Federal Register Vol. 82, No.246,

This final rule incorporates by reference into 10 CFR part 430 the following commercial standard: NSF/ANSI 51-2007 (“NSF/ANSI 51”), Food equipment materials, revised and adopted April 2007. Copies of NSF/ANSI 51 may be purchased from NSF International, P.O. Box 130140, 789 North Dixboro Road, Ann Arbor, MI 48113-0140, 1-800-673-6275, or go to http://www.nsf.org.

For a further discussion of this standard, see section IV.M.

Pursuant to 42 U.S.C. 6295(l)(4) of the Energy Policy and Conservation Act of 1975 (EPCA),1 Public Law 94-163 (42 U.S.C. 6291-6317, as codified), DOE is required to collect unit sales data for calendar years 2010 through 2025, in consultation with the National Electrical Manufacturers Association (NEMA), for rough service, shatter-resistant, 3-way incandescent lamps, 2,601-3,300 lumen general service incandescent lamps, and vibration service lamps. For each of these five lamp types, DOE, in consultation with NEMA, must also construct a model based on coincident economic indicators that closely match the historical annual growth rates of each lamp type to provide a neutral comparison benchmark estimate of future unit sales. (42 U.S.C. 6295(l)(4)(B). Section 321(a)(3)(B) of the Energy Independence and Security Act of 2007 (EISA 2007) in part amends paragraph 325(l) of EPCA by adding paragraphs (4)(D) through (H), which direct DOE to initiate an accelerated rulemaking to establish an energy conservation standard for these lamps if the actual annual unit sales of any of the lamp types in any year between 2010 and 2025 exceed the benchmark estimate of unit sales by at least 100 percent (i.e., are greater than 200 percent of the anticipated sales). (42 U.S.C. 6295(l)(4)(D)-(H)) If the Secretary of Energy (Secretary) does not complete the accelerated rulemakings within one year from the end of the previous calendar year during which predicted sales were exceeded, there is a “backstop requirement” for each lamp type, which would establish, by statute, energy conservation standard levels and related requirements. Id. For 2,601-3,300 lumen general service incandescent lamps, this backstop is automatically imposed once the benchmark unit sales estimates are exceeded.

By this action, DOE is placing in the Code of Federal Regulations (CFR) the statutory backstop requirements for rough service lamps and vibration service lamps prescribed in 42 U.S.C. 6295(l)(4)(D)(ii) and (E)(ii). These sections, which were added by EISA 2007, establish energy conservation standard levels and related requirements for rough service lamps and vibration service lamps if DOE does not complete a rulemaking in an accelerated 1 year period after issuing a finding that the specified benchmark unit sales estimates had been exceeded.

Section 321(a)(1)(B) of EISA 2007 amended section 321(30) of EPCA by adding the definition of “vibration service lamp.” A “vibration service lamp” means a lamp that—(i) has filament configurations that are C-5, C-7A, or C-9, as listed in Figure 6-12 of the 9th Edition of the IESNA [Illuminating Engineering Society of North America] Lighting Handbook or similar configurations; (ii) has a maximum wattage of 60 watts; (iii) is sold at retail in packages of 2 lamps or less; and (iv) is designated and marketed specifically for vibration service or vibration-resistant applications, with—(I) the designation appearing on the lamp packaging; and (II) marketing materials that identify the lamp as being vibration service only. (42 U.S.C. 6291(30)(AA))

Section 321(a)(1)(B) of EISA 2007 amended section 321(30) of EPCA by adding the definition of “rough service lamp.” A “rough service lamp” means a lamp that—(i) has a minimum of 5 supports with filament configurations that are C-7A, C-11, C-17, and C-22 as listed in Figure 6-12 of the 9th edition of the IESNA Lighting handbook, or similar configurations where lead wires are not counted as supports; and (ii) is designated and marketed specifically for “rough service” applications, with—(I) the designation appearing on the lamp packaging; and (II) marketing materials that identify the lamp as being for rough service. (42 U.S.C. 6291(30)(X))

DOE published a notice of data availability (NODA) in April 2016, which indicated that the shipments of vibration service lamps were over 7 million units in 2015. This equates to 272.5 percent of the benchmark estimate, which was 2,594,000 units. 81 FR 20261, 20263 (April 7, 2016). Therefore, vibration service lamps exceeded the statutory threshold for the first time, thus triggering an accelerated rulemaking to be completed no later than December 31, 2016. Id. Furthermore, NEMA submitted revised data for rough service lamps following the publication of the April 2016 NODA at 81 FR 20261. The revised data showed sales of 10,914,000 rough service lamps in 2015, which exceeded 100% of the benchmark estimate of 4,967,000 units for 2015.2 This resulted in a requirement for DOE to initiate an accelerated rulemaking for rough service lamps. In an October 2016 notice of proposed definition and data availability (NOPDDA), DOE indicated it must conduct an energy conservation standards rulemaking for rough service lamps to be completed no later than the end of the 2016 calendar year. 81 FR 71794, 71800 (Oct. 18, 2016).

If the Secretary does not complete these accelerated rulemakings within the one year time frame accorded by EPCA, the statute provides a backstop requirement that becomes an energy conservation standard for vibration service and rough service lamps. This backstop requirement would require vibration service lamps to: (1) Have a maximum 40-watt limitation and (2) be sold at retail only in a package containing one lamp. 42 U.S.C. 6295(l)(4)(E)(ii). For rough service lamps, the backstop requires that the lamps: (1) Have a shatter-proof coating or equivalent technology that complies with NSF/ANSI 51 and is designed to contain the glass if the glass envelope of the lamp is broken and to provide effective containment over the life of the lamp; (2) have a maximum 40-watt limitation; and (3) be sold at retail only in a package containing one lamp. 42 U.S.C. 6295(l)(4)(D)(ii).

Since unit sales for vibration service lamps and rough service lamps exceeded 200 percent of the benchmark estimate in 2015, and DOE did not complete an energy conservation standards rulemaking for these lamps by the end of calendar year 2016, the backstop requirement was triggered, without discretion, and is now applicable. For this final rule, DOE codifies at 10 CFR 430.32 the statutory requirements that apply to rough service lamps and vibration service lamps in 42 U.S.C. 6295(l)(4)(D)(ii) and (E)(ii). These energy conservation levels and requirements apply to rough service lamps and vibration service lamps manufactured on or after January 25, 2018. While DOE did not meet its statutory deadline to complete an accelerated rulemaking by the end of calendar year 2016, an effective date of January 25, 2018, remains generally consistent with the intent of Congress to provide for a one calendar year period between imposition of the energy conservation standard and compliance with such standard. The Secretary will continue to collect and model data for rough service lamps and vibration service lamps for two years after this effective date, in accordance with 42 U.S.C. 6295(l)(4)(I)(ii).

DOE has determined, pursuant to 5 U.S.C. 553(b)(B), that prior notice and an opportunity for public comment on this final rule are unnecessary. DOE is merely placing in the CFR, verbatim, certain requirements and wattage limitations for rough service lamps and vibration service lamps prescribed by Congress in EPCA. DOE is not exercising any of the discretionary authority that Congress has provided to the Secretary of Energy in EPCA. As such, prior notice and an opportunity for comment would serve no purpose in this instance. DOE, therefore, finds that good cause exists to waive prior notice and an opportunity to comment for this rulemaking.

This final rule is a “significant regulatory action” under section 3(f)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563. Accordingly, this action was subject to review by the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB).

The purpose of this Regulatory Impact Analysis (RIA) is to describe the range of potential costs related to applying the statutorily-established 40 watt maximum energy use and packaging limitation to rough and vibration service lamps as well as the shatter-proof coating requirement for rough service lamps. This RIA presents three separate consumer substitution scenarios due to the elimination of greater than 40 watt rough and vibration service lamps from the market. These three scenarios provide lower and upper bounds of the range of potential monetized costs, but they do not take into account lost utility caused by the substitutions. DOE estimates this rule to eliminate 80% of the rough and vibration service lamp market. DOE took this bounding approach because data are unavailable to forecast consumer response to the rule.

In the first scenario, consumers are assumed to substitute rough and vibration service lamps greater than 40 watts with rough and service lamps less than 40 watts. In the second scenario, consumers are assumed to substitute greater than 40 watt rough and vibration service lamps with shatter-resistant lamps greater than 40 watts. In the third scenario, consumers are assumed to substitute greater than 40 watt rough and vibration service lamps with LEDs emitting equivalent lumens as the lamps they would replace. In all three scenarios, consumers would still have access to rough and vibration service lamp less than 40 watts but would pay more per unit due to the new packaging limitations and shatter proofing requirements.

Table 1 summarizes the three substitution scenarios as potential incremental costs and market value associated with this rulemaking. For a lower bound, the rule could increase aggregate consumer spending by $14.7 million if all consumers substituted greater than 40 watt rough and vibration service lamps with those less than 40 watts. For an upper bound, the rule could increase consumer spending by $72.8M if all consumers substituted greater than 40 watt rough and vibration service lamps with LEDs that emit equivalent lumens. In practice, there will likely be a mix of market responses across consumers. In the lower bound estimated especially there is likely to be additional, non-quantified lost utility because consumers are substituting lower wattage bulbs that deliver less light.

These requirements apply as a result of these lamps exceeding sales thresholds specified as required by EPCA.

Pursuant to reporting and tracking requirements in 42 U.S.C. 6295(l)(4)(D) and (E), NEMA reported to DOE the following figures for rough service lamp and vibration service lamp shipments for the year 2015:

Because unit sales for rough service and vibration service lamps exceeded 100 percent of the neutral benchmark estimate of unit sales in 2015,3 and DOE did not complete an accelerated rulemaking establishing standards for these lamps within the statutorily required timeframe, EPCA mandates the following backstop requirement that becomes an energy standard for vibration and rough service lamps. This backstop requirement requires vibration service lamps to: (1) Have a maximum 40-watt limitation and (2) be sold at retail only in a package containing one lamp. 42 U.S.C. 6295(l)(4)(E)(ii). For rough service lamps, the backstop requires that the lamps: (1) Have a shatter-proof coating or equivalent technology that complies with NSF/ANSI 51 and is designed to contain the glass if the glass envelope of the lamp is broken and to provide effective containment over the life of the lamp; (2) have a maximum 40-watt limitation; and (3) be sold at retail only in a package containing one lamp. 42 U.S.C. 6295(l)(4)(D)(ii). These energy conservation levels and requirements apply to rough service and vibration service lamps manufactured on or after January 25, 2018.

The practical effect of the backstop requirement is to remove rough and vibration service lamps over 40 watts from the market starting on January 25, 2018. DOE conducted an order of magnitude analysis to assess the likely costs associated with this action. As a first step, DOE looked at the revenue of the lamps above 40 watts that will no longer be generated by industry.

Because DOE was previously prohibited from collecting data regarding incandescent lamps, including the subject lamps, DOE does not have data regarding the percentage of lamps sold of both types above 40 watts. DOE estimates that about 80 percent of rough and vibration service lamps are over 40 watts and will therefore no longer be available. Based on a review of home center prices, DOE concluded that these lamps sell for an average of $1.95 per lamp. Using this average sales price of $1.95, at the volumes reported in 2015, the market for rough and vibration service lamps greater than 40 watts was just over $28 million, out of a total market value of just over $35 million for all rough and vibration service lamps. Table 2 summarizes estimated current revenue associated with the subject lamps greater than 40 watts.

On March 5, 2018, the Federal Election Commission will officially relocate to a new street address: 1050 First Street NE, Washington, DC 20463. Until March 5, 2018, the Commission will continue to reside and accept mail at 999 E Street NW, Washington, DC 20463.

The Commission is promulgating these amendments without advance notice or an opportunity for comment because they fall under the “good cause” exemption of the Administrative Procedure Act. 5 U.S.C. 553(b)(B). The Commission finds that notice and comment are unnecessary here because these amendments are merely technical; they effect no substantive changes to any rule. For the same reason, these amendments fall within the “good cause” exception to the delayed effective date provisions of the Administrative Procedure Act and the Congressional Review Act. 5 U.S.C. 553(d)(3), 808(2). Moreover, because these amendments are exempt from the notice and comment procedure of the Administrative Procedure Act under 5 U.S.C. 553(b), the Commission is not required to conduct a regulatory flexibility analysis under 5 U.S.C. 603 or 604. See 5 U.S.C. 601(2), 604(a). Nor is the Commission required to submit these amendments for congressional review under the Federal Election Campaign Act of 1971, as amended, the Presidential Election Campaign Fund Act, as amended, or the Presidential Primary Matching Payment Account Act, as amended. See 52 U.S.C. 30111(d)(1), (4) (providing for congressional review when Commission “prescribe[s]” a “rule of law”); 26 U.S.C. 9009(c)(1), (4), 9039(c)(1), (4) (same).

For the reasons set out in the preamble, the Federal Election Commission amends 11 CFR chapter I as follows:

The FAA has determined that notice of, and opportunity for prior public comment on, these special conditions is impracticable because these procedures would significantly delay issuance of the Type Certificate approval and thus, delivery of the affected engines.

In addition, the substance of these special conditions has been subjected to the notice and comment period in prior instances, and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, because a delay would significantly affect the certification of the engine, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions.

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

On April 14, 2017, LHTEC applied for an amendment to Type Certificate No. TE2CH to include the new CTS800-4AT turboshaft engine model. The CTS800-4AT turboshaft engine model is a derivative model in the CTS800 turboshaft engine series. The CTS800-4AT is a free-turbine turboshaft engine and will incorporate a novel or unusual design feature, which is a 30-minute AEO power rating. LHTEC has requested this rating to support helicopter search and rescue missions that require hover operations at high power.

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) § 21.101, LHTEC must show that the CTS800-4AT turboshaft engine model meets the applicable provisions of the regulations incorporated by reference in Type Certificate No. TE2CH or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” The regulations incorporated by reference in TE2CH are as follows: 14 CFR part 33 dated June 3, 1964, as amended by Amendments 33-1 through 33-18 inclusive.

If the Administrator finds that the applicable airworthiness regulations do not contain adequate or appropriate safety standards for the LHTEC, CTS800-4AT turboshaft engine model because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the engine model(s) for which they are issued. Should the type certificate for that engine model be amended later to include any other engine model(s) that incorporates the same novel or unusual design feature, or should any other engine model(s) already included on the same type certificate be modified to incorporate the same novel or unusual design feature, the special conditions would also apply to the other engine model(s) under § 21.101.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.17 or § 21.101.

The CTS800-4AT turboshaft engine model will incorporate a novel or unusual design feature, which is a 30-minute AEO power rating. This rating will be used to support helicopter search and rescue missions that require hover operations at high power.

Under the provisions of 14 CFR 21.17(a)(1) and 21.101(a), LHTEC must show that the CTS800-4AT turboshaft engine meets the provisions of the applicable regulations in effect on the date of application, unless otherwise specified by the FAA. The type certification basis for the derivative model CTS800-4AT turboshaft engine is 14 CFR part 33, Amendments 33-1 through 33-18 effective August 19, 1996, which does not contain adequate safety standards concerning a 30-minute AEO power rating. Therefore, these special conditions will add requirements to the rating definition, instructions for continued airworthiness (ICA), engine ratings and operating limitations, instrument connection, and endurance testing.

The 30-minute time limit applies to each instance the rating is used. In addition, there is no limit to the number of times the rating can be used during any one flight, and there is no cumulative time limitation. The ICA requirement is intended to address the unknown nature of the actual rating usage and associated engine deterioration. LHTEC will assess the expected usage and publish ICAs with airworthiness limitations section (ALS) limits in accordance with those assumptions, such that engine deterioration is not excessive. Because the CTS800-4AT engine has a continuous one engine inoperative (OEI) rating and limits equal to or higher than the 30-minute AEO power rating, the test time performed at the continuous OEI rating may be credited toward the 25-hour requirement. However, test time spent at other rating elements of the test, such as takeoff or other OEI ratings (that may be equal to or higher), may not be counted toward the 25 hours of required running. Therefore, special conditions are issued under the provisions of 14 CFR 11.19, 21.16, and 21.17(a)(2).

As discussed above, these special conditions are applicable to the CTS800-4AT turboshaft engine model. Should LHTEC apply at a later date for a change to the type certificate to include another model on the same type certificate incorporating the same novel or unusual design feature, the special conditions would apply to that model as well.

This action affects only certain novel or unusual design features on the CTS800-4AT turboshaft engine. It is not a rule of general applicability and applies only to LHTEC, who requested FAA approval of this engine feature.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for LHTEC, CTS800-4AT turboshaft engine model.

In addition to the requirements of § 1.1, the following definition applies to this special condition: “Rated 30-minute all engines operating (AEO) power means the approved brake horsepower developed under static conditions at the specified altitude and temperature, and within the operating limitations under part 33, and limited in use to periods not exceeding 30 minutes each.”

In addition to the airworthiness standards in 14 CFR part 33, the following special conditions apply:

(a) Sections 33.1, Applicability and 33.3, General. As applicable, all documentation, testing and analysis required to comply with the part 33 type certification basis must account for the 30-minute AEO power rating, limits, and usage.

(b) Section 33.4, Instructions for Continued Airworthiness. In addition to the requirements of § 33.4, the ICA must:

(1) Include instructions to ensure that in-service engine deterioration due to the rated 30-minute AEO power usage will not exceed that assumed for establishing the engine maintenance program and all other approved ratings, including OEI, are available (within associated limits and assumed usage) for every flight.

(2) Validate the adequacy of the maintenance actions required under paragraph (b)(1) of this special condition.

(3) Include in the airworthiness limitations section any mandatory inspections and serviceability limits related to the use of the 30-minute AEO power rating.

(c) Section 33.7, Engine ratings and operating limitations. In addition to the ratings provided in § 33.7(a) and (c), a rated 30-minute AEO power and operating limitations are established relating to the following:

(1) Horsepower, torque, shaft speed (r.p.m), and gas temperature.

(2) The rated 30-minute AEO power and associated limitations must not exceed the rated takeoff power and associated limitations.

(d) Section 33.29, Instrument connection. If dependence is placed on instrumentation needed to monitor the rating's use, the applicant must make provision for the installation of that instrumentation, specify the provisions for instrumentation in the engine installation instructions, and declare them mandatory in the engine approval documentation.

(e) Section 33.87, Endurance test. In addition to the requirements of § 33.87(a) and (d), the overall test run must include a minimum of 25 hours of operation at rated 30-minute AEO power and limits, divided into periods of not less than 30 minutes, but not more than 60 minutes at rated 30-minute AEO power, and alternate periods at maximum continuous power or less.

(1) Each § 33.87(d) continuous OEI rating test period of 60 minutes duration, run at power and limits equal to or higher than the 30-minute AEO power rating, may be credited toward this requirement. Note that the test time required for the takeoff or other OEI ratings may not be counted toward the 25 hours of testing required at the 30-minute AEO power rating.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Accordingly, pursuant to the authority delegated to me,

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

Section 335 of the Tariff Act of 1930 (19 U.S.C. 1335) authorizes the Commission to adopt such reasonable procedures, rules, and regulations as it deems necessary to carry out its functions and duties. This rulemaking amends provisions of the Commission's existing Rules of Practice and Procedure that concern the Privacy Act.

On September 27, 2017, the Commission published a Notice of Proposed Rulemaking (NPRM) in the Federal Register. 82 FR 44982, September 27, 2017. In the NPRM, the Commission proposed to revise 19 CFR 201.32, which governs exemptions to certain Privacy Act requirements. Pursuant to 5 U.S.C. 552a(k), the Commission proposed to delete two exemptions that pertain only to Privacy Act systems of records that were being removed, add exemptions for a new Privacy Act system of records, and correct a typographical error.

In the NPRM, the Commission requested public comment on the proposed revisions to its rules, but no comments were received. The Commission found no reason to change the proposed rules before adopting them as final rules, which are republished below. A more detailed analysis of the rules can be found at 82 FR 44982 (September 27, 2017).

The Commission certifies that these amendments to the Commission's rules will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) because it does not create an economic impact and does not affect small entities. The amendments are concerned only with the administration of Privacy Act systems of records within the Commission.

The amendments to the Commission's rules do not contain any information collection requirements subject to the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

No actions are necessary under title II of the Unfunded Mandates Reform Act of 1995, Public Law 104-4 (2 U.S.C. 1531-1538) because the amendments to the Commission's rules will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year (adjusted annually for inflation), and will not significantly or uniquely affect small governments.

The Commission has determined that these rules do not meet the criteria described in section 3(f) of Executive Order 12866 (58 FR 51735, October 4, 1993) and thus do not constitute a “significant regulatory action” for purposes of the Executive Order.

The amendments to the Commission's rules do not have Federalism implications warranting the preparation of a federalism summary impact statement under Executive Order 13132 (64 FR 43255, August 10, 1999).

The amendments to the Commission's rules are not “major rules” as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.).

For the reasons stated in the preamble, under the authority of 19 U.S.C. 1335, the United States International Trade Commission amends 19 CFR part 201 as follows:

I. Background

Upon request, FDA has classified the external negative pressure airway aid as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On August 18, 2014, Sommetrics submitted a request for De Novo classification of the cNEP Airway Management System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on December 23, 2015, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 868.5105. We have named the generic type of device external negative pressure airway aid, and it is identified as a prescription device that applies negative pressure to a patient's neck to aid in providing a patent airway during procedures requiring anesthesia.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

At the time of classification, external negative pressure airway aids are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 868 is amended as follows:

Pursuant to the authority granted in 33 U.S.C. 1605, the DoN amends 32 CFR part 706.

This amendment provides notice that the DAJAG (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS TULSA (LCS 16) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I paragraph 2 (a)(i), pertaining to the height of the forward masthead light above the hull; Annex I, paragraph 2(f)(i), pertaining to the placement of the masthead light or lights above and clear of all other lights and obstructions; Annex I, paragraph 2(f)(ii), pertaining to the vertical placement of task lights; Annex I, paragraph 3(a), pertaining to the location of the forward masthead light in the forward quarter of the ship, and the horizontal distance between the forward and after masthead light; Rule 27(b)(i) and Annex I, paragraph 9(b)(i), pertaining to the arc of visibility of middle tasks lights. The DAJAG (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

For the reasons set forth in the preamble, the DoN amends part 706 of title 32 of the Code of Federal Regulations as follows:

On November 1, 2017, the Coast Guard published a temporary deviation entitled “Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, Alligator River, Columbia, NC” in the Federal Register (82 FR 50577). That document resulted from North Carolina Department of Transportation's request for a temporary deviation, occurring from 7 a.m. on November 6, 2017, through 7 p.m. on November 17, 2017, from normal operation of the drawbridge to facilitate bridge maintenance. Subsequent to the approval of that request, North Carolina Department of Transportation requested a modification, extending the temporary deviation from 7:01 p.m. on November 17, 2017, through 6 p.m. on March 29, 2018, to allow more time to perform and complete additional bridge maintenance discovered during the previous temporary deviation. Therefore, through this document, the Coast Guard modifies the dates of the previously approved temporary deviation to allow the US 64/Alligator River Bridge that carries US 64 over the AICW, Alligator River, mile 84.2, at near Columbia, NC, to remain in the closed-to-navigation position from 7 a.m. to 7 p.m., on Wednesday, December 27, 2017, through Saturday, December 30, 2017; Monday, January 1, 2018, through Saturday, January 5, 2018; and Monday, January 8, 2018, through Tuesday, January 9, 2018. During these closure periods the bridge will open on signal, if at least 2 hours notice is given. The bridge will also remain in the closed-to-navigation position 24 hours a day, 7 days a week, from 6 a.m. on Wednesday, January 10, 2018, through 6 p.m. on Wednesday, January 17, 2018; and from 6 a.m. on Wednesday, March 14, 2018, through 6 p.m. on Wednesday, March 21, 2018. Alternative work dates for these closure periods will be from noon on Thursday, January 18, 2018, through 6 p.m. on Wednesday, January 24, 2018; and from noon on Thursday, March 22, 2018, through 6 p.m. on Thursday, March 29, 2018. If the alternative work dates from noon on Thursday, January 18, 2018, through 6 p.m. on Wednesday, January 24, 2018 are used, the bridge will also remain in the closed-to-navigation position from 7 a.m. to 6 p.m., Monday through Saturday, from January 22, 2018, through March 14, 2018; except for scheduled daily openings at noon, if at least 2 hours notice is given. If the alternative work dates from noon on Thursday, January 18, 2018, through 6 p.m. on Wednesday, January 24, 2018 are not used, the bridge will also remain in the closed-to-navigation position from 7 a.m. to 6 p.m., Monday through Saturday, from January 17, 2018, through March 14, 2018; except for scheduled daily openings at noon, if at least 2 hours notice is given. The Coast Guard will inform the users of the waterway through our Broadcast Notices to Mariners, if the alternative work dates will be used. The bridge has a vertical clearance of 14 feet above mean high water in the closed position and unlimited feet above mean high water in the open position. The bridge will open on signal at all other times. The current operating schedule is set out in 33 CFR 117.5.

The AICW, Alligator River is used by a variety of vessels including, small commercial vessels, tug and barge traffic, and recreational vessels. The Coast Guard has carefully coordinated the restrictions with waterway users in publishing this temporary deviation.

Vessels able to pass through the bridge in the closed-to-navigation position may do so at any time. During the closure periods, the bridge will not be able to open for emergencies and the Croatan Sound to the Pamlico Sound can be used as an alternative route for vessels unable to pass through the bridge in the closed position. During the closure periods with scheduled openings at noon, the bridge will be able to open up for emergencies, if at least one hour notice is given. The Coast Guard will also inform the users of the waterway through our Local Notice and Broadcast Notices to Mariners of the change in operating schedule for the bridge so vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

I. General Information A. Notice and Comment Under the Administrative Procedures Act (APA)

Section 553 of the APA, 5 U.S.C. 553(b)(3)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. The EPA has determined that there is good cause for making this rule final without prior proposal and opportunity for comment because no significant EPA judgment is involved in making a finding of failure to submit SIPs, or elements of SIPs, required by the CAA, where states have made no submissions or incomplete submissions, to meet the requirement. Thus, notice and public procedure are unnecessary. The EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

CAA section 110(a) imposes an obligation upon states to submit SIPs that provide for the implementation, maintenance and enforcement of a new or revised NAAQS within three years following the promulgation of that NAAQS. Section 110(a)(2) lists specific requirements that states must meet in these SIP submissions, as applicable. The EPA refers to this type of SIP submission as the “infrastructure” SIP because it ensures that states can implement, maintain and enforce the air standards. Within these requirements, section 110(a)(2)(D)(i) contains requirements to address interstate transport of NAAQS pollutants. A SIP revision submitted for this sub-section is referred to as an “interstate transport SIP.” In turn, section 110(a)(2)(D)(i)(I) requires that such a plan contain adequate provisions to prohibit emissions from the state that will contribute significantly to nonattainment of the NAAQS in any other state (“prong 1”) or interfere with maintenance of the NAAQS in any other state (“prong 2”). Section 110(a)(2)(D(i)(II) requires that such a plan contain adequate provisions to prohibit emissions from the state that will interfere with measures required of any other state to prevent significant deterioration of air quality (“prong 3”) or that will interfere with measures required of any other state to protect visibility (“prong 4”). These are the requirements relevant to this finding.

Pursuant to CAA section 110(k)(1)(B), the EPA must determine no later than six months after the date by which a state is required to submit a SIP whether a state has made a submission that meets the minimum completeness criteria established per section 110(k)(1)(A). The EPA refers to the determination that a state has not submitted a SIP submission that meets the minimum completeness criteria as a “finding of failure to submit.” If the EPA finds a state has failed to submit a SIP to meet its statutory obligation to address section 110(a)(2)(D)(i), pursuant to section 110(c)(1) the EPA has not only the authority, but the obligation, to promulgate a FIP within two years to address the CAA requirement. This finding therefore starts a two-year clock for promulgation by the EPA of a FIP, in accordance with section 110(c)(1), unless prior to such promulgation the state submits, and the EPA approves, a submittal to meet the requirements of section 110(a)(2)(D)(i) for the 2012 annual PM2.5 NAAQS. The EPA will work with the state subject to this finding of failure to submit and provide assistance as necessary to help the state develop an approvable submittal in a timely manner. The EPA notes this action does not start a mandatory sanctions clock pursuant to CAA section 179 because this finding of failure to submit does not pertain to a part D plan for nonattainment areas required under section 110(a)(2)(I) or a SIP call pursuant to section 110(k)(5).

On December 14, 2012, the EPA promulgated a revised primary annual PM2.5 NAAQS to provide increased protection of public health and welfare from fine particle pollution.1 In that action, the EPA revised the primary annual PM2.5 standard, strengthening it from 15.0 micrograms per cubic meter (μg/m3) to 12.0 μg/m3, which is attained when the three-year average of the annual arithmetic means does not exceed 12.0 μg/m3. Infrastructure SIPs addressing the revised standard were due on December 14, 2015. CAA § 110(a)(1).

To date, Massachusetts has not submitted a good neighbor SIP for the 2012 annual PM2.5 NAAQS. Accordingly, the EPA is issuing a finding that Massachusetts has failed to submit a SIP addressing the requirements of section 110(a)(2)(D)(i) of the CAA, 42 U.S.C. 7410(a)(2)(D)(i) (prongs 1-4), for the 2012 annual PM2.5 NAAQS.

This notice is making a procedural finding that Massachusetts has failed to submit a SIP to address CAA section 110(a)(2)(D)(i) for the 2012 annual PM2.5 NAAQS. The EPA did not conduct an environmental analysis for this rule, because this rule would not directly affect the air emissions from particular sources. Because this rule will not directly affect the air emissions from particular sources, it does not affect the level of protection provided to human health or the environment. Therefore, this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action is not an Executive Order 13771 regulatory action, because it is not a significant regulatory action under Executive Order 12866.

This action does not impose an information collection burden under the provisions of the PRA, 44 U.S.C. 3501 et seq. This final rule does not establish any new information collection requirement apart from what is already required by law.

This action is not subject to the RFA. The RFA applies only to rules subject to notice and comment rulemaking requirements under the APA, 5 U.S.C. 553, or any other statute. This rule is not subject to notice and comment requirements, because the agency has invoked the APA “good cause” exemption under 5 U.S.C. 553(b).

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. The action implements mandates specifically and explicitly set forth in the CAA under section 110(a) without the exercise of any policy discretion by the EPA.

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 rule responds to the requirement in the CAA for states to submit SIPs under section 110(a) to address CAA section 110(a)(2)(D)(i) for the 2012 annual PM2.5 NAAQS. No tribe is subject to the requirement to submit an implementation plan under section 110(a) within 3 years of promulgation of a new or revised NAAQS. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental 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 13211, because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations, because it does not affect the level of protection provided to human health or the environment. The EPA's evaluation of environmental justice considerations is contained in section IV of this notice.

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).

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

Philadelphia Air Management Services submitted a negative declaration letter to EPA certifying on March 28, 2012 that there are no SSI units subject to the requirements of sections 111(d) and 129 of the CAA in its respective air pollution control jurisdiction. The negative declaration letter and EPA's technical support document for this action are available in the docket for this rulemaking and available online at www.regulations.gov.

Please see additional information provided in the direct final action published in the Federal Register on October 26, 2017 (82 FR 49511) and in the companion proposed rule which was also published on October 26, 2017 (82 FR 49563). In the DFR, we stated that if we received adverse comment by November 27, 2017, the rule would be withdrawn and not take effect. EPA subsequently received an adverse comment. EPA will address the comment received in a subsequent final action based upon the proposed action also published on October 26, 2017. EPA will not institute a second comment period on this action. As a result of the comment received, EPA is withdrawing the direct final rule approving the negative declaration submitted by the City of Philadelphia for existing SSI units.

On May 10, 2016, the State of Maryland submitted a formal revision (MD Submittal #16-05) to its CAA section 111(d)/129 State Plan for MWCs. The revisions contain Maryland's amendments to COMAR 26.11.08, “Requirements for an Existing Large MWC with a Capacity Greater Than 250 Tons Per Day.” These amendments update the MWC references to opacity compliance previously made by the Maryland Department of the Environment. The Maryland state submittal is available in the docket for this rulemaking and available online at www.regulations.gov.

Please see additional information provided in the direct final action published in the Federal Register on November 6, 2017 (82 FR 51350) and in the companion proposed rule which was also published on November 6, 2017 (82 FR 51380). In the DFR, we stated that if we received adverse comment by December 6, 2017, the rule would be withdrawn and not take effect. EPA subsequently received an adverse comment. As a result of the comment received, EPA is withdrawing the DFR approving the revisions submitted by the State of Maryland to their CAA section 111(d)/129 State Plan for MWCs. EPA will address the comment received in a subsequent final action based upon the proposed action also published on November 6, 2017. EPA will not institute a second comment period on this action.

Preamble acronyms and abbreviations. We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here:

Background information. On August 29, 2017, the EPA proposed revisions to the Wool Fiberglass Manufacturing NESHAP based on our technology review of the source category's bonded RS lines. In addition, the proposal included certain revisions to the July 29, 2015, emission standards for the bonded FA lines. In this action, we are finalizing decisions and revisions for the rule. We summarize some of the more significant comments we timely received regarding the proposed rule and provide our responses in this preamble. A summary of all other public comments on the proposal and the EPA's responses to those comments is available in the document titled, National Emissions Standards for Hazardous Air Pollutants for Wool Fiberglass Manufacturing (40 CFR part 63, subpart NNN)—Technology Review, Final Amendments: Response to Public Comments on August 29, 2017 Proposal, which is available in the docket for this action (Docket ID No. EPA-HQ-OAR-2010-1042). A “track changes” version of the regulatory language that incorporates the changes in this action is also available in the docket.

Organization of this document. The information in this preamble is organized as follows:

Regulated entities. Table 1 includes the categories and entities potentially regulated by this action.

Table 1 of this preamble is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by the final action for the source category listed. To determine whether your facility is affected, you should examine the applicability criteria in the appropriate NESHAP. If you have any questions regarding the applicability of any aspect of this NESHAP, please contact the appropriate person listed in the preceding FOR FURTHER INFORMATION CONTACT section of this preamble.

In addition to being available in the docket, an electronic copy of this final action will also be available on the internet. Following signature by the EPA Administrator, the EPA will post a copy of this final action at: https://www.epa.gov/stationary-sources-air-pollution/wool-fiberglass-manufacturing-national-emissions-standards. Following publication in the Federal Register, the EPA will post the Federal Register version and key technical documents at this same website.

Additional information is available on the RTR website at http://www.epa.gov/ttn/atw/rrisk/rtrpg.html. This information includes an overview of the RTR program, links to project websites for the RTR source categories, and detailed emissions and other data we used as inputs to the risk assessments.

Under Clean Air Act (CAA) section 307(b)(1), judicial review of this final action is available only by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit by February 26, 2018. Under CAA section 307(b)(2), the requirements established by this final rule may not be challenged separately in any civil or criminal proceedings brought by the EPA to enforce the requirements.

Section 307(d)(7)(B) of the CAA further provides that only an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review. This section also provides a mechanism for the EPA to reconsider the rule if the person raising an objection can demonstrate to the Administrator that it was impracticable to raise such objection within the period for public comment or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule. Any person seeking to make such a demonstration should submit a Petition for Reconsideration to the Office of the Administrator, U.S. EPA, Room 3000, EPA WJC South Building, 1200 Pennsylvania Ave. NW, Washington, DC 20460, with a copy to both the person(s) listed in the preceding FOR FURTHER INFORMATION CONTACT section, and the Associate General Counsel for the Air and Radiation Law Office, Office of General Counsel (Mail Code 2344A), U.S. EPA, 1200 Pennsylvania Ave. NW, Washington, DC 20460.

Section 112 of the CAA establishes a two-stage regulatory process to address emissions of hazardous air pollutants (HAP) from stationary sources. In the first stage, we must identify categories of sources emitting one or more of the HAP listed in CAA section 112(b) and then promulgate technology-based NESHAP for those sources. “Major sources” are those that emit, or have the potential to emit, any single HAP at a rate of 10 tons per year (tpy) or more, or 25 tpy or more of any combination of HAP. For major sources, these standards are commonly referred to as maximum achievable control technology (MACT) standards and must reflect the maximum degree of emission reductions of HAP achievable (after considering cost, energy requirements, and non-air quality health and environmental impacts). In developing MACT standards, CAA section 112(d)(2) directs the EPA to consider the application of measures, processes, methods, systems, or techniques, including, but not limited to those that reduce the volume of or eliminate HAP emissions through process changes, substitution of materials, or other modifications; enclose systems or processes to eliminate emissions; collect, capture, or treat HAP when released from a process, stack, storage, or fugitive emissions point; are design, equipment, work practice, or operational standards; or any combination of the above.

For these MACT standards, the statute specifies certain minimum stringency requirements, which are referred to as MACT floor requirements, and which may not be based on cost considerations. See CAA section 112(d)(3). For new sources, the MACT floor cannot be less stringent than the emission control achieved in practice by the best-controlled similar source. The MACT standards for existing sources can be less stringent than floors for new sources, but they cannot be less stringent than the average emission limitation achieved by the best-performing 12 percent of existing sources in the category or subcategory (or the best-performing five sources for categories or subcategories with fewer than 30 sources). In developing MACT standards, we must also consider control options that are more stringent than the floor under CAA section 112(d)(2). We may establish standards more stringent than the floor, based on the consideration of the cost of achieving the emissions reductions, any non-air quality health and environmental impacts, and energy requirements.

In the second stage of the regulatory process, the CAA requires the EPA to undertake two different analyses, which we refer to as the technology review and the residual risk review. Under the technology review, we must review the technology-based standards and revise them “as necessary (taking into account developments in practices, processes, and control technologies)” no less frequently than every 8 years, pursuant to CAA section 112(d)(6). In conducting this review, the EPA is not required to recalculate the MACT floor. Natural Resources Defense Council (NRDC) v. EPA, 529 F.3d 1077, 1084 (DC Cir. 2008). Association of Battery Recyclers, Inc. v. EPA, 716 F.3d 667 (DC Cir. 2013). Under the residual risk review, we must evaluate the risk to public health remaining after application of the technology-based standards and revise the standards, if necessary, to provide an ample margin of safety to protect public health or to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect. The residual risk review is required within 8 years after promulgation of the technology-based standards, pursuant to CAA section 112(f). In conducting the residual risk review, if the EPA determines that the current standards provide an ample margin of safety to protect public health, it is not necessary to revise the MACT standards pursuant to CAA section 112(f).1 Additionally, CAA section 112(h) allows the agency to adopt a work practice standard in lieu of a numerical emission standard only if it is “not feasible in the judgment of the Administrator to prescribe or enforce an emission standard for control of a hazardous air pollutant.” This phrase is defined as applying where “the Administrator determines that the application of measurement methodology to a particular class of sources is not practicable due to technological and economic limitations.” CAA section 112(h)(1) and (2).

In this action, the EPA is finalizing the technology review for RS lines in accordance with section 112(d)(6) of the CAA. In addition, the EPA is amending certain emission standards promulgated on July 29, 2015, for FA lines at wool fiberglass manufacturing facilities.

The EPA promulgated the Wool Fiberglass Manufacturing NESHAP on June 14, 1999 (62 FR 31695). The standards are codified at 40 CFR part 63, subpart NNN. The Wool Fiberglass Manufacturing source category consists of facilities that produce wool fiberglass from sand, feldspar, sodium sulfate, anhydrous borax, boric acid, or any other materials. This source category currently comprises three wool fiberglass manufacturing facilities operating bonded RS lines, and two facilities operating bonded FA lines. The EPA is not currently aware of any planned or potential new or reconstructed bonded RS or FA lines.

On July 29, 2015, we published the final rule amendments to the Wool Fiberglass Manufacturing NESHAP resulting from our completion of certain aspects of the CAA section 112(f)(2) residual risk review and the CAA section 112(d)(6) technology review for that NESHAP RTR. 80 FR 45280. Specifically, the July 29, 2015, final rule:

• Established a chromium emission limit for gas-fired, glass-melting furnaces under CAA section 112(f)(2);

• Revised the particulate matter emission limit for gas-fired, glass-melting furnaces at major sources under CAA section 112(d)(6);

• Established work practice standards for hydrogen chloride and hydrogen fluoride emissions from glass-melting furnaces at wool fiberglass manufacturing facilities under CAA section 112(h);

• Eliminated the use of formaldehyde as a surrogate and established revised limits for formaldehyde and first-time limits for methanol and phenol emitted from FA lines under CAA sections 112(d)(2) and (d)(3);

• Eliminated FA line subcategories;

• Removed the exemption for startup and shutdown periods and established work practice standards that apply during startup and shutdown periods; and

• Established chromium emission limits for both new and existing gas-fired, glass-melting furnaces at area sources in the Wool Fiberglass Manufacturing source category under CAA section 112(d)(5).

In the July 2015 rule, we did not finalize proposed emission limits for formaldehyde, methanol, and phenol emissions from forming, cooling, and collection processes on bonded RS lines under CAA sections 112(d)(2) and (3). We explained that this decision was based on comments we received on our various proposals indicating that the proposed limits likely relied on incorrect data. We explained that we had issued an Information Collection Request (ICR) under CAA section 114 for purposes of obtaining the requisite data. 80 FR 45293.

On August 29, 2017, the EPA published a proposed rule in the Federal Register for the Wool Fiberglass Manufacturing NESHAP, 40 CFR part 63, subpart NNN, that took into consideration the new data received in response to the ICR. We also explained that since our July 29, 2015, final rule, we had received new information and data from a facility that operates FA lines that cast doubts on information and data that the agency relied on in promulgating the July 2015 final rule emission limits for FA lines. In the August 29, 2017, Federal Register, we proposed the following:

• Readopting the formaldehyde emission limits for bonded RS lines that were in the original 1999 NESHAP under CAA section 112(d)(6);

• Establishing new emission limits for methanol from bonded RS lines under CAA section 112(d)(2) and (3);

• Establishing work practice standards for phenol from bonded RS lines under CAA section 112(h);

• Amending the incinerator operating limits to include cooling emissions from both RS and FA limits under CAA section 112(d)(2) and (3);

• Establishing new subcategories of FA lines under CAA section 112(d)(1), defined as: (1) Aerospace, Air Filtration, and Pipe Products; (2) Heating, Ventilation, and Air Conditioning (HVAC); and (3) Original Equipment Manufacturer (OEM);

• Establishing new emission limits for formaldehyde, methanol, and phenol from most of the newly proposed FA line subcategories under CAA section 112(d)(2) and (3); and

• Setting work practice standards for phenol from one newly proposed FA line subcategory under CAA section 112(h).

This action finalizes the EPA's determinations, as proposed, pursuant to the CAA section 112(d)(6) review for the Wool Fiberglass Manufacturing source category and amends the Wool Fiberglass Manufacturing NESHAP based on those determinations. This action also finalizes, with minor revisions to our proposals, other changes to the NESHAP, including establishing first-time limits for methanol emissions from forming, cooling, and collection processes on new and existing bonded RS lines at wool fiberglass manufacturing facilities under CAA sections 112(d)(2) and (3), and establishing work practices standards for phenol emissions from forming, cooling, and collection processes on new and existing bonded RS lines at wool fiberglass manufacturing facilities under CAA section 112(h).

Additionally, consistent with our proposal, this action finalizes our decision to create three subcategories of FA lines at wool fiberglass manufactuirng facilities based on the type of product that is manufactured. This action also finalizes, as proposed, emission limits for formaldehyde, methanol, and phenol emissions under CAA section 112(d)(2) and (3) for two of these subcategories, and finalizes emission limits for formaldehyde and methanol under CAA section 112(d)(2) and (3), and work practices standards for phenol emissions under CAA section 112(h), for the third subcategory.

We are readopting the current emissions standards for formaldehyde from forming, cooling, and collection processes on existing, new, and reconstructed bonded RS lines at wool fiberglass manufacturing facilities under CAA section 112(d)(6) as the result of our technology review.

Under CAA sections 112(d)(2) and (d)(3), we are establishing emission limits for methanol from forming, cooling, and collection processes on existing, new, and reconstructed bonded RS lines at wool fiberglass manufacturing facilities.

We are establishing work practice standards for phenol emissions from combined fiber/collection, curing, and cooling processes on existing, new, and reconstructed bonded RS lines at wool fiberglass manufacturing facilities under CAA section 112(h).

Other changes to the NESHAP include:

• Finalizing the proposed subcategories for FA lines and their associated emissions standards for existing, new, and reconstructed bonded FA lines at wool fiberglass manufacturing facilities;

• Adding an annual operating requirement for designating the appropriate subcategory for FA lines;

• Clarifying that the Aerospace subcategory includes pipe products;

• Establishing the compliance period for both RS and FA lines; and

• Revising the recordkeeping requirement for free-formaldehyde and free-phenol content of binders.

The revisions to the MACT standards being promulgated in this action are effective on December 26, 2017. The compliance date for existing RS and FA manufacturing lines is December 26, 2020. New sources must comply with the all of the standards immediately upon the effective date of the standard, December 26, 2017, or upon startup, whichever is later.

CAA section 112(i)(3) requires that existing sources must comply as expeditiously as practicable, but no later than 3 years after promulgation of standards under CAA section 112(d). (“Section 112(i)(3)'s three-year maximum compliance period applies generally to any emissions standard . . . promulgated under CAA [section 112].” Ass'n of Battery Recyclers v. EPA, 716 F.3d 667, 672 (DC Cir. 2013)). Additionally, we may not reset compliance deadlines for revisions that are unaccompanied by changes to a MACT standard. NRDC v. EPA, 489 F.3d 1364, 1374 (DC Cir. 2007) (EPA may not revise compliance deadlines “for compliance with Section 112 standards anytime it adjusts reporting terms.”). This final action reflects our conclusion that sources will need the 3-year period to comply with the various final rule requirements, which are not just reporting requirements. For instance, with regard to FA lines, subcategories have been newly created, and numerical emission limits for formaldehyde and methanol emissions are being promulgated. Thus, owners or operators of affected sources will need to conduct performance tests in order to demonstrate initial compliance with these final standards. Additionally, as explained at proposal, the work practice standards for phenol emisisons from both RS and FA lines call for vendor specifications, which will likely require vendor bids and selections, and the likely institution of new practices to address the final recordkeeping requirements.

As we proposed, the EPA is taking steps to increase the ease and efficiency of data submittal and data accessibility. Specifically, the EPA is finalizing the requirement for owners or operators of wool fiberglass manufacturing facilities to submit electronic copies of certain required performance test reports.

Data will be collected by direct computer-to-computer electronic transfer using EPA-provided software. This EPA-provided software is an electronic performance test report tool called the Electronic Reporting Tool (ERT). The ERT will generate an electronic report package which will be submitted to the Compliance and Emissions Data Reporting Interface (CEDRI) and then archived to the EPA's Central Data Exchange (CDX). A description of the ERT and instructions for using ERT can be found at http://www3.epa.gov/ttn/chief/ert/index.html. CEDRI can be accessed through the CDX website (http://www.epa.gov/cdx). Once submitted, a performance test report will be available to the public through the EPA WebFIRE database (https://cfpub.epa.gov/webfire/).

The requirement to submit performance test data electronically to the EPA does not create any additional performance testing and will apply only to those performance tests conducted using test methods that are supported by the ERT. A listing of the pollutants and test methods supported by the ERT is available at the ERT website. With electronic reporting, industry will save time in the performance test submittal process. Additionally, this rulemaking benefits industry by reducing recordkeeping costs as the performance test reports that are submitted to the EPA using CEDRI are no longer required to be kept in hard copy.

State, local, and tribal air agencies may benefit from more streamlined and accurate review of performance test data that will become available to the public through WebFIRE. Having such data publicly available enhances transparency and accountability. For a more thorough discussion of electronic reporting of performance tests using direct computer-to-computer electronic transfer and using EPA-provided software, see the discussion in the preamble of the proposal.

In summary, in addition to supporting regulation development, control strategy development, and other air pollution control activities, having an electronic database populated with performance test data will save industry, state, local, and tribal air agencies, and the EPA significant time, money, and effort.

For each issue, this section provides a description of what we proposed and what we are finalizing for the issue, the EPA's rationale for the final decisions and amendments, and a summary of key comments and responses. For all comments not discussed in this preamble, comment summaries and the EPA's responses are contained in the comment summary and response document available in the docket for this action.

In the August 29, 2017, action (82 FR 40970), we proposed readopting the current NESHAP emission limits for formaldehyde from forming, cooling, and collection processes on existing, new, and reconstructed bonded RS lines at wool fiberglass manufacturing facilities under CAA section 112(d)(6).

We are not changing our technology review findings from the August 29, 2017, proposal.

One commenter disagreed with our proposal to readopt the current formaldehyde emission limits for existing and new sources. The commenter stated that the EPA's refusal to increase protections against formaldehyde emissions from RS lines is unlawful and irrational and is not consistent with 42 U.S.C. 7412(d)(6), which is intended to drive pollution reductions. The commenter said that the EPA's proposal to retain the current NESHAP emission limits for formaldehyde from RS lines, even though the EPA identified developments in practices, processes, and control technologies under the technology review, does not meet the requirements of 42 U.S.C. 7412(d)(6) which requires the EPA to “account” for such developments consistent with the CAA. The commenter asserted that failing to strengthen the emission limits will allow sources to emit at higher levels without consequence, and will remove a strong incentive for the industry to complete the transition to non-phenol formaldehyde (PF) binders.

We disagree with the commenter. As explained in the August 29, 2017, action (82 FR 40975), we considered mandating the use of non-PF binders for lines currently using PF binders, and/or mandating the use of non-PF binders for all bonded lines as part of the required CAA section 112(d)(6) technology review. We did not propose this option, however, and, instead, we proposed to readopt the current limits because the source category has already achieved approximately 95-percent reduction in formaldehyde emissions due to the replacement of the PF binders with non-PF binders. We explained that this industry trend would likely continue given industry indications that non-PF binders are less expensive than PF binders and, as also explained at proposal, that cost considerations will move the industry in the direction of complete elimination of PF binders in the absence of regulation. However, as also noted at proposal, the remaining sources that continue to operate RS lines using PF binders manufacture products for customers with specifications that preclude the use of any currently available non-PF binders and, therefore, if PF binders were banned, these facilities would likely no longer be able to produce these products. Furthermore, we noted that mandating non-PF binders would likely be viewed as penalizing sources that continued to utilize PF binders. Therefore, we continue to conclude that it would be inappropriate to ban PF binders at this time. We also explained that our review of the 2015 ICR indicated that all bonded RS lines are equipped with air pollution control devices for formaldehyde emissions as compared to the time of promulgation of the 1999 MACT standards. Specifically, we found that formaldehyde emissions were significantly below the 1999 MACT and we attributed these reductions to both control technologies in use and the phase out of PF binders. We expressed our belief that sources would maintain these control technologies and, thus, that the lower emissions remain somewhat assured, even without our lowering of the existing MACT standards. We continue to believe that sources will maintain control technologies that address formaldehyde emissions from the various processes on RS lines post promulgation of standards that they are already meeting, partly because most (or potentially all) of these sources would likely not be able to comply with the current formaldehyde limits or the new methanol limits without these controls. We also note that because we were confident of the continued use of existing control technologies that achieve formaldehyde emissions reductions that are well below the existing MACT, we also did not propose requiring initial compliance demonstration, but rather proposed to allow sources to use test reports submitted in response to the 2015 ICR as a means of demonstrating initial compliance with the proposed emission limits, when finalized (82 FR 40976). This final rule contains this requirement, as proposed. Additionally, these existing MACT limits are reflected in operating permits for these sources and, thus, remain enforceable until otherwise revised.

As noted in the proposal preamble (82 FR 40974), this source category has already achieved approximately 95-percent reduction in formaldehyde emissions due to the replacement of PF binders with non-PF binders. We conclude that the industry will continue this trend without the need for tighter regulation due to cost considerations (i.e., non-PF binders are less expensive than PF binders). Additionally, as explained above, facilities are currently using PF binders because of customers' specifications for certain products and, thus, would be unable to manufacture such products if we mandate the use of non-PF binders. Therefore, we are finalizing our proposal to readopt the current NESHAP formaldehyde emission limits for existing, new, and reconstructed bonded RS lines at wool fiberglass manufacturing facilities.

In the August 29, 2017, action (82 FR 40970), we proposed first-time standards for methanol emitted from forming, cooling, and collection processes on existing, new, and reconstructed bonded RS lines at wool fiberglass manufacturing facilities. We established the MACT floor for methanol emissions based on application of the upper prediction limit (UPL) method to the best-performing five sources in the test data collected under Part 2 of the 2015 ICR. We considered beyond-the-floor options for methanol for all combined collection and curing operation designs as required by CAA section 112(d)(2); however, we did not propose any limits based on the beyond-the-floor analyses because of the potential adverse impacts of additional controls, including the cost of control devices, non-air environmental impacts, and energy implications associated with use of these additional controls.

In this final action, we are revising the methanol emission limits for new and existing bonded RS lines by reflecting just two significant figures, based on comments received on the August 29, 2017, proposal. This is consistent with current bonded RS line emission limits.

One commenter stated that the EPA's proposal illegally and arbitrarily relied on the UPL, instead of following the CAA's requirement to set an emission limitation that is not less stringent than the “average emission limitation achieved” by the relevant best-performing sources. The commenter also argued that there was ample support in the record for proposal and adoption of beyond-the-floor limits such as material switching.

We disagree with the commenter. Section 112(d)(3) of the CAA requires the EPA to promulgate standards for major sources of HAP that are based on MACT performance. For existing sources, MACT standards must be at least as stringent as the average emission limitation achieved by the best-performing 12 percent of existing sources (for which the Administrator has emissions information) or the best-performing five sources for source categories with less than 30 sources. For new sources, the MACT standards must be at least as stringent as the control level achieved in practice by the best-controlled similar source. MACT standards also have to be continuously achievable as specified by CAA section 302(k).

Although CAA section 112(d) includes language such as “existing source,” “best performing,” and “achieved in practice” in referring to source operations, the CAA language does not address whether sources' emission levels should be evaluated over time or be based on a single test result. In fact, the D.C. Circuit has long recognized the ambiguity in the term “average emission limitation.” See NACWA v. EPA, 734 F.3d at 1131 (noting that the court has accorded Chevron deference to the EPA's interpretation of CAA sections 129 MACT floor requirement) and 112 (“the phrase `average emission limitation achieved by the best performing 12 percent of units' could be interpreted several different ways, with several different variations of what the MACT floor is supposed to represent”). The phrase “average emission limitation achieved by the best performing 12 percent of units” does not specify the methodology that the EPA should use to determine the emissions levels achieved by the best-performing sources. Therefore, the EPA has discretion to interpret the phrase “average emission limitation achieved” by the best performing source or sources. Further, the D.C. Circuit has held repeatedly that the EPA may take the variability of best-performing sources into account in establishing MACT floors. Sierra Club v. EPA, 479 F.3d 875, 881-882 (D.C. Cir. 2007). See also, Cement Kiln Recycling Coalition v. EPA, 255 F. 3d 861, 865 (D.C. Cir. 2001); National Lime Ass'n v. EPA, 627 F.2d 416, 431 n.46, 443 (D.C. Cir. 1980). Consequently, we apply the UPL approach in developing numeric emission standards when using short-term test data, rather than calculating a straight average of test runs which does not address the performance of a source over time. The UPL is a statistical method to compensate for limited data and account for variability in emissions in determining what emission limitations have been achieved by the best-performing sources. The EPA's use of the UPL has been upheld based on explanations previously provided in U.S. Sugar Corp. v. EPA, 830 F.3d 579, 632-637 (D.C. Cir. 2016). “We believe that the EPA has carried its burden of demonstrating that the UPL reflect[s] a reasonable estimate of the emissions achieved in practice by the best performing sources.” Id., at 635 (Internal citations omitted).

With regard to the comment that we should have set beyond-the-floor limits in light of evidence of material switching, as explained at proposal, there are potential adverse impacts of additional controls for methanol, such as control devices costs, non-air quality health impacts, and energy implications (82 FR 40976). Additionally, as also previously explained, customer specifications preclude the use of products with any currently available non-PF binders and, therefore, requiring non-PF binders as a beyond-the-floor measure would result in these products likely no longer being produced. (“Nothing in section 7429(a)(2) requires the agency to impose a cost so disproportionate to the expected gains.” Id., at 640).

We based the final methanol emission limits for the forming, cooling, and collection processes on existing, new, and reconstructed RS lines at wool fiberglass manufacturing facilities on data collected under Part 2 of the 2015 ICR. We conclude that, based on the UPL for the best-performing five sources, these limits represent the MACT level of control for methanol emissions currently being achieved on RS line processes by using add-on control devices (e.g., gas scrubbers, thermal oxidizers). In response to the proposed rule, we did not receive any additional emissions and process data for consideration.

In the August 29, 2017, action (82 FR 40970), we proposed establishing work practice standards under CAA section 112(h) that represent MACT for phenol emissions from forming, cooling, and collection processes on bonded RS lines. We concluded that it was not feasible to prescribe or enforce an emission limit for these processes due to the prevalence of emission test values reported as below the detection limit (BDL) of the test method.

We did not change our proposal to establish work practice standards for phenol emissions under CAA section 112(h) for RS lines. However, based on our evaluation of public comments, we concluded that methods for determining the free-formaldehyde and free-phenol content of binder formulations does not exist. We have, therefore, removed the proposed requirement for facilities to record the free-formaldehyde and free-phenol content of binder formulations, and instead revised the proposed requirement for facilities to record and maintain records of the free-formaldehyde and free-phenol content of the resin purchased. In addition, facilities are required to record and maintain records of the formaldehyde and phenol content of the product binder formulations.

One commenter noted that the proposed rule requires owners or operators to record the free-formaldehyde and free-phenol content of binder, but did not specify the method for determining these values. The proposed rule did not specify the procedures for determining the binder free-formaldehyde and free-phenol content because we were unaware of a published method for conducting the measurement. Based on discussions with the commenter, the industry does not have methods for assessing these parameters in binder formulations. Consequently, we are removing the requirement in the final rule to record the free-formaldehyde and free-phenol content of binder formulations. We have revised the rule to require facilities to record and maintain records of the free-formaldehyde and free-phenol content of the resin purchased.

One commenter said that the EPA failed to meet the required tests for setting only work practice standards instead of numerical emission limits. The commenter noted that the EPA may promulgate work practice standards instead of numerical standards “only if measuring emission levels is technologically or economically impracticable” (Sierra Club v. EPA, 479 F.3d 875, 883-84 (D.C. Cir. 2007)) and only if doing so “is consistent with the provisions of subsection (d) or (f).” 42 U.S.C. 7412(h)(1). The commenter stated that the presence of BDL values in the test data does not provide an excuse for the EPA to evade the requirement to set numeric standards.

We disagree with the commenter that numerical standards are appropriate for phenol emissions from RS lines. Sections 112(h)(1) and (h)(2)(B) of the CAA provide the EPA with the discretion to adopt a work practice standard, rather than a numeric standard, when “the application of measurement methodology to a particular class of sources is not practicable due to technological and economic limitations.” The “application of measurement methodologies” (described in CAA section 112(h)(2)(B)) means not only conducting a measurement, but also that a measurement has some reasonable relation to what the source is emitting (i.e., that the measurement yields a meaningful value). That is not the case here. Therefore, as proposed, we concluded that it is not feasible to establish a numerical standard for phenol emissions from RS lines. Moreover, a numerical limit established at some level greater than the detection limit (which would be a necessity since any numeric standard would have to be measurable) could authorize and allow more emissions of these HAP than would otherwise be the case.

As explained in the proposal preamble, approximately 60 percent of the phenol concentration values were reported as BDL values. Under these circumstances, it is not technologically and economically feasible to measure reliably phenol emissions from RS lines. This is also consistent with our approach in previous rulemakings (e.g., NESHAP for Coal- and Oil-Fired Electric Utility Steam Generating Units, NESHAP for Primary Aluminum Reduction Plants) where test results were predominantly found to be BDL (e.g., more than 55 percent of the test run results). In these instances, the EPA established work practice standards for the pollutants in question from the subject sources because we concluded that emissions of the pollutants are too low to reliably measure and quantify. Similarly, we are finalizing work practice standards for phenol emissions from FA lines.

In the August 29, 2017, action (82 FR 40976), we proposed three subcategories for FA lines under CAA section 112(d)(1) based on recent information indicating that there are technical or design differences that distinguish FA lines that manufacture different wool fiberglass products: (1) Aerospace and Air Filtration; (2) HVAC; and (3) OEM. (See also proposed 40 CFR 63.1381.) We also proposed revisions to the formaldehyde, methanol, and phenol emission limits for FA lines promulgated on July 29, 2015 (80 FR 45280), to reflect these new subcategories and proposed a 1-year compliance period. In a separate action on July 6, 2017 (82 FR 34858), we proposed extending the compliance period for the July 29, 2015, final rule requirements for existing FA lines to 3 years in order to allow the EPA time to review corrected data provided by the industry.

Consistent with our August 29, 2017, proposal, we revised the formaldehyde, methanol, and phenol limits for FA lines to incorporate updated production data received from the industry. We also revised the definition of the Aerospace subcategory to include FA lines that manufacture pipe products to reflect comments we received on our proposal. Table 2 shows the final emission limits for the FA line subcategories.

One commenter noted that we did not use the correct production rate values in calculating the test run values (expressed in terms of pounds of pollutant per ton of glass pulled) that we used in the UPL analysis. We acknowledge the error in the industry data, and the emission limits for FA lines in the final rule, reflects the updated production values.

One commenter noted that the Aerospace and Air Filtration Products subcategory should include pipe products because the same base resin is used in manufacturing these products. We agree with the commenter that it is appropriate for pipe products and the Aerospace and Air Filtration Products subcategory to meet the same emission limits; therefore, we revised the Table 2 to 40 CFR part 63, subpart NNN in the final rule.

Another commenter stated that the EPA's proposal to subcategorize FA lines so that each individual source is its own subcategory is irrational and unlawful and does not meet the statutory test for subcategorization specified in CAA section 112(d)(1), which is based on the “classes, types, and sizes” of sources. The commenter said that the EPA failed to provide the necessary determination to subcategorize, including a demonstration of: (1) Why these different products make the different lines somehow appropriate to divide into subcategories; (2) why the different products require the use of different binders, some with greater amounts of pollutants; or (3) why the EPA is changing its prior proposal not to subcategorize FA lines. The commenter also stated that there was no support for the work practice standard for phenol emissions from the Aerospace, Air Filtration, and Pipe Products subcategory.

We disagree with the commenter. In the April 15, 2013, proposal (78 FR 22387), we proposed to eliminate the heavy density and pipe subcategories of FA manufacturing lines because we no longer believe that a technical basis exists to distinguish these subcategories, and, in the July 29, 2015, action, we finalized emission limits for FA lines that apply to all types of products. However, as noted in the August 29, 2017, proposal (82 FR 40977), the data (that we used to determine that FA line emission limits) contained errors in the analytical results for formaldehyde, methanol, and phenol. In fact, the data used to set the 2015 emission limits did not represent every product manufactured by the source category. Our review of the corrected FA line data received from the industry identified that the phenol emission from certain FA production lines were 1- to 2-orders of magnitude higher than other FA lines. In addition, we found that some FA lines, due to their lower pull rates, were never represented in the data used to set the 2015 emission limits for FA lines. Based on discussions with Johns Manville (the only company currently operating FA lines), we were able to attribute the differences in phenol emissions to the use of different binder formulations in the manufacture of different wool fiberglass products for specific customer demands and end uses. We had also explained that PF binder application varies with the result that phenol emissions are either higher or lower depending on the product being manufactured (82 FR 40977). Additionally, proposed 40 CFR 63.1381 presented the proposed subcategories. Based on our proposal, we conclude that the different products manufactured, and their represented manufacturing processes are an acceptable basis that Congress intended for distinguishing between classes or types of sources. We also note that “type” is “undefined and unrestricted” in CAA section 112(d)(1). U.S. Sugar Corp., 830 F.3d at 656.

One commenter noted that the final rule should include criteria for designating the appropriate subcategory for individual FA lines and suggested that the subcategory be assigned based on the type of product manufactured for 75 percent of the FA line's operating hours. We agree with the commenter. Therefore, we have revised the subcategory definitions in the final rule to include the percent-operating time criteria.

One commenter objected to the EPA's proposal to extend the compliance date for FA lines because the EPA's action violates: (1) The clear compliance deadline requirements for air toxics standards provided in 40 U.S.C. 7412(i)(3); (2) the prohibition on a delay of effectiveness of more than 3 months for the purpose of reconsideration according to 40 U.S.C. 7607(d)(7)(B); and (3) the core public notice-and-comment requirements of the CAA and reasoned decision-making because the EPA did not provide any information, data, or documents related to the erroneous data in the public docket. The commenter also asserted that the EPA's proposed action is arbitrary and capricious because it is unsupported by evidence in the record and it conflicts with evidence in the record. The commenter argued that the EPA is changing its prior determination of the 2-year compliance date without the required acknowledgment and a reasoned explanation, including a justification for disregarding the facts previously found. The commenter also said EPA has given no indication that the concern it raised applies to more than one facility or a sufficient number of facilities to justify considering a new compliance date for all sources, as opposed to evaluating a request for a single compliance date extension of 1 year under the statutory mechanism for that purpose. In addition, the EPA has failed to consider or address in any way the health and environmental effects of the compliance delay it proposes.

We disagree with the commenter. The direct final action did not stay the effectiveness of the July 29, 2015, final rule but rather extended the compliance date for FA lines by one year. (82 FR 34858). Moreover, because the EPA received adverse comments, the direct final notice was subsequently withdrawn and did not go into effect. Additionally, in a separate action, of August 29, 2017, the EPA proposed a different approach that was based on new data and information provided by Johns Manville, which can be found in the docket for this rulemaking. In this document, the EPA is taking action to finalize the approach presented in the August 29, 2017, that includes the creation of subscategories for FA lines. As such, assertions that the approach presented in the direct final and parallel proposal were insufficiently supported by the record are not relevant to this action. The final action is consistent with the statutory mandate and fully supported by the rulemaking record. As previously explained, CAA section 112(i)(3)(A) specifies that the compliance date for existing sources must provide for compliance as expeditiously as practicable, no later than 3 years after the effective date of the standard. The compliance deadline in this final rule does not exceed the 3-year period allowed under CAA section 112(i)(3)(A). As also previously explained, it reflects the period the EPA believes sources need to comply with these revised standards and conduct the necessary compliance tests (refer to section III.E of this action).

We also disagree that the 3-month period for staying the effectiveness of a rule is relevant. The compliance extension contained within this action does not stay the effectiveness of a rule by altering the effective date. Instead, it simply extends the compliance date—an action which has its own effective date. Moreover, the CAA requirements at 40 U.S.C. 7607(d)(7)(B) specify the conditions for submitting and the requirements for responding to a petition for reconsideration. As we explained in the July 2017 action, we extended the compliance date on our own initiative because we discovered that the data on which the July 2015 final rule was based contained errors. We were not proceeding in response to a petition for reconsideration of the rule.

As previously discussed regarding the response to comments on our proposed work practice standards for phenol emissions from RS lines, in section IV.C of this preamble, we disagree with the commenter that numerical standards are appropriate for phenol emissions from FA lines. For the reasons provided in section IV.C, we conclude that it is not feasible to establish a numerical standard for phenol emissions from FA lines manufacturing aerospace, air filtration, and pipe products.

Based on the corrected phenol emissions data and the different binder formulations used, we conclude it is appropriate to establish the Aerospace, HVAC, and OEM subcategories and their associated emission standards for FA lines in this final rule. We are providing a period of 3 years to allow owners and operators of FA lines sufficient time to plan and conduct compliance tests, submit notifications and compliance status reports, and to evaluate current control technology conditions, if needed.

In the August 29, 2017, action we proposed amendments to the incinerator operating limits specified in 40 CFR 63.1382(c)(6) to clearly indicate that the subsection applies to total RS or FA line emissions. In addition, we proposed revisions to 40 CFR 63.1383(g)(1) to include this clarification as it relates to monitoring requirements.

In the August 29, 2017, proposed rule, we revised 40 CFR 63.1382(c)(8)(i) to include corrective action requirements as they apply to the new RS line emission limits, and the revised FA line emission limits. Similarly, we proposed revisions to 40 CFR 63.1383(h) to reflect monitoring requirements applicable to the new RS line emission limits, and the revised FA line emission limits. In addition, we revised 40 CFR 63.1383(i)(1) to address owner or operators who use process modifications to control both formaldehyde and methanol emissions.

The August 29, 2017, proposed rule included clarification for performance test requirements, as included in 40 CFR 63.1384(a)(3), and revised 40 CFR 63.1384(a)(9) to require the requirement to monitor and record the free-phenol content of the binder formulation.

Lastly, we proposed to allow owners or operators that conducted emissions tests in 2016 in response to the EPA's ICR to submit those performance test results to demonstrate initial compliance with the new methanol emission limits for RS lines, rather than conducting additional tests.

Based on comments received, we reiterate in this final action that the incinerator operating limits of 40 CFR 63.1382(c)(6) apply to total emissions from forming, cooling, and collection for RS lines and to total emissions from forming, cooling, and collection for FA lines.

One commenter noted that in the August 29, 2017, proposed rule preamble the EPA stated that “We are also proposing amendments to the incinerator operating limits specified in 40 CFR 63.1382(c)(6) to clearly indicate that the subsection applies to cooling emissions. Incinerators would be required to control the final formaldehyde, methanol, and, where applicable, phenol emissions from forming, curing, and cooling processes for both FA and bonded RS lines.” 82 FR 40976. The commenter suggested that the EPA should make clear that an owner or operator must meet the incinerator requirements in the event the cooling section on a particular line uses incineration as a means of control. The commenter indicated that the rule text revision was acceptable, but the preamble language was contradictory.

We have finalized 40 CFR 63.1382(c)(g) as proposed, but have provided clarification in this preamble to indicate that the incinerator operating limit applies to the total emissions from the production line, and does not apply to individual incinerators used for each of the processes within the production line.

As noted in section IV.C.2 of this preamble, one commenter noted that the proposed rule requires owners or operators to record the free-phenol content of binder, but did not specify the method for determining free-phenol content of the binders. Based on discussions with the commenter, the industry does not have a method for assessing this parameter in binder formulations. We have, therefore, revised 40 CFR 63.1384(a)(9) to require facilities to record and maintain records of the free-phenol content of the resin purchased. In addition, the facilities are required to maintain records of the formaldehyde and phenol content of the binder formulations used in the products.

We have revised the requirement for monitoring and recording the free-phenol content to specify that facilities must monitor and record the free-phenol content of the resin purchased, and not of the binder formulation. All other proposed rule revisions are finalized as proposed. We provide clarification in this preamble the intent of the incinerator operating limits included in the final rule, and indicate they are applicable to the RS and FA lines at wool fiberglass manufacturing facilities.

Currently, only three wool fiberglass manufacturing facilities continue to use RS lines to manufacture a bonded product. These three facilities operate six bonded RS lines that would be affected by the revised emission limits. Additionally, two facilities continue to use FA lines to manufacture a bonded product. The EPA is not currently aware of any planned or potential new or reconstructed bonded RS or FA lines.

Based on the test data received in response to the 2015 ICR, the three facilities with bonded RS lines currently meet the final emission limits for formaldehyde and methanol. Furthermore, based on available information, we expect the two facilities with bonded FA lines will be able to meet the emission limits for formaldehyde, methanol and phenol without additional controls. Therefore, the emission limits for formaldehyde, methanol and phenol will likley not result in further HAP emissions reductions. Also, we do not anticipate secondary environmental impacts from the final amendments to the Wool Fiberglass Manufacturing NESHAP because we expect that owners or operators will not need to install additional control devices to meet any of the standards.

Because the existing facilities will not need to install add-on control devices or implement process modifications to comply with the final emissions standards, and because the EPA is allowing facilities to use the test reports submitted in response to Part 2 of the ICR to demonstrate initial compliance with the final emission limits for RS lines, the five facilities that are subject to the final emission standards will not incur increased costs for installing or upgrading emissions control systems. However, the facilities that are subject to this final action will each incur costs related to the testing and notifications requirements related to emission limits, and additional monitoring and recordkeeping activities related to work practice standards. The total annual cost of this final action is approximately $13,131/year (2016 dollars).

Economic impact analyses evaluate changes in market prices and output levels. If changes in market prices and output levels in the directly affected markets are significant, impacts on other markets are also examined. Both the magnitude of costs needed to comply with the rule and the distribution of these costs among affected facilities can have a role in determining how the market will change in response to a rule.

The final standards for RS lines at wool fiberglass manufacturing facilities do not impose control costs or additional testing costs on affected facilities. However, affected facilities will have reporting requirements (i.e., an initial notification and a notification of compliance status) associated with the final formaldehyde and methanol emission limits and monitoring and recordkeeping requirements associated with the phenol work practice standard. We estimate that the total annual cost of this final action is approximately $13,131/year (2016 dollars). The economic impacts associated with the costs of this final action are quite low; each affected firm is estimated to experience an impact of less than 0.01 percent of their revenues.

Based on the data collected under Part 2 of the ICR, the actual formaldehyde emissions from all bonded RS lines are lower than the level allowed under the 1999 NESHAP. Although the final standards for formaldehyde from RS lines do not achieve further emissions reductions, the final emission limits for methanol and the work practice standards for phenol ensure that the emissions reductions that have been achieved since the 1999 NESHAP will persist into the future and that emissions will not increase.

This action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994), and it does not establish an environmental health or safety standard.

This final action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget (OMB) for review.

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 under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 1160.10. This action does not change the information collection requirements.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. None of the five entities affected by this action are small entities, using the Small Business Administration definition of small business for the affected NAICS code (327993), which is 1,500 employees for the ultimate parent company.

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector.

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 readopts the existing emission limit for formaldehyde and establishes new emission limits for methanol and a work practice standard for phenol emissions for RS lines. This action also includes revisions to the standards for FA lines. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental 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 13211 because it is not a significant regulatory action under Executive Order 12866.

This action involves technical standards. Therefore, the EPA conducted searches for the Wool Fiberglass Manufacturing Area Source NESHAP through the Enhanced National Standards Systems Network (NSSN) Database managed by the American National Standards Institute (ANSI). We also contacted voluntary consensus standards (VCS) organizations and accessed and searched their databases.

As discussed in the November 2014 supplemental proposal (79 FR 68029), under 40 CFR part 63, subpart NNN, we conducted searches for EPA Methods 5, 318, 320, 29, and 0061 of 40 CFR part 60, Appendix A. These searches did not identify any VCS that were potentially applicable for this rule in lieu of EPA reference methods.

The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). It does not establish an environmental health or safety standard.

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).

For the reasons stated in the preamble, the EPA is amending title 40, chapter I, part 63 of the Code of the Federal Regulations as follows:

The contents of this preamble are listed in the following outline:

Entities potentially affected by this rule are fuel producers and distributors who do business in Louisiana.

The above table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. The table lists the types of entities of which EPA is aware that could be affected by this rule. Other types of entities not listed on the table could also be affected. To determine whether your organization may be affected by this rule, you should carefully examine the regulations in 40 CFR 80.27. If you have questions regarding the applicability of this action to a particular entity, call the person listed in the FOR FURTHER INFORMATION CONTACT section of this preamble.

The statutory authority for this action is granted to EPA by sections 211(h) and 301(a) of the CAA, as amended; 42 U.S.C. 7545(h) and 7601(a).

This final rule approves a request from the state of Louisiana to change the federal RVP standard for the parishes of Beauregard, Calcasieu, Jefferson, Lafayette, Lafourche, Orleans, Pointe Coupee, St. Bernard, St. Charles, St. James, and St. Mary from 7.8 psi to 9.0 psi by amending EPA's regulations at 40 CFR 80.27(a)(2). EPA is not addressing in this final rule LDEQ's request that EPA also relax the federal RVP standard for the 5-parish Baton Rouge area. EPA will address that request in a separate rulemaking in the future.

The preamble for this rulemaking is organized as follows: Section III, provides the history of the federal gasoline volatility regulation; Section IV, describes the policy regarding relaxation of volatility standards in ozone nonattainment areas that are redesignated as attainment areas; Section V, provides information specific to Louisiana's request for the 11 parishes addressed by this action; Section VI, provides a response to the comments EPA received; and Section VII, presents the final action in response to Louisiana's request.

On August 19, 1987 (52 FR 31274), EPA determined that gasoline nationwide was becoming increasingly volatile, causing an increase in evaporative emissions from gasoline-powered vehicles and equipment. Evaporative emissions from gasoline, referred to as volatile organic compounds (VOCs), are precursors to the formation of tropospheric ozone and contribute to the nation's ground-level ozone problem. Exposure to ground-level ozone can reduce lung function, thereby aggravating asthma and other respiratory conditions, increase susceptibility to respiratory infection, and may contribute to premature death in people with heart and lung disease.

The most common measure of fuel volatility that is useful in evaluating gasoline evaporative emissions is RVP. Under CAA section 211(c), EPA promulgated regulations on March 22, 1989 (54 FR 11868) that set maximum limits for the RVP of gasoline sold during the regulatory control periods that were established on a state-by-state basis in the final rule. The regulatory control periods addressed the portion of the year when peak ozone concentrations were expected. These regulations constituted Phase I of a two-phase nationwide program, which was designed to reduce the volatility of gasoline during the high ozone season. On June 11, 1990 (55 FR 23658), EPA promulgated more stringent volatility controls as Phase II of the volatility control program. These requirements established maximum gasoline RVP standards of 9.0 psi or 7.8 psi (depending on the state, the month, and the area's initial ozone attainment designation with respect to the 1-hour ozone NAAQS).

The 1990 CAA Amendments established a new section 211(h) to address fuel volatility. CAA section 211(h) requires EPA to promulgate regulations making it unlawful to sell, offer for sale, dispense, supply, offer for supply, transport, or introduce into commerce gasoline with an RVP level in excess of 9.0 psi during the high ozone season. CAA section 211(h) also prohibits EPA from establishing a volatility standard more stringent than 9.0 psi in an attainment area, except that EPA may impose a lower (more stringent) standard in any former ozone nonattainment area redesignated to attainment.

On December 12, 1991 (56 FR 64704), EPA modified the Phase II volatility regulations to be consistent with CAA section 211(h). The modified regulations prohibited the sale of gasoline with an RVP above 9.0 psi in all areas designated attainment for ozone, effective January 13, 1992. For areas designated as nonattainment, the regulations retained the original Phase II standards published on June 11, 1990 (55 FR 23658), which included the 7.8 psi ozone season limitation for certain areas. As stated in the preamble to the Phase II volatility controls and reiterated in the proposed change to the volatility standards published in 1991, EPA will rely on states to initiate changes to their respective volatility programs. EPA's policy for approving such changes is described below in Section IV. of this preamble.

The state of Louisiana initiated the change being finalized in this action by requesting that EPA relax the 7.8 psi RVP standard to 9.0 psi for the parishes of Beauregard, Calcasieu, Jefferson, Lafayette, Lafourche, Orleans, Pointe Coupee, St. Bernard, St. Charles, St. James, and St. Mary. See Section V. of this preamble for information specific to Louisiana's request.

As stated in the preamble for EPA's amended Phase II volatility standards (See 56 FR 64706, December 12, 1991), any change in the gasoline volatility standard for a nonattainment area that was subsequently redesignated as an attainment area must be accomplished through a separate rulemaking that revises the applicable standard for that area. Thus, for former 1-hour ozone nonattainment areas where EPA mandated a Phase II summertime volatility standard of 7.8 psi RVP in the December 12, 1991 rulemaking, the federal 7.8 psi gasoline RVP requirement remains in effect, even after such an area is redesignated to attainment, until a separate rulemaking is completed that relaxes the federal RVP standard in that area from 7.8 psi to 9.0 psi.

As explained in the December 12, 1991 rulemaking, EPA believes that relaxation of an applicable gasoline RVP standard is best accomplished in conjunction with the redesignation process. In order for an ozone nonattainment area to be redesignated as an attainment area, CAA section 107(d)(3) requires the state to make a showing, pursuant to CAA section 175A, that the area is capable of maintaining attainment for the ozone NAAQS for ten years. Depending on the area's circumstances, this maintenance plan will either demonstrate that the area is capable of maintaining attainment for ten years without the more stringent volatility standard or that the more stringent volatility standard may be necessary for the area to maintain its attainment with the ozone NAAQS. Therefore, in the context of a request for redesignation, EPA will not relax the gasoline volatility standard unless the state requests a relaxation and the maintenance plan demonstrates to the satisfaction of EPA that the area will maintain attainment for ten years without the need for the more stringent volatility standard.

As explained in the proposal to this final rule, some former 1-hour ozone nonattainment areas that remain subject to the federal summertime RVP limit of 7.8 psi have been designated as attainment areas for both the 1997 and 2008 ozone NAAQS and based on the latest available air quality data are also attaining the more stringent 2015 ozone NAAQS. These states submitted, and EPA approved, CAA section 110(a)(1) maintenance plans for these areas, as required by the Phase 1 implementation rule for the 1997 ozone NAAQS (69 FR 23951, April 30, 2004).

As further explained at proposal, EPA has concluded that there is neither an implementation plan revision nor a CAA section 110(l) demonstration required in order for EPA to approve a state's request to relax the federal summertime gasoline RVP limit under the circumstances described above for such areas as these 11 parishes. Rather, in order for EPA to approve a request to relax the federal RVP limit for such areas, the Governor or his/her designee must request that the Administrator revise the federal gasoline RVP regulations to remove the subject areas from the list of required areas in 40 CFR 80.27(a)(2). The state may provide any relevant supporting information such as recent air quality data, designation status for ozone and information on previously approved ozone maintenance plans. The Administrator's decision on whether to grant a state's request to revise the federal gasoline RVP regulations in such cases would be documented through notice-and-comment rulemaking. See the August 9, 2017 proposal for further background (82 FR 37184).

On April 10, 2017, LDEQ requested that EPA relax the current federal gasoline RVP volatility standard of 7.8 psi to 9.0 psi for 16 Louisiana parishes, the 5 parishes of the Baton Rouge area, and 11 other parishes: Beauregard, Calcasieu, Jefferson, Lafayette, Lafourche, Orleans, Pointe Coupee, St. Bernard, St. Charles, St. James, and St. Mary. These other 11 parishes attained the 1-hour ozone NAAQS and were redesignated to attainment with approved CAA section 175A maintenance plans. They were then designated as attainment for the 1997 ozone NAAQS. As such, the State was required by EPA's Phase 1 rule, which implemented the 1997 ozone NAAQS, to submit CAA section 110(a)(1) maintenance plans for these parishes that addressed the 10-year period from 2004 to 2014. (See 69 FR 23951, April 30, 2004.) 2 The Phase 1 implementation rule for the 1997 ozone NAAQS did not require Louisiana to submit second 10-year CAA section 175A maintenance plans for the 1-hour ozone NAAQS for these parishes. In 2012, all 11 parishes were designated as attainment for the 2008 ozone NAAQS. Because they were designated as attainment for both the 1997 and 2008 ozone NAAQS, they were not required to submit a CAA section 110(a)(1) maintenance plan for the 2008 ozone NAAQS. Therefore, as explained earlier above, these parishes are no longer within the timeframe that was addressed by any approved maintenance plan for any ozone NAAQS. The 11 parishes that are the subject of this action are all attaining the more stringent 2015 ozone NAAQS, and the State did not recommend that any of these 11 parishes be designated as nonattainment for the 2015 ozone NAAQS.3

EPA's August 9, 2017 proposal included several pieces of information that supports the State's request:

• The current ozone design values for the parishes in question, based upon 2013-2015 air quality data are well below the 2015 ozone NAAQS of 70 parts-per-billion (ppb). For more information on current design values for the 11 parishes refer to Table 1 in the August 9, 2017 proposal (82 FR 37186).

• Moreover, the projections for VOC emissions (i.e., the ozone precursor controlled through RVP limitations) from the previously approved CAA section 110(a)(1) maintenance plans for the 1997 ozone NAAQS for the areas covered by the State's request show relatively flat or downward VOC emissions trends through 2014. For more information on trends in VOC emissions in the 11 parishes refer to Table 2 in the August 9, 2017 notice of proposed rulemaking (82 FR 37187).

• There are also national rules that result in VOC and/or NOx emission reductions that will contribute to the downward trend in ozone concentrations in the 11 parishes into the future. See EPA's August 9, 2017 proposal for further information (82 FR 37184).

EPA received four comments on its August 9, 2017 (82 FR 37184) proposal to relax the gasoline RVP standard from 7.8 psi to 9.0 psi. EPA found that these comments were either supportive of the proposed change or fell outside the scope of this action as discussed further below.

Comment: An organization representing the Louisiana oil and gas industry provided comments in support of the proposed relaxation of summertime gasoline RVP from 7.8 to 9.0 psi.

Response: EPA acknowledges that the commenter supported the proposal.

Comment: EPA received two sets of comments that were not related to any of the issues addressed in the proposal, while a third expressed general disagreement with relaxing any environmental regulations for any reason without addressing the specific issue of the subject RVP relaxation.

Response: Regarding the generic objection to the relaxation of environmental regulations, EPA deemed this outside the scope of the proposal because it did not address EPA's conclusion that approving the proposed relaxation would not adversely impact air quality in the covered areas, nor would it interfere with those areas' ability to meet any other applicable NAAQS. As discussed above and in the proposal, EPA has concluded based on current air quality data and available VOC and NOx emissions information that the RVP relaxation will not have any appreciable effect on air quality in the 11 parishes, and therefore, the requested relaxation is approvable.

EPA is taking final action to approve Louisiana's request for the Agency to relax the RVP applicable to gasoline introduced into commerce from June 1 to September 15 of each year for the parishes of Beauregard, Calcasieu, Jefferson, Lafayette, Lafourche, Orleans, Pointe Coupee, St. Bernard, St. Charles, St. James, and St. Mary. Specifically, this action amends the applicable gasoline RVP standard from 7.8 psi to 9.0 psi provided at 40 CFR 80.27(a)(2) for the 11 named parishes. This approval is based on the redesignation of the named areas to attainment of the 1-hour ozone NAAQS and their designation as attainment for the 1997 and 2008 ozone NAAQS. Additionally, recent air quality data from monitors in the parishes demonstrates that they are attaining the 2015 ozone NAAQS of 70 ppb. Lastly, emission reductions from national rules aimed at reducing VOCs and NOx that were not previously claimed or accounted for in the State's projection of air quality trends for its maintenance plans will ensure continued attainment of the 2015 ozone NAAQS.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action is considered an Executive Order 13771 deregulatory action. This final rule provides meaningful burden reduction because it relaxes the federal RVP standard for gasoline, and as a result, fuel suppliers will no longer be required to provide 7.8 psi lower RVP gasoline in the 11 parishes during the summer months (June 1st through September 15th). Relaxing the volatility requirements will also be beneficial because this action can improve the fungibility of gasoline sold in the State of Louisiana by allowing the gasoline sold in the 11 named parishes to be identical to the fuel sold in most of the remainder of the State.

This action does not impose an information collection burden under PRA, because it does not contain any information collection activities.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. The small entities subject to the requirements of this action are refiners, importers or blenders of gasoline that choose to produce or import low RVP gasoline for sale in Louisiana and gasoline distributers and retail stations in Louisiana. This action relaxes the federal RVP standard for gasoline sold in 11 Louisiana parishes during the high ozone season. This rule does not impose any requirements or create impacts on small entities beyond those, if any, already required by or resulting from the CAA section 211(h) Volatility Control program. We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.

This final rule does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action implements mandates specifically and explicitly set forth in CAA section 211(h) without the exercise of any policy discretion by the EPA.

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 final rule will affect only those refiners, importers or blenders of gasoline that choose to produce or import low RVP gasoline for sale and gasoline distributers and retail stations in the 11 Louisiana parishes. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental 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. EPA has no reason to believe that this action may disproportionately affect children based on available ozone air quality data and VOC and NOX emissions information. EPA has concluded that a relaxation of the gasoline RVP will not interfere with the attainment of the ozone NAAQS, or any other applicable CAA requirement in these 11 Louisiana parishes.

This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not affect the applicable ozone NAAQS which establish the level of protection provided to human health or the environment. This rule relaxes the applicable volatility standard of gasoline during the high ozone season (June 1 to September 15 of each year). EPA has concluded that the relaxation will not cause a measurable increase in ozone concentrations that would result in a violation of any ozone NAAQS including the 2008 ozone NAAQS or the more stringent 2015 ozone NAAQS. Therefore, disproportionately high and adverse human health or environmental effects on minority or low-income populations are not an anticipated result.

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 of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

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

The statutory authority for this action is granted to EPA by sections 211(h) and 301(a) of the Clean Air Act, as amended; 42 U.S.C. 7545(h) and 7601(a).

For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:

The EPA received adverse comment on the direct final rule “Protection of Stratospheric Ozone: Refrigerant Management Regulations for Small Cans of Motor Vehicle Refrigerant,” published on September 28, 2017 (82 FR 45202). The direct final rule stated that if the Agency received adverse comment by October 30, 2017, the direct final rule would not take effect and EPA would publish a timely withdrawal in the Federal Register. Because we received adverse comment on that direct final rule during that comment period we are withdrawing the direct final rule in this document. We will address relevant comments in any subsequent final action, which would be based on the parallel proposed rule also published on September 28, 2017 (82 FR 45253). The Agency intends to act expeditiously on the parallel proposed rule. As stated in the direct final rule and the parallel proposed rule, there will not be a second comment period on this action.

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0258 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before February 26, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0258, by one of the following methods.

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

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

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

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of September 15, 2017 (82 FR 43352) (FRL-9965-43), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-11045) filed by Spring Trading Company on behalf of Ashland Specialty Ingredients, 203 Dogwood Trail Magnolia, Texas 77354. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic acid, 2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl); 193743-10-1. That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any comments.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and use in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .” and specifies factors EPA is to consider in establishing an exemption.

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

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). 2-Propenoic acid, 2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl) conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.

3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

7. The polymer's number average MW of 20,600 is greater than or equal to 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000.

Thus, 2-propenoic acid, 2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl) meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2-propenoic acid,2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl).

For the purposes of assessing potential exposure under this exemption, EPA considered that 2-propenoic acid, 2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl) could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 2-propenoic acid, 2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl) is 20,600 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, 2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl) conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

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

EPA has not found 2-propenoic acid, 2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl) to share a common mechanism of toxicity with any other substances, and 2-propenoic acid, 2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl) does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 2-propenoic acid,2-methyl-, dodecyl ester, polymer with1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl) does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 2-propenoic acid, 2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl), EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 2-propenoic acid,2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl).

Not Available.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for 2-propenoic acid, 2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl).

Accordingly, EPA finds that exempting residues of 2-propenoic acid, 2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl) from the requirement of a tolerance will be safe.

This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

EPA's authority to promulgate this rule is found in sections 1002, 2002(a), 3001-3004, and 3017 of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act (RCRA), and as amended by the Hazardous and Solid Waste Amendments, 42 U.S.C. 6901 et seq., 6912, 6921-6924, and 6938.

The application of confidentiality determinations to RCRA export, import, and transit documents in this action generally affects three (3) groups: (1) All persons who export or import (or arrange for the export or import of) of hazardous waste for recycling or disposal, including those hazardous wastes subject to the alternate management standards for (a) universal waste for recycling or disposal, (b) spent lead-acid batteries (SLABs) being shipped for reclamation, (c) industrial ethyl alcohol being shipped for reclamation, (d) hazardous waste samples of more than 25 kilograms being shipped for waste characterization or treatability studies, and (e) hazardous recyclable materials being shipped for precious metal recovery; (2) all recycling and disposal facilities who receive imports of such hazardous wastes for recycling or disposal; and (3) all persons who export (or arrange for the export of) conditionally excluded cathode ray tubes (CRTs) being shipped for recycling.

Potentially affected entities may include, but are not limited to:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. If you have questions regarding the applicability of this rule to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

On November 28, 2016, EPA proposed revisions to the current RCRA regulations governing imports and exports of hazardous waste and certain other materials in parts 260, 262, 264, 265, and 267 in order to strengthen public accessibility and transparency of import and export-related documentation to better monitor proper compliance with EPA's hazardous waste regulations and help ensure that hazardous waste shipments are properly received and disposed (81 FR 85459). The internet Posting of and Confidentiality Determinations for Hazardous Waste Export and Import Documents Proposed Rule was a companion action to EPA's Hazardous Waste Export-Import Revisions Final Rule (“Revisions Final Rule”) published on November 28, 2016 (81 FR 85696), which was one of the Agency's priority actions under its plan for periodic retrospective reviews of existing regulations, as required by Executive Order 13563. Under the Revisions Final Rule, export notices for hazardous waste and excluded CRTs exported for recycling are currently required to be submitted electronically to EPA using EPA's Waste Import Export Tracking System (WIETS) as of December 31, 2016. Export annual reports for hazardous waste and excluded CRTs exported for recycling will be required to be submitted electronically to EPA using WIETS on March 1, 2019. Other import and export documents for hazardous waste and excluded CRTs exported for recycling are transitioning from paper submittal to electronic submittal, and will be required to be submitted electronically to EPA using WIETS on a future compliance date to be announced in a future, separate Federal Register notice.

The proposed rulemaking for this final action consisted of two parts. First, EPA proposed requiring exporters and receiving facilities of hazardous waste from foreign sources to post confirmation of receipt and confirmation of recovery or disposal documents on publicly accessible websites when such documents are required for individual export and import shipments of hazardous wastes. EPA proposed that the documents be publicly accessible on company websites by the first of March of each year and that the websites include all of the confirmations of receipt and confirmations of recovery or disposal received by the exporter or sent out by the receiving facility related to exports or imports of hazardous waste made during the previous calendar year. Each document was to be made available for a period of at least three years following the date on which each document was first posted to the website. The proposed internet posting requirement was planned to be effective during the interim period prior to the electronic import-export reporting compliance date when electronic submittal to EPA of confirmations of receipt and confirmations of recovery or disposal for hazardous waste shipments will be required in EPA's WIETS system per the Revisions Final Rule. The second part of the proposed rule consisted of applying confidentiality determinations such that no person could assert CBI claims for individual documents and compiled data for required documents related to the export, import, and transit of hazardous waste and export of conditionally excluded cathode ray tubes (CRTs).

This section provides an overview of this final rule and describes the way in which it differs from the proposal. With this action, EPA finalizes the application of confidentiality determinations such that no CBI claims may be asserted by any person with respect to any of the following documents related to the export, import, and transit of hazardous waste and export of excluded CRTs:

(1) Documents related to the export of Resource Conservation and Recovery Act (RCRA) hazardous waste under 40 CFR part 262, subpart H, including but not limited to the notifications of intent to export, contracts submitted in response to requests for supplemental information from countries of import or transit, RCRA manifests, annual reports, EPA acknowledgements of consent, any subsequent communication withdrawing a prior consent or objection, responses that neither consent nor object, exception reports, transit notifications, and renotifications;

(2) Documents related to the import of hazardous waste, under 40 CFR part 262, subpart H, including but not limited to contracts and notifications of intent to import hazardous waste into the U.S. from foreign countries or U.S. importers;

(3) Documents related to the confirmation of receipt and confirmation of recovery or disposal of hazardous waste exports and imports, under 40 CFR part 262, subpart H;

(4) Documents related to the transit of hazardous waste, under 40 CFR part 262, subpart H, including notifications from U.S. exporters of intent to transit through foreign countries, or notifications from foreign countries of intent to transit through the U.S.;

(5) Documents related to the export of cathode ray tubes (CRTs), under 40 CFR part 261, subpart E, including but not limited to notifications of intent to export CRTs;

(6) Documents related to the export and import of non-crushed spent lead acid batteries (SLABs) with intact casings, under 40 CFR part 266 subpart G, including but not limited to notifications of intent to export SLABs;

(7) Submissions from transporters under 40 CFR part 263, or from treatment, storage or disposal facilities under 40 CFR parts 264 and 265, related to exports or imports of hazardous waste, including but not limited to receiving facility notices of the need to arrange alternate management or return of an import shipment under 40 CFR 264.12(a) and 265.12(a); and

(8) Documents related to the export and import of RCRA universal waste under 40 CFR part 273, subparts B, C, D, and F.

(9) Documents required under 40 CFR 262, subparts E, F, and H and submitted in accordance with consents issued prior to December 31, 2016.

Unless otherwise required by Federal law, EPA is not considering the documents described in items (1) through (9) in this preamble to be final until March 1 of the year after which the shipments occur.

These changes will be reflected in revisions to 40 CFR part 260, as proposed, and in conforming revisions to 40 CFR parts 261 and 262.

EPA is not finalizing the proposed internet posting requirement of confirmation of receipt and confirmation of recovery or disposal documents where they would have been required for individual export and import shipments of hazardous wastes. As required under the recordkeeping requirements for exports and imports of hazardous waste under 40 CFR part 262, subpart H, exporters and receiving facilities of hazardous waste from foreign sources are required to retain paper copies of such confirmations such that copies are available for viewing and production if requested by any EPA or authorized state inspector. Once electronic submittals of the confirmation documents are required after the electronic import-export reporting compliance date that EPA will establish in a separate Federal Register notice, electronically submitted confirmations can be retained in EPA's Waste Import Export Tracking System (WIETS), or its successor system, such that copies are available for viewing and production if requested by any EPA or authorized state inspector.

The Agency received seven unique comments in response to its November 28, 2016 proposed rule. Of the seven comments, two were submitted anonymously, two were submitted from individual companies, one was submitted by a trade association representing hazardous waste treatment, recycling and disposal companies, one was submitted by a coalition representing generators of hazardous waste, and one was submitted by a trade association representing fuel and petrochemical manufacturers.

With respect to the proposed internet posting requirement, two anonymous commenters expressed their support, stating that it would improve transparency and environmental awareness of the potential environmental and health risks associated with exposure to hazardous waste, and potentially lead to reduced generation and improved management of hazardous waste. The remaining five commenters from industry expressed concern with the proposed internet posting requirement. These commenters stated that EPA underestimated the costs associated with posting information on company websites and were apprehensive about the burden of complying with a temporary requirement that would be in place for an unspecified amount of time. Two commenters suggested that the lag in time between when the confirmations of receipt and confirmations of recovery or disposal are required to be sent and when the documents would be posted on company websites would cause confusion and an incorrect perception by the general public of mismanagement. Two commenters also suggested that requiring industry to submit export and import documentation to EPA, rather than post on individual company websites, would provide better consistency to the regulated community and ensure greater compliance with export and import regulations. Finally, one commenter suggested that EPA develop its own website to post the documents to improve public access to the information. (See Section “II.C. Changes to the Proposed Rule” of this preamble for EPA's rationale for not finalizing the proposed internet posting requirement.)

EPA received only one comment on the proposed confidentiality determination. The commenter expressed concerns about the application of a confidentiality determination to aggregate data related to exports and imports of hazardous waste. EPA considers aggregate data to be a list of consolidated information about shipments organized by company. According to the commenter, the application of a confidentiality determination to aggregate data poses different concerns from those raised by application of confidentiality determinations to individual documents. The commenter was specifically concerned about the potential for competitive harm from public release of customer lists and issues related to national security if aggregate data about shipments were available to individuals with the intent to do harm. Because of the substantial effort required to compile a customer list from individual export and import documents, the commenter did not have similar concerns with respect to the release of individual hazardous waste export and import documents. (See response to comments document and Section “II.D. Rationale for Final Rule” of this preamble for details on EPA's response to these comments.)

After considering all the submitted comments, EPA is finalizing, as proposed, the application of confidentiality determinations to documents related to the export, import and transit of hazardous waste and export of excluded CRTs. We provide our rationale in the following section. EPA is not finalizing the proposed internet posting requirement that exporters and receiving facilities of hazardous waste from foreign sources upload confirmations of receipt and confirmations of recovery or disposal on their websites. This internet posting requirement was intended to be in effect on a temporary basis while EPA develops its Waste Import Export Tracking System (WIETS) to be able to receive electronic submittals of the documents. Recognizing that the internet posting requirement would be superseded when exporters and receiving facilities are required to submit confirmations electronically, EPA has decided to avoid the potential confusion as described by some commenters, that may result from requiring internet posting of documents on a temporary basis on company websites and from the time lag between the receipt and posting of confirmations of receipt and confirmations of recovery or disposal.

This final rule applies confidentiality determinations such that EPA will no longer accept future CBI claims for individual documents and/or aggregate data related to the export, import, and transit of hazardous waste and export of excluded CRTs. EPA is making these changes to apply a consistent approach in addressing confidentiality claims for export and import documentation which will result in cost-savings and greater efficiency for EPA and the regulated community. Moreover, as described in the proposed rulemaking, EPA will no longer publish the annual Federal Register notice requesting comment from third party affected businesses (other than original submitters), as defined in 40 CFR 2.201(d), on their need to assert confidentiality claims for documents submitted to EPA related to hazardous waste exports and imports as well as data compiled from such documents, prior to EPA considering such documents releasable upon public request. The Federal Register notice covers documents related to the export, import and transit of RCRA hazardous waste, including those hazardous wastes managed under the special management standards in 40 CFR part 266 (e.g., spent lead acid batteries) and 40 CFR part 273 (e.g., universal waste batteries, universal waste mercury lamps), and related to the export of CRTs under 40 CFR part 261, made during the previous calendar year. The annual Federal Register notices have not addressed CBI claims likely to be made by the original submitters, since RCRA regulations at 40 CFR 260.2(b) already address the CBI requirements for original submitters.

Our rationale for applying confidentiality determinations to these documents is summarized in the following paragraphs.

As discussed in the proposed rulemaking, application of confidentiality determinations is consistent with the non-CBI treatment of hazardous waste manifests at the Federal and state level. Manifests contain similar information as that required by the documents related to the export, import and transit of hazardous waste and export of conditionally excluded CRTs within the scope of this action. On February 7, 2014, EPA published the Hazardous Waste Management System; Modification of the Hazardous Waste Manifest System; Electronic Manifests final rule (79 FR 7518) which made a categorical determination for individual RCRA hazardous waste manifest records and aggregate data. In that action, EPA concluded that information contained in individual manifested records and aggregate data are essentially public information and therefore is not eligible under Federal law for treatment as CBI. The effect of this decision was that EPA made a categorical determination that it will not accept any CBI claims that might be asserted in connection with processing, using, or retaining individual paper or electronic manifests or aggregate data (see 40 CFR 260.2(c)(1)). The decision in that action is consistent with how manifests are treated in many states that have policies that do not recognize CBI claims for manifests as individual documents or as aggregate data. Because the information contained in RCRA hazardous waste manifests is largely similar to the information contained in hazardous waste export and import documents, such as information about the waste being shipped (waste codes, type, quantity) and contact information for the generator, transporter, and destination or receiving facility, EPA concludes that application of confidentiality determinations in this action is consistent with the categorical determination that electronic manifests are not CBI.

Furthermore, EPA believes that any CBI claim that might be asserted with respect to the hazardous waste documents within the scope of this action would be extremely difficult to sustain under the substantive CBI criteria set forth in the Agency's CBI regulations (40 CFR part 2, subpart B). For example, to make a CBI claim, a business must satisfactorily show that it has taken reasonable measures to protect the confidentiality of the information, and that it intends to continue to take such measures. The documents related to the export, import, and transit of hazardous waste and export of excluded CRTs submitted to EPA are also shared with several commercial entities while they are being processed and used. As a result, a business concerned with protecting its commercial information would find it exceedingly difficult to protect its records from disclosure by all the other persons who come into contact with the documents.

Moreover, to substantiate a CBI claim, a business must also show that the information is not, and has not been, reasonably obtainable without the business's consent by other persons (other than governmental bodies) by use of legitimate means (other than discovery based on a showing of special need in a judicial or quasi-judicial proceeding). Since the documents are shared with several commercial entities throughout the chain of custody of a hazardous waste shipment, they are easily accessible to other parties without the business's explicit consent.

For these reasons, EPA believes that any CBI claim that might be asserted with respect to hazardous waste export and import documents would be difficult to sustain under the substantive CBI criteria (40 CFR part 2, subpart B).

EPA has also established precedent in determining that the information contained in certain hazardous waste export documents is not entitled to confidential treatment. To date, our records indicate that EPA has received four assertions of confidentiality for documents within the scope of this action and for which EPA has made a CBI determination: One from Horizon Environment, Inc. in 2004, two from Johnson Controls Battery Group, Inc. in 2010 and 2011, and one from Waste Technologies Industries in 1994. In three of the four cases, the Agency determined that the information claimed as confidential was not entitled to confidential treatment.

In the confidentiality claims presented by Horizon Environment, Inc. and Johnson Controls Battery Group, Inc., both companies asserted confidentiality for certain hazardous waste export documents that were responsive to Freedom of Information Act (FOIA) requests to EPA. The FOIA, 5 U.S.C. 552(a), section 3007(b) of RCRA, and EPA regulations implementing the FOIA and RCRA section 3007(b) generally mandate the disclosure to the public of information and records in the possession of government agencies. However, there are nine categories of information that may be exempt from disclosure, and one such category of information (Exemption 4) is for “trade secrets and commercial information obtained from a person and privileged or confidential” (see 5 U.S.C. 552(b)(4)). Under these statutes and regulations, “business information” means information which pertains to the interests of a business, was acquired or developed by the business, and which is possessed by EPA in a recorded form (see 40 CFR 2.201(c)). Such business information may be claimed by an “affected business” to be entitled to treatment as CBI if the business information is a “trade secret” or other type of proprietary information which produces business or competitive advantages for the business, such that the business has a legally protected right to limit the use of the information or its disclosure to others. See § 2.201(e).

In order for information to meet the requirements of Exemption 4, EPA must find that the information is either (1) a trade secret; or (2) commercial or financial information obtained from a person and privileged or confidential (commonly referred to as “Confidential Business Information” (CBI)). Horizon Environment's claims related to export notices, and Johnson Controls Battery Group's claims related to annual reports. Both companies claimed the information to be confidential, but did not claim that the information was privileged. Information that is required to be submitted to the Government is confidential if its “disclosure would be likely either (1) to impair the Government' s ability to obtain necessary information in the future; or (2) to cause substantial harm to the competitive position of the person from whom the information was obtained.”' Critical Mass, 975 F.2d at 878 (quoting National Parks and Conservation Association v. Morton, 498 F.2d 765, 770 (DC Cir. 1974)) (footnote omitted). In these cases, the Agency had the authority to require the submission of the information and exercised it. Therefore, EPA concluded that the information was a required submission and was not voluntary.

EPA also found that the information the companies claimed as confidential did not meet EPA's CBI criteria. As set forth in EPA's regulations at 40 CFR 2.208, required business information is entitled to confidential treatment if: The business has satisfactorily shown that disclosure of the information is likely to cause substantial harm to the business's competitive position. After careful consideration of the arguments submitted by both companies, EPA concluded that neither claim explained specifically how disclosure of the information in the submissions would likely cause substantial competitive harm to the companies, and therefore did not support the claim of competitive harm. Accordingly, EPA concluded that release of this was not likely to cause substantial harm to the companies' competitive positions.

As a result of these analyses, EPA found that the information the companies claimed as confidential was not within the scope of Exemption 4 of the FOIA.

For the fourth confidentiality claim submitted by Waste Technologies Industries in 1994, EPA determined that the identities and addresses of the foreign generators listed in its import notification letters were entitled to confidential treatment under EPA's criteria (40 CFR 2.208). Since that time, EPA promulgated the Electronic Manifest final rule in which it was determined that manifests and the data contained therein are not CBI (79 FR 7518). Because the contact information of foreign generators is a required data element on manifests, this information is no longer treated as confidential. EPA found the record pertaining to this case after the proposed rule was published.

Based on EPA's analysis and decision in three of the four confidentiality claims asserted by companies for their hazardous waste export notices and annual reports, EPA expects to similarly conclude that these and the other documents within the scope of this rulemaking are not entitled to confidential treatment. As for the fourth decision in the Waste Technologies Industries' claim, EPA's more recent determination that manifests are no longer CBI supersedes the decision to withhold the information as confidential in 1994.

Finally, EPA has never received a claim of confidentiality from a third-party business with respect to hazardous waste export and import documentation. As described previously, EPA issues a Federal Register notice each year requesting comment from affected businesses (other than original submitters), as defined in 40 CFR 2.201(d), on their need to assert confidentiality claims for documents submitted to EPA related to hazardous waste exports and imports as well as data compiled from such documents, prior to EPA considering such documents releasable upon public request. To date, EPA has never received a comment from any business not an original submitter as a result of the annual Federal Register notice.

EPA received one comment in response to our request for input about applying confidentiality determinations to individual documents and aggregate data related to hazardous waste export and import shipments. In its comment, a trade association for the hazardous waste treatment industry expressed concern about the ability of competitors to gain an unfair advantage from access to aggregate export and import data. The commenter also indicated that access to aggregate data could pose national security concerns if sensitive shipment information were available to parties with malicious intent. The commenter stated that aggregate shipment data are a more efficient means to gain access to customer lists and export and import patterns compared to individual documents, which would require significant cost and labor to compile. However, as stated previously, at the Federal level and in many states, CBI claims are not accepted with respect to individual or aggregate manifest data. The main difference between the manifest and the export and import documents is that the manifest provides information on domestic management of hazardous waste shipments, while the export and import documents provide information related to both the domestic and the international part of those shipments. Because the information contained in hazardous waste export and import documents is so similar to that contained in manifests, EPA believes that it is appropriate to treat the domestic and international shipping documents the same.

Nonetheless, while EPA is not accepting CBI claims for either individual documents or aggregate data related to exports and imports, EPA recognizes that the information in its possession may not be ready for general release to the public because it is not yet “final.” As with manifests, hazardous waste exporters, importers, receiving facilities and brokers acting on their behalf need sufficient time to address discrepancies or exceptions related to hazardous waste shipments and to verify and correct data recorded on their documents. Until such time as these corrections can be made and data can be verified and finalized, the data in these documents, just as in manifests, will be considered “in process.” To that end, unless otherwise required by Federal law, EPA is not considering such documents to be final until March 1 of the year after which the shipments occur. EPA believes this timeframe is responsive to the concerns about competitive harm and national security risk with respect to access to aggregate data. EPA believes that this relatively long timeframe also makes it more likely that the shipment will have been received and the waste recovered or disposed by the time the documents are considered final.

Furthermore, in response to the national security concerns raised by commenters on the proposed rule and on the e-manifest user fee proposed rule (81 FR 49072, July 26, 2016), EPA has consulted with the Department of Homeland Security (DHS) to determine whether public access to certain shipment information in the e-Manifest system poses a significant chemical security risk and if so, the action the Agency should take to mitigate that risk. Because the export and import data are similar to the data collected on manifests, EPA will apply mitigating measures to manage export and import data in a manner consistent with those implemented by the e-Manifest system.

The Agency conducted an economic assessment for the proposed rule to this action which evaluated costs, cost savings, benefits, and other impacts, such as environmental justice, children's health, unfunded mandates, regulatory takings, and small entity impacts. The costs incurred by the regulated community under the proposed rule were associated with the proposed internet posting requirement only. Because EPA is not finalizing the proposed internet posting requirement, there are no costs associated with this action and the economic assessment conducted for the proposed rule no longer applies. Rather, the final rule reduces burden and results in cost-savings.

There are a number of qualitative benefits associated with this final rule. By providing a consistent approach to addressing confidentiality claims with respect to the documents within the scope of this rulemaking, this action will result in cost-savings and greater efficiency to both the regulated community and EPA. The Agency will not incur the costs associated with developing and publishing the annual Federal Register notice requesting comment from affected businesses (other than original submitters), as defined in 40 CFR 2.201(d), on their need to assert confidentiality claims for documents submitted to EPA related to hazardous waste exports and imports. Industry cost-savings result from the avoided costs associated with reading and responding to the Federal Register notice. Furthermore, this action will achieve greater transparency by excluding export and import documents from CBI claims.

Under section 3006 of RCRA, EPA may authorize qualified States to administer their own hazardous waste programs in lieu of the Federal program within the State. Following authorization, EPA retains enforcement authority under sections 3008, 3013, and 7003 of RCRA, although authorized States have primary enforcement responsibility. The standards and requirements for State authorization are found at 40 CFR part 271. Prior to enactment of the Hazardous and Solid Waste Amendments of 1984 (HSWA), a State with final RCRA authorization administered its hazardous waste program entirely in lieu of EPA administering the Federal program in that State. The Federal requirements no longer applied in the authorized State, and EPA could not issue permits for any facilities in that State, since only the State was authorized to issue RCRA permits. When new, more stringent Federal requirements were promulgated, the State was obligated to enact equivalent authorities within specified time frames. However, the new Federal requirements did not take effect in an authorized State until the State adopted the Federal requirements as State law.

In contrast, under RCRA section 3006(g) (42 U.S.C. 6926(g)), which was added by HSWA, new requirements and prohibitions imposed under HSWA authority take effect in authorized States at the same time that they take effect in unauthorized States. EPA is directed by the statute to implement these requirements and prohibitions in authorized States, including the issuance of permits, until the State is granted authorization to do so. While States must still adopt HSWA related provisions as State law to retain final authorization, EPA implements the HSWA provisions in authorized States until the States do so.

Authorized States are required to modify their programs only when EPA enacts Federal requirements that are more stringent or broader in scope than existing Federal requirements. RCRA section 3009 allows the States to impose standards more stringent than those in the Federal program (see also 40 CFR 271.1). Therefore, authorized States may, but are not required to, adopt Federal regulations, both HSWA and non-HSWA, that are considered less stringent than previous Federal regulations.

Because of the Federal government's special role in matters of foreign policy, EPA does not authorize States to administer Federal import/export functions in any section of the RCRA hazardous waste regulations. This approach of having Federal, rather than State, administering of the import/export functions promotes national coordination, uniformity and the expeditious transmission of information between the United States and foreign countries.

Although States do not receive authorization to administer the Federal government's import/export functions in 40 CFR part 262, subpart H, or the import/export relation functions in any other section of the RCRA hazardous waste regulations, State programs are still required to adopt the provisions in this rule to maintain their equivalency with the Federal program (see 40 CFR 271.10(e)).

This final rule contains amendments to 40 CFR 260.2 such that no claim of business confidentiality may be asserted by any person with respect to information from cathode ray tube export documents prepared, used and submitted under §§ 261.39(a)(5) and 261.41(a) and hazardous waste export, import, and transit documents prepared, used and submitted under §§ 262.82, 262.83, 262.84, 263.20, 264.12, 264.71, 265.12, 265.71, and 267.71.

The States that have previously adopted 40 CFR part 262, subparts E, F and H, 40 CFR part 263, 40 CFR part 264, 40 CFR part 265, and any other import/export related regulations, and that will be adopting the revisions in the Hazardous Waste Export-Import Revisions Final Rule (81 FR 85696) must adopt the revisions to those provisions in this final rule. But only States that have previously adopted the optional CRT conditional exclusion in 40 CFR 261.39 are required to adopt the revisions related to that exclusion in this final rule.

When a State adopts the import/export provisions in this rule, they must not replace Federal or international references or terms with State references or terms.

The provisions of this rule will take effect in all States on the effective date of the rule, since these export and import requirements will be administered by the Federal government as a foreign policy matter, and will not be administered by States.

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

This final rule is a non-significant regulatory action because it does not have a significant economic impact nor does it raise novel legal or policy issues. The Office of Management and Budget (OMB) waived review.

This action is considered an Executive Order 13771 deregulatory action. This final rule provides burden reduction by providing a consistent approach to addressing confidentiality claims with respect to the documents within the scope of this rulemaking. As a result, this action will result in cost-savings and greater efficiency for industry and EPA. EPA will no longer expend resources to publish an annual Federal Register notice related to confidential business information and industry will avoid the costs and burden associated with reading and responding to the annual Federal Register notice.

This action does not impose an information collection burden under the PRA because it does not contain any information collection activities.

EPA certifies that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. The small entities subject to the requirements of this action are hazardous waste exporters, importers, receiving facilities and brokers acting on their behalf. There are no costs associated with this action; rather, the final rule results in cost-savings. We have therefore concluded that this action will relieve regulatory burden for all directly regulated small entities.

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. Thus, it is not subject to Sections 202, 203, and 205 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This action does not have federalism implications because the state and local governments do not administer the export and import requirements under RCRA. 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. No exporters, importers or transporters affected by this action are known to be owned by Tribal governments or located within or adjacent to Tribal lands. Thus, Executive Order 13175 does not apply to this action.

This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.

This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994), because this action only applies a confidentiality determination such that no person can assert confidential business information (CBI) claims for documents related to the export, import, and transit of hazardous waste and export of excluded cathode ray tubes (CRTs).

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).

For the reasons stated in the preamble, EPA amends 40 CFR parts 260, 261, and 262 as follows:

Table of Contents I. Introduction II. NPL Deletion Criteria III. Deletion Procedures IV. Basis for Site Deletion V. Deletion Action I. Introduction

EPA Region III is publishing this direct final Notice of Deletion of the C&D Recycling Superfund Site, from the National Priorities List (NPL). The NPL constitutes Appendix B of 40 CFR part 300, which is the Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980, as amended. EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). As described in § 300.425(e)(3) of the NCP, sites deleted from the NPL remain 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 Site and demonstrates how it meets the deletion criteria. Section V discusses EPA's action to delete the Site from the NPL unless adverse comments are received during the public comment period.

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

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

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

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

EPA may initiate further action to ensure continued protectiveness at a deleted site if new information becomes available that indicates it is appropriate. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.

The following procedures apply to deletion of the Site:

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

(2) EPA has provided the Commonwealth 30 working days for review of this direct final Notice of Deletion and the parallel Notice of Intent to Delete prior to their publication today, and the Commonwealth, through PADEP, has concurred on the deletion of the Site from the NPL.

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

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

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

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

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

The C&D Recycling Superfund Site (the Site) (CERCLIS ID PAD021449244) encompasses approximately 110 acres and is located in a rural area along Brickyard Road in Foster Township, Luzerne County, Pennsylvania. From 1963 to 1978, Lurgan Corporation operated a metal reclamation facility at the Site. In 1979, the business was conveyed to C&D Recycling, Inc. Both Lurgan Corporation and C&D Recycling, Inc.'s operations involved the reclamation of metals (i.e., copper and/or lead) from cable and/or scrap metal transported to the Site. Available documentation suggests that lead was recovered from cable and wire until the mid-1970's, after which limited burning of lead cable at the Site occurred. Typical Site operations involved mechanical removal of the outer plastic casing and burning of the inner lining, sheathing or insulation to expose the copper cable in one of five furnaces located at the Site. The copper was returned to the generator and the plastic casing was stockpiled at the Site. Site operations ceased in 1984. Currently, portions of the Site are being used as a wildlife refuge, while other portions are either undeveloped, or contain private residences.

EPA and PADEP collected analytical data in 1984 and 1985 to evaluate the relative hazards posed by the Site in the Hazard Ranking System (HRS). An HRS score of 43.92 was calculated for the Site in April 1985, based primarily upon the elevated levels of contamination in Site soils, and sediment suspended within the shallow dairy farm well existing at the Site. In September 1985, EPA proposed the Site for inclusion on the NPL (50 FR 37630). The Site was placed on the NPL on February 21, 1990 (55 FR 6154). In April 1986, PADEP requested that EPA take the lead on the Site response action.

EPA entered into an Administrative Order on Consent, Docket Number III-87-30-DC, on September 1, 1987, which was subsequently amended in June 1988, Docket Number III-87-31-DC, (collectively Consent Order) with AT&T Nassau Metals Corporation (Nassau) under which Nassau was required to: (1) Implement erosion controls and security measures to stabilize the Site; and (2) investigate the nature and extent of contamination and risks and develop alternatives to address the contamination at the Site. Nassau was the only potentially responsible party (PRP) to cooperate with EPA with respect to Site response actions. At the time of the Consent Order, Nassau was a wholly owned subsidiary of Lucent Technologies, Inc. (Lucent). Lucent subsequently merged with Alcatel SA of France on December 1, 2006 to form Alcatel-Lucent SA. For clarity, Nassau and Lucent will hereinafter collectively be referred to as the PRP.

The PRP conducted the following removal action activities under the Consent Order:

• Consolidation and covering of ash piles at the Site;

• Construction of sedimentation and erosion controls to minimize migration of contaminated soil from the Site in surface water runoff;

• Installation of fencing and seeding to prevent exposure to contaminated soil areas; and

• Removal of piles of cable casings and transport off-site for recycling.

The RI/FS was initiated at the Site in September 1987. The final RI/FS Report was completed in January 1992 and approved by EPA in March 1992. The area of contamination identified in the RI/FS Report included the following:

• Approximately 26,273 cubic yards (yds 3) of soil contaminated with lead, copper, antimony and/or other contaminants;

• Several small piles of ash (approximately 165 yds 3) resulting from the burning of material at the Site contaminated with lead, copper, and low levels of dioxins and furans;

• Approximately 1,200 linear feet of Mill Hopper Creek (the Creek) containing sediment contaminated with lead, copper, and zinc;

• A 0.5-acre pond (Mill Hopper Pond or the Pond) with contaminated sediment (approximately 1,900 yds 3);

• Abarn and milkhouse used when the property at the Site was a dairy farm;

• A main facility building including four furnaces used to burn cable;

• An underground storm water sewer system, which contained approximately 24 yds 3 of contaminated sediment; and

• A small isolated furnace once used to burn cable.

EPA issued the Record of Decision (ROD) for the Site on September 30, 1992. The Remedial Action Objectives (RAOs) specified in the ROD consisted of:

1. Protection of human health and the environment;

2. Source control and prevention of migration of contamination from the Site via wind and surface water transport;

3. Source control of contaminants in soil such that leaching of contamination to groundwater will not occur in the future;

4. Source control of soil, sediment, and ash with lead concentrations greater than 500 parts per million (ppm);

5. Decontamination of Site buildings; and

6. Prevention to exposure to contaminants.

The remedy selected in the ROD (Selected Remedy) addressed contaminated soil, ash, sediment, buildings, and structures and consisted of the following components:

1. Confirmation, e.g., via sampling, of the areal limits of soil and sediment with lead contamination above 500 ppm (including soil beneath buildings and concrete slabs constructed after 1963 as well as pavement and sediment in Mill Hopper Creek and wetlands);

2. Performance of a Phase 1B archeological survey in areas possessing high or moderate archeological sensitivity potentially impacted by the Remedial Action;

3. Removal and off-Site disposal and/or recycling of casing and wire;

4. Excavation of all soil with lead contamination above 500 ppm resulting from Site operations (excluding soil beneath buildings and concrete slabs constructed after 1963, or pavement which shall otherwise be maintained to prevent migration of contamination from the Site);

5. Excavation of sediment from the banks of Mill Hopper Pond with lead levels greater than 500 ppm and excavation of the top two feet of sediment (or an amount sufficient to secure a new substrate) from the pond bottom to ensure that pond water quality is not impacted;

6. Removal of sediment within Mill Hopper Creek contaminated with lead above 500 ppm;

7. Removal and sampling of all sediment located within the storm water sewer system located at the Site and evaluation of the system's integrity (including drainage ditches) to determine the potential for releases of hazardous substances from the Site into the soil and ground water and any necessary response actions;

8. Excavation of all ash located at the Site;

9. Post excavation/removal sampling to confirm that ash, soil and sediment cleanup levels are met;

10. On-Site stabilization of the contaminated soil and sediment, excavated and removed as described above, to remove any characteristic of hazardous waste;

11. On-Site stabilization of the contaminated ash, excavated as described above, to remove any characteristic of hazardous waste;

12. Off-Site disposal of stabilized soil, sediment, and ash into a non-hazardous (RCRA Subtitle D) waste disposal facility;

13. Decontamination of Site buildings with lead levels in walls and floors above 500 ppm, including dismantling of non-structural components and removal of equipment and debris which may inhibit decontamination to required levels, or demolition of buildings that cannot be cleaned to 500 ppm lead;

14. Dismantling of the old furnace and other structures, as necessary, which inhibit soil or sediment remediation and which shall not be maintained, as necessary, to prevent migration of contaminants from the Site;

15. Off-Site disposal of material generated from dismantling of Site buildings into a non-hazardous (Subtitle D) waste disposal facility or decontamination and recycling of dismantled material;

16. Performance of biota toxicity tests on remaining soil and sediment to ensure that remediated soil (i.e., soil with lead levels no higher than 500 ppm) does not pose a threat to the environment (procedures to be determined during Remedial Design);

17. Site grading, revegetation, and related work, to ensure that Site topography and drainage ways adequately convey water from the Site, and that soil excavation does not result in low lying areas;

18. Air monitoring during on-Site activities, and implementation of dust control or other necessary abatement actions to prevent migration of contaminants to the surrounding community during the Remedial Action;

19. Abandoning wells which serve no useful long-term purpose;

20. Periodic monitoring of ground water and surface water; and

21. If the soil beneath pavement, or soil beneath buildings and concrete slabs constructed after 1963, contains concentrations of lead greater than 500 ppm and these structures are not demolished, then institutional controls, (e.g., deed restrictions) will be implemented to prevent residential use potentially affecting the protectiveness of the Selected Remedy, and to ensure that Site contaminants which may remain beneath buildings and pavement are properly identified.

Consistent with the Site RAOs, the Selected Remedy included decontamination and/or demolition of contaminated buildings and structures; stabilization of contaminated soil, ash, and sediment with lead levels greater than 500 ppm, as needed; and disposal of the stabilized and/or decontaminated material into an off-Site landfill. As stated in the ROD, EPA determined that the selected soil cleanup level of 500 ppm lead (i.e., no confirmatory sample collected shall exceed 500 ppm) is protective of human health and would not impact the environment. The cleanup level of 500 ppm ensures that the average soil lead level remaining on any two-acre plot is less than approximately 235 ppm, including theoretical residential plots located on the Site. Thus, EPA determined that residual soil lead levels remaining at the Site are protective.

All Remedial Design (RD), Remedial Action (RA) and Operation and Maintenance (O&M) activities for the Site were conducted in accordance with a Unilateral Administrative Order (UAO) which was issued to the PRP on August 9, 1994 (EPA Docket No. III-94-18-DC). The UAO was subsequently converted to a Consent Decree that was signed and lodged with the District Court for the Western District of Pennsylvania on July 22, 1998 (Consent Decree) (Civil Action No. 3:96-CV-562).

The RD was performed from October 1996 through February 1997 and approved by EPA on May 8, 1998. During the RD phase, Site preparation work involved the removal of various types of debris and cable casings from the Site, as well as demolition and off-Site disposal of the old furnace.

Construction of the RA was conducted between February 1998 and August 1999. EPA approved the September 27, 2000 Remedial Action Completion Report (RACR) documenting completion of the RA. Biotoxicity sampling of the Pond and Creek and well abandonment, as selected in the ROD, were completed in 2003 and 2002, respectively. In June 2016, EPA approved the Work Completion Certification and Report (WCCR) documenting completion of these remaining components of the Selected Remedy.

The 2000 RACR documented that the RA had attained the following Performance Standards as specified in the ROD:

1. The Phase IB Archeological Survey shall comply with Guidelines on Archaeology and Historic Preservation, 48 FR.44716-42 (September 29, 1983), 36 CFR parts 65 and 800.

2. Site activity shall not cause exceedance of Pennsylvania Water Quality Standards in Mill Hopper Creek, 25 PA Code §§ 93.3 through 93.8, or exceedance of background water quality in Mill Hopper Creek should background quality exceed Pennsylvania Water Quality Standards, 25 PA Code § 93.5 and water quality criteria for toxic substances of 25 PA Code Chapter 16. However, compliance with Chapter 16 regulations will consider the ambient background water quality of Mill Hopper Creek and Mill Hopper Pond.

3. The stabilization process and/or earth moving shall not generate dust exceeding National Ambient Air Quality Standards within 100 feet of the Area of Contamination [Clean Air Act section 109, National Primary and Secondary Ambient Air Quality Standards for lead, 40 CFR 50.12, and particulate matter, 40 CFR 50.6 and 40 CFR part 52, subpart NN] [Pennsylvania's Air Pollution Control Act, 25 PA Code §§ 123.1 et. seq, and 131.1 et. seq.]. Dust suppression methods, e.g., wind screens, water spray, or chemical agents, shall be utilized to minimize dust. Air monitoring shall be performed in accordance with 40 CFR part 50, Appendix G [25 PA Code §§ 123.1 et. seq. and 131.1 et. seq.].

4. Excavation and consolidation of the soil, sediment and ash shall comply with the Pennsylvania Erosion Control Regulations, 25 PA Code §§ 102.1 et. seq., Pennsylvania's Air Pollution Control Act, 25 PA Code §§ 123.1 et. seq. and 131.1 et. seq.

5. Diversion of Mill Hopper Creek during implementation of Selected Remedy shall comply with Pennsylvania Dam Safety and Waterway Management Regulations, 25 PA Code § 105.1 et. Seq.

6. Disposal of hazardous waste debris generated from the decontamination, dismantling and/or demolition of Site buildings, the old furnace and any other structures, shall comply with the Land Disposal Restriction requirements of 40 CFR part 268.

7. The stabilized soil, sediment, and ash shall be analyzed using the Toxic Characteristic Leaching Procedure. No sample of leachate from tested stabilized material shall exceed the levels specified in Table 20, below.

8. Cleanup levels for contaminants of concern in soil and sediment (Table 20) shall not be exceeded in any soil or sediment sample, excluding areas not impacted by the Site, remaining after Site remediation.

Post-RA sampling data demonstrated that the Selected Remedy achieved the RAOs selected in the ROD. Protection of human health and the environment (RAO #1) and prevention to exposure to contaminants (RAO #6) were achieved by ensuring that all performance standards selected in the ROD were met, as explained in Section 5.0 of the RACR. Source control RAOs (RAO #2, #3, and #4) were achieved by stabilizing contaminated soil, ash, and sediment with lead levels greater than 500 ppm, as needed; and by disposing the stabilized material into an off-Site landfill, as explained in Sections 3.4 and 3.5 of the RACR. Decontamination of on-Site buildings (RAO #5) was achieved by ensuring that all on-Site building surfaces were free from Site contaminants, as explained in Section 3.3 of RACR.

During the RA, Site soils and sediments with identified lead concentrations of greater than the Site clean-up level of 500 ppm were excavated, stabilized as appropriate, and transported off-site for disposal at an approved facility. Soil was excavated to depths of up to four feet resulting in the removal of approximately 43,800 cubic yards of material. A total of 267 post-excavation soil samples were collected, and confirmed that all identified contamination was removed from the Site, and that the cleanup level for lead of 500 ppm selected in the ROD was achieved.

As part of the RI/FS at the Site, a monitoring well network consisting of 17 wells was completed. The wells were sampled multiple times during the course of the RI/FS. In the ROD, EPA determined that the data obtained during performance of the RI/FS demonstrated that groundwater had not been impacted by Site activities. The ROD required additional monitoring of Site groundwater for lead to evaluate any possible impacts caused by the RA. One pre-construction and two post-construction groundwater sampling events were conducted. Four on-site shallow wells were sampled for lead to monitor groundwater quality. The groundwater sampling results confirmed that Site construction activities during the RA did not impact the groundwater underlying the Site. Since all of the groundwater monitoring activities selected in the ROD were completed, the remaining monitoring wells located on-Site were subsequently abandoned on August 26 through August 29, 2002.

The ROD also selected the “performance of biota toxicity tests on remaining soil/sediment to ensure that remediated soil (i.e., soil with lead levels no higher than 500 ppm) does not pose a threat to the environment”. The biotoxicity testing procedures employed at the Site in order to meet the above-described ROD requirement were established in the Biotoxicity Testing Plan (BTP).

The baseline biotoxicity sampling/evaluation was conducted in May 1998 prior to the start of the RA. This testing was conducted for the purpose of establishing the baseline biotoxicity of Site sediments that were known to contain lead concentrations that exceeded the Site cleanup goal of 500 ppm. The evaluation was conducted on samples collected at the Site and at a nearby off-site reference location (a pond approximately eight miles from the Site).

The biotoxic effect threshold of Site sediments was established to be 842 ppm lead based on the results of the baseline biotoxicity evaluation. Three additional biotoxicity sampling events were conducted after the August 13, 1999 RA completion date in accordance with the BTP. The Year 1 event occurred on August 30, 2000, the Year 2 event occurred on September 20, 2002 and the Year 3 event occurred on October 29, 2003.

During these three post-RA sampling events, three out of a total of 52 sediment sample results from the Pond and Creek were found to contain lead in excess of the 500 ppm Site cleanup level. In each instance, when an elevated sample result for lead was identified, the PRP performed additional sediment sampling to delineate the extent of lead sediment concentrations in excess of 500 ppm and then implemented a focused excavation program to remove these sediments from the Site. A total of eight sampling rounds associated with the three biotoxicity sampling events were conducted after completion of the RA.

All lead analytical results of sediments remaining in place after the focused removal of sediments from the Pond and Creek were less than the Site lead cleanup goal of 500 ppm. Therefore, subsequent bioassay testing of the Year 1, 2 and 3 samples was not performed.

Finally, sampling conducted by the PRP in 1989 as part of the RI/FS showed the isolated presence of low levels of dioxin in the ash piles stored on-Site. Specifically, two dioxin samples were collected at the Site in 1989 from two separate ash piles (designated ASH-B and ASH-F) which were subsequently excavated. The piles were analyzed for 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD), 2,3,7,8,-tetrachlorodibenzofuran (TCDF) and specific 2,3,7,8-dioxin congeners. Both of the samples contained low levels of chlorinated dioxins/furans. After issuance of the 2012 preliminary remediation goals for dioxin in soil, by letter dated July 24, 2014, EPA required the PRP to collect additional soil samples at the Site to confirm that the Selected Remedy was protective of human health and the environment. By letter dated October 13, 2015, EPA informed the PRP that the sampling results indicated that dioxin did not exceed residential or commercial screening levels in any of the samples collected from native soil at the Site.

EPA subsequently issued a Final Close Out Report (FCOR) for the Site dated October 4, 2016. The FCOR summarized all of the remedial activities conducted at the Site, and concluded that EPA has successfully completed all response actions for the Site in accordance with Close Out Procedures for National Priorities List Sites (OSWER Directive 9320.2-09A-P).

An O&M Plan dated April 29, 1998 was approved by EPA as part of the RD. The O&M Plan identifies the O&M activities that would be performed at the Site after the RA was completed. The O&M activities were intended to address: (1) Erosion and sedimentation control measures until sufficient vegetative cover had re-established itself; (2) post-remedy ground water sampling; and (3) the sampling/inspection requirements specified in the BTP.

RA activities were completed on August 13, 1999. Lucent conducted inspections of the Site for the first year after completion of the Site remediation activities. These inspections were conducted on a monthly basis and after known significant storm events (e.g., rain events over one inch), as outlined in the O&M Plan. Inspections were not performed during winter months when the ground was frozen or snow covered. After the first year of monthly inspections, quarterly inspections of the Site were conducted for the following four years as required by the O&M Plan. During each Site inspection, the vegetative cover, drainage channels and swales, and remediated Creek downstream of the Pond were inspected to verify that they were in good condition and functioning properly.

In accordance with the O&M Plan, the revegetated Site was to be left in its natural state and not mowed and no future O&M is required.

The ROD selected ICs if soils containing concentrations of lead over 500 ppm remain beneath the pavement, or buildings and concrete slabs constructed on-Site after 1963. Since all Site soils with lead concentrations in excess of 500 ppm were removed from the Site during implementation of the Selected Remedy, no ICs are required at the Site. However, as an added precaution, in March 1999, the then-current owner of the original 46-acre C&D property which contains the main C&D Recycling building and several abandoned farm structures, known as Tax Parcel 11, filed a deed restriction in the land records for that parcel. This deed restriction limits access to the Site, and prevents the Tax Parcel 11 from being used for residential, commercial, agricultural and/or recreational purposes.

In May 2002, Tax Parcel 11 was purchased at a tax sale, and title to the property was redeeded under a corporation named “Green Meadows Conservancy, Inc.” on July 10, 2006. Tax Parcel 11 property is now classified as a wildlife preserve and there are no plans for its redevelopment.

Based on the above information, EPA has determined that there are no hazardous substances present on-Site above levels allowing for unlimited use and unrestricted exposure now that the Selected Remedy is complete. The Site is, therefore, protective of human health and the environment. No Five-Year Reviews have been performed and they are not required pursuant to CERCLA section 121(c).

EPA community relations staff conducted an active campaign to ensure that the residents were well informed about activities at the Site. Community relations activities included the following:

• Public Meetings: May 1997.

• Township Supervisor Meetings: April 1997 and May 1998.

• Fact Sheets: April 1998, December 1998, and June 1999.

Additionally, during the RA, EPA's Remedial Project Manager (RPM) met with Foster Township representatives on a weekly basis to provide an update on the work accomplished and the upcoming scheduled work.

In accordance with the requirements of 40 CFR 300.425(e)(4), EPA's community involvement activities associated with this deletion will consist of placing the deletion docket in the local Site information repository and placing a public notice (of EPA's intent to delete the Site from the NPL) in the Standard Speaker, a local newspaper of general circulation.

Construction of the Selected Remedy at the Site has been completed and O&M was completed in accordance with the EPA-approved O&M Plan. All RAOs, Performance Standards, and cleanup goals established in the ROD have been achieved and the Selected Remedy is protective of human health and the environment. No further Superfund response is necessary to protect human health and the environment.

The Site Deletion procedures specified in 40 CFR 300.425(e) have been followed for the deletion of the Site.

EPA, with concurrence of the Commonwealth through PADEP, has determined that all appropriate response actions under CERCLA, have been completed. Therefore, EPA is deleting the Site from the NPL.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication. This action will be effective February 26, 2018 unless EPA receives adverse comments by January 25, 2018. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final notice of deletion before the effective date of the deletion, and it will not take effect. EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to delete and the comments already received. There will be no additional opportunity to comment.

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

You may be potentially affected by this action if you own or operate facilities that have 10 or more full-time employees or the equivalent of 20,000 employee hours per year that manufacture, process, or otherwise use toxic chemicals listed on the TRI, and that are required under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) or section 6607 of the Pollution Prevention Act (PPA) to report annually to EPA and States or Tribes their environmental releases or other waste management quantities of covered chemicals. (A rule was published on April 19, 2012 (77 FR 23409), requiring facilities located in Indian country to report to the appropriate tribal government official and EPA instead of to the state and EPA).

The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Facilities included in the following 2012 NAICS manufacturing codes (corresponding to Standard Industrial Classification (SIC) codes 20 through 39): 311*, 312*, 313*, 314*, 315*, 316, 321, 322, 323*, 324, 325*, 326*, 327, 331, 332, 333, 334*, 335*, 336, 337*, 339*, 111998*, 211112*, 212324*, 212325*, 212393*, 212399*, 488390*, 511110, 511120, 511130, 511140*, 511191, 511199, 512220, 512230*, 519130*, 541712*, or 811490*. (*Exceptions and/or limitations exist for these NAICS codes.)

• Facilities included in the following 2012 NAICS codes (corresponding to SIC codes other than SIC codes 20 through 39): 212111, 212112, 212113 (corresponds to SIC code 12, Coal Mining (except 1241)); or 212221, 212222, 212231, 212234, 212299 (corresponds to SIC code 10, Metal Mining (except 1011, 1081, and 1094)); or 221111, 221112, 221113, 221118, 221121, 221122, 221330 (limited to facilities that combust coal and/or oil for the purpose of generating power for distribution in commerce) (corresponds to SIC codes 4911, 4931, and 4939, Electric Utilities); or 424690, 425110, 425120 (limited to facilities previously classified in SIC code 5169, Chemicals and Allied Products, Not Elsewhere Classified); or 424710 (corresponds to SIC code 5171, Petroleum Bulk Terminals and Plants); or 562112 (limited to facilities primarily engaged in solvent recovery services on a contract or fee basis (previously classified under SIC code 7389, Business Services, NEC)); or 562211, 562212, 562213, 562219, 562920 (limited to facilities regulated under the Resource Conservation and Recovery Act, subtitle C, 42 U.S.C. 6921 et seq.) (corresponds to SIC code 4953, Refuse Systems).

• Federal facilities. Under Executive Order 13693 (80 FR 15871, March 25, 2015), all federal facilities are required to comply with the provisions set forth in section 313 of EPCRA and section 6607 of the PPA. On June 10, 2015, the White House Council on Environmental Quality (CEQ) issued Instructions for Implementing Executive Order 13693, requiring federal agencies and contractors to comply with these laws regardless of NAICS code delineations (see 80 FR 34149, June 15, 2015).

If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed in the FOR FURTHER INFORMATION CONTACT section.

EPA is taking final action under sections 313(g)(1) and 328 of EPCRA, 42 U.S.C. 11023(g)(1) and 11048. In general, section 313 of EPCRA requires owners and operators of covered facilities in specified SIC codes that manufacture, process, or otherwise use listed toxic chemicals in amounts above specified threshold levels to report certain facility specific information about such chemicals, including the annual releases and other waste management quantities. Section 313(g)(1) of EPCRA requires EPA to publish a uniform toxic chemical release form for these reporting purposes, and it also prescribes, in general terms, the types of information that must be submitted on the form. Congress also granted EPA broad rulemaking authority to allow the Agency to fully implement the statute. EPCRA section 328 states that: “The Administrator may prescribe such regulations as may be necessary to carry out this chapter.” 42 U.S.C. 11048.

In response to OMB's revisions to the NAICS codes effective January 1, 2017, EPA is amending 40 CFR part 372 to include the relevant 2017 NAICS codes for TRI reporting. EPA is also modifying the list of exceptions and limitations previously included in the CFR for the applicable NAICS codes for TRI reporting purposes.

Under this action, TRI reporting requirements remain unchanged. However, due to the 2017 NAICS modifications, some facilities will need to modify their reported NAICS codes as outlined in the table in Unit II.B., which identifies only the revised TRI NAICS reporting codes and is not an exhaustive list of all NAICS reporting codes subject to EPCRA section 313 and PPA section 6607. A complete listing of all TRI covered facilities can be found in the regulations at 40 CFR 372.23.

The Agency received a comment on the proposed rule, which is addressed more fully in Unit II.C., stating that the listing of updated NAICS codes in the CFR text was incomplete, in that it did not include the update to the code for natural gas extraction facilities. The Agency agrees with that comment and is including the update for that NAICS code in the table in Unit II.B. and in the final CFR text.

Crosswalk tables between all 2012 NAICS codes and 2017 NAICS codes can be found on the internet at http://www.census.gov/epcd/www/naics.html.

EPA is also modifying the list of exceptions and limitations previously included in the CFR for the applicable NAICS codes for TRI reporting purposes. Because NAICS codes may cross-reference some SIC codes in both TRI-covered and non-covered TRI sectors, EPA has historically included descriptive text in 40 CFR part 372 to help indicate exceptions and limitations to TRI coverage for a specific NAICS code in order to better correspond with the previous SIC code descriptors. However, OMB updates NAICS codes every five years, and these updates may require a corresponding change by EPA to the regulatory text describing any exceptions or limitations to the scope of a particular NAICS code. Consequently, this descriptive text does not always align fully with SIC codes' full descriptions.

For example, historically, 40 CFR part 372 would list NAICS code 323211 with the following exception: “Exception is limited to facilities primarily engaged in reproducing text, drawings, plans, maps, or other copy, by blueprinting, photocopying, mimeographing, or other methods of duplication other than printing or microfilming (i.e., instant printing) (previously classified under SIC 7334, Photocopying and Duplicating Services, (instant printing))”. This action simplifies the listing to display only the SIC code and title rather than include the description: “Exception is limited to facilities previously classified under SIC 7334, Photocopying and Duplicating Services”. The Agency received no comments, adverse or otherwise, on this type of modification, and so is finalizing this language in the CFR.

Moving forward, in 40 CFR part 372, EPA will not include descriptive text for SIC codes when listing the limitations and exceptions applicable to TRI-covered NAICS codes. Instead, the Agency will simply list the SIC codes, including their titles, as applicable limitations and exceptions. Because exceptions and limitations are included in 40 CFR part 372.23(b) and (c) to align the listing of NAICS codes with the list of SIC codes covered by TRI reporting requirements as shown in 40 CFR part 372.23(a), the SIC codes rather than the descriptive text defines the types of facilities covered by TRI. By removing the descriptive text from the exceptions and limitations listed in these two paragraphs, this action mitigates potential confusion caused by qualitative descriptions of SIC codes and does not alter the universe of the facilities affected by TRI reporting requirements. Facilities with questions regarding the SIC code descriptions should refer to the SIC manual, available at: https://www.osha.gov/pls/imis/sicsearch.html.

EPA previously received relevant adverse public comment on the direct final rule. While the commenter largely supported the update to OMB's 2017 NAICS codes, it noted that the 2012 NAICS code 211112 (Natural Gas Liquid Extraction) was not included in the direct final rule's revised codes, although OMB had updated NAICS code 211112 to NAICS code 211130 (Natural Gas Extraction) in 2017. EPA agrees with this comment. The 2012 NAICS code 211112, which was updated to 211130 in the 2017 NAICS codes revision, was intended to be captured in the direct final rule. The direct final inadvertently omitted this update. Thus, EPA withdrew the direct final and is proceeding to amend the NAICS code list with this final rule.

EPA analyzed the potential costs and benefits associated with this action, and determined that since this action will not add or remove any reporting requirements, there is no net increase in respondent burden or other economic impacts.

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action is not expected to be 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. Facilities that are affected by the rule are already required to report their industrial classification codes on the approved reporting forms under section 313 of EPCRA and 6607 of the PPA. In addition, OMB has previously approved the information collection requirements contained in 40 CFR part 372 under the provisions of the PRA, 44 U.S.C. 3501 et seq., and has assigned OMB control number 2025-0009 (EPA ICR No. 1363-21) for Form R and Form A. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This final rule adds no new reporting requirements, and there would be no net increase in respondent burden. This rule would only update the NAICS codes already reported by respondents. This final rule will not impose any requirements on small entities.

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. The action would impose no enforceable duty on any state, local or tribal governments or the private sector.

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. The action would impose no enforceable duty on any state, local or tribal governments or the private sector.

This action does not have tribal implications as specified in Executive Order 13175. This final rule will not impose substantial direct compliance costs on Indian tribal governments. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental 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 13211, because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. This regulatory action is a procedural change and does not have any impact on human health or the environment.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://regulations.gov. Follow the search instructions on that website to view public comments.

Stakeholders representing Medicare Shared Savings Program (Shared Savings Program) Accountable Care Organizations (ACOs) located in the geographic areas impacted by Hurricanes Harvey, Irma, and Maria and the California wildfires have reported significant impacts on healthcare provider operations and on area infrastructure. (For more detailed information, see the interim final rule with comment period titled Medicare Program; Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year that appeared in the Federal Register on November 16, 2017 (hereinafter referred to as the Quality Payment Program IFC) (82 FR 53568 and 53895). For example, Hurricane Maria devastated Puerto Rico on September 20, 2017. Stakeholders located in Puerto Rico report that while federal and local agencies have been working around the clock to restore infrastructure in Puerto Rico, local communication systems are still not fully functioning, some residents do not have water services, and many residents do not have access to electric power. Under such circumstances, healthcare providers report that their main focus is to manage chronically ill patients; provide essential services such as dialysis, chemotherapy, and blood transfusions; deal with trauma; and dispense maintenance medications, including insulin. Many healthcare providers in Puerto Rico have been unable to reopen their offices not only because they lack power and water, but also because access to fuel for operating alternate power generators has been limited.

In addition, other stakeholders report that the loss of infrastructure has significantly affected the utilization and cost of services furnished to the Medicare beneficiaries they serve. For example, stakeholders representing ACOs in Florida indicate there has been a significant increase in emergency department services, hospitalizations, and skilled nursing facility (SNF) admissions because of Hurricane Irma. They believe that the increased numbers of medical services being furnished in their geographic areas is a direct result of hurricane-related factors affecting healthcare providers that are beyond their control. Stakeholders report that, in some cases, beneficiaries located in hurricane-affected areas who are being treated for chronic conditions, such as diabetes, have limited access to their primary clinicians and have not been able to obtain timely refills for their prescribed medications, resulting in an increased volume of hospital and SNF admissions, as well as increased volumes of other medical services. Stakeholders suggest that beneficiaries in affected areas are more likely to be admitted to hospitals and SNFs, and to require other additional medical services when basic infrastructure has been damaged, such as when beneficiaries are unable to utilize ventilators or other medically necessary equipment at home or in another less intensive setting because of widespread electrical outages. Further, ACOs located in affected areas report that ACO providers/suppliers, including hospitals and SNFs, are struggling to help beneficiaries meet their post-discharge needs, including for housing, family support, and personal care. Stakeholders report that as a result, in some cases, patients may have remained in inpatient facilities due to the lack of appropriate post-discharge services.

Under the Shared Savings Program, ACOs that successfully meet quality and savings requirements can share a percentage of the achieved savings with Medicare. Eligible ACOs share in savings only if they meet both the quality performance standards and generate shareable savings (see §§ 425.604(a)(7), (b) and (c); 425.606(a)(7), (b) and (c); and 425.610(a)(7), (b) and (c)). ACOs participating in a two-sided risk model are required to share losses with the Medicare program when expenditures over the benchmark exceed the minimum loss rate (see §§ 425.606(b), (f) and (g); and 425.610(b), (f) and (g)). ACOs have expressed concerns that disaster-related effects on their ACO participants and assigned beneficiary population could affect their ability to successfully meet the quality performance standards, and in the case of ACOs under performance-based risk, to avoid shared losses. Stakeholders are concerned about the impact on ACO performance results when comparing performance year expenditures that reflect disaster-related spikes in utilization and costs of medical services against historical benchmarks that do not include the costs of a disaster. For instance, in light of the challenges being faced by healthcare providers in Puerto Rico, stakeholders estimate that it might take ACO participants in Puerto Rico from 3 to 6 months, at a minimum, to comply with quality measures reporting requirements for performance year 2017. Stakeholders are also concerned that ACOs and ACO participants affected by disasters could be unfairly assessed for performance year 2017 based on the quality and claims data that would be available during financial reconciliation for performance year 2017. For example, stakeholders have expressed the following concerns:

• There could be very limited ability to obtain beneficiary survey responses to the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey through phone calls and mailings. Further, the widespread devastation of infrastructure and the impact on healthcare providers would likely adversely impact beneficiary access to care and beneficiary ratings of services, which could negatively affect results on the CAHPS survey measures.

• ACO quality performance scores could be adversely affected by a limited ability to furnish and/or submit claims for cancer screening services, diabetic eye exams, or other preventive services. This would impact ACOs' quality performance scores because higher rates are better for many of the quality measures, such as ACO-19 Colorectal Cancer Screening or ACO-20 Breast Cancer Screening.

• There could be a high number of unplanned hospital and SNF admissions, and high use of emergency room services due to multiple disaster-related factors, such as beneficiary exposure to contagious illnesses and limited access to medicines for beneficiaries with chronic conditions. This could significantly impact ACOs' quality performance scores because lower rates of admissions are better for measures, such as ACO-35 SNF 30-day All-Cause Readmission Measure or ACO-36 All-Cause Unplanned Admissions for Patients with Diabetes.

• The impact of the disasters on an ACO's financial performance could be unpredictable as a result of the increase in utilization and cost of services furnished to the Medicare beneficiaries it serves. In some cases, ACO participants might be unable to coordinate care because of migration of patient populations leaving the impacted areas. Stakeholders have expressed concerns that existing Track 2 and Track 3 ACOs may be unable to remain in a two-sided risk track if they are held fully accountable for repaying shared losses associated with these disasters. We also note that our experience with the Shared Savings Program has been that the majority of ACOs that owe shared losses subsequently terminate their agreements.

These stakeholders further suggest that in the future providers and suppliers could be reluctant to participate in the Shared Savings Program under a two-sided risk model because of concerns that ACOs participating under a two-sided risk model could be required to share losses with the Medicare program for expenditures resulting from extreme and uncontrollable circumstances.

Disasters may have several possible effects on our ability to measure ACO quality performance. For instance, displacement of beneficiaries may make it difficult for ACOs to access medical record data required for quality reporting, as well as reduce the beneficiary response rate on survey measures. Further, for practices damaged by a disaster, the medical records needed for quality reporting may be inaccessible.

We also believe that disasters may affect the infrastructure of ACO participants, ACO providers/suppliers, and potentially the ACO legal entity itself, thereby disrupting routine operations related to their participation in the Shared Savings Program and achievement of program goals. The effects of a disaster could include challenges in communication between the ACO and its participating providers and suppliers and in implementation of and participation in programmatic activities. These factors could jeopardize an ACO's ability to remain in the program, particularly for ACOs that have accepted performance-based risk under Tracks 2 and 3. Stakeholders have requested that we develop policies under the Shared Savings Program to recognize the impact of extreme and uncontrollable circumstances on ACO quality and financial performance.

We agree with stakeholders that the financial and quality performance of ACOs located in areas subject to extreme and uncontrollable circumstances could be significantly and adversely affected. We also agree that due to the widespread disruptions that have occurred during 2017 in areas affected by Hurricanes Harvey, Irma, and Maria, and the California wildfires, new policies are warranted for assessing quality and financial performance of Shared Savings Program ACOs in the affected areas. We believe it is appropriate to adopt policies to address stakeholder concerns that displacement of beneficiaries may make it difficult for ACOs to access medical record data required for quality reporting, and might reduce the beneficiary response rate on survey measures. In addition, medical records needed for quality reporting may be inaccessible. We also believe it is appropriate to adopt policies to address stakeholders' concerns that ACOs might be held responsible for sharing losses with the Medicare program resulting from catastrophic events outside the ACO's control given the increase in utilization, migration of patient populations leaving the impacted areas, and the mandatory use of natural disaster payment modifiers making it difficult to identify whether a claim would otherwise have been denied under normal Medicare fee-for-service (FFS) rules.

Under the Shared Savings Program, we do not currently have policies for addressing ACO quality performance scoring and the determination of the shared losses owed by ACOs participating under performance-based risk tracks in the event of an extreme or uncontrollable circumstance. In the Quality Payment Program IFC (82 FR 53895), we established an automatic policy to address extreme and uncontrollable circumstances, including Hurricanes Harvey, Irma, and Maria, for the Merit-based Incentive Payment System (MIPS) for the 2017 performance year. (The specific regions identified as being affected by Hurricanes Harvey, Irma, and Maria for the 2017 MIPS performance year are provided in detail in section III.B.1.e. of the Quality Payment Program IFC (82 FR 53898)). In the Quality Payment Program IFC, we stated that should additional extreme and uncontrollable circumstances arise for the 2017 MIPS performance period that trigger the automatic extreme and uncontrollable circumstance policy under the Quality Payment Program, we would communicate that information through routine communication channels, including but not limited to issuing program memoranda, emails to stakeholders, and notices on the Quality Payment Program website, qpp.cms.gov (82 FR 53897). For example, we recently issued guidance to stakeholders indicating that the MIPS Extreme and Uncontrollable Circumstance Policy also applies to MIPS eligible clinicians affected by the California wildfires (see https://www.cms.gov/Medicare/Quality-Payment-Program/Resource-Library/Interim-Final-Rule-with-Comment-fact-sheet.pdf).

We believe it is also appropriate to establish automatic extreme and uncontrollable circumstances policies under the Shared Savings Program for performance year 2017 due to the urgency of providing relief to Shared Savings Program ACOs impacted by Hurricanes Harvey, Irma, and Maria, and the California wildfires, because their quality scores could be adversely affected by these disasters and some ACOs could be at risk for additional shared losses due to the costs associated with these extreme and uncontrollable events. Therefore, given the broad impact of the three hurricanes and the wildfires, and to address any additional extreme and uncontrollable circumstances that may arise during 2017 or the quality data reporting period for the performance year, we are establishing the policies described below for the Shared Savings Program for performance year 2017.

For program clarity and to reduce unnecessary burdens on affected ACOs, we are aligning the automatic extreme and uncontrollable circumstances policies under the Shared Savings Program with the policy established under the Quality Payment Program. Specifically, the Shared Savings Program extreme and uncontrollable circumstances policies will apply when we determine that an event qualifies as an automatic triggering event under the Quality Payment Program. We will use the determination of an extreme and uncontrollable circumstance under the Quality Payment Program, including the identification of affected geographic areas and applicable time periods, for purposes of determining the applicability of the extreme and uncontrollable circumstances policies with respect to both financial performance and quality reporting under the Shared Savings Program. These policies will also apply with respect to the determination of the ACO's quality performance in the event that an extreme and uncontrollable event occurs during the applicable quality data reporting period for performance year 2017 and the reporting period is not extended. We believe it is appropriate to extend these policies to encompass the quality reporting period, unless the reporting period is extended, because we would not have the quality data necessary to measure an ACO's quality performance for 2017 if the ACO were unable to submit its quality data as a result of a disaster occurring during the submission window. For example, if an extreme and uncontrollable event were to occur in February 2018, which is during the quality data reporting period for performance year 2017 that is currently scheduled to end on March 16, 2018 at 8 p.m. eastern daylight time, then the extreme and uncontrollable circumstances policies would apply for quality data reporting for performance year 2017, if the reporting period is not extended. We do not believe it is appropriate to extend this policy to encompass the quality data reporting period if the reporting period is extended because affected ACOs would have an additional opportunity to submit their quality data, enabling us to measure their quality performance in 2017. However, we note that, because a disaster that occurs after the end of the performance year would have no impact on the determination of an ACO's financial performance for performance year 2017, we will make no adjustment to shared losses in the event an extreme or uncontrollable event occurs during the quality data reporting period.

ACOs and their ACO participants and ACO providers/suppliers are frequently located across several different geographic regions or localities, serving a mix of beneficiaries who may be differentially impacted by hurricanes, wildfires, or other triggering events. Therefore, we need to establish a policy for determining when an ACO, which may have ACO participants and ACO providers/suppliers located in multiple geographic areas, should qualify for the automatic extreme and uncontrollable circumstance policies for the determination of quality performance. We will determine whether an ACO has been affected by an extreme and uncontrollable circumstance by determining whether 20 percent or more of the ACO's assigned beneficiaries resided in counties designated as an emergency declared area in performance year 2017, as determined under the Quality Payment Program as discussed in section III.B.1.e. of the Quality Payment Program IFC (82 FR 53898) or the ACO's legal entity is located in such an area. An ACO's legal entity location is based on the address on file for the ACO in CMS' ACO application and management system. We are using 20 percent of the ACO's assigned beneficiary population as the minimum threshold to establish an ACO's eligibility for the policies regarding quality reporting and quality performance scoring included in this interim final rule with comment period because we believe the 20 percent threshold provides a reasonable way to identify ACOs whose quality performance may have been adversely affected by an extreme or uncontrollable circumstance, while excluding ACOs whose performance would not likely be significantly affected. The 20 percent threshold was selected to account for the effect of an extreme or uncontrollable circumstance on an ACO that has the minimum number of assigned beneficiaries to be eligible for the program (5,000 beneficiaries), and in consideration of the average total number of unique beneficiaries for whom quality information is required to be reported in the combined CAHPS survey sample (860 beneficiaries) and the CMS web interface sample (approximately 3,500 beneficiaries). (There may be some overlap between the CAHPS sample and the CMS web interface sample.) Therefore, we estimated that an ACO with an assigned population of 5,000 beneficiaries typically would be required to report quality information on a total of 4,000 beneficiaries. Thus, we believe the 20 percent threshold ensures that an ACO with the minimum number of assigned beneficiaries would have an adequate number of beneficiaries across the CAHPS and CMS web interface samples in order to fully report on these measures. Of the ACOs we have estimated will be impacted by the disasters in 2017, 92 percent have more than 20 percent of their assigned beneficiaries residing in emergency declared areas. However, we also understand that some ACOs that have fewer than 20 percent of their assigned beneficiaries residing in affected areas have a legal entity that is located in an emergency declared area. Consequently, their ability to quality report may be equally impacted since the ACO legal entity may be unable to collect the information from the ACO participants or experience infrastructure issues related to capturing, organizing and reporting the data to CMS. If less than 20 percent of the ACO's assigned beneficiaries reside in an affected area and the ACO's legal entity is not located in a county designated as an affected area, then we believe that there is unlikely to be a significant impact upon the ACO's ability to report or on the representativeness of the quality performance score that is determined for the ACO.

We will determine what percentage of the ACO's performance year assigned population was affected by a disaster based on the final list of beneficiaries assigned to the ACO for the performance year. Although beneficiaries are assigned to ACOs under Track 1 and Track 2 based on preliminary prospective assignment with retrospective reconciliation after the end of the performance year, these ACOs will be able to use their quarterly assignment lists, which include beneficiaries' counties of residence, for early insight into whether they are likely to meet the 20 percent threshold. We have used preliminary information on beneficiary assignment for the 2017 performance year to estimate the number of ACOs that were affected by the hurricanes and the California wildfires in 2017. We estimate that 105 of the 480 ACOs (approximately 22 percent) would meet the minimum threshold of having 20 percent or more of their assigned beneficiaries residing in an area designated as impacted by Hurricanes Harvey, Irma, and Maria, and the California wildfires or have their legal entity located in one of these areas.

For purposes of determining quality performance scoring for performance year 2017, if 20 percent or more of an ACO's assigned beneficiaries reside in an area impacted by the disaster or the ACO's legal entity is located in such an area, the ACO's minimum quality score will be set to equal the mean Shared Savings Program ACO quality score for all ACOs for performance year 2017. We are setting the minimum quality score equal to the mean quality score for all Shared Savings Program ACOs nationwide, because the mean reflects the full range of quality performance across all ACOs in the Shared Savings Program. More specifically, the mean ACO quality score is equal to the combined ACO quality score for all ACOs meeting the quality performance standard for the performance year divided by the total number of ACOs meeting the quality performance standard for the performance year. To illustrate, we note that the mean Shared Savings Program ACO quality performance score for all participating ACOs for performance year 2016 was approximately 95 percent. In the event an affected ACO is able to complete quality reporting for performance year 2017, and the ACO's calculated quality score is higher than the mean Shared Savings Program ACO quality score, then we would apply the higher score.

In earlier rulemaking, we finalized a policy under which ACOs that demonstrate quality improvement on established quality measures from year-to-year will be eligible for up to 4 bonus points per domain (79 FR 67927 through 67931, § 425.502(e)(4)). To earn bonus points, an ACO must demonstrate a net improvement in performance on measures within a domain. If an ACO is not able to complete quality reporting for performance year 2017, it will not be possible for us to assess the ACO's improvement on established quality measures since performance year 2016. Therefore, if an ACO receives a quality score based on the mean quality score, the ACO is not eligible for bonus points awarded based on quality improvement.

We believe it is appropriate to adjust the quality performance scores for ACOs in affected areas because we anticipate that such ACOs will likely be unable to collect or report the necessary information to CMS as a result of the extreme and uncontrollable circumstance, and/or the ACO's quality performance score will be significantly and adversely affected. Section 1899(b)(3)(C) of the Act gives us the authority to establish the quality performance standards used to assess the quality of care furnished by ACO. Accordingly, we are modifying the quality performance standard specified under § 425.502 by amending paragraph (e)(4) and adding a new paragraph (f) to address potential adjustments to the quality performance score for performance year 2017 of ACOs determined to be affected by extreme and uncontrollable circumstances. For performance year 2017, including the applicable quality data reporting period for the performance year if the reporting period is not extended, in the event that we determine that 20 percent or more of an ACO's final list of assigned beneficiaries for the performance year, as determined under subpart E of the Shared Savings Program regulations, reside in an area that is affected by an extreme and uncontrollable circumstance as determined under the Quality Payment Program, or that the ACO's legal entity is located in such an area, we will use the following approach to calculate the ACO's quality performance score instead of the methodology specified in § 425.502(a) through (e).

• The ACO's minimum quality score will be set to equal the mean Shared Savings Program ACO quality score for performance year 2017.

• If the ACO is able to completely and accurately report all quality measures, we will use the higher of the ACO's quality score or the mean Shared Savings Program ACO quality score.

• If the ACO receives a quality score based on the mean, the ACO is not eligible for bonus points awarded based on quality improvement.

We will apply determinations made under the Quality Payment Program with respect to whether an extreme and uncontrollable circumstance has occurred and the affected areas. We have sole discretion to determine the time period during which an extreme and uncontrollable circumstance occurred, the percentage of the ACO's assigned beneficiaries residing in the affected areas, and the location of the ACO legal entity.

For purposes of the MIPS APM scoring standard, MIPS eligible clinicians in Medicare Shared Savings Program ACOs that do not completely report quality for 2017; and therefore, receive the mean ACO quality score under the Shared Savings Program would receive a score of zero percent in the MIPS quality performance category. However, these MIPS eligible clinicians would receive a score of 100 percent in the improvement activities (IAs) performance category, which would be sufficient for them to receive a 2017 MIPS final score above the performance threshold. This would result in at least a slight positive MIPS payment adjustment in 2019. Additionally, if the ACO participants are able to report advancing care information (ACI), the MIPS eligible clinicians in the ACO will receive an ACI performance category score under the APM scoring standard which would further increase their final score under MIPS.

In addition, we are modifying the payment methodology under Tracks 2 and 3 established under the authority of section 1899(i) of the Act to mitigate shared losses owed by ACOs affected by extreme and uncontrollable circumstances during performance year 2017. Under this policy, we will reduce the ACO's shared losses, if any, determined to be owed under the existing methodology for calculating shared losses in part 425, subpart G, of the regulations by an amount determined by multiplying the shared losses by two factors: (1) The percentage of the total months in the performance year affected by an extreme and uncontrollable circumstance; and (2) the percentage of the ACO's assigned beneficiaries who reside in an area affected by an extreme and uncontrollable circumstance. We will determine the percentage of the ACO's performance year assigned beneficiary population that was affected by the disaster based on the final list of beneficiaries assigned to the ACO for the performance year. For example, assume that an ACO is determined to owe shared losses of $100,000 for performance year 2017, a disaster was declared for October through December during the performance year, and 25 percent of the ACO's assigned beneficiaries reside in the disaster area. In this scenario, we would adjust the ACO's losses in the following manner:

We believe it is appropriate to adopt this policy to address stakeholders' concerns that ACOs could be held responsible for sharing losses with the Medicare program resulting from catastrophic events outside the ACO's control given the increase in utilization, difficulty of coordinating care for patient populations leaving the impacted areas, and the mandatory use of natural disaster payment modifiers making it difficult to identify whether a claim would otherwise have been denied under normal Medicare FFS rules. Absent this relief, we believe ACOs that are currently participating in Tracks 2 and 3 may reconsider whether they are able to continue their participation in the Shared Savings Program under a performance-based risk track. The approach we are adopting in this interim final rule with comment period balances the need to offer relief to affected ACOs with the need to continue to hold those ACOs accountable for losses incurred during the months in which there was no applicable disaster declaration and for the assigned beneficiary population that was outside the area affected by the disaster. We also note that these policies do not change the status of Track 2 or Track 3 of the Shared Savings Program as an Advanced Alternative Payment Model (APM) for purposes of the Quality Payment Program, or prevent an eligible clinician in a performance-based risk ACO from becoming a Qualifying APM Participant for purposes of the APM incentive under the Quality Payment Program.

We also explored an alternative approach for mitigating the potential losses for ACOs in performance-based risk tracks that are affected by extreme and uncontrollable circumstances. Under this approach, we would remove claims for services furnished to assigned beneficiaries in the impacted areas by an ACO participant that are submitted with a natural disaster modifier before calculating financial performance. However, we believe that this alternative approach could, for some affected ACOs, result in the exclusion of a significant amount of their total claims at financial reconciliation, making it very difficult to measure the ACOs' financial performance.

We also want to emphasize that all ACOs will continue to be entitled to share in any savings they may achieve for performance year 2017. The calculation of savings and the determination of shared savings payment amounts will not be affected by the policies to address extreme and uncontrollable circumstances. ACOs in all three tracks of the program will receive shared savings payments, if any, as determined under part 425, subpart G.

We also considered the possible impact of extreme and uncontrollable circumstances on an ACO's expenditures for purposes of determining the benchmark (§§ 425.602 and 425.603). The additional costs incurred as a result of an extreme or uncontrollable circumstance would likely impact the benchmark determined for the ACO's subsequent agreement period in the Shared Savings Program, as performance years of the current agreement period become the historical benchmark years for the subsequent agreement period. We currently believe that the increase in expenditures for a particular calendar year would result in a higher benchmark value when the same calendar year is used to determine the ACO's historical benchmark, and in calculating adjustments to the rebased benchmark based on regional FFS expenditures (§ 425.603). We believe that any effect of including these additional expenditures in determining the ACO's benchmark for the subsequent agreement period could be mitigated somewhat because the ACO's expenditures during the three base years included in the benchmark are weighted equally, and regional expenditures would also increase as a result of the disaster. Therefore, we anticipate the effect on the regional adjustment under § 425.603(c)(9) would be minimal. Although we are not modifying the program's historical benchmark methodology in this interim final rule with comment period, we plan to observe the impact of the 2017 hurricanes and wildfires on ACO expenditures, and may revisit the need to make adjustments to the methodology for calculating the benchmark in future rulemaking.

To exercise our authority under section 1899(i)(3) of the Act to use other payment models, we must demonstrate that the payment model— (1) “ . . . does not result in spending more for such ACO for such beneficiaries than would otherwise be expended . . . if the model were not implemented. . . .” and (2) “will improve the quality and efficiency of items and services furnished under” Medicare. In assessing the impacts of the policy for mitigating shared losses for Track 2 and Track 3 ACOs affected by extreme and uncontrollable circumstances in 2017, we considered: The impact of the potential loss of participation in the program by ACOs affected by disasters should we not implement the policy described in this interim final rule with comment period, and the anticipated minimal impact of adjusting losses for ACOs affected by disasters, as described in the regulatory impact statement. On the basis of this assessment, we believe incorporating this extreme and uncontrollable circumstances policy into the payment methodologies for Tracks 2 and 3 would meet the requirements of section 1899(i) of the Act by not increasing expenditures above the costs that would be incurred under the statutory payment methodology under section 1899(d) of the Act and by encouraging affected ACOs to remain in the program, which we believe will increase the quality and efficiency of the items and services furnished to the beneficiaries they serve. We also note that to the extent the policies in this interim final rule with comment constitute a change to the Shared Savings Program payment methodology for 2017 after the start of the performance year, we believe that, consistent with section 1871(e)(1)(A)(ii) of the Act, and for reasons discussed in section III of this interim final rule with comment period, it would be contrary to the public interest not to adjust the shared losses calculated for ACOs in Tracks 2 and 3 to reflect the impact of the extreme and uncontrollable circumstances during 2017.

We invite comments on the policies being finalized in this interim final rule with comment period for performance year 2017, including the applicable quality data reporting period for performance year 2017 under the Shared Savings Program. We believe these automatic extreme and uncontrollable circumstance policies will reduce burden and financial uncertainty for ACOs, ACO participants, and ACO providers/suppliers affected by catastrophes, including ACOs affected by Hurricanes Harvey, Irma, and Maria, and the California wildfires, and will also align with existing Medicare policies under the Quality Payment Program for 2017.

We note that in future rulemaking, we intend to propose permanent policies under the Shared Savings Program to address extreme and uncontrollable circumstances in future performance years. Therefore, we also invite public comment on policies and issues that we should consider when developing proposals for these permanent policies.

We also welcome comments on how to address the impact of extreme and uncontrollable events on historical benchmark calculations, which we will consider in developing any future proposals. In particular, we seek comments as to whether and how the historical benchmark should be adjusted to reflect extreme and uncontrollable events that occur during a benchmark year, how to establish the threshold for determining whether a significant change in expenditures occurred, whether and how to account for changes in expenditures that have an aggregate positive or negative impact on the historical benchmark, and whether and how to reweight the benchmark years when calculating the historical benchmark if one or more benchmark years is impacted by an extreme and uncontrollable event.

Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rule in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rule in the Federal Register and provide a period of not less than 60 days for public comment. Section 553(b)(B) of the APA provides for exceptions from the notice and comment requirements; in cases in which these exceptions apply, section 1871(b)(2)(C) of the Act provides for exceptions from the notice and 60-day comment period requirements of the Act as well. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment process is impracticable, unnecessary, or contrary to the public interest.

We find that there is good cause to waive the notice and comment requirements under sections 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act due to the impact of the recent disasters, as described in section I of this interim final rule with comment period, and the need to provide relief to impacted Shared Savings Program ACOs, ACO participants, and ACO providers/suppliers. Based on the size and scale of the destruction and displacement caused by these disasters in the affected regions, we believe it is likely that some ACOs and their ACO participants and ACO providers/suppliers have been significantly adversely affected by these events. It is possible that some ACO providers/suppliers may lack access to their EHR technology or other clinical data they would need in order to submit quality data for the 2017 performance period. Undertaking notice-and-comment rule-making would not provide certainty for ACOs that must prepare now for quality reporting for performance year 2017, which begins on January 22, 2018. Moreover, there is no certainty that a final rule could be issued and in effect before the end of the quality reporting period for performance year 2017 on March 16, 2018. Absent this certainty, the prudent action for impacted ACOs would be to direct their attention and resources to attempt to report quality data for performance year 2017.

We believe it is likely that despite this effort, many affected ACOs would be unable to completely, accurately, and timely report given the lack of clinical information and infrastructure as a result of the disasters. This would result in unnecessary burden to impacted ACOs and their ACO participants and ACO providers/suppliers in the event a final rule is issued during or after the quality data submission period, and the ACO would have been afforded relief under the policies included in the final rule. Further, absent this certainty, ACOs participating under Tracks 2 and 3 that are located in disaster areas and that have experienced increased utilization would be concerned about being at risk for shared losses and would likely direct their attention and resources to contingency planning activities to develop options for offsetting the potential additional costs. These ACOs may also reconsider whether they are able to continue to their participation in the Shared Savings Program in a performance-based risk track. We believe it is also possible that potential ACO applicants could be reluctant to initiate the necessary advance planning and investments required to develop the capability to participate under a two-sided risk model during future performance years if they believe that we would be hesitant to provide similar flexibility in the event of future disasters, such that they may be at risk for losses resulting from circumstances beyond their control. Consequently, we believe it is in the public interest to adopt these interim final policies to provide relief to affected ACOs and their ACO participants and ACO providers/suppliers by mitigating the negative effects of the disasters during performance year 2017 on their quality and financial performance under the Shared Savings Program and allowing them to direct their resources toward caring for their patients and repairing structural damage to facilities.

We find that it would be impracticable and contrary to the public interest to undergo notice and comment procedures before finalizing, on an interim basis with an opportunity for public comment, policies under the Shared Savings Program to address extreme and uncontrollable circumstances that impact an entire region or locale in performance year 2017, including the applicable quality data reporting period. Therefore, we find good cause to waive the notice of proposed rulemaking as provided under section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act and to issue this interim final rule with an opportunity for public comment. We are providing a 60-day public comment period as specified in the DATES section of this document.

As stated in section 3022 of the Patient Protection and Affordable Care Act, Chapter 35 of title 44, United States Code, shall not apply to the Shared Savings Program. However, we note that this document does not impose any new information collection requirements (that is, reporting, recordkeeping, or third-party disclosure requirements).

These policies for addressing extreme and uncontrollable circumstances are unlikely to have a significant economic impact on the Shared Savings Program. We estimated the impact of these policies by simulating their effect on actual 2016 financial and quality performance results, the most recent available reconciled financial and quality results, for the ACOs currently participating in the program that are potentially impacted by these policies. The total increase in shared savings payments and total reduction in shared loss payments anticipated for ACOs impacted by the policies in this rule in 2017 is estimated to be approximately $3.5 million in total (which would round to zero assuming precision to the nearest $10 million). This interim final rule is not subject to the requirements of Executive Order 13771 because it is expected to result in no more than de minimis costs.

Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all public comments we receive by the date and time specified in the DATES section of this document, and, when we proceed with a subsequent document, we will respond to the public comments in the preamble to that document.

For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR part 425 as set forth below: