Federal Register Vol. 83, No.186,

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to remove AD 2017-14-03, Amendment 39-18947 (82 FR 34838, July 27, 2017) (AD 2017-14-03) and add a new AD. AD 2017-14-03 applied to Sikorsky Model S-92A helicopters and required inspecting and reducing the retirement lives of certain landing gear components. AD 2017-14-03 was prompted by Sikorsky's updated fatigue analysis of the nose and main landing gear, which revealed that certain components required a reduced service life and one component required a repetitive visual and ultrasonic inspection. When we issued AD 2017-14-03, we determined that the age of the existing U.S. fleet and the compliance time for the repetitive inspection would allow enough time for notice and public comments on some actions.

The NPRM published in the Federal Register on May 17, 2018 (83 FR 22883). The NPRM proposed to retain the actions in AD 2017-14-03, reduce the life limits of additional components, and require repeating the visual and ultrasonic inspections. These actions are intended to detect and prevent cracks or failure of a landing gear component, which could result in damage and loss of control of the helicopter.

We gave the public the opportunity to participate in developing this AD, but we did not receive any comments on the NPRM.

We have reviewed the relevant information and determined that an unsafe condition exists and is likely to exist or develop on other helicopters of this same type design and that air safety and the public interest require adopting the AD requirements as proposed.

We reviewed Ultrasonic Inspection Technique No. UT 5077, Revision 0, dated July 25, 2014 (UT 5077). UT 5077 contains the inspection method, equipment and materials, calibration, and inspection procedure for performing an ultrasonic inspection of nose gear actuator fitting part number (P/N) 92209-01101-101.

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 also reviewed Sikorsky S-92 Helicopter Alert Service Bulletin 92-32-004, Basic Issue, dated January 30, 2015 (ASB). The ASB describes procedures for conducting a visual inspection of the nose landing gear (NLG) airframe fitting assembly and an ultrasonic inspection by following the procedures in UT 5077.

We estimate that this AD affects 80 helicopters of U.S. Registry.

We estimate that operators may incur the following costs in order to comply with this AD. At an average labor rate of $85 per work-hour:

• Replacing a wheel axle P/N 2392-2334-001 requires 2 work-hours and required parts cost $22,000, for a cost per helicopter of $22,170.

• Replacing a main landing gear (MLG) or NLG threaded hinge pin P/N 2392-2311-003 requires 1 work-hour and required parts cost $3,800, for a cost per helicopter of $3,885.

• Replacing a NLG cylinder P/N 2392-4006-005 requires 1 work-hour and required parts cost $27,200, for a cost per helicopter of $27,285.

• Replacing a NLG hinge pin P/N 2392-4312-003 requires 1 work-hour and required parts cost $4,400, for a cost per helicopter of $4,485.

• Replacing a landing gear actuator rod end P/N 2392-0876-901 requires 1 work-hour and required parts cost $900, for a cost per helicopter of $985.

• Replacing a MLG cylinder P/N 2392-2006-005 requires 2 work-hours and required parts cost $33,100, for a cost per helicopter of $33,270.

• Replacing a MLG pin outboard P/N 2392-2312-003 requires 1 work-hour and required parts cost $4,300, for a cost per helicopter of $4,385.

• Replacing a MLG bulkhead left-hand side P/N 92201-08111-105, -107, and -109 requires 70 work-hours and required parts cost $12,550, for a cost per helicopter of $18,500.

• Replacing a MLG bulkhead right-hand side P/N 92201-08111-106, -108, and -110 requires 70 work-hours and required parts cost $12,550, for a cost per helicopter of $18,500.

• Inspecting the NLG airframe fitting assembly P/N 92209-01101-041 requires 8 work-hours, and required parts cost is minimal, for a cost of $680 per helicopter and $54,400 for the U.S. fleet, per inspection cycle.

• If required, replacing a NLG actuator fitting P/N 92209-01101-101 requires 70 work-hours, and required parts cost $10,000, for a cost per helicopter of $15,950.

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 have 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 DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska to the extent that a regulatory distinction is required, 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 supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Viking Air Limited Models DHC-2 Mk. I, DHC-2 Mk. II, and DHC-2 Mk. III airplanes. The SNPRM published in the Federal Register on May 7, 2018 (83 FR 19983). We preceded the SNPRM with a notice of proposed rulemaking (NPRM) that published in the Federal Register on September 8, 2017 (82 FR 42489). The NPRM proposed to require inspecting the wing rear spar and flap/aileron support brackets within 400 hours time-in-service (TIS) and reporting the results to the manufacturer. The NPRM was based on mandatory continuing airworthiness information (MCAI) originated by Transport Canada, the aviation authority for Canada. The MCAI states:

The MCAI requires inspecting the left-hand and right-hand wing rear spar and the flap/aileron hinge air support brackets for cracks, damage, or discrepancies and repairing or replacing any parts with cracks, damage, or discrepancies. The MCAI can be found in the AD docket on the internet at https://www.regulations.gov/document?D=FAA-2017-0867-0002.

The SNPRM proposed to revise the compliance times to require the inspections within 400 hours TIS or 6 months, whichever occurs first, to match the compliance times in the MCAI.

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

We reviewed the relevant data, considered the comment received, 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:

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

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

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

Viking Air Limited has issued Viking DHC-2 Beaver Service Bulletin Number: V2/0009, Revision A, dated February 10, 2017. The service information describes procedures for inspecting the left-hand and right-hand wing rear spars, the flap/aileron hinge brackets, and the exterior store support bracket for cracks, damage, and discrepancies. The service information also specifies repairing or replacing any parts that have cracks, damage, or discrepancies. 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 consider this AD interim action. The inspection report required by this AD allows us to obtain better information into the nature, cause, and extent of the damage to the wing rear spars and flap/aileron hinge arm support brackets and to develop final action to address the unsafe condition. After evaluating the inspection results, we may consider further rulemaking.

We estimate that this AD will affect 140 products of U.S. registry. We also estimate that it will take about 11 work-hours per product to comply with the basic inspection requirements of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the basic cost of this AD on U.S. operators to be $130,900, or $935 per product.

Reporting the inspection findings would require about 5 minutes, for a cost of $7 per airplane and $980 for the U.S. operator fleet.

In addition, the following is an estimate of possible necessary follow-on replacement actions. We have no way of determining the number of products that may need these actions.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, completing and reviewing the collection of information. All responses to this collection of information are mandatory. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.

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 is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes, gliders, balloons, airships, domestic business jet transport airplanes, and associated appliances to the Director of the Policy and Innovation Division.

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, 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 by searching for and locating Docket No. FAA-2017-0867; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the SNPRM, the regulatory evaluation, any comments received, and other information. The street address for Docket Operations (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Discussion

On May 17, 2018, at 83 FR 22886, the Federal Register published our notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR part 39 by adding an AD that would apply to Airbus Helicopters Model AS355E, AS355F, AS355F1, AS355F2, and AS355N helicopters. The NPRM proposed to require measuring the T/R drive vibration level without balancing, cleaning the fan, and repeating the vibration level measurement. If the difference between the two amplitude values is greater than 0.75 inch per second (ips), the NPRM proposed to require replacing each T/R fan bearing. The proposed requirements were intended to prevent degradation of the main gearbox (MGB) oil cooler fan bearing (bearing), which could result in loss of MGB and engine oil cooling function, loss of the rear transmission, and subsequent loss of control of the helicopter.

The NPRM was prompted by AD No. 2017-0159, dated August 25, 2017, issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for Airbus Helicopters Model AS355E, AS355F, AS355F1, AS355F2, and AS355N helicopters. EASA advises of two occurrences on Model AS355 military helicopters in which the MGB bearing installed on the T/R drive shaft experienced significant degradation. EASA states that while investigation has not determined the cause of the failures, this condition may also occur on other Model AS355 helicopters due to design commonality. According to EASA, this condition, if not detected and corrected, could result in loss of MGB and engine oil cooling function, loss of the rear transmission, and subsequent loss of control of the helicopter. To address this unsafe condition and as an interim measure, the EASA AD requires two vibration level measurements of the forward portion of the tail rotor drive line, one before and one after cleaning the MGB oil cooler fan, and replacing the bearings if excessive level or level trends are detected. The EASA AD also specifies that after the effective date of the AD, only those MGB oil cooler fan assembly bearings that are new or that have passed the vibration level measurements may be installed.

We gave the public the opportunity to participate in developing this AD, but we did not receive any comments on the NPRM.

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

We consider this AD to be an interim action. The manufacturer is currently developing a terminating action for the unsafe condition described in this AD. If a terminating action is identified, we may consider further rulemaking then.

Airbus Helicopters has issued Alert Service Bulletin No. AS355-05.00.77, Revision 0, dated July 3, 2017, which contains procedures for checking the condition of the fan assembly bearings by measuring the vibration levels of the first section of the T/R drive.

We estimate that this AD affects 104 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD.

At an average labor rate of $85 per work-hour, measuring the vibration levels requires about 5 work-hours, for a cost of $425 per helicopter and $44,200 for the U.S. fleet. If required, replacing both fan assembly bearings requires about 8 work-hours, and required parts cost $1,064, for a cost of $1,744 per helicopter.

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 helicopters identified in this rulemaking action.

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

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

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

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

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

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

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

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

This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

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. 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. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary.

This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

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. 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. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

Section 1301.63(a) currently states that Executive Order 13526 requires that each agency that originates or handles classified information designate a senior agency official to direct and administer its information security program. TVA's senior agency official is currently the Director, Enterprise Information Security & Policy. TVA is revising § 1301.63(a) to align with organizational and personnel changes within the agency.

Section 1301.67(c) currently states that requests shall be in writing, and shall be sent to: Director, Enterprise Information Security & Policy, Tennessee Valley Authority, 1101 Market St., Chattanooga, TN 37402. TVA is revising § 1301.67(c) to align with organizational and personnel changes within the agency.

TVA considers this rule to be a procedural rule which is exempt from notice and comment under 5 U.S.C. 533(b)(3)(A). This rule is not a significant rule for purposes of Executive Order 13526 and has not been reviewed by the Office of Management and Budget. As required by the Regulatory Flexibility Act, TVA certifies that these regulatory amendments will not have a significant impact on small business entities. Since this rule in non-substantive, it is being made effective September 25, 2018.

For the reasons stated in the preamble, TVA amends 18 CFR part 1301 as follows:

I. Introduction

In a document published in the Federal Register of May 31, 2017 (82 FR 24912), we announced that we filed a color additive petition (CAP 7C0311) submitted by Glo Eyes, LLC (petitioner), 5501 Highway 199, suite 202, Fort Worth, TX 76114. The petition proposed to amend the color additive regulations in 21 CFR part 74, Listing of Color Additives Subject to Certification by expanding the permitted uses of D&C Yellow No. 8 (principally the disodium salt of fluorescein) to include use in coloring contact lens solution at a level not to exceed 0.044 percent in the contact lens solution. Because the colored contact lens solution is intended for coloring disposable daily-wear hydrogel-based soft (hydrophilic) contact lenses and because D&C Yellow No. 8 in these colored contact lenses will come into direct contact with the user's eyes for a significant amount of time, this color additive is subject to section 721 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379e).

D&C Yellow No. 8 is currently approved under § 74.1708 (21 CFR 74.1708) for coloring externally applied drugs in amounts consistent with good manufacturing practice (GMP). D&C Yellow No. 8 is also approved under § 74.2708 (21 CFR 74.2708) for coloring externally applied cosmetics in amounts consistent with GMP. The regulations for D&C Yellow No. 8 require that all batches of the color additive be certified in accordance with regulations in part 80.

D&C Yellow No. 8 (CAS 518-47-8) is principally the disodium salt of fluorescein. In the subject petition, D&C Yellow No. 8 is proposed for use as a color additive in contact lens solution intended for soaking disposable daily-wear hydrogel-based soft (hydrophilic) contact lenses for up to 12 hours. The treated lenses are to be used one time and then discarded. The treated contact lenses, when exposed to ultraviolet light, fluoresce a yellow-green color for cosmetic purposes. The treated color contact lenses are expected to be used for limited, celebratory, and special occasions, and not every day. The maximum intended use level of D&C Yellow No. 8 in the contact lens solution is 0.044 percent. The contact lens solution colored with D&C Yellow No. 8 is intended for distribution by prescription only and for use in accordance with the directions supplied. Based on data and information provided in the petition on the identity, properties, manufacturing process, and composition of the color additive, we have determined that the color additive meets the specifications for D&C Yellow No. 8 in § 74.1708 (Ref. 1).

Under section 721(b)(4) of the FD&C Act (21 U.S.C. 379e(b)(4)), a color additive may not be listed for a particular use unless the data and information available to FDA establish that the color additive is safe for that use. Our color additive regulations at § 70.3(i) (21 CFR 70.3(i)) define “safe” to mean that there is convincing evidence establishing with reasonable certainty that no harm will result from the intended use of the color additive.

As part of our safety evaluation of the color additive, we considered the projected human exposure to D&C Yellow No. 8 and any impurities resulting from the petitioned use of the color additive. We also considered results from ocular irritation, skin sensitization, oral mucosal irritation, acute systemic toxicity, and cytotoxicity studies that tested extracts from contact lenses soaked in contact lens solution colored with D&C Yellow No. 8.

During our safety assessment of the use of D&C Yellow No. 8 in contact lens solution, we considered the estimated exposure to D&C Yellow No. 8 that would result from the petitioned use in amounts not to exceed 0.044 percent in contact lens solution. The petitioner determined that the theoretical maximum amount of D&C Yellow No. 8 that could be absorbed by, and potentially extracted from, a contact lens is 17 micrograms per lens (µg/lens). The petitioner considers 17 µg/lens or 34 µg/person/day (p/d) (for two lenses) to be a conservative estimate of the exposure to the color additive under the proposed use conditions (Ref. 1). FDA agrees with the petitioner's estimate. We note that the estimated exposure (17 µg/lens or 34 µg/p/d) represents a theoretical maximum amount of the color additive per use and is based on the worst-case assumption that all the water in the hydrogel-based soft contact lens is displaced by the colored contact lens solution. However, this exposure estimate is not an estimate of chronic daily exposure since the treated contact lenses are for occasional wear and not for everyday use. Furthermore, the actual exposure to D&C Yellow No. 8 from the petitioned use is expected to be lower than 17 µg/lens or 34 µg/p/d based on the amount of color additive extracted from the contact lenses soaked in the colored contact lens solution as indicated in the instructions for use (Ref. 1).

To establish that D&C Yellow No. 8 is safe for use in a contact lens solution intended for soaking disposable daily-wear hydrogel-based soft (hydrophilic) contact lenses, the petitioner submitted toxicity studies including an ocular irritation test in rabbits, a Guinea pig maximization sensitization test, an oral mucosal irritation study in hamsters, an acute systemic toxicity test in mice, and a cytotoxicity test that tested extracts from representative contact lenses soaked in contact lens solution colored with D&C Yellow No. 8. The results of these studies indicate that the color additive is not an irritant to the skin, eyes or oral mucosa, is not a sensitizer, is not cytotoxic, and shows no systemic toxicity (Ref. 2). Therefore, we conclude that the available toxicology data are sufficient to support the safety of the proposed expanded safe use of D&C Yellow No. 8.

Based on the data and information in the petition and other available relevant information, we conclude that the petitioned use of D&C Yellow No. 8 for coloring contact lens solution intended for soaking disposable daily-wear hydrogel-based soft (hydrophilic) contact lenses is safe. We further conclude that this color additive will achieve its intended technical effect and is suitable for the petitioned use. Consequently, we are amending the color additive regulations in 21 CFR part 74 as set forth in this document. We also conclude that batch certification of D&C Yellow No. 8 continues to be necessary to protect the public health.

In accordance with §  71.15(a) (21 CFR 71.15(a)), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see ADDRESSES). As provided in §  71.15(b), we will delete from the documents any materials that are not available for public disclosure.

We previously considered the environmental effects of this rule, as stated in the May 31, 2017, Federal Register notice of filing for CAP 7C0311 (82 FR 24912). We stated that we had determined, under 21 CFR 25.32(l), that this action “is of a type that does not individually or cumulatively have a significant effect on the human environment” such that neither an environmental assessment nor an environmental impact statement is required. We have not received any new information or comments that would affect our previous determination.

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

This rule is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file electronic objections to this docket at https://www.regulations.gov, or written objections with the Dockets Management Staff (see ADDRESSES). You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.

Any objections received in response to the regulation may be seen in the Dockets Management Staff office between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register.

The following references are on display with the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of the Food and Drugs, 21 CFR part 74 is amended as follows:

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Sector New Orleans DHS Department of Homeland Security FR Federal Register MM Mile marker NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

The Coast Guard was notified that Zito Company, LLC would be conducting a fireworks display from 9 p.m. through 10 p.m. on October 6, 2018. The fireworks are to be launched from a barge on the Lower Mississippi River at approximate mile marker (MM) 94.5, above Head of Passes, off Algiers Point, New Orleans, LA. Hazards from firework displays include discharge of fireworks, dangerous projectiles, and falling hot embers or other debris. The Captain of the Port Sector New Orleans (COTP) has determined that potential hazards associated with the fireworks display will be a safety concern for anyone within a one-mile stretch of the river.

In response, on July 19, 2018, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Lower Mississippi River, Mile Markers 94 to 95 Above Head of Passes, New Orleans, LA (83 FR 34092). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this fireworks display. During the comment period that ended August 20, 2018 we received no comments.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be contrary to the public interest because immediate action is needed to respond to the potential safety hazards associated with the fireworks display.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Sector New Orleans (COTP) is establishing a temporary safety zone from 9 p.m. through 10 p.m. on October 6, 2018. The safety zone covers all navigable waters of the Lower Mississippi River between MM 94 and MM 95, above Head of Passes. The duration of the zone is intended to ensure the safety of persons, vessels, and the marine environment on these navigable waters before, during, and after the scheduled fireworks display.

As noted above, we received no comments on our NPRM published on July 19, 2018. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule establishes a safety zone from 9 p.m. to 10 p.m. on October 6, 2018. The safety zone covers all navigable waters of the Lower Mississippi River between MM 94 and MM 95, above Head of Passes. The duration of the zone is intended to ensure the safety of persons, vessels, and the marine environment on these navigable waters before, during, and after the scheduled fireworks display.

No vessel or person is permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector New Orleans. Vessels requiring entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM Channel 16 or 67. Persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative. The COTP or a designated representative would inform the public of the enforcement times and date for this safety zone through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Broadcasts (MSIBs) as appropriate.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders and we discuss First Amendment rights of protestors.

Executive Orders 13563 (“Improving Regulation and Regulatory Review”) and 12866 (“Regulatory Planning and Review”) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”) directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”

The Office of Management and Budget (OMB) has not designated this rule a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it. As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See OMB's Memorandum “Guidance Implementing Executive Order 13771, Titled `Reducing Regulation and Controlling Regulatory Costs' ” (April 5, 2017).This regulatory action determination is based on the size and short duration of the safety zone, which would impact a one-mile stretch of the Lower Mississippi River for one hour on one evening. In addition, vessel traffic seeking to transit the area may seek permission from the COTP or a designated representative to do so.

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 received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities.

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

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule 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 would 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 Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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.

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a determination 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 a safety zone lasting one hour that would prohibit entry on one-mile stretch of the Lower Mississippi River. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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 amends 33 CFR part 165 as follows:

Pea Ridge National Military Park (the park), established in 1956 and opened to the public in 1963, preserves and commemorates the site of the March 1862 Civil War battle that helped Union forces maintain physical and political control of the State of Missouri. Administered by the National Park Service (NPS), the 4,300-acre battlefield is situated in the foothills of the Ozark Mountains 10 miles north of Rogers, Arkansas, just off of U.S. Highway 62. The park is divided into two sections: The main portion of the park is located north of U.S. Highway 62 and encompasses a majority of the historic battleground. The main portion consists of a dedicated series of soft surface trails for equestrians and pedestrians, as well as the tour road, which bicyclists share with vehicle users. The second, smaller portion is located to the south of U.S. Highway 62 along the bluffs of Little Sugar Creek and contains the Federal Trenches of the Union troops. This non-contiguous section is currently accessible from a small parking lot along Sugar Creek Road, which intersects with US Highway 62, with a trail leading to the trenches.

The park contains a portion of the northern route of the Trail of Tears that is one of the few places the Trail of Tears passes through Arkansas. Eleven Cherokee Removal contingents used this route from 1837 to 1839. Through the park, the Trail of Tears generally followed the route of Telegraph Road, which is eligible for the National Register of Historic Places.

The park contains an existing road and trail system (including the Federal Trenches trail) that provides pedestrians, hikers, bicyclists, and equestrians with interpretive and recreational opportunities. This system consists of a total of 32 miles of trail, including 7.6 miles of asphalt trail, 13.9 miles of off-road hiking trail, and 10.8 miles of horse trail. Bicycles are allowed on roads but not on trails within the park.

The area surrounding the park—including local communities such as Pea Ridge, Garfield, Bentonville, Rogers, Springdale, and Fayetteville—has experienced dynamic population growth in recent years. Increased visitation to the park has created a need to improve the existing road and trail system to better accommodate travel through the park by various methods (e.g., automobile, pedestrian, equestrian, bicycle). In addition to enhancing interpretive and recreational opportunities, an improved road and trail system will generate operational efficiencies. There are opportunities to combine trails or locate trails adjacent to other trail types or facilities (e.g., water, restrooms, phones) to maximize the efficiency of performing park maintenance. By removing duplicative trails and infrastructure, the NPS can reduce overall maintenance costs.

In November 2017, the NPS published the Pea Ridge National Military Park Trail Master Plan/Environmental Assessment (EA). The EA evaluates two action alternatives that are designed to improve visitor access to the park's historical and interpretive sites while avoiding or minimizing impacts to these sites by consolidating and restructuring the existing trail network. These alternatives also seek to improve multi-modal trail connections within the park while linking to a regional trail network outside of the park. Under both action alternatives, the NPS would expand and enhance opportunities for pedestrian trail interpretation, construct additional trailheads, modify trail loops for simplicity and interpretive value, construct additional ADA-accessible trails, install signage for the Trail of Tears, improve multi-use trails, and improve equestrian trails to avoid erosion-prone areas. These actions will meet the increasing recreational needs of the area while protecting the cultural and natural resources within the park.

The EA identifies one of the action alternatives as the NPS preferred alternative. This alternative would allow bicycle use on two multi-use trails that would require trail construction activities. The first would be a 0.55-mile trail from U.S. Highway 62 to the visitor center. The second would be a 1.17-mile trail from Arkansas Highway 72 to the Sugar Creek Greenway on the western edge of the park. Bicycles would also be allowed on Ford Road, which is closed to motor vehicle use by the public, but open to motor vehicle use for administrative purposes. Bicycles would also be allowed on segments of the Tour Road, which is paved and open to motor vehicle use by the public.

With respect to the bike trails, the EA evaluates (i) the suitability of the trails for bicycle use; and (ii) life cycle maintenance costs, safety considerations, methods to prevent or minimize user conflict, and methods to protect natural and cultural resources and mitigate impacts associated with bicycle use on the trails. After a public review period, the Regional Director of the Midwest Region signed a Finding of No Significant Impact (FONSI) in June 2018 that identified the preferred alternative (Alternative 3) in the EA as the selected action. At the same time, the Regional Director signed a written determination that bicycle use on the two trails is consistent with the protection of the park area's natural, scenic, and aesthetic values; safety considerations and management objectives; and will not disturb wildlife or park resources.

The EA, FONSI and written determination, which contain a full description of the purpose and need for taking action, scoping, the alternatives considered, maps, and the environmental impacts associated with the project, may be viewed on the park's planning website at http://parkplanning.nps.gov/peri, by clicking on the link entitled “Trail Master Plan/Environmental Assessment” and then clicking on the link entitled “Document List.”

This rule implements the selected action in the FONSI and authorizes the Superintendent to designate bicycle use on the two trails described above. In order to accommodate bicycles, both trails will require construction activities that will be conducted in accordance with sustainable trail design principles and guidelines. NPS regulations at 36 CFR 4.30 require a special rule to designate these trails for bicycles use because they are located outside of developed areas. Bicycle use will not be authorized by the Superintendent until the trail construction activities are completed.

The rule adds a new section 7.95 to 36 CFR part 7—Special Regulations, Areas of the National Park System for the park. The rule requires the Superintendent to notify the public of trail designation for bicycle use and identify the designation on maps available in the office of the Superintendent and other places convenient to the public. The rule authorizes the Superintendent to establish closures, conditions, or restrictions for bicycle use on designated trails in accordance with 36 CFR 4.30. After notifying the public, the Superintendent may take these actions for reasons of public health and safety, natural and cultural resource protection, and other management activities and objectives.

The NPS published a proposed rule in the Federal Register on March 13, 2018 (83 FR 11650). The NPS accepted comments on the proposed rule through the mail, hand delivery, and through the Federal eRulemaking Portal at www.regulations.gov. Comments were accepted through May 15, 2018. A summary of the pertinent issues raised in the comments and NPS responses are provided below. After considering the public comments and after additional review, the NPS did not make any changes to the rule.

1. Comment: One commenter suggested that the trails should be experienced in ways—such as hiking and walking—that are less destructive to the environment and more conducive to their short length.

NPS Response: The NPS determined in the FONSI that bicycle use on the trails will not have a significant impact on the environment. A more detailed discussion of the environmental impacts of bicycle use on these trails can be found in the EA, FONSI, and written determination. With respect to the length of the trails, the segments of trail within the park will connect to the regional trail network identified in the Northwest Arkansas Regional Bicycle and Pedestrian Master Plan. The length of the larger network of trails is conducive to bicycling, as are the segments within the park that the NPS expects will be used by bicyclists as a new way of experiencing the historical and cultural resources within the park. The rolling topography of the park will lengthen the amount of time it will take a visitor to travel by bicycle, making the trails more conducive to this form of transportation.

2. Comment: One commenter asked the NPS to provide evidence for the statement in the proposed rule that population growth in the areas surrounding the park support the need for providing increased recreational opportunities such as bicycling.

NPS Response: U.S. Census Bureau data from 2016 show that the Northwest Arkansas metro area accounted for most of the state's population growth in the previous five years. The Northwest Arkansas Council's recent analysis of new U.S. Census Bureau population estimates indicate the region will be listed in the Top 100 largest metropolitan areas by 2019. More information can be found online at http://www.nwacouncil.org/news/2018/3/22/analysis-northwest-bentonville-fayetteville-arkansas-census-top-100-population.

3. Comment: One commenter requested more information about the construction activities that the NPS will undertake to accommodate bicycles on the trails. In particular, the commenter raised concerns about impacts to soil in erosion-prone areas. This commenter also asked for more information about the sustainable trail design principles and guidelines that will govern the construction activities.

NPS Response: The trail alignments identified in the EA primarily use established road beds that have suitable soil compaction for bicycle use. The selected action includes the removal of redundant trail alignments and relocation of existing pedestrian and equestrian trails that are currently experiencing extensive erosion in order to minimize impacts to natural and cultural resources. The EA identifies applicable mitigation measures to minimize impacts caused by construction activities. Section 9.2.2 of NPS Management Policies (2006) requires that all trails be carefully situated, designed and managed to protect park resources. The NPS will design and construct the trails to avoid or minimize disturbance to sensitive resources and will incorporate design techniques to reduce the likelihood and presence of social trailing.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.

Executive Order 13563 reaffirms the principles of Executive Order 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. Executive Order 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. The NPS has developed this rule in a manner consistent with these requirements.

Enabling regulations are considered deregulatory under guidance implementing E.O. 13771 (M-17-21). This rule authorizes the Superintendent to allow a recreational activity for the public to enjoy and experience certain areas within the National Park System that would otherwise be prohibited.

This rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). This certification is based on information contained in the economic analyses found in the report entitled “Benefit-Cost and Regulatory Flexibility Threshold Analyses: Bicycle Trails at Pea Ridge National Military Park” which is available on www.regulations.gov in Docket ID: NPS-2018-0004.

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

(a) Does not have an annual effect on the economy of $100 million or more.

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

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

This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local or tribal governments or the private sector. It addresses public use of national park lands, and imposes no requirements on other agencies or governments. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq.) is not required.

This rule does not effect a taking of private property or otherwise have takings implications under Executive Order 12630. A takings implication assessment is not required.

Under the criteria in section 1 of Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism summary impact statement. This rule only affects use of federally-administered lands and waters. It has no outside effects on other areas. A Federalism summary impact statement is not required.

This rule complies with the requirements of Executive Order 12988. This rule:

(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and

(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

The Department of the Interior strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and tribal sovereignty. The NPS has evaluated this rule under the criteria in Executive Order 13175 and under the Department's tribal consultation policy and has determined that tribal consultation is not required because the rule will have no substantial direct effect on federally recognized Indian tribes.

Nevertheless, the NPS recognizes that the park contains significant archeological sites and the Trail of Tears, which are considered very important to the following tribes: Absentee Shawnee Tribe, Cherokee Nation of Oklahoma, Jena Band of the Choctaw Indians, The Osage Nation, Shawnee Tribe of Oklahoma, Quapaw Tribe of Oklahoma, United Keetoowah Band of Cherokee Indians, The Chickasaw Nation, Caddo Nation, and the Muscogee (Creek) Nation. The park consulted with these tribes throughout the development of the EA and incorporated comments by adjusting trails to mitigate or avoid impacts to these areas of interest.

This rule does not contain information collection requirements, and a submission to the Office of Management and Budget under the Paperwork Reduction Act is not required. The NPS may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 is not required because the NPS reached a Finding of No Significant Impact. A copy of the EA and FONSI can be found online at http://parkplanning.nps.gov/peri, by clicking on the link entitled “Trail Master Plan/Environmental Assessment” and then clicking on the link entitled “Document List.”

This rule is not a significant energy action under the definition in Executive Order 13211. A Statement of Energy Effects in not required.

In consideration of the foregoing, the National Park Service amends 36 CFR part 7 as set forth below:

Title 38, United States Code, section 1710(b)(2) authorizes VA to provide needed domiciliary care to veterans whose annual income does not exceed the applicable maximum annual rate of VA pension and to veterans who have no adequate means of support. Prior to the proposed changes to the definition “domiciliary care” was defined at 38 CFR 17.30(b) as the furnishing of a home to a veteran, embracing the furnishing of shelter, food, clothing and other comforts of home, including necessary medical services, as well as travel and incidental expenses pursuant to 38 CFR 70.10. Veterans eligible for domiciliary care include only: Those whose annual income does not exceed the maximum annual rate of pension payable to a veteran in need of regular aid and attendance; or those who have no adequate means of support, as this phrase is defined in 38 CFR 17.47(b)(2), who can perform the activities specified in 38 CFR 17.46(b) but who suffer from a chronic disability, disease, or defect that results in the veteran being unable to earn a living for a prospective period. See 38 CFR 17.47(b)(2) and (c).

The domiciliary program is authorized to provide eligible veterans with a home and coordinated ambulatory medical care as needed. Typically, domiciliaries are co-located with VA medical centers or exist as designated bed-settings within the centers.

While the above-referenced statutory definitions and eligibility criteria still apply as do the regulatory criteria of §§ 17.46(b) and 17.47(b)(2), the scope of services furnished under the program has evolved significantly, requiring revision of §§ 17.30(b) and 17.47(c). We proposed to amend the definition of domiciliary care to reflect that change.

The scope of clinical services available to VA domiciliary residents has necessarily become specialized over time due to the characteristics of the patient populations served by the residential rehabilitation treatment model. In 2005, VA's supervision of domiciliary care facilities was moved from the Office of Geriatrics and Extended Care to the Office of Mental Health Services. In 2010, VA merged domiciliary care facilities and RRTPs (which began in 1995) into one system of residential care under the MH RRTP designation to fully integrate mental health residential rehabilitation and treatment and domiciliary care. MH RRTPs provide comprehensive supervised treatment and rehabilitative services to veterans with mental health or substance use disorders, and coexisting medical or psychosocial needs such as homelessness and unemployment. MH RRTPs identify and address goals of rehabilitation, recovery, health maintenance, improved quality of life, and community integration in addition to specific treatment of medical conditions, mental illnesses, addictive disorders, and homelessness. These services are intended to restore, to the maximum extent possible, the physical, mental, and psychological functioning of veterans receiving residential rehabilitation treatment. VA domiciliaries are used currently for VA's Domiciliary Residential Rehabilitation Treatment Programs; Domiciliary Care for Homeless Veterans Program, Health Maintenance Domiciliary beds program; General Domiciliary or Psychosocial Residential Rehabilitation Treatment Program; Domiciliary Substance Abuse programs; and Domiciliary Post-Traumatic Stress Disorder (PTSD) programs.

On April 6, 2018, we proposed amending the definition of domiciliary care in § 17.30(b) to also include MH RRTP. (83 FR 14804). We also proposed clarifying in both §§ 17.30(b) and 17.47(c) that domiciliary care provides a temporary home, not permanent. This clarification is consistent with VA's long-standing practice of providing domiciliary care as a non-permanent living arrangement for eligible veterans.

We provided a 60-day period in which the public had the opportunity to submit comments on the proposed rule. The comment period ended on June 5, 2018, and we received 4 comments, all of which were generally supportive of the proposed changes. One commenter stated that he supported the effort to provide clear and concise rules regarding the scope of domiciliary care. Another commenter stated that providing domiciliary care consistent with the proposed rule supports the services that homeless veterans need such as mental health, counseling, and substance treatment while providing a chance to implement change in their life and creating realistic timelines to facilitate progress.

We appreciate the comments and believe that the MH RRTP provides important and necessary support to those veterans requiring such services. We make no changes based on public comments.

Based on the rationale set forth in the proposed rule and in this document, VA adopts the proposed rule as final, with no changes.

Title 38 of the Code of Federal Regulations, as revised by this final rulemaking, represents VA's implementation of its legal authority on this subject. Other than future amendments to this regulation or governing statutes, no contrary guidance or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible or, if not possible, such guidance is superseded by this rulemaking.

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

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule directly affects only individuals and will not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” which requires review by the Office of Management and Budget (OMB), as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.” VA has examined the economic, interagency, budgetary, legal, and policy implications of this regulatory action and determined that the action is not a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's website at http://www.va.gov/orpm by following the link for VA Regulations Published from FY 2004 through FYTD. This rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.

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

The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.005—Grants to States for Construction of State Home Facilities; 64.008—Veterans Domiciliary Care; 64.011—Veterans Dental Care; 64.012—Veterans Prescription Service; 64.013—Veterans Prosthetic Appliances; 64.014—Veterans State Domiciliary Care; 64.015—Veterans State Nursing Home Care; 64.024—VA Homeless Providers Grant and Per Diem Program; 64.026—Veterans State Adult Day Health Care; 64.033—VA Supportive Services for Veteran Families Program; 64.035—Veterans Transportation Program; 64.040—VHA Inpatient Medicine; 64.041—VHA Outpatient Specialty Care; 64.042—VHA Inpatient Surgery; 64.043—VHA Mental Health Residential; 64.044—VHA Home Care; 64.045—VHA Outpatient Ancillary Services; 64.046—VHA Inpatient Psychiatry; 64.047—VHA Primary Care; 64.048—VHA Mental Health clinics; 64.049—VHA Community Living Center; 64.050—VHA Diagnostic Care; 64.054—Research and Development.

The Secretary of Veterans Affairs approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Wilkie, Secretary, Department of Veterans Affairs, approved this document on September 19, 2018, for publication.

For the reasons stated in the preamble, Department of Veterans Affairs amends 38 CFR part 17 as follows:

I. Background

On November 17, 2017, DAQ submitted a SIP revision seeking to remove 26 counties from the expanded I/M program contained in the North Carolina SIP. This removal consequently removes reliance on the I/M reduction credits gained from the 26 counties' participation in the expanded I/M program from the State's NOX emissions budget—a component of the State's response to the NOX SIP Call. North Carolina indicated that it no longer needs these reduction credits in order to meet its obligations under the NOX SIP Call. In addition, North Carolina provided a technical demonstration showing that removing the 26 counties from the expanded I/M program will not interfere with North Carolina's attainment or maintenance of any National Ambient Air Quality Standard (NAAQS) or with any other applicable requirement of the CAA.

The EPA published a proposed rulemaking on July 26, 2018 (83 FR 35444), proposing to approve this SIP revision. The proposed approval was based on the EPA's proposed findings that the removal of the 26 counties from the State's expanded I/M program will not interfere with North Carolina's obligations under the NOX SIP Call and will not interfere with North Carolina's attainment or maintenance of any NAAQS or with any other applicable requirement of the CAA. The details of North Carolina's submittal and the rationale for the EPA's action are explained in the proposed rulemaking. The comment period for this proposed rulemaking closed on August 27, 2018. The EPA received two comments supporting the proposed action. The remaining comments received were not relevant.

The EPA is taking final action to approve the November 17, 2017, revision to the North Carolina SIP. Specifically, the EPA is approving the removal of Brunswick, Burke, Caldwell, Carteret, Catawba, Chatham, Cleveland, Craven, Edgecombe, Granville, Harnett, Haywood, Henderson, Lenoir, Moore, Nash, Orange, Pitt, Robeson, Rutherford, Stanly, Stokes, Surry, Wayne, Wilkes, and Wilson counties from the SIP-approved expanded I/M program. Additionally, the EPA is finding that North Carolina's removal of the 26 counties from the SIP-approved expanded I/M program (and the removal of reliance on the I/M emissions reductions generated from those counties as part of the “credits” in North Carolina's NOX emissions budget) will not interfere with the State's obligations under the NOX SIP Call to meet its Statewide NOX emissions budget. The EPA is also finding that the removal of the 26 counties from the SIP-approved I/M program will not interfere with continued attainment or maintenance of any applicable NAAQS or with any other applicable requirement of the CAA, and that North Carolina has satisfied the requirements of section 110(l) of the CAA.

The EPA has determined that this action is effective immediately upon publication under the authority of 5 U.S.C. 553(d)(1). The purpose of the 30-day waiting period prescribed in section 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Section 553(d)(1) allows an effective date less than 30 days after publication if a substantive rule “relieves a restriction.” This action qualifies for the exception under section 553(d)(1) because it relieves the 26 counties identified above from the requirements of North Carolina's SIP-approved expanded I/M program.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. This action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

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

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

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

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

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 26, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

Throughout this document, whenever “we,” “us,” or “our” is used, we mean the EPA.

This document is simply an announcement of a finding that we have already made. EPA Region 2 sent a letter to the New Jersey Department of Environmental Protection on August 16, 2018, stating that the 2017 motor vehicle emissions budgets (“budgets”) in the submitted state implementation plan (“SIP”) for the 2008 national ambient air quality standard for ozone for the New Jersey portions of the New York-Northern New Jersey-Long Island, NY-NJ-CT 8-hour ozone nonattainment area are adequate for transportation conformity purposes. These budgets are associated with the SIP's reasonable further progress milestone demonstration and must apply to future transportation conformity determinations conducted by the North Jersey Transportation Planning Authority (“NJTPA”).

On December 22, 2017, the New Jersey Department of Environmental Protection submitted a SIP revision for the New Jersey portion of the New York-Northern New Jersey-Long Island, NY-NJ-CT 2008 8-hour ozone nonattainment area. This revision to the SIP included 2017 summer day volatile organic compound (“VOC”) and nitrogen oxides (“NOX”) motor vehicle emissions budgets associated with the SIP's reasonable further progress demonstration. We announced availability of the plan and related budgets on the EPA's transportation conformity website on February 8, 2018, requesting comments by March 12, 2018. We received no comments in response to the adequacy review posting.

This finding will also be available at the EPA's conformity website: https://www.epa.gov/state-and-local-transportation/conformity-adequacy-review-region-2.

The motor vehicle emissions budgets are provided in Table 1 below.

Transportation conformity is required by Clean Air Act section 176(c). The EPA's conformity rule requires that long-range transportation plans, transportation improvement programs, and transportation projects conform to a state's air quality SIP and establishes the criteria and procedures for determining whether or not they conform. Conformity to a SIP means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the NAAQS.

The criteria the EPA uses to determine whether a SIP's motor vehicle emission budgets are adequate for conformity purposes are outlined in 40 CFR 93.118(e)(4). We have further described our process for determining the adequacy of submitted SIP budgets in 40 CFR 93.118(f), and we followed this rule in making our adequacy determination. Please note that an adequacy review is separate from the EPA's completeness review and should not be used to prejudge the EPA's ultimate action on the SIP. Even if we find a budget adequate, the SIP could later be disapproved.

Pursuant to 40 CFR 93.104(e), within 2 years of the effective date of this document, NJTPA and the U.S. Department of Transportation will need to demonstrate conformity to the new budgets. For demonstrating conformity to the budgets in this plan, the on-road motor vehicle emissions from implementation of the long-range transportation plan should be projected consistently with the budgets in this plan.

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On August 3, 2018 (83 FR 38102), the EPA published a Notice of Proposed Rulemaking (NPRM) for the State of New Hampshire. The NPRM proposed approval of New Hampshire's amended regulation for the New Hampshire motor vehicle inspection and maintenance (I/M) program. The formal SIP revision was submitted by New Hampshire on June 7, 2016. The rationale for the EPA's proposed action is explained in the NPRM and will not be restated here.

The EPA received one comment during the comment period, which discussed subjects outside the scope of this SIP action, does not explain (or provide a legal basis for) how the proposed action should differ in any way, and makes no specific mention of the proposed action. As such, the comment is not germane and does not require further response to finalize the action as proposed.

The EPA is approving New Hampshire's amended I/M regulation as a revision to the New Hampshire SIP.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the amended New Hampshire Code of Administrative Rules Chapter Saf-C 3200 entitled, “Official Motor Vehicle Inspection Requirements,” described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available through https://www.regulations.gov and at the EPA Region 1 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the State implementation plan, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.1

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• This action is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866;

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

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4);

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

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

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 26, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

I. Background

On December 14, 2012, EPA revised the primary Annual PM2.5 NAAQS to 12.0 micrograms per cubic meter (μg/m3). See 78 FR 3086 (January 15, 2013). An area meets the standard if the three-year average of its annual average PM2.5 concentration (at each monitoring site in the area) is less than or equal to 12.0 μg/m3. States were required to submit infrastructure SIP submissions for the 2012 Annual PM2.5 NAAQS to EPA no later than December 14, 2015.

CAA section 110(a)(1) requires states to submit SIP revisions within three years after promulgation of a new or revised NAAQS in order to provide for the implementation, maintenance, and enforcement of the new or revised NAAQS. CAA section 110(a)(2) outlines the applicable requirements of such SIP submissions, which EPA has historically referred to as “infrastructure SIP” submissions. Section 110(a)(2) requires states to address basic SIP elements such as monitoring, basic program requirements (e.g., permitting), and legal authority that are designed to assure attainment and maintenance of the newly established or revised NAAQS. Thus, section 110(a)(1) provides the procedural and timing requirements for infrastructure SIPs, and section 110(a)(2) lists specific elements that states must meet for the infrastructure SIP requirements related to a newly established or revised NAAQS. The contents of an infrastructure SIP submission may vary depending upon the data and analytical tools available to the state, as well as the provisions already contained in the state's implementation plan at the time in which the state develops and submits the submission for a new or revised NAAQS.

Section 110(a)(2)(D) has two subsections: 110(a)(2)(D)(i) and 110(a)(2)(D)(ii). Section 110(a)(2)(D)(i) includes four distinct components, commonly referred to as “prongs,” that must be addressed in infrastructure SIP submissions. The first two prongs, which are codified in section 110(a)(2)(D)(i)(I), require plans to prohibit any source or other type of emissions activity in one state from contributing significantly to nonattainment of the NAAQS in another state (prong 1) and from interfering with maintenance of the NAAQS in another state (prong 2). The third and fourth prongs, which are codified in section 110(a)(2)(D)(i)(II), are provisions that prohibit emissions activity in one state from interfering with measures required to prevent significant deterioration of air quality in another state (prong 3) or from interfering with measures to protect visibility in another state (prong 4). Section 110(a)(2)(D)(ii) requires SIPs to include provisions insuring compliance with sections 115 and 126 of the Act, relating to interstate and international pollution abatement.1

In a notice of proposed rulemaking (NPRM) published on August 9, 2018 (83 FR 39387), EPA proposed to approve the prong 1 and prong 2 portions of infrastructure SIP submissions transmitted under cover letter by: Alabama (dated December 9, 2015); Florida (dated December 14, 2015); Georgia (dated December 14, 2015); Kentucky (dated February 8, 2016); Mississippi (dated December 8, 2015); North Carolina (dated December 4, 2015); South Carolina (dated December 14, 2015); and Tennessee (dated December 16, 2015), as demonstrating that these states do not significantly contribute to nonattainment or interfere with maintenance of the 2012 Annual PM2.5 NAAQS in any other state.2 All other applicable infrastructure SIP requirements for these SIP submissions have been or will be addressed in separate rulemakings. The specific details of the SIP submissions and the rationale for EPA's actions on prongs 1 and 2 are discussed in the NPRM. Comments on the proposed rulemaking were due on or before August 30, 2018. EPA received three comments that are not relevant to the proposed actions and one comment in support of the proposed actions. These comments can be found in the docket for these actions.

EPA is taking final action to approve the portions of the infrastructure SIP submissions transmitted under cover letter by: Alabama (dated December 9, 2015); Florida (dated December 14, 2015); Georgia (dated December 14, 2015); Kentucky (dated February 8, 2016); Mississippi (dated December 8, 2015); North Carolina (dated December 4, 2015); South Carolina (dated December 14, 2015); and Tennessee (dated December 16, 2015) addressing prongs 1 and 2 of section 110(a)(2)(D)(i)(I) for the 2012 Annual PM2.5 NAAQS. EPA is taking final action to approve section 110(a)(2)(D)(i)(I) for the aforementioned infrastructure SIP submissions for the 2012 Annual PM2.5 NAAQS because the submissions are consistent with section 110 of the CAA.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. These actions merely approve state law as meeting Federal requirements and do not impose additional requirements beyond those imposed by state law. For that reason, these actions:

• Are not significant regulatory actions subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Are not Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory actions because SIP approvals are exempted under Executive Order 12866;

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

• Are certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Do not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

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

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

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

• Are not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Do not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The SIPs subject to these actions, with the exception of the South Carolina SIP, are not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law. With respect to the South Carolina SIP, EPA notes that the Catawba Indian Nation Reservation is located within South Carolina, and pursuant to the Catawba Indian Claims Settlement Act, S.C. Code Ann. 27-16-120, “all state and local environmental laws and regulations apply to the Catawba Indian Nation and Reservation and are fully enforceable by all relevant state and local agencies and authorities.” Thus, the South Carolina SIP applies to the Catawba Reservation; however, because the action related to South Carolina is not approving any specific rule into the South Carolina SIP, but rather finding that the State's already approved SIP meets certain CAA requirements, EPA has determined that there are no substantial direct effects on the Catawba Indian Nation. EPA has also determined that the action related to South Carolina's SIP will not impose any substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 26, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

The site to be deleted from the NPL is: Eureka Mills Superfund Site, Eureka, Utah. A Notice of Intent to Delete for this Site was published in the Federal Register (83 FR 38672-38675) on August 7, 2018.

The closing date for comments on the Notice of Intent to Delete was September 6, 2018. Two comments were received. One comment discusses air pollution and air monitoring in China and India. The other comment is about air travel. These comments are not germane to the proposed ruling. A responsiveness summary was prepared and placed in both the docket, EPA-HQ-SFUND-2002-0001, on www.regulations.gov, and in the local repositories listed above.

EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Deletion from the NPL does not preclude further remedial action. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system. Deletion of a site from the NPL does not affect responsible party liability in the unlikely event that future conditions warrant further actions.

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

The site to be deleted from the NPL is: Davis Timber Company Superfund Site (Site) located in Hattiesburg, Lamar County, Mississippi. A Notice of Intent to Delete for this Site was published in the Federal Register 83 FR 33182 on July 17, 2018.

The closing date for comments on the Notice of Intent to Delete was August 16, 2018. One public comment was received and it does not address the rule-making or deletion. Since the comment was not related to the deletion of this Site, EPA believes the deletion action is appropriate. A responsiveness summary was prepared and placed in both the docket, EPA-HQ-SFUND-2000-0003, on www.regulations.gov, and in the local repositories listed above.

EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Deletion from the NPL does not preclude further remedial action. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system. Deletion of a site from the NPL does not affect responsible party liability in the unlikely event that future conditions warrant further actions.

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

The site to be deleted from the NPL is: Reasor Chemical Company Site in Castle Hayne, North Carolina. A Notice of Intent to Delete for this Site was published in the Federal Register (83 FR 36844) on July 31, 2018.

The closing date for comments on the Notice of Intent to Delete was August 30, 2018. One public comment was received. EPA believes this is not a site-specific adverse comment opposing the rule-making. EPA believes it is still appropriate to delete the site, and will proceed with the deletion action. A responsiveness summary was prepared and placed in both the docket, EPA-HQ-SFUND-2002-0001, on www.regulations.gov, and in the local repositories listed above.

EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Deletion from the NPL does not preclude further remedial action. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system. Deletion of a site from the NPL does not affect responsible party liability in the unlikely event that future conditions warrant further actions.

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

Abbreviations and Terms AAR Association of American Railroads APA Administrative Procedure Act CFR Code of Federal Regulations CPC Casualty Prevention Circular DOT Department of Transportation DP system Distributive Power EA Environmental Assessment ECP Electronically Controlled Pneumatic EOT End-of-Train FAST Act Fixing America's Surface Transportation Act of 2015 FR Federal Register FRA Federal Railroad Administration GAO Government Accountability Office HHFT High-Hazard Flammable Train HHFUT High-Hazard Flammable Unit Train HMR Hazardous Materials Regulations HMT Hazardous Materials Table NEPA National Environmental Policy Act NPRM Notice of Proposed Rulemaking NPV Net Present Value NTSB National Transportation Safety Board OMB Office of Management and Budget PG Packing Group PV Present Value PHMSA Pipeline and Hazardous Materials Safety Administration RFA Regulatory Flexibility Act RIA Regulatory Impact Analysis RIN Regulation Identifier Number RSAC Railroad Safety Advisory Council RSI Railway Supply Institute TDG Transportation of Dangerous Goods U.S.C. United States Code Table of Contents I. Background II. Good Cause Justification III. Section-by-Section Review IV. Regulatory Analyses and Notices A. Statutory/Legal Authority for This Rulemaking B. Executive Order 12866, Executive Order 13563, Executive Order 13610, and DOT Regulatory Policies and Procedures C. Executive Order 13771 D. Executive Order 13132 E. Executive Order 13175 F. Regulatory Flexibility Act, Executive Order 13272, and DOT Procedures and Policies G. Unfunded Mandates Reform Act of 1995 H. Paperwork Reduction Act I. Regulation Identifier Number (RIN) J. Environmental Assessment K. Privacy Act L. Executive Order 13609 and International Trade Analysis M. National Technology Transfer and Advancement Act List of Subjects I. Background

On May 8, 2015, in collaboration with the Federal Railroad Administration (FRA), PHMSA published the final rule “Hazardous Materials: Enhanced Tank Car Standards and Operational Controls for High-Hazard Flammable Trains” (hereafter referred to as “HM-251 final rule”). The HM-251 final rule was an integral part of the Department's comprehensive approach to ensuring the safe transportation of energy products by rail. Many provisions in HM-251, including those pertaining to advanced brake systems, were the culmination of industry-led efforts to improve tank car safety in anticipation of increased crude oil shipments by rail, which began in 2008.

In September of 2007, FRA published a notice of proposed rulemaking (NPRM) proposing to revise FRA power brake regulations “to provide for and encourage the safe implementation and use of ECP brake system technologies” (72 FR 50820). The rulemaking was initiated following a joint petition by BNSF Railway (BNSF) and Norfolk Southern (NS) to FRA for a waiver from existing brake power requirements to allow those railroads to operate ECP brake pilot trains.1 The NPRM proposed incorporating by reference the Association of American Railroad's (AAR) existing ECP brake system standards. In December of 2008, FRA published a final rule adopting updated AAR ECP brake standards and granting regulatory relief from certain requirements tied to traditional power brakes (e.g. extended the distance between brake inspections for train operations using ECP brakes), which added regulatory flexibility by allowing the use of ECP brakes without the need to apply for a waiver.

In 2011, FRA and the Railway Supply Institute (RSI) met to discuss improvements to tank cars used for the transportation of crude oil in unit trains. The main intent of the meeting was to spur discussion about innovative ways to improve tank car safety for potential future changes in the hazardous materials transportation supply chain. The meeting resulted in the RSI members offering to develop an industry standard (non-regulatory in nature) in collaboration with the AAR, the Renewable Fuels Association (RFA), Growth Energy, and the American Petroleum Institute (API). This collaborative effort was conducted through AAR's Tank Car Committee Task Force, T87.6.2 The T87.6 Task Force carried out technical analyses and generated information for tank car safety improvements, including findings on alternative brake signal propagation systems (i.e., “brake systems”). The advanced brake systems considered in the T87.6 Task Force meetings included conventional air brake systems, ECP brake systems, distributive power (DP) systems, and two-way end-of-train (EOT) devices.

On September 6, 2013, PHMSA published an Advance Notice of Proposed Rulemaking (ANPRM) titled, “Hazardous Materials: Rail Petitions and Recommendations To Improve the Safety of Railroad Tank Car Transportation” (78 FR 54849), specifically requesting comments pertaining to the use of these advanced brake propagation systems to reduce the kinetic energy associated with a derailment based on the understanding that a reduction in kinetic energy would, on average, reduce the number of tank cars involved in the derailment. Similarly, FRA and the Railroad Safety Advisory Committee (RSAC) considered and evaluated the usefulness of advanced brake systems. On August 1, 2014, PHMSA issued an NPRM titled “Hazardous Materials: Enhanced Tank Car Standards and Operational Controls for High-Hazard Flammable Trains” (79 FR 45016). In the NPRM, PHMSA and FRA considered comments submitted to the ANPRM and, where relevant, proposed to adopt revisions based on the comments. Additionally, in the NPRM, PHMSA requested additional comments pertaining to advanced brake systems.

On May 8, 2015, PHMSA issued the HM-251 final rule (80 FR 26644). In the final rule, PHMSA amended the Hazardous Materials Regulations (HMR; 49 CFR parts 171 through 180) by codifying new definitions for trains carrying large volumes of flammable liquids, “high-hazard flammable trains” (HHFTs) and “high-hazard flammable unit trains” (HHFUTs),3 and by implementing additional operational restrictions (e.g., requirements related to speed, braking systems, and routing) for such trains. Specifically, as it relates to this final rule, HM-251 included amendments requiring all tank cars in HHFUTs operating under certain conditions to be equipped with ECP brake systems.

On December 4, 2015, President Barack Obama signed the Fixing America's Surface Transportation Act of 2015 (FAST Act) into law. Title VII of the FAST Act, called the Hazardous Materials Transportation Safety Improvement Act of 2015, outlines several requirements pertaining to the HMR. Section 7311 specifically mandates the study and testing of ECP brake systems, focusing on requirements that were promulgated under the HM-251 final rule. Furthermore, the FAST Act instructs the Department of Transportation to incorporate the results of the Government Accountability Office's (GAO) evaluations and the testing of ECP brake systems by the National Academy of Sciences into an updated regulatory impact analysis (RIA) of the ECP brake system requirements, and to solicit public comment on the updated RIA. Additionally, the FAST Act required that within two years of the mandate, the DOT must determine, based on the updated RIA, whether the ECP brake system requirements in the HM-251 final rule were justified.

In October 2016, GAO submitted a report 4 with four major recommendations concerning the ECP brake system requirements. GAO recommended that DOT: (1) When updating the RIA, take into account potential uncertainty in key variables and assumptions (e.g., fuel prices and future rail traffic of crude oil and ethanol), discuss this uncertainty, and present ranges of possible scenarios; (2) create a plan to collect data from railroads' ongoing and future operational experiences using ECP brake systems; (3) require freight railroads to collect and provide data to FRA on their ongoing operational experience with ECP brake systems if a new requirement were adopted; and (4) publish information that would allow a third party to fully assess and replicate the analysis used in support of the HM-251 final rule. In May 2017, GAO produced a separate report 5 in response to a congressional inquiry, which further indicated that DOT's forecasted values for some of the variables associated with the transportation by rail of crude oil and ethanol (such as the forecasted number of tank cars used to ship crude oil and ethanol, derailment rate, average amount of product lost per derailment, and number of injuries and deaths) may be higher than values realized in 2015 and 2016 based on preliminary data.

In October 2017, PHMSA and FRA published a notice of availability and request for comments (82 FR 48006) on a revised RIA updating the original RIA associated with the ECP brake provisions. As mandated by the FAST Act, DOT updated the RIA and made a determination regarding whether the applicable ECP brake system requirements are economically justified. Based on that revised analysis, the Department determined that the expected benefits, including safety benefits, of implementing ECP brake system requirements do not exceed the associated costs of equipping tank cars with ECP brake systems, and therefore are not economically justified. For this reason, PHMSA is issuing this final rule to remove the ECP brake system requirements from the HMR.

The estimated costs and benefits for the 20-year analysis used in the final revised RIA are presented in Table 1 (below) in three different scenarios labeled “high,” “low,” and “sensitivity.” The three scenarios are based on various levels of future crude oil shipped by rail, to reflect uncertainty regarding those future volumes and to evaluate the ECP brake system requirements over a reasonably wide range of scenarios to determine whether the cost-benefit ratio would be affected by varying levels of crude oil transportation by rail.

The scenario labeled “high” describes a projection in which the highest crude oil by rail volumes of the three scenarios were produced. The “high” scenario was derived from an analysis by linear regression of crude oil carloads on crude oil production volumes using data from 2010 through 2016. A similar model was run comparing volumes of ethanol shipped by rail to ethanol production volumes. The forecasted streams of rail carloads from both models were then added to obtain the total forecast carload volume as presented in Table 8.2a of the docketed RIA.

The “low” scenario presents a crude oil volume forecast that is essentially flat at the 5-year average at a lower volume than that produced by the linear forecast described above. The “low” scenario used the linear forecast model for ethanol as described above to forecast ethanol carload volumes and used an average of the most recent 5 years for which data is complete (2012-2016) to forecast crude oil volumes into the future. These years coincide with the emergence of high crude oil by rail volumes (volumes in excess of 100,000 carloads per year). The carload figures for this forecast are also presented in Table 8.2a of the docketed RIA.

Finally, DOT examined a third scenario which forecast crude oil by rail volumes to continue their recent decline for a few more years and bottom out at 120,000 carloads per year, which were added to the linear ethanol forecast volumes as described above in the “high” scenario description. This scenario was presented in the sensitivity analysis section, and hence was labeled “sensitivity” in the table. It produced the lowest volume crude oil by rail forecast of the three scenarios, and was intended to capture the potential impacts of increased pipeline capacity or other factors that might lead to further declines in crude oil by rail volumes. These scenarios capture a wide range of future flammable liquids by rail volumes, over which the ECP brake requirements were evaluated. As can be seen below, and as reflected in the final updated RIA, the ECP brake system requirements are not expected to be cost-beneficial under any scenario assessed.