Federal Register Vol. 81, No.86,

In FR Doc. 2016-03433 of March 2, 2016 (81 FR 11000), make the following correcting amendments:

The Rural Business-Cooperative Service, Rural Housing Service, Rural Utilities Service, and Farm Service Agency published a document in the Federal Register on March 2, 2016 (81 FR 11000), entitled “Environmental Policies and Procedures.” This correction will replace the introductory text to paragraph (a) of § 1955.136.

For the reasons set forth in the preamble, chapter XVIII, title 7, Code of Federal Regulations is amended as follows:

The substance of these special conditions has been subject to the public-comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance.

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

We 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 March 29, 2012, Gulfstream Aerospace Corporation applied for a type certificate for their new Model GVII-G500 airplane. The Model GVII-G500 airplane will be a business jet capable of accommodating up to 19 passengers. It will incorporate a low, swept-wing design with winglets and a T-tail. The powerplant will consist of two aft-fuselage-mounted Pratt & Whitney turbofan engines.

Under Title 14, Code of Federal Regulations (14 CFR) 21.17, Gulfstream must show that the Model GVII-G500 airplane meets the applicable provisions of 14 CFR part 25, as amended by Amendments 25-1 through 25-129.

If the Administrator finds that the applicable airworthiness regulations (i.e., part 25) do not contain adequate or appropriate safety standards for the Model GVII-G500 airplane 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, Model GVII-G500 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 must issue a finding of regulatory adequacy under section 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 Model GVII-G500 airplane will incorporate the following novel or unusual design feature:

Gulfstream wants the option to include side-facing seats in their new Model GVII-G500 airplane. Side-facing seats (i.e., seats positioned in the airplane with the occupant facing 90 degrees to the direction of airplane travel) are considered a novel design for transport-category airplanes that include Amendment 25-64 in their certification basis, and were not considered when those airworthiness standards were issued. The FAA has determined that the existing regulations do not provide adequate or appropriate safety standards for occupants of side-facing seats. To provide a level of safety that is equivalent to that afforded to occupants of forward- and aft-facing seats, additional airworthiness standards in the form of special conditions are necessary.

On June 16, 1988, 14 CFR part 25 was amended to revise the emergency-landing conditions that must be considered in the design of transport-category airplanes. Amendment 25-64 revised the static-load conditions in § 25.561, and added a new § 25.562 that required dynamic testing for all seats approved for occupancy during takeoff and landing. The intent of Amendment 25-64 was to provide an improved level of safety for occupants on transport-category airplanes. However, because most seating on transport-category airplanes is forward-facing, the pass/fail criteria developed in Amendment 25-64 focused primarily on these seats.

For some time, the FAA granted exemptions for the multiple-place side-facing-seat installations because the existing test methods and acceptance criteria did not produce a level of safety equivalent to the level of safety provided for forward-and aft-facing seats. These exemptions were subject to many conditions that reflected the injury-evaluation criteria and mitigation strategies available at the time of the exemption issuance. The FAA also issued special conditions to address single-place side-facing seats because we believed that those conditions provided the same level of safety as for forward- and aft-facing seats.

Continuing concerns regarding the safety of side-facing seats prompted the FAA to conduct research to develop an acceptable method of compliance with §§ 25.562 and 25.785(b) for side-facing seat installations. That research has identified injury considerations and evaluation criteria in addition to those previously used to approve side-facing seats (see published report DOT/FAA/AR-09/41, July 2011). One particular concern that was identified during the FAA's research program, but not addressed in the previous special conditions, was the significant leg injuries that can occur to occupants of both single- and multiple-place side-facing seats. Because this type of injury does not occur on forward- and aft-facing seats, the FAA determined that, to achieve the level of safety envisioned in Amendment 25-64, additional requirements would be needed as compared to previously issued special conditions. Nonetheless, the research has now allowed the development of a single set of special conditions that is applicable to all fully side-facing seats.

On November 5, 2012, the FAA released PS-ANM-25-03-R1, “Technical Criteria for Approving Side-Facing Seats,” to update existing FAA certification policy on §§ 25.562 and 25.785(a) at Amendment 25-64 for single- and multiple-place side-facing seats. This policy addresses both the technical criteria for approving side-facing seats and the implementation of those criteria. The FAA methodology detailed in PS-ANM-25-03-R1 has been used in establishing a new set of proposed special conditions. Some of the conditions issued for previous exemptions are still relevant and are included in these new special conditions. However, others have been replaced by different criteria that reflect current research findings.

As discussed above, these special conditions are applicable to the Gulfstream Model GVII-G500 airplane. Should Gulfstream apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only a certain novel or unusual design feature on one model series of airplane. 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, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon publication in the Federal Register.

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.

In addition to the airworthiness standards in §§ 25.562 and 25.785, the FAA issues the following special conditions (based on Policy Statement PS-ANM-25-03-R1) as part of the type certification basis for the Gulfstream Model GVII series airplanes. Items 1 and 2 are applicable to all side-facing seat installations, whereas items 3 through 16 represent additional requirements applicable to side-facing seats equipped with an airbag system in the shoulder belt.

1. Additional requirements applicable to tests or rational analysis conducted to show compliance with §§ 25.562 and 25.785 for side-facing seats:

a. The longitudinal test(s) conducted in accordance with § 25.562(b)(2), to show compliance with the seat-strength requirements of § 25.562(c)(7) and (8) and these special conditions, must have an ES-2re anthropomorphic test dummy (ATD) (49 CFR part 572 subpart U) or equivalent, or a Hybrid II ATD (49 CFR part 572, subpart B as specified in § 25.562) or equivalent, occupying each seat position and including all items (e.g., armrest, interior wall, or furnishing) contactable by the occupant if those items are necessary to restrain the occupant. If included, the floor representation and contactable items must be located such that their relative position, with respect to the center of the nearest seat place, is the same at the start of the test as before floor misalignment is applied. For example, if floor misalignment rotates the centerline of the seat place nearest the contactable item 8 degrees clockwise about the airplane x-axis, then the item and floor representations must be rotated by 8 degrees clockwise also, to maintain the same relative position to the seat place, as shown in Figure 1. Each ATD's relative position to the seat after application of floor misalignment must be the same as before misalignment is applied. To ensure proper occupant seat loading, the ATD pelvis must remain supported by the seat pan, and the restraint system must remain on the pelvis and shoulder of the ATD until rebound begins. No injury-criteria evaluation is necessary for tests conducted only to assess seat-strength requirements.

b. The longitudinal test(s) conducted in accordance with § 25.562(b)(2), to show compliance with the injury assessments required by § 25.562(c) and these special conditions, may be conducted separately from the test(s) to show structural integrity. In this case, structural-assessment tests must be conducted as specified in paragraph 1a, above, and the injury-assessment test must be conducted without yaw or floor misalignment. Injury assessments may be accomplished by testing with ES-2re ATD (49 CFR part 572 subpart U) or equivalent at all places. Alternatively, these assessments may be accomplished by multiple tests that use an ES-2re ATD at the seat place being evaluated, and a Hybrid II ATD (49 CFR part 572, subpart B, as specified in § 25.562) or equivalent used in all seat places forward of the one being assessed, to evaluate occupant interaction. In this case, seat places aft of the one being assessed may be unoccupied. If a seat installation includes adjacent items that are contactable by the occupant, the injury potential of that contact must be assessed. To make this assessment, tests may be conducted that include the actual item, located and attached in a representative fashion. Alternatively, the injury potential may be assessed by a combination of tests with items having the same geometry as the actual item, but having stiffness characteristics that would create the worst case for injury (injuries due to both contact with the item and lack of support from the item).

c. If a seat is installed aft of structure (e.g., an interior wall or furnishing) that does not have a homogeneous surface contactable by the occupant, additional analysis and/or test(s) may be required to demonstrate that the injury criteria are met for the area that an occupant could contact. For example, different yaw angles could result in different injury considerations and may require additional analysis or separate test(s) to evaluate.

d. To accommodate a range of occupant heights (5th percentile female to 95th percentile male), the surface of items contactable by the occupant must be homogenous 7.3 inches (185 mm) above and 7.9 inches (200 mm) below the point (center of area) that is contacted by the 50th percentile male size ATD's head during the longitudinal test(s) conducted in accordance with paragraphs a, b, and c, above. Otherwise, additional head-injury criteria (HIC) assessment tests may be necessary. Any surface (inflatable or otherwise) that provides support for the occupant of any seat place must provide that support in a consistent manner regardless of occupant stature. For example, if an inflatable shoulder belt is used to mitigate injury risk, then it must be demonstrated by inspection to bear against the range of occupants in a similar manner before and after inflation. Likewise, the means of limiting lower-leg flail must be demonstrated by inspection to provide protection for the range of occupants in a similar manner.

e. For longitudinal test(s) conducted in accordance with § 25.562(b)(2) and these special conditions, the ATDs must be positioned, clothed, and have lateral instrumentation configured as follows:

(1) ATD positioning:

Lower the ATD vertically into the seat while simultaneously (see Figure 2 for illustration):

(a) Aligning the midsagittal plane (a vertical plane through the midline of the body; dividing the body into right and left halves) with approximately the middle of the seat place.

(b) Applying a horizontal x-axis direction (in the ATD coordinate system) force of about 20 lb (89 N) to the torso at approximately the intersection of the midsagittal plane and the bottom rib of the ES-2re or lower sternum of the Hybrid II at the midsagittal plane, to compress the seat back cushion.

(c) Keeping the upper legs nearly horizontal by supporting them just behind the knees.

(d) After all lifting devices have been removed from the ATD:

(i) Rock it slightly to settle it into the seat.

(ii) Separate the knees by about 4 inches (100 mm).

(iii) Set the ES-2re ATD's head at approximately the midpoint of the available range of z-axis rotation (to align the head and torso midsagittal planes).

(iv) Position the ES-2re ATD's arms at the joint's mechanical detent that puts them at approximately a 40-degree angle with respect to the torso. Position the Hybrid II ATD hands on top of its upper legs.

(v) Position the feet such that the centerlines of the lower legs are approximately parallel to a lateral vertical plane (in the airplane coordinate system).

(2) ATD clothing: Clothe each ATD in form-fitting, mid-calf-length (minimum) pants and shoes (size 11E) weighing about 2.5 lb (1.1 Kg) total. The color of the clothing should be in contrast to the color of the restraint system. The ES-2re jacket is sufficient for torso clothing, although a form-fitting shirt may be used in addition if desired.

(3) ES-2re ATD lateral instrumentation: The rib-module linear slides are directional, i.e., deflection occurs in either a positive or negative ATD y-axis direction. The modules must be installed such that the moving end of the rib module is toward the front of the airplane. The three abdominal-force sensors must be installed such that they are on the side of the ATD toward the front of the airplane.

f. The combined horizontal/vertical test, required by § 25.562(b)(1) and these special conditions, must be conducted with a Hybrid II ATD (49 CFR part 572 subpart B as specified in § 25.562), or equivalent, occupying each seat position.

g. Restraint systems:

(1) If inflatable restraint systems are used, they must be active during all dynamic tests conducted to show compliance with § 25.562.

(2) The design and installation of seat-belt buckles must prevent unbuckling due to applied inertial forces or impact of the hands or arms of the occupant during an emergency landing.

2. Additional performance measures applicable to tests and rational analysis conducted to show compliance with §§ 25.562 and 25.785 for side-facing seats:

a. Body-to-body contact: Contact between the head, pelvis, torso, or shoulder area of one ATD with the adjacent-seated ATD's head, pelvis, torso, or shoulder area is not allowed. Contact during rebound is allowed.

b. Thoracic: The deflection of any of the ES-2re ATD upper, middle, and lower ribs must not exceed 1.73 inches (44 mm). Data must be processed as defined in Federal Motor Vehicle Safety Standards (FMVSS) 571.214.

c. Abdominal: The sum of the measured ES-2re ATD front, middle, and rear abdominal forces must not exceed 562 lbs (2,500 N). Data must be processed as defined in FMVSS 571.214.

d. Pelvic: The pubic symphysis force measured by the ES-2re ATD must not exceed 1,350 lbs (6,000 N). Data must be processed as defined in FMVSS 571.214.

e. Leg: Axial rotation of the upper-leg (femur) must be limited to 35 degrees in either direction from the nominal seated position.

f. Neck: As measured by the ES-2re ATD and filtered at Channel Frequency Class 600 as defined in SAE J211, “Instrumentation for Impact Test—Part 1—Electronic Instrumentation.”

(1) The upper-neck tension force at the occipital condyle (O.C.) location must be less than 405 lb (1,800 N).

(2) The upper-neck compression force at the O.C. location must be less than 405 lb (1,800 N).

(3) The upper-neck bending torque about the ATD x-axis at the O.C. location must be less than 1,018 in-lb (115 Nm).

(4) The upper-neck resultant shear force at the O.C. location must be less than 186 lb (825 N).

g. Occupant (ES-2re ATD) retention: The pelvic restraint must remain on the ES-2re ATD's pelvis during the impact and rebound phases of the test. The upper-torso restraint straps (if present) must remain on the ATD's shoulder during the impact.

h. Occupant (ES-2re ATD) support:

(1) Pelvis excursion: The load-bearing portion of the bottom of the ATD pelvis must not translate beyond the edges of its seat's bottom seat-cushion supporting structure.

(2) Upper-torso support: The lateral flexion of the ATD torso must not exceed 40 degrees from the normal upright position during the impact.

3. For seats with an airbag system in the shoulder belts, show that the airbag system in the shoulder belt will deploy and provide protection under crash conditions where it is necessary to prevent serious injury. The means of protection must take into consideration a range of stature from a 2-year-old child to a 95th percentile male. The airbag system in the shoulder belt must provide a consistent approach to energy absorption throughout that range of occupants. When the seat system includes an airbag system, that system must be included in each of the certification tests as it would be installed in the airplane. In addition, the following situations must be considered:

a. The seat occupant is holding an infant.

b. The seat occupant is a pregnant woman.

4. The airbag system in the shoulder belt must provide adequate protection for each occupant regardless of the number of occupants of the seat assembly, considering that unoccupied seats may have an active airbag system in the shoulder belt.

5. The design must prevent the airbag system in the shoulder belt from being either incorrectly buckled or incorrectly installed, such that the airbag system in the shoulder belt would not properly deploy. Alternatively, it must be shown that such deployment is not hazardous to the occupant, and will provide the required injury protection.

6. It must be shown that the airbag system in the shoulder belt is not susceptible to inadvertent deployment as a result of wear and tear, or inertial loads resulting from in-flight or ground maneuvers (including gusts and hard landings), and other operating and environmental conditions (vibrations, moisture, etc.) likely to occur in service.

7. Deployment of the airbag system in the shoulder belt must not introduce injury mechanisms to the seated occupant, or result in injuries that could impede rapid egress. This assessment should include an occupant whose belt is loosely fastened.

8. It must be shown that inadvertent deployment of the airbag system in the shoulder belt, during the most critical part of the flight, will either meet the requirement of § 25.1309(b) or not cause a hazard to the airplane or its occupants.

9. It must be shown that the airbag system in the shoulder belt will not impede rapid egress of occupants 10 seconds after airbag deployment.

10. The airbag system must be protected from lightning and high-intensity radiated fields (HIRF). The threats to the airplane specified in existing regulations regarding lighting, § 25.1316, and HIRF, § 25.1317, are incorporated by reference for the purpose of measuring lightning and HIRF protection.

11. The airbag system in the shoulder belt must function properly after loss of normal aircraft electrical power, and after a transverse separation of the fuselage at the most critical location. A separation at the location of the airbag system in the shoulder belt does not have to be considered.

12. It must be shown that the airbag system in the shoulder belt will not release hazardous quantities of gas or particulate matter into the cabin.

13. The airbag system in the shoulder-belt installation must be protected from the effects of fire such that no hazard to occupants will result.

14. A means must be available for a crewmember to verify the integrity of the airbag system in the shoulder-belt activation system prior to each flight, or it must be demonstrated to reliably operate between inspection intervals. The FAA considers that the loss of the airbag-system deployment function alone (i.e., independent of the conditional event that requires the airbag-system deployment) is a major-failure condition.

15. The inflatable material may not have an average burn rate of greater than 2.5 inches/minute when tested using the horizontal flammability test defined in part 25, appendix F, part I, paragraph (b)(5).

16. The airbag system in the shoulder belt, once deployed, must not adversely affect the emergency-lighting system (i.e., block floor proximity lights to the extent that the lights no longer meet their intended function).

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 717-200 airplanes. The NPRM published in the Federal Register on October 6, 2015 (80 FR 60307) (“the NPRM”). The NPRM was prompted by multiple reports of the vertical stabilizer leading edge showing signs of fastener distress. The NPRM proposed to require a detailed inspection for any distress of the vertical stabilizer leading edge skin, and related investigative and corrective actions if necessary. The NPRM also proposed to require, for certain airplanes, repetitive detailed inspections of the spar cap for any loose and missing fasteners, repetitive ETHF and RT inspections of the spar cap for any crack, and related investigative and corrective actions if necessary. We are issuing this AD to detect and correct any crack in the vertical stabilizer leading edge and front spar cap, which may result in the structure becoming unable to support limit load, and may lead to the loss of the vertical stabilizer.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment. Boeing and an anonymous commenter indicated their support for the NPRM.

Boeing requested that we add a “Credit for Previous Actions” paragraph to the proposed AD that would give credit for prior accomplishment of the initial inspection in paragraph (g) of the NPRM. Boeing stated that operator structural inspection credit has been incorporated as a precedent in previous ADs.

We agree with the commenter's request. Boeing MOM-MOM-14-0437-01B(R1), dated July 3, 2014, provides the same action and level of safety for the initial inspection specified in this AD. We have revised this AD by adding new paragraph (j) of this AD to give credit for the initial inspection in paragraph (g) of this AD, if that inspection was performed before the effective date of this AD using Boeing MOM-MOM-14-0437-01B(R1), dated July 3, 2014. We have redesignated the remaining paragraphs accordingly.

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

• Αre consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

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

We reviewed Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015. The service information describes procedures for a detailed inspection for any distress of the vertical stabilizer leading edge skin, a detailed inspection for any loose and missing fasteners of the spar cap, ETHF and RT inspections of the spar cap for any crack, and related investigative and corrective actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 106 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.

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

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

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

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

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

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

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

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to the specified products. The NPRM was published in the Federal Register on February 2, 2016 (81 FR 5395). The NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-7490.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (81 FR 5395, February 2, 2016).

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

Turbomeca S.A. has issued Service Bulletin (SB) No. 283 72 0811, Version A, dated August 25, 2015. The SB describes procedures for inspection of the 3rd stage turbine wheel. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 9 engines installed on helicopters of U.S. registry. We also estimate that it will take about 5 hours per engine to comply with this AD. The average labor rate is $85 per hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $3,825.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2004-19-11, Amendment 39-13805 (69 FR 58828, October 1, 2004) (“AD 2004-19-11”). AD 2004-19-11 applied to certain Airbus Model 320 series airplanes. The NPRM published in the Federal Register on November 27, 2015 (80 FR 74058) (“the NPRM”). The NPRM was prompted by a determination that the previously optional terminating action is necessary to address the unsafe condition. The NPRM proposed to retain the requirements of AD 2004-19-11, and requires the previously optional terminating action. We are issuing this AD to prevent fatigue cracking of the inner rear spar, which may lead to reduced structural integrity of the wing and the MLG.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0169, dated July 17, 2014, corrected July 22, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on certain Airbus Model 320 series airplanes. The MCAI states:

The modification includes modifying all specified fastener holes in the inner rear spar of the wing. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-5811.

We gave the public the opportunity to participate in developing this AD. We considered the comment received. United Airlines provided its support for the content of the NPRM.

We have added a new paragraph (l)(1) to this AD to provide credit for actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A320-57-1060, Revision 1, dated April 26, 1993. We have redesignated paragraphs (l)(1) and (l)(2) of the proposed AD as paragraphs (l)(2) and (l)(3) of this AD.

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

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

Airbus has issued Airbus Service Bulletin A320-57-1089, Revision 03, dated February 9, 2001. This service information describes procedures for modification of the airplane by accomplishing cold re-expansion of the holes in the inner rear spar for the attachment of gear rib 5, forward pintle fitting, and actuating cylinder anchorage; and the installation of interference fit fasteners in the rear spar and gear rib 5. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 84 airplanes of U.S. registry.

The actions required by AD 2004-19-11, and retained in this AD take about 684 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost about $13,644 per product. Based on these figures, the estimated cost of the actions that were required by AD 2004-19-11 is $71,784 per product.

We also estimate that it takes about 980 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $32,727 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $9,746,268, or $116,027 per product.

We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.

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

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

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Model A320-214, -232, and -233 airplanes; and Airbus Model A321-211 and -231 airplanes. The NPRM published in the Federal Register on October 19, 2015 (80 FR 63134) (“the NPRM”).

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0256, dated November 26, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A320-214, -232, and -233 airplanes; and Airbus Model A321-211 and -231 airplanes. The MCAI states:

Related investigative actions include a detailed inspection to determine if the jiffy joint connector works properly. Corrective actions include rework or replacement of the jiffy joint connectors.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-3990.

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

We reviewed the available data and determined that air safety and the public interest require adopting this AD as proposed, except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

Airbus has issued the following service information.

• Airbus Service Bulletin A320-25-1B20, dated October 9, 2014. This service information describes procedures for inspecting for affected PSU part numbers and serial numbers, and depending on findings, doing applicable related investigative and corrective actions. Related investigative actions include a detailed inspection to determine if the jiffy joint connector works properly. Corrective actions include rework or replacement of the jiffy joint connectors.

• Airbus Operations GmbH Vendor Service Bulletin Z315H-25-004, dated September 26, 2014, including Attachment 1, “List of affected PSU PNR and S/N” (the attachment is not numbered or dated). This service information describes procedures for inspecting for the connection of the jiffy joint connectors, and depending on findings, doing rework or replacement of the jiffy joint connectors.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 7 airplanes of U.S. registry.

We also estimate that it takes about 5 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost $0 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $2,975, or $425 per product.

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

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

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-3990; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.

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

Discussion

We have received a report indicating that an operator, while on a maintenance visit, found a flex hose of the occupant backup air supply disconnected from the adjacent fiberglass duct on two airplanes. One of the flex hoses had a tear on the disconnected edge. A Boeing investigation found that these incidents were caused by the incorrect clamp installation on the inboard end of the flex hose, which is a quality control problem that allowed the flex hose to slowly become disconnected from the adjacent fiberglass duct. No related system faults were reported. We are issuing this AD to detect and correct an incorrect clamp installation on the inboard end of the flex hose, which allows the flex hose to slowly become disconnected from the adjacent fiberglass duct, and damage to the hose. This condition, in conjunction with a cargo fire event, can potentially lead to decreased airflow to the main deck, possibly resulting in smoke and/or toxic fumes penetrating into the main deck passenger compartment, which could result in injury to the passengers or cabin crew.

We reviewed Boeing Alert Service Bulletin 747-21A2571, dated December 4, 2015. The service information describes procedures for a detailed visual inspection of the clamp installation on the inboard end of the flex hose and general visual inspection of the flex hose for damage, and related investigative and corrective actions if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD requires accomplishing the actions specified in the service information described previously.

The phrase “related investigative actions” is used in this AD. Related investigative actions are follow-on actions that (1) are related to the primary action, and (2) further investigate the nature of any condition found. Related investigative actions in an AD could include, for example, inspections.

The phrase “corrective actions” is used in this AD. Corrective actions correct or address any condition found. Corrective actions in an AD could include, for example, repairs.

There are currently no domestic operators of this product. Therefore, we find that notice and opportunity for prior public comment are unnecessary and that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2016-6147 and Directorate Identifier 2016-NM-021-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

Currently, there are no affected airplanes on the U.S. Register. However, if an affected airplane is imported and placed on the U.S. Register in the future, we estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary repairs that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need this repair:

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

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

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

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

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

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

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

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

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Walla Walla, WA.

On November 27, 2015, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to modify Class D airspace, Class E surface area airspace, Class E surface area airspace designated as an extension, and Class E airspace extending upward from 700 feet above the surface at Walla Walla Regional Airport, Walla Walla, WA, (80 FR 74063) Docket No. FAA-2015-3675. The FAA found these modifications necessary to ensure the safety and management of Instrument Flight Rules (IFR) operations for arriving and departing aircraft at the airport. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class D and Class E airspace designations are published in paragraph 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1.

This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class D airspace, Class E surface area airspace, Class E surface area airspace designated as an extension, and Class E airspace extending upward from 700 feet above the surface at Walla Walla Regional Airport, Walla Walla, WA. Class D airspace and all Class E airspace areas are modified to correct geographic latitude and longitude (lat./long.) errors in the legal description. Class E airspace designated as an extension is modified to include that area within 2.7 miles each side of the Walla Walla Airport 215° bearing extending from the 4.3-mile radius to 7.5 miles southwest of the airport, and that airspace within 4.1 miles each side of the airport 035° bearing extending from the 4.3-mile radius to 13.4 miles northeast of the airport. Class E airspace extending upward from 700 feet above the surface is modified to include that area bounded by a line beginning at lat. 45°52′29″ N., long. 118°23′027″ W.; to lat. 45°49′51″ N., long. 118°26′02″ W.; to lat. 45°57′17″ N., long. 118°40′49″ W.; to lat. 46°10′22″ N., long. 118°27′48″ W.; to lat. 46°08′46″ N., long. 118°24′32″ W.; to lat. 46°14′38″ N., long. 118°18′44″ W.; to lat. 46°16′07″ N., long. 118°21′47″ W.; to lat. 46°29′20″ N., long. 118°08′35″ W.; to lat. 46°22′02″ N., long. 117°53′24″ W.; to lat. 46°14′25″ N., long. 118°01′11″ W.; and that airspace within a 13.4-mile radius of point in space coordinates at lat. 46°03′27″ N., long. 118°12′20″ W., from the 052° bearing from the Walla Walla Regional Airport clockwise to the 198° bearing.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

I. Executive Summary A. Purpose of Direct Final Rule

FDA is issuing this direct final rule because revision and removal of certain general biological products standards will update outdated requirements and accommodate new and evolving technology and testing capabilities without diminishing public health protections. FDA is taking this action because the existing codified requirements are duplicative of requirements that are also specified in biologics license applications (BLAs) or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products.

This direct final rule removes the requirements contained in § 610.20 (21 CFR 610.20) from the regulations. FDA is taking this action because the standard preparations listed in the regulation are obsolete, no longer available, or described on a product specific basis in BLAs. In addition, FDA believes that it is no longer necessary to restrict the source of standard preparations to the Center for Biologics Evaluation and Research (CBER), since appropriate standard preparations can often be obtained from other sources. Section 610.21 is removed because these potency limits are either obsolete or best described on a product specific basis in the BLA. Section 610.50 is amended to remove references to §§ 610.20 and 610.21 and official potency tests and to reflect FDA's updated approach to establishing dates of manufacture. Section 610.53 is amended to remove products no longer manufactured and products for which dating information is identified in the BLA of each individual product, and to reflect updated practices for the remaining products.

FDA is taking this action under the biological products provisions of the Public Health Service Act (PHS Act), and the drugs and general administrative provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

Because this direct final rule does not impose any additional regulatory burdens, this regulation is not anticipated to result in any compliance costs and the economic impact is expected to be minimal.

In the document entitled “Guidance for FDA and Industry: Direct Final Rule Procedures,” announced and provided in the Federal Register of November 21, 1997 (62 FR 62466), FDA described its procedures on when and how the Agency will employ direct final rulemaking. The guidance may be accessed at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm. We have determined that this rule is appropriate for direct final rulemaking because we believe that it includes only noncontroversial amendments and we anticipate no significant adverse comments. Consistent with our procedures on direct final rulemaking, FDA is also publishing elsewhere in this issue of the Federal Register a companion proposed rule proposing to amend the general biological products standards relating to dating periods and to remove those relating to standard preparations and limits of potency. The companion proposed rule provides a procedural framework within which the rule may be finalized in the event that the direct final rule is withdrawn because of any significant adverse comments. The comment period for the direct final rule runs concurrently with the companion proposed rule. Any comments received in response to the companion proposed rule will be considered as comments regarding the direct final rule.

We are providing a comment period on the direct final rule of 75 days after the date of publication in the Federal Register. If we receive any significant adverse comments, we intend to withdraw this direct final rule before its effective date by publication of a notice in the Federal Register. A significant adverse comment is defined as a comment that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants terminating a direct final rulemaking, we will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process. Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered significant or adverse under this procedure. A comment recommending a regulation change in addition to those in this direct final rule would not be considered a significant adverse comment unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to part of this rule and that part can be severed from the remainder of the rule (e.g., where, as here, a direct final rule deletes several unrelated regulations), we may adopt as final those provisions of the rule that are not the subject of the significant adverse comment.

If any significant adverse comments are received during the comment period, FDA will publish, before the effective date of this direct final rule, a document withdrawing the direct final rule. If we withdraw the direct final rule, any comments received will be applied to the proposed rule and will be considered in developing a final rule using the usual notice-and-comment procedures.

If FDA receives no significant adverse comments during the specified comment period, FDA intends to publish a document confirming the effective date within 30 days after the comment period ends.

On January 18, 2011, President Barack Obama issued Executive Order 13563, “Improving Regulation and Regulatory Review” (76 FR 3821, January 21, 2011). One of the provisions in the Executive Order requires Agencies to consider how best to promote the retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned (76 FR 3821 at 3822). As one step in implementing the Executive Order, FDA published a notice in the Federal Register of April 27, 2011 (76 FR 23520) entitled “Periodic Review of Existing Regulations; Retrospective Review Under E.O. 13563.” In that notice, FDA announced that it was conducting a review of existing regulations to determine, in part, whether they can be made more effective in light of current public health needs and to take advantage of, and support, advances in innovation that have occurred since those regulations took effect. As part of this initiative, FDA is updating outdated regulations as specified in this rule.

FDA's general biological products standards in part 610 are intended to help ensure the safety, purity, and potency of biological products administered to humans. The revision and removal of certain general biological products standards are designed to update outdated requirements and accommodate new and evolving manufacturing and control testing technology. The rule provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.

Standard preparations are generally used to perform lot release testing or other specific product characterization assays. Under the current standard preparations, § 610.20, FDA requires specific standard preparations to be used for a small number of the biological products FDA regulates unless a modification is permitted under § 610.9. Specifically, according to current § 610.20 Standard preparations, standard preparations, made available by CBER, are required to be used in the testing of potency or opacity of certain biological products, mostly biological products that were initially licensed several decades ago. Most of these standard preparations requirements are now obsolete, because either CBER no longer provides the listed standard preparations, or the specific biological products are no longer manufactured, or both. In addition, standard preparations to help ensure the safety, purity, and potency of particular biological products can often be obtained from sources other than CBER now, including international sources, or can be developed internally by the applicant. Thus, FDA believes it is no longer necessary to specify CBER as the source of standard preparations in § 610.20. For these reasons, FDA is removing § 610.20. Consistent with current practice and BLAs, CBER will continue to make and supply standard preparations when appropriate, as well as continue to collaborate with external organizations in the development and assessment of physical standard preparations for biological products.

Under the current § 610.21 Limits of potency, FDA specifies minimal potency limits to be met for the antibodies and antigens listed. However, most of the biological products subject to the specified potency limits are no longer manufactured. In addition, for those that are still manufactured, or for anyone wanting to manufacture the listed products, FDA's updated practice is to have the potency limit also be specified in the BLA. For this reason, FDA is removing § 610.21. As a result of removing §§ 610.20 and 610.21, part 610, subpart C is removed and reserved.

In addition to sometimes being duplicative of information provided in the BLA and unnecessarily restrictive regarding the source of standard preparations, the codification by regulation of many of the standard preparations and limits of potency for certain biological products sometimes does not keep abreast of technological advances in science related to manufacturing and testing. For many years, because of the potential for impeding scientific progress, FDA has not codified additional specific standard preparations and limits of potency for licensed biological products, but instead the standards are established in the BLA. Failure to conform to applicable standards established in the license is grounds for revocation under § 601.5(b)(1)(iv) (21 CFR 601.5(b)(1)(iv)). Notwithstanding the changes in this rule, FDA will continue to require that each biological product meet standards to assure that the product is safe, pure, and potent, and will continue to require that each lot demonstrate conformance with the standards applicable to that product (see § 610.1) through appropriate testing. Therefore, we expect that standard preparations and potency limits will be established in the BLA and may be changed only in accordance with regulations for reporting post-approval changes (see § 601.12). Furthermore, no lot of any licensed product may be released by the manufacturer prior to the completion of tests for conformity with standards applicable to such product (see § 610.1).

FDA is therefore amending its regulations to remove §§ 610.20 and 610.21 because appropriate standard preparations and potency limits for any listed product are specified during the licensing process on a product specific basis. The removal of §§ 610.20 and 610.21 will also increase regulatory flexibility by allowing industry and FDA to more readily use and incorporate current scientific technology and other appropriate reference materials in the manufacture and regulation of licensed biological products.

A biological product is expected to remain stable and retain its identity, strength, quality, and purity for a period of time after manufacture when it is properly stored. The dating period limitations regulations provided at §§ 610.50 and 610.53 specify how the date of manufacture for biological products will be determined, when the dating begins, and dating periods for certain biological products. The existing § 610.50 prescribes how the date of manufacture is determined for biological products and relies in part upon §§ 610.20 and 610.21 or official standards of potency (i.e., a specific test method described in regulation). With the removal of §§ 610.20 and 610.21 for reasons described in this document, FDA is revising § 610.50 to reflect FDA's updated approach to establishing dates of manufacture.

In addition, current § 610.50(b) does not provide FDA or applicants with flexibility to consider the variety of manufacturing situations and technologies that exist today and which may occur in the future. Since 1977, when the regulation was last amended, new methods of manufacture and testing often associated with new biological products have been developed. The revisions to § 610.50 provided in this direct final rule therefore allow additional manufacturing activities other than those currently listed to be used to determine the date of manufacture.

Under the revised regulation, the date of manufacture must be identified in the approved BLA. FDA recommends that applicants discuss a suitable date of manufacture with FDA during late clinical development and propose a date of manufacture in the BLA. We consider the underlying science and manufacturing process testing methods in determining the date of manufacture for each specific product. The approved BLA will specify how the date of manufacture is determined. A paragraph is being added, § 610.50(c), specifying how the date of manufacture for Whole Blood and blood components is determined. This will assist in complying with the dating periods prescribed for Whole Blood and blood components in the revised table in redesignated § 610.53(b).

The current table at § 610.53(c) lists dating periods, manufacturer's storage periods, and storage conditions for many biological products. The table in § 610.53(c) (which is redesignated as § 610.53(b)) is revised to remove products where storage conditions and dating periods are established to help ensure the continued safety, potency, and purity of each individual product, based upon information submitted in the relevant BLA. The dating period and storage conditions for these products will be identified in the BLA. The table in § 610.53(c) is also revised to delete those products that are no longer manufactured. We are retaining those products, specifically Whole Blood and blood components, whose dating periods are based upon data relating to the anticoagulant or preservative solution in the product, usage, clinical experience, laboratory testing, or further processing. The list is updated to include currently licensed Whole Blood and blood component products with their applicable storage temperatures and dating periods.

In listing the dating periods for Whole Blood and blood component products, we took into account existing regulations, guidance documents, package inserts for solutions used for manufacture or storage of Whole Blood and blood components, and operator instruction manuals for devices used in the manufacture of Whole Blood and blood component products. Because we understand from these materials that these dating periods are in current use, and because blood establishments can request an exception under § 640.120 (21 CFR 640.120), we do not anticipate significant objections to codifying this information. Similarly, we are removing § 610.53(d) because it is duplicative of § 640.120. In addition, we recognize that future scientific understanding and new technology, such as the implementation of pathogen reduction technology or the approval of extended storage systems, could affect what dating periods would be necessary, as a scientific matter, for Whole Blood and blood components. For this reason, the rule allows for changes to the dating periods specified in § 610.53(b) when the dating period is otherwise specified in the instructions for use by the blood collection, processing, and storage system approved or cleared for such use by FDA.

In conclusion, the amendments to the regulations provided by this rule are designed to be consistent with updated practices in the biological product industry and to remove unnecessary or outdated requirements. FDA is taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations to provide flexibility without diminishing public health protection. Given the additional flexibility provided by these revised regulations, FDA does not anticipate that applicants for licensed biological products will need to revise information in BLAs in order to conform to the revised regulations.

FDA is revising the general biological products standards relating to dating periods and removing certain standard preparations and limits of potency. These changes are designed to remove unnecessary or outdated requirements, and accommodate new and evolving technology and testing capabilities without diminishing public health protections. FDA is issuing these revisions directly as a final rule because the Agency believes they include only noncontroversial amendments and FDA anticipates no significant adverse comments.

FDA is removing § 610.20 because the standard preparations listed are obsolete or no longer available; standard preparations to ensure the safety, purity, and potency of a product can best be determined on a product specific basis; and standard preparations may be obtained from other sources. Applicants for biological product licenses currently identify standard preparations in the BLA, and the proposed standard preparations and their purpose are reviewed by FDA during the regulatory process. The standard preparations may include standard preparations developed by the applicant as well as appropriate standard preparations that can be obtained from other sources. Consistent with current practice, CBER will continue to make and supply standard preparations when appropriate, as well as continue to collaborate with external organizations in the development and assessment of physical standard preparations for licensed biological products.

We are removing § 610.21 because these potency limits are best described in the BLAs on a product specific basis. Applicants for biological product licenses already identify standards for potency to help ensure the safety, purity, and potency of the product within their BLA, and the proposed standards are reviewed by FDA during the regulatory process. The use of a potency limit is suitably described in the specific product's BLA and allows for its continued and appropriate use in the absence of § 610.21.

We are revising § 610.50 by making a minor amendment to the section heading, removing the current language, redesignating § 610.53(b) as § 610.50(a) with edits, revising § 610.50(b), and adding new § 610.50(c). Current § 610.53(b), which applies to all biological products, has been moved to § 610.50(a) and edits have been made for better organization and clarification. Section 610.50(b) is being revised and § 610.50(c) is being added to clarify how the date of manufacture is set for purposes of determining the dating period for general biological products and for Whole Blood and blood components, respectively.

We are amending the section heading of § 610.53 to reflect that it only addresses dating periods for Whole Blood and blood components. We are revising § 610.53(a) since this section only applies to the dating periods for Whole Blood and blood components. We are redesignating § 610.53(c) as § 610.53(b) and revising the text to provide an explanation on using the table and to correspond with 21 CFR 606.121(c)(7). We are revising the text and table to eliminate those products for which storage periods, storage conditions, and dating periods are better established by data submitted in the BLA, and to delete those products which are no longer manufactured. The dating period and storage conditions for these products are identified in the BLA. We are including an updated list of Whole Blood and blood component products with their applicable storage temperatures and dating periods, which are based upon available information, including data relating to the anticoagulant or preservative solution in the product, usage, clinical experience, laboratory testing, or further processing. The table contains a list of storage temperatures and dating periods for Whole Blood and blood components that FDA has reviewed and determined to be necessary to help ensure the safety, potency, and purity of these products. In listing the dating periods for the Whole Blood and blood component products, we took into account existing guidance documents, package inserts for solutions used for manufacture or storage of Whole Blood and blood components, and operator instruction manuals for devices used in the manufacture of Whole Blood and blood component products. We are redesignating § 610.53(c) as § 610.53(b) and removing all products regulated by FDA's Center for Drug Evaluation and Research (CDER) from the table. Finally, we are removing § 610.53(d) because it is duplicative of § 640.120.

FDA is issuing this rule under the biological products provisions of the PHS Act (42 U.S.C. 216, 262, 263, 263a and 264) and the drugs and general administrative provisions of the FD&C Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, and 381). Under these provisions of the PHS Act and the FD&C Act, we have the authority to issue and enforce regulations designed to ensure that biological products are safe, pure, and potent, and prevent the introduction, transmission, and spread of communicable disease.

We have examined the impacts of the direct final rule under Executive Order 12866, Executive Order 13563, and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this direct final rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the direct final rule is removing regulations and revising regulations to be consistent with updated practice, we certify that this direct final rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. This direct final rule would not result in an expenditure in any year that meets or exceeds this amount.

We have determined under 21 CFR 25.31(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

We have analyzed this direct final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

This direct final rule contains collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collections of information in part 610 have been approved under OMB control number 0910-0338. The removal of § 610.53(d) impacts OMB control number 0910-0338. We are removing § 610.53(d) because it is duplicative of § 640.120, which is also approved under the same collection of information. While there is no net change in the burden estimate, the current approved collection of information will be updated to reflect this removal. The actions taken by this direct final rule do not create a substantive or material modification to this approved collection of information. Therefore, FDA concludes that OMB has already approved this information collection and the requirements in this document are not subject to additional review by OMB.

Therefore, under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 610 is amended as follows:

On March 1, 2016, the Department published an interim final rule (81 FR 10475) to extend the deadline by which a relative of a deceased Indian can apply for burial assistance for the deceased Indian from 30 days following death to 180 days following death.

The Department received three comments on the rule, all of which were supportive of the rule. None of the comments requested changes to the rule. Consequently, the Department did not make any change to the interim final rule as a result of this comment. For these reasons, the Department confirms the interim rule published March 1, 2016 (81 FR 10475), as final without change.

Background

Section 301.7701-2(c)(2)(i) states that, except as otherwise provided, a business entity that has a single owner and is not a corporation under § 301.7701-2(b) is disregarded as an entity separate from its owner (a disregarded entity). However, § 301.7701-2(c)(2)(iv)(B) provides that an entity that is a disregarded entity is treated as a corporation for purposes of employment taxes imposed under subtitle C of the Internal Revenue Code (Code). Therefore, the disregarded entity, rather than the owner, is considered to be the employer of the entity's employees for purposes of employment taxes imposed by subtitle C.

While § 301.7701-2(c)(2)(iv)(B) treats a disregarded entity as a corporation for employment tax purposes, this rule does not apply for self-employment tax purposes. Specifically, § 301.7701-2(c)(2)(iv)(C)(2) provides that the general rule of § 301.7701-2(c)(2)(i) applies for self-employment tax purposes. After setting forth this general rule, the regulation applies this rule in the context of a single individual owner by stating that the owner of an entity that is treated in the same manner as a sole proprietorship is subject to tax on self-employment income. The regulation, at § 301.7701-2(c)(2)(iv)(D), also includes an example that specifically illustrates the mechanics of the rule. In the example, the disregarded entity is subject to employment tax with respect to employees of the disregarded entity. The individual owner, however, is subject to self-employment tax on the net earnings from self-employment resulting from the disregarded entity's activities. The regulations do not include a separate example in which the disregarded entity is owned by a partnership.

It has come to the attention of the Treasury Department and the IRS that even though the regulations set forth a general rule that an entity is disregarded as a separate entity from the owner for self-employment tax purposes, some taxpayers may have read the current regulations to permit the treatment of individual partners in a partnership that owns a disregarded entity as employees of the disregarded entity because the regulations did not include a specific example applying the general rule in the partnership context. Under this reading, which was not intended, some taxpayers have permitted partners to participate in certain tax-favored employee benefit plans. The Treasury Department and the IRS note that the regulations did not create a distinction between a disregarded entity owned by an individual (that is, a sole proprietorship) and a disregarded entity owned by a partnership in the application of the self-employment tax rule. Rather, § 301.7701-2(c)(2)(iv)(C)(2) provides that the general rule of § 301.7701-2(c)(2)(i) applies for self-employment tax purposes for any owner of a disregarded entity without carving out an exception regarding a partnership that owns such a disregarded entity. In addition, the Treasury Department and the IRS do not believe that the regulations alter the holding of Rev. Rul. 69-184, 1969-1 CB 256, which provides that: (1) Bona fide members of a partnership are not employees of the partnership within the meaning of the Federal Insurance Contributions Act, the Federal Unemployment Tax Act, and the Collection of Income Tax at Source on Wages (chapters 21, 23, and 24, respectively, subtitle C, Internal Revenue Code of 1954), and (2) such a partner who devotes time and energy in the conduct of the trade or business of the partnership, or in providing services to the partnership as an independent contractor, is, in either event, a self-employed individual rather than an individual who, under the usual common law rules applicable in determining the employer-employee relationship, has the status of an employee.

To address this issue, the Treasury Department and the IRS clarify in these temporary regulations that the rule that a disregarded entity is treated as a corporation for employment tax purposes does not apply to the self-employment tax treatment of any individuals who are partners in a partnership that owns a disregarded entity. The rule that the entity is disregarded for self-employment tax purposes applies to partners in the same way that it applies to a sole proprietor owner. Accordingly, the partners are subject to the same self-employment tax rules as partners in a partnership that does not own a disregarded entity.

This document contains amendments to the Procedure and Administration Regulations (26 CFR part 301) under section 7701 of the Code to clarify that a disregarded entity that is treated as a corporation for purposes of employment taxes imposed under subtitle C of the Code is not treated as a corporation for purposes of employing its individual owner, who is treated as a sole proprietor, or employing an individual that is a partner in a partnership that owns the disregarded entity. Rather, the entity is disregarded as an entity separate from its owner for this purpose. Existing regulations already provide that the entity is disregarded for self-employment tax purposes and specifically note that the owner of an entity treated in the same manner as a sole proprietorship under § 301.7701-2(a) is subject to tax on self-employment income. These temporary regulations apply this existing general rule to illustrate that, if a partnership is the owner of a disregarded entity, the partners in the partnership are subject to the same self-employment tax rules as partners in a partnership that does not own a disregarded entity.

While these temporary regulations provide that a disregarded entity owned by a partnership is not treated as a corporation for purposes of employing any partner of the partnership, these regulations do not address the application of Rev. Rul. 69-184 in tiered partnership situations. Several commenters have requested that the IRS provide additional guidance on the application of Rev. Rul. 69-184 to tiered partnership situations, and have also suggested modifying the holding of Rev. Rul. 69-184 to allow partnerships to treat partners as employees in certain circumstances, such as, for example, employees in a partnership who obtain a small ownership interest in the partnership as an employee compensatory award or incentive. However, these commenters have not provided detailed analyses and suggestions as to how the employee benefit and employment tax rules would apply in such situations. The Treasury Department and the IRS request comments on the appropriate application of the principles of Rev. Rul. 69-184 to tiered partnership situations, the circumstances in which it may be appropriate to permit partners to also be employees of the partnership, and the impact on employee benefit plans (including, but not limited to, qualified retirement plans, health and welfare plans, and fringe benefit plans) and on employment taxes if Rev. Rul. 69-184 were to be modified to permit partners to also be employees in certain circumstances.

In order to allow adequate time for partnerships to make necessary payroll and benefit plan adjustments, these temporary regulations will apply on the later of: (1) August 1, 2016, or (2) the first day of the latest-starting plan year following May 4, 2016, of an affected plan (based on the plans adopted before, and the plan years in effect as of, May 4, 2016) sponsored by an entity that is disregarded as an entity separate from its owner for any purpose under § 301.7701-2. For these purposes, an affected plan includes any qualified plan, health plan, or section 125 cafeteria plan if the plan benefits participants whose employment status is affected by these regulations. For rules that apply before the applicability date of these regulations, see 26 CFR part 301 revised as of April 1, 2016.

Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact 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. For applicability of the Regulatory Flexibility Act (5 U.S.C. chapter 6), please refer to the Special Analysis section in the preamble to the cross-referenced notice of proposed rulemaking in the Proposed Rules section of this issue of the Federal Register. Pursuant to section 7805(f) of the Code, these regulations were 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 Andrew Holubeck of the Office of the Division Counsel/Associate Chief Counsel (Tax Exempt and Government Entities). However, other personnel from the IRS and the Treasury Department participated in their development.

Accordingly, 26 CFR part 301 is amended as follows:

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security E.O. Executive Order FR Federal Register NPRM Notice of proposed rulemaking Pub. L. Public Law § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because final details of this event were not provided until April 12, 2016, making it impracticable to publish an NPRM.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be contrary to public interest because immediate action is needed to protect race participants and spectators from the hazards associated with a paddleboard race.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port North Carolina (COTP) has determined that potential hazards associated with the Barrier Island Challenge Paddle Board Race on May 07, 2016 will be a safety concern when race participants cross the Lower Swash Channel on the Cape Fear River, Southport, North Carolina, a major shipping channel. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone.

The Coast Guard is establishing a temporary safety zone on the navigable waters of the Lower Swash Channel on the Cape Fear River. The safety zone will encompass all waters within a shape bounded by the following coordinates: 33°55′05″ N., 078°00′04″ W.; 33°54′57″ N., 078°00′04″ W.; 33°54′56″ N., 078°00′54″ W.; 33°55′04″ N., 078°00′54″ W.; thence back to the point of origin (NAD 83) in Southport, North Carolina. This safety zone will be established in the interest of public safety due to the participants crossing the Cape Fear River. This rule will be enforced on May 07, 2016 during the times of 9:30 a.m. through 11:30 a.m., unless otherwise cancelled earlier by the COTP.

Except for vessels authorized by the Captain of the Port or her Representative, no person or vessel may enter or remain in the safety zone during the time frame listed. The Captain of the Port will give notice of the enforcement of the safety zone by all appropriate means to provide the widest dissemination of notice among the affected segments of the public. This will include publication in the Local Notice to Mariners and Marine Information Broadcasts.

We developed this rule after considering numerous statutes and Executive Orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.

E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

The primary impact of these regulations will be on limiting all vessels wishing to transit the affected waterways during enforcement of the safety zone on the Cape Fear River within all waters within a shape bounded by the following coordinates: 33°55′05″ N., 078°00′04″ W.; 33°54′57″ N., 078°00′04″ W.; 33°54′56″ N., 078°00′54″ W.; 33°55′04″ N., 078°00′54″ W.; thence back to the point of origin (NAD 83) in Southport, North Carolina on May 07, 2016 from 9:30 a.m. through 11:30 a.m., unless otherwise cancelled by the COTP. Although these regulations prevent traffic from transiting a portion of the Cape Fear River during this event, that restriction is limited in duration, affects only a limited area, and will be well publicized to allow mariners to make alternative plans for transiting the affected area.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A. above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

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

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.

Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a safety zone to limit vessels within all waters within a shape bounded by the following coordinates: 33°55′05″ N., 078°00′04″ W.; 33°54′57″ N., 078°00′04″ W.; 33°54′56″ N., 078°00′54″ W.; 33°55′04″ N., 078°00′54″ W.; thence back to the point of origin (NAD 83) in Southport, North Carolina on May 07, 2016 from 9:30 a.m. through 11:30 a.m. to protect life and property of mariners from the hazards associated with the event. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

For the reasons discussed in the preamble, the Coast Guard temporarily amends 33 CFR part 100 as follows:

Table of Contents I. Proposed Actions A. Determinations of Attainment B. Extensions of Marginal Area Attainment Dates C. Determinations of Failure To Attain and Reclassification D. Moderate Area SIP Revision Submission Deadline E. Rescission of Clean Data Determination and Proposed SIP Call for the 1997 8-Hour Ozone NAAQS for the New York-N. New Jersey-Long Island (NY-NJ-CT) Nonattainment Area II. Final Actions A. Determinations of Attainment B. Extensions of Marginal Area Attainment Dates C. Determinations of Failure To Attain and Reclassification D. Moderate Area SIP Revision Submission Deadline E. Rescission of Clean Data Determination and Final SIP Call for the 1997 8-Hour Ozone NAAQS for the New York-N. New Jersey-Long Island (NY-NJ-CT) Nonattainment Area III. Environmental Justice Considerations IV. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Paperwork Reduction Act (PRA) C. Regulatory Flexibility Act (RFA) D. Unfunded Mandates Reform Act (UMRA) E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act (CRA) L. Judicial Review I. Proposed Actions

On August 27, 2015, the EPA proposed to find that 17 Marginal areas attained the 2008 NAAQS by the applicable attainment date of July 20, 2015, based on complete, quality-assured and certified ozone monitoring data for 2012-2014. See 80 FR 51992. The EPA also proposed to find that eight areas met the criteria, as provided in CAA section 181(a)(5) and 40 Code of Federal Regulations (CFR) 51.1107, to qualify for a 1-year attainment date extension for the 2008 ozone NAAQS even though they did not attain the NAAQS by the applicable deadline. Finally, the EPA proposed to find that 11 areas failed to attain the 2008 ozone NAAQS by the applicable Marginal attainment date and that they did not qualify for a 1-year attainment date extension. Under CAA section 181(b)(2)(A), if the EPA determines that an area failed to attain a given NAAQS by the applicable attainment date, the area shall be reclassified to a higher classification. In the EPA's August 2015 proposal, the EPA specified those 11 areas would be reclassified to Moderate. The reclassified areas must attain the standard as expeditiously as practicable, but in any event no later than July 20, 2018.

The EPA proposed two options for establishing a deadline for states to submit the SIP revisions required for Moderate areas once their areas are reclassified from Marginal. The first option would have required state air agencies to submit the required SIP revisions as expeditiously as practicable, but no later than the beginning of the ozone season in 2017 for each respective area. The second option would have required state air agencies to submit the required SIP revisions as expeditiously as practicable, but no later than January 1, 2017. After consideration of the comments received on these proposed options, the EPA is finalizing a due date of no later than January 1, 2017, for all Moderate area SIP requirements that apply to newly reclassified areas.

In the proposal, the EPA evaluated data from air quality monitors in the 36 areas classified as Marginal for the 2008 ozone NAAQS in order to determine each area's attainment status as of the applicable attainment date of July 20, 2015. Seventeen of the 36 nonattainment areas' monitoring sites with valid data had a design value 1 equal to or less than 0.075 parts per million (ppm) based on 2012-2014 monitoring period.2 Thus, the EPA proposed to determine, in accordance with section 181(b)(2)(A) of the CAA and the EPA's implementing regulations at 40 CFR 51.1103, that the 17 areas listed in the following Table 1 attained the standard by the applicable attainment date for Marginal areas for the 2008 ozone NAAQS.

Of the 36 Marginal nonattainment areas for the 2008 ozone NAAQS, there are eight areas for which the EPA proposed to grant a 1-year attainment date extension based on determinations that these areas met the requirements for an extension under CAA section 181(a)(5), including compliance with all commitments and requirements in the applicable implementation plan and “clean” data in the year preceding the attainment year. In addition, for each of these areas, at least one state with jurisdiction over all or part of the area requested such an extension.

The EPA proposed that eight Marginal nonattainment areas for the 2008 ozone NAAQS failed to attain the NAAQS by July 20, 2015, but met the attainment date extension criteria of CAA section 181(a)(5), as interpreted in 40 CFR 51.1107. The EPA proposed to find that all implicated states were meeting the obligations and commitments of their applicable implementation plans, in accordance with CAA section 181(a)(5)(A), and that, per CAA section 181(a)(5)(B) and the implementing regulations, the 4th highest daily maximum 8-hour average concentrations for all monitors in each area were not greater than 0.075 ppm for 2014, the year preceding the attainment year (see 40 CFR 51.1107). The EPA, therefore, proposed to grant a 1-year extension of the applicable Marginal area attainment date from July 20, 2015, to July 20, 2016, for the nonattainment areas listed in Table 2.

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 docket ID number EPA-HQ-OPP-2015-0014 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 July 5, 2016. 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-2015-0014, 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. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of April 6, 2015 (80 FR 18327) (FRL-9924-00), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4F8323) by Syngenta Crop Protection, LLC., 410 Swing Road, Greensboro, NC 27419. The petition requested that 40 CFR 180.546 be amended by establishing tolerances for residues of the fungicide mefenoxam, methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate, in or on rapeseed crop subgroup 20A at 0.05 parts per million (ppm). That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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 mefenoxam including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with mefenoxam 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. Mefenoxam is the enriched R-enantiomer of metalaxyl which is a racemic mixture that contains approximately 50% each of the R- and S-enantiomers. EPA conducted side-by-side comparison of the available toxicity data for mefenoxam and metalaxyl and concluded that mefenoxam has similar toxicity to that of metalaxyl. Therefore, the metalaxyl data may be used to support regulatory actions for mefenoxam.

The Agency reassessed the toxicity databases for metalaxyl and mefenoxam in accordance with current policies and determined that many of the effects previously noted in several toxicological studies are no longer considered to be adverse (i.e. body weight gain without changes in absolute body weight; hepatocyte hypertrophy without necrosis; enzyme leakage to bloodstream or disruption of lipid homeostasis). In rat and dog repeat dose (i.e., subchronic and chronic) oral toxicity studies, there were no indications of adverse effects up to the highest dose tested (HDT).

Adverse effects were only observed from acute exposure to rats. In the rat developmental toxicity study of metalaxyl, maternal toxicity consisted of dose-related increased incidence of convulsions that occurred shortly after dosing, as well as other clinical signs. In a range-finding acute neurotoxicity study of mefenoxam, females showed abnormal functional observation battery (FOB) findings at lower doses than males. However, there was no indication of toxicity up to the HDT in the mefenoxam subchronic neurotoxicity study, which confirms the lack of adverse effects observed in all other repeated-dose studies.

There was no indication of developmental toxicity in studies of mefenoxam or metalaxyl. There was no indication of immunotoxicity in a mouse immunotoxicity study of mefenoxam. Metalaxyl and mefenoxam have been classified as “not likely to be carcinogenic in humans” based on the results for metalaxyl in the carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in rats.

Specific information on the studies received and the nature of the adverse effects caused by mefenoxam as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Mefenoxam, Human Health Risk Assessment” at pages 14-17 in docket ID number EPA-HQ-OPP-2015-0014.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for mefenoxam used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to mefenoxam, EPA considered exposure under the petitioned-for tolerances as well as all existing mefenoxam tolerances in 40 CFR 180.546 and metalaxyl tolerances 40 CFR 180.408. EPA assessed dietary exposures from mefenoxam/metalaxyl 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 mefenoxam. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 National Health and Nutrition Examination Survey/What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA conducted a somewhat refined acute dietary exposure assessment for the proposed food use of mefenoxam on the rapeseed subgroup 20A and the existing uses of both metalaxyl and mefenoxam. Residues were assumed to be present at tolerance levels in plant commodities, with additional factors applied to certain plant commodities to include all residues of concern for risk assessment. Tolerance-level residues adjusted upward to account for metalaxyl/mefenoxam residues of concern in livestock commodities were used and based on data from metabolism studies on goats and hens. DEEM default and empirical processing factors were used as available. It was assumed that 100% of the crops were treated (100% CT).

ii. Chronic exposure. No such effects were identified in the toxicological studies for mefenoxam; therefore, a quantitative chronic dietary exposure assessment is unnecessary.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that mefenoxam 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 percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for mefenoxam. Tolerance-level residues and/or 100% CT were assumed for all food commodities

2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for mefenoxam in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of mefenoxam. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Surface Water Concentration Calculator (SWCC) and the Pesticide Root Zone Model-Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of mefenoxam for acute exposures are estimated to be 741 parts per billion (ppb) for surface water and 3,700 ppb for ground water. These modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

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).

Mefenoxam is currently registered for the following uses that could result in residential exposures: Residential turf and ornamentals, including nonbearing citrus trees. EPA assessed residential exposure using the following assumptions: Residential handler exposure is expected to be short-term in duration. Intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners. Residential post-application exposure was assessed based on short-term incidental oral risk estimates for children 1 < 2 years old. Dermal post-application risk assessments were not conducted because an adverse systemic dermal hazard was not identified for mefenoxam. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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 mefenoxam to share a common mechanism of toxicity with any other substances, and mefenoxam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that mefenoxam 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides

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 Safety Factor (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. There is no evidence that mefenoxam results in increased susceptibility from in utero exposure to rats or rabbits in the prenatal developmental studies or exposure to young rats in the 2-generation reproduction study.

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 metalaxyl and mefenoxam is complete.

ii. In the rat prenatal developmental toxicity with metalaxyl, maternal animals exhibited clinical signs indicative of neurobehavioral effects as previously discussed.

In the range-finding acute neurotoxicity study with mefenoxam, females exhibited abnormal functional observation battery (FOB) findings at doses lower than in males. In the subchronic neurotoxicity study with mefenoxam, there were no indications of neurotoxicity up to the HDT. In metalaxyl and mefenoxam treated adult animals, clinical signs and abnormal FOB findings were noted. However, a developmental neurotoxicity (DNT) study is not required for metalaxyl or mefenoxam because (1) there are no indications of increased susceptibility for infants or children; (2) the convulsions observed in the rat prenatal developmental toxicity study occurred in the maternal animals with no effects being observed in the young; (3) the convulsions occurred only after a bolus dose; (4) the available developmental and range-finding acute neurotoxicity studies provided clear NOAELs and LOAELs for evaluating effects; (5) the current POD is below the level at which any effects were seen in either study, and (6) there were no other indications of neurotoxicity in the mefenoxam or metalaxyl databases, which include a subchronic (adult rat) neurotoxicity study for mefenoxam. Therefore, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. In metalaxyl and mefenoxam treated animals, there was no evidence of increased susceptibility following pre-/postnatal exposure in the prenatal developmental toxicity studies or the reproduction and fertility effects study. There is no evidence that mefenoxam results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance levels or upper bound residue estimates. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to mefenoxam in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by mefenoxam.

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. The acute aggregate risk assessment considers exposure estimates from dietary consumption of mefenoxam (food and drinking water). Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to mefenoxam will occupy 95% of the aPAD for children <1 years old, the population group receiving the greatest exposure, but this is below the level of concern.

2. Chronic risk. A chronic aggregate risk assessment takes into account chronic exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from repeated exposure was identified and no chronic dietary endpoint was selected. Therefore, mefenoxam is not expected to pose a chronic risk.

3. Short-term and Intermediate-term risk. Short-term and intermediate-term aggregate exposure takes into account both short-term and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Mefenoxam is currently registered for uses that could result in short-term and intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate short-term and intermediate-term residential exposures to mefenoxam. Using the exposure assumptions described in this unit for short-term and intermediate-term exposures, EPA has concluded the combined short-term and intermediate-term food, water, and residential exposures result in aggregate MOEs of 79,000 for adult; and 1,000 for children 1 < 2 years old. Because EPA's level of concern for mefenoxam is a MOE of 100 or below, these MOEs are not of concern.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, mefenoxam is not expected to pose a cancer risk to humans.

5. 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 mefenoxam residues.

Several methods are available for enforcing tolerances: (1) A gas-liquid chromatography procedure employing an alkali flame ionization detector (GLC/AFID); (2) a method using GLC/nitrogen phosphorus detection; and (3) a multi-residue method in PAM, Vol 1.

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: [email protected].

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.

The Codex has not established a MRL for mefenoxam for the rapeseed crop subgroup 20A.

Therefore, tolerances are established for residues of mefenoxam, methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate, in or on rapeseed subgroup 20A at 0.05 ppm.

This action 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 action has been exempted from review under Executive Order 12866, this action 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 action 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 action 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 action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (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 (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:

Background

The Council adopted Framework 27 on December 3, 2015, and submitted a draft of the framework to NMFS on December 22, 2015, that presented Council recommended measures, rationale, impacts for review, and a draft EA. NMFS published a proposed rule, including a reference on how to obtain the framework and the draft final EA, for approving and implementing Framework 27 on February 24, 2016 (81 FR 9151). The proposed rule included a 30-day public comment period that closed on March 25, 2016. The Council submitted a final EA to NMFS on March 14, 2016, for approval. This annual action includes catch, effort, and quota allocations and adjustments to the rotational area management program for fishing year 2016. Framework 27 specifies measures for fishing year 2016, and includes fishing year 2017 measures that will go into place as a default should the next specifications-setting framework be delayed beyond the start of fishing year 2017. NMFS has approved all of the measures recommended by the Council and described below. The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) permits NMFS to approve, partially approve, or disapprove measures proposed by the Council based only on whether the measures are consistent with the fishery management plan, the Magnuson-Stevens Act and its National Standards, and other applicable law. We must defer to the Council's policy choices unless there is a clear inconsistency with the law or the FMP. Details concerning the development of these measures were contained in the preamble of the proposed rule and are not repeated here.

Table 1 outlines the scallop fishery catch limits derived from the ABC values.

This action deducts 1.25 million lb (567 mt) of scallops annually for 2016 and 2017 from the ABC and sets it aside as the Scallop RSA to fund scallop research and to compensate participating vessels through the sale of scallops harvested under RSA projects. As of March 1, 2016, this set-aside has been available for harvest by RSA-funded projects in open areas. Framework 27 allows RSA to be harvested from the Mid-Atlantic Access Area (MAAA), but prevents RSA harvesting from access areas under 2017 default measures. Of this 1.25 million-lb (567-mt) allocation, NMFS has already allocated 3,393 lb (1.5 mt) to multi-year projects it previously funded as part of the 2015 RSA awards process. NMFS reviewed proposals submitted for consideration of 2016 RSA awards and announced project selections on April 7, 2016. Details on the 2016 RSA awards can be found on our Web site here: http://www.nefsc.noaa.gov/coopresearch/news/scallop-rsa-2016.html.

This action sets aside 1 percent of the ABC for the industry-funded observer program to help defray the cost of scallop vessels that carry an observer. The observer set-aside is 379 mt for fishing year 2016 and 379 mt for fishing year 2017. In fishing year 2016, the compensation rates for limited access vessels in open areas fishing under days-at-sea (DAS) is 0.11 DAS per DAS fished. For access area trips, the compensation rate is 175 lb (79 kg), in addition to the vessel's possession limit for the trip for each day or part of a day an observer is onboard. LAGC IFQ vessels may possess an additional 175 lb (79 kg) per trip in open areas when carrying an observer. NMFS may adjust the compensation rate throughout the fishing year, depending on how quickly the fleets are using the set aside. The Council may adjust the 2017 observer set-aside when it develops specific, non-default measures for 2017.

This action implements vessel-specific DAS allocations for each of the three limited access scallop DAS permit categories (i.e., full-time, part-time, and occasional) for 2016 and 2017 (Table 2). Fishing year 2016 DAS allocations are higher than those allocated to the limited access fleet in 2015 (30.86 DAS for full-time, 12.94 DAS for part-time, and 2.58 DAS for occasional vessels). Framework 27 also sets a 2017 DAS allocations equal to fishing year 2016 as a default measure in the event the 2017 specifications action is delayed past the start of the 2017 fishing year. The 2016 level default measure is expected to be more precautionary than the 2017 projected level. The allocations in Table 2 exclude any DAS deductions that are required if the limited access scallop fleet exceeded its 2015 sub-ACL. In addition, these DAS values take into account a 0.14-DAS per vessel reduction necessary to compensate for a measure implemented in Framework Adjustment 26 to the FMP (80 FR 22119; April 21, 2015) that allows vessel to transit to ports south of 39° N Lat. while not on DAS.

For fishing year 2016 and the start of 2017, Framework 27 keeps all three Georges Bank Access Areas (i.e., Nantucket Lightship, Closed Area 1, and Closed Area 2 Access Areas) closed and keeps the MAAA open to the limited access fleet. This action closes a new area, the Closed Area 2 Extension, to protect small scallops located south of the current Closed Area 2 boundary. The Council will reconsider opening this closure area to scallop fishing in a future framework action when the scallops are larger and ready for harvest.

Table 3 outlines the limited access allocations that can be fished from the MAAA, which each vessel can take in as many trips as needed, so long as the trip possession limits (also in Table 3) are not exceeded.

1. Delayed Harvesting of Default 2017 MAAA Allocations. Although the Framework includes default access area allocations for the 2017 fishing year (see 2017 allocations in Table 3), vessels have to wait to fish these allocations until April 1, 2017. This measure is precautionary to help to protect scallops when scallop meat weights are lower than other times of the year (generally, this change in meat-weight is a physiological change in scallops due to spawning). However, if a vessel has not fully harvested its 2016 scallop access area allocation in fishing year 2016, it may still fish the remainder of its allocation in the first 60 days of 2017 (i.e., March 1, 2017, through April 29, 2017).

2. 2017 RSA Harvest Restrictions. This action prohibits vessels participating in RSA projects from harvesting RSA in access areas while default 2017 measures are in place. If default measures are in place at the start of 2017, RSA can only be harvested from open areas. The Council will re-evaluate this measure in the framework action that would set final 2017 specifications.

1. ACL for LAGC vessels with IFQ permits. For LAGC vessels with IFQ permits, this action implements a 1,845-mt ACL for 2016 and an initial ACL of 1,845 mt for 2017 (see Table 1). The Council and NMFS calculate IFQ allocations by applying each vessel's IFQ contribution percentage to these ACLs. IFQ allocations for each vessel assume that LAGC IFQ fleet does not trigger any accountability measures (AMs). The AM dictates that if a vessel exceeds its IFQ in a given fishing year, its IFQ for the subsequent fishing year is reduced by the amount of the overage.

Because Framework 27 will go into effect after the March 1 start of fishing year 2016, the default 2016 IFQ allocations went into place automatically on March 1, 2016. This action implements IFQ allocations greater than the default allocations. NMFS sent a letter to IFQ permit holders providing both March 1, 2016, IFQ allocations and Framework 27 IFQ allocations so that vessel owners know what mid-year adjustments will occur now that Framework 27 is approved.

2. ACL for Limited Access Scallop Vessels with IFQ Permits. For limited access scallop vessels with IFQ permits, this action implements a 184-mt ACL for 2016 and a default 184-mt ACL for 2017 (see Table 1). We calculate IFQ allocations by applying each vessel's IFQ contribution percentage to these ACLs. IFQ allocations for each vessel assume that the LAGC IFQ fleet doesn't trigger any AMs. The AM dictates that if a vessel exceeds its IFQ in a given fishing year, its IFQ for the subsequent fishing year would be reduced by the amount of the overage.

3. LAGC IFQ Trip Allocations and Possession Limits for Scallop Access Areas. Framework 27 allocates LAGC IFQ vessels a fleetwide number of trips in the MAAA and a fleetwide number of trips in the northern portion of the Nantucket Lightship Access Area (NLSN). This action does not grant the limited access fleet access to the NLSN.

Framework 27 allocates 2,068 and 602 trips in 2016 and the same default amounts for 2017, respectively, to the MAAA. Under default 2017 measures, LAGC IFQ vessels must wait to fish these trips until April 1, 2017. It also allocates 485 trips to the NLSN for fishing year 2016. The total number of trips for both areas combined (2,553) for fishing year 2016 is equivalent to the overall proportion of total catch from access areas compared to total catch. Framework 27 does not allocate any trips to either fleet category in NLSN for the 2017 fishing year.

4. NGOM Total Allowable Catch (TAC). The Framework 27 proposed rule proposed a 70,000-lb (31,751-kg) annual NGOM TAC for fishing years 2016 and 2017. However, the year-end analysis of the fishing year 2015 NGOM fishery shows a 2,546-lb (1,155-kg) overage in the NGOM TAC. The regulations implementing the Scallop FMP require that we implement an AM that reduces the NGOM TAC by the amount of the overharvest. Therefore, as a result of the fishing year 2015 catch overage, this action implements that AM, reducing the fishing year 2016 NGOM TAC to 67,454 lb (30,597 kg).

5. Scallop Incidental Catch Target TAC. This action allocates a 50,000-lb (22,680-kg) scallop incidental catch target TAC for fishing years 2016 and a default target TAC for 2017 to account for mortality from this component of the fishery, and to ensure that F targets are not exceeded. The Council and NMFS may adjust this target TAC in a future action if vessels catch more scallops under the incidental target TAC than predicted.

Despite the comments opposing the action, we find that the justification and analysis support the Council's recommendations, and that the Council process, in adopting Framework 27, followed up by the proposed and final rulemaking process, provided Council members and the public sufficient analysis to consider the proposed alternatives, including opening NLSN to LAGC vessels only, and adequate opportunity to comment on such alternatives. We have determined the Council's recommendations are consistent with law and we intend to approve all measures. Under the Magnuson-Stevens Act we can only disapprove a Council measure if it is not consistent with all applicable law. Otherwise, we give deference to the Council's policy recommendations.

This action includes several revisions to the regulatory text to address text that is unnecessary, outdated, unclear, or NMFS could otherwise improve. NMFS proposed these changes consistent with section 305(d) of the Magnuson-Stevens Act, which provides that the Secretary of Commerce may promulgate regulations necessary to ensure that amendments to an FMP are carried out in accordance with the FMP and the Magnuson-Stevens Act. The first revision, at § 648.14(i)(2)(ii)(B)(7), clarifies that the crew member restrictions, specified in § 648.51(c) and § 648.51(e)(3)(i), apply in all access areas. The second revision, at § 648.14(i)(3)(v)(C), clarifies that LAGC IFQ vessels must be declared into the Sea Scallop Access Area Program if they fish for, possess, or land scallops in or from any Sea Scallop Access Area. The third revision, at § 648.51(e)(2), clarifies that vessels participating in the small dredge program may carry component parts on board the vessel such that they do not conform with the definition of “dredge or dredge gear.” The fourth revision, at § 648.52(f), clarifies that LAGC IFQ vessels are permitted to possess no more than 75 bu (26.4 hL) of in-shell scallops outside of the Access Areas. Finally, the fifth revision, at § 648.60(g)(2), clarifies that LAGC IFQ vessels may fish with trawl gear in the MAAA.

NMFS received several comments on Framework 27 after the Council voted to submit the action but prior to the publication of the proposed rule. The majority of these comments objected to the alternative to allow exclusive LAGC effort in the NLSN, but we also received comments supporting this alternative. We considered these comments when preparing the proposed rule, but they did not present sufficient legal concerns that would require us to discuss possible disapproval of the measure in the proposed rule. Because these comments were mostly mirrored in comments on the proposed rule, we have not summarized them here.

We received 17 comment letters on the proposed rule during the public comment period, including letters from 14 individuals; the Associated Fisheries of Maine (AFM); the Virginia Department of Environmental Quality; and Fisheries Survival Fund (FSF). The following summarizes the issues raised in the comments and NMFS's responses.

Comment 1: Thirteen individuals wrote in support approving of the measure that allocates LAGC trips in the NLSN. These commenters were LAGC IFQ vessel owners and/or operators from New England. They believe that access to the NLSN will be extremely beneficial to their businesses and will allow them to fish closer to their homeports. They urged NMFS to approve this measure.

Response: NMFS has approved all of the measures recommended by the Council, as supported by these commenters.

Comment 2: Regarding the measure that allocates LAGC trips in the NLSN, AFM highlighted that the biological and economic analysis could not identify any negative impacts to the scallop resource or human communities because the amount of proposed harvest would be very small. It also highlighted that the Council has moved LAGC access area trips from Closed Area 2 to areas closer to shore in previous actions. AFM views the alternative to provide LAGC access to NLSN as a similar accommodation for a fleet comprised primarily of small vessels.

Response: NMFS agrees that accommodating one specific fleet, whether the Limited Access fleet or LAGC fleet, with area-specific allocations is consistent with the Scallop FMP and with prior Council actions.

Comment 3: The Virginia Department of Environmental Quality commented that it has no concerns with the proposed rule, and it believes the action is unlikely to have adverse impacts on fisheries resources under its jurisdiction.

Response: We appreciate Virginia Department of Environmental Quality's comment.

Comment 4: An individual was concerned that Framework 27 will adversely affect the income of the fishermen involved. He stated that the open area cannot withstand the increased effort due to an increase in the LAGC ACL. He asserts that vessels will target small scallops and prices will drop as a result of this increase. He also stated that the IFQ fleet will have a large amount of carryover because of poor catch rates in fishing year 2015, and that the LAGC fleet was caught off guard by this unforeseen anticipated increase.

Response: We disagree with the commenter's concern about small scallops. Scallop dredges are required to have 4-inch rings that are designed to allow smaller scallops to pass through the gear, which should reduce the ability of vessel operators to target small scallops. Further, because larger scallops draw a higher price per pound there is generally an incentive to target larger scallops. Therefore, it is not likely to be in a vessel's best interest to target small scallops. In any event, because this substantial increase is only applicable to 5.5 percent of the fleet, analysis shows that it would not have a meaningful effect on price. The estimated ex-vessel price for the preferred alternative is $11.50, which is equal to or similar to the ex-vessel price in all of the other viable alternatives. Regarding carryover, LAGC IFQ vessels are limited to carrying over 15 percent of their available catch from fishing year 2015. However, despite this additional 15 percent that the LAGC fleet could carry over into fishing year 2016, that 15 percent carryover is unlikely to cause unexpected negative impacts resulting from additional catch on top of an already-increased sub-ACL. Finally, we projected an increase in the LAGC IFQ ACL during the fishing year 2015 specifications process in Framework 26. Because the LAGC ACL is formulaic, the magnitude of this increase was dependent on the result of the 2015 summer surveys. Once the surveys were completed, Council staff presented the potential increase in the LAGC ACL to the public in September of 2015. Therefore, this increase was not unforeseen. The quota allocations for fishing years 2016 and 2017 are based on the best scientific information available and are consistent with the control rules outlined in the ACL process established under Amendment 15 to the FMP.

Comment 5: FSF, which represents a majority of the limited access scallop fleet, commented generally in favor of the Framework 27 measures, but, in a comment, recommended we disapprove the measure that allocates only LAGC effort in the NLSN. FSF stated in its comment its opinion that approval of this alternative is not legally permissive because of procedural flaws by the Council and NMFS. FSF contends that because the analysis was not included in the draft Framework until the day the Council voted on preferred alternatives (December 3, 2015), we cannot approve this measure because approval would violate the National Environmental Policy Act (NEPA) and the Administrative Procedure Act (APA). In support of this comment FSF notes, that, “alternatives considered by the Council must be `encompassed by the range of alternatives discussed in the relevant environmental documents,' ” citing NEPA and Agency Planning regulations at 40 CFR 1501.1(e).

Response: FSF conflates the Council process with legal requirements on NMFS mandated by NEPA and APA. The legal adequacy of the relevant documents subject to NEPA and APA are not the draft documents considered by the Council at the December meeting because the Council is not a federal agency subject to these laws. Rather, the relevant documents are the final EA prepared after the December Council meeting and the proposed rule proposing to adopt the framework. The final EA encompasses a range of alternatives, including the NLSN measure, which are thoroughly analyzed for environmental and socioeconomic impacts and address the concerns raised by FSF. Further, the proposed rule provided ample opportunity for the public in general, and FSF in particular, to comment on the Framework, the EA analysis completed after the December Council meeting and referenced in the proposed rule, and the NLSN measure in particular.

Comment 6: FSF cites 50 CFR 648.55(f) and states that the biological analysis for the measure allowing only LAGC vessels in the NLSN was conducted during the December Council meeting and not prior to, as required by law, and that the Council did not “provide the public with advance notice of the availability of both the proposals and the analyses, and opportunity to comment on them prior to and at the second Council meeting.” FSF cites the regulations at § 648.55(f) which state: “After considering the PDT's findings and recommendations, or at any other time, if the Council determines that adjustments to, or additional management measures are necessary, it shall develop and analyze appropriate management actions over the span of at least two Council meetings . . . The Council shall provide the public with advance notice of the availability of both the proposals and the analyses, and opportunity to comment on them prior to and at the second Council meeting . . .” FSF comments that any public notice deficiencies or, procedural irregularities at the Council level cannot be remedied by this rulemaking process. FSF goes on to state that the addition of the NSLN alternative could not be approved as a “logical outgrowth” of other alternatives.

Response: We disagree with FSF's comment that we cannot approve the NLSN alternative because it is inconsistent with § 648.55(f) by failing to provide sufficient public notice and analysis before the Council voted on the alternative. First, there was sufficient public notice, analysis and full discussion before the Council voted to adopt the alternative. Although this specific alternative was not explicitly incorporated into the draft EA for Framework 27 at the beginning of the Council meeting, the public, and FSF in particular, were aware of this alternative well before the Council meeting and at the very least it is a logical outgrowth of measures that were being considered by the Council during the development of the framework. The Council initiated Framework 27 at its June 18, 2015, meeting and developed alternatives over several meetings including its September and December meetings, as well as the September 17, 2015, and the November 19, 2015, Scallop Oversight Committee meetings. Based on a Committee motion from its September 17, 2015, meeting, the concept of an alternative to allow fishing by all scallopers in NSLN was first included in a draft framework document for the September Council meeting. Members of the Scallop Advisory Panel, on which members of FSF sit, first suggested limiting scallop fishing in the NLSN to LAGC vessels only as an alternative at their meeting on November 18, 2015. The Advisory Panel suggested this alternative only after the Advisory Panel suggested a new alternative, created and raised by FSF, which proposed to have all access area effort in the MAAA. The next day, the Committee, in its meeting attended by representatives of FSF, requested that the Scallop Plan Development Team (PDT) analyze both the restricted NSLN alternative and the FSF sponsored alternative for the December Council meeting. Once analysis was complete, the PDT held a conference call on December 1, 2015. The notice for this call was posted on the Council Web site on November 23, 2015, and an automatic email was sent out on November 24, 2015, to anyone who registered to be informed on Council scallop issues. Members of the public, including representatives from FSF, attended the call. The next day, the Council summarized the details of that call in a PDT memo dated December 2, 2015, and made the memo available to the public at the Council meeting prior to the scallop discussion on December 3, 2015. The PDT memo provided both a biological and an economic analysis of the alternative.

The Council heard public comment during the discussion of this measure both against and in support of this alternative, including comments against the measure from different representatives of FSF. The analyses included in the PDT memo, in combination with the public comment solicited at the meeting, and other analyses in Framework 27, allowed the Council to make an informed decision on this alternative. While this timing was tight, the process was consistent with the intent of the cited regulation in that it gave advance notice and analysis to the public over the course of two meetings (the November Committee meeting and the December Council meeting) before the measure was adopted. The Council frequently adjusts specific management alternatives that are logical outgrowths in the actions it is considering at or just before the final Council meeting. This provides the Council with the flexibility to consider sensible solutions or adjustments to these logical outgrowth alternatives without postponing action. Indeed, FSF was pushing for the adoption of its own sponsored proposed alternative even though it was subject to the same sequence of events and given the same analysis and consideration as the NSLN alternative. Therefore, we conclude that the Council and the public, including FSF, had more than adequate opportunity to consider and comment on the NLSN measure. Further, the adoption of this measure by the Council was consistent with the Council's procedural requirements to ensure that measures it adopts are sufficiently analyzed and the public is sufficiently aware of the analysis and propose alternatives before it adopts such a measure. Even if the Council's activity marginally infringed its established procedures because of the tight timing, courts, including those cited by FSF, have held that if there were procedural irregularities, they would not necessarily invalidate a regulation if such irregularities resulted in only “harmless error,” or there is no evidence that our decision to approve the alternative was materially affected by the Council's procedural irregularities (for which there is no evidence in this instance). Indeed, the Ninth U.S. Circuit Court of Appeals has held that “[i]if the Secretary has followed the appropriate rulemaking procedures and has established a rational basis for this action in promulgating regulations based on the submitted amendment, procedural challenges for irregularities at the Council level will not provide a justification for invalidating the regulations.” Atlantic Factory Trawler Association, et al. v. Baldridge, et al., 831 F. 2d 1456,1464 (9th Cir. 1987). FSF's comments that there was not adequate or sufficient understanding of and discussion about the alternative at the Council meeting is not supported by the facts as discussed above. There can be no doubt that there was a rational basis for the Council and NMFS adopting this alternative and nothing in the Council process materially affected our decision regarding this framework. Therefore any inconvenience FSF or the public may have experienced was at worst “harmless error,” which has been cured through notice and comment rulemaking.

Comment 7: FSF alleges that the alternative that allocates LAGC trips in the NLSN violates the Scallop FMP access area guidelines, claiming that Amendment 10 to the Scallop FMP (69 FR 35194; June 23, 2004), “describes access area policies in terms that plainly anticipate that such areas are either open proportionally to both fleets or to neither.” FSF also cites a section of Amendment 11 to the Scallop FMP (73 FR 20090; April 14, 2008) referring to access area allocations for LAGC vessels that states that once an area is designated as controlled access, “it is understood that a specific percentage of the TAC per access area would be allocated to the General Category fleet.” FSF further contends that the Scallop FMP does not provide for decoupling of limited access and LAGC access to access areas, and the Council has never embarked on this path before. Finally, FSF quotes the Regional Administrator, who commented at the December Council meeting that he was concerned this alternative, “[takes] a chink out of this rotational closure and allows one group in early.”

Response: There is nothing in the guidelines or policy underlying the Scallop FMP that prohibits this type of measure. Granting increased access area allocation to one part of the scallop fleet and not the other is not only contemplated by the Scallop FMP, it has been done in the past. The Environmental Impact Statement (EIS) to Amendment 11 acknowledges the possibility of differential allocations of area access specifically where it was determined that “it may not be effective to allocate the same percent per access area to the general category fishery. About 2 percent of the total TAC has been allocated to the general category fishery in previous access programs, but it was noted during this process that it may be most effective to consider variable percents for different access areas. For example, the 2 percent allocated in Closed Area 2 has never been caught by the general category fishery. It was discussed that these decisions are best considered in future framework actions that set specifications and allocations for the access area program and there is nothing in current regulations to prevent different percentages from being considered.” (EIS for Amendment 11 to the Scallop FMP; pg. 65). FSF's citation to Amendment 11 action comes from the description of a considered but rejected alternative. The rationale for rejection provides the same analysis as stated above that “it was discussed that it may not be effective to allocate the same percent per access area to the general category fishery.” FSF's reference to Amendment 10's intent is not specifically documented, and, in any event, Amendment 11 clearly allows for variable allocations among the Limited Access and LAGC fleets. Framework Adjustment 25 to the Scallop FMP (79 FR 26690; May 9, 2014) serves as the most recent example of the Council deciding to differentially allocate harvesting opportunities to one group of scallopers and not the other without any objection from FSF. In that framework, the Council allowed access to Closed Area 2 to the limited access fleet only, while permitting the LAGC fleet trips to another area based on a determination of equivalency of the LAGC fleet fishing in Closed Area 2. The fact that the Regional Administrator both spoke and voted against this measure at the December Council meeting does not by itself justify disapproval of the measure. The Regional Administrator's comments expressed policy, but not legal, concerns about the measure. Under the Magnuson-Stevens Act, even though the Regional Administrator may not be in favor of this measure on policy grounds, we can only disapprove a Council measure if it is not consistent with all applicable law, which is not the case here.

Comment 8: FSF was concerned that the alternative that allocates LAGC trips in the NLSN differentially affects LAGC vessels homeported in New England differently than those homeported in the Mid-Atlantic, and the Council did not hold any meetings or hearings on this issue in the Mid-Atlantic region.

Response: The Framework 27 EA discusses that this alternative may have a different impact on vessels regionally. Analysis in the EA suggests that allowing LAGC access to the NLSN may reduce the number of New England vessels traveling to the MAAA to fish, therefore increasing the total number of MAAA trips available to the Mid-Atlantic LAGC fleet. Furthermore, industry members from all regions had an equal opportunity to comment on the proposed rule, and there are members of the Advisory Panel, the Committee, and the Council that have LAGC and/or Mid-Atlantic interests. The fact that meetings were not held in an affected region does not mean that the framework is invalid, particularly when there was adequate opportunity for different regional fishers to comment.

Comment 9: FSF asserts that “required analyses were inadequate or entirely lacking both prior to and at the meeting during which the Council took its vote.” It goes on to cite NEPA requirements for an EIS and they extend these requirements to the EA that the Council prepared for Framework 27.

Response: NEPA regulations at 40 CFR 1508.9 state that an EA, “Shall include brief discussions of the need for the proposal, of alternatives as required by section 102(2)(E), of the environmental impacts of the proposed action and alternatives, and a listing of agencies and persons consulted.” The final EA includes these requirements. As stated above, the Council is not required to have a completed EA during the development of an action because it is not a Federal agency. In fact, it is impossible to analyze the action as a whole until after the Council selects preferred alternatives. While this regulation imposes a requirement ultimately of NMFS, the Council uses a draft EA as a means to present and analyze alternatives, and, in turn, submits that as part of the Council's recommendation to NMFS on the action. NMFS adopts the draft document prepared by the Council and works with the Council to finalize it. Nevertheless, we disagree with FSF's comment that there was inadequate analysis at the Council meeting before the Council took its vote. The analysis of the alternative that allocates LAGC trips in the NLSN that was available to the Council at the December meeting (the December 2, 2015, PDT memo) before any vote was taken was on par with other alternatives in the document. This analysis contained detailed images describing where fishing would occur and the condition of the resource in that area, both biological and economic projections of the impacts of the alternative, and a comparative analysis of those impacts compared to alternatives already in the document. This analysis found that the allowing LAGC access into the NLSN had the highest total benefits of any alternative in 2016 and no noticeable biological impact. Once the Council chose preferred alternatives, Council staff worked with NMFS to fully analyze all the alternatives and meet NEPA requirements for Framework 27.

Comment 10: FSF believes that Framework 27 failed to sufficiently analyze economic impacts such as regional variation in lease prices.

Response: FSF is incorrect. Framework 27 includes an economic and social analysis of all of the considered alternatives in Section 5.4 and it specifically analyzes regional variation in leasing in Section 5.4.3.12.3. Framework 27 concludes that “the distribution of access area allocations could have some impacts on (lease) prices, however, those impacts would be uncertain given that not only the size of scallops but several other factors, including the distance to each area from the homeports of IFQ holders, the fuel and trip costs, total amount of IFQ available, distribution of IFQ holdings among the active vessels, relative price of scallops by market category have an influence on lease prices.” Furthermore, as stated above, the PDT analysis available to the Council during its December meeting found that the allowing LAGC access into the NLSN had the highest total benefits of any alternative in 2016.

Comment 11: FSF also claims that the alternative that allocates LAGC trips in the NLSN is an allocative measure and requires an amendment, as opposed to a framework, and also an EIS versus an EA. They cite NMFS' Operational Guidelines that limit a framework action, by definition, to “a mechanism for implementing recurrent, routine, or foreseeable actions in an expedited manner.”

Response: This measure is not fundamentally allocative in the way suggested by FSF. The NLSN provision is only a one-year specification that does not increase total allocations or take away any allocations from the limited access fleet. The provision merely shifts around how LAGC scallopers can harvest their allocations based on their particular circumstances, not the amount they are allocated. This type of specification is a regular annual action that is foreseeable and consistent with the Scallop FMP, as discussed in the response to comment 7, which allows for differential access to access areas for the limited access and LAGC fleets depending on the annual needs of each fleet. Thus, although controversial, this action was a routine specifications action that is appropriate for a Framework. 50 CFR 648.55(f) describes the types of measures that the Council can decide to adjust. It allows for adjustments to area-specific trip allocations, specifications for IFQs for limited access general category vessels, and any other management measures currently included in the FMP. The controversiality of a measure in terms of its desirability is not justification to conduct an EIS. Only when the analysis of an action is controversial in terms of its validity is an EIS required. Finally, there is no law or provision of the Magnuson-Stevens Act that requires an amendment for allocative issues. Nor does NEPA require an EIS because of significant economic impacts as suggested by FSF.

Comment 12: FSF says that the Council made the decision that NLSN was not ready to be opened as a biological matter. FSF states that the alternative that allocates LAGC trips in the NLSN violates National Standard 2 requiring that “conservation and management measures shall be based upon the best scientific information available.” FSF asserts that the Council made their decision to allow LAGC effort in the NLSN area based on politics and not the best available science.

Response: This is not true as even acknowledged by FSF. In fact, alternatives in the document considered access to NLSN. The PDT determined that the NLSN area could handle a small amount of limited access effort (52 trips at 17,000 lb (400 mt)) and this alternative was included in Framework 27. Allowing the LAGC trips in the NLSN included in this final rule will result in approximately 132 mt of harvest. The Council's non-selected alternative to open the NLSN to both fleets at a very limited level would have resulted in approximately 400 mt of scallop harvest. The reason the broader NLSN alternative was not selected was not biological, but rather it was not supported by the limited access fleet because only 16.6 percent of the full-time limited access fleet would receive a trip in NLSN.

The best available science shows that allowing access to the LAGC fleet will not harm the resource. Indeed, the analysis in the draft and final EA and the PDT memo concludes that the alternative allowing three times more access (400 mt) by limited access vessels and LAGC vessels would not jeopardize sustainability of the scallop resource. The decision was a policy decision of how much to allocate between the two fleets. The Council has the right to make these types of decisions, and we can only disapprove if it is inconsistent with Magnuson-Stevens Act requirements and the applicable law, not on whether we disagree with the policy underlying the measure. The Council made its decision based on the scientific analysis provided in the December 2, 2015, PDT memo, public and Council member testimony, and other analyses in the Framework 27 EA. FSF has not offered any other science or biological analysis to contradict the scientific information upon which the Council made its decision. FSF even notes that the PDT analysis in the memo could not identify negative biological impacts to the scallop resource because the amount of proposed harvest would be very small. Also, the draft and final EA concluded that there would be overall positive economic impacts for the scallop fleet, with relatively higher positive economic impacts for LAGC vessels homeported in the New England states. The Advisory Panel, including members of FSF preferred access to MAAA over NSLN in part because it allowed the entire limited access fleet into the area. It was only when the limited access fleet requested this alternative, that members of the LAGC fleet requested that 19 percent of their MAAA trip allocation be moved into the NLSN.

Comment 13: FSF claims that the alternative that allocates LAGC trips in the NLSN violates National Standard 8 because it analyzed only impacts on the LAGC fleet that fished from ports closer to the access area rather than how it affects the entire LAGC fleet.

Response: National Standard 8 requires that “Conservation and management measures shall . . . take into account the importance of fishery resources to fishing communities by utilizing economic and social data . . . in order to (A) provide for the sustained participation of such communities, and (B) to the extent practicable, minimize adverse economic impacts on such communities.” (16 U.S.C. 1851, Sec 301(a)(8)). The final version of the Framework, the expanded draft EA available when the proposed rule was published, and the final EA specifically analyze the differential impacts and conclude that because fewer northern vessels will go down to the MAAA, the Mid-Atlantic vessels, i.e., those farther from the NLSN, may have more quota to fish. While this analysis was not specifically available at the time the Council approved the NLSN measure there was a general mention of possible differential impacts in the PDT report that was available during the Council meeting and a self-evident understanding by Council members and the public that area-based allocations are, by their very nature, going to have more benefits to regions that are closer to areas open to fishing. As discussed above, the public had additional opportunity to comment on the draft EA which was made available for review at the time of the publication of the proposed rule. Ultimately, the adequacy of the NEPA analysis is determined by the final EA not the draft NEPA analysis available at the Council meeting. This level of analysis alerting the public and FSF to the differential impacts to communities as required by National Standard 8, followed up by more complete analysis in the draft and final EA is consistent with Magnuson-Stevens Act and NEPA requirements.

We included changes to the regulatory text to § 648.62 to implement an AM due to the overage of the NGOM TAC.

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is consistent with the FMP, other provisions of the Magnuson-Stevens Act, the ESA, and other applicable law.

The Office of Management and Budget (OMB) has determined that this rule is not significant pursuant to Executive Order (E.O.) 12866.

This final rule does not contain policies with federalism or “takings” implications, as those terms are defined in E.O. 13132 and E.O. 12630, respectively.

This action does not contain any collection-of-information requirements subject the Paperwork Reduction Act (PRA).

The Assistant Administrator for Fisheries has determined that the need to implement these measures in an expedited manner in order to help achieve conservation objectives for the scallop fishery and certain fish stocks constitutes good cause, under authority contained in 5 U.S.C. 553(d)(3), to waive the 30-day delay in effectiveness and to make the Framework 27 final measures effective upon publication in the Federal Register.

Because Framework 27 has not yet been approved and implemented, certain default measures, including access area designations and DAS, IFQ, research set-aside and observer set-aside allocations, are automatically put into place. These default allocations were purposely set to be more conservative than what would eventually be implemented under Framework 27. Under default measures, each full-time vessel has 26 DAS and one access area 17,000-lb (7,711-kg) trip in the MAAA. We have good cause to waive the 30-day delay in effectiveness because this action provides full-time vessels with an additional 8.55 DAS (34.55 DAS total) and 34,000 lb (15,422 kg) in access area allocation (51,000 lb (23,133 kg) total) into the MAAA. Further, LAGC IFQ vessels will receive an additional 330 mt (2,029 mt total) of allocation and 1,466 trips into the MAAA (2,068 trips total) and 485 trips in the NLSN. Framework 27 could not have been put into place sooner to allow for a 30-day delayed effectiveness because the information and data necessary for the Council to develop the framework was not available in time. We received the final submission of the EA from the Council on March 14, 2016. We published the proposed rule on February 24, 2016, and the comment period did not close until March 25, 2016. Delaying the implementation of Framework 27 for 30 days would delay positive economic benefits to the scallop fleet and could negatively impact the access area rotation program by delaying fishing in access areas that should be available. There are no new measures that implement additional burdens on the fleet, and we do not expect that any members of the scallop industry will be aggrieved by waiving this delay.

NMFS, pursuant to section 604 of the Regulatory Flexibility Act (RFA), has completed a final regulatory flexibility analysis (FRFA) in support of Framework 27 in this final rule. The FRFA incorporates the IRFA, a summary of the significant issues raised by the public comments in response to the IRFA, NMFS responses to those comments, a summary of the analyses completed in the Framework 27 EA, and this portion of the preamble. A summary of the IRFA was published in the proposed rule for this action and is not repeated here. A description of why this action was considered, the objectives of, and the legal basis for this rule is contained in Framework 27 and in the preamble to the proposed and this final rule, and is not repeated here. All of the documents that constitute the FRFA are available from NMFS and a copy of the IRFA, the Regulatory Impact Review (RIR), and the EA are available upon request (see ADDRESSES).

There were no specific comments on the IRFA. The Comments and Responses section summarizes the comments that highlight concerns about the economic impacts and implications of impacts on small businesses (i.e., comments 4, 8, 9, 10, and 13).

The regulations affect all vessels with limited access and LAGC scallop permits. The Framework 27 EA provides extensive information on the number and size of vessels and small businesses that will be affected by the regulations, by port and state (see ADDRESSES). There were 313 vessels that obtained full-time limited access permits in 2014, including 250 dredge, 52 small-dredge, and 11 scallop trawl permits. In the same year, there were also 34 part-time limited access permits in the sea scallop fishery. No vessels were issued occasional scallop permits. NMFS issued 220 LAGC IFQ permits in 2014 and 128 of these vessels actively fished for scallops that year (the remaining permits likely leased out scallop IFQ allocations with their permits in Confirmation of Permit History). The RFA defines a small business in shellfish fishery as a firm that is independently owned and operated and not dominant in its field of operation, with receipts of up to $5.5 million annually. Individually-permitted vessels may hold permits for several fisheries, harvesting species of fish that are regulated by several different fishery management plans, even beyond those impacted by this action. Furthermore, multiple permitted vessels and/or permits may be owned by entities with various personal and business affiliations. For the purposes of this analysis, “ownership entities” are defined as those entities with common ownership as listed on the permit application. Only permits with identical ownership are categorized as an “ownership entity.” For example, if five permits have the same seven persons listed as co-owners on their permit applications, those seven persons would form one “ownership entity,” that holds those five permits. If two of those seven owners also co-own additional vessels, that ownership arrangement would be considered a separate “ownership entity” for the purpose of this analysis.

Ownership data from 2014 result in 166 distinct ownership entities for the limited access fleet and 106 distinct ownership entities for the LAGC IFQ fleet. Of these, and based on the Small Business Administration (SBA) guidelines, 152 of the limited access distinct ownership entities and 102 of the LAGC IFQ entities are categorized as small. The remaining 14 of the limited access and 4 of the LAGC IFQ entities are categorized as large entities, all of which are shellfish businesses.

This action contains no new collection-of-information, reporting, or recordkeeping requirements.

During the development of Framework 27, NMFS and the Council considered ways to reduce the regulatory burden on, and provide flexibility for, the regulated entities in this action. For example, they opened the NLSN to LAGC vessels to provide vessels homeported in Massachusetts an opportunity to fish in an access area without traveling to the MAAA. This measure addresses safety and economic concerns for smaller northern LAGC vessels when fishing in an access area. Final actions and alternatives are described in detail in Framework 27, which includes an EA, RIR, and IRFA (available at ADDRESSES). The measures implemented by this final rule minimize the long-term economic impacts on small entities to the extent practicable. The only alternatives for the prescribed catch limits that were analyzed were those that met the legal requirements to implement effective conservation measures. Catch limits are fundamentally a scientific calculation based on the Scallop FMP control rules and SSC approval, and therefore are legally limited to the numbers contained in this rule. Moreover, the limited number of alternatives available for this action must be evaluated in the context of an ever-changing fishery management plan that has considered numerous alternatives over the years and have provided many mitigating measures applicable every fishing year.

Overall, this rule minimizes adverse long-term impacts by ensuring that management measures and catch limits result in sustainable fishing mortality rates that promote stock rebuilding, and as a result, maximize yield. The measures implemented by this final rule also provide additional flexibility for fishing operations in the short-term. This final rule implements measures that enable small entities to offset some portion of the estimated economic impacts. These measures include allocating about 19 percent of LAGC IFQ access area trips (or 300,000 lb (136 mt)) to the NLSN which is open to LAGC vessels only. Because of the proximity of the LAGC vessels, which are smaller in size and homeported in Massachusetts to NLSN, this option will reduce fishing costs and have positive impacts on their profits; and allowing about 1.5 million lb (680 mt) of the total LAGC allocation of 4.4 million lb (1,996 mt) to be harvested from access areas.

For the reasons set out in the preamble, 50 CFR part 648 is amended as follows:

This final rule implements Amendment 109 to the BSAI FMP. NMFS published a notice of availability (NOA) for Amendment 109 in the Federal Register on January 21, 2016 (81 FR 3374), with comments invited through March 21, 2016. The Secretary of Commerce approved Amendment 109 on April 15, 2016, after considering information from the public, and determining that Amendment 109 is consistent with the BSAI FMP, the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), and other applicable law. NMFS published a proposed rule to implement Amendment 109 and the regulatory amendments on February 8, 2016 (81 FR 6489). The comment period on the proposed rule ended on March 9, 2016. NMFS received one letter of comment on proposed Amendment 109 and one letter of comment on the proposed rule. NMFS responds to these comments in the section titled Comments and Responses. No changes were made from the proposed rule in response to these comments. Several minor editorial revisions are made in the amendatory instructions of this final rule to be consistent with two final rules that were implemented since the proposed rule for Amendment 109 was published. These revisions are described in the section titled Changes from the Proposed Rule.

This section summarizes background information about the CDQ Program and the regulatory constraints on the small catcher vessel hook-and-line halibut and groundfish CDQ fisheries that led the North Pacific Fishery Management Council (Council) to recommend Amendment 109 and this final rule. Additional background is included in the proposed rule (81 FR 6489; February 8, 2016) and is not repeated here.

The CDQ Program is an economic development program associated with federally managed fisheries in the BSAI. The purpose of the CDQ Program is to provide western Alaska communities with the opportunity to participate and invest in BSAI fisheries, to support economic development in western Alaska, to alleviate poverty and provide economic and social benefits for residents of western Alaska, and to achieve sustainable and diversified local economies in western Alaska. The CDQ Program also is a catch share program that allocates a portion of the BSAI total allowable catch limits for specific target crab and groundfish species, a portion of the commercial catch limits for halibut, and portions of certain prohibited species catch (PSC) limits to the CDQ Program. These amounts are then further allocated among the six CDQ groups as allocations that may be transferred among the CDQ groups. The primary focus of Amendment 109 is on the halibut CDQ allocations, the Pacific cod CDQ allocations, and the halibut PSC in the groundfish CDQ fisheries.

The successful harvest of CDQ Program allocations is integral to achieving the goals of the CDQ Program and the community development plans of each CDQ group. One of the most effective ways the CDQ groups provide benefits to residents of their CDQ communities is to use the CDQ allocations to create local small-scale commercial fisheries. For purposes of this final rule, “local small-scale” means CDQ fisheries prosecuted by catcher vessels that are less than or equal to 46 ft LOA, using hook-and-line gear, and homeported or operated from CDQ communities. These local small-scale fisheries provide opportunities for residents of the CDQ communities to earn income from the sale of the commercially harvested fish.

Certain Federal regulations have restricted the ability of fishermen in CDQ communities to harvest allocations of Pacific cod CDQ with small hook-and-line catcher vessels. In particular, requirements for full observer coverage and an LLP license limit the ability of CDQ community fishermen to retain Pacific cod CDQ when participating in the halibut CDQ fisheries or to develop separate local small-scale directed fisheries for Pacific cod CDQ. These regulatory constraints are described in more detail in the preamble to the proposed rule (81 FR 6489; February 8, 2016).

This final rule amends regulations governing the CDQ Program to support increased participation in the groundfish CDQ fisheries (primarily Pacific cod) by catcher vessels less than or equal to 46 ft LOA using hook-and-line gear as intended by Amendment 109. Specifically, this final rule:

• Exempts operators of registered catcher vessels greater than 32 ft LOA and less than or equal to 46 ft LOA using hook-and-line gear from the requirement to obtain and carry an LLP license when groundfish CDQ fishing (catcher vessels less than or equal to 32 ft LOA already are exempt from the LLP requirements in the BSAI under existing regulations);

• Implements new in-season management and catch accounting procedures to properly account for the harvest of groundfish and halibut and the accrual of halibut PSC by operators of catcher vessels less than or equal to 46 ft LOA using hook-and-line gear when halibut or groundfish CDQ fishing;

• Allows halibut caught by operators of catcher vessels less than or equal to 46 ft LOA using hook-and-line gear when groundfish CDQ fishing to accrue as either halibut CDQ, halibut individual fishing quota (IFQ), or halibut PSC, on a trip-by-trip basis; and

• Places catcher vessels less than or equal to 46 ft LOA using hook-and-line gear in the partial observer coverage category when they are groundfish CDQ fishing. In addition to these changes for Amendment 109, the final rule removes a table and some explanatory text from observer program regulations at § 679.51(f) that are no longer necessary.

This final rule is intended to facilitate increased participation by residents of CDQ communities in the BSAI groundfish CDQ fisheries and to support economic development in western Alaska. This final rule benefits the six CDQ groups and the operators of the small hook-and-line catcher vessels that the CDQ groups authorize to fish on their behalf by reducing the costs of participating in the groundfish CDQ fisheries. More information about the Council's and NMFS' rationale for this final rule and its expected impacts are provided in the proposed rule (81 FR 6489; February 8, 2016). The elements of this final rule are summarized in the following section of this preamble.

Regulations exempting specific vessels from LLP license requirements are codified at § 679.4(k)(2). This final rule adds a new paragraph (vi) to § 679.4(k)(2) to establish an LLP exemption for registered catcher vessels greater than 32 ft LOA and less than or equal to 46 ft LOA using hook-and-line gear when groundfish CDQ fishing. The operators of catcher vessels eligible for the LLP exemption are not required to obtain and carry an LLP license when they are groundfish CDQ fishing provided that certain vessel registration requirements are met prior to groundfish CDQ fishing.

This final rule adds a new paragraph at § 679.5(m) that includes the vessel registration requirements that must be met to receive an LLP exemption. To receive an LLP exemption, a CDQ group representative must register each eligible catcher vessel through NMFS' online CDQ vessel registration system (“the CDQ vessel registration system”). To successfully register a catcher vessel, the CDQ group representative must log into the CDQ vessel registration system using the CDQ group's existing NMFS ID and password and provide the information required on the computer screen. NMFS will add each catcher vessel successfully registered to the CDQ vessel registration list, and NMFS will post that list on the NMFS Alaska Region Web site at http://alaskafisheries.noaa.gov. The CDQ group representative may add eligible catcher vessels to the CDQ vessel registration list at any time during the groundfish fishing year (January 1 through December 31); there is no deadline for vessel registration with NMFS.

With each successful registration, the CDQ vessel registration system will provide the CDQ group representative with an LLP exemption letter documenting that the vessel is eligible for the LLP exemption when groundfish CDQ fishing. The CDQ group representative must provide a copy of the LLP exemption letter to the vessel operator. NMFS will not provide the LLP exemption letter directly to vessel operators. The vessel operator must maintain a legible copy of the LLP exemption letter on board the named vessel at all times when that vessel is groundfish CDQ fishing. Because registered vessels must have a legible copy of the LLP exemption letter on board the vessel before the vessel operator starts groundfish CDQ fishing, the CDQ group representative and the vessel operator must allow sufficient time to complete the registration process prior to the start of groundfish CDQ fishing by the vessel.

The LLP exemption letter also will provide printable confirmation to the CDQ group of a successfully completed vessel registration. Once registered, a vessel will remain on the CDQ vessel registration list until removed by the CDQ group. The CDQ groups are not required to re-register vessels annually.

A CDQ group representative may remove a vessel from the CDQ vessel registration list at any time by logging into the CDQ vessel registration system and following the applicable instructions. To remove a vessel from the CDQ vessel registration list, the CDQ group representative must certify to NMFS that 1) the vessel operator has been given notice by the CDQ group that the vessel is being removed from the list, and 2) the vessel operator is not groundfish CDQ fishing at the time of removal. The CDQ vessel registration system will provide a printable confirmation that a vessel has been removed from the CDQ vessel registration list. Once a vessel is removed from the CDQ vessel registration list, that vessel is no longer exempt from the LLP requirements, even if the operator still possesses the LLP exemption letter. This final rule does not require a CDQ group representative to remove registered vessels from the CDQ vessel registration list when they are participating in a non-CDQ fishery.

To further clarify the vessel operator's responsibility, this final rule adds a new prohibition at § 679.7(d)(9) to prohibit the operator of a vessel eligible for the LLP exemption from conducting groundfish CDQ fishing without having a legible copy of the LLP exemption letter issued to a CDQ group for that vessel on board the vessel. In addition, this final rule adds a new prohibition at § 679.7(d)(10) to prohibit a CDQ group representative from removing a vessel from the CDQ vessel registration list without first providing notice to the operator of the registered vessel that the vessel is being removed from the CDQ vessel registration list, or when the vessel is groundfish CDQ fishing.

This final rule adds a new paragraph at § 679.32(c)(3)(iii) to establish the catch accounting and fishery monitoring requirements that apply to catcher vessels less than or equal to 46 ft LOA using hook-and-line gear when groundfish CDQ fishing and to the CDQ groups authorizing these vessels. Current regulations at § 679.32(c)(3)(i)(D) and (c)(3)(ii)(D) will continue to apply to catcher vessels greater than 46 ft LOA using hook-and-line gear when groundfish CDQ fishing.

This final rule also establishes catch accounting procedures in § 679.32(c)(3)(iii) that provide CDQ groups and vessel operators with the opportunity to retain halibut CDQ or halibut IFQ when groundfish CDQ fishing. If the vessel operator is relying on halibut CDQ from a CDQ group to support the retained catch of legal-size halibut during a fishing trip, the CDQ group must provide adequate halibut CDQ to this vessel operator to account for all the legal-size halibut caught by the vessel during the entire fishing trip. A CDQ group's halibut prohibited species quota (PSQ) will not be reduced if halibut is present in the landing. Landed halibut CDQ or halibut IFQ will accrue to the account balance of the permit holder identified by the processor in the landing report based on the permits held by the vessel operator or persons on board the vessel.

The operator of a hook-and-line catcher vessel less than or equal to 46 ft LOA who retains any halibut CDQ or halibut IFQ during the groundfish CDQ fishing trip must retain all legal-size halibut caught during that fishing trip. NMFS will continue to consider sub-legal-size halibut as wastage associated with the halibut fishery. As long as at least one halibut (IFQ or CDQ) is included in the groundfish CDQ landing, NMFS will not accrue any estimates of halibut PSC from the small catcher vessel groundfish CDQ fisheries to the CDQ group's halibut PSQ or to any component of the BSAI halibut PSC limit.

If no halibut are included in a groundfish CDQ landing, NMFS will accrue an estimate of halibut PSC to the CDQ group's small catcher vessel halibut PSC limit (described below). NMFS will estimate the halibut PSC associated with these types of groundfish CDQ fishing trips using halibut PSC rates as calculated by NMFS, and apply the halibut PSC rates when halibut fishing is closed or when halibut fishing is open but no halibut are included in a landing.

Under this final rule, NMFS will create a new quota category available to each CDQ group called the “small catcher vessel halibut PSC limit.” If a CDQ group wants to have a small hook-and-line catcher vessel groundfish CDQ fishery, the CDQ group must transfer halibut PSQ from its halibut PSQ to its small catcher vessel halibut PSC limit through a CDQ Transfer Request. The CDQ Transfer Request requirements are described under § 679.5(n). CDQ groups that do not want to have a local small-scale groundfish CDQ fishery do not have to transfer any halibut PSQ to this account. Each CDQ group will, in collaboration with NMFS, decide the appropriate amount of halibut PSQ to transfer to the small catcher vessel halibut PSC limit based on the amount of groundfish CDQ it wants to allocate to its small hook-and-line catcher vessel groundfish CDQ fishery and the expected use of halibut PSC in that fishery.

With the exception of sablefish CDQ fishing, which will continue to be managed under § 679.32(c)(1), this final rule will prohibit groundfish CDQ fishing by catcher vessels less than or equal to 46 ft LOA using hook-and-line gear unless NMFS publishes notification in the Federal Register authorizing a CDQ group to conduct such fishing. In deciding whether to authorize groundfish CDQ fishing by these vessels, NMFS will consider whether a CDQ group has sufficient halibut in its small catcher vessel halibut PSC limit to support groundfish CDQ fishing by these catcher vessels.

If NMFS determines that a CDQ group's small catcher vessel halibut PSC limit has been or will be reached, NMFS will issue a notice in the Federal Register prohibiting groundfish CDQ fishing by the small hook-and-line catcher vessels fishing for that CDQ group. NMFS will be responsible for issuing fishing closures to the small hook-and-line catcher vessel groundfish CDQ fisheries to maintain halibut PSC by these vessels within the small catcher vessel halibut PSC limit established by a CDQ group. NMFS will manage these fisheries to stay within the applicable CDQ groups' halibut PSC amount to the best of its ability, and will manage the small hook-and-line catcher vessel groundfish CDQ fishery conservatively to ensure that these PSC limits are not exceeded.

Even with conservative management, it is possible that a small catcher vessel halibut PSC limit could be exceeded due to the high degree of variability in halibut PSC rates that can occur in hook-and-line fisheries. If NMFS is unable to close a CDQ group's small catcher vessel groundfish CDQ fishery before it exceeds the amount of halibut PSC allocated to the small catcher vessel halibut PSC limit, NMFS will not consider this a violation, and NMFS will not require the CDQ group to transfer an amount of halibut PSQ needed to cover the negative balance. However, this final rule will allow a CDQ group to voluntarily choose to transfer additional halibut PSQ to bring the balance of its small catcher vessel halibut PSC limit to zero.

If a CDQ group's small catcher vessel halibut PSC limit has a negative balance at the end of the groundfish fishing year (December 31), and if the CDQ group has remaining halibut PSQ on that date, NMFS will transfer an amount of halibut PSQ into the CDQ group's small catcher vessel halibut PSC limit to bring the balance of the small catcher vessel halibut PSC limit to zero. NMFS will make this administrative transfer only after all fishing by a CDQ group is completed for the year, after data from the fishing year is finalized, and if the CDQ group has sufficient remaining halibut PSQ.

This final rule also will permit a CDQ group to transfer halibut from its small catcher vessel halibut PSC limit back to the CDQ group's halibut PSQ. In reviewing a request to transfer halibut from the small catcher vessel halibut PSC limit back to the CDQ group's halibut PSQ, NMFS will consider the status of CDQ fisheries through the end of the year and anticipated halibut PSC rates for any remaining groundfish CDQ fishing by vessels managed under the small catcher vessel halibut PSC limit for the requesting CDQ group.

This final rule adds paragraph (a)(1)(i)(D) to § 679.51 and revises § 679.51(a)(2)(i)(C)(2) to place catcher vessels less than or equal to 46 ft LOA that are using hook-and-line gear when groundfish CDQ fishing in the partial observer coverage category. Under current regulations, the owners or operators of vessels in the partial observer coverage category are placed in an observer selection pool based on the requirements of the Annual Deployment Plan (ADP). Since implementation of the ADP process in 2013, vessels less than 40 ft (12.2 m) LOA have been placed in the “no selection pool.” These vessels are not required to carry observers or register fishing trips with NMFS. Vessels 40 ft LOA or greater are in the “trip selection pool” and must log all of their fishing trips in the Observer Declare and Deploy System (ODDS). This is an online system for registering fishing trips and receiving information about whether a particular trip is selected for observer coverage. If selected for observer coverage, the catcher vessel is required to carry an observer. Operators of vessels selected for observer coverage are required to comply with all vessel responsibilities in § 679.51(e)(1). More information about logging trips in ODDS is on the NMFS Alaska Region Web site under “Frequently Asked Questions” about the Observer Program (http://alaskafisheries.noaa.gov/sustainablefisheries/observers/).

This final rule removes the table in § 679.51(f) that summarizes the observer coverage requirements for different management programs and industry sectors, and the introductory text about the table that is at the beginning of § 679.51. Prior to Observer Program Restructuring (77 FR 70062, November 21, 2012), this table was located at the beginning of subpart E as a table of contents or guide to observer coverage requirements. However, with the reorganization of observer coverage requirements in 2012 and the placement of this table at the end of § 679.51, it no longer serves its previous function as a table of contents for the section. Therefore, this table is removed.

During the public comment periods for the NOA for Amendment 109 and the proposed rule to implement Amendment 109, NMFS received one letter of comment on the NOA and one letter of comment on the proposed rule. Both of these letters were from one member of the public. NMFS' responses to these comments are presented below.

Comment 1: Both letters of comment expressed concern about overfishing and opposition to the overall management of the BSAI groundfish fisheries, including allocations to the CDQ Program to support economic development in Western Alaska and any regulations to increase participation in the CDQ fisheries.

Response: This final rule does not change the overall harvest levels or allocations in the BSAI groundfish fisheries, or the total amount of groundfish, halibut, or PSC allocated to the CDQ Program. Therefore, the comments expressing concern about overfishing, or expressing opposition about the overall management of the BSAI groundfish fisheries are outside of the scope of the NOA and proposed rule. As for the comments in opposition to increased participation in the CDQ Program, NMFS supports the Council's and CDQ groups' efforts to increase participation in the CDQ fisheries by owners and operators of small catcher vessels using hook-and-line gear. Participation in the CDQ Program by small, local fishing fleets is consistent with the goals and objectives of the CDQ Program in the Magnuson-Stevens Act and the BSAI FMP. Any increased participation by small, local hook-and-line catcher vessels in the groundfish CDQ fisheries will be conducted within the existing allocations to the CDQ Program and to the CDQ groups, and within other applicable conservation and management regulations.

The paragraph numbers for two additions to prohibitions at § 679.7(d) are renumbered from paragraphs (d)(8) and (d)(9) to paragraphs (d)(9) and (d)(10), respectively, because a new paragraph (d)(8) was recently added to § 679.7 under the cost recovery program final rule (81 FR 150, January 5, 2016).

The final rule includes three revisions to § 679.51(a)(1)(i) to insert additional punctuation and make minor wording changes (moving placement of the word “or”) to the list of vessels that are in the partial observer coverage category. These minor changes are needed to reflect the addition of paragraph (a)(1)(i)(C) in § 679.51 through the final rule for Amendment 112 to the BSAI FMP and Amendment 102 to the Fishery Management Plan for Groundfish of the Gulf of Alaska (81 FR 17403; March 29, 2016).

The Administrator, Alaska Region, NMFS, determined that Amendment 109 and this final rule are necessary for the conservation and management of the BSAI groundfish fisheries and that they are consistent with the Magnuson-Stevens Act and other applicable law.

Regulations governing the U.S. fisheries for Pacific halibut are developed by the International Pacific Halibut Commission (IPHC), the Pacific Fishery Management Council, the North Pacific Fishery Management Council (Council), and the Secretary of Commerce. Section 5 of the Northern Pacific Halibut Act of 1982 (Halibut Act, 16 U.S.C. 773c) allows the Regional Council having authority for a particular geographical area to develop regulations governing the allocation and catch of halibut in U.S. Convention waters as long as those regulations do not conflict with IPHC regulations. The final rule is consistent with the Council's authority to allocate halibut catches among fishery participants in the waters in and off Alaska.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a final regulatory flexibility analysis, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. The preamble to the proposed rule (81 FR 6489; February 8, 2016) and the preamble to this final rule serve as the small entity compliance guide. This rule does not require any additional compliance from small entities that is not described in the preamble to the proposed rule and this final rule. Copies of the proposed rule and this final rule are available from NMFS at the following Web site: http://alaskafisheries.noaa.gov.

Section 604 of the Regulatory Flexibility Act (RFA) requires an agency to prepare a FRFA after being required by that section or any other law to publish a general notice of proposed rulemaking and when an agency promulgates a final rule under section 553 of Title 5 of the U.S. Code. The following paragraphs constitute the FRFA for this action.

Section 604 describes the required contents of a FRFA: (1) A statement of the need for, and objectives of, the rule; (2) a statement of the significant issues raised by the public comments in response to the initial regulatory flexibility analysis, a statement of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments; (3) the response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration in response to the proposed rule, and a detailed statement of any change made to the proposed rule in the final rule as a result of the comments; (4) a description of and an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available; (5) a description of the projected reporting, recordkeeping, and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirement and the type of professional skills necessary for preparation of the report or record; and (6) a description of the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.

A description of the need for, and objectives of, the rule is contained in the preamble to the proposed rule and this final rule and is not repeated here. This FRFA incorporates the Initial Regulatory Flexibility Analysis (IRFA) (see ADDRESSES) and the summary of the IRFA in the proposed rule (81 FR 6489; February 8, 2016).

NMFS published a proposed rule to implement Amendment 109 and the regulatory amendments on February 8, 2016 (81 FR 6489). An IRFA was prepared and summarized in the Classification section of the preamble to the proposed rule. The comment period on the proposed rule ended on March 9, 2016. NMFS received one letter of comment on the proposed rule. This letter did not address the IRFA or the economic impacts of the rule more generally. The Chief Counsel for Advocacy of the Small Business Administration did not file any comments on the proposed rule.

This final rule will directly regulate two classes of small entities: (1) The six CDQ groups, which are non-profit corporations that represent the 65 western Alaska communities that are eligible to participate in the CDQ Program; and (2) the owners and operators of small hook-and-line catcher vessels who are authorized by a CDQ group to harvest groundfish or halibut CDQ allocations.

The RFA recognizes and defines three kinds of small entities: (1) Small businesses, (2) small non-profit organizations, and (3) small government jurisdictions. The CDQ groups are considered small entities due to their status as non-profit corporations. The Small Business Administration has established size standards for all major industry sectors in the United States. A business primarily involved in finfish harvesting is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual gross receipts not in excess of $20.5 million, for all its affiliated operations worldwide.

It is difficult to predict how many small hook-and-line catcher vessels may participate in the future under this final rule because no catcher vessels less than or equal to 46 ft LOA using hook-and-line gear currently are conducting directed fishing for groundfish CDQ. The best estimate of the upper bound of the number of future participants in the small catcher vessel Pacific cod CDQ fisheries is the maximum of 278 vessels less than or equal to 46 ft LOA that participated in the halibut CDQ fisheries from 2000 through 2013. NMFS assumes that all of the vessels that could be directly regulated by this action would be small entities based on estimated revenues of less than $20.5 million for all vessels and their known affiliations.

This final rule contains three new reporting and recordkeeping requirements that affect small entities. First, each CDQ group that authorizes catcher vessels greater than 32 ft LOA and less than or equal to 46 ft LOA using hook-and-line gear to fish for groundfish CDQ with an exemption from the LLP must register the vessel in an online CDQ vessel registration system developed and maintained by NMFS. All six CDQ groups will be subject to the vessel registration requirement if they have vessels participating.

Second, the operator of any registered catcher vessels greater than 32 ft LOA and less than or equal to 46 ft LOA using hook-and-line gear that is exempt from the LLP license requirements must maintain a legible copy of an LLP exemption letter on board the vessel at all times when groundfish CDQ fishing. The LLP exemption letter is generated through the CDQ vessel registration system when a CDQ group registers an eligible vessel. The CDQ group representative must provide this letter to the registered vessel operator. Depending on the level of participation, all six CDQ groups and all vessel operators could be subject to this requirement.

Third, small catcher vessels fishing for groundfish CDQ under this final rule will be placed in the partial observer coverage category. Vessels subject to observer coverage are determined annually through the Observer Program's ADP. Since inception of the ADP process in 2013, vessels less than 40 ft LOA have been placed in the “no selection pool” and have had no additional reporting or recordkeeping requirements. Vessels 40 ft LOA or greater are in the “trip selection pool” and must log all of their fishing trips in ODDS. This is an online system for registering fishing trips and receiving information about whether a particular trip is selected for observer coverage.

Vessels between 40 ft LOA and 46 ft LOA already log their halibut CDQ and halibut IFQ fishing trips in ODDS. Therefore, if these vessels are combining groundfish CDQ fishing with halibut CDQ or halibut IFQ fishing, they will not incur any additional reporting requirements associated with placement in the partial observer coverage category because the halibut trips already are in partial observer coverage. However, if any of these vessels start fishing for groundfish CDQ separate from their halibut CDQ or halibut IFQ fishing trips, then those additional fishing trips must be logged in ODDS. The cost of logging trips in ODDS represents an additional cost associated with the new small catcher vessel groundfish CDQ fisheries.

The RFA requires identification of any significant alternatives to the final rule that would accomplish the stated objectives of the proposed action, consistent with applicable statutes, and that would minimize any significant economic impact of the proposed rule on small entities. As noted in the IRFA, this final rule is expected to create a net benefit for the directly regulated small entities. The benefits of this action are expected to outweigh the reporting, recordkeeping, and other compliance costs described in the previous section.

The Council considered a status quo alternative (Alternative 1), and two action alternatives (Alternatives 2 and 3) in addition to this final rule (which was Alternative 4, the Council's preferred alternative). Neither Alternative 2 nor 3 would have provided more benefits to the directly regulated small entities or reduced reporting, recordkeeping, or compliance costs more than the preferred alternative that is implemented by this final rule.

Under Alternative 2, the maximum retainable amount (MRA) of Pacific cod in the halibut CDQ fisheries would have been increased so the operators of the small hook-and-line vessels could retain more Pacific cod when halibut CDQ fishing and still be considered directed fishing for halibut rather than directed fishing for Pacific cod. Alternative 2 was considered because the more costly LLP license requirements, observer coverage requirements, and vessel monitoring system (VMS) requirements do not apply to vessels halibut CDQ fishing in the BSAI (except that the VMS requirements apply to vessels halibut fishing in the Aleutian Islands). Increasing the MRAs for Pacific cod when halibut CDQ fishing would allow the small vessels to retain more Pacific cod without triggering requirements that apply to vessels directed fishing for Pacific cod. The Council did not select Alternative 2 because this final rule accomplishes a similar outcome to Alternative 2 without creating a situation where vessels with the same catch composition are defined as fishing for halibut in the CDQ fisheries and fishing for Pacific cod in the non-CDQ fisheries. Also, Alternative 2 would have increased monitoring and enforcement costs relative to this final rule.

Alternative 3 would have created a new type of LLP license specific to the small CDQ vessels in contrast to this final rule which provides an exemption to the LLP. However, Alternative 3 would not have resulted in a reduction in reporting, recordkeeping, and compliance costs in comparison to this final rule. Issuing a new CDQ LLP license would have required applications to NMFS and the issuance of a CDQ LLP license with certain conditions. Alternative 3 would have increased costs relative to this final rule.

This final rule contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA) which have been approved by the Office of Management and Budget (OMB) under control numbers 0648-0269, 0648-0318, and 0648-0334. The information collections are presented by OMB control number.

Public reporting burden for CDQ Vessel Registration to add or remove vessels online that are exempt from the LLP license requirements is estimated to average five minutes per individual response and five minutes for maintenance of the LLP exemption letter on board a vessel that is groundfish CDQ fishing.

The Groundfish/Halibut CDQ and Prohibited Species Quota (PSQ) Transfer Request is mentioned in this final rule, but no changes occur in the individual response for each requirement.

The Observer Declare and Deploy System is mentioned in this final rule, but the individual response for each requirement is not changed.

The individual response for each requirement of the LLP mentioned in this final rule is not changed.

These estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding these burden estimates or any other aspect of these collections, including suggestions for reducing the burden, to NMFS (see ADDRESSES), and by email to [email protected], or fax to 202-395-5806.

Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number. All currently approved NOAA collections of information may be viewed at: http://www.cio.noaa.gov/services_programs/prasubs.html.

For the reasons set out in the preamble, 50 CFR part 679 is amended as follows:

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

The second seasonal apportionment of the Pacific halibut bycatch allowance specified for the deep-water species fishery in the GOA is 256 metric tons as established by the final 2016 and 2017 harvest specifications for groundfish of the GOA (81 FR 14740, March 18, 2016), for the period 1200 hours, A.l.t., April 1, 2016, through 1200 hours, A.l.t., July 1, 2016.

In accordance with § 679.21(d)(6)(i), the Administrator, Alaska Region, NMFS, has determined that the second seasonal apportionment of the Pacific halibut bycatch allowance specified for the trawl deep-water species fishery in the GOA has been reached. Consequently, NMFS is prohibiting directed fishing for the deep-water species fishery by vessels using trawl gear in the GOA. The species and species groups that comprise the deep-water species fishery include sablefish, rockfish, deep-water flatfish, rex sole, and arrowtooth flounder. This closure does not apply to fishing by vessels participating in the cooperative fishery in the Rockfish Program for the Central GOA.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of the deep-water species fishery by vessels using trawl gear in the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of April 28, 2016.

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

This action is required by § 679.21 and is exempt from review under Executive Order 12866.