Federal Register Vol. 83, No.214,

We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0906; Product Identifier 2018-NM-122-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

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

Fatigue damage can occur locally, in small areas or structural design details, or globally, in widespread areas. Multiple-site damage is widespread damage that occurs in a large structural element such as a single rivet line of a lap splice joining two large skin panels. Widespread damage can also occur in multiple elements such as adjacent frames or stringers. Multiple-site damage and multiple-element damage cracks are typically too small initially to be reliably detected with normal inspection methods. Without intervention, these cracks will grow, and eventually compromise the structural integrity of the airplane. This condition is known as WFD. It is associated with general degradation of large areas of structure with similar structural details and stress levels. As an airplane ages, WFD will likely occur, and will certainly occur if the airplane is operated long enough without any intervention.

The FAA's WFD final rule (75 FR 69746, November 15, 2010) became effective on January 14, 2011. The WFD rule requires certain actions to prevent structural failure due to WFD throughout the operational life of certain existing transport category airplanes and all of these airplanes that will be certificated in the future. For existing and future airplanes subject to the WFD rule, the rule requires that DAHs establish a limit of validity (LOV) of the engineering data that support the structural maintenance program. Operators affected by the WFD rule may not fly an airplane beyond its LOV, unless an extended LOV is approved.

The WFD rule (75 FR 69746, November 15, 2010) does not require identifying and developing maintenance actions if the DAHs can show that such actions are not necessary to prevent WFD before the airplane reaches the LOV. Many LOVs, however, do depend on accomplishment of future maintenance actions. As stated in the WFD rule, any maintenance actions necessary to reach the LOV will be mandated by airworthiness directives through separate rulemaking actions.

In the context of WFD, this action is necessary to enable DAHs to propose LOVs that allow operators the longest operational lives for their airplanes, and still ensure that WFD will not occur. This approach allows for an implementation strategy that provides flexibility to DAHs in determining the timing of service information development (with FAA approval), while providing operators with certainty regarding the LOV applicable to their airplanes.

We are issuing this AD to address any cracking of the top wing skin stringer joints at rib 19, which could result in reduced structural integrity of the wing.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2018-0174, dated August 14, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus SAS Model A310-304, -322, -324, and -325 airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0906.

Airbus has issued Service Bulletin A310-57-2108, dated November 9, 2017. This service information describes procedures for accomplishing a rototest inspection of the fastener holes in the affected areas and repair if necessary, and modifying the fastener holes. 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.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This proposed AD would require accomplishing the actions specified in the service information described previously.

The compliance time for the replacement specified in this proposed AD for addressing WFD was established to ensure that discrepant structure is replaced before WFD develops in airplanes. Standard inspection techniques cannot be relied on to detect WFD before it becomes a hazard to flight. We will not grant any extensions of the compliance time to complete any AD-mandated service bulletin related to WFD without extensive new data that would substantiate and clearly warrant such an extension.

We estimate that this proposed AD affects 14 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

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

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

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

This proposed 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 transport category airplanes and associated appliances to the Director of the System Oversight Division.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 proposed regulation:

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0905; Product Identifier 2018-NM-115-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

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

Agência Nacional de Aviação Civil (ANAC), which is the aviation authority for Brazil, has issued Brazilian Airworthiness Directive 2018-07-01, effective July 24, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Embraer S.A. Model ERJ 190-100 STD, -100 LR, -100 IGW, -200 STD, -200 LR, and -200 IGW airplanes. The MCAI states:

Corrective actions include repair or replacement of affected forward and aft pintle pins of the left- and right-hand MLG shock struts. You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0905.

Embraer has issued Service Bulletin 190-32-0065, Revision 02, dated November 1, 2017. This service information describes procedures for repetitive inspections of affected forward and aft pintle pins of the MLG shock struts for discrepancies, and repair or replacement of any discrepant affected pintle pin.

Embraer has also issued Task 32-11-001-1034, “MLG Shock Strut Pintle Pins—Internal,” of the Embraer 190/195 Maintenance Review Board Report (MRBR) 1928, Revision 11, dated May 10, 2017. This service information describes procedures for the inspection of pintle pins of the MLG shock struts at areas covered by the MLG shock strut and trunnion.

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.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This proposed AD would require accomplishing the actions specified in the service information described previously.

We estimate that this proposed AD affects 96 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

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

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 proposed 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 transport category airplanes and associated appliances to the Director of the System Oversight Division.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 proposed regulation:

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

Comments Invited

We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0903; Product Identifier 2018-NM-113-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

We issued AD 2016-19-14, Amendment 39-18663 (81 FR 71602, October 18, 2016) (“AD 2016-19-14”), for certain Airbus SAS Model A318 and A319 series airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. AD 2016-19-14 requires repetitive inspections for cracking of the 10VU rack fitting lugs, and repair of any cracking. AD 2016-19-14 resulted from a report of cracks found during maintenance inspections on certain 10VU rack fitting lugs. We issued AD 2016-19-14 to address reading difficulties of flight-critical information displayed to the flightcrew during a critical phase of flight, such as an approach or takeoff, which could result in loss of airplane control at an altitude insufficient for recovery.

AD 2016-19-14 applies to the identified airplane models on which Airbus Modification 35869 has not been embodied in production. Since we issued AD 2016-19-14, we have determined that the unsafe condition may also exist on airplanes in a post-Airbus Modification 35869 configuration.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0131, dated June 19, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus SAS Model A318 and A319 series airplanes; A320-211, -212, -214, -216, -231, -232, and -233 airplanes; and A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0903.

The Airbus SAS Model A320-216 was type certificated on December 19, 2016. Before that date, any EASA ADs that affected Model A320-216 airplanes were included on the Required Airworthiness Actions List (RAAL). One or more Model A320-216 airplanes have subsequently been placed on the U.S. Register, and will now be included in FAA AD actions. For Model A320-216 airplanes, the requirements that correspond to AD 2014-20-04 were mandated by the MCAI via the RAAL. Although that RAAL requirement is still in effect, for continuity and clarity we have identified Model A320-216 airplanes in paragraph (c) of this AD; the requirements of paragraphs (g) through (i) in this proposed AD would therefore apply to those airplanes.

Airbus has issued Service Bulletins A320-92-1087, Revision 03, dated July 31, 2017; and A320-92-1119, dated July 28, 2017. This service information describes procedures for repetitive inspections for cracking of the 10VU rack fitting lugs, and repair of any cracking. These documents are distinct since they apply to airplanes in different configurations. 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.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This proposed AD would retain all of the requirements of AD 2016-19-14 and expand the applicability to include additional airplanes. This proposed AD would require accomplishing the actions specified in the service information described previously except as discussed under “Differences Between this Proposed AD and the MCAI or Service Information.” This proposed AD also would require sending the inspection results to Airbus SAS.

This proposed AD would not permit further flight if cracks are detected in any 10VU rack fitting lug, but the MCAI permits flight for a limited time if cracking is detected in a single 10VU rack fitting lug. We have determined that, because of the safety implications and consequences associated with that cracking, any cracked 10VU rack fitting lug must be repaired before further flight. This difference has been coordinated with the EASA.

We estimate that this proposed AD affects 461 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

We estimate that it would take about 1 work-hour per product to comply with the reporting requirement in this proposed AD. The average labor rate is $85 per hour. Based on these figures, we estimate the cost of reporting the inspection results on U.S. operators to be $85 per product.

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

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to 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 current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW, Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.

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 proposed 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 transport category airplanes and associated appliances to the Director of the System Oversight Division.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 proposed regulation:

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

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

3. Will not affect intrastate aviation in Alaska, and

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

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

We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0904; Product Identifier 2018-NM-108-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this NPRM. We will consider all comments received by the closing date and may amend this NPRM because of those comments.

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

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0151, dated July 16, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus SAS Model A330-200 Freighter series, Model A330-200 series, Model A330-300 series, Model A340-200 series, Model A340-300 series, Model A340-500 series, and Model A340-600 series airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0904.

Airbus SAS has issued the following service information.

• Airbus Service Bulletin A330-27-3226, dated April 5, 2018.

• Airbus Service Bulletin A340-27-4206, dated April 3, 2018.

• Airbus Service Bulletin A340-27-5071, dated April 3, 2018.

The service information describes procedures for repetitive detailed inspections of the LH and RH track station 4 drive station elements; repetitive general visual inspections of the LH and RH track station 4 sensor struts; a detailed inspection of the track station 5 drive station elements if any discrepancy is found during a general visual inspection; and corrective actions (i.e., replacement of affected parts). These documents are distinct since they apply to different models. 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.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This proposed AD would require accomplishing the actions specified in the service information described previously. This proposed AD also would require sending the inspection results to Airbus SAS.

We estimate that this proposed AD affects 105 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

We estimate that it would take about 1 work-hour per product to comply with the proposed reporting requirement in this proposed AD. The average labor rate is $85 per hour. Based on these figures, we estimate the cost of reporting the inspection results on U.S. operators to be $8,925, or $85 per product.

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

According to the manufacturer, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all known costs in our cost estimate.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to 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 current valid OMB control number. The control number for the collection of information required by this NPRM is 2120-0056. The paperwork cost associated with this NPRM has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this NPRM is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW, Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.

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 proposed 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 transport category airplanes to the Director of the System Oversight Division.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 proposed regulation:

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would remove Class E airspace extending upward from 700 feet above the surface at Chase Field Industrial Airport, Beeville-Chase Field, TX, that is no longer required.

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2018-0917/Airspace Docket No. 18-ASW-14.” The postcard will be date/time stamped and returned to the commenter.

All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by removing Class E airspace extending upward from 700 feet above the surface at Chase Field Industrial Airport, Beeville-Chase Field, TX.

The FAA is proposing this action due to the cancellation of the standard instrument approach procedures at the airport making the airspace no longer necessary.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

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

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would support the route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System.

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers (FAA Docket No. FAA-2018-0713; Airspace Docket No. 18-AWP-10) and be submitted in triplicate to the Docket Management Facility (see ADDRESSES section for address and phone number). You may also submit comments through the internet at http://www.regulations.gov.

Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2018-0713; Airspace Docket No. 18-AWP-10.” The postcard will be date/time stamped and returned to the commenter.

All communications received on or before the specified comment closing date will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the office of the Western Service Center, Operations Support Group, Federal Aviation Administration, 2200 South 216th Street, Des Moines, WA 98198.

This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is planning decommissioning activities for the Clovis, CA, VOR in 2019 as one of the candidate VORs identified for discontinuance by the FAA's VOR MON program and listed in the final policy statement notice, “Provision of Navigation Services for the Next Generation Air Transportation System (NextGen) Transition to Performance-Based Navigation (PBN) (Plan for Establishing a VOR Minimum Operational Network),” published in the Federal Register of July 26, 2016 (81 FR 48694), Docket No. FAA-2011-1082. Although the VOR portion of the Clovis, CA, VORTAC NAVAID is planned for decommissioning, the tactical air navigation (TACAN) portion is being retained. The ATS routes effected by the Clovis VOR decommissioning are VOR Federal airways V-23, V-165, V-230 and jet routes J-65 and J-110.

With the planned decommissioning of the Clovis VOR, the remaining ground-based NAVAID coverage in the area is insufficient to enable the continuity of the affected airways. As such, proposed modifications to V-23, J-65, and J-110 would result in gaps in the route structures.

To overcome the gap in V-23, instrument flight rules (IFR) traffic could use adjacent VOR Federal airways V-113 and V-107 between the Modesto VOR/DME through Panoche VORTAC down to Avenal VOR/DME to the west and V-459 between Linden VOR/DME and Shafter VORTAC further east.

To overcome the gap in J-65, IFR traffic could use VOR Federal airways J-189 between the Linden VOR/DME and Avenal VOR/DME.

To overcome the loss of a portion of J-110, IFR traffic could file point to point from Oakland and then use Q-160 and Q-158 between the Clovis, VORTAC, decommissioned area and the Boulder City VORTAC area. Additionally, IFR traffic could file point to point through the affected area using fixes that will remain in place, or receive air traffic control (ATC) radar vectors through the area. Visual flight rules pilots who elect to navigate via the airways through the affected area could also take advantage of the adjacent VOR Federal airways or ATC services previously listed.

The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying jet routes (J-65 and J-110) and domestic VOR Federal airways (V-23, V-165 and V-230). The proposed route changes are outlined below.

J-65: J-65 currently extends between the San Antonio TX, VORTAC to the Seattle WA, VORTAC. The FAA would remove the segments between the Shafter, CA, VORTAC and the Sacramento, CA, VORTAC causing a gap in the route. The new route would stop at the Shafter, CA, VORTAC and resume at the Sacramento, CA, VORTAC. The unaffected portion of the existing route would remain as charted.

J-110: J-110 currently extends between the Oakland, CA, VOR/DME to the Coyle, NJ, VORTAC. The FAA would remove the segments between the Oakland, CA, VOR/DME and the Boulder City, NV, VORTAC. The route would now begin at the Boulder City, NV, VORTAC. The unaffected portion of the existing route would remain as charted.

V-23: V-23 currently extends between the Mission Bay CA, VORTAC and the Whatcom WA, VORTAC, and then to the Canadian border (approximately 7 miles northwest of the Whatcom WA, VORTAC). The FAA would amend the segment between the Shafter, CA, VORTAC and the Linden, CA, VOR/DME. The new route would stop at the FRAME intersection (INT Shafter 338°(T) 324°(M) and Panoche 096°(T) 080°(M) radials) and resume at the EBTUW intersection (INT Panoche 035°(T) 019°(M) and Linden 141°(T) 124°(M) radials) causing a gap in the route. The unaffected portion of the existing route would remain as charted.

V-165: V-165 currently extends between the Mission Bay, CA, VORTAC and the Whatcom WA, VORTAC. The FAA would amend the segment between the Tule, CA, VOR/DME and the Mustang, NV, VORTAC. The new route follows V-459 from the Tule, CA, VOR/DME to the Friant VORTAC and then to the DARBY intersection (INT Linden, CA 077°(T) 060°(M) and Mustang, NV, 183°(T) 167°(M) radials) which rejoins the original V-165 enroute to Mustang, NV, VORTAC. The unaffected portion of the existing route would remain as charted.

V-230: V-230 currently extends between the intersection of the Big Sur, CA, VORTAC 325° and the Salinas, CA, VORTAC 281° radials to the Mina, NV, VORTAC. The FAA will amend the segment between the Panoche, CA, VORTAC and the Friant, CA, VORTAC. The new route proceeds from the Panoche CA, VORTAC to the BLEAR intersection (Panoche 077°(T) 061°(M) and Friant 239°(T) 222°(M) radials) to the Friant VORTAC. The unaffected portion of the existing route would remain as charted.

Jet routes are published in paragraph 2004 and domestic VOR Federal airways in paragraph 6010 of FAA Order 7400.11C dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The jet routes and Domestic VOR Federal airways listed in this document will be subsequently published in the Order.

The FAA has determined that this proposed 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 Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

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

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

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2018-0250; Airspace Docket No. 17-AGL-3.” The postcard will be date/time stamped and returned to the commenter.

All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

This document proposes to amend FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is proposing an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace area extending upward from 700 feet above the surface to within a 6.7-mile radius of Williston Basin International Airport, Williston, ND, to accommodate new standard instrument approach procedures. This action would enhance safety and the management of IFR operations at the airport.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

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

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

President Obama signed the Middle Class Tax Relief and Job Creation Act of 2012 (the Act), Public Law 112-96, on February 22, 2012. Title II of the Act amended 42 U.S.C. 503, to add a new subsection (l) permitting States to enact legislation to require drug testing of UC applicants as a condition of UC eligibility under two specific circumstances. The first circumstance is if the applicant was terminated from employment with the applicant's most recent employer because of the unlawful use of a controlled substance. See 42 U.S.C. 503(l)(1)(A)(i). The second circumstance is if the only available suitable work (as defined in the law of the State providing the UC) for an individual is “in an occupation that regularly conducts drug testing (as determined under regulations issued by the Secretary).” See 42 U.S.C. 503(l)(1)(A)(ii). States are not required to drug test in either circumstance; the law merely makes it permissible for States to enact legislation to do so when one of the two circumstances is present. A State may deny UC to an applicant who tests positive for drug use under either of these circumstances. See 42 U.S.C. 503(l)(1)(B).

On October 9, 2014, the Department published an NPRM determining occupations that regularly conduct drug testing for the purposes of 42 U.S.C. 503(l)(1)(A)(2). See 79 FR 61013 (Oct. 9, 2014). After reviewing the comments received, the Rule, as proposed in the NPRM, was modified, and on August 1, 2016, the Secretary of Labor (Secretary) published a regulation determining each occupation “that regularly conducts drug testing” in the Federal Register as 20 CFR part 620. It became effective on September 30, 2016.

The 2016 Rule included several components. It identified seven specific occupations that regularly conduct drug testing: An occupation that requires the employee to carry a firearm, along with six specific occupational categories identified in Federal regulations in which the employee must be tested. The Rule also included within its determination any occupation specifically identified in a State or Federal law as requiring an employee to be tested for controlled substances. Finally, the Rule defined key terms as used in the Act. At the same time the Department published its previous NPRM, it issued guidance to States in Unemployment Insurance Program Letter No. 01-15 to address other issues related to the implementation of drug testing under 42 U.S.C. 503(l). On March 31, 2017, President Trump signed a resolution of disapproval under the Congressional Review Act (CRA) (5 U.S.C. 801 et seq.) as Public Law 115-17. The joint resolution was enacted under the authority of 5 U.S.C. 801(b), enacted by the CRA, Public Law 104-121. Section 801(b) provides that a disapproved rule can not take effect, and that such a rule cannot be reissued in substantially the same form unless authorized by Congress. Consistent with this law, the Department published the notice of revocation of the regulation in the Federal Register at 82 FR 21916 (May 11, 2017).

Because the statute was not repealed or amended following the resolution of disapproval, the statute continues to require the Secretary to issue regulations to enable the determination of occupations in which drug testing regularly occurs. But the CRA prohibits the Department from reissuing the rule “in substantially the same form” or issuing “a new rule that is substantially the same” as the old rule. 5 U.S.C. 801(b). To comply with both the mandate to issue regulations to enable the determination of occupations in which drug testing regularly occurs, and the CRA prohibition on reissuing the rule “in substantially the same form,” the Department has carefully considered the Act, the 2016 Rule, and the congressional notice of disapproval.

In this NPRM, the Department now proposes a substantially different and more flexible approach to the statutory requirements than the 2016 Rule, enabling States to enact legislation to require drug testing for a far larger group of UC applicants than the previous Rule permitted. This flexibility is intended to respect the diversity of States' economies and the different roles played by employment drug testing in those economies. The Department recognizes that imposing a nationally uniform list—like the one-size-fits-all approach that the Department attempted in the disapproved 2016 rule—may not fully effectuate Congress' intent, as expressed in 42 U.S.C. 503(l)(1)(A)(ii), that States be permitted to drug test when the only suitable work for an applicant is in an occupation that regularly conducts such tests. Employers exercise a variety of approaches and practices in conducting drug testing of employees. Some States have laws that impose very minimal restrictions on employer drug testing of employees while other States have very detailed and proscriptive requirements about what actions the employer can take. That diversity of State treatment also renders an exhaustive list of such occupations impractical. The proposed Rule therefore lays out a flexible standard that States can individually meet under the facts of their specific economies and practices. In the Departments' view, the Rule's substantially different scope and fundamentally different approach satisfies the requirements of the CRA, at least where, as here, the Department is under a continuing statutory obligation to propose regulations in this space.

This proposed Rule is not expected to be subject to the requirements of Executive Order (E.O.) 13771 because this proposed rule is expected to result in no more than de minimis costs.

When developing the previous proposed Rule published in 2014, the Department consulted with a number of Federal agencies with expertise in drug testing to inform the proposed regulation. Specifically, the Department consulted with the Substance Abuse and Mental Health Services Administration (SAMHSA) in the U.S. Department of Health and Human Services (HHS); the U.S. Department of Transportation (DOT); the U.S. Department of Defense (DOD); the U.S. Department of Homeland Security (DHS); DOL's Bureau of Labor Statistics (BLS); and DOL's Occupational Safety and Health Administration (OSHA). The Department consulted these agencies because they have experience with required drug testing. DOD and DHS deferred to SAMHSA for interpretation of the drug testing requirements, and the Department gave due consideration to the SAMHSA guidance when developing the 2014 proposed Rule.

In revisiting these regulations, the Department determined that these consultations with Federal agencies are sufficient, although it took steps to ensure that the information provided remains current.

As it did in developing the previous Rule, the Department has canvassed State laws to develop an understanding of what occupations require regular drug testing at the State level. In particular, the Department reviewed all current State legislation implementing 42 U.S.C. 503(l), as part of developing this proposal.

Reflecting their diverse needs and workforces, States vary widely in their drug testing requirements. Some State laws identify specific classes of positions for which drug testing of applicants and/or employees is required. For example, State laws commonly require employers to drug test employees in occupations where public safety is involved. States may require private employers to conduct at least some drug testing of employees and/or job applicants who work as drivers of school transportation vehicles and commercial motor vehicles (similar to federal law requirements), or who work for nursing homes and home health agencies, residential childcare facilities, public works projects contractors, corrections facilities, and nuclear and radioactive storage and transfer facilities.

Other States have enacted laws that permit and encourage, but do not require, employers to conduct drug testing of applicants and/or employees. Some State laws identify types of positions for which employers may conduct drug testing, such as individuals employed in safety-sensitive positions or in an occupation which has been designated as a high-risk or safety-sensitive occupation. At least one State permits testing of individuals who “participate in activities upon which pari-mutuel wagering is authorized.” 1 Most States allow a private employer to decide whether and when to drug test job applicants and employees, often in accordance with a written policy created by the employer according to State law. In some instances, State law specifies that the employer may test job applicants and current employees for any job-related purpose consistent with business necessity and the terms of the employer's written policy.

When States provide restrictions on workplace drug testing, they commonly provide more protection to current employees than to job applicants. For example, a State's law may permit employers to require all job applicants with conditional offers of employment to take drug tests, but permit an employer to require an employee to submit to a drug test only if the employer has reasonable suspicion that use of drugs is impairing the employee's job performance, or has probable cause to believe that the employee, while on the job, is using or is under the influence of drugs.

At least six States also provide various discounts and credits to employers that adopt drug-free workplace programs. Some States' programs require drug testing of applicants and/or employees as part of these programs, while others do not. Some States that require participating employers to test job applicants nevertheless allow the employers to limit such testing based on reasonable classifications of job positions. Employer sponsorship of a drug-free workplace program is usually voluntary, but may be required for State contractors.

DOL's research of Federal and State laws related to drug testing found that these laws often refer to classes of positions with similar functions and duties that are required to be drug tested (e.g., positions requiring an employee to carry a firearm, or positions involving the operation of motor vehicles carrying members of the public).

Since 42 U.S.C. 503 was amended to add subsection 503(l) in 2012, three States, Mississippi, Texas, and Wisconsin, have enacted laws specifically addressing drug testing of unemployment compensation applicants that directly refer to drug testing under 42 U.S.C. 503(l)(1)(A)(ii).2

The proposed Rule implements the statutory requirement that the Secretary issue regulations determining how to identify “an occupation that regularly conducts drug testing” for the purposes of requiring an applicant for UC benefits, for whom the only suitable work is in an occupation that regularly drug tests, to pass a drug test to be eligible for UC benefits.

The proposed new Rule takes a fundamentally different approach to identifying these occupations than did the Department's earlier rule. The 2016 Rule limited the list of occupations that “regularly” conduct drug testing to certain specifically listed occupations and those in which drug testing is required by Federal or State law. The Department has reconsidered that list in light of the congressional disapproval of the 2016 Rule. The Department now acknowledges that the list did not adequately account for the significant variation in State practices with respect to drug testing. An occupation that is regularly drug tested in one State may not be regularly tested in another, making a national one-size-fits-all list inappropriate. This variation also makes developing a nationally applicable and exhaustive list of occupations that “regularly” conduct drug testing wholly impractical. Therefore, the Secretary has determined in this proposed Rule to include in the list of occupations that regularly conduct drug testing those occupations for which a State has a factual basis for finding that employers in that State conduct drug testing as a standard eligibility requirement for employing or retaining employees. This new addition provides substantially more flexibility to States and recognizes the reality that, in some States, drug testing is regularly conducted in many more occupations than were initially listed in the 2016 Rule.

This proposed regulation also provides definitions of key terms. It identifies positions or classes of positions with similar functions or duties as “occupations,” for the purposes of determining “occupations” that regularly test for drugs in this proposed Rule. While the Department considered adopting a specific taxonomy of occupations, such as the Standard Occupational Classification (SOC) System, the proposed Rule does not do so, in order to provide flexibility to States to choose a system that matches its workforce best. Due to the wide variation in State economies and practices, a one-size-fits-all taxonomy imposed by the Federal government could not be tailored to each State's situation and would thus be impracticable. States may utilize the SOC system, the O*NET system developed under a grant by the Department by the North Carolina State Department of Commerce, or another system of the State's choosing.

The Department, in proposing this new Rule, adopts the finding in the 2016 Rule that any occupation for which Federal or State law requires drug testing is among those that are drug tested “regularly.” The Department recognizes that Federal and State laws may evolve in identifying which positions or occupations are required to drug test. Thus, the new proposed Rule allows for occupations identified in future Federal or State laws as requiring drug testing to be occupations that States will be able to consider for drug testing of UC applicants.

Finally, the proposed Rule includes a section on conformity and substantial compliance.

The Department seeks comments on the entirety of the proposed Rule, and, in the section-by-section description of the proposed Rule, highlights areas where comments would be particularly helpful.

Proposed § 620.1 explains that the purpose of the NPRM is to implement 42 U.S.C. 503(l)(A)(ii), permitting drug testing of UC applicants for the use of controlled substances, where suitable work (as defined under the State's UC law) is only available in an occupation for which drug testing is regularly conducted (as determined under this part 620).

“Applicant” means an individual who files an initial claim for UC under State law. “Applicant” excludes an individual already found initially eligible and filing a continued claim. The Department came to this conclusion based on how the word “applicant” is used elsewhere in 42 U.S.C. 503 and the Social Security Act. Specifically, in enacting 42 U.S.C. 503(l), Congress also enacted 42 U.S.C. 503(a)(11), which describes in different language those seeking continued eligibility. Paragraph (a)(11) provides that a State unemployment law must include “[a] requirement that, as a condition of eligibility for regular compensation for any week, a claimant must be able to work, available to work, and actually seeking work.” Thus, Congress distinguished “applicants” and “claimants” in the Act. This distinction appears elsewhere in Section 503. Paragraphs (d)(2)(A) and (e)(2)(A) both refer to “new applicants” in the context of individuals whose UC eligibility has yet to be determined. In contrast, paragraph (j)(1) refers to “new claimants” in the context of individuals who have been found eligible for UC. Likewise, 42 U.S.C. 503(h)(3)(B) and (i)(1)(A)(ii), which require UC information disclosures to HHS and the Department of Housing and Urban Development, both refer to an individual who “is receiving, has received, or has made application for” UC. There as well, the Act, distinguishes an individual making “application for” UC benefits from one who “is receiving” or “has received” UC. This distinction between applicants and recipients is similar to that found elsewhere in the Social Security Act. See, e.g., 42 U.S.C. 1396w(b)(1)(A) (“applicant for, or recipient of, medical assistance”); id. § 1320b-6(j)(1)(A) (“applicant for, or recipient of, benefits”); § 1396a(a)(4) (“services to applicants and recipients”).

“Controlled substance,” as defined by 42 U.S.C. 503(l)(2)(B), has the same meaning given such term in Sec. 102 of the Controlled Substances Act (Pub. L. 91-513, 21 U.S.C. 802). “Controlled substance” means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of 21 U.S.C. 801 et seq. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.

“Occupation” means a position or class of positions with similar functions and duties. As discussed above, Federal and State drug testing laws do not generally specify or refer to “occupations” requiring drug testing, but rather identify classes or categories of positions, in descriptive terms—such as, for example, positions requiring the carrying of a firearm, or positions that use motor vehicles to carry members of the public. These types of position descriptions identify a crucial aspect, function, or duty of these positions (e.g., driving a motor vehicle, or carrying a firearm) that is the basis for the drug testing requirement. This definition gives States flexibility to identify occupations based on their own systems for classifying occupations. The Department considered and rejected mandating the use of the Standard Occupational Classification (SOC) system. While the SOC system provides a methodology for classifying workers into occupational categories for the purpose of data collection and statistical analysis, it may not provide the best mechanism to support states in identifying the occupations in which employers regularly drug test. To assist states in identifying additional occupations that regularly drug test, the definition of “occupation,” for purposes of this rule, clarifies that the positions or classes of positions identified as occupations must have similar functions and duties, a change from the 2016 Final Rule. As noted previously, employer drug testing, whether mandated by law or not, tends to focus on positions where employees are carrying out specific functions and duties such as jobs in which the worker carries a firearm, transports the public, or handles financial transactions. States remain free to choose to use the SOC system, but are not required to use it.

“Suitable Work” means suitable work as defined under the UC law of the State against which the claim is filed. This is the same definition of “suitable work” under that State's law as the State otherwise uses for determining UC eligibility based on seeking work or refusing work.

“Unemployment Compensation” is defined in Sec. 303(l)(2)(A) of the Social Security Act (SSA), to have the same meaning given to the term in 42 U.S.C. 503(d)(2)(A), which states the term unemployment compensation means any unemployment compensation payable under State law (including amounts payable pursuant to an agreement under a Federal unemployment compensation law.)

Section 3306(h) of the Federal Unemployment Tax Act (26 U.S.C. 3306(h)) defines compensation to mean cash benefits payable to individuals with respect to their unemployment.

In this proposed Rule, the Department recognizes both the historic Federal-State partnership that is a key hallmark of the UC program as well as the wide variation among States' economies and practices. The proposed rule thus recognizes the need for States' participation in identifying which, and whether additional, occupations regularly conduct drug testing in each State. Proposed § 620.3 describes a number of different occupations that the Department has determined regularly drug test. States may use this list, in addition to the broader criterion, in identifying occupations for which drug testing is regularly conducted based on the criteria set by the Secretary under these regulations.

Proposed subsection 620.3(a) includes the class of positions that requires the employee to carry a firearm as an “occupation” that regularly drug tests.

Proposed subsections 620.3(b)-(g) include various specific occupations that were listed in the previous Rule as ones that regularly drug test, since various Federal laws require drug testing of employees in each of these occupations. The proposed Rule identifies in subsections 620.3(b)-(g) six specific sections of regulations issued by several agencies of DOT and the Coast Guard that identify the classes of positions that are subject to drug testing. Any position with a Federal legal requirement for drug testing unquestionably constitutes an occupation that regularly drug tests.

Proposed subsections 620.3(h) and (i) include in the list of occupations that regularly drug test any occupation that is required to be drug tested under any future Federal law or under the law of the State seeking to drug test UC applicants in that occupation. As with the previous six sections, any position with a legal requirement for drug testing unquestionably constitutes an occupation that regularly drug tests.

Proposed subsection 620.3(j) adds to the list of occupations that regularly drug test a significant provision not contained in the previous Final Rule that fundamentally transforms the regulatory approach and scope of the proposed regulation, and thus satisfies the requirements of the CRA, at least where, as here, the Department is under a continuing statutory obligation to propose regulations in this space. Proposed subsection 620.3(j) provides that a State may identify additional occupations in that State where employers require pre-hire or post-hire drug testing as a standard eligibility requirement and consider those occupations as regularly conducting drug testing. This provision reflects the Secretary's determination that, because there is wide variation among State economies and employment practices, it is not practicable to exhaustively list all occupations that “regularly conduct[ ] drug testing.” Instead, the Department sets out a Federal standard by which it is possible to assess—under Federal, not State, law—whether a State has a sufficient basis to require drug testing of a particular class of UC applicants. That proposed Federal standard is as follows: When identifying an occupation that regularly conducts drug testing, the State must identify a factual basis for its finding that employers conduct pre-employment or post-hire drug testing as a standard eligibility requirement for obtaining or maintaining employment in the identified occupation. Factual bases may include, but are not limited to: Labor market surveys; reports of trade and professional organizations; and academic, government, or other studies. This proposed standard effectuates the plain meaning of the Act's authorization of drug testing where suitable work “is only available in an occupation that regularly conducts drug testing.” Section 303(l)(1)(A)(ii) (emphasis added). If this rule were enacted as proposed, the Department would review States' factual bases through reports authorized under 42 U.S.C. 503(a)(6) and 20 CFR 601.3; these reports are currently made through States' submissions of Form MA-8-7.

DOL seeks comments on whether it should instead impose a heightened standard of evidence to demonstrate that an occupation is one that regularly conducts drug tests and therefore can be considered an occupation for which drug testing is a standard eligibility requirement. If so, what heightened level of evidence of drug testing would be appropriate?

DOL also seeks comments on any suggested additions, deletions, or edits to the list and descriptions of occupations that regularly conduct drug testing, or on the scope of the latitude accorded to States in the approach proposed here. DOL likewise seeks comments on its determination that it is impracticable to develop a nationally uniform list of occupations that regularly drug test, given the wide variations in regional economies and in State law.

Finally, DOL seeks comments on its planned approach of using submissions through Form MA-8-7 as the method for reviewing States' factual bases for finding that employers conduct pre-employment or post-hire drug testing as a standard eligibility requirement for obtaining or maintaining employment in the identified occupation.

Proposed § 620.4, consistent with 42 U.S.C. 503(l), provides that a State may require applicants to take and pass a test for the illegal use of controlled substances as a condition of initial eligibility for UC under specified conditions, and that applicants may be denied UC based on the results of these tests. States are not required to drug test as a condition of UC eligibility based on any of the occupations set out under this proposed Rule. States may choose to do so based on some or all of the identified occupations, however, States may not, except as permitted by 42 U.S.C. 503(l)(1)(A)(i) (governing drug testing of individuals terminated for the unlawful use of a controlled substance), drug test based on any occupation that does not meet the definition in § 620.3 for purposes of determining UC eligibility.

Proposed subsection 620.4(a) provides that an applicant, as defined in proposed § 620.2, may be tested for the unlawful use of one or more controlled substances, also as defined in proposed § 620.2, as an eligibility condition for UC, if the individual is one for whom suitable work, as defined by that State's UC law, is only available in an occupation that regularly conducts drug testing, as determined under proposed § 620.3. As discussed in the Summary of the proposed Rule, the term “applicant” means that only an individual who is filing an initial UC claim, not a claimant filing a continued claim, may be subject to drug testing.

Proposed subsection 620.4(b) provides that a State choosing to require drug testing as a condition of UC eligibility may apply drug testing based on one or more of the occupations under § 620.3. This flexibility is consistent with the statute, which permits, but does not require, drug testing, and the partnership nature of the Federal-State UC system.

Proposed subsection 620.4(c) provides that no State would be required to drug test UC applicants under this part 620. This provision was not in the 2016 Final Rule, but again reflects the partnership nature of the Federal-State UC system and the Department's understanding that the Act permitted, but did not require, States to drug test UC applicants under the identified circumstances.

While 42 U.S.C. 503(l) requires the Secretary to issue regulations determining the occupations that regularly conduct drug testing, the Secretary may address other issues relating to 42 U.S.C. 503(l) in guidance, such as program letters and other issuances, and may issue additional guidance as needed.

Proposed subsection 620.5(a) explains that implementation of drug testing of UC applicants as authorized under State laws must be in conformity with these regulations for States to be certified as eligible to receive Federal grants for the administration of its UC program under 42 U.S.C. 502. The procedures for resolving issues of conformity or compliance with the requirements of the proposed Rule, and the remedies for failure to conform or comply, are found in 20 CFR 601.5.

E.O.s 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives, and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. For a “significant regulatory action,” E.O. 12866 asks agencies to describe the need for the regulatory action and explain how the regulatory action will meet that need, as well as assess the costs and benefits of the regulation.3 This regulation is necessary because of the statutory requirement contained in 42 U.S.C. 503(l)(1)(A)(ii), which requires the Secretary to determine the occupations that regularly conduct drug testing for the purpose of determining which applicants may be drug tested when applying for State unemployment compensation. The Department considers this proposed Rule to be a “significant regulatory action,” as defined in Sec. 3(f) of E.O. 12866, because it raises novel legal or policy issues arising out of legal mandates. Before the amendment of Federal law to add the new 42 U.S.C. 503(l)(1), drug testing of applicants for UC as a condition of eligibility was prohibited.

The proposed Rule is entirely voluntary on the part of the States, and the Department does not yet have sufficient data to predict how many States will establish a drug testing program. Before the enactment of the Federal law in 2012, States were not permitted to condition eligibility for UC on drug testing. The unsettled federal regulatory landscape since that time may have chilled States' interest in pursuing drug testing, and it is uncertain to what extent States' costs in administering drug testing would be offset by savings in their UC programs. Whatever the reason, to date, only three States have enacted State laws to pursue drug testing of UC applicants under this statutory provision.

There are limited data on which to base estimates of the cost associated with establishing a testing program, or the offsetting savings that a testing program could realize. Only one of the three States that have enacted conforming drug testing laws issued a fiscal estimate. That State, Texas, estimated that the 5-year cost of administering the program would be $1,175,954, taking into account both one-time technology personnel services to program the system and ongoing administrative costs for personnel. The Texas analysis estimated a potential savings to the Unemployment Trust Fund of $13,700,580 over the 5-year period, resulting in a net savings of approximately $12.5 million. The Department believes it would be inappropriate to extrapolate the Texas analysis to all States, in part because of differences in the Texas law and the requirements in this proposed Rule. The Department has included this information about Texas for illustrative purposes only and emphasizes that by doing so, it is not commenting on or endorsing the methodology or assumptions in the Texas analysis.

The Department requests comments from interested stakeholders on the costs of establishing and administering a State-wide testing program; the number of applicants for unemployment compensation that fit the criteria established in the law; estimates of the number of individuals who would subsequently be denied unemployment compensation due to a failed drug test; and the offsetting savings that could result.

In the absence of such data, the Department is unable to quantify the administrative costs States will incur if they choose to implement drug testing pursuant to this proposed Rule. No additional funding has been appropriated for this purpose, and current Federal funding for the administration of State unemployment compensation programs may be insufficient to support the additional costs of establishing and administering a drug testing program, which would include the cost of the drug tests, staff for administration of the drug testing function, and technology to track drug testing outcomes. States would also incur ramp up costs to implement the processes necessary for determining whether an applicant is one for whom drug testing is legally permissible; referring and tracking applicants referred for drug testing; and conducting and processing the drug tests. States would also have to factor in increased costs of adjudication and appeals of both the determination that an individual is subject to drug testing and resulting determinations of benefit eligibility based on the test results.

The Department has determined that this proposed Rule does not contain a “collection of information,” as the term is defined. See 5 CFR 1320.3(c). DOL expressly seeks comments on this determination.

Section 6 of E.O. 13132 requires Federal agencies to consult with State entities when a regulation or policy may have a substantial direct effect on the States, the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government, within the meaning of the E.O. Section 3(b) of the E.O. further provides that Federal agencies must implement regulations that have a substantial direct effect only if statutory authority permits the regulation and it is of national significance.

This proposed Rule does not have a substantial direct effect on the States, the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of Government, within the meaning of the E.O. This is because drug testing authorized by the regulation is voluntary on the part of the State—it is not required.

This regulatory action has been reviewed in accordance with the Unfunded Mandates Reform Act of 1995 (the Reform Act). Under the Reform Act, a Federal agency must determine whether a regulation proposes a Federal mandate that would result in the increased expenditures by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more in any single year. The Department has determined that, since States have the option to drug test UC applicants and can elect not to do so, this proposed Rule does not include any Federal mandate that could result in increased expenditure by State, local, and tribal governments. Drug testing under this proposed Rule is purely voluntary, so any increased cost to the States is not the result of a mandate. Accordingly, it is unnecessary for the Department to prepare a budgetary impact statement.

The Department drafted this proposed Rule in plain language.

The Department certifies that this proposed Rule has been assessed according to Sec. 654 of the Treasury and General Government Appropriations Act, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999 (Pub. L. 105-277, 112 Stat. 2681) for its effect on family well-being. The Department certifies that this proposed Rule does not adversely impact family well-being as discussed under Sec. 654 of the Treasury and General Government Appropriations Act of 1999.

The Regulatory Flexibility Act (RFA), at 5 U.S.C. 603(a), requires agencies to prepare and make available for public comment an initial regulatory flexibility analysis, which describes the impact of the proposed Rule on small entities. Section 605 of the RFA allows an agency to certify a Rule, in lieu of preparing an analysis, if the proposed rulemaking is not expected to have a significant economic impact on a substantial number of small entities. This proposed Rule does not affect small entities as defined in the RFA. Therefore, the proposed Rule will not have a significant economic impact on a substantial number of these small entities. The Department has certified this to the Chief Counsel for Advocacy, Small Business Administration, pursuant to the RFA.

I. Background

Nearly all tobacco product use begins during youth and young adulthood (Ref. 1). While the current use of any tobacco product among U.S. middle and high school students has decreased from 2011-2017, there has been an alarming increase in e-cigarette use over this time. In fact, since 2014, e-cigarettes 1 have been the most commonly used tobacco products among youth, used by 1.73 million (11.7 percent) high school students and 390,000 (3.3 percent) middle school students in 2017 (Ref. 2). Youth e-cigarette use raises a number of health concerns including risk of addiction to nicotine early on in life, potential harm to the developing adolescent brain, and exposure to chemicals including carbonyl compounds and volatile organic compounds known to have adverse health effects; the full range of possible health effects is not yet completely understood (Ref. 3).

On April 24, 2018, FDA announced its Youth Tobacco Prevention Plan. This plan focuses on three key strategies: Prevention of youth access to tobacco products, curbing the marketing of tobacco products aimed at youth, and educating teens about the dangers of using any tobacco products.2 FDA recently launched an expansion of its “The Real Cost” campaign to educate youth on the dangers of e-cigarette use 3 and increased enforcement actions to address this critically important public health concern.4

In addition to the prevention of initiation, which will be the cornerstone of any successful effort to curb youth e-cigarette use, FDA is also exploring additional approaches to address youth e-cigarette use. One such approach may be the development of drug therapies, as part of multimodal treatment strategies, including behavioral interventions, to support tobacco product cessation. To date, research on youth tobacco product cessation has been limited and focused on smoking (i.e., combustible products) cessation. One recent review found a paucity of data on either behavioral or drug therapies for smoking cessation in young people (age less than 20 years) and concluded that “there continues to be a need for well-designed, adequately powered, randomized controlled trials of interventions for this population of smokers” (Ref. 4). FDA is not aware of any research examining either drug or behavioral interventions for the cessation of youth or adult e-cigarette use. In contrast, there is a large body of research on adult smoking cessation, and multiple drugs for smoking cessation are approved for the adult population, including a variety of prescription and over-the-counter nicotine replacement therapy (NRT) products, as well as the prescription drugs varenicline and bupropion hydrochloride sustained release (see Appendix A).

FDA is holding a public hearing to obtain the public's perspectives on the potential role drug therapies may play in the broader effort to eliminate youth e-cigarette and other tobacco product use, as well as the appropriate methods and study designs for evaluating youth e-cigarette cessation therapies and the safety and efficacy of such therapies. The Agency has determined that a public hearing is the most appropriate way to ensure public engagement on this issue, which is of great importance to the public health. FDA believes it is critical to obtain input across the medical and research fields, the pharmaceutical and tobacco industries, and among public health stakeholders (including adolescents) regarding approaches to eliminate youth e-cigarette and other tobacco product use, including exploring whether there is a need for drug therapies to support youth e-cigarette cessation, and if so, how FDA can support the development of such therapies.

Considering the broad range of activities focused on this public health issue, FDA is interested in the public's view on approaches to eliminating e-cigarette and other tobacco product use among youth. Although FDA welcomes all feedback on any public health, scientific, regulatory or legal considerations relating to this topic, we particularly encourage commenters to consider the following questions as they prepare their comments or statements. Responses to questions should include supporting scientific justification.

1. FDA notes that the factors driving e-cigarette use among youth likely differ from those in the adult population. How might such differences impact the need for, or use of, drug therapies for e-cigarette cessation among youth?

2. FDA is interested in whether there is a population of youth e-cigarette users who would be likely to benefit from the use of drug therapies for e-cigarette cessation. What age groups (older adolescent vs. younger adolescent), patterns in tobacco use (duration and frequency of use), and clinical features (level of addiction, presence/absence of comorbidities including psychiatric disease) might characterize this population? What types of products (NRT vs. non-NRT; prescription vs. over-the-counter) might be useful?

3. Describe the scientific, clinical, and societal factors that could either encourage or impede the conduct of clinical trials designed to evaluate drugs intended for youth e-cigarette cessation. What approaches could be used to encourage research and overcome barriers to research?

4. What methods and study designs are appropriate for assessing drug therapies for youth e-cigarette cessation? What are the appropriate control groups? What are the most informative endpoints and the best assessment tools to evaluate these endpoints?

5. Acknowledging that to date research has been limited, are there data available from the adult experience with smoking cessation that could potentially be leveraged in the effort to develop drug therapies for youth e-cigarette cessation? Have any drug therapies demonstrated potential to help adults discontinue e-cigarette use? Are there differences between adolescents and adults that impact the ability to extrapolate efficacy findings from the adult population to the adolescent population? Could existing NRT products be useful for youth e-cigarette cessation?

6. While this hearing is focused on the topic of e-cigarette use among youth, as e-cigarettes are currently the most commonly used form of tobacco in this population, FDA also welcomes comments regarding the potential need for drug therapies to support cessation of other tobacco products, including combustible products (i.e., cigarettes or cigars) and smokeless tobacco products, among youth and the issues impacting the development of such therapies.

Registration and Requests for Oral Presentations: The FDA Conference Center at the White Oak location is a Federal facility with security procedures and limited seating. Attendance will be free and on a first-come, first-served basis. For those interested in presenting at the meeting, either with a formal oral presentation or as a speaker in the open public hearing session, please register by Friday, November 23, 2018, at https://www.eventbrite.com/e/fda-pediatric-tobacco-cessation-part-15-public-hearing-tickets-50167147288. If you wish to attend either in person or by Webcast (see Streaming Webcast of the Public Hearing), please register for the hearing by Monday December 3, 2018, at https://www.eventbrite.com/e/fda-pediatric-tobacco-cessation-part-15-public-hearing-tickets-50167147288. Those without internet or email access can register and/or request to participate as an open public hearing speaker or a formal presenter by contacting Theresa Wells by the above dates (see FOR FURTHER INFORMATION CONTACT).

FDA will try to accommodate all persons who wish to make a presentation. Formal oral presenters may use an accompanying slide deck, while those participating in the Open Public Hearing will have less allotted time than formal oral presenters and will deliver oral testimony only (no accompanying slide deck). Individuals wishing to present should identify the number of the specific question, or questions, they wish to address. This will help FDA organize the presentations. Individuals and organizations with common interests should consolidate or coordinate their presentations and request time for a joint presentation. Individual organizations are limited to a single presentation slot. FDA will notify registered presenters of their scheduled presentation times. The time allotted for each presentation will depend on the number of individuals who wish to speak. Registered presenters making a formal oral presentation are encouraged to submit an electronic copy of their presentation (PowerPoint or PDF) to [email protected] with the subject line “Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies” on or before Wednesday, November 28, 2018. Persons registered to present are encouraged to arrive at the hearing room early and check in at the onsite registration table to confirm their designated presentation time. Actual presentation times, however, may vary based on how the meeting progresses in real-time. An agenda for the hearing and any other background materials will be made available 5 days before the hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm620744.htm.

If you need special accommodations because of a disability, please contact Theresa Wells (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the hearing.

Streaming Webcast of the Public Hearing: For those unable to attend in person, FDA will provide a live Webcast of the hearing. To join the hearing via the Webcast, please go to https://collaboration.fda.gov/ptc120518.

Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Dockets Management Staff (see Comments). A transcript will also be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's website at https://www.fda.gov.

The Commissioner of Food and Drugs is announcing that the public hearing will be held in accordance with 21 CFR part 15. The hearing will be conducted by a presiding officer, who will be accompanied by FDA senior management from the Office of the Commissioner, the Center for Drug Evaluation and Research, and the Center for Tobacco Products. Under § 15.30(f), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members can pose questions; they can question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (21 CFR part 10, subpart C). Under § 10.205, representatives of the media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b) (see Transcripts). To the extent that the conditions for the hearing, as described in this notice, conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in § 15.30(h).

The following references marked with an asterisk (*) are on display at the Dockets Management Staff and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

I. Background

We are announcing the availability of a draft guidance for industry entitled “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

The draft guidance, when finalized, will provide questions and answers on topics related primarily to implementing two final rules: (1) “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments” (81 FR 34000 (May 27, 2016)) and (2) “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (81 FR 33742 (May 27, 2016)). This draft guidance also discusses formatting issues for dual-column labeling, products that have limited space for nutrition labeling, and additional issues dealing with compliance.

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 101 have been approved under OMB control number 0910-0381.

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.

Background I. Section 956

The Revenue Act of 1962 (the “1962 Act”), Pub. L. 87-834, sec. 12, 76 Stat. at 1006, enacted sections 951 and 956 as part of subpart F of part III, subchapter N, chapter 1 of the 1954 Internal Revenue Code (“subpart F”), as amended. Subpart F was enacted in order to limit the use of low-tax jurisdictions for the purposes of obtaining indefinite deferral of U.S. tax on certain earnings that would otherwise be subject to U.S. federal income tax. H.R. Rep. No. 1447 at 57 (1962). Congress enacted subpart F in part to address taxpayers who had “taken advantage of the multiplicity of foreign tax systems to avoid taxation by the United States on what could ordinarily be expected to be U.S. source income.” Id. at 58.

Before the 1962 Act, United States shareholders (as defined in section 951(b)) (“U.S. shareholders”) of controlled foreign corporations (as defined in section 957) (“CFCs”) were not subject to U.S. tax on earnings of the foreign corporations unless and until earnings of the foreign corporations were distributed to the shareholders as a dividend. S. Rep. No. 1881 at 78 (1962). The subpart F regime eliminated deferral for certain—generally passive or highly mobile—earnings of CFCs by subjecting those earnings to immediate U.S. taxation regardless of whether there was an actual distribution. Id. at 80. Earnings that were not subject to immediate U.S. taxation under the subpart F regime were generally taxable only upon repatriation, as those earnings did not present the same concerns regarding indefinite tax deferral compared to earnings subject to subpart F.

Section 956 was enacted alongside the subpart F regime in the 1962 Act to ensure that a CFC's earnings not subject to immediate tax when earned (under the subpart F regime) would be taxed when repatriated, either through a dividend or an effective repatriation. Recognizing that repatriation of foreign earnings was possible through means other than a taxable distribution, Congress enacted section 956 “to prevent the repatriation of income to the United States in a manner which does not subject it to U.S. taxation.” H.R. Rep. No. 1447 at 58. Congress determined that the investment by a CFC of its earnings in United States property, including obligations of a U.S. person, “is substantially the equivalent of a dividend.” See S. Rep. No. 1881 at 88 (1962). See also S. Rep. No. 94-938 at 226 (1976) (“[S]ince the investment . . . in the stock or debt obligations of a related U.S. person or its domestic affiliates makes funds available for use by the U.S. shareholders, it constitutes an effective repatriation of earnings which should be taxed.”). Accordingly, Congress enacted section 956 as an anti-abuse measure to tax a CFC's investment of earnings in United States property in the same manner as if it had distributed those earnings to the United States. See JCS-10-87 at 1081-82 (1987) (“In general, two kinds of transactions are repatriations that end deferral and trigger tax. First, an actual dividend payment ends deferral. . . . Second, in the case of a controlled foreign corporation, an investment in U.S. property, such as a loan to the lender's U.S. parent or the purchase of U.S. real estate, is also a repatriation that ends deferral (Code sec. 956).”). Failure to tax CFC investments in United States property would have allowed taxpayers to circumvent the U.S. system of deferral by effectively repatriating earnings without paying U.S. tax on the substantial equivalent of a taxable dividend. Section 956 was thus designed to ensure symmetry between the tax treatment of repatriations through dividends and effective repatriations. See generally Notice 2014-52, 2014-42 I.R.B. 712 (“In the absence of section 956, a U.S. shareholder of a CFC could access the CFC's funds (untaxed earnings and profits) in a variety of ways other than by the payment of an actual taxable dividend, such that there would be no reason for the U.S. shareholder to incur the dividend tax. Section 956 eliminates this disincentive to pay a dividend by ensuring parity of treatment for different ways that CFC earnings can be made available for use in the United States or for use by the U.S. shareholder.”).

Section 951(a)(1)(B) requires a U.S. shareholder of a CFC to include in gross income the amount determined under section 956 (the “section 956 amount”) with respect to the CFC to the extent not excluded from gross income under section 959(a)(2) (the inclusion, a “section 956 inclusion”). See sections 951(a)(1)(B), 959(a)(2), and 959(f)(1). Section 951(b) defines a U.S. shareholder as a United States person that owns within the meaning of section 958(a), or is considered as owning by reason of the constructive ownership rules of section 958(b), 10 percent or more of the voting power or value of a foreign corporation. A U.S. shareholder's section 956 amount with respect to a CFC for a taxable year is the lesser of (1) the excess (if any) of such shareholder's pro rata share of the average of the amounts of United States property held (directly or indirectly) by the CFC as of the close of each quarter of such taxable year, over the amount of earnings and profits described in section 959(c)(1)(A) with respect to such shareholder, or (2) such shareholder's pro rata share of the applicable earnings of the CFC. See section 956(a). Applicable earnings are defined as the sum of accumulated earnings and profits (not including deficits) described in section 316(a)(1) and current earnings and profits described in section 316(a)(2), reduced by distributions made during the year and earnings and profits described in section 959(c)(1). See section 956(b)(1). Under section 956(c), United States property includes tangible property located in the United States, stock of a domestic corporation, an obligation of a United States person, and any right to use in the United States certain intangible property. Enacted as part of the Omnibus Budget Reconciliation Act of 1993, Pub. L. 103-66, sec. 13232(b), 107 Stat. 312, section 956(e) grants the Secretary of the Department of Treasury (the “Secretary”) the authority to prescribe “such regulations as may be necessary to carry out the purposes of this section, including regulations to prevent the avoidance of the provisions of this section through reorganizations or otherwise.”

This regulatory authority is not limited to the adoption of anti-avoidance rules, but rather permits the Secretary to ensure that the application of section 956 is consistent with the “purposes of this section”—chief among them, to ensure symmetry between the treatment of actual dividends and payments which are “substantially the equivalent of a dividend.” S. Rep. No. 1881 at 88 (1962). Consistent with this understanding, the Department of Treasury (the “Treasury Department”) and the IRS have exercised this regulatory authority to tailor the application of section 956 to the abuse that motivated its adoption, ensuring that the provision applies to the transactions Congress sought to tax, but does not extend to transactions the taxation of which would be inconsistent with the purpose of section 956.1 For example, in 1964, shortly after section 956 was first enacted, the Treasury Department and the IRS issued regulations containing Treas. Reg. section 1.956-2(d)(2)(ii), providing that any debt collected within one year from the time incurred did not constitute an obligation that could be United States property. See T.D. 6704, 29 FR 2599, 2603. This short-term loan exception was removed when the Treasury Department and the IRS issued regulations in 1988 regarding the treatment of factoring receivables as United States property. See T.D. 8209, 53 FR 22163, 22169. A one-year debt exception would have been inconsistent with Congress's expansion of section 956 in 1984 to reach factoring receivables, which are often outstanding for less than one year.

Alongside the removal of the 1964 short-term loan exception in the 1988 regulations, the Treasury Department and the IRS issued Notice 88-108, 1988-2 C.B. 466, which indicated that regulations would be issued providing a narrower exception from the definition of obligation for purposes of section 956 for obligations collected within 30 days from the time incurred (the “30-day rule”). However, the notice provided that the exception would not apply to a CFC that holds for 60 or more calendar days during the taxable year obligations which, without regard to the 30-day rule, would constitute United States property. The 30-day rule was expanded to 60 days in order to facilitate the flow of funds from foreign subsidiaries during a financial crisis beginning in 2008, which expansion was also extended to 2009 and 2010. See Notice 2008-91, 2008-43 I.R.B. 1001; Notice 2009-10, 2009-5 I.R.B. 419; Notice 2010-12, 2010-4 I.R.B. 326. The 30 day rule was ultimately adopted in final regulations issued on July 12, 2018, as Treas. Reg. section 1.956-2(d)(2)(iv). See T.D. 9834, 83 FR 32524, 32537-38.

Since 1964, Congress has modified section 956 several times without addressing Treasury's short-term debt exception; indeed, since then Congress adopted section 956(e) as a positive grant of regulatory authority in 1993, and explicitly validated the short-term debt exception in its legislative history. See H.R. Rep. 103-111 at 701 (1993) (“The bill is not intended to change the measurement of U.S. property that may apply, for example, in the case of certain short-term obligations, as provided in IRS Notice 88-108 (1988-2 C.B. 445), interpreting present law.”).

Conversely, the Treasury Department and the IRS have at times expanded the scope of section 956 by regulation to ensure that the provision reaches the type of transactions intended by Congress. See, e.g., T.D. 9402, 73 FR 35580, 35582 (adding rules modifying the basis of property transferred to a CFC in certain non-recognition transactions solely for the purposes of section 956 and providing that “[t]he purpose of this [rule] is to prevent the effective repatriation of earnings and profits of a controlled foreign corporation that acquires United States property in connection with an exchange to which this [rule] applies without a corresponding income inclusion under section 951(a)(1)(B) by claiming a basis in the United States property less than the amount of earnings and profits effectively repatriated”). See also T.D. 9834, 83 FR 32524.

On December 22, 2017, Congress enacted the Tax Cuts and Jobs Act, Public Law 115-97 (the “Act”), which established a participation exemption system for the taxation of certain foreign income. Under section 245A(a), in the case of any dividend received from a specified 10-percent owned foreign corporation by a domestic corporation which is a U.S. shareholder with respect to such foreign corporation, there is allowed as a deduction an amount equal to the foreign-source portion of such dividend. A specified 10-percent owned foreign corporation is defined in section 245A(b) as any foreign corporation (other than certain passive foreign investment companies) with respect to which a domestic corporation is a U.S. shareholder. Section 245A(g) grants the Secretary authority to prescribe such regulations or other guidance as may be necessary or appropriate to carry out the provisions of section 245A, including regulations for the treatment of U.S. shareholders owning stock of a specified 10-percent owned foreign corporation through a partnership.

Under section 246(c)(1) and (5), a domestic corporation that is a U.S. shareholder is not permitted a section 245A deduction in respect of any dividend on any share of stock of a specified 10-percent owned foreign corporation that the domestic corporation holds for 365 days or less during the 731-day period beginning on the date that is 365 days before the date on which the share becomes ex-dividend with respect to the dividend. Under section 246(c)(1)(B), a section 245A deduction is also not allowed to the extent the domestic corporation is under an obligation to make related payments with respect to positions in substantially similar or related property.

The Treasury Department and the IRS have determined that as a result of the enactment of the participation exemption system, the current broad application of section 956 to corporate U.S. shareholders would be inconsistent with the purposes of section 956 and the scope of transactions it is intended to address. Congress determined that certain investments by a CFC of its earnings in United States property are “substantially the equivalent of a dividend” and enacted section 956 to provide similar treatment for dividends and certain investments in United States property constituting effective repatriations. S. Rep. No. 1881 at 88. Before the Act, section 956 applied appropriately to domestic corporations because both dividends from, and investments in United States property by, CFCs were included in income by such domestic corporations. As noted, the purpose of section 956 is generally to create symmetry between the taxation of actual repatriations and the taxation of effective repatriations, by subjecting effective repatriations to tax in the same manner as actual repatriations. Under the participation exemption system, however, earnings of a CFC that are repatriated to a corporate U.S. shareholder as a dividend are typically effectively exempt from tax because the shareholder is generally afforded an equal and offsetting dividends received deduction under section 245A. A section 956 inclusion of a corporate U.S. shareholder, on the other hand, is not eligible for the dividends received deduction under section 245A (because it is not a dividend). As a result, the application of section 956 after the Act to corporate U.S. shareholders of CFCs that would qualify for section 245A deductions would result in disparate treatment of actual dividends and amounts “substantially the equivalent of a dividend”—a result directly at odds with the manifest purpose of section 956.

Accordingly, the proposed regulations continue the Treasury Department and the IRS's longstanding practice of conforming the application of section 956 to its purpose. The proposed regulations exclude corporate U.S. shareholders from the application of section 956 to the extent necessary to maintain symmetry between the taxation of actual repatriations and the taxation of effective repatriations. In general, under section 245A and the proposed regulations, respectively, neither an actual dividend to a corporate U.S. shareholder, nor such a shareholder's amount determined under section 956, will result in additional U.S. tax.

To achieve this result, the proposed regulations provide that the amount otherwise determined under section 956 with respect to a U.S. shareholder for a taxable year of a CFC is reduced to the extent that the U.S. shareholder would be allowed a deduction under section 245A if the U.S. shareholder had received a distribution from the CFC in an amount equal to the amount otherwise determined under section 956. The proposed regulations provide special rules with respect to indirect ownership. Due to the broad applicability of section 245A, in many cases a corporate U.S. shareholder will not have a section 956 inclusion as a result of a CFC holding U.S. property under the proposed regulations.

Section 956 will continue to apply without modification to U.S. shareholders other than corporate U.S. shareholders, such as individuals, to ensure that, consistent with the purposes of section 956, amounts that are substantially the equivalent of a dividend will be treated similarly to actual dividends. This treatment will apply to individuals regardless of whether they make an election under section 962. Because individuals are not eligible for a dividends received deduction under section 245A even if they make an election under section 962, the current application of section 956 to individuals is still necessary to ensure substantial equivalence between an actual repatriation and a deemed repatriation. Similarly, section 956 will continue to apply without reduction to regulated investment companies and real estate investment trusts because they are not allowed the dividends received deduction under section 245A. See sections 852(b)(2)(C) and 857(b)(2)(A).

In addition to carrying out the purposes of section 956, the proposed regulations would significantly reduce complexity, costs, and compliance burdens for corporate U.S. shareholders of CFCs. Absent the proposed regulations, corporate U.S. shareholders would need to continue to carefully monitor the application of section 956 to their operations, including provisions related to loans, guarantees, and pledges, to ensure that earnings were repatriated only through actual dividends, and therefore allowed a participation exemption, rather than through a deemed repatriation under section 956 subject to additional U.S. tax. Similarly, in the absence of the proposed regulations, a U.S.-parented group in many cases would need to engage in complex and costly restructuring upon the acquisition of a foreign corporation that owns domestic subsidiaries (since the foreign corporation becomes a CFC and the stock of its domestic subsidiaries represents United States property) solely to avoid a section 956 inclusion. Absent the proposed regulations, section 956 could also serve as a “trap for the unwary” for domestic corporations that fail to recognize that, even though they are entitled to the deduction under section 245A for actual dividends, their section 956 inclusions would continue to be fully subject to U.S. tax.

The proposed regulations also add, in proposed § 1.956-1(g)(5), the effective date for § 1.956-1(e)(6) that was inadvertently deleted in TD 9792, published in the Federal Register on November 3, 2016 (81 FR 76497, as corrected at 81 FR 95470 and 95471).

The Treasury Department and the IRS intend to make conforming amendments to the examples throughout the regulations under section 956 upon finalization of the proposed regulations.

These changes are proposed to apply to taxable years of a CFC beginning on or after the date of publication of the Treasury decision adopting these rules as final regulations in the Federal Register (the “finalization date”), and to taxable years of a U.S. shareholder in which or with which such taxable years of the CFC end. With respect to taxable years of a CFC beginning before the finalization date, a taxpayer may rely on the proposed regulations for taxable years of a CFC beginning after December 31, 2017, and for taxable years of a U.S. shareholder in which or with which such taxable years of the CFC end, provided that the taxpayer and United States persons that are related (within the meaning of section 267 or 707) to the taxpayer consistently apply the proposed regulations with respect to all CFCs in which they are U.S. shareholders.

The Administrator of the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget, has waived review of this proposed rule in accordance with section 6(a)(3)(A) of Executive Order 12866. OIRA will subsequently make a significance determination of the final rule, pursuant to section 3(f) of Executive Order (E.O.) 12866 and the April 11, 2018, Memorandum of Agreement between the Department of Treasury and the Office of Management and Budget (OMB).

Pursuant to the Regulatory Flexibility Act (5 U.S.C. chapter 6), it is hereby certified that this regulation, if adopted, will not have a significant economic impact on a substantial number of small entities, although some small entities that are domestic corporations could be affected by the regulation and comments are requested on the application of the regulation to domestic partnerships. However, even if a substantial number of small entities were to be affected by this regulation, the Treasury Department and the IRS estimate that the economic impact on such small entities would not be significant as the regulation is expected to marginally reduce compliance costs for smaller entities. This is because the Treasury Department and the IRS believe that the cost-saving benefits of the proposed regulations with respect to complex third-party borrowing arrangements, internal financial management structures, and restructurings of worldwide operations will generally be available only to large U.S. multinational corporations with 20 or more CFCs. The Treasury Department and the IRS believe that U.S. multinational corporations with less than 20 CFCs generally will not have the types of arrangements in place that would otherwise need to be structured and monitored to avoid section 956. The proposed regulations, if adopted, generally will not affect small entities that are not domestic corporations. The Treasury Department and the IRS invite comments on the impact of this rule on small entities.

Pursuant to section 7805(f), this notice of proposed rulemaking has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small businesses.

Before these proposed regulations are adopted as final regulations, consideration will be given to any comments that are submitted timely to the IRS as prescribed in this preamble under the ADDRESSES heading. The Treasury Department and the IRS request comments on all aspects of the proposed rules. In particular, comments are requested as to the appropriate application of the proposed regulations to U.S. shareholders that are domestic partnerships, which may have partners that are a combination of domestic corporations, U.S. individuals, or other persons. For example, one approach could be to reduce the amount otherwise determined under section 956 with respect to a domestic partnership to the extent that a domestic corporate partner would be entitled to a section 245A deduction if the partnership received the amount as a distribution. An alternative could be to determine a domestic partnership's section 956 amount and section 956 inclusion without regard to the status of its partners, but then provide that a corporate U.S. shareholder partner's distributive share of the section 956 inclusion is not taxable. Comments are also requested with respect to the maintenance of previously taxed earnings and profits accounts under section 959 and basis adjustments under section 961. Additionally, comments are requested on the interaction between the proposed regulations and section 245A(e). All comments will be available at http://www.regulations.gov or upon request.

A public hearing will be scheduled if requested in writing by any person that timely submits written comments. If a public hearing is scheduled, notice of the date, time, and place for the public hearing will be published in the Federal Register.

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

Accordingly, 26 CFR part 1 is proposed to be amended as follows:

Legal Authority for This Program

This program was established by Congress for abused dependents of military personnel based on (Pub. L. 103-160) in 1994. This rule consolidates and clarifies existing procedural requirements established by the Act and currently found in internal DOD guidance.

The legislation authorized temporary payments for families in which the active duty soldier had been court-martialed with a qualifying sentence (forfeiture of all pay and allowances, or bad conduct discharge, or dishonorable discharge, or in the instance of officers and commissioned warrant officers, dismissal from the Service) or was being administratively separated from the military as a result of a dependent-abuse offense. DOD began authorizing payments in August 1995 in accordance with DoD Instruction (DoDI) 1342.24, Transitional Compensation for Abused Dependents which was last updated in January 1997 and can be found at http://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/134224p.pdf.

To be eligible for the benefit a family member (spouse or dependent child) must have been living in the home of the Service member. The Service member must have been administratively separated for a dependent-abuse offense; or convicted of a dependent-abuse offense and either separated under a court-martial sentence or sentenced to a forfeiture of all pay and allowances.

A dependent-abuse offense must be the basis for the administrative separation or conviction, although it does not have to be the primary reason. Active duty victims of dependent-abuse are also eligible for transitional compensation, when the offender is also active duty.

• Amount of the benefit: The compensation amount is based on the Dependency and Indemnity Compensation, which changes annually. Current amounts can be found at the Department of Veterans Affairs Dependency and Indemnity Compensation website at https://benefits.va.gov/compensation/types-dependency_and_indemnity.asp.

• Length of the benefit: The transitional compensation is available for the longer of 12 months or the unserved portion of the Service member's obligated active service. Compensation will not extend beyond 36 months.

• Maintaining eligibility: Individuals become ineligible for compensation and benefits if they remarry or move back in with the former Service member while receiving benefits.

• Recertifying eligibility: If compensation is available for more than 12 months, recertification is required annually to ensure eligibility for transitional compensation.

• Other benefits: As part of the Transitional Compensation Program, individuals may be eligible for other benefits including medical care, exchange privileges and commissary privileges.

Transitional compensation is one of the many resources available to military families. Each installation's Family Advocacy Program or legal assistance office can help a family apply for transitional compensation as well as other means of assistance.

Per DoD's Financial Management Regulation at https://comptroller.defense.gov/Portals/45/documents/fmr/current/07b/07b_60.pdf, transitional compensation payments are not taxable. Transitional compensation recipients should not expect to receive a Form 1099 for tax purposes. Also, recipients need not report transitional compensation payments on their tax return.

According to DoD Policy, transitional compensation for a dependent spouse or former spouse is at the same rate as defined in 38 U.S.C. 1311—Dependency & Indemnity Compensation to a Surviving Spouse. There is also an additional amount for children under this section. For children without a mil-spouse parent, the amount is the same as the rate defined in 38 U.S.C. 1313—Dependency & Indemnity Compensation to Children. You can find annual updates to these payments on the DoD Comptroller's website at https://comptroller.defense.gov/Portals/45/documents/fmr/Volume_07b.pdf.

The intent of this program is to encourage victims of dependent-abuse to come forward and report abuse, provide assistance to victims to separate from the abuser, inform the victims of resources available to them as a victim of dependent-abuse, ensure the safety and well-being of the victims, and ensure the Department of Defense does not leave a spouse and family financially destitute when the abusing Service member is discharged from the military for a dependent-abuse offense. In accordance with statute, the rate of payment varies based on the rank of the Service member, but it is designed to cover living expenses such as food, clothing and housing. The Department spends approximately $17M each fiscal year in transitional compensation payments. This proposed rule publishes instructions internal to DoD without any changes to the policies already in place, and therefore will not result in any changes to the number of TC recipients or the amount they are paid.

Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget (OMB).

This proposed rule is not expected to by subject to the requirements of E.O. 13771 (82 FR 9339, February 3, 2017) because this proposed rule is expected be related to agency organization, management, or personnel.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1532) requires agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. This rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.

The Department of Defense certifies that this proposed rule is not subject to the Regulatory Flexibility Act because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

Section 111.6(f)(1) of this proposed rule contains information collection requirements. These reporting requirements have been approved by the Office of Management and Budget and assigned OMB Control Number 0704-0578, “Transitional Compensation for Abused Dependents (TCAD).”

The applicable Systems of Records Notice (SORN) is T7347b, Defense Military Retiree and Annuity Pay System Records (January 7, 2009, 74 FR 696), http://dpcld.defense.gov/Privacy/SORNsIndex/DOD-wide-SORN-Article-View/Article/570196/t7347b/. The Privacy Impact Assessment (PIA) is available at https://www.dfas.mil/dam/jcr:5cf8a068-89c7-47eb-b844-1e2020ed5f73/Defense%20Retiree%20and%20Annuitant%20Pay%20System%20(DRAS)%202016.pdf; or https://www.dfas.mil/dfas/foia/privacyimpactassessments.html.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This proposed rule will not have a substantial effect on State and local governments.

On October 10, 2018, Pyrotecnico, Inc., of New Castle, PA, notified the Coast Guard that it will be conducting a fireworks display from 7:45 p.m. to 8 p.m. on December 1, 2018, sponsored by The Wharf DC. The fireworks are to be launched from a barge in the Washington Channel, adjacent to The Wharf DC in Washington, DC. Additional details were received on October 18, 2018. Hazards from the fireworks display include accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris. The Captain of the Port Maryland-National Capital Region (COTP) has determined that potential hazards associated with the fireworks to be used in this display would be a safety concern for anyone within 200 feet of the fireworks barge.

The purpose of this rulemaking is to ensure the safety of vessels on the navigable waters within 200 feet of the fireworks barge on the Washington Channel before, during, and after the scheduled event. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231.

Because of when final details of the event were provided to the Coast Guard, the Coast Guard does not have time to provide a full 30 day comment period and publish a final rule. Instead, the Coast Guard is providing 14 day comment period. The Coast Guard believes that 14 days will provide adequate time for interested individuals to review and provide meaningful comment on the proposal.

The COTP proposes to establish a temporary safety zone in the Washington Channel from 7 p.m. to 9 p.m. on December 1, 2018. The safety zone would cover all navigable waters within 200 feet of the fireworks barge in the Washington Channel located within an area bounded on the south by latitude 38°52′30″ W, and bounded on the north by the Francis Case (I-395) Memorial Bridge, located at Washington, DC. The duration of the safety zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled fireworks display. No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. The regulatory text we are proposing appears at the end of this document.

We developed this proposed 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 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, duration, and time-of-day of the safety zone. Although vessel traffic will not be able to safely transit around this safety zone, the impact would be for 2 hours during the evening when vessel traffic in Washington Channel is normally low. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed 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 safety zone may be small entities, for the reasons stated in section IV.A above, this proposed 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 (Pub. L. 104-121), we want to assist small entities in understanding this proposed 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. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed 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 proposed 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 proposed 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 proposed 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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary 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 proposed rule involves a safety zone lasting 2 hours that would prohibit entry within a portion of the Washington Channel. 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 preliminary Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

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

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit http://www.regulations.gov/privacyNotice.

Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:

Background

The Orrin G. Hatch-Bob Goodlatte Music Modernization Act, Public Law 115-264, 132 Stat. 3676 (Oct. 11, 2018) (MMA), implements changes in administration of copyright royalties relating to the music industry. The most sweeping changes relate to the copyrights of songwriters and publishers of nondramatic musical works. Prior to enactment of the MMA, section 115 of title 17 (Copyright Act) detailed procedures for administration of the compulsory license (also known as the “mechanical” compulsory license) to reproduce and distribute, including by digital transmissions, phonorecords embodying copyrighted musical works.

Chapter 8 of the Copyright Act requires the Copyright Royalty Judges (Judges) to conduct proceedings every five years to determine the rates and terms for the section 115 license. See 17 U.S.C. 801(b)(1), 804(b)(4). In the MMA, Congress authorized designation of an entity, the Mechanical License Collective (MLC) to serve as a clearinghouse for collection and distribution of royalties and to develop a comprehensive database to ensure efficient and appropriate payment and distribution of those royalties.

Creation of the MLC and the other statutory changes in the MMA requires or authorizes modification of the Judges' regulations relating to section 115. For example, section 102(d) of the MMA requires the Judges, not later than 270 days after enactment of the MMA, to amend part 385 of 37, Code of Federal Regulations (CFR) “to conform the definitions used in such part to the definitions of the same terms described in section 115(e) of title 17, United States Code, as added by” section 102(a) of the MMA. That provision also directs the Judges to “make adjustments to the language of the regulations as necessary to achieve the same purpose and effect as the original regulations with respect to the rates and terms previously adopted by the [Judges].” In addition, the MMA authorizes the Judges to adopt regulations concerning proceedings to set the administrative assessment established by the statute to fund the MLC. 17 U.S.C. 115(d)(7)(D)(viii), 115(d)(12)(A).

The MMA also adds a new section 801(b)(8) to the Copyright Act, which authorizes the Judges “to determine the administrative assessment to be paid by digital music providers under section 115(d)” but states that “[t]he provisions of section 115(d) shall apply to the conduct of proceedings by the [Judges] under section 115(d) and not the procedures in this section, or section 803, 804, or 805.”

The Judges seek input from persons and entities who reasonably believe they have a significant interest in the content of necessary or appropriate changes to the regulations in chapter III, title 37, Code of Federal Regulations (CFR). The Judges also seek input from persons and entities who reasonably believe they have a significant interest in interpreting and applying the changes the MMA purports to make to chapter 8 of the Copyright Act.

Specifically, but not exclusively, the Judges seek comments regarding the following questions.

(1) What regulations in chapter III, title 37 CFR, if any, must be changed and how?

(2) What regulations in chapter III, title 37 CFR, if any, should be changed and how?

(3) What effect, if any, does the new language in subparagraph 8 of section 801(b) have on the Judges' ability to make necessary procedural or evidentiary rulings under sections 801, 803, 804, and/or 805 1 of the Copyright Act, and, in particular, does the new language have the effect that the Judges are now required to adopt new regulations, notwithstanding their general authority under section 801(c)?

(4) If the new language in subparagraph 8 of section 801(b) affects the Judges' authority under other subsections of section 801, how does it change that authority or the procedures to exercise that authority?

The Judges solicit proposed new or modified regulatory language that may be necessary to fully implement the MMA. Commenting persons and entities must support each legal conclusion and each proposed regulatory change with appropriate legal analysis and citation to authority. After considering the proposals, if the Judges determine that rulemaking is required, the Judges will publish a formal notice of proposed rulemaking in accordance with the provisions of the Administrative Procedures Act.

On September 18, 2001, North Carolina submitted a rule section regarding the control of NOX emissions from large stationary combustion sources to EPA for approval into its SIP.1 The rule section—NCAC 15A 02D .1400—contained Rules .1401—“Definitions”; .1403—“Compliance Schedules”; .1413—“Sources Not Otherwise Listed in This Section”; .1414—“Tune-up Requirements”; and .1423—“Large Internal Combustion Engines” as well as other rules not related to today's proposed action. The submittal also included a rule entitled “.1406 Utility Boilers (Repealed)” with no regulatory text. EPA approved the September 18, 2001, SIP revision on December 27, 2002, with the exception of Rule .1406 and the addition of Rules .1413, and .1414, among others. EPA did not act on Rule .1406 because the rule contained no regulatory text and because Rule .1406 was not in the SIP, thus there was nothing to repeal. See 67 FR 78987 for further information.

On August 14, 2002, North Carolina submitted a SIP revision to EPA containing changes to its Section 1400 NOX rules. The submission included changes to Rule .1401—“Definitions”; .1403—“Compliance Schedules”; .1413—“Sources Not Otherwise Listed in This Section”; .1414—“Tune-up Requirements”; and .1423—“Large Internal Combustion Engines” as well as changes to other rules not related to today's proposed action. The submittal again included a rule entitled “.1406 Utility Boilers (Repealed)” with no regulatory text. North Carolina took these rule changes to hearing on May 21, 2001, and June 5, 2001. EPA did not act on the August 14, 2002, submittal.

On June 5, 2017, North Carolina withdrew its August 14, 2002, SIP submittal and resubmitted the changes to Rules .1401, .1403, .1413, .1414, and .1423 contained in the 2002 submittal along with the repeal of Rule .1406. The June 5, 2017, submittal relies on the hearing record associated with the August 14, 2002, submittal because the rule text is identical. On June 28, 2018, North Carolina supplemented its June 5, 2017, submittal to acknowledge that Rules .1413 and .1414 are not in the SIP.

EPA has reviewed the June 5, 2017, submittal, as supplemented on June 28, 2018, and proposes to act on Rules .1401, .1413, and .1414 and not to act on Rules .1403, .1406, and .1423, as discussed below.2

North Carolina modified Rule .1401 to clarify which definitions outside of the rule apply to Section .1400, including definitions from the Code of Federal Regulations (CFR) as discussed below; add a definition of “combustion turbine”; revise several existing definitions; and renumber the paragraphs within the rule. The State added the definition of “combustion turbine” from 40 CFR 96.2—“an enclosed fossil or other fuel-fired device that is comprised of a compressor, a combustor, and a turbine, and in which the flue gas resulting from the combustion of fuel in the combustor passes through the turbine, rotating the turbine”—for consistency with the federal rule. The revised definitions are discussed below.

North Carolina modified the definition of “reasonable effort” to replace the term “optimization of” with “utilization” in the phrase “`Reasonable effort' means the proper installation of technology designed to meet the requirements of Rule .1407, .1408, or .1409 of this Section and the optimization of this technology, according to the manufacturer's recommendations or other similar guidance for not less than six months, in an effort to meet the applicable limitation for a source.” Given the limited applicability of the provision, the continued requirement to follow manufacturers' recommendations or other similar guidance, the fact that it was state effective in 2002, and the lack of nonattainment areas in the State for any criteria pollutant, EPA does not believe that incorporating the revision into the SIP will interfere with any applicable requirement regarding attainment and reasonable further progress or any other applicable CAA requirement.

Under the SIP-approved definitions of “emergency generator” and “emergency use internal combustion engines,” subject internal combustion engines are included only during the loss of primary power at the facility that is beyond the control of the owner or operator of the facility or during maintenance “when necessary to protect the environment.” In its June 5, 2017, SIP revision, North Carolina replaced the phrase “when necessary to protect the environment” with the phrase “when maintenance is being performed on the power supply to equipment that is essential in protecting the environment or to such equipment itself.” EPA believes that this is a clarifying change and therefore does not relax the rule.

The State made a number of additional clarifying changes. North Carolina reworded the definition of “fossil fuel fired” to clarify that the term applies to certain sources where fossil fuel is combusted either alone or in combustion with other fuel. The definition of “ozone season” is revised in the submittal to clarify that it begins on May 31 and ends on September 30 for 2004 and begins on May 1 and ends on September 30 for all other years. The definitions of “seasonal energy input” and “seasonal energy output” are also revised to clarify that they cover the period beginning on May 1 and ending on September 30. In addition, the State clarified that the definitions in 15A NCAC 2D .0101 from the general definitions and references section of Chapter 2D apply to Section 1400 (unless there is a conflict, in which case the definitions in Rule .1401 control) as well as N.C.G.S. 143-121 and 143-213, the definitions in the governing state air statute. The State also added paragraph (b) stating that whenever reference is made to the CFR, the definitions in the CFR apply unless specifically stated otherwise. These clarifying changes do not alter the meaning of these definitions.

The version of Rule .1403 included in the June 5, 2017, SIP revision was state effective in 2002. However, on January 31, 2008, the State submitted a SIP revision to EPA containing a version of the rule that was state effective on July 1, 2007. EPA approved the portion of that SIP revision regarding Rule .1403 and incorporated the July 1, 2007, version of the rule into the SIP on May 9, 2013 (78 FR 27065). Because the later version of the rule superseded the July 15, 2002, version contained in the June 5, 2017, SIP revision, EPA is not taking action on the portion of the submittal regarding Rule .1403.

The June 5, 2017, SIP revision includes a rule entitled “.1406 Utility Boilers (Repealed)” with no regulatory text. EPA is not proposing to act on Rule .1406 because the rule contains no regulatory text and because Rule .1406 is not in the SIP.

Rule .1413 requires subject sources of NOX other than boilers, indirect-fired process heaters, stationary combustion turbines, and stationary internal combustion engines at facilities with a potential to emit of 100 tons per year or more of NOX or 560 pounds per calendar day or more from May 1 through September 30 to apply Reasonably Available Control Technology (RACT). The rule also requires owners or operators of such sources to submit certain information to the State, including a proposed limitation for consideration as RACT, and requires the Director to approve the proposed limitation if he finds that the source has submitted all of the necessary information, the source is covered under the rule, and that the proposed limitation is RACT for the source.

The June 5, 2017, SIP revision identified changes to Rule .1413 in a redline/strikeout format; however, EPA has never incorporated Rule .1413 into the SIP. Therefore, on June 28, 2018, North Carolina supplemented its submittal with a revised redline/strikeout version of the rule acknowledging that none of the rule text is in the SIP. EPA is now proposing to incorporate Rule .1413 into the SIP because the rule imposes NOX emissions controls on sources in the State and is thus a SIP strengthening measure.

Rule .1414 provides tune-up requirements for certain boilers, indirect-fired process heaters, and stationary internal combustion engines. Owners and operators with equipment subject to the rule must perform tune-ups at least annually in accordance with manufacturers' recommendations and maintain records of the tune-ups.

The June 5, 2017, SIP revision identified changes to Rule .1414 in a redline/strikeout format; however, EPA has never incorporated Rule .1414 into the SIP. Therefore, on June 28, 2018, North Carolina supplemented its submittal with a revised redline/strikeout version of the rule acknowledging that none of the rule text is in the SIP. EPA is now proposing to incorporate Rule .1414 into the SIP because the rule imposes maintenance requirements on certain NOX emitting equipment in the State to ensure proper operation and is thus a SIP strengthening measure.

EPA is not proposing to act on the changes to Rule .1423 at this time.

In this document, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference North Carolina regulations 15 NCAC 02D .1401—“Definitions,” modified to clarify which definitions outside of the rule apply to Section .1400, including definitions from the CFR, add a definition for “combustion turbine,” modify the definition of “reasonable effort,” “emergency generator,” “emergency use internal combustion engines,” “fossil fuel fired,” “ozone season,” “seasonal energy input” and “seasonal energy output,” and renumber the paragraphs within the rule, state effective on July 15, 2002; .1413—“Sources Not Otherwise Listed in This Section,” which includes rules for NOX sources not otherwise listed in section .1400, state effective on July 18, 2002; and .1414—“Tune-Up Requirements,” which includes tune-up requirements for certain boilers, indirect-fired process heaters and stationary internal combustion engines, state effective on July 18, 2002. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 office (please contact the person identified in the For Further Information Contact section of this preamble for more information).

Pursuant to section 110 of the CAA, EPA is proposing to approve the aforementioned changes to the North Carolina SIP. EPA has evaluated the relevant portions of North Carolina's June 5, 2017, SIP revision, as supplemented on June 28, 2018, and is proposing to determine that they meet the applicable requirements of the CAA and its implementing regulations.

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 they meet the criteria of the CAA. This action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed 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 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 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.

I. Background

Under section 110 of the CAA, states are required to have SIPs that provide for the implementation, maintenance, and enforcement of the NAAQS. States are further required to make a SIP submission meeting the applicable requirements of sections 110(a)(1) and (2) within three years of EPA promulgating a new or revised NAAQS.1 EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of CAA sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Sections 110(a)(1) and (2) require states to address basic SIP elements such as for monitoring, basic program requirements and legal authority that are designed to assure attainment and maintenance of the newly established or revised NAAQS. More specifically, section 110(a)(1) provides the procedural and timing requirements for SIPs; section 110(a)(2) lists specific elements that states must meet for infrastructure SIPs 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.

This action pertains to one of the requirements of section 110(a)(2) that is relevant in the context of a state's development, and EPA's evaluation of, infrastructure SIP submissions: the minor source requirements of section 110(a)(2)(C). Specifically, this action pertains to the Kentucky infrastructure SIP submissions for the 2012 annual primary PM2.5, 2010 primary NO2, and 2010 primary SO2 NAAQS. All other applicable infrastructure requirements for the 2012 PM2.5, 2010 NO2, and 2010 SO2 NAAQS for Kentucky are being or have been addressed in separate rulemakings.

A brief background regarding the NAAQS relevant to today's proposal is provided below. For comprehensive information on these NAAQS, please refer to the Federal Register rulemakings cited below.

On December 14, 2012 (78 FR 3086, January 15, 2013), EPA revised the primary annual PM2.5 NAAQS. The standard was strengthened from 15.0 micrograms per cubic meter (μg/m3) 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. For the 2012 PM2.5 NAAQS, EPA is proposing to approve the minor source element of the infrastructure SIP submission submitted by KDAQ on February 8, 2016.2

On January 22, 2010 (75 FR 6474, February 9, 2010), EPA established a new 1-hour primary NAAQS for NO2 at a level of 100 parts per billion (ppb), based on a 3-year average of the 98th percentile of the yearly distribution of 1-hour daily maximum concentrations. States were required to submit infrastructure SIP submissions for the 2010 NO2 NAAQS to EPA no later than January 22, 2013. For the 2010 NO2 NAAQS, EPA is proposing to approve the minor source element of the infrastructure SIP submission submitted by KDAQ on April 26, 2013.3

On June 2, 2010 (75 FR 35520, June 22, 2010), EPA revised the primary SO2 NAAQS to an hourly standard at a level of 75 ppb, based on a 3-year average of the annual 99th percentile of 1-hour daily maximum concentrations. States were required to submit infrastructure SIP submissions for the 2010 1-hour primary SO2 NAAQS (“2010 SO2 NAAQS”) to EPA no later than June 2, 2013. For the 2010 SO2 NAAQS, EPA is proposing to approve the minor source element of the infrastructure SIP submission submitted by KDAQ on April 26, 2013.4

Section 110(a)(2)(C) requires SIPs to “include a program to provide for the enforcement of the measures described in subparagraph (A) [i.e., enforceable emission limitations and measures], and regulation of the modification and construction of any stationary source within the areas covered by the plan as necessary to assure that the [NAAQS] are achieved, including the permit program as required in parts C and D of this subchapter.” Generally, EPA summarizes the requirements of 110(a)(2)(C) as requiring that SIPs address three components: enforcement, state-wide regulation of new and modified minor sources and minor modifications of major sources; and prevention of significant deterioration (PSD) permitting of major sources and major modifications in areas designated attainment or unclassifiable for the subject NAAQS as required by CAA title I part C (i.e., the PSD program).5 EPA is proposing action only on the minor source program element of 110(a)(2)(C) for Kentucky's infrastructure SIP submissions for the 2012 PM2.5, 2010 NO2, and 2010 SO2 NAAQS.

EPA rules addressing SIP requirements for pre-construction regulatory programs that apply to minor sources and minor modifications are at 40 CFR 51.160 through 51.164. Pursuant the 2013 guidance, EPA's review of infrastructure SIP submissions with respect to the minor source requirements in section 110(a)(2)(C) focuses on assuring that the state's SIP meets basic minor source program requirements. Thus, EPA evaluates whether the state has identified existing EPA-approved SIP provisions (or submitted for approval new provisions) containing requirements for minor sources and minor modifications (minor new source review (NSR) program) and whether the program addresses the pollutants relevant to that NAAQS.6

On April 26, 2013, and February 8, 2016, KDAQ submitted infrastructure SIP submissions to EPA that addressed the minor source element of section 110(a)(2)(C) for the pollutants relevant to the 2012 PM2.5, 2010 NO2, and 2010 SO2 NAAQS, in addition to other infrastructure SIP requirements. KDAQ also provided clarifying information to EPA on December 18, 2017, and May 2, 2018, describing Kentucky's suite of SIP-approved regulations which comprise the basic structural elements of the minor source program in the Commonwealth.7 Specifically, the Commonwealth cited to the following Kentucky Administrative Regulations (KAR) under title 401 to meet the minor source SIP requirements: Kentucky's NSR permitting regulations are found at 401 KAR 51:001, Definitions of Chapter 51; 401 KAR 51:017, Prevention of significant deterioration of air quality; and 401 KAR 51:052, Review of new sources in or impacting upon nonattainment areas. Kentucky addresses requirements for public participation and public availability of information through 401 KAR 52:100, Public, affected state, and U.S. EPA review. 401 KAR 50:060, Enforcement, establishes legally enforceable procedures. Air dispersion modeling requirements under the NSR permitting process are addressed in 401 KAR 51:017; 401 KAR 51:052; and 401 KAR 50:040, Air quality models. 401 KAR 50:065, Conformity of general federal actions, sets forth procedures for determining the conformity of general federal actions to the Kentucky SIP and requires consultation between federal government and state government, and, as applicable, any local agency. 401 KAR 50:042, Good engineering practice stack height, addresses stack height requirements. Further, Kentucky's May 2, 2018, correspondence describes how minor sources are evaluated in the NSR permitting process, including how these sources are incorporated into NSR air dispersion modeling analyses as relevant to each case.

Based on the information Kentucky provided in its SIP submissions dated February 8, 2016, and April 26, 2013, and clarified in correspondence to EPA dated December 18, 2017, and May 2, 2018, EPA is proposing to determine Kentucky has a SIP-approved minor NSR program that addresses the pollutants relevant to the 2012 PM2.5, 2010 NO2, and 2010 SO2 NAAQS. EPA has therefore made the preliminary determination that Kentucky's SIP satisfies section 110(a)(2)(C) for new and modified minor sources and minor modifications of major sources related to the 2012 PM2.5, 2010 NO2, and 2010 SO2 NAAQS.

As described above, EPA is proposing to approve the portions of the infrastructure SIP submissions from Kentucky dated February 8, 2016, and April 26, 2013, addressing the minor source requirements of section 110(a)(2)(C) of the CAA for the 2012 PM2.5, 2010 NO2, and 2010 SO2 NAAQS. EPA is proposing approval of the minor source portions of these submissions because they 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 they meet the criteria of the CAA. These actions merely propose to approve state law as meeting Federal requirements and do not impose additional requirements beyond those imposed by state law. For that reason, these proposed 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 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 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.

For additional information, see the direct final rule published in the “Rules and Regulations” section of this Federal Register.

We will accept written comments and information during this reopened comment period on our proposed designation of critical habitat for the spring pygmy sunfish that was published in the Federal Register on October 2, 2012 (77 FR 60180); the revision to the proposed boundaries of Unit 1 described in our April 29, 2013, Federal Register publication (78 FR 25033); the potential exclusions to the designation that we described in our February 5, 2014, Federal Register publication (79 FR 6871); and the new proposed Unit 3 that is described in this document. We will consider information and recommendations we receive from all interested parties. We intend that any final action resulting from this proposal will be based on the best scientific data available and be as accurate and effective as possible.

We request comments or information from any interested party on any aspect of the proposed designation. However, we particularly seek comments concerning:

(1) The reasons why we should or should not designate habitats as “critical habitat” under section 4 of the Act, including whether there are threats to the species from human activity, the degree of which can be expected to increase due to the designation, and whether that increase in threat outweighs the benefit of designation such that the designation of critical habitat is not prudent.

(2) Land use designation and current or planned activities in the subject areas and their possible impacts on proposed critical habitat.

If you submitted comments or information on the proposed rule during the initial comment period from October 2, 2012, to December 3, 2012; during the second comment period from April 29, 2013, to May 29, 2013; or during the third comment period from February 5, 2014, to March 7, 2014, please do not resubmit them. We have incorporated them into the public record as part of the previous three comment periods, and we will fully consider them in the preparation of our final determination.

You may submit your comments and materials by one of the methods listed in ADDRESSES. If you submit a comment via http://www.regulations.gov, your entire comment—including any personal identifying information—will be posted on the website. We will post all hardcopy comments on http://regulations.gov as well. If you submit a hardcopy comment that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so.

Comments and materials we receive, as well as supporting documentation we used in preparing the proposed rule, are available for public inspection on http://www.regulations.gov at Docket No. FWS-R4-ES-2013-0010, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Alabama Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

For information on the spring pygmy sunfish's biology, status, distribution, and habitat, refer to the October 12, 2012, proposed listing and critical habitat rule (77 FR 60180), and the October 2, 2013, final listing rule (78 FR 60766).

On October 2, 2012, we published a proposed rule (77 FR 60180) to list the spring pygmy sunfish as a threatened species and to designate critical habitat for the species. In that proposed rule, we proposed to designate two critical habitat units, totaling approximately 12.9 kilometers (km) (8 stream miles (mi)) and 654.4 hectares (ha) (1,617 acres (ac)) of spring system habitat and adjacent upland buffer in Limestone County, Alabama. Previous Federal actions occurring before October 2, 2012, are summarized in that proposed rule.

On April 29, 2013, we published a document (78 FR 25033) reopening the comment period on the proposed listing and critical habitat for 30 days. That document requested public comments on amendments to the required determinations section of the October 2, 2012, proposal, the draft economic analysis, and a proposed reduction in the size of the critical habitat designation based on information we received during the original public comment period. Specifically, we proposed to reduce the size of Unit 1 by 27.3 ha (67.6 ac), resulting in a proposed critical habitat designation totaling approximately 12.9 km (8 stream mi) and 627.02 ha (1,549.4 ac).

On October 2, 2013, we published a final rule (78 FR 60766) listing the spring pygmy sunfish as a threatened species.

On February 5, 2014, we again reopened the comment period, for an additional 30 days, on the proposed designation of critical habitat to announce exclusions we are considering to proposed critical habitat Unit 1 (79 FR 6871). In that document, we asked for public comments on excluding lands enrolled in candidate conservation agreements with assurances (CCAAs) in accordance with section 4(b)(2) of the Act. Specifically, we are considering excluding all areas covered by the Belle Mina Farms Ltd., McDonald Farm, and Horton Farm CCAAs based on our partnerships with the landowners and the conservation benefits that these agreements afford the spring pygmy sunfish. We will make the final determination on these exclusions in our final rule.

It is our intent to discuss only those topics directly relevant to the designation of critical habitat for the spring pygmy sunfish in this document.

Section 3 of the Act defines critical habitat as the specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the Act, on which are found those physical or biological features (PBFs) essential to the conservation of the species and that may require special management considerations or protection, and specific areas outside the geographical area occupied by a species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. If the proposed rule is made final, section 7 of the Act will prohibit destruction or adverse modification of critical habitat by any activity funded, authorized, or carried out by any Federal agency. Federal agencies proposing actions affecting critical habitat must consult with us on the effects of their proposed actions, under section 7(a)(2) of the Act.

In November 2015, surveys conducted by the Geologic Survey of Alabama (GSA) and Service employees on Wheeler National Wildlife Refuge (NWR) in Madison County, Alabama, verified a new population of spring pygmy sunfish in Blackwell Swamp following the documentation of the species at the swamp in September 2015, by researchers from Jacksonville State University. The discovery of the new population is significant because it occurs outside the Beaverdam Spring complex, the only known occupied site on October 2, 2013, when we listed the spring pygmy sunfish as a threatened species under the Act, and increases the number of known metapopulations from one to two. Based on new information gathered during the November 2015 survey, we are revising the proposed designation of critical habitat to include a new unit (Unit 3) in Madison County, Alabama. This new unit contains all of the PBFs for the spring pygmy sunfish. Because of the limited range of the spring pygmy sunfish, we have determined that the new population in Blackwell Swamp and its associated habitat is essential to the conservation of the species and may require special management considerations or protection. A map of proposed Unit 3 appears under Proposed Regulation Promulgation, below.

Based on the above information, we are proposing to revise the proposed critical habitat designation to include Blackwell Swamp as Unit 3. We provide occupancy and ownership tables below that include information on all three proposed critical habitat units.

We present a brief description of Unit 3, and reasons why it meets the definition of critical habitat, below.

Unit 3 includes a total of 123 ha (303 ac) of Federal land and 2.3 stream km (1.4 mi), all of which is federally owned within the Wheeler NWR in Madison County, Alabama. This unit is located about 4.3 km (2.7 mi) due west of the town of Triana. This unit is 0.96 km (0.6 mi) north of Blackwell Run's confluence with the Tennessee River; approximately 1 km (0.5 mi) south of Swancott Road SW; about 1 km (0.5 mi) west of Landess Circle; and just to the east of B. Road/County Line Road SW. Unit 3 is currently occupied by spring pygmy sunfish and contains all the PBFs essential to the species' survival and eventual recovery. Unit 3 provides habitat for the spring pygmy sunfish via the spring systems of Blackwell Swamp, which include spring runs and a large spring-fed pool that was enlarged after Blackwell Spring Run was impounded (PBF 1).

There is adequate water quality (PBF 2), water quantity and flow (PBF 3), and a diversity of emergent vegetation (PBF 4) to support the normal life stages and behavior of the spring pygmy sunfish and its prey sources (PBF 4).

Wheeler NWR actively manages water levels in proposed Unit 3 to enhance use by waterfowl. The water in the unit is replenished by surface flow from runoff, a small stream in the northeast corner, and numerous spring seeps of the Blackwell Spring system. The Tennessee River does not influence the spring pool unless allowed to enter the pool through the water control structure, which may occur in the course of waterfowl management. During flood conditions, water inundates and enters secondary channels and sloughs located to the south and southeastern portion of the unit and flows in a southerly direction with the spring run, sometimes overtopping the roads on the west and east side of the unit.

Threats to the spring pygmy sunfish and its habitat in Unit 3 that may require special management or protection of the PBFs include structures, such as boat ramps; an unpaved, gravel-maintained, refuge road (11.7 km; 7.3 mi) circling the unit; and sewer, gas, and water easements, including a City of Huntsville sewer line right-of-way to the east. Additional threats outside and adjacent to the unit include increased agriculture, urbanization, and industrialization activities (such as channel modification for flood control, construction of impoundments, and water extraction) that significantly alter spring flow regime and water quality and quantity; inadequate stormwater management; water diversion; significant changes in streambed material composition and quality as a result of construction projects and maintenance activities that damage or destroy aquatic vegetation and vegetation in the riparian zone; off-road vehicle use; bridge and road construction and maintenance, and culvert and pipe placement; and other watershed and floodplain disturbances that release sediments or nutrients into the water. Many threats that result in decreased water quality and quantity are likely to be amplified during drought events.

The spring pygmy sunfish occurs in Unit 3, which is entirely within Wheeler NWR. In areas where the spring pygmy sunfish is present, Federal agencies already are required to consult with the Service under section 7 of the Act on activities they authorize, fund, or carry out that may affect the species. If we finalize the proposed critical habitat designation, measures to avoid the destruction or adverse modification of critical habitat would be incorporated into the existing consultation process for refuge activities. Therefore, the draft economic analysis prepared for Unit 1 and Unit 2 (78 FR 25033) is not significantly affected by the addition of Unit 3 in proposed critical habitat.

The primary authors of this document are the staff members of the Alabama Ecological Services Field Office.

Accordingly, we propose to further amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as proposed to be amended at 77 FR 60180 (October 2, 2012) as set forth below: