Discussion

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Trig Avionics Limited TT31, Avidyne Corporation AXP340, and BendixKing/Honeywell International KT74 Mode S transponders. The NPRM published in the Federal Register on March 22, 2019 (84 FR 10735). The NPRM was prompted by the discovery that the retaining cam that engages in the mounting tray may not withstand g-forces experienced during an emergency landing. The NPRM proposed to require one-time inspection of the transponder installation to determine if it is a conventional aft-facing installation, and depending on the findings, removal of the affected transponder for modification. The FAA is issuing this AD to address the unsafe condition on these products.

The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2018-0247, dated November 13, 2018 (referred to after this as “the MCAI”), to address the unsafe condition on these products. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-1081.

The FAA gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.

An individual commenter commented that paragraph (g)(1) of the NPRM does not state clearly that no further action is required if the transponder is installed in a conventional rear facing installation.

The FAA agrees. The FAA added a new paragraph (g)(2) to this AD to indicate that no further action is required if the transponder is installed in a conventional aft-facing avionics rack. Because of this change, paragraph (g)(2) in the NPRM becomes paragraph (g)(3) and paragraph (g)(3) in the NPRM becomes paragraph (g)(4) in this AD.

An individual commenter supported the AD because it is cost-effective and the manufacturer may cover some of the costs under warranty.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the change described previously and minor editorial changes. The FAA has determined that these minor changes:

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

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

The FAA has also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.

The FAA reviewed Trig Avionics Limited Service Bulletin (SB) SUP/TT31/027, Issue 1.0, dated October 1, 2018; Trig Avionics Limited SB SUP/AXP340/002, Issue 1.0, dated October 1, 2018; and Trig Avionics Limited SB SUP/KT74/005, Issue 1.0, dated October 1, 2018.

Trig Avionics Limited SB SUP/TT31/027, Issue 1.0, dated October 1, 2018, describes procedures for determining the direction of the Trig Avionics Limited TT31 Mode S transponder installation and removal of these affected transponders for replacement or repair. Trig Avionics Limited SB SUP/AXP340/002, Issue 1.0, dated October 1, 2018, describes procedures for determining the direction of the Avidyne Corporation AXP340 Mode S transponder installation and removal of these affected transponders for replacement or repair. Trig Avionics Limited SB SUP/KT74/005, Issue 1.0, dated October 1, 2018, describes procedures for determining the direction of the BendixKing/Honeywell International KT74 Mode S transponder installation and removal of these affected transponders for replacement or repair.

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.

The FAA estimates that this AD affects 2,390 transponders installed on airplanes of U.S. registry.

The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any necessary repairs that are required based on the results of the inspection. The FAA has no way of determining the number of aircraft that might need these repairs:

According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all costs in our cost estimate.

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.

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.

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

For the reasons discussed above, I certify this AD:

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

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

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

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

Discussion

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all The Boeing Company Model 737 series airplanes. The NPRM published in the Federal Register on March 1, 2019 (84 FR 6981). The NPRM was prompted by a report that structural fatigue cracks can develop in certain aluminum pressure module check valves prior to the design limit. The NPRM proposed to require an inspection to determine the part numbers of the four hydraulic systems A and B pressure module check valves and applicable on-condition actions.

The FAA is issuing this AD to address structural fatigue cracks in certain aluminum pressure module check valves, which could cause separation of the check valve head from the check valve body when hydraulic pressure is applied, resulting in injuries to maintenance personnel.

The FAA gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.

Two commenters supported the NPRM. United Airlines (UAL) agreed with the need for the NPRM. A private citizen also expressed support for the NPRM, but added that cost should not be an issue in relation to airplane safety, the cost of the proposed rule is especially low, and that the FAA has an ethical duty to protect the public by adopting the proposed rule.

Aviation Partners Boeing stated that the installation of winglets per Supplemental Type Certificate (STC) ST00830SE or STC ST01219SE does not affect the accomplishment of the manufacturer's service instructions.

The FAA agrees with the commenter that STC ST00830SE and STC ST01219SE do not affect the accomplishment of the manufacturer's service instructions. Therefore, the installation of STC ST00830SE or STC ST01219SE does not affect the ability to accomplish the actions required by this AD. The FAA has not changed this AD in this regard.

UAL requested that the FAA change the proposed applicability from including all The Boeing Company Model 737-8 and 737-9 airplanes, to use the effectivity specified in Boeing Special Attention Requirements Bulletin 737-29-1126 RB, dated October 2, 2018, which specifies The Boeing Company Model 737-8 and 737-9 airplanes, line numbers 5602 through 7050. UAL mentioned that Boeing Special Attention Service Bulletin 737-29-1126, dated October 2, 2018, states that “Airplanes after line number 7050 cannot use Parker check valves as an optional part,” and that this statement is counter to the applicability stated in the NPRM. UAL stated the understanding of this statement to be that The Boeing Company Model 737-8 and 737-9 airplanes, line number 7051 and later were delivered without part number (P/N) H61C0552M1; that the illustrated parts catalog (IPC) does not authorize installation of that part after delivery; and that omission from the IPC should ensure unapproved parts are not installed on The Boeing Company Model 737-8 and 737-9 airplanes, line number 7051 and later; therefore providing an acceptable level of safety.

The FAA disagrees with the request to change the applicability of this AD. The FAA does not control or approve the Boeing IPC, and P/N H61C0552M1 is considered a rotable part. Therefore, the FAA has determined that these parts could later be installed on airplanes that were initially delivered with acceptable parts, making those airplanes subject to the unsafe condition. The FAA has not changed this AD in this regard.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. The FAA has determined that these minor changes:

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

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

The FAA reviewed the following service information.

• Boeing Special Attention Requirements Bulletin 737-29-1123 RB, dated October 2, 2018.

• Boeing Special Attention Requirements Bulletin 737-29-1126 RB, dated October 2, 2018.

• Boeing Special Attention Requirements Bulletin 737-29-1127 RB, dated October 8, 2018.

The service information describes procedures for an inspection to determine the part numbers of the four hydraulic systems A and B pressure module check valves and applicable on-condition actions. On-condition actions include replacement of Parker pressure module check valves, P/N H61C0552M1, with Crissair pressure module check valves, P/N 1C4196. These documents are distinct since they apply to different airplane 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.

The FAA estimates that this AD affects 1,747 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any necessary on-condition actions (per check valve replacement) that would be required. The FAA has 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.

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.

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

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

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

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

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

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 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 proposed rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it establishes Class E airspace extending upward from 700 feet above the surface at Cortland County Airport-Chase Field, Cortland, NY; Elmira/Corning Regional Airport, Elmira/Corning, NY; Ithaca Tompkins Regional Airport, Ithaca, NY; and Tri-Cities Airport, Endicott, NY to support standard instrument approach procedures for IFR operations at these airports.

The FAA published a notice of proposed rulemaking in the Federal Register (84 FR 25497, June 3, 2019) for Docket No. FAA-2019-0347 to establish Class E airspace extending upward from 700 feet above the surface at Cortland County Airport-Chase Field, Cortland, NY; Elmira/Corning Regional Airport, Elmira/Corning, NY; Ithaca Tompkins Regional Airport, Ithaca, NY; and Tri-Cities Airport, Endicott, NY. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. Two comments were received supporting the proposal, as well as displaying concerns on how the airspace may affect the commercial traffic flow to larger airports in the area. The FAA has determined that this airspace will have no negative effect on IFR operations in the area, as Class E airspace only restricts aircraft that are flying using visual flight rules. This Class E airspace protects aircraft departing and landing using IFR procedures.

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 part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends 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.

This amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface within a 7-mile radius of Cortland County Airport-Chase Field, Cortland, NY; within a 12.5-mile radius of Elmira/Corning Regional Airport, Elmira/Corning, NY; within a 9.5-mile radius of Ithaca Tompkins Regional Airport, Ithaca, NY; and within an 8-mile radius of Tri-Cities Airport, Endicott, NY, providing the controlled airspace required to support the RNAV (GPS) standard instrument approach procedures for IFR operations at these airports.

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

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

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

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 supports amending the air traffic service route structure in the western United States to maintain the efficient flow of air traffic.

The FAA published a notice of proposed rulemaking for Docket No. FAA-2018-0713 in the Federal Register (83 FR 55308; November 5, 2018), amending 2 jet routes (J-65 and J-110) and 3 Domestic VOR Federal airways (V-23, V-165 and V-230) in the Western United States. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.

This document amends 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.

This rule has a change from the NPRM. The NPRM proposed to amend route V-165. Due to additional coordination required for flight check satisfaction, V-165 will not be included in this final rule, but will be finalized at a later date.

This action amends 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 and V-230. The route changes are outlined below.

J-65: J-65 currently extends between the San Antonio, TX, VORTAC to the Seattle, WA, VORTAC. The FAA is removing the segments between the Shafter, CA, VORTAC and the Sacramento, CA, VORTAC, causing a gap in the route. The route stops at the Shafter, CA, VORTAC and resumes at the Sacramento, CA, VORTAC. The unaffected portion of the existing route will remain as charted.

J-110: J-110 currently extends between the Oakland, VA, VOR/DME to the Coyle, NJ, VORTAC. The airway segment between the Oakland, CA, VOR/DME and the Boulder City, NV, VORTAC is removed. The route now starts at the Boulder City, NV, VORTAC and extends to the Coyle, NJ, VORTAC. The unaffected portion of the existing route will 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 removed the sections between the Shafter, CA, VORTAC and the Linden, CA, VOR/DME. The route now stops at the FRAME intersection (INT Shafter 338° and Panoche 096° radials) and resumes at the EBTUW intersection (INT Panoche 035° and Linden 141° radials) causing a gap in the route. The unaffected portion of the existing route will 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 amended the route 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° and Friant 239° radials) to the Friant, CA, VORTAC. The unaffected portion of the existing route will remain as charted.

All radials in the route descriptions are unchanged and stated in True degrees.

Jet routes are published in paragraph 2004 and domestic VOR Federal airways are published in paragraph 6010(a), 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 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 only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action of modifying two jet routes (J-65 and J-110) and two domestic VOR Federal airways (V-23 and V-230) qualifies for categorical exclusion under the National Environmental Policy Act and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F—Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points). As such, this action is not expected to cause any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, this action has been reviewed for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis, and it is determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment.

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

Section 104(b)(1)(B) of the Consumer Product Safety Improvement Act (CPSIA), also known as the Danny Keysar Child Product Safety Notification Act, requires the Commission to promulgate consumer product safety standards for durable infant or toddler products. The law requires that these standards are to be “substantially the same as” applicable voluntary standards or more stringent than the voluntary standards if the Commission concludes that more stringent requirements would further reduce the risk of injury associated with the product.

The CPSIA also sets forth a process for updating CPSC's durable infant or toddler standards when the voluntary standard upon which the CPSC standard was based is changed. Section 104(b)(4)(B) of the CPSIA provides that if an organization revises a standard that has been adopted, in whole or in part, as a consumer product safety standard under this subsection, it shall notify the Commission. In addition, the revised voluntary standard shall be considered to be a consumer product safety standard issued by the Commission under section 9 of the Consumer Product Safety Act (15 U.S.C. 2058), effective 180 days after the date on which the organization notifies the Commission (or such later date specified by the Commission in the Federal Register ) unless, within 90 days after receiving that notice, the Commission notifies the organization that it has determined that the proposed revision does not improve the safety of the consumer product covered by the standard and that the Commission is retaining the existing consumer product safety standard.

Section 104(c) of the CPSIA treated cribs (both full-sized and non-full-sized cribs) differently than other products covered by section 104. Section 104(c) of the CPSIA stated that the standards for FS cribs would apply to persons (such as those owning or operating child care facilities and places of public accommodation) in addition to persons usually subject to consumer product safety rules. 1 Pursuant to section 104(b)(1) and section 104(c) of the CPSIA, on December 28, 2010, the Commission published a mandatory consumer product safety standard that incorporated by reference ASTM F1169-10, Standard Consumer Safety Specification for Full-Size Baby Cribs, codified under CPSC regulations at 16 CFR part 1219. (75 FR 81766).

On August 12, 2011, in Public Law No. 112-28, Congress amended section 104 and specifically addressed the revision of the crib standards, stating that any revision of the crib standards after their initial promulgation “shall apply only to a person that manufactures or imports cribs,” unless the Commission determines that application to any others covered by the initial crib standards is “necessary to protect against an unreasonable risk to health or safety.” If the Commission does apply the revised crib standard to additional persons, it must provide at least 12 months for those persons to come into compliance. The Commission is not expanding the applicability of the revised FS crib standard in this rule. Thus, the revised FS crib standard will apply to the same entities and in the same manner as other rules the Commission issues under section 104 of the CPSIA.

The ASTM standard for full-size cribs establishes performance requirements and test procedures to determine the structural integrity of full-size cribs. It also contains design requirements addressing entanglement on crib corner post extensions, and requirements for warning labels and instructional materials. In addition, the standard addresses bassinet, changing table, or similar accessories to a crib that attaches to or rests on a crib in the occupant retention area.

The ASTM FS crib standard was revised in 2011, and the Commission incorporated by reference the revised standard as the mandatory FS crib standard on July 31, 2012 (77 FR 45242). The ASTM standard was revised again in 2013, and the Commission incorporated by reference the revised standard as the mandatory FS crib standard on December 9, 2013 (78 FR 73692). On May 2, 2019, ASTM notified the Commission that it has revised ASTM's FS crib standard; the current ASTM standard is ASTM F1169-19, Standard Consumer Safety Specification for Full-Size Baby Cribs. Based on a review of the changes between the current CPSC standard, 16 CFR part 1219 and ASTM F1169-19, the Commission concludes that each change made in ASTM F1169-19 either improves the safety of FS cribs or is neutral in its safety impact.

Section 8.4 of ASTM 1169 was revised to require all warning labels to be affixed to the product. Previous versions of ASTM F1169 required the highest priority warning messages ( e.g., the suffocation warning) to be “visible in [their] entirety when one short side and one long side of the crib are positioned in a corner formed by two vertical walls” (Section 8.3.1); however, the provision allowed some additional lower-priority warning messages ( e.g., strangulation and fall) to be placed in another location, as long as the “visible” warning identified the location of the additional warnings. ASTM 1169-19 revised section 8.4 to make clear that all warnings, including lower-priority warnings, must be affixed somewhere on the crib, and not merely referenced in a manual or instructions.

The Commission concludes that this change adds clarity and improves the safety of the standard. The Commission determines that all warnings that are intended to be on a FS crib should be affixed to the product because on-product warnings stay with the product through multiple users, whereas an instruction manual could be discarded, lost, or otherwise not be available to another user of the product.

ASTM F1169-19 also includes several non-substantive changes that do not affect the safety of FS cribs, such as spacing, grammar, and punctuation ( e.g., “in” to “in.”; “manufacturers” to “manufacturer's”; and “as per” to “in accordance with”). Under section 1.5, Scope, ASTM added language stating that ASTM developed the standard in accordance with principles recognized by the World Trade Organization. In addition, under section 1.4, the word “environmental” was added to the following sentence: “It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.” The Commission concludes that these editorial changes and additions do not impact the safety of FS cribs.

The Office of the Federal Register (OFR) has regulations concerning incorporation by reference. 1 CFR part 51. Under these regulations, agencies must discuss, in the preamble to the final rule, ways that the materials the agency incorporates by reference are reasonably available to interested persons and how interested parties can obtain the materials. In addition, the preamble to the final rule must summarize the material. 1 CFR 51.5(b).

In accordance with the OFR's requirements, section B of this preamble summarizes the major provisions of the ASTM F1169-19 standard that the Commission incorporates by reference into 16 CFR part 1219. The standard is reasonably available to interested parties, and interested parties may purchase a copy of the standard from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959 USA; phone: 610-832-9585; www.astm.org. A copy of the standard can also be inspected at CPSC's Division of the Secretariat, U.S. Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814, telephone 301-504-7923.

The Congressional Review Act (CRA; 5 U.S.C. 801-808) states that, before a rule may take effect, the agency issuing the rule must submit the rule, and certain related information, to each House of Congress and the Comptroller General. 5 U.S.C. 801(a)(1). The submission must indicate whether the rule is a “major rule.” The CRA states that the Office of Information and Regulatory Affairs (OIRA) determines whether a rule qualifies as a “major rule.” Pursuant to the CRA, OIRA designated this rule as not a “major rule,” as defined in 5 U.S.C. 804(2). In addition, to comply with the CRA, the Office of the General Counsel will submit the required information to each House of Congress and the Comptroller General.

Section 14(a) of the CPSA requires that products subject to a consumer product safety rule under the CPSA, or to a similar rule, ban, standard, or regulation under any other act enforced by the Commission, be certified as complying with all applicable CPSC requirements. 15 U.S.C. 2063(a). Such certification must be based on a test of each product, or on a reasonable testing program, or, for children's products, on tests on a sufficient number of samples by a third party conformity assessment body accredited by the Commission to test according to the applicable requirements. As noted in the preceding discussion, standards issued under section 104(b)(1)(B) of the CPSIA are “consumer product safety standards.” Thus, they are subject to the testing and certification requirements of section 14 of the CPSA.

Because FS cribs are children's products, samples of these products must be tested by a third party conformity assessment body whose accreditation has been accepted by the Commission. These products also must comply with all other applicable CPSC requirements, such as the lead content requirements in section 101 of the CPSIA, the phthalates prohibitions in section 108 of the CPSIA, the tracking label requirement in section 14(a)(5) of the CPSA, and the consumer registration form requirements in section 104(d) of the CPSIA.

In accordance with section 14(a)(3)(B)(iv) of the CPSA, the Commission has previously published a notice of requirements (NOR) for accreditation of third party conformity assessment bodies for testing FS cribs (73 FR 62965 (Oct. 22, 2008)). The NOR provided the criteria and process for our acceptance of accreditation of third party conformity assessment bodies for testing FS cribs to 16 CFR part 1219. The NOR is listed in the Commission's rule, “Requirements Pertaining to Third Party Conformity Assessment Bodies.” 16 CFR part 1112.

The revision to section 8.4 concerning the on-product warning label clarifies the existing standard and does not require a new test. The requirement that the warning label be attached to the product can be assessed by visual inspection. Accordingly, there is no significant change in the way that third party conformity assessment bodies test these products for compliance with the FS crib standard. Laboratories would begin testing to the new standard when ASTM F1169-19 goes into effect, and the existing accreditations that the Commission has accepted for testing to this standard previously would also cover testing to the revised standard. Therefore, the existing NOR for this standard will remain in place, and CPSC-accepted third party conformity assessment bodies are expected to update the scope of the testing laboratories' accreditation to reflect the revised standard in the normal course of renewing their accreditation.

The Commission is issuing this rule as a direct final rule. Although the Administrative Procedure Act (APA) generally requires notice and comment rulemaking, section 553 of the APA provides an exception when the agency, for good cause, finds that notice and public procedure are “impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(B). The Commission concludes that when the Commission updates a reference to an ASTM standard that the Commission has incorporated by reference under section 104(b) of the CPSIA, notice and comment is not necessary.

Under the process set out in section 104(b)(4)(B) of the CPSIA, when ASTM revises a standard that the Commission has previously incorporated by reference as a Commission standard for a durable infant or toddler product under section 104(b)(1)(b) of the CPSIA, that revision will become the new CPSC standard, unless the Commission determines that ASTM's revision does not improve the safety of the product. Thus, unless the Commission makes such a determination, the ASTM revision becomes CPSC's standard by operation of law. The Commission is allowing ASTM F1169-19 to become CPSC's new standard. The purpose of this direct final rule is merely to update the reference in the Code of Federal Regulations so that it accurately reflects the version of the standard that takes effect by statute. Public comment will not impact the substantive changes to the standard or the effect of the revised standard as a consumer product safety standard under section 104(b) of the CPSIA. Under these circumstances, notice and comment is not necessary. In Recommendation 95-4, the Administrative Conference of the United States (ACUS) endorsed direct final rulemaking as an appropriate procedure to expedite promulgation of rules that are noncontroversial and that are not expected to generate significant adverse comment. See 60 FR 43108 (August 18, 1995). ACUS recommended that agencies use the direct final rule process when they act under the “unnecessary” prong of the good cause exemption in 5 U.S.C. 553(b)(B). Consistent with the ACUS recommendation, the Commission is publishing this rule as a direct final rule because we do not expect any significant adverse comments.

Unless we receive a significant adverse comment within 30 days, the rule will become effective on October 28, 2019. In accordance with ACUS's recommendation, the Commission considers a significant adverse comment to be one where the commenter explains why the rule would be inappropriate, including an assertion challenging the rule's underlying premise or approach, or a claim that the rule would be ineffective or unacceptable without change.

Should the Commission receive a significant adverse comment, the Commission would withdraw this direct final rule. Depending on the comments and other circumstances, the Commission may then incorporate the adverse comment into a subsequent direct final rule or publish a notice of proposed rulemaking, providing an opportunity for public comment.

The Regulatory Flexibility Act (RFA) generally requires that agencies review proposed and final rules for their potential economic impact on small entities, including small businesses, and prepare regulatory flexibility analyses. 5 U.S.C. 603 and 604. The RFA applies to any rule that is subject to notice and comment procedures under section 553 of the APA. Id. As explained above, the Commission has determined that notice and comment is not necessary for this direct final rule. Thus, the RFA does not apply. We also note the limited nature of this document, which updates the incorporation by reference to reflect the mandatory CPSC standard that takes effect under section 104 of the CPSIA.

The FS crib standard contains information collection requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The revision made no changes to that section of the standard. Thus, the revision will not have any effect on the information collection requirements related to the standard.

The Commission's regulations provide a categorical exclusion for the Commission's rules from any requirement to prepare an environmental assessment or an environmental impact statement because they “have little or no potential for affecting the human environment.” 16 CFR 1021.5(c)(2). This rule falls within the categorical exclusion, so no environmental assessment or environmental impact statement is required.

Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a consumer product safety standard is in effect and applies to a product, no state or political subdivision of a state may either establish or continue in effect a requirement dealing with the same risk of injury unless the state requirement is identical to the federal standard. Section 26(c) of the CPSA also provides that states or political subdivisions of states may apply to the CPSC for an exemption from this preemption under certain circumstances. Section 104(b) of the CPSIA refers to the rules to be issued under that section as “consumer product safety rules,” thus, implying that the preemptive effect of section 26(a) of the CPSA would apply. Therefore, a rule issued under section 104 of the CPSIA will invoke the preemptive effect of section 26(a) of the CPSA when it becomes effective.

Under the procedure set forth in section 104(b)(4)(B) of the CPSIA, when a voluntary standard organization revises a standard upon which a consumer product safety standard was based, the revision becomes the CPSC standard within 180 days of notification to the Commission, unless the Commission determines that the revision does not improve the safety of the product, or the Commission sets a later date in the Federal Register . The Commission has not set a different effective date. Thus, in accordance with this provision, this rule takes effect 180 days after we received notification from ASTM of revision to this standard. As discussed in the preceding section, this is a direct final rule. Unless we receive a significant adverse comment within 30 days, the rule will become effective on October 28, 2019.

For the reasons stated above, the Commission amends Title 16 CFR chapter II as follows:

Why is the Department promulgating this rule?

The Adoptive Family Relief Act (Pub. L. 114-70) (the Act) amended Section 221(c) of the Immigration and Nationality Act (INA), 8 U.S.C. 1201(c), to allow for the waiver or refund of certain immigrant visa fees for a lawfully adopted child, or a child coming to the United States to be adopted by a United States citizen (hereinafter referred to as adoptive children), subject to criteria prescribed by the Secretary of State. More than 350 American families have successfully adopted children from the Democratic Republic of the Congo. However, since September 25, 2013, some families have not been able to bring their adoptive children home to the United States because the Democratic Republic of the Congo suspended the issuance of “exit permits” for these children. As the permit suspension drags on, however, American families are repeatedly paying visa renewal and related fees, while also continuing to be separated from their adoptive children. The waiver or refund provides “support and relief to American families seeking to bring their adoptive children from the Democratic Republic of the Congo home to the United States, and would also provide relief to similarly situated adoptive families should barriers arise in other countries in the future.” See 161 Cong. Rec. S2796-01.

The Department is amending current rules regarding immigrant visa fees found in §§ 22.1, 42.71(b) and 42.74 of 22 CFR in order to implement the Act. Thus, the current text of § 42.71(b) will become § 42.71(b)(1) and a new paragraph (b)(2) will set forth the requirements for the waiver or refund of immigrant visa fees for adoptive families who must renew a visa for an adoptive child who, through no fault of the parent(s) or child, is unable to travel to the United States. If an immigrant visa was issued on or after March 27, 2013 and an adoptive child was unable to use that visa as a direct result of extraordinary circumstances beyond the control of the adoptive child or adoptive parent(s), such as denial of an exit permit, the adoptive child, adoptive parent(s), or their representative may request a waiver or refund of the immigrant visa fee relating to a replacement of such visa. All other visa replacement requirements still apply. This rule also adds this exemption to the Schedule of Fees at 22 CFR 22.1 and adds a paragraph at § 42.74(a)(3) on replacement immigrant visas for adoptive children covered by the Act.

In addition to implementing the Act, this rule also updates existing regulations regarding immigrant visa application procedures to more accurately reflect new technologies, application forms, and procedures that have been implemented in recent years. Obsolete language in §§ 42.71, 42.73, and 42.74 regarding discontinued immigrant visa issuance procedures and outdated forms has been deleted. Superfluous language in § 42.71 related to an outdated procedure has been removed. Both §§ 42.73 and 42.74 have been reorganized for readability and § 42.73 has been revised to more closely track the equivalent provision to procure issuance of nonimmigrant visas at § 41.113. In addition, language related to the locations of specific immigrant visa content on the Department's websites has been deleted, as websites and their content are generally subject to frequent reorganization and other changes. More specific guidance is available in Volume 9 of the Foreign Affairs Manual ( see fam.state.gov ) and on travel.state.gov.

The Department is publishing this rule as a final rule, with an effective date less than 30 days from the date of publication, based on the “good cause” exceptions set forth at 5 U.S.C. 553(b)(3)(B) and 553(d)(3). The Department is issuing this final rule with an effective date on the date of publication. The APA permits a final rule to become effective fewer than 30 days after the publication if the issuing agency finds good cause. 5 U.S.C. 553(d)(3). The Department finds that good cause exists for an early effective date in this instance because Congress has already mandated that, subject to criteria prescribed by the Secretary of State, the visa fees for certain lawfully adopted children may be waived, or, if paid, may be refunded. This rulemaking implements the Congressional mandate.

Because this final rule is exempt from notice-and-comment rulemaking under 5 U.S.C. 553, it is exempt from the Regulatory Flexibility Act (5 U.S.C. 603 and 604). Because this rule is exempt, the Department did not conduct an economic analysis of the impact on small entities.

The Unfunded Mandates Reform Act of 1995 (codified at 2 U.S.C. 1532) generally requires agencies to prepare a statement before proposing any rule that may result in an annual expenditure of $100 million or more by State, local, or tribal governments, or by the private sector. This rule will not result in any such expenditure, nor will it significantly or uniquely affect small governments.

This rule is not a major rule as defined by 5 U.S.C. 804(2).

The Department has considered this rule in light of Executive Orders 12866 and 13563 and affirms that this regulation is consistent with the guidance therein. The Office of Management and Budget has designated this rule not significant for purposes of E.O. 12866. The Department does not consider this rule to be an economically significant rulemaking action.

This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. The rule will not have federalism implications warranting the application of Executive Orders 12372 and 13132.

This rule is not subject to the requirements of E.O. 13771 (82 FR 9339, February 3, 2017) because it is not significant under E.O. 12866.

The Department has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not pre-empt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking.

The Department has reviewed the regulation in light of sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

This rule does not impose any new information collection requirements under the provisions of the Paperwork Reduction Act, 44 U.S.C. chapter 35. The Office of Information and Regulatory Affairs previously approved the application for a refund under the Adoptive Family Relief Act (OMB Control No. 1405-0223).

Accordingly, for the reasons stated in the preamble, 22 CFR parts 22 and 42 are amended as follows:

I. Background

The Transportation, Housing and Urban Development, and Related Agencies Appropriations Act, 2015 (division K of Pub. L. 113-235, approved December 16, 2014) (2015 Appropriations Act) provided that “the Secretary shall collect fees from borrowers . . . to result in a credit subsidy cost of zero for guaranteeing” Section 108 loans. Identical language was continued or included in the Department's continuing resolutions and appropriations acts authorizing HUD to issue Section 108 loan guarantees during Fiscal Years (FYs) 2016, 2017, 2018, and 2019. The Fiscal Year (FY) 2020 HUD appropriations bill under consideration in the House of Representatives (H.R. 3163) also has identical language regarding the fees and credit subsidy cost for the Section 108 Program.

On November 3, 2015, HUD published a final rule (80 FR 67626) that amended the Section 108 Program regulations at 24 CFR part 570 to establish additional procedures, including procedures for announcing the amount of the fee each fiscal year when HUD is required to offset the credit subsidy costs to the Federal Government to guarantee Section 108 loans. For FYs 2016, 2017, 2018, and 2019, HUD published notifications to set the fees. 1

This document sets the fee for Section 108 loan disbursements under loan guarantee commitments awarded for FY 2020 at 2.00 percent of the principal amount of the loan. HUD will collect this fee from borrowers of loans guaranteed under the Section 108 Program to offset the credit subsidy costs of the guaranteed loans pursuant to commitments awarded in FY 2020. For this fee announcement, HUD is not changing the underlying assumptions or creating new considerations for borrowers. The calculation of the FY 2020 fee uses a similar calculation model as the FY 2016, FY 2017, FY 2018, and FY 2019 fee notifications, but incorporates updated information regarding the composition of the Section 108 portfolio and the timing of the estimated future cash flows for defaults and recoveries. The calculation of the fee is also affected by the discount rates required to be used by HUD when calculating the present value of the future cash flows as part of the Federal budget process.

As described in 24 CFR 570.712(b), HUD's credit subsidy calculation is based on the amount required to reduce the credit subsidy cost to the Federal Government associated with making a Section 108 loan guarantee to the amount established by applicable appropriation acts. As a result, HUD's credit subsidy cost calculations incorporated assumptions based on: (1) Data on default frequency for municipal debt where such debt is comparable to loans in the Section 108 loan portfolio; (2) data on recovery rates on collateral security for comparable municipal debt; (3) the expected composition of the Section 108 portfolio by end users of the guaranteed loan funds ( e.g., third-party borrowers and public entities); and (4) other factors that HUD determined were relevant to this calculation ( e.g., assumptions as to loan disbursement and repayment patterns).

Taking these factors into consideration, HUD determined that the fee for disbursements made under loan guarantee commitments awarded in FY 2020 will be 2.00 percent, which will be applied only at the time of loan disbursements. Note that future notifications may provide for a combination of upfront and periodic fees for loan guarantee commitments awarded in future fiscal years but, if so, will provide the public an opportunity to comment if appropriate under 24 CFR 570.712(b)(2).

The expected cost of a Section 108 loan guarantee is difficult to estimate using historical program data because there have been no defaults in the history of the program that required HUD to invoke its full faith and credit guarantee or use the credit subsidy reserved each year for future losses. 2 This is due to a variety of factors, including the availability of Community Development Block Grant (CDBG) funds as security for HUD's guarantee as provided in 24 CFR 570.705(b). As authorized by Section 108 of the Housing and Community Development Act of 1974, as amended (42 U.S.C. 5308), borrowers may make payments on Section 108 loans using CDBG grant funds. Borrowers may also make Section 108 loan payments from other anticipated sources but continue to have CDBG funds available should they encounter shortfalls in the anticipated repayment source. Despite the program's history of no defaults, Federal credit budgeting principles require that the availability of CDBG funds to repay the guaranteed loans cannot be assumed in the development of the credit subsidy cost estimate (see 80 FR 67629, November 3, 2015). Thus, the estimate must incorporate the risk that alternative sources are used to repay the guaranteed loan in lieu of CDBG funds, and that those sources may be insufficient. Based on the rate that CDBG funds are used annually for repayment of loan guarantees, HUD's calculation of the credit subsidy cost must acknowledge the possibility of future defaults if those CDBG funds were not available. The fee of 2.00 percent of the principal amount of the loan will offset the expected cost to the Federal Government due to default, financing costs, and other relevant factors. To arrive at this measure, HUD analyzed data on comparable municipal debt over an extended period. The estimated rate is based on the default and recovery rates for general purpose municipal debt and industrial development bonds. The cumulative default rates on industrial development bonds were higher than the default rates on general purpose municipal debt during the period from which the data were taken. These two subsectors of municipal debt were chosen because their purposes and loan terms most closely resemble those of Section 108 guaranteed loans.

In this regard, Section 108 guaranteed loans can be broken down into two categories: (1) Loans that finance public infrastructure and activities to support subsidized housing (other than financing new construction) and (2) other development projects ( e.g., retail, commercial, industrial). The 2.00 percent fee was derived by weighting the default and recovery data for general purpose municipal debt and the data for industrial development bonds according to the expected composition of the Section 108 portfolio by corresponding project type. Based on the dollar amount of Section 108 loan guarantee commitments awarded from FY 2013 through FY 2018, HUD expects that 43 percent of the Section 108 portfolio will be similar to general purpose municipal debt and 57 percent of the portfolio will be similar to industrial development bonds. In setting the fee at 2.00 percent of the principal amount of the guaranteed loan, HUD expects that the amount generated will fully offset the cost to the Federal Government associated with making guarantee commitments awarded in FY 2020. Note that the FY 2020 fee represents a 0.23 percent decrease from the FY 2019 fee of 2.23 percent.

This document establishes a rate that does not constitute a development decision that affects the physical condition of specific project areas or building sites. Accordingly, under 24 CFR 50.19(c)(6), this document is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).

This document contains final regulations amending 26 CFR parts 1 and 602, to specify the notification requirement of section 501(c)(4) organizations under section 506 of the Code. Section 506, which was added by the PATH Act (Pub. L. 114-113, div. Q), requires an organization to notify the IRS of its intent to operate as a section 501(c)(4) organization.

Section 501(a) of the Code generally provides that an organization described in section 501(c) is exempt from federal income tax. Section 501(c)(4) describes certain civic leagues or organizations operated exclusively for the promotion of social welfare and certain local associations of employees. An organization is described in section 501(c)(4) and exempt from tax under section 501(a) if it satisfies the requirements applicable to such status. Subject to certain exceptions, section 6033, in part, requires organizations exempt from taxation under section 501(a) to file annual information returns or notices, as applicable.

Although an organization may apply to the IRS for recognition that the organization qualifies for tax-exempt status under section 501(c)(4), there is no requirement to do so (except as provided in section 6033(j)(2), which requires organizations that lose tax-exempt status for failure to file required annual information returns or notices and want to regain tax-exempt status to apply to obtain reinstatement of such status). Accordingly, a section 501(c)(4) organization that files annual information returns or notices (Form 990, “Return of Organization Exempt From Income Tax,” or, if eligible, Form 990-EZ, “Short Form Return of Organization Exempt From Income Tax,” or Form 990-N (e-Postcard)), as required under section 6033, need not seek an IRS determination of its qualification for tax-exempt status in order to be described in and operate as a section 501(c)(4) organization.

Section 405(a) of the PATH Act added section 506 to the Code, requiring an organization to notify the IRS of its intent to operate as a section 501(c)(4) organization. In addition, section 405(b) and (c) of the PATH Act amended sections 6033(f) and 6652(c), relating to information that section 501(c)(4) organizations may be required to include on their annual information returns and penalties for certain failures by tax-exempt organizations to comply with filing or disclosure requirements, respectively.

Section 506(a) requires a section 501(c)(4) organization, no later than 60 days after the organization is established, to notify the Secretary of the Department of the Treasury (Secretary) that it is operating as a section 501(c)(4) organization (the notification). Section 506(b) provides that the notification must include: (1) The name, address, and taxpayer identification number of the organization; (2) the date on which, and the state under the laws of which, the organization was organized; and (3) a statement of the purpose of the organization. Section 506(c) requires the Secretary to send the organization an acknowledgment of the receipt of its notification within 60 days. Section 506(d) permits the Secretary to extend the 60-day notification period in section 506(a) for reasonable cause. Section 506(e) provides that the Secretary shall impose a reasonable user fee for submission of the notification. Section 506(f) provides that, upon request by an organization, the Secretary may issue a determination with respect to the organization's treatment as a section 501(c)(4) organization and that the organization's request will be treated as an application for exemption from taxation under section 501(a) subject to public inspection under section 6104. 1

In addition, the PATH Act amended section 6033(f) to require a section 501(c)(4) organization submitting the notification to include with its first annual information return after submitting the notification any additional information prescribed by regulation that supports the organization's treatment as a section 501(c)(4) organization.

The PATH Act also amended section 6652(c) to impose penalties for failure to submit the notification by the date and in the manner prescribed in regulations. In particular, section 6652(c)(4)(A) imposes a penalty on an organization that fails to submit the notification equal to $20 per day for each day such failure continues, up to a maximum of $5,000. Additionally, section 6652(c)(4)(B) imposes a similar penalty on persons who fail to timely submit the notification in response to a written request by the Secretary.

Section 405(f)(1) of the PATH Act provides that, in general, the requirement to submit the notification and the related amendments to sections 6033 and 6652 apply to section 501(c)(4) organizations that are established after December 18, 2015, the date of enactment of the PATH Act. Section 405(f)(2) of the PATH Act provides that these provisions also apply to any other section 501(c)(4) organizations that had not, on or before the date of enactment of the PATH Act: (1) Applied for a written determination of recognition as a section 501(c)(4) organization; or (2) filed at least one annual information return or notice required under section 6033(a)(1) or (i). Organizations described in section 405(f)(2) of the PATH Act must submit the notification within 180 days after the date of enactment of the PATH Act.

The Treasury Department and the IRS issued Notice 2016-09, 2016-6 IRB 306, to provide interim guidance regarding section 405 of the PATH Act. Specifically, Notice 2016-09 extended the due date for submitting the notification until at least 60 days from the date that implementing regulations are issued in order to provide adequate transition time for organizations to comply with the new requirement to submit the notification. With respect to the separate procedure by which an organization may request a determination from the IRS that it qualifies for tax-exempt status under section 501(c)(4), Notice 2016-09 stated that organizations seeking IRS recognition of section 501(c)(4) status should continue using IRS Form 1024, Application for Recognition of Exemption Under Section 501(a)   2 until further guidance was issued. Notice 2016-09 also clarified that the filing of Form 1024 does not relieve an organization of the requirement to submit the notification.

On July 12, 2016, the Department of Treasury and the IRS published in the Federal Register (81 FR 45008) temporary regulations under section 506 (TD 9775) that prescribe the manner in which a section 501(c)(4) organization must submit notification under section 506 of its intent to operate under section 501(c)(4). The temporary regulations were effective and applicable on July 8, 2016. Also on July 12, 2016, the Department of Treasury and the IRS published in the Federal Register (81 FR 45088) a notice of proposed rulemaking (REG-101689-16) cross-referencing the temporary regulations and soliciting public comments and requests for a hearing. In conjunction with the issuance of the temporary regulations and the notice of proposed rulemaking, the Department of Treasury and the IRS issued Rev. Proc. 2016-41, 2016-30 IRB 165, which sets forth the procedure for an organization to notify the IRS that it is operating as a section 501(c)(4) organization. Specifically, the preamble to the temporary regulations noted that the revenue procedure provides that the notification must be submitted on Form 8976, “Notice of Intent to Operate Under Section 501(c)(4)” (or its successor). Revenue Procedure 2016-41 provides additional information on the procedure for submitting the form and information on requesting relief from a failure to file penalty under section 6652(c)(4), including an example of a situation in which reasonable cause relief would be appropriate.

The temporary regulations, in accordance with section 506(a), generally required a section 501(c)(4) organization to submit the notification to the IRS on Form 8976 no later than 60 days after the date the organization is organized. Because the Form 8976 was not previously available, the temporary regulations provided transitional relief from the notification requirement for organizations that, on or before July 8, 2016, either (1) applied for a written determination of recognition as a section 501(c)(4) organization (using a Form 1024 application); or (2) filed at least one annual return or notice required under section 6033(a)(1) (that is, a Form 990, or if eligible, Form 990-EZ or Form 990-N) (“Form 990 series return or notice”). For organizations that did not qualify for this relief, the temporary regulations also provided a transition rule that extended the due date of the notification to September 6, 2016.

Consistent with section 506(b), the temporary regulations specified that the notification must include: (1) The name, address, and taxpayer identification number of the organization; (2) the date on which, and the state or other jurisdiction under the laws of which, the organization was organized; and (3) a statement of the purpose of the organization. In addition, the temporary regulations provided that the notification must include such additional information as may be specified in published guidance in the Internal Revenue Bulletin or in other guidance, such as forms or instructions, issued with respect to the notification. To ensure that the statutorily required items of information in the notification are correlated accurately within existing IRS systems, Form 8976 requires organizations to provide their annual accounting period.

The temporary regulations also provided that the notification must be accompanied by payment of the user fee authorized by section 506(e), which will be set forth by published guidance in the Internal Revenue Bulletin or in other guidance, such as forms or instructions, issued with respect to the notification. Consistent with section 506(d), the temporary regulations stated that the 60-day period for submitting the notification may be extended for reasonable cause.

Further, the temporary regulations provided that, within 60 days after receipt of the notification, the IRS will send the organization an acknowledgment of such receipt. The temporary regulations specified that this acknowledgment is not a determination with respect to tax-exempt status. Thus, it is not a determination on which an organization may rely or a determination or a failure to make a determination with respect to which the organization may seek declaratory judgment under section 7428. Furthermore, the temporary regulations specified that the process by which an organization may request an IRS determination that it qualifies for section 501(c)(4) exempt status is separate from the procedure for submitting the notification. Section 506(f) provides that an organization subject to the section 506 notification requirement may request a determination to be treated as an organization described in section 501(c)(4). This indicates that the procedure by which an organization may request a determination that it is described in section 501(c)(4) is separate from the procedure for submitting the notification required by section 506. Accordingly, the temporary regulations provided that submission of the notification does not constitute a request for an IRS determination that the organization qualifies for tax-exempt status under section 501(c)(4). Rather, an organization that seeks IRS recognition of tax-exempt status under section 501(c)(4) must separately request a determination in the manner prescribed in Rev. Proc. 2019-5, (2019-1 IRB 230), or its successor.

The temporary regulations also referred to section 6652(c)(4) through (6) for information on the applicable penalties for failure to submit the section 506 notification. The temporary regulations specifically referred to section 6652(c)(5), which provides a reasonable cause exception, and section 6652(c)(6), which provides other special rules that generally apply for purposes of section 6652(c) penalties.

The IRS received three comments in response to the notice of proposed rulemaking, two that addressed several issues, which are discussed in detail below, and one that was withdrawn from regulations.gov. The two comments that were not withdrawn are available at www.regulations.gov or upon request. No public hearing was requested or held.

The IRS has considered all the issues addressed in the comments. The proposed regulations that cross-referenced the text of the temporary regulations are adopted without substantive change by this Treasury decision, except that this Treasury decision removes the temporary regulations.

This section discusses comments received in response to the notice of proposed rulemaking.

One commenter recommended that final regulations clarify whether an organization that is included as a subordinate organization on a group return on Form 990 filed on or before July 8, 2016, is exempt from the requirement to submit Form 8976. The commenter also suggested that final regulations clarify whether an organization that merely filed an application for extension of time to file Form 990 (Form 8868) on or before July 8, 2016, and not the Form 990 itself, is exempt from the requirement to submit Form 8976.

The PATH Act provides that the requirement to submit the notification does not apply to certain organizations that notified the IRS of their existence on or before December 18, 2015. The Treasury Department and the IRS recognized that additional organizations may have notified the IRS of their existence, after the enactment of the PATH Act but before the availability of the new electronic Form 8976 for submitting the notification, by applying for a written determination of tax-exempt status or filing a required information return or notice. Accordingly, § 1.506-1T(b) provided two special rules for organizations that were organized on or before July 8, 2016. First, the temporary regulations noted that the requirement to submit the notification does not apply to a section 501(c)(4) organization that, on or before December 18, 2015, either (i) applied for a written determination of recognition as a section 501(c)(4) organization; or (ii) filed at least one annual information return or notice required under section 6033(a)(1) or (i). Second, the temporary regulations provided that a section 501(c)(4) organization is not required to submit the notification if, on or before July 8, 2016, the organization either (i) applied for a written determination of recognition as a 501(c)(4) organization; or (ii) filed at least one annual information return or annual electronic notification required under section 6033(a)(1) or (i).

Under § 1.6033-2(d)(4), a group return is considered the return of each subsidiary organization included on the return. Consequently, an organization that is included as a subordinate organization on a group return on Form 990 filed on or before July 8, 2016, qualified for the special rules in § 1.506-1T(b), and an additional provision in the regulations is not required. However, filing an extension of time to file Form 990 does not provide the IRS with the information required under section 506, including the date of organization. Accordingly, the special rules apply only to a Form 990 series return or notice, not to a request for an extension of time to file. For these reasons, the commenter's suggestions are not incorporated into the final regulations.

One commenter suggested that the final regulations confirm that a single-member limited liability company (LLC), the sole member of which is a section 501(c)(4) organization and that is disregarded as an entity separate from its owner, is not required to submit Form 8976.

Unless the entity elects otherwise, a domestic eligible entity that has a single owner is disregarded as an entity separate from its owner. See § 301.7701-2(c)(2)(i). For this reason, the instructions to Form 990 provide that an LLC treated as a disregarded entity by its tax-exempt member should not file a separate Form 990; instead the sole member includes activities conducted by the disregarded entity LLC on its Form 990. Similarly, a single-member LLC organization, the sole member of which is a section 501(c)(4) organization, should not submit a separate Form 8976 if it intends to be disregarded as an entity separate from its owner and only the sole member section 501(c)(4) organization should submit a Form 8976. Therefore, any further clarification in the final regulations is not necessary.

One commenter requested that the final regulations include an exception from the requirement to submit Form 8976 for organizations terminated or dissolved before September 6, 2016 (the extended due date for organizations as provided in § 1.506-1T(b)(3)). Although there is no statutory basis for exempting organizations that terminated by a certain date from the requirement to submit Form 8976, the commenter suggested that it would serve little purpose for the organization to notify the IRS that it intended to operate as an organization described in section 501(c)(4) if the organization had already terminated by the time it was required to submit Form 8976. However, such organizations may still be included in the IRS's Exempt Organizations Business Master File, and a filed Form 8976 would serve the purpose of notifying the IRS that it operated as an organization described in section 501(c)(4). Thus, these final regulations do not provide the requested exception.

One commenter requested that the final regulations provide that an organization should be treated as satisfying the requirement under section 506 if it files Form 1024-A, rather than Form 8976, within the 60-day notice period.

The notification requirement under section 506(a) is separate and distinct from the application process. See section 506(f). In addition, it is not administrable for the IRS to treat Form 1024-A as the notification required under section 506. First, there is no systemic process for the IRS to use the Form 1024-A both as a required notification under section 506 and as an optional application for exempt status. Second, the Service is required under section 506(c) to acknowledge receipt of the notification within 60 days, but review of an application for exempt status may require more time than 60 days (as reflected in the 270-day period under the declaratory judgment procedures in section 7428). Thus, the timeline for processing an application for exempt status does not align with the timeline for processing Form 8976 and it would be impractical for the Service to maintain two separate processes for responding to Form 1024-A. Therefore, these final regulations do not adopt the suggestion.

Both commenters inquired whether a subordinate organization included in a group exemption letter is excepted from the requirement to submit Form 8976, or in the alternative, whether the requirement to notify the IRS that a subordinate organization intends to operate under section 501(c)(4) is satisfied if the central organization informs the IRS that it is adding the subordinate organization to the group exemption letter within 60 days from when the subordinate is organized.

A group exemption letter is a ruling or determination letter that is issued to a central organization recognizing, on a group basis, the exemption from federal income tax under section 501(a) of subordinate organizations on whose behalf the central organization has applied for recognition of exemption (see Rev. Proc. 80-27, 1980-1 C.B. 677). Under the group ruling procedures of Rev. Proc. 80-27, the central organization is required to submit annually to the IRS at least 90 days before the close of its annual accounting period any changes to the subordinates in the group ruling, including any subordinates that are no longer included in the group exemption letter and any subordinates that are to be added to the group exemption letter.

As discussed in the Background section, the PATH Act provided that the requirement to submit the notification does not apply to organizations that either filed Form 1024 or filed at least one Form 990 series return or notice on or before December 18, 2015. To reduce the burden on organizations and the IRS, the temporary regulations similarly relieved from the notification requirement any organization that filed Form 1024 or filed a Form 990 series return or notice on or before July 8, 2016, the date that Form 8976 became available. Unlike the transition relief provided in the temporary regulations, there is no similar statutory basis for relieving subordinates included in a group exemption letter from the requirement to submit Form 8976 if they do not meet one of these special rules. For the administrative convenience of taxpayers and the IRS, Rev. Proc. 80-27 relieves each of the subordinates covered by a group exemption letter from filing its own application for recognition of exemption. However, this administrative relief from the application requirements does not apply with respect to section 506 because the process for recognition of exemption is separate from the section 506 notification process. See section 506(f).

Similar to annual Form 990 series returns or notices, an annual group exemption update as required by Rev. Proc. 80-27, may replicate the information provided on Form 8976. However, the annual group exemption update also requires different information than the organization initially provides on the Form 8976, such as detailed information on the organization's activities, and the annual group exemption update may be filed significantly later than the 60 days required by section 506 and the Form 8976 depending on when the subordinate joins the group exemption and the due date of the annual group exemption update.

Furthermore, Rev. Proc. 80-27 provides that a central organization must submit information on subordinate organizations to be added to the group exemption letter in an annual update that is due at least 90 days before the end of the central organization's annual accounting period. There is not a procedure for updating the group exemption letter within 60 days of a subordinate organization's date of organization. Allowing such updates to serve in place of the statutory notification required under section 506 would lead to additional administrative burdens on central organizations and the IRS to process changes to group exemption letters multiple times per year rather than once annually.

Accordingly, these final regulations do not adopt the suggestions.

One commenter recommended that final regulations define the “date of organization” of an organization that was not initially formed as a section 501(c)(4) organization as the date the change in status to section 501(c)(4) is accomplished (such as the date that the organization's governing document is amended) or in the case of a foreign organization, the date that the foreign organization first commences activities or receives income that would cause it to have a filing requirement under section 6033.

The section 506(a) notification requirement applies no later than 60 days after the organization is established. Section 506(b)(2) further provides that the 506(a) notification shall include the date on which, and the state under the laws of which, the organization was organized. Section 506 did not indicate that any difference was intended between the use of “established” in section 506(a) and the reference to “organized” in section 506(b). Accordingly, the temporary regulations provided that, except as provided in paragraph (b) of the section, an organization (whether domestic or foreign) described in section 501(c)(4) must, no later than 60 days after the date the organization is organized, notify the Commissioner that it is operating as an organization described in section 501(c)(4) by submitting a completed Form 8976. See § 1.506-1T(a)(1). Following the longstanding approach on forms used to apply for exemption and for entering data into the IRS system, the temporary regulations in § 1.506-1T(a)(2)(ii) clarify that the date an organization is “organized” for section 506 purposes is the date on which it is formed as a legal entity.

It would be administratively difficult if the date of organization reported on Form 8976 were different from the date of legal formation reflected on organizational documents and used for other reporting purposes. For this reason, these final regulations do not adopt the suggestion. However, see section 7 of this Summary of Comments and Explanation of Provisions for discussion of availability of reasonable cause relief.

One commenter suggested that the IRS extend automatic reasonable cause relief to: (1) Organizations formed before December 18, 2015, that timely submit a first Form 990 after July 8, 2016; (2) foreign organizations that file Forms 8976 within 60 days after first commencing activities or receiving income that would cause them to have a section 6033 filing requirement; (3) small organizations; and (4) organizations formed as organizations described in another paragraph of section 501(c) that file Form 8976 within 60 days after amending their organizing document to qualify under section 501(c)(4). With regard to small organizations, the commenter recommended that the IRS provide small organizations with automatic reasonable cause relief similar to the relief provided under Rev. Proc. 2014-11 regarding reinstatement of exempt status after automatic revocation under section 6033(j). Alternatively, the commenter recommended that the IRS expand the example of reasonable cause relief provided in Rev. Proc. 2016-41 to include a non-exhaustive list of factors that will weigh in favor of finding “reasonable cause” for a failure to timely submit Form 8976.

Section 6652(c)(5) provides that no penalty shall be imposed under this subsection with respect to any failure if it is shown that such failure is due to reasonable cause. Reasonable cause is determined based on all the facts and circumstances. This reasonable cause provision does not include a provision for automatic reasonable cause.

Furthermore, Rev. Proc. 2014-11 does not provide a helpful model for a procedure to establish automatic reasonable cause relief from section 6652(c) penalties for small organizations because the IRS does not have similar information for Form 8976 as it does for organizations under Rev. Proc. 2014-11 relief. Under section 4.01 of Rev. Proc. 2014-11, the IRS determined that it may retroactively reinstate an organization's exempt status without requiring the organization to show reasonable cause for the failure to file a Form 990 series return or notice for three consecutive years. In this situation, the IRS already has information in its systems and obtains additional information as part of the application for retroactive reinstatement of exempt status that shows that the size of the organization made it eligible to file Form 990-EZ or 990-N for each of the three years. By contrast, the IRS does not have similar information at the time Form 8976 is filed that would enable the IRS to identify the organization as a “small organization” eligible for the relief requested by the commenter. Thus, the streamlined procedure described in section 4 of Rev. Proc. 2014-11 is not adaptable to the section 506 notification requirement.

Although the final regulations do not provide for a procedure for automatic reasonable cause relief, organizations (including organizations formed before December 18, 2015, foreign organizations, small organizations, and organizations that originally operated under sections other than section 501(c)(4)) may seek reasonable cause relief by following the instructions in the penalty letter, as provided in Rev. Proc. 2016-41. Rev. Proc. 2016-41 includes an example of a situation in which reasonable cause relief would be appropriate regarding foreign organizations. The reasonable cause example included in Rev. Proc. 2016-41 is just one example of reasonable cause for purposes of section 506 only. Similar to the foreign organization discussed in the example provided in Rev. Proc. 2016-41, an organization (other than a section 501(c)(3) organization) that did not originally intend to operate under section 501(c)(4) is subject to the requirement to submit Form 8976 once it begins to operate as a section 501(c)(4) organization. Such an organization that files a Form 8976 within 60 days of amending its organizing document to be described in section 501(c)(4) would have reasonable cause for not filing a Form 8976 within 60 days of formation. The organization may obtain relief from the penalty described under section 6652(c)(4) by submitting a request in response to the correspondence from the IRS regarding the penalty. Because reasonable cause is determined on a case by case basis, it was not intended that Rev. Proc. 2016-41 would provide all situations where reasonable cause relief may be appropriate.

Accordingly, the final regulations do not adopt these suggestions.

One commenter requested the final regulations clarify that Form 8976 may be submitted by any individual authorized by the organization to submit the form on its behalf and that the authorized individual may receive certain communications regarding Form 8976, including the acknowledgment required by section 506(c). The commenter further requested that guidance clarify that the Form 8976 does not need to be submitted by an officer or a person holding a power of attorney on file with the IRS. Lastly, the commenter recommended that a central organization may submit Form 8976 on behalf of its subordinate organization.

The temporary regulations did not address authorization to submit Form 8976 on behalf of an organization. However, Rev. Proc. 2016-41, section 4.01(2) provides that the individual submitting Form 8976 on behalf of a section 501(c)(4) organization must establish an account at www.irs.gov to submit Form 8976 electronically. The IRS may then send electronically to the account of the individual submitting the Form 8976 on behalf of the organization (1) the confirmation of transmittal of Form 8976 described in section 6.02 of Rev. Proc. 2016-41, (2) the notice of non-acceptance for processing of Form 8976 described in section 5 of Rev. Proc. 2016-41, and/or (3) the acknowledgement of receipt of Form 8976 described in section 6.01 of Rev. Proc. 2016-41. Accordingly, just like any communications regarding a taxpayer's filing obligations, an organization should ensure that the individual submitting the Form 8976 is not only authorized by the organization to submit the Form 8976 on its behalf, but also to receive communications from the IRS relating to the organization's submission. This would also apply to a subordinate organization included in a group exemption letter, as the organization should ensure that any individual (including an individual who represents the central organization) is authorized by the subordinate organization to submit Form 8976 on behalf of the subordinate organization and to receive communications from the IRS. No additional clarification within the final regulations is needed; thus, the final regulations do not adopt these suggestions.

Lastly, one commenter requested clarification in the final regulations that there is no obligation to update Form 8976 if any of the information on the Form 8976 was originally correct, but later changes. The temporary regulations did not address corrections to Form 8976 as this issue is more appropriately addressed, if necessary, in non-regulatory guidance or the instructions to the form.

The Treasury Department and the IRS note, however, that Rev. Proc. 2016-41, section 4.04 provides that a Form 8976 submitted by an organization is complete if it provides accurate responses for each required line item of the form, consistent with the form instructions, and section 5.03 provides that if an organization attempts to submit more than one Form 8976, only the first Form 8976 will be accepted for processing. Thus, Rev. Proc. 2016-41 indicates that there is no obligation to submit a new Form 8976 if the organization's information changes, or if the Form 8976 was accepted for processing. Rather, any updated information should be reported on the organization's annual information return or notice, as provided in the instructions to that form. Therefore, the final regulations do not adopt this suggestion.

The temporary regulations have applied since July 8, 2016, and this Treasury decision adopts the proposed regulations that cross-referenced the text of those temporary regulations without substantive change. Thus, for clarity and continuity in application, the final regulations apply on and after July 8, 2016.

This regulation is not subject to review under section 6(b) of Executive Order 12866 pursuant to the Memorandum of Agreement (April 11, 2018) between the Department of the Treasury and the Office of Management and Budget regarding review of tax regulations.

The collection of information contained in these final regulations has been reviewed and approved by the Office of Management and Budget under control number 1545-2268 in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)). The collection of information is in § 1.506-1(a)(2). The likely respondents are organizations described in section 501(c)(4) of the Code (section 501(c)(4) organizations). The collection of information in § 1.506-1(a)(2) flows from section 506(b) of the Code, which requires a section 501(c)(4) organization to submit a notification including the following items of information: (1) The name, address, and taxpayer identification number of the organization; (2) the date on which, and the state under the laws of which, the organization was organized; and (3) a statement of the purpose of the organization. The final regulations provide that the notification must be submitted on Form 8976, “Notice of Intent to Operate Under Section 501(c)(4),” or its successor. In addition to the specific information required by statute, the final regulations require that an organization provide any additional information that may be specified in published guidance in the Internal Revenue Bulletin or in other guidance, such as forms or instructions, issued with respect to the notification. Form 8976 requires an organization to provide its annual accounting period to ensure that the statutorily-required items of information in the notification are correlated accurately within existing IRS systems.

For purposes of the Paperwork Reduction Act, the reporting burden associated with the collection of information with respect to section 506(b), will be reflected in the IRS Form 8976 Paperwork Reduction Act Submission (OMB control number 1545-2161, published in the Federal Register on 10/21/2016). The IRS Form 8976 Paperwork Reduction Act Submission estimated for 2016 the total number of filers at 2,500, with an estimated average time per filer of 45 minutes to complete Form 8976, and with an estimated total annual burden of 1,875 hours. A valuation of the burden hours leads to a Paperwork Reduction Act estimate of the reporting costs to taxpayers of $85,031. This is a one-time paperwork burden, as the Treasury Department and the IRS anticipate that substantially all paperwork burdens related to these final regulations will only be incurred by the taxpayer in the year of formation. All organizations operating under section 501(c)(4), regardless of their size, are required to notify the Commissioner utilizing Form 8976.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the Office of Management and Budget. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and return information are confidential, as required by 26 U.S.C. 6103.

It is hereby certified that this rule will not have a significant economic impact on a substantial number of small entities. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. This certification is based on the fact that the registration and filing fee for Form 8976 is $50.00 and the IRS Form 8976 Paperwork Reduction Act Submission (OMB control number 1545-2161) estimates the time to complete Form 8976 at 45 minutes, which should not constitute an economic burden upon small organizations. Pursuant to section 7805(f), the temporary and proposed regulations preceding these final regulations were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business and no comments were received.

The principal authors of these regulations are Peter A. Holiat and Melinda Williams of the Office of Associate Chief Counsel (Tax Exempt and Government Entities). However, other personnel from the IRS and the Treasury Department participated in their development.

IRS Revenue Procedures, Revenue Rulings, notices and other guidance cited in this preamble are published in the Internal Revenue Bulletin (or Cumulative Bulletin) and are available from the Superintendent of Documents, U.S. Government Publishing Office, Washington, DC 20402, or by visiting the IRS website at http://www.irs.gov.

Accordingly, 26 CFR parts 1 and 602 are amended as follows:

Electronic Availability

This document and additional information concerning OFAC are available from OFAC's website ( www.treasury.gov/ofac ).

HIFPAA. On October 25, 2018, the President signed HIFPAA into law. HIFPAA amends the Hizballah International Financing Prevention Act of 2015 (HIFPA), Public Law 114-102, to impose certain specified sanctions on: (1) Foreign persons that knowingly assist in or provide significant support for fundraising or recruitment activities for Hizballah (section 101(a) of HIFPAA); (2) agencies of foreign states that knowingly provide certain significant support to Hizballah (section 103(a) of HIFPAA); and (3) affiliated networks of Hizballah (section 201(b) of HIFPAA).

More specifically, section 101(a) of HIFPAA provides for blocking sanctions on any foreign person that the President determines knowingly provides significant financial, material, or technological support for or to: (1) Bayt al-Mal, Jihad al-Bina, the Islamic Resistance Support Association, the Foreign Relations Department of Hizballah, the External Security Organization of Hizballah, or any successor or affiliate thereof as designated by the President; (2) al-Manar TV, al Nour Radio, or the Lebanese Media Group, or any successor or affiliate thereof as designated by the President; (3) a foreign person determined by the President to be engaged in fundraising or recruitment activities for Hizballah; or (4) a foreign person owned or controlled by a person described in paragraph (1), (2), or (3). Section 103(a) of HIFPAA provides for blocking sanctions on any agency or instrumentality of a foreign state that the President determines has, on or after October 25, 2018 (the date of the enactment of HIFPAA), knowingly: (A) Conducted significant joint combat operations with, or significantly supported combat operations of, Hizballah; or (B) provided significant financial support for or to, or significant arms or related materiel to, Hizballah.

Section 201(b) of HIFPAA provides for specified sanctions with respect to affiliated networks of Hizballah, including, as appropriate, by reason of significant transnational criminal activities engaged in by such networks. Section 201(b) requires the President to impose on such networks sanctions applicable with respect to Hizballah pursuant to any provision of law, including Executive Order (E.O.) 13581 (relating to blocking property of transnational organizations).

Section 301 of HIFPAA provides authority for the President to promulgate regulations “as necessary for the implementation of this Act and the amendments made by this Act.” Pursuant to the Presidential Memorandum of May 24, 2019, “Delegation of Function under the Hizballah International Financing Prevention Act of 2015, as Amended” (84 FR 24975, May 30, 2019), the President delegated the function vested in the President by section 102(d) of HIFPA, as amended by HIFPAA, to the Secretary of the Treasury, in consultation with the Secretary of State. Pursuant to the Presidential Memorandum of January 15, 2019, “Delegation of Functions and Authorities under the Hizballah International Financing Prevention Act of 2015, as Amended, and the Hizballah International Financing Prevention Amendments Act of 2018” (84 FR 3963, February 13, 2019), the President delegated, among other things, the functions and authorities set forth in sections 101(a), 101(b)(1), 102(a), 102(c), 102(d), 103(a), 201(a-b), 204(b), and 302 of HIFPA, as amended by HIFPAA, as well as section 301 of HIFPAA, to the Secretary of the Treasury, in coordination with the State Department and other relevant departments and agencies.

Section 302(a) of HIFPAA provides for exemptions from the prohibitions in sections 101, 102, 103 and 201 for certain activities, including authorized U.S. intelligence, law enforcement or national security activities as well as transactions necessary for the U.S. to comply with United Nations obligations. These exemptions are being added to the GTSR in § 594.207.

Shields Act. On December 21, 2018, the President signed the Shields Act into law. The Shields Act states that it shall be U.S. policy to condemn the use of innocent civilians as human shields. Section 3(b) of the Shields Act provides that the President shall submit to Congress within one year, and annually thereafter until the expiration of the Shields Act on December 31, 2023, a list of: (1) Each foreign person that the President determines on or after December 21, 2018, is (A) a member of Hizballah or HAMAS or is knowingly acting on behalf of Hizballah or HAMAS and (B) knowingly orders, controls, or otherwise directs the use of civilians protected as such by the law of war to shield military objectives from attack; and (2) each foreign person or agency or instrumentality of a foreign state, that the President determines on or after December 21, 2018, knowingly and materially directs or supports any such act by such a person. Sections 3(a)(1) and (d) require the President, with certain exceptions, to exercise powers granted by the International Emergency Economic Powers Act (IEEPA) to the extent necessary to block, and prohibit all transactions in, all property and interests in property that are in the United States, that come within the United States, or that are or come within the possession or control of any United States person of a listed person.

Section 3(c) of the Shields Act urges the President to submit to Congress within one year, and annually thereafter until the expiration of the Shields Act on December 31, 2023, a list of each foreign person that the President determines on or after December 21, 2018, knowingly directs the use of civilians protected by the law of war to shield military objectives from attack, excluding those foreign persons included in the most recent mandatory sanctions list under Section 3(b). Sections 3(a)(2) and (d) provide that the President may, with certain exceptions, exercise powers granted by IEEPA to the extent necessary to block, and prohibit all transactions in, all property and interests in property that are in the United States, that come within the United States, or that are or come within the possession or control of any United States person of a listed person.

Section 3(h)(2) of the Shields Act provides authority for the President to promulgate regulations “as may be necessary to implement this section.” Pursuant to the “Delegation of Functions and Authorities under the Sanctioning the Use of Civilians as Defenseless Shields Act,” May 24, 2019, and Public Law 115-348, the President delegated to the Secretary of the Treasury, in consultation with the Secretary of State, the functions and authorities vested in the President by sections 3(a), 3(b), 3(c), 3(d)(1), and 3(h) of the Shields Act.

Regulatory Amendments. The GTSR, 31 CFR part 594, implements E.O. 13224 of September 23, 2001 (“Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism”), in which the President declared a national emergency generally with respect to “grave acts of terrorism and threats of terrorism committed by foreign terrorists.”

Subpart B of the GTSR implements the prohibitions contained in E.O. 13224. See §  594.201. This rule amends § 594.201 of the GTSR to implement the additional sanctions prohibitions of HIFPAA and the Shields Act. Persons designated by or under the authority of the Secretary of the Treasury, in consultation with the Secretary of State, pursuant to these amendments or otherwise subject to blocking pursuant to the GTSR are referred to throughout the GTSR as “persons whose property and interests in property are blocked pursuant to §  594.201(a).” The names of persons designated pursuant to the HIFPAA, the Shields Act, or E.O. 13224 are published on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List), which is accessible via OFAC's website. Those names also are published in the Federal Register as they are added to the SDN List.

In addition, in subpart C, which defines key terms used throughout the GTSR, OFAC is adding several definitions. Specifically, OFAC is adding definitions for agency or instrumentality of a foreign state in new § 594.318, HAMAS in new § 594.319, Hizballah in new § 594.320, knowingly in new § 594.321, and arms or related material in new § 594.322.

As noted above, section 201(b) of HIFPAA also provides for blocking sanctions with respect to affiliated networks of Hizballah, including, as appropriate, by reason of significant transnational criminal activities engaged in by such networks. The TCOSR, 31 CFR part 590, implement E.O. 13581 of July 24, 2011 (“Blocking Property of Transnational Criminal Organizations”), in which the President declared a national emergency generally with respect to the activities of “significant transnational criminal organizations.” Accordingly, OFAC is amending the TCOSR to reference the authorities from section 201(b) of HIFPAA.

The President, through the issuance of E.O. 13224 and E.O. 13581, has put in place prohibitions and designation criteria that encompass all of the prohibitions and designation criteria contained in the provisions of HIFPAA and the Shields Act discussed above and has thereby already taken the steps necessary to implement those provisions. OFAC is issuing these amendments to the GTSR and the TCOSR to reflect the various provisions of HIFPAA and the Shields Act in the GTSR and the TCOSR.

On March 15, 2019, the President, invoking the authority of, inter alia, IEEPA, issued E.O.13863 (84 FR 10255, March 15, 2019) (E.O. 13863). In E.O. 13863, the President took additional steps to deal with the national emergency with respect to significant transnational criminal organizations declared in E.O. 13581, in view of the evolution of these organizations as well as the increasing sophistication of their activities, which threaten international political and economic systems and pose a direct threat to the safety and welfare of the United States and its citizens, and given the ability of these organizations to derive revenue through widespread illegal conduct, including acts of violence and abuse that exhibit a wanton disregard for human life as well as many other crimes enriching and empowering these organizations. E.O. 13863 amends subsection (e) of section 3 of E.O. 13581 to define the term “significant transnational criminal organization” to mean “a group of persons that includes one or more foreign persons; that engages in or facilitates an ongoing pattern of serious criminal activity involving the jurisdictions of at least two foreign states, or one foreign state and the United States; and that threatens the national security, foreign policy, or economy of the United States.”

OFAC is amending the TCOSR to implement E.O. 13863, pursuant to authorities delegated to the Secretary of the Treasury in E.O. 13581. Specifically, OFAC is amending § 590.201 of the TCOSR to reference E.O. 13863 and is incorporating the amended definition of significant transnational criminal organization into the TCOSR by adding new § 590.315. The TCOSR were published in abbreviated form for the purpose of providing immediate guidance to the public. A copy of E.O. 13581 appears in appendix A and a copy of E.O. 13863 is being added in a new appendix B to part 590. OFAC intends to supplement part 590 with a more comprehensive set of regulations, which may include additional interpretive and definitional guidance, general licenses, and statements of licensing policy. The appendices to part 590 will be removed at that time.

On April 15, 2016, OFAC published the HFSR (81 FR 22185, April 15, 2016) to implement the requirements of the HIFPA. This rule amends the HFSR to make certain technical and conforming changes and to update certain provisions.

First, in § 566.309, this rule corrects two internal references to § 566.304 to read: “covered financial institution, as defined in § 566.303.” Second, in subpart G of the HFSR, which describes the civil and criminal penalties applicable to violations of the HFSR, OFAC is adding new § 566.705 regarding the procedures governing the potential issuance of a Finding of Violation and makes conforming changes by removing other references to a Finding of Violation in §§ 566.702 and 566.703. Third, OFAC is revising § 501.901 to reflect approval by the Office of Management and Budget (OMB) of the information collection set forth in § 566.504(b).

Finally, section 302(a) of HIFPAA provides for exemptions from the prohibitions in sections 101, 102, 103, and 201 for certain activities, including authorized U.S. intelligence, law enforcement or national security activities as well as transactions necessary for the U.S. to comply with United Nations obligations. These exemptions are being added to the HFSR in § 566.203.

Because the amendments of the GTSR, the TCOSR, and the HFSR involve a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date, as well as the provisions of Executive Order 13771, are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.

The collections of information in the TCOSR, the GTSR, and § 566.601 of the HFSR are made pursuant to the Reporting, Procedures and Penalties Regulations (RPPR), 31 CFR part 501, and have been approved by OMB under control number 1505-0164. The collection of information in § 566.504(b) of the HFSR has been approved by OMB under control number 1505-0255.

With respect to all of the foregoing collections of information, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.

For the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control amends 31 CFR parts 566, 590 and 594 as follows:

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Detroit DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The Coast Guard did not receive the final details of this fireworks display in time to publish an NPRM. As such, it is impracticable to publish an NPRM because we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule. Furthermore, immediate action is needed to allow the Coast Guard to enhance the safety of this event.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would inhibit the Coast Guard's ability to protect participants, mariners and vessels from the hazards associated with this event.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Detroit (COTP) has determined that potential hazard associated with fireworks from 9:30 p.m. through 11 p.m. on July 23, 2019 will be a safety concern to anyone within a 200-yard radius of the launch site. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks are being displayed.

This rule establishes a safety zone from 9:30 p.m. through 11 p.m. on July 23, 2019. The safety zone will encompass all U.S. navigable waters of the Detroit River, Detroit, MI, within a 200-yard radius of position 42°19.529′ N, 083°02.436′ W (NAD 83). No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

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

Executive Orders 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 rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule 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, location, duration, and time-of-year of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of the Detroit River from 9:30 p.m. through 11 p.m. on July 23, 2019. Moreover, the Coast Guard will issue Broadcast Notice to Mariners (BNM) via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter 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 rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting one and a half hours on two nights that will prohibit entry into a designated area. It is categorically excluded from further review under paragraph L[60](a) in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES .

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

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

This action is directed to the public in general. This action may, however, be of particular interest to those who conduct human research on substances regulated by EPA. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

The Agency is finalizing the amendments to its human studies rules as proposed in December 2018 (83 FR 62760) (FRL-9987-01-ORD). These amendments include the following:

• Revisions to regulatory citation references in subparts C and D;

• Harmonization, where appropriate, of language in subpart K with revisions in subpart A due to revisions to the Common Rule, 82 FR 7149 (January 19, 2017); and

• Correction of a typographical error in subpart M.

These amendments are authorized under the following legal authorities. The amendments to subparts C and D, which relate to research conducted or sponsored by EPA are authorized pursuant to 5 U.S.C. 301. The amendments to subparts K and M, which govern third-party research involving intentional human exposure to pesticides or to other substances where such research is used for purposes of pesticide decision-making are authorized under sections 3(a) and 25(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136a(a) and 136w(a), and section 408(e)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)(1)(C).

In response to a comment received, the Agency is clarifying that it is not relying on the section 201 of the Department of the Interior, Environment, and Related Agencies Appropriations Act, 2006, Public Law 109-54 (“2006 Appropriations Act”) as authority for this rulemaking. The reference to the 2006 Appropriations Act included in the preamble to the December 2018 proposed rule was to explain in part the authority for EPA's initial promulgation in 2006 of its rules governing research with human subjects beyond the provisions contained in the Common Rule, including the subparts being updated herein. As noted in the Agency's Response to Comments Document prepared as part of the record for the 2013 revisions to EPA's human studies rule, the Agency has determined that the 2006 Appropriations Act is no longer in effect and does not provide authority for new regulatory provisions. See https://www.regulations.gov, in Docket No. EPA-HQ-OPP-2010-0785, document number 38.

As discussed in the preamble to the proposed rule, on January 19, 2017, several federal departments and agencies, including EPA, adopted revisions to the provisions of the Common Rule, a set of regulations intended to create a uniformity across the federal government for the protection of human subjects involved in research. See 82 FR 7149 (January 19, 2017). Those revisions, which were intended to “modernize, strengthen, and make [the Common Rule] more effective”, established new requirements for the informed consent process; allowed the use of broad consent ( i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens; established new exempt categories of research based on their risk profile; required the use of a single institutional review board (IRB) for U.S.-based cooperative research; and removed the continuing review requirement for certain research, in addition to making minor changes intended to improve the clarity and accuracy of the rule. Id. at 7150. EPA's codification of the Common Rule provisions is located in 40 CFR part 26, subpart A. Compliance with these revisions was required starting on January 21, 2019. See 83 FR 28497.

In addition to the provisions of the subpart A, EPA's regulations governing human studies research include several additional subparts at 40 CFR 26, including subparts B through D, which govern research conducted or sponsored by EPA involving pregnant or nursing women and children, and subparts, K through Q, which govern third-party pesticide research involving intentional exposure of human subjects and EPA's reliance on research involving intentional exposure of human subjects. In particular, EPA's provisions in subpart K, which govern the conduct of pesticide-related third-party research involving intentional exposure of human subjects, borrowed heavily from the Common Rule provisions based on the Agency's conclusion that it would be appropriate to apply ethical standards to third-party research that were equivalent to the protections for human subjects participating in research conducted or sponsored by EPA. See 70 FR 53838, 53845 (September 12, 2005).

EPA is finalizing revisions to its human studies regulations as proposed. As discussed in the preamble to the proposed rule, these revisions include updating numerical references in subparts C and D to accurately refer to exemption text in subpart A and to eliminate language concerning tribal laws that is no longer necessary due to the revisions in subpart A. These revisions are necessary to ensure that the exemptions will apply as intended to research conducted or sponsored by EPA and avoid unnecessary confusion about the applicability of tribal law.

In addition, this final rule also includes revisions as proposed to subpart K to harmonize, as appropriate, language governing third-party research with the revisions in subpart A and to clarify the timing and applicability of these revisions. These revisions are important to encourage equivalency in protections of human subjects between research conducted or sponsored by federal departments and agencies and third-party research, wherever appropriate. Furthermore, the harmonization of provisions allows investigators and IRBs to follow equivalent or similar standards for regulating the ethical conduct of research involving human subjects, regardless of who conducts that research. Consistency in standards will result in greater clarity and less regulatory burden as well as less potential for confusion and misapplication of standards for the regulated community.

Finally, EPA is correcting a typographical error in subpart M, as discussed in the preamble.

Public comments on the proposed rule are discussed here, in general terms, along with EPA's response to the comments. EPA received a total of nine public comments during the 60-day comment period. All comments were submitted by individuals, two self-identified and seven anonymous. The docket (ID Number EPA-HQ-ORD-2018-0280) includes all the comments submitted to EPA on the proposed amendments.

One commenter described the changes concerning Subpart D the commenter considers necessary (1) to maintain access to the exemptions integrated by reference and the provision limiting the application (of exemptions) in research involving children; (2) to withdraw the clarification concerning preemption of tribal laws; and (3) to comprise reference to the new general provisions in the Common Rule. EPA agrees that these changes are necessary and, indeed, are reflected in the revisions to Subpart D as proposed.

One person commented on references to the 2006 Appropriations Act in the preamble to the proposal and in the regulatory citation to legal authorities. As explained above, this final rulemaking is being promulgated under 5 U.S.C. 301, FIFRA sections 3(a) and 25(a), and FFDCA section 408(e)(1)(C), not the 2006 Appropriations Act. The commenter asserts that changes to the authorities citation in the regulatory text are necessary to enable the Agency to make potential, future revisions to part 26. The Agency disagrees that the authority citation needs to be revised in this action in order to facilitate future revisions, as such questions can be taken up in relevant future actions. As explained above, this action is limited to revisions in subparts C, D, K, and M; changes that may impact other subparts of part 26 or part 26 more broadly are considered to be beyond the limited scope of the revisions in this rulemaking.

One commenter drew attention to the proposed changes in Subpart K to harmonize IRB membership requirements with those in the revised Common Rule (Subpart A). As noted in the comment, the revised Common Rule removes the language that had been found in 40 CFR 26.107(b), requiring that “[e]very nondiscriminatory effort . . . be made to ensure that no IRB consists entirely of men or entirely of women, including the IRB's consideration of qualified persons of both sexes, so long as no selection is made on the basis of gender” and prohibiting IRBs from consisting entirely of members of one profession. The commenter expressed concern that because third-party research subject to subpart K may be more likely to be conducted overseas and subject to IRB review outside the United States than research conducted or sponsored by EPA, it is appropriate to retain the pre-2018 Common Rule language in 26.1107(b), rather than harmonize with the revised Common Rule language, in order to ensure that the same membership diversity continue to be required of the overseas IRBs.

EPA disagrees with the comment that IRB membership requirements for IRBs that review third-party research subject to subpart K warrant a divergence from the harmonization objectives of this action. EPA acknowledges that some research subject to subpart K may be conducted overseas and subject to the membership requirements and foreign procedures of international IRBs. EPA already has provisions in place that permit EPA to approve of the use of the foreign procedures in lieu of the procedural requirements in subpart K upon determining that those procedures are at least as protective as EPA's regulations. See 40 CFR 26.1603(f). Under this current language, EPA may approve research conducted in a foreign country that does not meet the current diversity requirements in 26.1107(b), as long as it determines the protections are at least equivalent to EPA's procedures for protecting human subjects. In that way, EPA does not view the revisions to the membership diversity requirements concerning gender and professional diversity as likely to meaningfully impact the integrity of the IRB reviews and approvals for research conducted overseas that is subject to subpart K. In any event, if EPA determines that the membership of the overseas IRB is so deficient that EPA cannot support a determination that the protections afforded by the foreign procedures are at least equivalent to subpart K, EPA would not be required to approve of the use of those procedures.

In addition, for the same reasons that were stated in the preamble to the Common Rule, EPA views the language in 26.107(a), which requires members to have varying backgrounds and such diversity of the members, including gender, as to promote respect for its advice, and in the revised 26.107(b), which requires IRBs to consist of at least one member whose primary concerns are scientific and one member whose primary concerns are nonscientific, to be sufficient to accomplish the same goal of diversity in IRB membership. See 82 FR 7149, 7203 (January 19, 2017). To the extent EPA considers the gender and professional diversity of an international IRB to be relevant to whether that IRB has protections in place that are at least equivalent to EPA's protections, EPA is not required to accept the use of those foreign procedures. For the rest of the third-party studies subject to subpart K, e.g., those conducted within the United States and reviewed by domestic IRBs, EPA sees no reason to deviate from the overall goal of harmonizing IRB requirements to reduce the potential for confusion and regulatory burden caused by conflicting requirements. Consequently, EPA is harmonizing 26.1107 with the revised language in 26.107 as proposed.

One commenter requested an extension of the comment period, but EPA did not do so. There were relatively few comments submitted, most supported the rulemaking, and the one commenter that requested additional time appeared to be concerned about issues that were not only outside the scope of this rulemaking, but primarily concerned with another federal agency.

The remaining comments were either supportive of the proposed amendments or were beyond the scope of this rule; as such, they provided no basis for any changes to the rule as proposed.

EPA received relatively few comments on the proposed rule. EPA considered the comments but ultimately concluded that none raised any issues that merit any change to the amendments as proposed. Accordingly, EPA is finalizing the amendments as proposed for the reasons stated herein.

In accordance with FIFRA section 25(a), EPA has submitted a draft of the rule to the FIFRA Scientific Advisory Panel (SAP), the Secretary of Agriculture (USDA), and appropriate Congressional Committees. The SAP waived its review on May 20, 2019. USDA responded on June 4, 2019 and had no substantive comments on the proposal. Both responses are in the docket for this rulemaking.

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

Because OMB considered this rulemaking to be a significant regulatory action when EPA issued its proposal, the Notice of Proposed Rule Making was reviewed by OMB under Executive Order 12866. Any changes made in response to OMB recommendations have been documented in the docket for this rulemaking as required by the Executive Order. After the proposed rule, OMB changed its determination to non-significant. This rule is expected to result in no more than de minimis costs since its purpose is to resolve internal discrepancies created by the recent revision to the Common Rule to avoid confusion, and potential compliance issues for researchers, institutions and sponsors who must follow EPA regulations.

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

This action does not impose any new information collection burden that would require additional review or approval by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. OMB previously approved the information collection requirements contained in the existing regulations at 40 CFR part 26 under OMB Control No. 2070-0169.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA.

The Agency has not identified any small entities subject to the requirements in this proposal, but it is possible that some small pesticide registrants may initiate research subject to EPA's Human Studies rule. The Agency has determined that impacted small entities, if any, may experience an impact of 0.02% as indicated in the “Economic Analysis of Final Rule: Protections for Human Research Participants” (January 12, 2006). The Agency does not have any information to support revising that analysis.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175. This action is not expected to have substantial direct effects on Indian Tribes, will not significantly or uniquely affect the communities of Indian Tribal governments, and does not involve or impose any requirements that affect Indian Tribes. Thus, Executive Order 13175 does not apply to this action.

EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks. EPA's regulations governing research involving human subjects applies to the conduct and review of research involving intentional exposure of human subjects, and prohibits the conduct of or EPA reliance on any such research involving subjects who are children, or pregnant or nursing women. These provisions remain in effect and would not be affected by the amendments.

This action is not a “significant energy action” because it is not likely to have any effect on the supply, distribution, or use of energy.

This action does not involve any technical standards.

This action does not entail special considerations of environmental justice-related issues as delineated by Executive Order 12898. The strengthened protections for human subjects participating in covered research established in the 2006 rule would not be altered by these amendments.

This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

EPA Region 5 is publishing this direct final Notice of Partial Deletion for the New Brighton/Arden Hills/Twin Cities Army Ammunition Plant Site (NB/AH/TCAAP Site), from the NPL. This partial deletion pertains to all soil (shallow and deep) located within the boundary of OU2 of the NB/AH/TCAAP Site and to the surface water and sediment (not groundwater) of the five aquatic sites located within the OU2 boundary: Rice Creek, Sunfish Lake, Marsden Lake North, Marsden Lake South and Pond G (see Figures 2-2 and 11-1 in the Docket). The remaining areas at the NB/AH/TCAAP Site, including OU1, OU3, groundwater in OU2 and a sixth aquatic site, Round Lake located southwest of the OU2 boundary, will remain on the NPL and are not being considered for deletion as part of this action.

The NPL constitutes Appendix B of the NCP, which EPA promulgated pursuant to CERCLA. EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). This partial deletion of the NB/AH/TCAAP Site is proposed in accordance with 40 CFR 300.425(e) and is consistent with the Notice of Policy Change: Partial Deletion of Sites Listed on the National Priorities List. 60 FR 55466 (Nov. 1, 1995). As described in 40 CFR 300.425(e)(3) of the NCP, a portion of a site deleted from the NPL remains eligible for Fund-financed remedial actions if future conditions warrant such actions.

Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the shallow and deep soil and the five aquatic sites located within OU2 of the NB/AH/TCAAP Site and demonstrates how they meet the deletion criteria. Section V discusses EPA's action to partially delete the soil and five aquatic sites located within the OU2 boundary of the NB/AH/TCAAP Site from the NPL unless adverse comments are received during the public comment period.

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

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

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

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

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

The following procedures apply to the deletion of the soil portion of OU2 and to the five aquatic sites located within the OU2 boundary of the NB/AH/TCAAP Site:

(1) EPA consulted with the State of Minnesota prior to developing this direct final Notice of Partial Deletion and the Notice of Intent for Partial Deletion co-published today in the “Proposed Rules” section of the Federal Register .

(2) EPA has provided the State 30 working days for review of this notice and the parallel Notice of Intent for Partial Deletion prior to their publication today, and the State, through the MPCA, has concurred on the partial deletion of the NB/AH/TCAAP Site from the NPL.

(3) Concurrent with the publication of this direct final Notice of Partial Deletion, an announcement of the availability of the parallel Notice of Intent for Partial Deletion is being published in three major local newspapers, the Minneapolis Star Tribune, The Mounds View/New Brighton Sun Focus and the Shoreview Press. The newspaper notices announce the 30-day public comment period concerning the Notice of Intent for Partial Deletion of the NB/AH/TCAAP Site from the NPL.

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

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

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

The following information provides EPA's rationale for deleting the soil portion of OU2 and the five aquatic sites located within the OU2 boundary (Rice Creek, Sunfish Lake, Marsden Lake North, Marsden Lake South and Pond G) of the NB/AH/TCAAP Site from the NPL:

The NB/AH/TCAAP Site (CERCLIS ID: MN7213820908) consists of a 25-square mile area located in Ramsey County, Minnesota. The NB/AH/TCAAP Site includes the 4-square mile area of the original TCAAP facility (about 2,370 acres) operated by the U.S Army (Army), located east of U.S. Interstate Highway 35W and north of Ramsey County Highway 96 at the time of NPL listing in 1983 (OU2) and portions of seven nearby communities with Site-related groundwater contamination (OU1 and OU3). These communities include: New Brighton, Arden Hills, St. Anthony, Shoreview, Mounds View, Columbia Heights and Minneapolis. See Figure 2-1 in in the Docket.

The TCAAP facility manufactured, stored and tested small-caliber ammunition and related materials for the United States military and handled and stored strategic and critical materials for other government agencies from 1941 to 2005. Between 1941 and 1981, the facility disposed of waste materials including volatile organic compounds (VOCs), heavy metals, corrosive materials and explosives at several locations on the TCAAP property. Alliant Techsystems Inc. (Alliant) was the Army's installation services contractor for TCAAP and also operated manufacturing facilities at the TCAAP property.

The U.S. Army Toxic Hazardous Materials Agency issued a report on waste disposal activities at TCAAP in 1978. In 1981, MPCA and the Minnesota Department of Health (MDH) began sampling water supply wells in the TCAAP area. The sampling found that municipal and private drinking water wells near the TCAAP facility and wells at TCAAP were contaminated with VOCs.

Due to the contamination, the City of New Brighton shut down six municipal wells, deepened two municipal wells and constructed three new municipal wells from 1982 to 1984. One of the City of St. Anthony's municipal wells was also contaminated and this well was closed.

In 1983 EPA installed carbon treatment filters on two of the City of New Brighton wells that were reopened to meet summertime peak demand. EPA also provided New Brighton with an additional deep well and carbon treatment for two of St. Anthony's municipal wells in the late 1980s.

In 1983, MPCA connected several private well users adjacent to the TCAAP facility to New Brighton's and Arden Hills' water mains. In 1984, MPCA constructed a temporary water connection from the City of St. Anthony to the City of Roseville to alleviate a water shortage due to the shutdown of one of St. Anthony's wells.

EPA proposed the NB/AH/TCAAP Site to the NPL on December 30, 1982 (47 FR 58476). EPA finalized the NB/AH/TCAAP Site on the NPL on September 8, 1983 (48 FR 40658).

The Army began a Phase I investigation at the TCAAP facility in 1981. The Army installed and sampled a significant number of monitoring wells at TCAAP to identify the overall contribution of the facility to the groundwater contamination identified by MPCA and MDH.

Site records and investigations conducted at TCAAP subsequent to the Army's 1978 waste disposal report identified 14 source areas of contamination at TCAAP. These areas were used for the burial or open-burning of waste or were industrial sources of contamination. The Army designated the source areas as Sites A, B, C, D, E, F, G, H, I, J, K, 129-3, 129-5 and 129-15. See Figure 3 in the Docket.

The Army entered into a Federal Facilities Agreement (FFA) with EPA and the State of Minnesota in 1987. The FFA establishes the framework, schedule and requirements for the Army to conduct a remedial investigation (RI) and feasibility study (FS) at the TCAAP facility and to implement the selected cleanup actions.

The Army implemented several interim remedial actions (IRAs) at the TCAAP facility ( i.e., OU2 of the NB/AH/TCAAP Site) under the Army's Installation Restoration Program (IRP). The Army conducted the IRAs in the 1980s and 1990s before an overall remedy was selected for OU2 in the OU2 Record of Decision (ROD) in 1997. These actions included unilateral actions by the Army, actions with EPA and State concurrence, and other actions initiated by the Army/Alliant. The IRAs were coordinated with the State and Federal regulatory agencies.

The Army implemented unilateral removal actions at TCAAP using its own delegated removal authorities under CERCLA Section 104. These actions included installing in-situ soil vapor extraction (SVE) systems at Sites D and G to remediate VOC-contaminated soils in 1986 and installing groundwater pump-and-treat systems at Sites A and K to treat VOC-contaminated groundwater in 1988.

Army IRAs at TCAAP undertaken with EPA and State concurrence included: (1) Installing a Boundary Groundwater Recovery System (BGRS) in 1987 to prevent additional groundwater contaminants from flowing off of the TCAAP property pursuant to a 1987 ROD; (2) expanding the BGRS into the TCAAP Groundwater Recovery System (TGRS) with source control wells installed downgradient of Sites D, G and I; (3) thermally treating 1,400 cubic yards of soil contaminated with polychlorinated biphenyls (PCBs) at Site D in 1989 pursuant to a 1989 ROD on Removal Action for PCB-Contaminated Soils Near Site D; (4) remediating heavy metal soil contamination through soil washing/leaching technologies at Site F from 1993-1997 under the Resource Conservation and Recovery Act (RCRA); and (5) modifying the Site A groundwater remediation system installed in 1983 to include eight boundary extraction wells in 1994.

Other IRAs the Army implemented at TCAAP included: Cleaning of the sanitary sewer system lines (Site J) from 1984 to 1986 and closing Site J in accordance with the EPA and MPCA-approved Final Site J Closure Report issued in 1994; and excavation by Alliant of the PCB-contaminated soils around Building 502 in 1985 and disposing of the soils at a permitted off-site facility in 1996.

Several property ownership transfers and reassignments of control have occurred at the TCAAP property since the NB/AH/TCCAP Site was listed on the NPL. See Figure 4 in the Docket. Since 1983, control of over 1,500 acres of TCAAP has been reassigned to the National Guard Bureau which licenses the use of the property to the Minnesota Army National Guard for the operation of the Arden Hills Army Training Site (AHATS) and to the U.S. Army Reserve. The National Guard Bureau and Army Reserve property is still federally-owned and is controlled by the Army, but it is no longer controlled by TCAAP, which reports to a different division.

Prior to 2010, the Army also transferred more than 270 acres of TCAAP that did not require land or groundwater use restrictions to Ramsey County and the City of Arden. This property consists of: Parcels 093023320001 and 093023240003 owned by Ramsey County (the unlabeled OU2 area in the northwest corner of OU2 on Figure 4 in the Docket); Parcel 153023340001 located at 1425 Paul Kirkwold Drive owned by Ramsey County; and Parcel ID 153023430001 located at 1245 Highway 96W owned by the City of Arden Hills (shown as the unlabeled OU2 areas along the southern boundary of OU2 on Figure 4).

In 2013, the Army transferred another 397 acres of TCAAP to Ramsey County and leased another 30 acres of TCAAP to the County. In 2017, the Army transferred the ownership of the 30 acres Ramsey County was leasing from the Army to Ramsey County.

Forty-seven of the 427 acres of property the Army transferred and leased to Ramsey County in 2013 did not require land or groundwater use restrictions (see the Operation and Maintenance section of this notice). The other 380 acres were restricted by land use controls (LUCs) for soil and groundwater.

Ramsey County conducted an additional soil investigation at the 380 acres of restricted property they owned or were leasing in 2014. Ramsey County remediated the areas of remaining soil contamination, including the soil contamination at Sites I and K located within the 380-acre area.

Following the additional cleanup, MPCA and EPA approved the soil in the 380-acre area to be suitable for unlimited use/unrestricted exposure (UU/UE). The Army removed the soil LUCs on the 380 acres in Revision 4 of the OU2 Land Use Control Remedial Design (LUCRD) dated August 2016. This property, however, is still subject to the groundwater LUCs (see Figure 5, Area with Groundwater LUCs, in the Docket).

The Army determined that the remaining 160 acres of the TCAAP property are surplus to the needs of the Federal government. This property is in the process of being transferred out of Federal ownership. These 160 acres are controlled by the Base Realignment and Closure (BRAC) Division of the Army, the organization to which TCAAP currently reports.

Ramsey County identified 108 acres of the remaining 160-acre TCAAP property (Parcels A through D) for use as part of the Rice Creek Regional Trail Corridor (RCRTC) (see Attachment B, Site Boundary—Rice Creek Regional Trail Parcels A-D in the Docket). Ramsey County completed an additional soil investigation and cleanup on the 108 acres to levels that are suitable for recreational use. The Army removed the soil LUCs on the 108-acre property in Revision 5 of the OU2 Land Use Control Remedial Design (LUCRD) dated March 2018.

The Army will transfer title to Parcels A, B, and D of the 108-acre property to Ramsey County. Parcel C will remain under Federal ownership, but the government intends to grant Ramsey County a perpetual easement to Parcel C for its use as part of the RCRTC.

This partial deletion pertains to all soil (shallow and deep) located within the OU2 boundary of the NB/AH/TCAAP Site (see Figure 2-2 in the Docket). This partial deletion also pertains to surface water and sediment (not groundwater) in the five aquatic sites located within the OU2 boundary of the NB/AH TCAAP Site: Rice Creek, Sunfish Lake, Marsden Lake North, Marsden Lake South and Pond G (see Figure 11-1 in the Docket).

The remaining areas at the NB/AH/TCAAP Site, including OU1, OU3, groundwater in OU2 and a sixth aquatic site, Round Lake located southwest of the OU2 boundary, will remain on the NPL and are not being considered for deletion as part of this action.

The Army conducted a RI at the TCAPP portion of the NB/AH/TCAAP Site (OU2) from 1988 to 1991. The purpose of the RI was to characterize the nature and extent of soil, sediment, surface water and groundwater contamination within the OU2 boundary. The FS developed and evaluated cleanup alternatives to address the unacceptable risks identified at OU2.

The Army completed the OU2 RI and conducted an OU2 Terrestrial Ecological Risk Assessment in 1991. The Army conducted a Tier II Ecological Risk Assessment for the OU2 aquatic sites in 2004. Due to EPA and MPCA concerns, the Army conducted additional sampling at Marsden Lake and Pond G in 2008. The Army issued a separate FS for the five aquatic sites located within the OU2 site boundary in 2011. The Army is addressing Round Lake, which is still considered part of OU2 but is located outside of the OU2 site boundary, southwest of OU2, separately.

EPA completed a Human Health Risk Assessment (HHRA) addressing OU1, OU2 and OU3 of the NB/AH/TCAAP Site in 1991. In 1992, the Army collected additional data as part of the FS development process to further characterize the nature and extent of OU2. The Army completed the OU2 FS in 1997. The OU2 FS included an updated list of additional contaminants of concern (COCs) and cleanup levels.

The Agency for Toxic Substances and Disease Registry (ATSDR) completed a Public Health Assessment of the NB/AH portion of the NB/AH/TCAAP Site (OU1 and OU3) in 1994. Based on the assessment, ATSDR considered the NB/AH portion of the NB/AH/TCAAP Site to be a “public health hazard” because people were exposed to past groundwater contaminants from TCAAP at concentrations that could result in adverse health effects.

The Army's RI identified all known or suspected sources of contamination at OU2 of the NB/AH/TCAAP Site. The RI separated the OU2 contamination into four categories: Shallow soil sites, with soil contamination less than 12 ft-bgs (Sites A, C, E, H, 129-3 and 129-5); deep soil sites, with soil contamination greater than 12 ft-bgs, down to depths between 50 and 170 feet (Sites D and G); shallow (Unit 1) groundwater contamination (Sites A, I and K); and deep (Units 3 and 4) groundwater contamination (groundwater underlying the southwestern portion of OU2, originating primarily from Sites D, G and I). Although Sites D and G were considered deep soil sites, shallow soil contaminants were also present at Site D, and Site G also contains a dump.

The Army addressed Sites F (RCRA) and J (sewer line cleaning) separately and did not include these areas in the OU2 RI. Also, the Army did not find any contamination in Site B other than part of a dump (Site B-3) that would require additional investigation.

The RI and additional FS sampling indicated that the shallow soil sites (Sites A, C, E, H, 129-3 and 129-5) were contaminated by heavy metals, VOCs, polynuclear aromatic hydrocarbons (PAHs) and PCBs. The contamination was generally present in the upper five to 10 feet of soil. Contaminated soil volumes ranged from as little as 15 cubic yards (CY) at Site 129-5 to as much as 2,600 CY at Site C.

Unpermitted landfills or dumps also existed within the boundaries of shallow soil Sites A, E and H. The estimated material in these dumps ranged from 4,400 CY at Site A to 12,200 CY at Site E. The RI identified two additional dumps in OU2. Dump Site B-3 was estimated to contain 12,400 CY of material. The other dump is Site 129-15 and is estimated to be 53,000 CY.

The RI did not investigate the material at Site B-3 or Site 129-15. The RI indicated that additional characterization would be required before response actions could be selected for these areas. There was no clear indication, however, that either dump was contaminating the groundwater.

The Army updated EPA's 1991 HHRA in the 1997 OU2 FS to incorporate the results of the additional sampling. The updated risk assessment in the FS indicated that the surface soil and debris at Sites A, C, H and 129-3 posed an unacceptable cancer and/or noncancer risk to on-site workers under a current industrial exposure scenario. Subsurface soil and debris at Sites A, C, H and 129-3 and at Sites D, E, G and 129-5 also posed an unacceptable cancer and/or noncancer risk to future construction workers in these areas. The risks were primarily due to the incidental ingestion of and dermal contact with surface and/or subsurface soil and debris.

According to the updated HHRA, surface soil and debris at Sites A, C, E, H and 129-3 posed an unacceptable cancer and/or noncancer risk to potential future residents living in these areas under a future residential exposure scenario. These risks were primarily due to the incidental ingestion of and dermal contact with surface soil and debris and to the ingestion of home-grown fruits and vegetables.

The Army developed remedial action objectives (RAOs) for the OU2 cleanup in the FS based on the current and most probable future land use for the property, which was industrial. The FS then developed numerical remediation goals for the cleanup based on applicable or relevant and appropriate requirements (ARARs), health-based risk values, background concentrations of metals, contaminant migration potential and technological limitations.

The health-based risk values developed for surface soil were based on the lower of either an excess lifetime cancer risk equal to one in a million or a noncancer hazard of one, adjusted for exposure to multiple contaminants. The industrial values were calculated based on the primary routes of exposure which were ingestion and dermal contact. The cleanup levels for the deep soil Sites D and G were based primarily on leaching-based goals that are protective of the underlying groundwater for use as residential drinking water. For Site 129-15, a one-time commercial, industrial or utility construction scenario was utilized. The construction scenario assumed that construction workers would be exposed to excavated soils for 40 days ( i.e., a two-month construction period) a year for two years. See the Cleanup Levels section below for additional information. The FS developed general response actions for the OU2 cleanup based on the technical applicability and the contaminant characteristics of each individual site within OU2. After initial screening, the FS retained a set of final cleanup alternatives for full evaluation. The alternatives evaluated for the shallow soil Sites A, C, E, H, 129-3 and 129-5 were: No action, in-situ fixation/capping, soil washing/soil leaching and excavation/stabilization with off-site disposal. The alternatives evaluated for the deep soil Sites D and G were: No action, continue shallow SVE, or expand the SVE systems vertically.

The only alternative the FS evaluated for the unpermitted landfills in Sites A, E and H was excavation and off-site disposal. The FS indicated that the landfills in Site B and Site 129-15 would require further characterization.

EPA, MPCA and the Army selected an industrial cleanup remedy for the OU2 shallow soil sites, dumps and deep soil sites in a 1997 OU2 ROD. The agencies also selected remedies for the five aquatic sites located within the OU2 boundary in OU2 ROD Amendment #4 (Rice Creek, Sunfish Lake, Marsden Lake North, Marsden Lake South and Pond G).

The selected remedy for the shallow soil Sites A, C, E, H, 129-3 and 129-5 and for the dumps within Sites A, E and H in the 1997 OU2 ROD included the following remedial components (see the 1997 ROD for information about the groundwater components of the OU2 remedy):

(1) Identification/characterization of contaminated soil boundaries, surface and subsurface debris and dump contents;

(2) Excavation and sorting of hazardous and nonhazardous dump materials, debris and ordnance;

(3) Removal and disposal of ordnance, debris and oversized material;

(4) On-site stabilization of hazardous and contaminated soils from Sites A, E, H, 129-3 and 129-5;

(5) Off-site disposal of stabilized materials from Sites A, E, H, 129-3 and 129-5;

(6) Off-site transport, incineration and disposal of soils containing low levels of dioxin-furans from Site C (if required);

(7) Backfill/regrade excavations;

(8) Restrict site access and use during remedy implementation; and

(9) A limited period of monitoring to verify remedy effectiveness.

The selected remedy for the dumps at shallow soil Sites B and 129-15 was characterization to determine the contents of the dumps. If the contents were found to be toxic, hazardous or contaminated, then a remedy for the landfill would be documented through a ROD Amendment. If the contents were not toxic, hazardous or contaminated then a no further action remedy will be selected.

The selected remedy for the shallow and deep soil contamination at Site D and for the deep soil contamination and dump at Site G was to expand the SVE systems vertically. The remedy included:

(1) Groundwater monitoring;

(2) Access and use restrictions;

(3) Installation and operation of deep SVE systems with modified shallow SVE systems, as appropriate;

(4) Evaluation and potential use of enhancements to the SVE systems;

(5) Maintenance of existing soil caps and surface drainage controls; and

(6) Characterization of shallow soils at Site D and the dump at Site G following cessation of SVE system operation to determine appropriate action.

The remedy in the 1997 OU2 ROD also included the characterization of the unsaturated Unit 1 soil at Site K as part of the Site K shallow groundwater remedy.

The 1997 OU2 ROD clarified that Site F, a former disposal area within OU2, was being closed under RCRA and was not addressed in the OU2 ROD. The 1997 OU2 ROD also confirmed that the 1994 Final Site J Closure Report for the sanitary sewer cleaning was approved by the regulatory agencies, documented the absence of contaminants above background levels and recommended no further action for this area.

Between 2007 and 2014, EPA, MPCA and the Army issued five ROD Amendments and an Explanation of Significant Differences (ESD) modifying various components of the selected remedies for the shallow soil sites, dumps and deep soil sites in the 1997 OU2 ROD and selecting remedies for the five aquatic sites located within the OU2 boundary.

OU2 ROD Amendment #1, issued in 2007, modified the requirements for Site C-2 shallow soil and sediment contamination discovered in 2004 in two Site C-2 ditches. Because the depth to groundwater is shallow at Site C-2, it was not feasible to remove all of the contaminated soil and sediment from this area. The OU2 ROD Amendment #1 modified the remedy to allow the placement of a 4-foot thick soil cover over the Site C-2 areas where the contamination remains in-place above the cleanup levels instead of excavating the material. The OU2 ROD Amendment #1 also specified LUCs to maintain the integrity of the soil cover, prohibit unauthorized disturbance to the underlying soil and sediment and to restrict the Site C area outside the soil cover to site-specific industrial use. The OU2 ROD Amendment #1 also included the creation of a new wetland within the TCAAP facility to replace the loss of existing wetland.

OU2 ROD Amendment #3 was issued in 2009 and modified the remedies for the shallow soil and dump sites as follows:

(1) Documented, as a final remedy, the additional actions performed for shallow soil at Site D (soil cover for residual PCB-contaminated soil following the 1985 interim remedial action and 1989 thermal treatment selected in the 1989 ROD for Removal Action for PCB-Contaminated Soils Near Site D, and excavation, stabilization and off-site disposal of other contaminated Site D soil) after completing the deep soil cleanup at Site D.

(2) Documented, as a final remedy, the additional action (capping) implemented for the dump at Site G after completing the Site G deep soil cleanup.

(3) Documented the use of soil covers as part of the final remedies, in addition to excavation and off-site disposal, at Sites E and H and as the primary remedy for the dump at Site 129-15.

(4) Documented that three OU2 areas not addressed in the 1997 OU2 ROD were acceptable for unrestricted use: 135 Primer/Tracer Area (PTA) Stormwater Ditch, Trap Range Site and Water Tower Area. The OU2 ROD Amendment #3 determined that the previous soil removals at the 135 PTA Stormwater Ditch in 2005 and at the Water Tower Area in 1993 reduced soil contamination to levels that allow for unrestricted use. ROD Amendment #3 also determined that, based on the 1999 preliminary assessment of the Trap Range Site, that the Trap Range Site is acceptable for unrestricted use.

(5) Documented the final remedies for two OU2 areas not addressed in the 1997 ROD: Grenade Range and Outdoor Firing Range. The OU2 ROD Amendment #3 determined that the 1993 and 1999 soil and unexploded ordnance removal actions at the Grenade Range and at the Outdoor Firing Range, and the construction of a soil cover at the Outdoor Firing Range in 2003-2004, cleaned up these areas to levels that are acceptable for industrial use.

(6) Requires long-term LUCs as an additional remedy component for shallow soil and dump Sites: D, E, G, H, 129-15, Grenade Range, and Outdoor Firing Range. The LUCs restrict these areas to site-specific industrial use, require the integrity of the soil covers to be maintained, and prohibit the unauthorized disturbance of materials underlying the soil covers. The exact details of the LUCs were to be specified and maintained in accordance with a LUCRD document approved by EPA and MPCA. ROD Amendment #3 concluded that LUCs are not needed for the 135 PTA Stormwater Ditch or Trap Range because contamination levels in these areas are suitable for UU/UE. The Amendment also concluded the Water Tower Area is suitable for UU/UE; however, it is located within the area of “blanket LUCs” the Army implemented as specified in the 2010 LUCRD so it is restricted.

ESD #2, issued in 2009, modified the 1997 OU2 ROD by requiring long-term LUCs as an additional remedy component for Sites A, C-1, 129-3 and 129-5 restricting these areas to industrial use. ESD #2 also documented that based on an additional investigation, the Site B dump is cleared for unrestricted use and no further action is the final remedy for Site B.

OU2 ROD Amendment #4 was signed in 2012. The OU2 ROD Amendment #4 documented remedy decisions for the five aquatic sites located within the OU2 boundary and the 535 PTA Site, which were not addressed in the 1997 OU2 ROD. OU2 ROD Amendment #4 also documented the remedy decision for the Site K unsaturated Unit 1 soil characterized as part of the Site K shallow groundwater remedy.

OU2 ROD Amendment #4 determined:

(1) No action is needed for Rice Creek, Sunfish Lake, Marsden Lake North or Marsden Lake South. The 2011 FS, which the Army prepared following the 2004 Tier II Ecological Risk Assessment, documented that there are no human health risks associated with these areas and that the ecological risks are considered to be acceptable. These aquatic areas are acceptable for unrestricted use.

(2) In-situ treatment to raise hardness is the selected cleanup remedy for Pond G. No human health risks were associated with Pond G, however, Pond G surface water contains lead above the State water quality standard and may not be protective of the entire aquatic ecosystem. Pond G surface water was to be chemically altered and monitored to verify that the adjusted level of hardness increases to the minimum required level to comply with the Class 2Bd Minnesota chronic surface water quality standard for lead.

(3) The 2009 removal actions at the 535 PTA Site and for the VOC-contaminated soil at Site K, which involved the excavation and off-site disposal of contaminated soil, cleaned up the soils for unrestricted use. No further action is necessary for the soil in these areas and LUCs are not required.

OU2 ROD Amendment #5 was signed in 2014. The OU2 ROD Amendment #5 documented remedy decisions for three additional areas of soil contamination not addressed in the 1997 OU2 ROD. The Army remediated these areas as a 2013 removal action and addressed: (1) Additional metal contamination at Site A, (2) PAH-contamination at Site 135 PTA, and (3) PAH and/or metals contamination discovered in two areas during an environmental baseline survey (EBS Areas) conducted by the Minnesota National Guard before the property was transferred to the National Guard Bureau.

The 2013 soil removal action involved excavating the soil that was contaminated above industrial use cleanup levels in these areas and disposing of the contaminated materials off-site. OU2 ROD Amendment #5 documented that the completed 2013 removal action constitutes the final remedy for these soil areas of concern. OU2 ROD Amendment #5 also added the requirement that these areas be covered by a LUC restricting the areas to industrial use.

Decision documents that address the groundwater components of the OU2 remedy (groundwater not included in this partial deletion) include: OU2 ROD (1997), OU2 ROD Amendment #2 (2009), OU2 ESD #1 (2009), OU2 ROD Amendment #4 (2012) and OU2 ROD Amendment #6 (2017).

The Army constructed a corrective action management unit (CAMU) to aid in the OU2 cleanup and initiated shallow soil site remediation in 1998 beginning with Site A. The CAMU was a bermed, asphalt pad with lined ponds to store rainwater runoff from the pad. The CAMU was to be a central staging area where soils from each site would be brought for treatment before loading for off-site disposal at a permitted landfill. In 1999, however, the Army discovered asbestos-containing material (ACM) at the shallow soil sites which made further use of the CAMU impractical. The safeguards needed to control the asbestos during handling defeated the cost savings of the central processing pad. The Army determined that it was more convenient and cost-effective to treat the soil at each site instead of moving the contaminated material to a central location for treatment.

The Army removed the CAMU in 2002. The Army decontaminated and removed the storage and storm water holding ponds, tested for contamination under the pad and ponds, and monitored the groundwater. EPA and MPCA approved the Army's CAMU Closeout Report in 2004. The CAMU Closeout Report states that there were no adverse impacts to soil or groundwater due to CAMU operations and that no LUCs are required for this area.

The Army completed the remedial actions at the shallow soil Sites A, C, E, H, 129-3, 129-5 and the Outdoor Firing Range from 1999 to 2010. The Army excavated debris and contaminated soil above industrial cleanup levels, stabilized the material and disposed of it at an off-site landfill. The Army excavated approximately: 16,300 CY from Site A; 21,450 CY from Site C; 20,900 CY from Site E; 8,620 CY from Site H; 3,470 CY from Site 129-3; 100 CY from Site 129-5 and 100 CY from the Outdoor Firing Range.

The Army also constructed a 2-foot thick protective soil cover over a portion of Site E and a 30-inch thick soil cover over a portion of Site H where ACM remains in-place; a 4-foot thick soil cover over portions of Site C where metals-contaminated soils and sediment from the former ditches remain in-place; and a 2-foot thick soil cover at the 1900 Yard Range of the Outdoor Firing Range where PAH-contaminated soils remain in place.

The Army investigated the Site 129-5 dump then constructed a protective soil cover over the materials. The Army also constructed a new wetland at Site C to replace the loss of existing wetlands when the Site C ditches were backfilled.

The Army completed the remediation work (shallow and deep soils) at the deep soil Sites D and G in 2004. The Army dismantled the SVE systems in 2000 after the deep soil cleanups were complete. At Site D, the Army then excavated 1,300 CY of shallow soils contaminated with non-VOCs and disposed of them at an off-site landfill. The Army also constructed a four to six foot soil cover over residual PCB-contaminated soils remaining at Site D after the 1985 interim remedial action. At Site G, the Army characterized the dump then constructed a 2-foot thick protective soil cover over the material.

The Army conducted five years of groundwater monitoring at the shallow soil sites and Site D from 2003 through 2007. The Army conducted three years of groundwater monitoring at the Grenade Range from 1999 to 2004. The Army conducted the monitoring to verify that the groundwater beneath these areas was not impacted by remediation activities.

The Army conducted the groundwater monitoring in accordance with groundwater monitoring plans that were reviewed and updated annually as part of the Army's Annual Performance Report (APR). Based on the monitoring data, the Army extended the monitoring at Site H. The groundwater sampling is now complete at all shallow soils sites and confirms that there are no adverse remedy impacts to groundwater in these areas. Groundwater monitoring for VOCs, however, continues as part of OU2 deep groundwater monitoring in the vicinity of Sites D and G.

The Army treated the Pond G surface water in 2012 in accordance with the Pond G RD/RA Work Plan. The Army monitored the Pond G surface water in 2012 and 2013. The monitoring results verified that the surface water in Pond G was in compliance with the surface water standard for lead. Since the Pond G remedy does not result in hazardous substances remaining in the Pond above levels that allow for UU/UE, long-term maintenance, monitoring, and LUCs are not required.

Reports documenting the completion of remedial activities for the shallow soil Sites A, C, E, H, 129-3, 129-5, 129-15, the shallow and deep soil in deep soil Site D and the deep soil and dump in deep soil Site G are in the Docket in the following reports: Final Remedial Action Completion and Shallow Soil Sites Close Out, Volumes I through VIII; Final Site 129-15 Dump Investigation, Characterization and Remedial Action Completion and Close Out Report; Final Site D Shallow and Deep Soil Volatile Organic Compound Investigation and Close Out Report; Final Site G Volatile Organic Compound Investigation and Dump Close Out Report; and Outdoor Firing Range 1900 Yard Range Cover Construction: Addendum to the Final Close Out Report, Outdoor Firing Range and #150 Reservoir Site Removal. The completed Pond G remedial action work and surface water monitoring results are documented in the 2013 Remedial Action Completion and Close Out Report, Pond G.

No action or no further action (other than LUCs) was required for shallow soil Site B, Site J, the Unit 1 soil in Site K, Grenade Range, Site 135 PTA, Site 135 PTA Stormwater Ditch, Site 535 PTA, the EBS areas, Water Tower Area, the Trap Range Site, Former Building 576, Rice Creek, Sunfish Lake, Marsden Lake North or Marsden Lake South. Also, Site F was closed under RCRA. Additional information about these areas is documented in the 1997 OU2 ROD, 2009 OU2 ROD Amendment #3, 2009 ESD #2, 2012 OU2 ROD Amendment #4 and 2014 ROD Amendment #5 and the following reports in the Docket: Final Site B Dump Investigation, Characterization, and Close Out Report; Final Close Out Report, Outdoor Firing Range and #150 Reservoir Site Soil Removal Action, Completion of Soil Removal; Remedial Action Report, Site K; Lead-Impacted Soil Cleanup documentation, TCAAP Former Building 576; Close Out Report: Removal of Contaminated Sediment at the 135 Primer/Tracer Area Stormwater Outfall; Removal Action Completion Report, Site K; Final Close Out Report for Soil Removal Action at 535 Primer/Tracer Area; and Removal Action Completion Report for Soil Areas of Concern—Site A, 135 Primer/Tracer Area, EBS Areas.

The cleanup levels for shallow soils in the 1997 OU2 ROD were derived specifically for each shallow soil site because MPCA did not have published rules or guidance values for soil at the time. The ROD selected cleanup levels for shallow soils based on background levels, ARARs and the more stringent of either the site-specific industrial health-based value or leaching-based goal (see Table 8 in the 1997 OU2 ROD in the Docket). The health-based values were the lower of either an excess lifetime cancer risk equal to one in a million or a noncancer hazard of one, adjusted for exposure to multiple contaminants. The cleanup levels for the deep soil Sites D and G were based primarily on leaching-based goals that are protective of the underlying groundwater.

The site-specific health-based values calculated for the shallow soils sites assumed that adult industrial workers at TCAAP would be exposed to contaminated soil through dermal contact and ingestion for 250 days a year for 25 years. The calculations assumed an adult body weight of 70 kilograms, a soil ingestion rate of 50 milligrams/day and a dermal exposure over 0.31 square meters of body surface.

For Site 129-15, a one-time commercial, industrial or utility construction scenario was utilized. The construction scenario assumed that construction workers would be exposed to excavated soils for 40 days ( i.e., a two-month construction period) a year for two years. The construction exposure assumes that the excavated soils are managed to eliminate or greatly reduce exposure to fugitive dusts; all other parameters were assumed to be the same as the industrial exposure scenario.

The leaching-based goals for shallow and deep soils were calculated by MPCA using a soil model for chemicals that were found at the site in groundwater above drinking water or health-based standards. The industrial soil cleanup level for lead of 1,200 milligrams per kilogram (mg/Kg) was calculated by EPA using the Exposure Model for Assessing Risks Associated with Adult Exposure to Lead in Soil. Additional information concerning the soil cleanup standards is in Appendix C of the 1997 OU2 ROD.

Additional soil cleanup standards were later added based on subsequent investigations for Site A (tetrachloroethene and TCE), Site D (antimony, lead, and nitroglycerine) and Site 129-15 (lead). PCBs were not specifically listed as COCs for Site D in the OU2 ROD; however, the PCBs that were “secured in-place” exist at concentrations that exceed the ARAR of 10 mg/Kg cited in the OU2 ROD, so the cleanup standard for PCBs is considered to be 10 mg/Kg. Nitroglycerine was listed as a COC for Site 129-3 in the OU2 ROD; however, no cleanup level was established. The current cleanup level for nitroglycerine was calculated at the time of soil remediation work at Site 129-3.

In 1999, the background number for arsenic in the TCAAP soils increased from 4 mg/Kg to 10 mg/Kg, as documented in a June 14, 1999 MPCA letter to the Army. This resulted in the cleanup level for arsenic increasing to 10 mg/Kg at Sites C and H. At Site 129-15 the highest arsenic concentration detected in soils was 5 mg/Kg and arsenic was dropped as a COC.

In 2002, the soil cleanup level for TCE at Site G increased to 36.1 mg/Kg. This revised cleanup standard is based on an updated soil leaching analysis that specifically accounted for the lower permeability of the Site G cover. EPA and MPCA agreed with this change on July 24, 2002. For cleanup levels that were established subsequent to the OU2 ROD, the health risk calculations are noted to be based on the same methodology and input parameters that were documented in Appendix C of the OU2 ROD.

The current cleanup standards for the OU2 shallow and deep soils sites are provided in Table 1 of the 2018 LUCRD Revision 5. A copy of Table 1 and the complete 2018 LUCRD document are available in the Docket.

The cleanup level for lead in Pond G is the Minnesota Class 2Bd surface water quality standard for lead, as promulgated in Minnesota Rule 7050.0222. The lead standard is calculated based on the hardness value of the surface water. At Pond G, the calculated lead standard ranged from a concentration of 11.4 micrograms per liter (μg/L) after initial treatment with lime and calcium to 1.6 to 2.0 μg/L approximately one year later.

The Army confirmed that the soil cleanup levels were attained at each of the shallow and deep soils sites through extensive soil verification sampling around each of the excavated areas, and by soil sampling below the shallow and deep vents at the SVE systems at Sites D and G. The Army conducted the verification sampling at the shallow soil Sites A, C, E, H, 129-3, 129-5, 129-15, the shallow soil at deep soil Site D and the dump at deep soil Site G through field and laboratory sampling and analysis at gridded locations in accordance with the 2000 Final Comprehensive Work Plan, Final Sampling and Analysis Plan and Final Site Safety and Health Plan, Shallow Soil Sites RD/RA Activities and associated Work Plan Clarifications. The Army conducted the verification sampling for deep soil at deep soil Sites D and G in accordance with the 1997 Final Work Plan, Sites D and G Pilot Study and the 1999 Addendum 1, Final Work Plan Sites D and G Pilot Study. The Army conducted the verification sampling at the other sites in accordance with the Removal Action Work Plan or other work plan for each area.

The Army confirmed that the cleanup level for lead in the Pond G surface water was met through four rounds of post-treatment monitoring. The Army detected lead during the second monitoring event at an average concentration of 0.61 μg/L. This concentration was well below the calculated standard for lead of 10.6 μg/L based on the average surface water hardness of 255 mg/L for that event. The Army did not detect lead in any of the other rounds of post-treatment monitoring.

Complete documentation of the verification of the cleanup levels for Pond G and the shallow and deep OU2 soils is available in the Remedial Action Completion Reports, Removal Action Completion Reports and Final Close Out Reports referenced in the Response Actions section above which are available in the Docket.

Operation and maintenance (O&M) for the soil portion of OU2 (shallow and deep) is limited to inspecting and maintaining the cautionary warning signs and the thicknesses of the soil covers at Sites C, D, E, G, H, 129-15 and the Outdoor Firing Range; annually removing woody vegetation from the Site G soil cover to prevent deep rooting that could cause increased infiltration by any VOCs remaining below the cover; and to maintain, monitor and enforce the ESD and ROD Amendment-required LUCs, which are in the form of the Army's OU2 LUCRD document approved by EPA and MPCA. No O&M or LUCs are required for the five aquatic sites within the OU2 boundary: Rice Creek, Sunfish Lake, Marsden Lake North, Marsden Lake South or Pond G.

The Army issued the initial EPA and MPCA-approved OU2 LUCRD (Revision 1) in 2010. The Army updated the LUCRD in 2011, 2015, 2016 and 2018 as portions of OU2 were further characterized, remediated as needed, and transferred for reuse and redevelopment. The current LUCRD is LUCRD Revision 5 issued in 2018.

The LUCRD documents that since 1997, the working presumption is that the OU2 property outside of the individual areas of concern ( i.e., the OU2 property beyond Site A, Site C, Site D, etc.) does not have soil contamination above the typical “industrial use” cleanup levels derived for the areas of contamination within OU2. Ongoing and future uses of the OU2 property outside of the areas of concern would be compatible with past uses. Land used for manufacturing could continue to be used for manufacturing; open space could continue to be used for open space. As such, the mostly open space along Rice Creek and the former OU2 staff housing area the Army previously transferred to Ramsey County and other OU2 property the Army transferred to the City of Arden Hills without any use restrictions (approximately 270 acres total) would remain acceptable for UU/UE.

LUCRD Revision 1 and subsequent revisions formalize the Army's decision to implement “blanket LUCs” limiting the OU2 property to industrial land use and restricting groundwater use across the remaining federally-owned OU2 property at the time LUCRD Revision 1 was issued in 2010 (except for Site F which the Army cleaned up to unrestricted use under RCRA). A map showing the initial federally-owned property with LUCs at the time of the 2010 LUCRD is in the September 2010 Figure 4 in the Docket.

The “blanket LUCs” resolved the outstanding LUC issues for the OU2 property outside of the individual areas of concern ( i.e., OU2 property beyond Site A, Site C, Site D, etc.,) because the remedy-required LUCs in the OU2 ESDs and ROD Amendments only apply to each individual area of concern, not to the OU2 property outside of those areas. The Army's “blanket LUCs” also address the uncertainty associated with not having soil data to characterize the entire OU2 property outside of the areas of concern. The 2010 LUCRD and subsequent revisions include additional restrictions for OU2 areas with soil covers and components of the OU2 groundwater extraction and treatment systems to protect the integrity of these remedies.

The 2010 LUCRD and subsequent revisions allow and formalize a process for the Army to demonstrate to EPA and MPCA that less restrictive uses of OU2 property are acceptable in anticipation of future redevelopment and property transfers at the NB/AH/TCAAP site.

The Army issued Revisions 2, 3, 4 and 5 to the LUCRD from 2011 to 2018. These revisions: (1) Cleared the Watchable Wildlife Area of AHATS for unrestricted public use and revised the LUCs for a portion of the AHATS Cantonment Area to allow uses compatible with a restricted commercial exposure scenario (Revision 2, 2011); (2) revised the LUCs for the remainder of the Cantonment Area and the Army Reserve Center to restricted commercial use and documented the transfer/lease of 427 acres of Army/BRAC controlled property to Ramsey County (Revision 3, 2015); (3) revised the LUCs to eliminate soil LUCs from the 380-acre “California-Shaped Area” of the 427 acres transferred to Ramsey County in 2013 following the County's additional investigation and soil cleanup to levels consistent with UU/UE (Revision 4, 2016); and (4) revised the LUCs to allow recreational use on 108 acres in the western portion of OU2 to be used as part of the Rice Creek Regional Trail Corridor (Revision 5, 2018).

The specific details of the current OU2 soil and groundwater use restrictions and the provisions for long-term stewardship of the LUCs are contained in the 2018 OU2 LUCRD Revision 5 which is available in the Docket. The technical basis and supporting documentation for the LUC revisions are included in Appendices B through E of LUCRD Revision 5. Maps showing the areas covered by the current soil and groundwater LUCs for OU2 are in Figures 4 and 5 in the Docket.

The Army is the lead agency for the NB/AH/TAACP Site and is responsible for conducting routine inspections to ensure that the LUCs are maintained and enforced. The Army is responsible for reporting the results of the inspections and any breach of the LUCs to the MPCA and EPA.

The Army is required to conduct statutory five-year reviews (FYR) at the NB/AH/TCAAP Site because hazardous substances, pollutants, or contaminants remain at the Site above levels that allow for UU/UE. The Army completed the last FYR of the NB/AH/TCAAP Site in 2014. The FYR was approved by MPCA and by EPA on August 19, 2014.

The Army's 2014 FYR concluded that the remedy has been completed for the OU2 soils sites: Sites A, C, D, E, G, H, 129-3, 129-5, 129-15, the Grenade Range and the Outdoor Firing Range. The FYR also determined that the protective soil covers at Sites C, D, E, G, H, 129-15 and the Outdoor Firing Range, in conjunction with the implemented LUCs, effectively prevent exposure to contaminated soils/debris remaining at OU2 above industrial exposure levels. The protective soil cover at Site G also minimizes infiltration and reduces the leaching of any remaining VOCs below the cover.

The 2014 FYR concluded that OU2 has been restored for industrial use. The Army also reviewed the toxicity data that the 1991 and 1997 health risk assessments for the soil sites were based on and determined that no changes have occurred that could potentially affect the protectiveness of the soil remedies. The 2014 FYR did not identify any issues or recommendations for the OU2 soils sites.

For OU2 groundwater, the FYR concluded that the OU2 groundwater remedies are protective in the short term. The groundwater containment systems are meeting the containment objectives and the treatment systems are meeting their discharge requirements. The alternate water supply and well abandonment program, along with Ramsey County's Special Well Construction Area permitting system, mitigate potential risks associated with private wells. At Site A, monitored natural attenuation is adequately controlling plume migration and water quality trends indicate that aquifer restoration continues to occur in both shallow and deep groundwater. A vapor intrusion investigation the Army conducted north of County Road I in 2014 indicates that there are no significant soil vapor risks and no further vapor intrusion investigation work is warranted (see the 2014 Site A Vapor Intrusion Investigation Report in the Docket).

The Army must complete the next FYR of the NB/AH/TCAAP Site and have it approved by EPA and MPCA on or before August 19, 2019.

The Army satisfied public participation activities for the NB/AH/TCAAP Site as required by Sections 113(k)(2)(B)(i-v) and 117 of CERCLA, 42 U.S.C. 9613(k)(2)(B)(i-v) and 9617. The communities near the NB/AH/TCAAP Site have been involved in NB/AH/TCAAP Site activities since the environmental problems were initially identified. The Army developed a Community Involvement Plan for the NB/AH/TCAAP Site in 1991 to establish processes for sharing knowledge and encouraging community participation concerning the hazardous waste remediation activities underway and planned at the NB/AH/TCAAP Site. The Community Relations Plan outlines specific community relations strategies for addressing these goals and for updating the plan as needed to adjust to evolving community needs and concerns. The Army updated the Community Involvement Plan in 1997.

Over the years the Army has prepared and distributed numerous fact sheets to a large number of local and interested residents to keep the community apprised of the remedial activities at the NB/AH/TCAAP Site. The Army sponsored tours of the facility and accompanying wildlife areas, in addition to providing monthly Technical Review Committee (TRC) meetings open to the public to review the status of restoration activities at the NB/AH/TCAAP Site.

The TCAAP Restoration Advisory Board (RAB) was established in 1996 to provide citizen input into the cleanup of the NB/AH/TCAAP Site. The RAB provides an opportunity for community representatives to review and analyze issues concerning the contamination and remediation of the NB/AH/TCAAP soils and groundwater; provide comments and recommendations regarding the remediation of contaminated areas at the site; and to provide advice on decisions that affect the quality of the environment of the communities that are impacted by the contamination.

The Army met the public participation requirements for selecting cleanup remedies and the amended cleanup remedies for the NB/AH/TCAAP Site required by CERCLA Sections 113(k)(a)(B)(i-v) and 117. The Army met these requirements by issuing fact sheets and Proposed Plans, notifying the public of the availability of the Proposed Plans in newspaper advertisements, holding public meetings and holding 30-day public comment periods.

The Army involves project stakeholders in the FYR process by notifying them at the start of each FYR. Project stakeholders notified at the start of the 2014 FYR include EPA, MPCA, Alliant Techsystems, Army National Guard, U.S. Army Environmental Command, U.S. Army Corp of Engineers, City of New Brighton, and the RAB.

The Army published a notice indicating that the 2014 FYR for the NB/AH/TCAAP Site was starting during the week of November 18, 2013 in the following newspapers: Minneapolis Star Tribune, Mounds View/New Brighton Sun Focus, and the Shoreview Press. The notice invited anyone interested in the FYR process to contact the Army TCAAP representative. The City of New Brighton was interested in participating in the FYR process.

The Army published a notice indicating that the FYR was complete and included contact information and the location of the public repository for the report (470 West Hwy. 96, Suite 100, Shoreview, MN 55126) in the newspapers after the FYR was finalized.

EPA has satisfied public participation activities for this partial deletion of the NB/AH/TCAAP Site as required by CERCLA section 113(k), 42 U.S.C. 9613(k), and CERCLA section 117, 42 U.S.C. 9617. EPA arranged to publish advertisements announcing this proposed direct final Partial Deletion and the 30-day public comment period in the Minneapolis Star Tribune, the Mounds View/New Brighton Sun Focus, and the Shoreview Press concurrent with publishing this partial deletion in the Federal Register . Documents in the deletion docket, which EPA relied on for recommending the partial deletion of the NB/AH/TCAAP Site from the NPL, are available to the public in the information repositories and at https://www.regulations.gov. Documents in the Docket include maps which identify the NB/AH/TCAAP Site, the locations of the OU2 areas of contamination/sites, the OU2 area included with this proposed direct final Partial Deletion, and the LUCs implemented for OU2.

The soil (shallow and deep) portion of OU2 and the five aquatic sites located within the OU2 boundary of the NB/AH/TCAAP Site: Rice Creek, Sunfish Lake, Marsden Lake North, Marsden Lake South and Pond G, meet all of the site completion requirements specified in Office of Solid Waste and Emergency Response (OSWER) Directive 9320.2-22, Close-Out Procedures for National Priorities List Sites. All cleanup actions and remedial action objectives for OU2 shallow and deep soil and these five aquatic sites set forth in the 1997 ROD, 2007 ROD Amendment #1, 2009 ROD Amendment #3, 2009 ESD #2, 2012 ROD Amendment #4 and 2014 ROD Amendment #5 have been implemented for all pathways of exposure. The selected remedial actions, RAOs, and associated cleanup levels for OU2 soil and the five aquatic sites located within the OU2 boundary are consistent with EPA policy and guidance. No further Superfund response is necessary to protect human health or the environment from the soil portion of OU2 (shallow and deep) or from the five aquatic sites located within the OU2 boundary.

Section 300.425(e) of the NCP states that a Superfund site or a portion of a site may be deleted from the NPL when no further response action is appropriate. EPA, in consultation with the State of Minnesota, has determined that all required response actions have been implemented for all soil (shallow and deep) located within the OU2 boundary of the NB/AH/TCAAP Site and for the five aquatic sites located within the OU2 boundary: Rice Creek, Sunfish Lake, Marsden Lake North, Marsden Lake South and Pond G, and that no further response action by the Army is appropriate for these media/areas.

EPA, with concurrence of the State of Minnesota, through the MPCA, has determined that all appropriate response actions under CERCLA, other than maintenance, monitoring and five-year reviews, have been completed for all soil (shallow and deep) located within the OU2 boundary and for the five aquatic sites located within the OU2 boundary: Rice Creek, Sunfish Lake, Marsden Lake North, Marsden Lake South and Pond G. Therefore, EPA is deleting all soil (shallow and deep) located within OU2 and these five aquatic sites located within the OU2 boundary from the NPL.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication. This action will be effective September 23, 2019 unless EPA receives adverse comments by August 22, 2019. If adverse comments are received within the 30-day public comment period, EPA will publish a timely notice of withdrawal of this direct final Notice of Partial Deletion before its effective date and the partial deletion will not take effect. EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to partially delete and the comments already received. There will be no additional opportunity to comment.

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

This document announces that, on June 17, 2019, OMB approved, until June 30, 2022, the information collection requirements associated with (i) the Commission's State EAS Plan Order, PS Docket No. 15-94, FCC 18-39, adopted on March 28, 2018, released on April 10, 2018, and published at 83 FR 37750, August 2, 2018, which among other things required State Emergency Communications Committees (SECC) to file State EAS Plans electronically and established an online Alert Reporting System (ARS) for that purpose; and, (ii) the false alert notification requirements, and rules governing “Live Code Tests” of the EAS contained in the Commission's Alerting Reliability Order, PS Docket Nos. 15-94 and 15-91, FCC 18-94, adopted on July 12, 2018, released on July 13, 2018, and published at 83 FR 39610, August 10, 2018. The Commission publishes this document as an announcement of the effective date of the false alert notification requirements, and rules governing “Live Code Tests” of the EAS contained in the Commission's Alerting Reliability Order. In addition, the Commission publishes this document as an announcement of OMB's approval of the information collection requirements associated with the State EAS Plan online reporting requirements contained in the Commission's State EAS Plan Order. The State EAS Plan Order stated that compliance with the State EAS Plan online reporting requirements would be required within one year of publication in the Federal Register of a Public Notice announcing: (i) OMB approval of ARS information collection requirements or (ii) the availability of the ARS to receive such information, whichever is later. Accordingly, compliance with the State EAS Plan online reporting requirements contained in the Commission's State EAS Plan Order will be required within one year of publication in the Federal Register of a Public Notice announcing the availability of the ARS for filing State EAS Plans.

If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Nicole Ongele, Federal Communications Commission, Room 1-A620, 445 12th Street SW, Washington, DC 20554. Please include the OMB Control Number, 3060-0207, in your correspondence. The Commission will also accept your comments via email at PRA@fcc.gov.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on June 17, 2019, for the information collection requirements contained in the modifications to the Commission's rules in 47 CFR part 11. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-0207.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-0207.

OMB Approval Date: June 17, 2019.

OMB Expiration Date: June 30, 2022.

Title: Part 11, Emergency Alert System, (EAS), Orders, FCC 18-94.

Form Number: N/A.

Respondents: Business and other for-profit entities, Not-for-profit institutions, and State, Local and Tribal Government.

Number of Respondents and Responses: 63,084 respondents; 3,588,830 responses.

Estimated Time per Response: 0.017-100 hours.

Frequency of Response: One-time reporting requirement and on-occasion reporting requirements.

Obligation to Respond: Mandatory. The statutory authority for this information collection is contained in sections 1, 2, 4(i), 4(o), 301, 303(r), 303(v), 307, 309, 335, 403, 624(g), 706, and 715 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i), 154(o), 301, 303(r), 303(v), 307, 309, 335, 403, 544(g), 606, and 615.

Total Annual Burden: 140,751 hours.

Total Annual Cost: No Cost.

Nature and Extent of Confidentiality: An assurance of confidentiality is not offered because this information collection does not require the collection of personally identifiable information (PII) from individuals.

Privacy Act Impact Assessment: No impact(s).

Needs and Uses: Section 11.21 of the Commission's part 11 (EAS) rules, 47 CFR 11.21, requires that State Emergency Communications Committees (SECC) prepare and submit State EAS Plans to the FCC for approval before State and local EAS alerts may be distributed within the state. On April 10, 2018, the Commission released the State EAS Plan Order, FCC 18-39, published at 83 FR 37750, August 2, 2018, requiring that SECCs file the State EAS Plans electronically using the ARS to provide a baseline level of uniformity across State EAS Plans, in terms of both format and terminology, and ensure more efficient and effective delivery of Presidential as well as state, local and weather-related alerts by providing the Commission, FEMA, and other authorized entities with the means to more easily review and identify gaps in the EAS architectures, detect problems, and take measures to address these shortcomings.

On July 13, 2018, the Commission released the Alerting Reliability Order, FCC 18-94, published at 83 FR 39610, August 10, 2018, which, among other things, required EAS Participants (the broadcasters, cable systems, and other service providers subject to the EAS rules) to notify the Commission (via email to the FCC Ops Center at FCCOPS@fcc.gov ) within twenty-four (24) hours of the EAS Participant's discovery that it has transmitted or otherwise sent a false alert to the public, and codified requirements for conducting “Live Code Tests” of the EAS, which are local and regional tests of the EAS that use the same alert codes as, and function identically to, alerts issued for an actual emergency. The false alert notification requirements should provide the Commission with the information necessary to identify and mitigate problems associated with false EAS alerts. Codification of the “live code test” requirements removed the burdens associated with the filing of waiver requests to conduct such tests, while maintaining the safeguards that ensure “live code tests” will not confuse the public that the alert is only a test.

This Final Rule is organized as follows:

For access to docket FMCSA-2018-0361 to read background documents, go to http://www.regulations.gov at any time, or to Docket Services at U.S. Department of Transportation, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

This final rule revises the list of offenses permanently disqualifying individuals required to have a commercial drivers' license (CDL) or a commercial learner's permit (CLP). This final rule reflects a change made by Congress in the “No Human Trafficking on Our Roads Act” (Pub. L. 115-106, 131 Stat. 2265, Jan. 8, 2018) (the Act). The Act prohibits an individual from operating a commercial motor vehicle (CMV), as defined in 49 U.S.C. 31301(4), for life, not eligible for reinstatement, if that individual uses a CMV in committing a felony involving a severe form of human trafficking, adding to the list of disqualifying offenses found in 49 U.S.C. 31310. A list of those existing disqualifying offenses already exists in 49 CFR 383.51; this final rule is necessary to update that list to include the new lifetime disqualifying offense established by the Act.

This final rule also sets a deadline for States to come into substantial compliance, as required by 49 U.S.C. 31311(a)(15).

This final rule is based on the authority of the Commercial Motor Vehicle Safety Act of 1986, as amended (CMVSA) (Pub. L. 99-570, Title XII, 100 Stat. 3207-170, 49 U.S.C. chapter 313). The CMVSA, implemented in 49 CFR parts 383 and 384, established the commercial driver's license (CDL) and commercial learner's permit (CLP) programs. As part of the standards governing the operation of CMVs for which a CDL or CLP is required, section 31310 sets forth the offenses for which the Secretary of Transportation (the Secretary) must disqualify an individual from operating a CMV. In accordance with 49 CFR 1.87, the FMCSA Administrator is delegated authority to carry out the motor carrier functions vested in the Secretary. Section 31311(a)(15) requires the State, in order to avoid having amounts withheld from apportionment under section 31314, to disqualify the individual from operating a CMV for the same reasons and time periods set forth in section 31310, subsections (b-e), (i)(1)(A), and (i)(2).

The specific authority for this final rule derives from the “No Human Trafficking on Our Roads Act” (the Act) (Pub. L. 115-106, 131 Stat. 2265, Jan. 8, 2018), which amended 49 U.S.C. 31310(d) by adding the use of a CMV in committing a felony involving a severe form of human trafficking as a basis for an individual to be disqualified from operating a CMV for life without the possibility of reinstatement. Today's rule adds this offense to the other bases for disqualification already set forth in 49 CFR 383.51.

The Administrative Procedure Act (APA) provides that notice and public comment procedures are not required when an Agency finds there is “good cause” to dispense with such procedures and incorporates the finding and a brief statement of reasons to support the finding in the rule issued. Good cause exists when the agency determines that notice and public comment procedures are impracticable, unnecessary, or contrary to the public interest (5 U.S.C. 553(b)(3)(B)). The statutory provision set forth in the Act is already in effect, and is enforceable regardless of whether it is incorporated into the CFR. This final rule incorporates the statutory provision into the CFR, to promote public awareness of this important provision and to ensure there is no discrepancy between statute and regulation, which could cause confusion. Because this final rule simply codifies already-existing statutory requirements into regulation, FMCSA would be unable to make any changes to this rule in response to comments. FMCSA therefore finds good cause that public comment procedures are unnecessary.

FMCSA is aware of the regulatory requirements concerning public participation in FMCSA rulemaking (49 U.S.C. 31136(g)). These requirements pertain to certain major rules, 1 but, because this final rule is not a major rule, they are not applicable here. In addition, the Agency finds that publication of an advance notice of proposed rulemaking under 49 U.S.C. 31136(g)(1)(A), or a negotiated rulemaking under 49 U.S.C. 31136(g)(1)(B), is unnecessary and contrary to the public interest in accordance with the waiver provision in 49 U.S.C. 31136(g)(3).

As noted above, the Act imposes a lifetime ban from operating a CMV on an individual who uses a CMV in committing a felony involving a severe form of trafficking in persons, as defined in 22 U.S.C. 7102(11). 2 As noted in the Senate Report accompanying the legislation, “Human trafficking, particularly sex trafficking, is known to be present at commercially operated truck stops and State-operated rest areas throughout the United States. Given their remoteness and insulation from communities, these locations can be a convenient place for sex traffickers to operate with minimal concerns for detection” (Senate Report 115-188, Nov. 30, 2017). While Congress noted that CMV drivers can play an important part in identifying trafficking incidents, it concluded that more can be done to combat human trafficking. The Act is therefore intended to serve as a deterrent measure, as well as to punish those felonies involving severe forms of trafficking in persons.

The Act, which is self-executing, disqualifies any individual who uses a CMV in committing a felony involving a severe form of trafficking in persons, as defined in 22 U.S.C. 7102(11), from operating a CMV for life. 22 U.S.C. 7102(11) defines the term “severe forms of trafficking in persons” to mean either “sex trafficking in which a commercial sex act is induced by force, fraud, or coercion, or in which the person induced to perform such act has not attained 18 years of age;” or “the recruitment, harboring, transportation, provision, or obtaining of a person for labor or services, through the use of force, fraud, or coercion for the purpose of subjection to involuntary servitude, peonage, debt bondage, or slavery.” The term “sex trafficking” is further defined as “the recruitment, harboring, transportation, provision, obtaining, patronizing, or soliciting of a person for the purpose of a commercial sex act” (22 U.S.C. 7102(12).

This final rule adds the lifetime disqualification without reinstatement to the list of disqualifying major offenses currently set forth in 49 CFR 383.51(b), Table 1.

This final rule also give States three years to come into substantial compliance with the Act, as required by 49 U.S.C. 31311(a)(15), which reads “The State shall disqualify an individual from operating a commercial motor vehicle for the same reasons and time periods for which the Secretary shall disqualify the individual under subsections (b)-(e), (i)(1)(A) and (i)(2) of section 31310.” Because, as noted above, the Act amended 49 U.S.C. 31310(d), States must satisfy the requirement to disqualify for life without reinstatement any individual who uses a CMV in committing a felony involving a severe form of trafficking in persons (as those terms are defined above). Recognizing that some States may need to conform their licensing statutes and regulations to include this new disqualifying offense, the Agency requires that States come into substantial compliance with 49 U.S.C. 31311(a) as soon as practicable, but not later than three years from the effective date of this final rule.

The FMCSRs, and any exceptions to the FMCSRs, apply only within the United States (and, in some cases, United States territories). Motor carriers and drivers are subject to the laws and regulations of the countries that they operate in, unless an international agreement states otherwise. Drivers and carriers should be aware of the regulatory differences amongst nations.

This final rule adds a new entry to 49 CFR 383.51(b), Table 1 to read as follows: (10) using the vehicle in the commission of a felony involving an act or practice of severe forms of trafficking in persons, as defined and described in 22 U.S.C. 7102(11).

This final rule also adds new paragraph (j) to 49 CFR 384.301, requiring States to come into substantial compliance with the changes made by this final rule within three years of its effective date.

FMCSA determined that this final rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by E.O. 13563 (76 FR 3821, January 21, 2011). Accordingly, the Office of Management and Budget has not reviewed it under that Order. The rule also is not significant within the meaning of DOT regulatory policies and procedures (DOT Order 2100.6 dated December 20, 2018).

The Agency does not expect this rule to result in incremental costs or benefits. This rule brings FMCSRs into alignment with statute by adding the statutory provision in 49 U.S.C. 31310(d) to 49 CFR part 383.51. As described above in “III. Legal Basis for the Rulemaking,” the Act added a lifetime disqualification, not eligible for reinstatement, from operating a CMV to the list of disqualifying offenses found in 49 U.S.C. 31310 for individuals using a CMV in committing a felony involving a severe form of human trafficking. This offense, resulting in disqualification for life without reinstatement, is currently enforceable under the Act as of January 8, 2018. Therefore, individuals operating a CMV are already subject to enforcement under the existing statute regardless of whether this rule is promulgated.

This final rule requires States to come into substantial compliance with these changes within three years of the effective date. This follows the Agency's precedent of allowing States three years to take any required conforming legislative or regulatory actions.

This rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) requires Federal agencies to consider the effects of the regulatory action on small business and other small entities and to minimize any significant economic impact. The term “small entities” comprises small businesses and 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. 3 Accordingly, DOT policy requires an analysis of the impact of all regulations on small entities, and mandates that agencies strive to lessen any adverse effects on these businesses.

FMCSA is not required to complete a regulatory flexibility analysis, because, as discussed earlier in the Legal Basis section, this action is not subject to notice and comment under section 553(b) of the APA.

In accordance with section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, FMCSA wants to assist small entities in understanding this final rule so they can better evaluate its effects on themselves and participate in the rulemaking initiative. If the final rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance; please consult the FMCSA point of contact listed in the For Further Information Contact section of this final rule.

Small businesses may send comments on the actions of Federal employees who enforce or otherwise determine compliance with Federal regulations to the Small Business Administration's Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of FMCSA, call 1-888-REG-FAIR (1-888-734-3247). DOT has a policy regarding the rights of small entities to regulatory enforcement fairness and an explicit policy against retaliation for exercising these rights.

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 $161 million (which is the value equivalent of $100,000,000 in 1995, adjusted for inflation to 2017 levels) or more in any one year. Though this final rule is not a discretionary regulatory action and thus will not result in such an expenditure, the Agency does discuss the effects of this rule elsewhere in this preamble.

This final rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for Federalism under Section 1(a) of Executive Order 13132 if it has “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” FMCSA has determined that this rule would not have substantial direct costs on or for States, nor would it limit the policymaking discretion of States. Nothing in this document preempts any State law or regulation. Therefore, this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Impact Statement.

This final rule meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminates ambiguity, and reduce burden.

E.O. 13045, Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, Apr. 23, 1997), requires agencies issuing “economically significant” rules, if the regulation also concerns an environmental health or safety risk that an agency has reason to believe may disproportionately affect children, to include an evaluation of the regulation's environmental health and safety effects on children. The Agency determined this final rule is not economically significant. Therefore, no analysis of the impacts on children is required. In any event, the Agency does not anticipate that this regulatory action could in any respect present an environmental or safety risk that could disproportionately affect children.

FMCSA reviewed this final rule in accordance with E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights, and has determined it will not effect a taking of private property or otherwise have taking implications.

The Consolidated Appropriations Act, 2005, (Pub. L. 108-447, 118 Stat. 2809, 3268, 5 U.S.C. 552a note), requires the Agency to conduct a privacy impact assessment (PIA) of a regulation that will affect the privacy of individuals. This rule does not require the collection of personally identifiable information (PII).

The E-Government Act of 2002, Public Law 107-347, 208, 116 Stat. 2899, 2921 (Dec. 17, 2002), requires Federal agencies to conduct PIA for new or substantially changed technology that collects, maintains, or disseminates information in an identifiable form. Because no new or substantially changed technology would collect, maintain, or disseminate information as a result of this rule, FMCSA did not conduct a privacy impact assessment.

The regulations implementing E.O. 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this program.

FMCSA has analyzed this final rule under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. The Agency has determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, it does not require a Statement of Energy Effects under E.O. 13211.

This rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards ( e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) are standards that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, FMCSA did not consider the use of voluntary consensus standards.

FMCSA analyzed this rule for the purpose of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ) and determined this action is categorically excluded from further analysis and documentation in an environmental assessment or environmental impact statement under FMCSA Order 5610.1 (69 FR 9680, March 1, 2004), Appendix 2, paragraph(s)(5). The Categorical Exclusion (CE) in paragraph(s) covers Regulations intended to help reduce or prevent truck and bus accidents, fatalities, and injuries by requiring drivers to have a single commercial motor vehicle driver's license and by disqualifying drivers who operate commercial motor vehicles in an unsafe manner and provide for periods of disqualification and penalties for those persons convicted of certain criminal and other offenses and serious traffic violations. The content in this rule is covered by this CE and the final action does not have any effect on the quality of the environment. The CE determination is available for inspection or copying in the Regulations.gov website listed under ADDRESSES .

In consideration of the foregoing, FMCSA amends 49 CFR chapter III as follows:

The snapper-grouper fishery of the South Atlantic includes golden tilefish and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

The commercial golden tilefish sector has two components, each with its own quota (ACL): The longline and hook-and-line components (50 CFR 622.190(a)(2)). The golden tilefish commercial ACL is allocated 75 percent to the longline component and 25 percent to the hook-and-line component. On December 4, 2018, NMFS published a final rule (83 FR 62508) that implemented Regulatory Amendment 28 to the FMP, which revised the commercial and recreational ACLs for golden tilefish. The commercial ACL was revised from 323,000 lb (146,510 kg), gutted weight, to 331,740 lb (150,475 kg), gutted weight, and the hook-and-line quota was set at 82,935 lb (37,619 kg), gutted weight, with the remainder of the commercial quota, 248,805 lb (112,856 kg), assigned to the longline component.

Under 50 CFR 622.193(a)(1)(i), NMFS is required to close the commercial hook-and-line component for golden tilefish when the hook-and-line component's commercial ACL (quota) has been reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined that the commercial ACL for the golden tilefish hook-and-line component in the South Atlantic will be reached by July 20, 2019. Accordingly, the hook-and-line component of South Atlantic golden tilefish is closed effective at 12:01 a.m., local time, July 23, 2019.

The commercial longline component for South Atlantic golden tilefish closed on March 14, 2019, and will remain closed for the remainder of the fishing year, until 12:01 a.m., local time, January 1, 2020 (84 FR 8997; March 13, 2019). Additionally, the recreational sector for South Atlantic golden tilefish closed on June 17, 2019, and will remain closed for the remainder of the fishing year, until 12:01 a.m., local time, January 1, 2020 (84 FR 27479; June 16, 2019). Therefore, because the recreational sector and the commercial longline component is already closed, and NMFS is closing the commercial hook-and-line component through this temporary rule, all fishing for South Atlantic golden tilefish in the EEZ will be closed effective at 12:01 a.m., local time, July 23, 2019, until 12:01 a.m., local time, January 1, 2020.

The operator of a vessel with a valid Federal commercial vessel permit for South Atlantic snapper-grouper having golden tilefish on board must have landed and bartered, traded, or sold such golden tilefish prior to 12:01 a.m., local time, July 23, 2019. During the closure, the harvest or possession and sale or purchase of golden tilefish taken from the EEZ is prohibited. The prohibition on sale or purchase does not apply to the sale or purchase of golden tilefish that were harvested by hook-and-line, landed ashore, and sold prior to 12:01 a.m., local time, July 23, 2019, and were held in cold storage by a dealer or processor. For a person on board a vessel for which a Federal commercial or charter vessel/headboat permit for the South Atlantic snapper-grouper fishery has been issued, the prohibitions on harvest or possession and sale and purchase provisions of the commercial closure for golden tilefish would apply regardless of whether the fish are harvested in state or Federal waters, as specified in 50 CFR 622.190(c)(1)(ii).

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of South Atlantic golden tilefish and is consistent with the Magnuson-Stevens Act and other applicable laws.

This action is taken under 50 CFR 622.193(a)(1) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

This action responds to the best scientific information available. The Assistant Administrator for Fisheries, NOAA (AA), finds that the need to immediately implement this action to close the commercial hook-and-line component for golden tilefish constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule itself has been subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because the capacity of the fishing fleet allows for rapid harvest of the commercial ACL for the hook-and-line component, and there is a need to immediately implement this action to protect golden tilefish. Prior notice and opportunity for public comment would require time and could potentially result in a harvest well in excess of the established commercial ACL.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq. ) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) and as implemented by the United States among the various domestic fishing categories, per the allocations established in Amendment 7 to the 2006 Consolidated Atlantic Highly Migratory Species Fishery Management Plan (2006 Consolidated HMS FMP) (Amendment 7) (79 FR 71510, December 2, 2014), and in accordance with implementing regulations. NMFS is required under ATCA and the Magnuson-Stevens Act to provide U.S. fishing vessels with a reasonable opportunity to harvest the ICCAT-recommended quota.

The current baseline quotas for the Harpoon and Reserve categories are 46 mt and 29.5 mt, respectively. See § 635.27(a). To date for 2019, NMFS has published two actions that have adjusted the available 2019 Reserve category quota, which currently is 143 mt (84 FR 3724, February 13, 2019, and 84 FR 6701, February 28, 2019). The 2019 Harpoon category fishery opened June 1 and is open through November 15, 2019, or until the Harpoon category quota is reached, whichever comes first.

Under § 635.27(a)(9), NMFS has the authority to transfer quota among fishing categories or subcategories, after considering regulatory determination criteria provided under § 635.27(a)(8). NMFS has considered the relevant determination criteria and their applicability to the Harpoon category fishery. These considerations include, but are not limited to, the following:

Regarding the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(a)(8)(i)), biological samples collected from BFT landed by Harpoon category fishermen and provided by BFT dealers continue to provide valuable data for ongoing scientific studies of BFT age and growth, migration, and reproductive status. Additional opportunity to land BFT in the Harpoon category would support the continued collection of a broad range of data for these studies and for stock monitoring purposes.

NMFS also considered the catches of the Harpoon category quota to date and the likelihood of closure of that segment of the fishery if no adjustment is made (§ 635.27(a)(8)(ii) and (ix)). As of July 17, 2019, the Harpoon category has landed 38.5 mt. Commercial-size BFT are currently readily available to vessels fishing under the Harpoon category quota. Without a quota transfer at this time, Harpoon category participants would have to stop BFT fishing activities with very short notice, while commercial-sized BFT remain available in the areas Harpoon category permitted vessels operate. Transferring 30 mt of BFT quota from the Reserve category would result in a total of 76 mt being available for the Harpoon category for the 2019 Harpoon category fishing season.

Regarding the projected ability of the vessels fishing under the particular category quota (here, the Harpoon category) to harvest the additional amount of BFT before the end of the fishing year (§ 635.27(a)(8)(iii)), NMFS considered Harpoon category landings over the last several years. Landings are highly variable and depend on access to commercial-sized BFT and fishing conditions, among other factors. NMFS anticipates that the Harpoon category could harvest the transferred 30 mt prior to the end of the Harpoon category season, subject to weather conditions and BFT availability. NMFS may transfer unused Harpoon category quota to other quota categories, as appropriate. NMFS also anticipates that some underharvest of the 2018 adjusted U.S. BFT quota will be carried forward to 2019 and placed in the Reserve category, in accordance with the regulations. Thus, this quota transfer would allow fishermen to take advantage of the availability of fish on the fishing grounds, consider the expected increases in available 2019 quota, and provide a reasonable opportunity to harvest the full U.S. BFT quota.

NMFS also considered the estimated amounts by which quotas for other gear categories of the fishery might be exceeded (§ 635.27(a)(8)(iv)) and the ability to account for all 2019 landings and dead discards. In the last several years, total U.S. BFT landings have been below the available U.S. quota such that the United States has carried forward the maximum amount of underharvest allowed by ICCAT from one year to the next. NMFS will need to account for 2019 landings and dead discards within the adjusted U.S. quota, consistent with ICCAT recommendations, and anticipates having sufficient quota to do that.

NMFS also considered the effects of the adjustment on the BFT stock and the effects of the transfer on accomplishing the objectives of the FMP (§ 635.27(a)(8)(v) and (vi)). This transfer would be consistent with the current quotas, which were established and analyzed in the 2018 BFT quota final rule (83 FR 51391, October 11, 2018), and with objectives of the 2006 Consolidated HMS FMP and amendments and is not expected to negatively impact stock health or to affect the stock in ways not already analyzed in those documents. Another principal consideration is the objective of providing opportunities to harvest the full annual U.S. BFT quota without exceeding it based on the goals of the 2006 Consolidated HMS FMP and amendments, including to achieve optimum yield on a continuing basis and to optimize the ability of all permit categories to harvest their full BFT quota allocations (related to § 635.27(a)(8)(x)).

Based on the considerations above, NMFS is transferring 30 mt of the available 143 mt of Reserve category quota to the Harpoon category. Therefore, NMFS adjusts the Harpoon category quota to 76 mt for the 2019 Harpoon category fishing season ( i.e., through November 15, 2019, or until the Harpoon category quota is reached, whichever comes first), and adjusts the Reserve category quota to 113 mt.

NMFS will continue to monitor the BFT fishery closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota adjustments and closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, Harpoon category vessel owners are required to report their own catch of all BFT retained or discarded dead, within 24 hours of the landing(s) or end of each trip, by accessing hmspermits.noaa.gov, using the HMS Catch Reporting app, or calling (888) 872-8862 (Monday through Friday from 8 a.m. until 4:30 p.m.).

Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional action ( i.e., quota and/or daily retention limit adjustment, or closure) is necessary to ensure available quota is not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. If needed, subsequent adjustments will be published in the Federal Register . In addition, fishermen may call the Atlantic Tunas Information Line at (978) 281-9260, or access hmspermits.noaa.gov, for updates on quota monitoring and inseason adjustments.

The Assistant Administrator for NMFS (AA) finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:

The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Affording prior notice and opportunity for public comment to implement the quota transfer for the remainder of 2019 is also contrary to the public interest as such a delay would likely result in closure of the Harpoon fishery when the baseline quota is met and the need to re-open the fishery, with attendant administrative costs and costs to the fishery. The delay would preclude the fishery from harvesting BFT that are available on the fishing grounds and that might otherwise become unavailable during a delay. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For these reasons, there also is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.

This action is being taken under § 635.27(a)(9), and is exempt from review under Executive Order 12866.

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

The final 2019 and 2020 harvest specifications for groundfish in the GOA (84 FR 9416, March 14, 2019) apportions the 2019 Pacific halibut PSC limit for trawl gear in the GOA to two trawl fishery categories: A deep-water species fishery and a shallow-water species fishery. The halibut PSC limit for these two trawl fishery categories is further apportioned by season, including four seasonal apportionments to the shallow-water species fishery and four seasonal apportionments to the deep-water species fishery. The two fishery categories also are apportioned a combined, fifth seasonal halibut PSC limit. Unused seasonal apportionments are added to the next season apportionment during a fishing year.

Regulations at § 679.21(d)(4)(iii)(D) require NMFS to combine management of the available trawl halibut PSC limits in the second season (April 1 through July 1) deep-water and shallow-water species fishery categories for use in either fishery from May 15 through June 30 of each year. Furthermore, NMFS is required to reapportion the halibut PSC limit between the deep-water and shallow-water species fisheries after June 30 to account for actual halibut PSC use by each fishery category during May 15 through June 30. As of July 17, 2019, NMFS has determined that the trawl deep-water and shallow-water fisheries used 51 metric tons (mt) and 32 mt of halibut PSC, respectively, from May 15 through June 30. Accordingly, pursuant to § 679.21(d)(4)(iii)(D), the Regional Administrator is reapportioning the combined first and second seasonal apportionments (860 mt) of halibut PSC limit between the trawl deep-water and shallow-water fishery categories to account for the actual PSC use (428 mt) in each fishery from January 1, 2019 through June 30, 2019. Therefore, Table 15 of the final 2019 and 2020 harvest specifications for groundfish in the GOA (84 FR 9416, March 14, 2019) is revised consistent with this adjustment.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would allow for harvests that exceed the originally specified apportionment of the halibut PSC limits to the deep-water and shallow-water fishery categories. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 17, 2019.

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

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