primarily to verify that natural attenuation of ground-water contamination is occurring. Monitoring consisted of semi-annual sampling of eight existing wells (MWT-31, MWS-06, MWD-07, CDM-02, CDM-03, MWF-27, MWD-29 and MWM-29), selected because of their historical exceedences of MCLs. Each well was sampled semi-annually until the groundwater contaminants decreased to levels below maximum contaminant levels (MCLs) for two consecutive rounds of sampling. Once this occurred, the wells were to be omitted from further semi-annual sampling events. The ROD required the final round of ground-water sampling to include all the monitoring wells at the site and that all contaminants of concern are below MCLs as requested by FDEP at the time the ROD was signed. Ground-water samples were to be analyzed for the analytes on EPA's target compound list, excluding semivolatile compounds, as these compounds were not observed above MCLs during the RI/FS.

On July 17, 2013 a restrictive covenant was filed to comply with the remedy component. The restrictive covenant states that the entire property is restricted to future use of commercial or industrial, that the potential for vapor intrusion into any newly constructed buildings is evaluated and properly addressed before construction, and that maintenance and inspection of all paved areas and building foundations in the areas for which the soil contamination levels did not meet the criteria for unlimited use is required yearly. All institutional controls have been implemented.

Post-ROD ground-water sampling was initiated in December 1995. Sampling continued on a semi-annual basis until 2007. After reviewing the results of the 2007 ground-water sampling, FDEP and EPA determined that the cleanup goals specified in the 1994 ROD had been met and that there was no need to continue with regular, semi-annual sampling of the monitoring wells. Further, upon consultation with FDEP, EPA issued the 2009 Explanation of Significant Difference (ESD) that removed the requirement for a final round of ground-water sampling.

The selected remedy was revised by the June 2009 ESD. The 2009 ESD removed the 1994 ROD requirement for a final round of ground-water sampling, this requirement was removed because performance standards were met for all monitoring wells in two consecutive rounds of sampling and FDEP concurred that the additional sampling was not necessary. In addition the 2009 ESD further outlined the requirements for the institutional controls to ensure the remedy remains protective.

The 2009 ESD required restrictive covenants be placed on the site properties to:

• Ensure that the integrity of existing impermeable surfaces is maintained.

• Ensure that future use of the property remains commercial or industrial.

• Ensure that the potential for vapor intrusion into any newly constructed buildings is evaluated and properly addressed.

The first five-year review was completed on October 24, 2001 and the second was signed on April 26, 2007. These reviews concluded that the selected remedy remains protective of human health and the environment.

The third statutory five-year review was signed on August 9, 2012 pursuant to EPA's Comprehensive Five-Year Review Guidance (OSWER No. 9355.7-03B-P, June 2001). The five-year review concluded that remedial actions at the B&B Chemical Co., Inc. Superfund Site are protective, in the short-term, of human health and the environment, and exposure pathways that could result in unacceptable risks are being controlled in the long term by the required restrictive covenants. On July 17, 2013 a restrictive covenant was filed to restrict the Site in the Clerk of Courts, Recorder's Office, Miami-Dade County, Florida, at Deed Book 438, pages 341-345. All institutional controls have been implemented.

Because hazardous materials remain at the Site below the pavement at levels above those that allow for unlimited use and unrestricted exposure, Section 121 of CERCLA requires ongoing statutory review to be conducted no less than every five years from the start of remedial actions. The next five-year review will be completed by August 2017.

Throughout the removal and remedial process, EPA has kept the public informed of the activities being conducted at the Site by way of public meetings, progress fact sheets, and the announcement through local newspaper advertisement on the availability of documents such as the RI/FS, Risk Assessment, ROD, Proposed Plan, ESD and five-year reviews.

Public participation activities have been satisfied as required in CERCLA section 113(k), 42 U.S.C. 9613(k), and CERCLA section 117, 42 U.S.C. 9617. Documents in the deletion docket which EPA relied on for recommendation of the deletion from the NPL are available to the public in the information repositories identified above.

This Site meets all the site completion requirements as specified in Office of Solid Waste and Emergency Response (OSWER) Directive 9320.22, Close Out Procedures for National Priorities List Sites. Specifically, confirmatory ground-water sampling verifies that the Site has achieved the ROD cleanup standards, and that all cleanup actions specified in the ROD and ESD have been implemented.

The EPA, with concurrence of the State of Florida through the FDEP, has determined that all appropriate response actions under CERCLA, other than maintenance of the pavement and five-year reviews have been completed. Therefore, EPA is deleting the Site from the NPL.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication. This action will be effective August 5, 2014 unless EPA receives adverse comments by July 7, 2014. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final notice of deletion before the effective date of the deletion, and it will not take effect. EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

For the reasons set out in this document, 40 CFR part 300 is amended as follows:

We, the U.S. Fish and Wildlife Service, recently became aware that, in part 17 of title 50 of the Code of Federal Regulations (CFR), we have two entries for the Sonoma County distinct population segment of the California tiger salamander. This error in § 17.95(d) is the result of an incorrect amendatory instruction that published in a 2011 final rule. This document corrects the error in 50 CFR 17.95(d).

In a proposed rule that published August 18, 2009 (74 FR 41662), the third amendatory instruction reads as follows:

“3. Amend § 17.95(d) by revising critical habitat for the California tiger salamander (Ambystoma californiense) in Sonoma County to read as follows:”

However, in the final rule that published August 31, 2011 (76 FR 54346), the third amendatory instruction reads like this:

“3. In § 17.95, amend paragraph (d) by adding an entry for “California Tiger Salamander (Ambystoma californiense) in Sonoma County” in the same order that the species appears in the table at § 17.11(h), to read as follows:”

The proposed rule was correct in using the word “revising,” as a critical habitat designation already existed for the Sonoma County distinct population segment of the California tiger salamander as the result of a final rule of December 14, 2005 (70 FR 74137). The August 31, 2011, final rule erroneously used the word “adding,” which resulted in an additional critical habitat entry being added to the CFR instead of replacing the entry that was already there. Therefore, with this document, we remove from 50 CFR 17.95(d) the entry pertaining to the California tiger salamander in Sonoma County, CA, that was added to the CFR following the 2005 final rule and which should have been removed in 2011.

For the reasons given in the preamble, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

In a final rule that published in the Federal Register on May 27, 2014, at 79 FR 30400, the following correction is made:

Background

Section 101(a)(5)(A) of the MMPA (16 U.S.C 1361 et seq. ) directs the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring, and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

The National Defense Authorization Act of 2004 (NDAA) (Pub. L. 108-136) removed the “small numbers” and “specified geographical region” limitations indicated above and amended the definition of “harassment” as it applies to a “military readiness activity” to read as follows (Section 3(18)(B) of the MMPA): (i) Any act that injures or has the significant potential to injure a marine mammal or marine mammal stock in the wild [Level A Harassment]; or (ii) Any act that disturbs or is likely to disturb a marine mammal or marine mammal stock in the wild by causing disruption of natural behavioral patterns, to a point where such behavioral patterns are abandoned or significantly altered [Level B Harassment].

On July 24, 2013, NMFS received an application from the Navy for the taking of marine mammals incidental to missile launches from San Nicolas Island (SNI), California. NMFS determined that the application was adequate and complete on November 18, 2013.

The Navy proposed to continue a launch program for missiles and targets from several launch sites on SNI between June 2014 and June 2019. These activities are considered military readiness activities. Marine mammals hauled out on SNI may be exposed to sound from missile launches. The Navy requests authorization to take three marine mammal species by Level B harassment: northern elephant seal ( Mirounga angustirostris ), Pacific harbor seal ( Phoca vitulina ), and California sea lion ( Zalophus californianus ).

The Navy is currently operating under an authorization to take marine mammals incidental to missile launches from SNI, which expires June 3, 2014 (74 FR 26587).

The Navy is continuing a launch program for missiles and targets from several launch sites on SNI. Missiles vary from tactical and developmental weapons to target missiles used to test defensive strategies and other weapons systems. Some launch events involve a single missile, while others involve the launch of multiple missiles either in quick succession or at intervals of a few hours. Up to 200 missiles (40 missiles per year) may be launched over the 5-year period, but the number and type of launch varies depending on operational needs.

The purpose of these launches is to support testing and training activities associated with operations on the NAWCWD Point Mugu Sea Range. The Sea Range is used by the U.S. and allied military services to test and evaluate sea, land, and air weapon systems; to provide realistic training opportunities; and to maintain operational readiness of these forces. Some of the launches are used for practicing defensive drills against the types of weapons simulated by these missiles and some launches are conducted for the related purpose of testing new types of targets.

Launches of this type have been occurring at SNI for many years and are expected to continue indefinitely into the future. NMFS is issuing a 5-year Letter of Authorization for missile launches taking place between June 2014 and June 2019. The timing of these launches is variable and subject to testing and training requirements and meteorological and logistical limitations. To meet the Navy's operational testing and training requirements, launches may be required at any time of year and any time of day. Up to 200 missiles (40 missiles per year) may be launched over the 5-year period and the Navy is proposing that up to 10 launches per year may occur at night. Given the launch acceleration and flight speed of the missiles, most launch events are of extremely short duration. Strong launch sounds are typically detectable near the surrounding beaches for no more than a few seconds per launch (Holst et al., 2005a, 2008, 2011).

SNI is one of the eight Channel Islands in the Southern California Bight, located about 105 kilometers (km) southwest of Point Mugu. Missile launches will occur from the western part of SNI (see Figure 2 in the Navy's LOA application). The missiles fly generally westward through the Point Mugu Sea Range. The primary launch locations are the Alpha Launch Complex, which is located on the west-central part of SNI, and Building 807 Launch Complex, which is located at the western end of SNI. Other launch pads are located nearby.

Missiles included in the Navy's request range from relatively small and quieter missiles like the Rolling Airframe Missile to larger and louder missiles like the Terrier Black-Brant. While other missiles may be launched in the future, the largest missile analyzed here is 23,000 kilograms (kg). A description of the types of missiles that may be launched at SNI during the 5-year period and their sound characteristics was provided in the proposed rule (79 FR 13022, March 7, 2014) and includes, in summary: the Rolling Airframe Missile (RAM), GQM-163A “Coyote,” Multi-stage Sea Skimming Target (MSST), Terrier (Black Brant, Lynx, and Orion), and RIM-161 Standard Missile 3 (SM-3).

General Launch Operations —Aircraft and helicopter flights between the Point Mugu airfield on the mainland, the airfield on SNI, and the target sites in the Sea Range are a routine part of a planned launch operation. These flights generally do not pass at low level over the beaches where pinnipeds are expected to be hauled out. Therefore, these flights are not further considered in this document.

Movements of personnel are restricted near the launch sites at least several hours prior to a launch for safety reasons. No personnel are allowed on the western end of SNI during launches. Movements of personnel or missiles near the island's beaches are also restricted at other times of the year for purposes of environmental protection and preservation of cultural resource sites. Launch monitoring equipment would be deployed and activated prior to the launches.

On March 7, 2014 (79 FR 13022), NMFS published a proposed rule to authorize the taking of marine mammals incidental to missile launches at SNI. During the 45-day public comment period, NMFS received comments from the Marine Mammal Commission (Commission) and a private citizen. The Commission's comment is specific to section 101(a)(5)(A) of the MMPA and NMFS' analysis of impacts to marine mammals and is summarized and addressed below and throughout the final rule.

Comment 1: The Commission recommended that NMFS require the Navy to estimate the number of sea lion takes based on the greatest mean number of takes that has been estimated in any previous monitoring year multiplied by 40.

Response: NMFS agrees that the potential number of annual launches (40) should be considered when estimating take in order to ensure that the Navy remains in compliance with the MMPA. NMFS reassessed the take estimates for California sea lion by calculating the annual average number of takes per launch and multiplying each average by 40. This total (24,360) is the number of California sea lions takes NMFS is authorizing over the 5-year rule (an average of 4,872 takes per year). This is the maximum number of takes expected, considering the Navy only conducted 42 launches over the past 5 years.

Comment 2: A private citizen recommended that the Navy submit annual reports describing non-compliance, if any, with required mitigation measures—including frequency of occurrence, date of occurrence, and reason for occurrence of non-compliance.

Response: It is standard practice for the Navy to include this type of information in their summary of implementation of mitigation measures in the annual interim technical reports and comprehensive technical reports submitted to NMFS. These reports are available on the NMFS Office of Protected Resources Web site at http://www.nmfs.noaa.gov/pr/permits/incidental.htm#applications .

There are seven species of marine mammals with possible or confirmed occurrence in the area of the specified activity: Northern elephant seals, harbor seals, California sea lions, northern fur seals ( Callorhinus ursinus ), Guadalupe fur seal ( Arctocephalus townsendi ), Steller sea lions ( Eumetopias jubatus ), and southern sea otters ( Enhydra lutris nereis ). The northern fur seal is considered depleted under the MMPA; the Guadalupe fur seal is listed as threatened under the Endangered Species Act (ESA) and depleted under the MMPA; and the eastern distinct population segment of Steller sea lion was delisted under the ESA in 2013. The northern fur seal, Guadalupe fur seal, and Steller sea lion are considered rare at SNI and takes of these species have not been observed under the Navy's current MMPA authorization. Therefore, these three species were not considered further. The southern sea otter is managed by the U.S. Fish and Wildlife Service and was also not considered further. Table 1 includes species-specific information on the three species likely to occur in the area of the specified activity.

Further information on the biology and local distribution of these species can be found in the Navy's application (see ADDRESSES ), and the NMFS Marine Mammal Stock Assessment Reports, which are available online at: http://www.nmfs.noaa.gov/pr/species/ .

This section of the proposed Incidental Harassment Authorization (IHA) (79 FR 13022, March 7, 2014) included a summary and discussion of the ways that the types of stressors associated with the specified activity (e.g., missile launch noise) have been observed to impact marine mammals. The “Estimated Take by Incidental Harassment” section later in this document will include a quantitative analysis of the number of individuals that are expected to be taken by this activity. The “Negligible Impact Analysis” section will include the analysis of how this specific activity will impact marine mammals and will consider the content of this section, the “Estimated Take by Incidental Harassment” section, the “Proposed Mitigation” section, and the “Anticipated Effects on Marine Mammal Habitat” section to draw conclusions regarding the likely impacts of this activity on the reproductive success or survivorship of individuals and from that on the affected marine mammal populations or stocks.

In summary, potential effects of the specified activity on marine mammals involve both acoustic and non-acoustic effects. Acoustic effects are related to sound produced by the engines of all launch vehicles, and, in some cases, their booster rockets. Potential non-acoustic effects could result from the physical presence of personnel during placement of video and acoustical monitoring equipment. However, careful deployment of monitoring equipment is not expected to result in any disturbance to pinnipeds hauled out nearby. Any visual disturbance caused by passage of a vehicle overhead is likely to be minor and brief as the launch vehicles are relatively small and move at great speed. Detailed information on each potential effect (acoustic impacts, behavioral reactions of pinnipeds to missile launches, stampede-related injury or mortality from missile launches) was provided in the proposed rule (79 FR 13022, March 7, 2014) and that information has not changed.

Three species of pinnipeds use various beaches around SNI as places to rest, molt, and breed. These beaches consist of sand, rock ledges, and rocky cobble. Pinnipeds continue to use beaches around the western end of SNI, and are expanding their use of some beaches, despite ongoing launch activities for many years. Similarly, it appears that sounds from prior launches have not affected use of coastal areas at Vandenberg Air Force Base where similar missile launches occur.

Pinnipeds do not feed when hauled out on these beaches and the airborne launch sounds will not persist in the water near the island for more than a few seconds. Therefore, it is not expected that the launch activities will have any impact on the food or feeding success of these pinnipeds.

Boosters from missiles may be jettisoned shortly after launch and fall on the island, but are not expected to impact beaches. Fuel contained in these boosters is consumed rapidly and completely, so there would be no risk of contamination even in the very unlikely event that a booster did land on a beach. Therefore, launch activities are not expected to have any long-term, significant effects on marine mammal habitat.

In order to issue an incidental take authorization (ITA) under section 101(a)(5)(A) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (where relevant).

The NDAA of 2004 amended the MMPA as it relates to military-readiness activities and the ITA process such that “least practicable adverse impact” shall include consideration of personnel safety, practicality of implementation, and impact of the effectiveness of the “military readiness activity.” The activities described in the Navy's application are considered military readiness activities.

As during launches conducted under previous regulations, where practicable, the Navy will implement the following mitigation measures, provided that doing so will not compromise operational safety, human safety, national security, or other requirements or mission goals:

(1) Limit activities near the beaches in advance of launches;

(2) Avoid launch activities during harbor seal pupping season (February through April);

(3) Limit launch activities during other pinniped pupping seasons;

(4) Not launch missiles from the Alpha Complex at low elevation (less than 305 m) on launch azimuths that pass close to pinniped haul-out sites when occupied;

(5) Avoid launching multiple missiles in quick succession over haul-out sites, especially when young pups are present; and

(6) Maintain a minimum altitude of 305 m from pinniped haul-outs and rookeries for aircraft and helicopter flight paths during missile launch operations, except in emergencies or for real-time security incidents (e.g., search-and-rescue, fire-fighting, adverse weather conditions), which may require approaching pinniped haul-outs and rookeries closer than 305 m.

NMFS has carefully evaluated the applicant's proposed mitigation measures and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. No additional mitigation measures were recommended during the public comment period on the proposed rule. Our evaluation of potential measures included consideration of the following factors in relation to one another:

• The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals;

• The proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and

• The practicability of the measure for applicant implementation, including consideration of personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.

Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:

1. Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).

2. A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to received levels of noise, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

3. A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to received levels of noise, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

4. A reduction in the intensity of exposures (either total number or number at biologically important time or location) to received levels of noise, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing the severity of harassment takes only).

5. Avoidance or minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.

6. For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

Based on our evaluation of the applicant's proposed measures, as well as other measures considered by NMFS, NMFS has determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, while also considering personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.

In order to issue an ITA for an activity, section 101(a)(5)(A) of the MMPA states that NMFS must set forth, “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for ITAs must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. The Navy submitted a marine mammal monitoring plan as part of their application. It can be found in section 13 of their application. NMFS did not receive any comments suggesting a modification or supplementation to the proposed monitoring plan during the public comment period.

Monitoring measures prescribed by NMFS should accomplish one or more of the following general goals:

1. An increase in the probability of detecting marine mammals, both within the mitigation zone (thus allowing for more effective implementation of the mitigation) and in general to generate more data to contribute to the analyses mentioned below.

2. An increase in our understanding of how many marine mammals are likely to be exposed to levels of noise that we associate with specific adverse effects, such as behavioral harassment, TTS, or PTS.

3. An increase in our understanding of how marine mammals respond to stimuli expected to result in take and how anticipated adverse effects on individuals (in different ways and to varying degrees) may impact the population, species, or stock (specifically through effects on annual rates of recruitment or survival) through any of the following methods:

a. Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information).

b. Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information).

c. Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli.

4. An increased knowledge of the affected species.

5. An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.

The Navy will conduct the following monitoring measures, which are further detailed in section 13 of their application:

• The Navy will continue a standard, ongoing, land-based monitoring program to assess effects on harbor seals, northern elephant seals, and California sea lions on SNI. This monitoring will occur at up to three sites at different distances from the launch site before, during, and after each launch, depending upon presence of pinnipeds during each launch. The monitoring will be via autonomous video or Forward Looking Infrared (FLIR) cameras. Pinniped behavior on the beach will be documented prior to the planned launch operations, during the launch, and following the launch. Northern elephant seals will not be specifically targeted for monitoring, though may be present in the field of view when monitoring other species.

• During each launch, the Navy will obtain calibrated recordings of the sounds of the launches as received at different distances from the missile's flightline. The Navy anticipates that acoustic data will be acquired at each video monitoring location, to estimate sounds received by pinnipeds, and at the launch site to estimate maximum potential sound received. These recordings will provide for a thorough description of launch sounds as received at different locations on western SNI, and of the factors that affect received sound levels. By analysis of the paired data on behavioral observations and received sound levels, the Navy will further characterize the relationship between the two. If there is a clear correlation, the Navy will determine the “dose-response” relationship.

Visual Monitoring —The Navy will conduct marine mammal and acoustic monitoring during launches from SNI, using simultaneous video recording of pinniped behavior and audio recording of launch sounds. The land-based monitoring will provide data required to characterize the extent and nature of the takes. In particular, the monitoring will provide the information needed to document the occurrence, nature, frequency, and duration of any changes in pinniped behavior that might result from missile launches. Components of this documentation will include the following:

• Identify and document any change in behavior or movements that may occur at the time of the launch;

• Compare received levels of launch sound with pinniped responses, based on acoustic and behavioral data from up to three monitoring sites at different distances from the launch site and missile path during each launch and attempt to establish the dose-response relationship for launch sounds under different launch conditions;

• Ascertain periods or launch conditions when pinnipeds are most and least responsive to launch activities; and

• Document take by harassment and, although unlikely, any mortality or injury.

The launch monitoring program will include remote video recordings before, during, and after launches when pinnipeds are present in the area of potential impact, and visual assessment by trained observers before and after the launch. Remote cameras are essential during launches because safety rules prevent personnel from being present in most of the areas of interest. In addition, video techniques will allow simultaneous observations at up to three different locations, and will provide a permanent record that could be reviewed in detail. No specific effort will be made to monitor elephant seals, though they may be present in mixed groups when monitoring other species.

Acoustical Monitoring —The Navy will take acoustical recordings during each monitored launch. These recordings should be suitable for quantitative analysis of the levels and characteristics of the received launch sounds. The Navy will use up to four autonomous audio recorders to make acoustical measurements. During each launch, these will be located as close as practical to monitored pinniped haul-out sites and near the launch pad itself. The monitored haul-out sites will typically include one site as close as possible to the missile's planned flight path and one or two locations farther from the flight path within the area of potential impact with pinnipeds present.

The Navy will submit annual interim technical reports to NMFS no later than December 31 for the duration of the regulations. These reports will provide full documentation of methods, results, and interpretation pertaining to all monitoring tasks for launches during each calendar year. However, only preliminary information will be included for any launches during the 60-day period immediately preceding submission.

The Navy will submit a draft comprehensive technical report to NMFS 180 days prior to the expiration of the regulations, providing full documentation of the methods, results, and interpretation of all monitoring tasks for launches to date. A revised final comprehensive technical report, including all monitoring results during the entire period of the regulations will be due 90 days after the regulations expire.

The Navy will ensure that NMFS is notified immediately if an injured or dead marine mammal is judged to result from launch activities at any time.

Between 2001 and 2012, a maximum of 1,990 California sea lions, 395 harbor seals, and 130 northern elephant seals were estimated to have been potentially harassed in any single monitoring year incidental to missile launches at SNI (Holst et al., 2008, 2010, 2011; Ugoretz and Greene, 2012). These numbers may represent multiple exposures of single animals, as beaches were monitored repeatedly over the course of the year during numerous launches. However, some animals that displayed behavioral reactions may have been missed, as not all areas can be monitored during the launches. Pinnipeds that were potentially affected left the haul-out site in response to the launch, left the water at a vigorous pace, or exhibited prolonged movement or behavioral changes relative to their behavior immediately prior to the launch.

The NDAA of 2004 (Pub. L. 103-136) removed the “small numbers” and “specified geographical region” limitations indicated above and amended the definition of “harassment” as it applies to a “military readiness activity” to read as follows (section 3(18)(B) of the MMPA): (i) Any act that injures or has the significant potential to injure a marine mammal or marine mammal stock in the wild [Level A Harassment]; or (ii) Any act that disturbs or is likely to disturb a marine mammal or marine mammal stock in the wild by causing disruption of natural behavioral patterns, including, but not limited to, migration, surfacing, nursing, breeding, feeding, or sheltering, to a point where such behavioral patterns are abandoned or significantly altered [Level B Harassment].

Any takes of marine mammals are most likely to result from operational noise as launch missiles pass near haul-out sites, and/or associated visual cues. This section estimates maximum potential take and the likely annual take of marine mammal species during missile launches at SNI.

The launch sounds could be received for several seconds and, to be conservative, are considered to be prolonged rather than transient sounds. Given the variety of responses documented previously for the sounds of man-made activities lasting several seconds, a sound exposure level of 100 dB re 20 microPascals  2 per second is considered appropriate as a disturbance criterion for pinnipeds hauled out at the west end of SNI, particularly for California sea lions and northern elephant seals. Some pinnipeds that haul-out on the western end of SNI are expected to be within the area where sound exposure levels exceed 100 dB. Far fewer pinnipeds are expected to occur within this area and none of the recorded sound exposure levels appear to be high enough to induce TTS.

Based on the reaction criterion, the distance to which it is assumed to extend, and the estimated numbers of pinnipeds exposed to sound exposure levels at or above 100 dB, the Navy estimated the number of pinnipeds on the west end of SNI that might be taken. The Navy made an additional adjustment for harbor seals, as they are known to sometimes react strongly to sound exposure levels below 100 dB. The Navy considered the percentage of animals that actually responded to launch noise in previous monitoring years in order to estimate the number of animals potentially harassed. Recorded sound exposure levels in different areas of SNI were compared to ground-based census data of pinnipeds. These censuses were typically conducted seasonally when maximum numbers of pinnipeds were known to occur on land.

To estimate the potential maximum numbers of northern elephant seals that might be exposed to sound levels at or above 100 dB in 2014, the highest pup counts within map areas K, L, and M (see Figure 16 of the Navy's application) in any year between 2000 and 2010 were used (yielding a total of 1,854), and a continuing growth rate of 7.3 percent since 2010 was applied. This results in a maximum potential pup count of 2,458 for those map areas in 2014. Based on data collected from 1988 to 2010, the total count of all age classes expected to be hauled out is approximately twice the number of pups hauled out. Therefore, the maximum number hauled out in areas of potential impact for 2014 was approximated by doubling the maximum potential calculated pup count. Thus, the maximum expected number of elephant seals that may be exposed to sound levels at or above 100 dB during 2014 is estimated to be 4,916.

In the absence of any contrary data, it is assumed that elephant seals exhibit high site fidelity when they return to shore, and that the 4,916 elephant seals calculated above represent the maximum total number that might be exposed to “strong” (at or above 100 dB) sounds during the year, assuming missiles are launched when all animals are hauled out and all beaches within the area receive strong sounds. If some seals haul out on different beaches at various times during the year, sometimes within and sometimes outside the area exposed to levels at or above 100 dB, then the number of times an individual elephant seal might be exposed to strong launch sounds would be reduced. However, the total number of individuals that would be exposed at least once over the course of the year would probably be increased. Movements from one beach to another may be more likely for juveniles than for older seals, given that this has been observed in other pinniped species (such as for harbor seal pups; Thompson et al. 1994).

Published studies and results from the 2001-2012 monitoring at SNI indicate that elephant seals are more tolerant of transient noise and other forms of disturbance than are California sea lions or harbor seals. If so, the actual impact zone is smaller than assumed here, and the number of elephant seals that might be taken by harassment would be substantially lower than the number of seals present within the area where sound levels are at or above 100 dB. For example, during the 2001-2012 launch program, the majority of northern elephant seals did not exhibit more than brief startle reactions in response to launches (Holst et al. 2005, 2008, 2010, 2011; Ugoretz and Greene, 2012). Most individuals merely raised their heads briefly upon hearing the launch sounds and then quickly returned to their previous activity pattern (usually sleeping). During some launches, a small proportion (typically much less than 10 percent) of northern elephant seals moved a short distance (<10 m) away from their resting site, but settled within minutes. Elephant seals rarely moved or reacted more than this.

Therefore, the Navy estimates that up to 10 percent of 4,916 elephant seals (or 492 seals) might be taken by Level B harassment during each year of planned launch operations.

To determine the potential numbers of harbor seals that might be taken by harassment, the Navy used the maximum total harbor seal count for SNI (858) and assumed that the population has remained relatively stable. Previous monitoring from 2001-2012 showed that most monitored harbor seals entered the water in response to launches. Previous monitoring also indicates that about 70 percent of harbor seals that haul out on SNI use the beaches within areas K, L, and M. The Navy conservatively estimates that 80 percent of harbor seals on SNI may be impacted by missile launches. Therefore, the Navy estimates that a maximum of 686 harbor seals might be taken by Level B harassment during a 1-year period.

To estimate the maximum potential number of sea lions that might be hauled out within areas exposed to sound levels at or above 100 dB, the Navy calculated the maximum number of sea lions occurring within map areas K, L, and M (Figure 16 of the Navy's application) in any year from 2001-2011. The Navy adjusted this maximum, 14,963 sea lions, for a population growth rate of 5.6 percent per year, which results in a maximum of 20,749 sea lions of all ages and sexes that might be hauled out within the areas exposed to sound levels at or above 100 dB in a single year. For most of the year, only females and pups are expected to be ashore, so the number of animals exposed to these sound levels from any one launch is likely less than the estimated total number.

Based on past monitoring, the Navy concluded that approximately 10 percent of the California sea lions exposed to launch sounds during each year of launch activity might exhibit behavioral disturbance. Therefore, the Navy estimated that a maximum of 2,740 California sea lions on SNI might be taken by Level B harassment during a 1-year period. However, based on the Commission's comment during the proposed rule public comment period, NMFS agreed that the maximum number of annual launches (40) should also be a factor when estimating take. NMFS used the Navy's draft comprehensive monitoring report to calculate the annual average of potential takes per launch. Then, each average was multiplied by 40 and summed to get 24,360 takes over a 5-year period. NMFS estimates that an average of 4,872 takes of California sea lions may occur each year.

NMFS is authorizing take according to the Navy's estimates and also considering monitoring results from the past 5 years and the potential for up to 40 launches to occur each year. The estimated take numbers are provided in Table 2 below for each marine mammal species. These take estimates do not take mitigation measures into consideration.

Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of Level B harassment takes, alone, is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through behavioral harassment, NMFS must consider other factors, such as the likely nature of any responses (their intensity, duration, etc.), the context of any responses (critical reproductive time or location, migration, etc.), as well as the number and nature of estimated Level A harassment takes, the number of estimated mortalities, and effects on habitat.

NMFS has determined that target and missile launch activities and aircraft and helicopter operations from SNI, as described in this document and in the Navy's application, will result in no more than Level B harassment of northern elephant seals, harbor seals, and California sea lions. The effects of these military readiness activities will be limited to short-term, localized changes in behavior, including temporarily vacating haul-outs, and possible temporary threshold shift in the hearing of any pinnipeds that are in close proximity to a launch pad at the time of a launch. These effects are not likely to have a significant or long-term impact on feeding, breeding, or other important biological functions. No take by injury or mortality is anticipated, and the potential for permanent hearing impairment is unlikely. Furthermore, during 5 years of monitoring under the Navy's current authorization, there was no evidence of injury, mortality, pup abandonment, or other significant impact beyond behavioral harassment during or immediately succeeding any of the 33 launches. No known pinniped injuries or mortalities have occurred since monitoring began in 2001, and few, if any, pinnipeds are believed to have received sound levels strong enough to elicit TTS.

Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the required monitoring and mitigation measures, NMFS finds that the total marine mammal take from the Navy's missile launches will have a negligible impact on the affected marine mammal species or stocks.

There are no relevant subsistence uses of marine mammals implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks will not have any unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

No species listed under the ESA are expected to be affected by these activities. Therefore, NMFS has determined that a section 7 consultation under the ESA is not required.

NMFS prepared an Environmental Assessment (EA) analyzing the potential issuance of regulations and an LOA to the Navy for the period 2014-2019. The final EA was prepared in May 2014 and NMFS issued a Finding of No Significant Impact for this action. These documents are available on our Web site at http://www.nmfs.noaa.gov/pr/permits/incidental.htm#applications. NMFS determined that issuance of the rulemaking and subsequent LOA will not significantly impact the quality of the human environment and that preparation of an Environmental Impact Statement is not required.

The Office of Management and Budget has determined that this proposed rule is not significant for purposes of Executive Order 12866.

Pursuant to the Regulatory Flexibility Act (RFA), the Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration at the proposed rule stage that this action will not have a significant economic impact on a substantial number of small entities. NMFS did not receive any public comments addressing this certification. Therefore, a Final Initial Regulatory Flexibility Analysis is not required and none has been prepared.

The Assistant Administrator for Fisheries has determined that there is good cause under the Administrative Procedure Act (5 U.S.C 553(d)(3)) to waive the 30-day delay in the effective date of the measures contained in the final rule. The existing regulations for SNI expire June 3, 2014 and launches may be scheduled soon after. Any delay of enacting the final rule would result in the Navy's non-compliance with the MMPA (should the Navy conduct missile launches without an LOA), thereby resulting in the potential for unauthorized takes of marine mammals. Moreover, the Navy is ready to implement the rule immediately. For these reasons, the Assistant Administrator finds good cause to waive the 30-day delay in the effective date.

For reasons set forth in the preamble, 50 CFR part 217 is amended as follows: