Federal Register Vol. 83, No.22,

The FAA has determined that notice of, and opportunity for prior public comment on, these special conditions is unnecessary because the substance of these special conditions has been subject to the public-comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon publication in the Federal Register.

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

We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

On March 29, 2012, Gulfstream applied for a type certificate for their new Model GVII-G500 airplane. This transport-category, twin-engine airplane will be a business jet capable of accommodating up to 19 passengers. The maximum takeoff weight is 91,000 lbs.

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

If the Administrator finds that the applicable airworthiness regulations (i.e., part 25) do not contain adequate or appropriate safety standards for the Model GVII-G500 airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, Model GVII-G500 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36. The FAA must issue a finding of regulatory adequacy under § 611 of Public Law 92-574, the “Noise Control Act of 1972.”

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.17(a)(2).

The Model GVII-G500 airplane will incorporate the following novel or unusual design feature:

An electronic flight-control system, the functions of which are dependent upon the electrical power-generation and distribution systems, whereby the loss of all electrical power may be catastrophic to the airplane. These special conditions retain the level of safety offered by 14 CFR 25.1351(d).

The Gulfstream Aerospace Corporation Model GVII-G500 airplane incorporates a fly-by-wire flight-control system that requires a continuous source of electrical power to keep the flight-control system operable. The current regulation, § 25.1351(d), Amendment 25-72, “Operation without normal electrical power,” states that the airplane must be operated safely in visual-flight-rules conditions for a period of not less than five minutes after loss of all normal electrical power. This rule was structured around a traditional design of mechanical control cables for flight control that allowed time for the crew to remedy an electrical failure, start the engine(s) if necessary, and re-establish some or all of the electrical power-generation capability.

To maintain the same level of safety associated with traditional designs, the Model GVII-G500 airplane design must not be time limited in its operation when the airplane is without its normal source of engine- or auxiliary-power-unit-generated electrical power. Service experience has shown that the loss of all electrical power generated by an airplane's engine generators or auxiliary power unit (APU) is not extremely improbable. Likewise, regulations require the applicant to demonstrate that the airplane has the power required for continued safe flight and landing with the use of its emergency electrical power systems. These emergency electrical power systems must be able to power all loads considered essential for continued safe flight and landing.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

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

This action affects only a certain novel or unusual design feature on one model series of airplanes. It is not a rule of general applicability.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, the FAA has determined that prior public notice and comment are unnecessary, and good cause exists for adopting these special conditions upon publication in the Federal Register.

The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

Because the total loss of normal, generated, electrical power in two-engine airplanes is not extremely improbable, and because the loss of all electrical power may be catastrophic to airplanes equipped with an electronic flight-control system, the following special conditions apply to Gulfstream Model GVII airplanes.

In lieu of § 25.1351(d), the following special conditions apply:

1. Gulfstream must show, by test or a combination of test and analysis, that the airplane is capable of continued safe flight and landing with all normal electrical power sources inoperative, as prescribed by paragraphs 1.a. and 1.b., below. For purposes of these special conditions, normal sources of electrical-power generation do not include alternate power sources such as the battery, ram-air turbine, or independent power systems such as the flight-control permanent-magnet generating system. In showing capability for continued safe flight and landing, Gulfstream must account for systems capability, effects on crew workload and operating conditions, and the physiological needs of the flightcrew and passengers for the longest diversion time for which Gulfstream is seeking approval.

a. In showing compliance with this requirement, Gulfstream must account for common-cause failures, cascading failures, and zonal physical threats.

b. Gulfstream may consider the ability to restore operation of portions of the electrical power generation and distribution system if it can be shown that unrecoverable loss of those portions of the system is extremely improbable. The design must provide an alternative source of electrical power for the time required to restore the minimum electrical-power generation capability required for safe flight and landing. Gulfstream may exclude unrecoverable loss of all engines when showing compliance with this requirement.

2. Regardless of electrical-power generation and distribution-system recovery capability shown under special condition 1, above, sufficient electrical-system capability must be provided to:

a. Allow time to descend, with all engines inoperative, at the speed that provides the best glide distance, from the maximum operating altitude to the top of the engine-restart envelope, and

b. Subsequently allow multiple start attempts of the engines and auxiliary power unit (APU). The design must provide this capability in addition to the electrical capability required by existing part 25 requirements related to operation with all engines inoperative.

3. The airplane emergency electrical-power system must be designed to supply:

a. Electrical power required for immediate safety, which must continue to operate without the need for crew action following the loss of the normal electrical power, for a duration sufficient to allow reconfiguration to provide a non-time-limited source of electrical power.

b. Electrical power required for continued safe flight and landing for the maximum diversion time.

4. If the applicant uses APU-generated electrical power to satisfy the requirements of these special conditions, and if reaching a suitable runway for landing is beyond the capacity of the battery systems, then the APU must be able to be started under any foreseeable flight condition prior to the depletion of the battery, or the restoration of normal electrical power, whichever occurs first. Flight test must demonstrate this capability at the most critical condition.

a. The applicant must show that the APU will provide adequate electrical power for continued safe flight and landing.

b. The airplane flight manual (AFM) must incorporate abnormal procedures that direct the pilot to take appropriate actions to activate the APU after loss of normal engine-driven generated electrical power.

5. As part of showing compliance with these special conditions, the tests to demonstrate loss of all normal electrical power must also take into account the following:

a. The assumption that the failure condition occurs during night instrument meteorological conditions (IMC) at the most critical phase of the flight, relative to the worst possible electrical-power distribution and equipment-loads-demand condition.

b. After an unrestorable loss of normal engine-driven generated electrical power, the airplane engine-restart capability is provided and operations are continued in IMC.

c. The airplane is demonstrated to be capable of continued safe flight and landing. The duration of this capability must be computed based on the maximum diversion-time capability for which the airplane is being certified. The applicant must account for airspeed reductions resulting from the associated failure or failures.

d. The airplane must provide adequate indication of loss of normal electrical power to direct the pilot to the abnormal procedures, and the AFM must incorporate abnormal procedures that will direct the pilot to take appropriate actions.

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

The FAA published a notice of proposed rulemaking in the Federal Register (82 FR 38857, August 16, 2017) Docket No. FAA-2017-0610 to amend Class E airspace extending upward from 700 feet or more above the surface at Sugarloaf Regional Airport, Carrabassett, ME.

Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005, of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by amending Class E airspace extending upward from 700 feet or more above the surface within the 7-mile radius of Sugarloaf Regional Airport, Carrabassett, ME. A 14.3-mile extension to the north is created, extending from the 7-mile radius of the airport for the new RNAV-(GPS-A) approach for the airport, and for continued safety and management of IFR operations.

The geographic coordinates of the airport are adjusted to coincide with the FAA's aeronautical database.

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. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

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

A. Background

Section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) established requirements concerning concentration limits for specified phthalates in children's toys and child care articles. In accordance with section 108 of the CPSIA, on October 27, 2017, the Commission published a phthalates final rule (phtahalates rule) in the Federal Register (82 FR 49938). That final rule made permanent the interim prohibition on children's toys that can be placed in a child's mouth and child care articles that contain concentrations of more than 0.1 percent of diisononyl phthalate (DINP). The phthalates rule extended this prohibition to cover all children's toys and child care articles containing concentrations of more than 0.1 percent of DINP. The phthalates rule also lifted the interim prohibitions on children's toys that can be placed in a child's mouth and child care articles that contain concentrations of more than 0.1 percent of di-n-octyl phthalate (DNOP) or diisodecyl phthalate (DIDP). In addition, the phthalates rule prohibited children's toys and child care articles that contain concentrations of more than 0.1 percent of diisobutyl phthalate (DIBP), Di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP). The permanent prohibitions on children's toys and child care articles that contain concentrations of more than 0.1 percent on the use of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and benzyl butyl phthalate (BBP) in children's toys and child care articles in section 108 of the CPSIA were unchanged by the phthalates rule.

On October 27, 2017, in the same issue of the Federal Register, the Commission published a notice of proposed rulemaking (NPR) to update the existing NOR in part 1112 for prohibitions of children's toys and child care articles containing specified phthalates. As explained further below, NORs provide the criteria and process for Commission acceptance of accreditation of third party testing laboratories that test products' conformance to CPSC requirements. The Commission previously issued an NOR for the statutory phthalate provisions, 76 FR 49286 (August 10, 2011). The October 27, 2017 NPR proposed to amend part 1112 to reflect the phthalates prohibited in children's toys and child care articles in the phthalates rule. Because the phthalates rule modified the statutorily prohibited phthalates in children's toys and child care articles listed in section 108 of the CPSIA (as stated in § 1307.3), this final rule amends the existing requirements for the prohibitions of children's toys and child care articles containing specified phthalates so that part 1112 reflects those changes.

Section 14(a) of the CPSA requires that products subject to a consumer product safety rule under the CPSA, or to a similar rule, ban, standard, or regulation under any other act enforced by the Commission, be certified as complying with all applicable CPSC requirements. 15 U.S.C. 2063(a). Such certification must be based on a test of each product, or on a reasonable testing program. Products that are subject to a children's product safety rule must be certified based on tests of a sufficient number of samples by a third party conformity assessment body accredited by the Commission to test according to the applicable requirements. The Commission's phthalates rule is considered a “children's product safety rule.” 15 U.S.C. 2063(f). Thus, products subject to the phthalates rule are subject to the testing and certification requirements of section 14 of the CPSA.

Because children's toys and child care articles are children's products, samples of these products must be tested by a third party conformity assessment body whose accreditation has been accepted by the Commission. These products also must comply with all other applicable CPSC requirements, such as the lead content requirements of section 101 of the CPSIA, the requirements of the toy standard, 16 CFR part 1250, and the tracking label requirement in section 14(a)(5) of the CPSA.

In accordance with section 14(a)(3)(B)(vi) of the CPSIA, the Commission has previously published two NORs for accreditation of third party conformity assessment bodies for testing children's toys and child care articles under section 108 of the CPSIA (76 FR 49286 (Aug. 10, 2011), 78 FR 15836 (March 12, 2013)).

As described in the NPR, the Commission will use the following process during the transition period from test method CPSC-CH-C1001-09.3 (2010) to a revised version of the method, test method CPSC-CH-C1001-09.4 (2018). CPSC will accept testing to support children's toys and child care article certifications to the new phthalates prohibitions if the laboratory is already CPSC-accepted to test to CPSC-CH-C1001-09.3 (2010). Laboratories that conduct testing to support product certifications to the new phthalates prohibitions must list in their test reports “16 CFR part 1307” and CPSC-CH-C1001-09.3 until laboratories have transitioned their accreditation scope and CPSC listing to CPSC-CH-C1001-09.4 (2018).

The CPSC will open the laboratory application process for test method CPSC-CH-C1001-09.4 (2018) on the date this final rule is published in the Federal Register. Laboratories that seek CPSC acceptance to the revised prohibitions for children's toys and child care articles in 16 CFR part 1307 will be required to update their accreditation scope. To be CPSC-accepted, a laboratory's scope of accreditation must include the reference to CPSC-CH-C1001-09.4 (2018). Laboratories that are currently CPSC-accepted to CPSC-CH-C1001-09.3 (2010) are instructed to update their accreditation scope to include CPSC-CH-C1001-09.4 (2018) as soon as possible, and submit their application for CPSC acceptance. Laboratories that were not previously CPSC-accepted to CPSC-CH-C1001-09.3 (2010) are instructed to work with their accreditation bodies to include “CPSC-CH-C1001-09.4 (2018)” in their scope documents.

CPSC will accept testing results to the new phthalates prohibitions in 16 CFR part 1307 from laboratories that are CPSC-accepted to CPSC-CH-C1001-09.3 (2010) for two years from the date of publication of this final rule in the Federal Register. This should allow adequate time for laboratories to work with their accreditation bodies to make official updates to their accreditation scope document to include the revised CPSC method “CPSC-CH-C1001-09.4 (2018)” and submit applications to the CPSC. On February 3, 2020, the CPSC will no longer accept laboratory applications that reference CPSC-CH-C1001-09.3 (2010), and any application to CPSC must reference “CPSC-CH-C1001-09.4 (2018).”

We received four comments on the NPR. Three comments addressed the DRAFT CPSC procedure CPSC-CH-C1001-09.4 (2017) that was published with the October 2017 NPR briefing package. The first comment requested clarification of the final list of prohibited phthalates. The second comment highlighted “that dissolved PVC-samples can be precipitated by adding hexane. The phthalates remain in solution. The centrifuged solution can then be measured in the GC.” The third comment came from a testing laboratory representative who recommended a few changes to add clarity and more specificity to the CPSC procedure. The fourth comment was outside the scope of the rule.

Staff made editorial clarifications to the DRAFT CPSC procedure based on the comments. Staff revised the test procedure to clarify the final list of eight prohibited phthalates. Also, staff made several additions to the test equipment and supplies section of the test method reflected in test method CPSC-CH-C1001-09.4 (2018) in response to comment.

Staff did not accept some of the commenters' suggested changes to the test method. The revised test method does not add a temperature specification to the sonication reference in the extraction steps because the extraction is not heat dependent. Additionally, the revised test method does not include suggested additional elements to the Table 1 Conditions for Gas Chromatography-Mass Spectrometry (GC-MS). Staff did not make changes to Table 1, as well as other recommended quality assurance changes to the analysis section of the test method, in order to allow accredited laboratories flexibility in setting up their internal standard operating and quality assurance procedures. Adding the suggested requirements to Table 1 might have forced accredited laboratories to alter already suitable quality assurance programs, thus reducing flexibility. The comment relating to use of hexane for PVC samples did not warrant a change to the test method because the test method already permits the use of hexane.

The final rule amends 16 CFR 1112.15(b)(31) introductory text, (b)(31)(i), and (c)(3)(i) to update the references to reflect the promulgation of 16 CFR part 1307 and revised CPSC test method CPSC-CH-C1001-09.4 (2018). CPSC test method CPSC-CH-C1001-09.4 (2018), has, among other things, been updated to reflect the list of phthalates prohibited in children's toys and child care articles in 16 CFR part 1307 (DEHP, DBP, BBP, DNOP, DIBP, DPENP, DHEXP, or DCHP). CPSC test method CPSC-CH-C1001-09.4 (2018) provides detailed information on the test methods that will be used by the CPSC testing laboratory for the analysis of phthalate content in children's toys and child care articles covered by the standard set forth in section 108 of the CPSIA and 16 CFR part 1307. The test method provides detailed information regarding equipment and supplies, the procedure for the measurement of phthalate concentration, sample preparation, the phthalate extraction method, and instrument parameters. The test method CPSC-CH-C1001-09.4 (2018) is substantially the same as the current testing procedure.

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

In accordance with the OFR's requirements, section D of this preamble summarizes CPSC test method CPSC-CH-C1001-09.4 (2018) that the Commission incorporates by reference into 16 CFR part 1112. The test method is reasonably available to interested parties, and interested parties may obtain a copy of the test method from CPSC National Product Testing and Evaluation Center, 5 Research Place, Rockville, MD 20850; www.cpsc.gov. The test method is also available on the CPSC website. https://cpsc.gov/Business-Manufacturing/Testing-Certification/Lab-Accreditation/Test-Methods/. A copy of the test method can also be inspected at CPSC's Office of the Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 East-West Highway, Bethesda, MD 20814, telephone 301-504-7923.

The APA generally requires that a substantive rule must be published not less than 30 days before its effective date. 5 U.S.C. 553(d)(1). The NPR proposed a 30-day effective date because the rule allows testing to continue under the existing testing method by testing laboratories that meet certain criteria for a period of up to two years after the publication of a final rule. However, to avoid possible confusion if the effective date for this rule differed from the effective date for the underlying phthalates rule, we are setting the effective date for the rule on April 25, 2018, the same date the phthalates rule takes effect. This is consistent with past practice setting the effective date for NORs for durable nursery products under section 104 of the CPSIA and updates to the mandatory toy standard ASTM F963 on the same date the underlying rule takes effect.

The Regulatory Flexibility Act (RFA) requires an agency to prepare a regulatory flexibility analysis for any rule subject to notice and comment rulemaking requirements under the APA, or any other statute, unless the agency certifies that the rulemaking will not have a significant economic impact on a substantial number of small entities. 5 U.S.C. 603 and 605. Small entities include small businesses, small organizations, and small governmental jurisdictions.

The Commission certified, in the NPR, that the rule would not have a significant impact on a substantial number of small entities because the revised testing method is substantially the same as the method that laboratories are already using, qualified testing laboratories should be able to adopt the new method without difficulty, and the 2-year window allowed to amend the accreditation scope documents would allow testing laboratories to time the amendments with their periodic reassessments by their accreditation bodies, which should result in minimal (if any) additional cost. The Commission did not receive any public comments that addressed the potential impact on small entities, nor has the Commission staff become aware of any new information that would change its previous determination regarding the impact on small entities.

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

For the reasons discussed in the preamble, the Commission amends title 16 CFR chapter II, as follows:

Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance in schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if he finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling 1 for up to one year. 21 U.S.C. 811(h)(2).

Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1). The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of his intention to temporarily place a substance in schedule I of the CSA.2 The Administrator transmitted notice of his intent to place valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in schedule I on a temporary basis to the Assistant Secretary for Health of HHS by letter dated October 20, 2017. The Assistant Secretary responded to this notice of intent by letter dated November 8, 2017, and advised that based on a review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications or approved new drug applications for valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of these seven substances in schedule I of the CSA. The DEA has taken into consideration the Assistant Secretary's comments as required by 21 U.S.C. 811(h)(4). Valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil are not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for these seven substances under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent to temporarily schedule valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil was published in the Federal Register on December 13, 2017. 82 FR 58575.

To find that placing a substance temporarily in schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in section 201(c) of the CSA, 21 U.S.C. 811(c): The substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).

A substance meeting the statutory requirements for temporary scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1).

Available data and information for valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil, summarized below, indicate that these synthetic opioids have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. The DEA's three-factor analysis and the Assistant Secretary's November 8, 2017 letter are available in their entirety under the tab “Supporting Documents” of the public docket of this action at www.regulations.gov under FDMS Docket ID: DEA-2017-0016-0001 (Docket Number DEA-475).

The recreational abuse of fentanyl-related substances continues to be a significant concern. These substances are distributed to users, often with unpredictable outcomes. Evidence suggests that the pattern of abuse of these fentanyl-related substances parallels that of heroin and prescription opioid analgesics. Valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil are fentanyl-related substances that have been encountered by law enforcement and/or reported in the scientific literature by public health officials. Adverse health effects and outcomes related to the abuse of fentanyl-related substances have been documented in previous temporary scheduling actions (see DEA 3-Factor Analysis).

On October 1, 2014, the DEA implemented STARLiMS (a web-based, commercial laboratory information management system) to replace the System to Retrieve Information from Drug Evidence (STRIDE) as its laboratory drug evidence data system of record. DEA laboratory data submitted after September 30, 2014, are reposited in STARLiMS. Data from STRIDE and STARLiMS were queried on November 2, 2017. STARLiMS registered the following reports: valeryl fentanyl (15), para-fluorobutyryl fentanyl (5), isobutyryl fentanyl (116), and cyclopentyl fentanyl (1). These identifications were made beginning in 2015.

The National Forensic Laboratory Information System (NFLIS) is a national drug forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by other federal, state and local forensic laboratories across the country. NFLIS was queried on November 3, 2017 3 and the following substances (number of drug reports) were identified from state and local forensic laboratories since 2015: valeryl fentanyl (69), para-fluorobutyryl fentanyl (220), para-methoxybutyryl fentanyl (1), and isobutyryl fentanyl (4). The identification in other countries of para-fluorobutyryl fentanyl (Poland and Sweden), para-methoxybutyryl fentanyl (Sweden), ocfentanil (Belgium and Switzerland), cylcopentyl fentanyl (Sweden), and para-chloroisobutyryl fentanyl (Sweden) in toxicological samples associated with fatal and non-fatal overdoses was reported in the scientific literature.

Fentanyl-related substances have recently re-emerged on the illicit market (see DEA 3-Factor Analysis for full discussion). Valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil have been identified in evidence submitted to law enforcement and/or reported in the scientific literature by public health forensic laboratories.

The identification of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in forensic evidence indicates that these substances are intended to be replacements for controlled synthetic opioids, heroin, and/or prescription opioids. Because abusers of these fentanyl-related substances obtain these substances through unregulated sources, the identity, purity, and quantity are uncertain and inconsistent, thus posing significant adverse health risks to the end user. Individuals who initiate (i.e., use a drug for the first time) abuse of these substances are likely to be at risk of developing substance use disorder, overdose, and death similar to that of other opioid analgesics (e.g., fentanyl, morphine).

With no legitimate medical use in the United States, valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil have emerged on the illicit drug market. Substances within this chemical structural class have demonstrated pharmacological profiles similar to that of fentanyl and other µ-opioid receptor agonists (see DEA 3-Factor Analysis). The abuse of these fentanyl-related substances poses significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone. The toxic effects of substances within this structural class in humans are demonstrated by overdose fatalities described in previous scheduling actions.

Based on information received by the DEA, the misuse and abuse of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil lead to, at least, the same qualitative public health risks as heroin, fentanyl and other opioid analgesic substances. As with any non-medically approved opioid, the health and safety risks for users are high. The public health risks attendant to the abuse of heroin and opioid analgesics are well established and have resulted in large numbers of drug treatment admissions, emergency department visits, and fatal overdoses.

In accordance with 21 U.S.C. 811(h)(3), based on the available data and information, summarized above, the continued uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for these seven substances in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed in schedule I. Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil indicate that these substances have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, by letter dated October 20, 2017, notified the Assistant Secretary of the DEA's intention to temporarily place these substances in schedule I. A notice of intent was subsequently published in the Federal Register on December 13, 2017. 82 FR 58575.

In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, and herein sets forth the grounds for his determination that it is necessary to temporarily schedule valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil in schedule I of the CSA to avoid an imminent hazard to the public safety.

Because the Administrator hereby finds it necessary to temporarily place these synthetic opioids in schedule I to avoid an imminent hazard to the public safety, this temporary order scheduling valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil is effective on the date of publication in the Federal Register, and is in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2).

The CSA sets forth specific criteria for scheduling a drug or other substance. Permanent scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures done “on the record after opportunity for a hearing” conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The permanent scheduling process of formal rulemaking affords interested parties with appropriate process and the government with any additional relevant information needed to make a determination. Final decisions that conclude the permanent scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6).

Upon the effective date of this temporary order, valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil will be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, engagement in research, and conduct of instructional activities or chemical analysis with, and possession of schedule I controlled substances including the following:

1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312, as of February 1, 2018. Any person who currently handles valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil, and is not registered with the DEA, must submit an application for registration and may not continue to handle valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil as of February 1, 2018, unless the DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312. Retail sales of schedule I controlled substances to the general public are not allowed under the CSA. Possession of any quantity of these substances in a manner not authorized by the CSA on or after February 1, 2018, is unlawful and those in possession of any quantity of these substances may be subject to prosecution pursuant to the CSA.

2. Disposal of stocks. Any person who does not desire or is not able to obtain a schedule I registration to handle valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil, must surrender all currently held quantities of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil.

3. Security. Valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil are subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of February 1, 2018.

4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil must be in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302. Current DEA registrants shall have 30 calendar days from February 1, 2018, to comply with all labeling and packaging requirements.

5. Inventory. Every DEA registrant who possesses any quantity of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil on the effective date of this order must take an inventory of all stocks of these substances on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all inventory requirements. After the initial inventory, every DEA registrant must take an inventory of all controlled substances (including valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil) on hand on a biennial basis, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

6. Records. All DEA registrants must maintain records with respect to valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 1304, 1312, 1317, and § 1307.11. Current DEA registrants shall have 30 calendar days from the effective date of this order to be in compliance with all recordkeeping requirements.

7. Reports. All DEA registrants who manufacture or distribute valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil must submit reports pursuant to 21 U.S.C. 827, and in accordance with 21 CFR parts 1304 and 1312, as of February 1, 2018.

8. Order Forms. All DEA registrants who distribute valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil must comply with order form requirements pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305, as of February 1, 2018.

9. Importation and Exportation. All importation and exportation of valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312, as of February 1, 2018.

10. Quota. Only DEA registered manufacturers may manufacture valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil in accordance with a quota assigned pursuant to 21 U.S.C. 826, and in accordance with 21 CFR part 1303, as of February 1, 2018.

11. Liability. Any activity involving valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, or ocfentanil not authorized by, or in violation of, the CSA, occurring as of February 1, 2018, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. As provided in this subsection, the Attorney General may, by order, schedule a substance in schedule I on a temporary basis. Such an order may not be issued before the expiration of 30 days from (1) the publication of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and (2) the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary. 21 U.S.C. 811(h)(1).

Inasmuch as section 201(h) of the CSA directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued, the DEA believes that the notice and comment requirements of the Administrative Procedure Act (APA) at 5 U.S.C. 553, do not apply to this temporary scheduling action. In the alternative, even assuming that this action might be subject to 5 U.S.C. 553, the Administrator finds that there is good cause to forgo the notice and comment requirements of 5 U.S.C. 553, as any further delays in the process for issuance of temporary scheduling orders would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety.

Further, the DEA believes that this temporary scheduling action is not a “rule” as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act. The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by the APA or any other law to publish a general notice of proposed rulemaking.

Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget (OMB).

This action 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. Therefore, in accordance with Executive Order 13132 (Federalism), it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. As noted above, this action is an order, not a rule. Accordingly, the Congressional Review Act (CRA) is inapplicable, as it applies only to rules. However, if this were a rule, pursuant to the CRA, “any rule for which an agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the federal agency promulgating the rule determines.” 5 U.S.C. 808(2). It is in the public interest to schedule these substances immediately to avoid an imminent hazard to the public safety. This temporary scheduling action is taken pursuant to 21 U.S.C. 811(h), which is specifically designed to enable the DEA to act in an expeditious manner to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h) exempts the temporary scheduling order from standard notice and comment rulemaking procedures to ensure that the process moves swiftly. For the same reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to move quickly to place these substances in schedule I because they pose an imminent hazard to the public safety, it would be contrary to the public interest to delay implementation of the temporary scheduling order. Therefore, this order shall take effect immediately upon its publication. The DEA has submitted a copy of this temporary order to both Houses of Congress and to the Comptroller General, although such filing is not required under the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808 because, as noted above, this action is an order, not a rule.

For the reasons set out above, the DEA amends 21 CFR part 1308 as follows:

The Ole Hansen and Sons, Inc., owner and operator of the Margate Boulevard/Margate Bridge that carries Margate Boulevard across the New Jersey Intracoastal Waterway, Beach Thorofare, mile 74.0, at Margate City, NJ, has requested a temporary deviation from the current operating schedule to facilitate maintenance of the structural steel and replacement of the structural steel support column of the double bascule drawbridge. The bridge has a vertical clearance of 14 feet above mean high water in the closed position and unlimited clearance in the open position. The current operating schedule is set out in 33 CFR 117.5. Under this temporary deviation, the bridge will be in the closed-to-navigation position between 7 a.m. on February 26, 2018, through 7 p.m. on March 12, 2018.

The Beach Thorofare is used by a variety of vessels including 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. The bridge will not be able to open for emergencies and there is no immediate alternative route for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge, so that 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.

In this Order, the Commission adopts a final rule concerning mail preparation changes. The final rule adopted by this Order amends an existing Commission rule located at 39 CFR part 3010.1 The rule as adopted incorporates suggestions presented by commenters that include slight modifications to the rule as proposed, but do not materially affect its substance.

The Commission is charged with enforcing its price cap rules, which require that the Postal Service make reasonable adjustments to its billing determinants to account for the effects of classification changes such as the introduction, deletion, or redefinition of rate cells. See 39 CFR 3010.23(d)(2). Under § 3010.23(d)(2), these classification changes can include changes to mail preparation requirements made by the Postal Service. In Docket No. R2013-10R, the Commission articulated a standard governing when mail preparation changes result in the deletion or redefinition of rate cells under § 3010.23(d)(2) of the price cap rules.2

After setting forth the standard applied to mail preparation requirements, the Commission instituted the present rulemaking “to create rules for the process and timeframes for the regulation of mail preparation requirement changes.” 3 As discussed below, the Commission issued an initial proposed rule that was later withdrawn and replaced with a revised proposed rule.

On January 22, 2016, the Commission published a notice of proposed rulemaking (Initial NPR) that proposed a procedural rule for issues concerning compliance with the price cap rules for mail preparation changes.4 The Commission identified a need to amend its rules to “ensure that the Postal Service properly accounts for the rate effects of mail preparation changes” under § 3010.23(d)(2). Order No. 3048 at 1.

The Initial NPR proposed adding a new section under the Commission's existing general motion rule that would create a separate motion procedure dedicated to compliance issues for mail preparation changes. Id. at 3-4. The initial proposed rule defined motions concerning mail preparation changes as “challenges to instances where an announced mail preparation change does not contain a Postal Service indication that the change has a rate effect requiring compliance with § 3010.23(d)(2). . . .” Id. at 7. The Initial NPR proposed parameters for motions specific to mail preparation changes, including a filing deadline and grounds required for the motion. Specifically, the Initial NPR proposed that any motions concerning mail preparation changes were to be filed within 30 days of “actual or constructive notice of the implementation date of the change” and were to contain a description of the change at issue and the “grounds by which the mail preparation change must comply with § 3010.23(d)(2). . . .” Id. The filing deadline would be triggered by written notice of the implementation date of the mail preparation change by the Postal Service. Id. at 3-4. The Postal Service would be required to “affirmatively designate only those changes that require compliance with § 3010.23(d)(2)” when it provided written notice of publication of the mail preparation change. Id. at 4.

Although the Initial NPR reiterated the Commission's previous explanation that the “Postal Service has the affirmative burden to determine whether a mail preparation change requires compliance with § 3010.23(d)(2) under the Commission's standard in Order No. 3047,” the initial rule did not propose including a statement of this affirmative burden in the rule.5

In proposing the initial rule, the Commission explained that the “primary purpose of the rulemaking is to ensure that the Postal Service properly accounts for the rate effects of mail preparation changes under § 3010.23(d)(2) of this chapter in accordance with the Commission's standard articulated in Order No. 3047.” Order No. 3048 at 1-2. The Commission stated that it also intended to “standardize the procedure and timeframe by which interested parties must file a motion with the Commission when they contend that a mail preparation change has a rate effect requiring compliance with the price cap rules.” Id. at 2. The Initial NPR was intended to provide “an avenue for interested parties to raise the possibility that the Postal Service may have erred by failing to account for the price cap impact of a mail preparation change.” Id. at 5.

In response to the Initial NPR, the Commission received numerous comments that raised questions about the utility of creating a separate procedural rule for motions concerning mail preparation changes. Commenters submitted concerns over how a separate motion procedure would affect the Commission's authority and responsibility to independently review mail preparations for compliance with the price cap rules.6 Commenters also raised questions concerning the potential redundancy of the proposed rule in light of the right to challenge the Postal Service's compliance with the price cap rules in existing proceedings before the Commission. See id. at 3. Commenters also suggested modifications to the various procedural components set forth in the initial proposed rule, raising concerns with the notice provisions and the filing deadline. See id. at 3-5.

The Postal Service did not share the concerns of the majority of the commenters. Instead, it suggested adding additional sections to the proposed motion procedure, including discovery, meet and confer requirements, and deadlines for resolving motions. Id. at 5-6.

On March 27, 2017, the Commission issued a revised notice of proposed rulemaking (Revised NPR) which, in response to comments on the Initial NPR, withdrew the initial proposed rule and proposed a revised rule.

The Revised NPR proposed adding a new section to the price cap rules, § 3010.23(d)(5). The revised proposed rule creates a standardized reporting process for mail preparation changes and memorializes the Postal Service's burden to demonstrate compliance with the price cap. Specifically, the revised proposed rule requires that the Postal Service publish notice of all mail preparation changes in a single, publicly available source. Order No. 3827 at 13-14. Under the revised rule, the Postal Service must file notice with the Commission designating the source it will use to provide public notice. Id. The revised proposed rule also requires the Postal Service to affirmatively state whether or not the mail preparation change requires compliance with § 3010.23(d)(2). Id. If the Postal Service's determination of price cap compliance is raised, the Postal Service is required to demonstrate, by a preponderance of the evidence, that the mail preparation change at issue does not require compliance with § 3010.23(d)(2).

The revisions to the rule were made “to better target the specific goal of ensuring that the Postal Service properly accounts for mail preparation requirement changes under § 3010.23(d)(2).” Id. at 11. The Revised NPR withdrew the initial proposal to create a separate motion procedure for issues concerning mail preparation changes. The Commission explained that it chose not to continue creating a separate motion procedure specific to compliance issues for mail preparation changes based on its review of existing procedures and practices and in response to commenter concerns. See id. at 8-11. The Commission requested comments in response to the Revised NPR.

The Postal Service, the Public Representative, the Association for Postal Commerce (PostCom), and the National Postal Policy Council, the National Association of Presort Mailers, and the Association for Mail Electronic Enhancement (collectively NPPC et al.) submitted comments in response to the Revised NPR.7

This supplementary information section is arranged as follows:

On October 5, 2017, at 82 FR 46434, EPA proposed to approve Illinois' nonattainment plans for the Lemont and Pekin SO2 nonattainment areas. These areas had been designated nonattainment on August 5, 2013, triggering a requirement for Illinois to submit plans to provide for attainment and to address other requirements under CAA sections 110, 172, and 192. Illinois submitted nonattainment plans for these areas on March 2, 2016, and submitted supplemental information on August 8, 2016 and May 4, 2017.

EPA's proposed rulemaking provides further background on Illinois' submittal. Within the body of this proposed rulemaking, the first section identified EPA's action designating the Lemont and Pekin areas as nonattainment, thereby triggering a requirement for Illinois to develop nonattainment plans for the areas.

The second section of the proposal provided an extensive discussion of EPA's guidance on the requirements that SO2 nonattainment plans must meet in order to obtain approval by EPA, including requirements to: Submit an emission inventory; provide for attainment; provide for reasonable further progress (RFP); implement RACM (including RACT); implement a new source permit program; and provide contingency measures. Of particular note, the proposal discussed the circumstances under which EPA expects to find that a plan that includes emission limits with averaging times of up to 30 days adequately provides for attainment of the 1-hour NAAQS.

The third section of the proposed rulemaking discussed EPA's review of Illinois' demonstration that its plans provide for attainment in the Lemont and Pekin areas. This section discussed the use of the atmospheric dispersion model known as AERMOD, the meteorological and emissions data used in the analysis, the emission limits that Illinois relied on, and the background concentrations that Illinois used. This included a discussion of Illinois' use of a 30-day average emission limit for the Powerton Generating Station (Powerton), operated by Midwest Generation, LLC, which is located in the Pekin area. Illinois set this limit at a level of about 58 percent of the level of the 1-hour limit that Illinois found would have provided for attainment, and which Illinois supplemented with a requirement that Powerton have less than five percent of the hours in any 30-day period exceeding the 1-hour emission limit that Illinois otherwise would have set. EPA also evaluated comments that Sierra Club submitted during the State's rulemaking process, including comments related to the proposed emission limit for Powerton. Finally, this section summarized EPA's review of Illinois' attainment demonstration, concluding that Illinois' proposed limit for Powerton, as supplemented, was comparably stringent to the 1-hour limit that would have been necessary to provide for attainment in accordance with EPA's guidance, and finding more generally that Illinois adequately demonstrated that its plans provided for attainment.

The fourth section of the proposal contained EPA's review of the rules Illinois adopted to limit the sulfur content of residual and distillate fuel oil, and EPA's conclusion that these limits were enforceable and approvable.

The fifth section of the proposal explained how Illinois' plans satisfied other nonattainment planning requirements, including requirements for a comprehensive emission inventory, RACM/RACT, an adequate new source review program, RFP, and contingency measures.

The sixth section of the proposal summarized EPA's proposed action, namely that EPA proposed to approve Illinois' plans and the emission limits in the underlying rules.

The seventh section of the proposal identified the rules that EPA was proposing to approve, and the eighth section contained EPA's review of statutory requirements and executive orders applicable to the proposed rulemaking.

In response to the proposed rulemaking, EPA received one comment letter, from Midwest Generation, LLC, dated November 6, 2017. The commenter indicated that it supports EPA's proposed rulemaking, provided SO2 air quality data for the Lemont and Pekin areas from 2013 through August 2017, and commented that “because significant SO2 emission reductions have already occurred in the designated non-attainment areas, the Illinois EPA will soon be authorized to submit a `clean data' petition to U.S. EPA for the ambient air monitoring sites that were the basis for the non-attainment designations.”

These comments, which support EPA's action, do not require any reassessment of the proposed rulemaking. Additionally, the proposed action did not address whether the Lemont and Pekin areas (at the monitoring sites and elsewhere) are currently attaining the SO2 standard; rather, the action evaluated Illinois' nonattainment plans for areas and proposed to find that those plans will provide for attainment. Therefore, the comments related to recent air quality monitoring data for the areas are not relevant to this rulemaking.

EPA is taking final action to approve Illinois' submission as a SIP revision, which the state submitted to EPA on March 2, 2016, and supplemented on August 8, 2016, and May 4, 2017, for attaining the 2010 1-hour SO2 NAAQS for the Lemont and Pekin SO2 nonattainment areas.

These SO2 nonattainment plans include Illinois' attainment demonstrations for the Lemont and Pekin SO2 nonattainment areas. These attainment demonstrations use dispersion modeling to demonstrate that the emission limits that Illinois adopted into Title 35 part 214 of the Illinois Administrative Code and submitted for EPA approval provide for air quality meeting the SO2 NAAQS.

These limits include a 30-day average limit for the Powerton power plant in the Pekin area. Illinois' modeling demonstrated that a 1-hour limit of 6,000 pounds of SO2 per hour for this facility, in conjunction with the other limits that Illinois adopted and submitted or otherwise has in place, provide for attainment in this area. Illinois demonstrated that a 30-day average limit of 3,452 pounds per hour is comparably stringent to a 1-hour limit of 6,000 pounds per hour at this facility. Therefore, and for reasons discussed in the proposed rulemaking, EPA finds that the limits submitted by Illinois, which for Powerton include a 30-day average limit of 3,452 pounds per hour supplemented by a requirement that emissions not exceed 6,000 pounds per hour for more than 5 percent of hours, provide for attainment of the 1-hour SO2 NAAQS.

These nonattainment plans also satisfy requirements for emission inventories, RACT/RACM, RFP, and contingency measures. Additionally, Illinois has previously addressed requirements regarding nonattainment area new source review. Therefore, EPA has determined that Illinois' SO2 nonattainment plans meet the applicable requirements of CAA sections 110, 172, and 192.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Illinois Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available through www.regulations.gov, and at the EPA Region 5 Office (please contact the person identified in the For Further Information Contact section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.1

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

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

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

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

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

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

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

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

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

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

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

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

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

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

40 CFR part 52 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

This rulemaking addresses a June 10, 2016, submission from the Indiana Department of Environmental Management (IDEM) intended to address all applicable infrastructure requirements for the 2012 PM2.5 NAAQS. On December 28, 2016, IDEM supplemented this submittal with additional documentation intended to address the transport requirements of Section 110(a)(2)(D) for the 2012 PM2.5 NAAQS; EPA will take action on this supplement in a separate rulemaking.

Under section 110(a)(1) and (2) of the CAA, states are required to submit infrastructure SIPs to ensure that their SIPs provide for implementation, maintenance, and enforcement of the NAAQS, including the 2012 PM2.5 NAAQS. These submissions must contain any revisions needed for meeting the applicable SIP requirements of section 110(a)(2), or certifications that their existing SIPs for the NAAQS already meet those requirements.

EPA highlighted this statutory requirement in an October 2, 2007, guidance document entitled “Guidance on SIP Elements Required Under Sections 110(a)(1) and (2) for the 1997 8-hour Ozone and PM2.5 1 National Ambient Air Quality Standards” (2007 Guidance) and has issued additional guidance documents, the most recent on September 13, 2013, entitled “Guidance on Infrastructure State Implementation Plan (SIP) Elements under CAA Sections 110(a)(1) and (2)” (2013 Guidance). The SIP submission referenced in this rulemaking pertains to the applicable requirements of section 110(a)(1) and (2), and addresses the 2012 PM2.5 NAAQS.

EPA is acting upon the SIP submission from Indiana that addresses the infrastructure requirements of CAA section 110(a)(1) and (2) for the 2012 PM2.5 NAAQS. The requirement for states to make SIP submissions of this type arises out of CAA section 110(a)(1), which states that states must make SIP submissions “within 3 years (or such shorter period as the Administrator may prescribe) after the promulgation of a national primary ambient air quality standard (or any revision thereof),” and these SIP submissions are to provide for the “implementation, maintenance, and enforcement” of such NAAQS. The statute directly imposes on states the duty to make these SIP submissions, and the requirement to make the submissions is not conditioned upon EPA's taking any action other than promulgating a new or revised NAAQS. Section 110(a)(2) includes a list of specific elements that “[e]ach such plan” submission must address.

EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of CAA section 110(a)(1) and (2) as “infrastructure SIP” submissions. Although the term “infrastructure SIP” does not appear in the CAA, EPA uses the term to distinguish this particular type of SIP submission from submissions that are intended to satisfy other SIP requirements under the CAA, such as SIP submissions that address the nonattainment planning requirements of part D and the prevention of significant deterioration (PSD) requirements of part C of title I of the CAA, and “regional haze SIP” submissions required to address the visibility protection requirements of CAA section 169A.

In this rulemaking, EPA will not take action on three substantive areas of section 110(a)(2): (i) Existing provisions related to excess emissions during periods of start-up, shutdown, or malfunction (“SSM”) at sources, that may be contrary to the CAA and EPA's policies addressing such excess emissions; (ii) existing provisions related to “director's variance” or “director's discretion” that purport to permit revisions to SIP approved emissions limits with limited public notice or without requiring further approval by EPA, that may be contrary to the CAA; and, (iii) existing provisions for PSD programs that may be inconsistent with current requirements of EPA's “Final NSR Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (“NSR Reform”). Instead, EPA has the authority to address each one of these substantive areas in separate rulemakings. A detailed history, interpretation, and rationale as they relate to infrastructure SIP requirements can be found in EPA's May 13, 2014, proposed rule entitled, “Infrastructure SIP Requirements for the 2008 Lead NAAQS” in the section, “What is the scope of this rulemaking?” (see 79 FR 27241 at 27242-27245).

On August 31, 2017 (82 FR 41379), EPA proposed to approve the above-cited elements of Indiana's infrastructure SIP submission for the 2012 PM2.5 NAAQS. In response to this proposed action, EPA received one comment from a person identifying as a “citizen of Indiana and a law student.” The commenter expressed support for EPA's proposed approval of the Indiana infrastructure SIP for the PM2.5 NAAQS, but “encourage[d] some sort of change that would be stricter on states regarding localities.” EPA thanks the commenter for her/his thoughts and support regarding rulemakings.

EPA is taking final action to approve most elements of a submission from Indiana certifying that its current SIP is sufficient to meet the required infrastructure elements under section 110(a)(1) and (2) for the 2012 PM2.5 NAAQS. EPA's actions for the state's satisfaction of infrastructure SIP requirements, by element of section 110(a)(2) and NAAQS, are contained in the table below.

In the above table, the key is as follows:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

40 CFR part 52 is amended as follows:

The factual background for this action is discussed in detail in our September 14, 2017 direct final rule (DFR) and proposal (82 FR 43180, 82 FR 43208) approving the revised Missoula Maintenance Plan into the Montana SIP. The EPA received one adverse comment on the rulemaking and attempted to withdraw the DFR prior to the effective date of November 13, 2017. However, the EPA inadvertently did not withdraw the DFR prior to that date and the rule became prematurely effective on November 13, 2017, revising the Montana SIP to reflect the approval of the revised Missoula Maintenance Plan. In this final rulemaking, the EPA is responding to the comments submitted on the proposed revision to the Montana SIP, and is re-approving the revised Missoula Maintenance Plan into the Montana SIP. The background information found in the DFR is still relevant and our September 14, 2017 proposal provides the basis for this final action.

The EPA finds that there is good cause under section 553(d)(3) of the Administrative Procedure Act (APA) to make this action re-approving the revisions to the Montana SIP effective upon publication in the Federal Register. Section 553(d)(3) of the APA allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. 553(d)(3). This rule does not create any new regulatory requirements and does not change any existing regulatory requirements. For these reasons, the EPA finds good cause under APA section 553(d)(3) for the re-approval to become effective on the date of publication of this action.

The EPA received two anonymous public comments, one which we considered adverse, on our action to approve Montana's September 19, 2016 SIP submittal. Below is a summary of each comment and the EPA's response.

Comment: The first commenter asked whether we were “expecting any push-back” from businesses in extending the carbon monoxide plan for another 10 years.

Response: Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state actions, provided that they meet the criteria of the CAA. With that, the EPA notes that we did not receive any comments from any individual businesses or business groups.

Comment: The second commenter asserted that the EPA had failed to consider the effects of approving the SIP submission on the economy or energy independence as required by a March 28, 2017 Executive Order entitled “Promoting Energy Independence and Economic Growth.” (E. O. 13783).

Response: Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state actions, provided that they meet the criteria of the CAA. The EPA cannot consider disapproving a SIP submission or require any changes based on E. O. 13783.

The EPA is re-approving the revised Missoula Maintenance Plan submitted on September 19, 2016. This maintenance plan meets the applicable CAA requirements, and we have determined it is sufficient to provide for maintenance of the 8-hour CO NAAQS over the course of the second 10-year maintenance period out to 2027. This rule, which responds to the adverse comment received, finalizes our proposed approval of the revised section of Montana's SIP.

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 2, 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).)

40 CFR part 52 is amended as follows:

I. Why is the EPA issuing this rule in final form without first issuing a proposal?

Today's final rule is limited to correcting a mistake to procedural requirements for administrative adjudicatory hearings and appeals from such hearings and from permit decisions. As an amendment to a procedural rule, this final rule itself is a procedural rule. Under the Administrative Procedure Act, an agency may issue “rules of agency organization, procedure, or practice” without first proposing such rules for public comment. 5 U.S.C. 553(b). Accordingly, public comment is not required.

In addition, EPA has determined that this rule is effective immediately upon publication in the Federal Register. In general, Section 5 U.S.C. 553(d) requires that substantive rules not become effective less than 30 days after publication. However, this action involves not a substantive rule but a procedural rule. Moreover, the purpose of the 30-day waiting period prescribed in section 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. This action does not create any new regulatory requirements such that affected parties would need time to prepare before the actions take effect. To the contrary, this action merely corrects typographical errors and restores regulatory text that was inadvertently deleted thereby restoring the prior status quo. Furthermore, the absence of these provisions may result in confusion to parties as well as inefficiencies in the appeals process and thus it is in the public interest have the restoration of those provisions effective immediately. See 5 U.S.C. 553(d)(3).

This action affects parties involved in EPA administrative adjudicatory proceedings for the assessment of civil penalties, issuance of various compliance orders, and termination or suspension of certain permits, under part 22 of title 40 of the CFR. See 40 CFR 22.1. This action also affects parties involved in appeal of EPA permits under part 124 of title 40 of the CFR.

The rule document published on January 9, 2017 (82 FR 2230), revised the filing and service procedures used in permit appeals to the Environmental Appeals Board. The EPA also revised 40 CFR 124.19(b)(1) and (2) so that the deadlines for filing a response to a petition for review are based on the date the petition for review is served, rather than the date it is filed. Subsections (3) and (4) were intended to remain unchanged but were inadvertently removed from the rule.

Additionally, in § 124.19(i)(2)(iii), the address for delivery by hand or courier to the Environmental Appeals Board incorrectly identifies the room number as 3334 when the actual room number is 3332 and language regarding methods of delivery by hand or courier was inadvertently omitted.

Finally, the language in § 124.19(i)(3)(ii) revising the service requirements to allow for service by email inadvertently contains an extra “or” that does not belong so that this provision of the rule now reads: “Service must be by first class U.S. mail, by any reliable commercial delivery service, or, if agreed to by the parties, by facsimile or other electronic means, including but not necessarily limited to or email.” Removal of the last “or” will make the sentence clearer.

As published on January 9, 2017 (82 FR 2230), the final regulation contains an error that resulted in the inadvertent removal of two procedural provisions that govern the participation of permit applicants, State, and Tribal Authorities in permit proceedings before the Environmental Appeals Board. The absence of these provisions may result in confusion to parties and inefficiencies in the appeals process and thus these provisions need to be reinstated. Additionally, revising the Environmental Appeals Board's address for delivery by hand or courier in § 124.19(i)(2)(iii) to reflect the correct room number and to include methods of delivery by hand or courier will avoid potential confusion. Finally, the superfluous “or” in the third sentence of § 124.19(i)(3)(ii) is confusing. Removal of that word will not change the meaning of the sentence and will make the provision clearer.

Accordingly, 40 CFR part 124 is corrected as follows:

This is a summary of the Commission's Order, DA 18-12, adopted and released on January 5, 2018. The document is available for download at http://transition.fcc.gov/Daily_Releases/Daily_Business/2018/db0105/DA-18-12A1.pdf. The complete text of this document is also available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW, Room CY-A257, Washington, DC 20554.

The Bipartisan Budget Act of 2015 included, as Section 701 thereto, the 2015 Inflation Adjustment Act, which amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410), to improve the effectiveness of civil monetary penalties and maintain their deterrent effect. Under the act, agencies are required to make annual inflationary adjustments by January 15 each year. The adjustments are calculated pursuant to Office of Management and Budget (OMB) guidance. OMB issued guidance on December 15, 2017, and this Order follows that guidance. We therefore update the civil monetary penalties set forth in the Commission's rules, to reflect an annual inflation adjustment that derives from OMB's cost-of-living multiplier of 1.02041.

This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

The Commission will send a copy of this Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 1 as follows:

General Background

Black sea bass are jointly managed by the Mid-Atlantic Fishery Management Council (Council) and the Atlantic States Marine Fisheries Commission (Commission) as part of the joint Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP). States manage black sea bass within 3 nautical miles (4.83 km) of their coasts under the Commission's plan. The applicable Federal regulations govern vessels and individual anglers fishing in Federal waters of the exclusive economic zone (EEZ), as well as vessels possessing a Federal black sea bass charter/party vessel permit, regardless of where they fish. This rule applies to black sea bass (Centropristis striata) in U.S. waters of the Atlantic Ocean from 35 E 13.3′ N lat. (the latitude of Cape Hatteras Lighthouse, Buxton, North Carolina) northward to the U.S./Canada border.

This action implements the addition of a Federal recreational black sea bass fishing season during February of 2018. Additional background information regarding the development of this action was provided in the proposed rule (83 FR 780; January 8, 2018) and is not repeated here. The Federal recreational measures for the remainder of 2018 are still in development and will be implemented through a separate rulemaking later this spring.

This action implements a 28-day winter season for the 2018 recreational black sea bass fishery during the month of February. The current black sea bass recreational management measures of a 12.5-inch (31.75-cm) minimum size and 15-fish possession limit still apply during this February season. As explained in the proposed rule, this action responds to the favorable 2016 benchmark stock assessment for black sea bass, and is intended to increase recreational fishing access to a stable stock at a time of year when few other recreational species are available.

Two states, North Carolina and Virginia, have formally declared their intent to participate in the February 2018 recreational season. To confirm their participation, both states submitted a plan to offset their expected harvest during this winter season through their recreational management measures for remainder of the 2018 fishing year.

Commission-based measures implemented by states may vary by state, and differ from the Federal water measures. Because only Virginia and North Carolina have committed to participate in this winter season, the fishery will only be open for these states. Federal permit holders are required to adhere to the more restrictive set of measures irrespective of whether the vessel is fishing in state or Federal waters. Similarly, private anglers must adhere to the recreational measures implemented by the state in which the fish will be landed as all the state-implemented measures place restrictions on season, minimum fish size, and per-angler possession limit. For additional information on state-implemented management measures, please contact the marine fisheries management agency for the state in question or the Commission (www.asmfc.org; 703-842-0740).

The public comment period for the proposed rule ended on January 23, 2018. Thirteen comments were received from the public on this rule. Many of the comments expressed similar concerns.

Comment 1: One commenter was dissatisfied with the regulatory flexibility analysis (RFA) process and believed that more input from small businesses should have been taken into account during the development stage of this rule.

Response 1: Thorough RFA analyses were prepared for this action consistent with Small Business Administration guidance. The action was also discussed at several public Council and Commission meetings where the concerns of small businesses were considered. This comment did not raise specific issues regarding the proposed rule or the economic impact analyses summarized in the initial RFA for this action. Rather, the commenter stated frustrations with the RFA process in general, stating that RFA regulations need to be updated and the small business community needs to be better included in policy discussions during their development. These are larger changes that are outside the purview of this action.

Comment 2: One commenter was in favor of this action and is looking forward to increased fishing opportunity.

Response 2: NMFS agrees and notes that increased opportunity is a key purpose of this action.

Comment 3: Several commenters opposed implementation of the proposed season, stating concerns over the reduction in the recreational harvest limit for the rest of the 2018 fishing year, the inability of northern states to adequately participate due to weather conditions, the unfavorable coastal distribution of black sea bass in February, and the feasibility of the season overall. Many of these commenters noted that better opportunities would be created by lengthening the existing seasons into April or October or changing the bag limits.

Response 3: The purpose of this action is to create more recreational fishing access and opportunity at a time when other options are limited or restricted in the winter. There are more varied recreational opportunities in the later months of the year. Only Virginia and North Carolina have committed to participate in this February season, so only those states will need to account for any catch during the rest of the 2018 fishing year. The expected harvest from these two states is expected to be minimal and will not appreciably reduce the quota available for the summer and fall fishery.

Comment 4: One commenter was upset about Federal agencies' varied interpretations and implementations of the National Environmental Policy Act (NEPA), arguing that state and local governments should play a larger role in cooperative actions to better represent the “human environment.”

Response 4: A full environmental assessment (EA) was prepared consistent with applicable NEPA guidance and Council for Environmental Quality (CEQ) requirements. This action was also developed with full collaboration from state agencies through the Commission. No comments were received that raised specific concerns or that noted deficiencies with the prepared NEPA analyses in support of this action.

Comment 5: The Massachusetts Division of Marine Fisheries (MA DMF) submitted a comment raising concerns about the lack of data, reporting, and accountability during Wave 1 in the recreational fishery. They also expressed concern about the potential implications of this season on future recreational rulemaking for states at the Commission level, and Council decisions at the Federal level.

Response 5: The Council and Commission openly acknowledged these concerns during this action's development. Furthermore, NMFS agrees, which is why the 2018 fishing opportunity is restricted to February and is, by design, a small scale endeavor to increase access with minimum risk. The Council is considering options to address the noted reporting and accountability issues in its development of the Wave 1 recreational Letter of Authorization program for 2019 and future years. NMFS encourages MA DMF to continue raising these concerns with the Council and Commission during continued development of a Wave 1 recreational black sea bass fishery.

Comment 6: One commenter asked that we protect the livelihoods of commercial fishermen.

Response 6: NMFS agrees and considers this a critical component of its overall mandate. However, this comment does not pertain to the subject action, which involves the recreational fishery.

Comment 7: One commenter claimed that black sea bass are intelligent and should not be farmed to extinction.

Response 7: The recent 2016 benchmark stock assessment showed that wild black sea bass populations are thriving at nearly three times the biomass target, and not at risk of extinction. Also, this action pertains to recreational fishing activities, not aquaculture or marine farming practices.

There are no changes from the proposed rule.

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

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

This final rule does not duplicate, conflict, or overlap with any existing Federal rules.

This action does not contain a collection of information requirement for purposes of the Paperwork Reduction Act.

The Assistant Administrator for Fisheries, NOAA, finds good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay of effectiveness period for this rule, to ensure that the action is in place on or about February 1, 2018. This action implements an additional Federal black sea bass recreational season during February 2018. A delay in its effectiveness would reduce the length of the open winter season; unnecessarily disadvantaging recreational anglers that wish to participate, and limiting the fishing opportunity that this action was meant to create.

Furthermore, regulated parties do not require any additional time to come into compliance with this rule. Unlike actions that require an adjustment period, charter/party operators will not have to purchase new equipment or otherwise expend time or money to comply with these management measures. Rather, complying with this final rule simply means adhering to the existing management measures for black sea bass while the charter/party operators are engaged in fishing activities during the new open season. This action has been discussed at multiple Council and Commission public meetings throughout its development and is expected by the recreational fishing sector.

This rule is being issued at the earliest possible date. Preparation of the proposed rule was dependent on completion of the EA in support of the recommendations developed by the Council and Commission. Documentation in support of the Council's recommended specifications is required for us to provide the public with information from the environmental and economic analyses, as required in rulemaking, and to evaluate the consistency of the Council's recommendation with the Magnuson-Stevens Act and other applicable law. The Council's decision to recommend a February season was not final until December 13, 2017, and a complete document was finalized in late December 2017. Due to this tight timeline, we were unable to prepare this action early enough to allow for both an appropriate public comment period and a 30-day delay in effectiveness. The proposed rule published on January 8, 2018, with a 15-day comment period ending January 23, 2018. This action creates an additional Federal recreational season for black sea bass and increases fishing opportunity and access in the winter that would otherwise be constrained under the current seasons. If this final rule were delayed for 30 days, the proposed 28-day recreational season would be severely shortened or may not become effective at all. This would diminish any opportunity created by opening a winter season, and would be contrary to the purpose of the action. For these reasons, a 30-day delay in effectiveness would be contrary to the public interest and is therefore waived.

The final regulatory flexibility analysis (FRFA) included in this final rule was prepared pursuant to 5 U.S.C. 604(a), and incorporates the initial regulatory flexibility analysis (IRFA) and a summary of analyses completed to support the action. A public copy of the environmental assessment/IRFA is available from the Council (see ADDRESSES). The preamble to the proposed rule included a detailed summary of the analyses contained in the IRFA, and that discussion is not repeated here.

NMFS received one comment on the RFA process in general, stating that RFA regulations need to be updated and the small business community needs to be afforded more inclusion in policy discussions during their development. However, this comment did not raise specific issues regarding the proposed rule or the economic analyses summarized in the IRFA. Refer to the “Comments and Responses” section of this preamble for more detail. No changes to the proposed rule are necessary as a result of the public comments.

This final rule affects small entities engaged in recreational fish harvesting operations within the black sea bass fishery. For the purposes of the RFA analysis, the ownership entities (or firms), not the individual vessels, are considered to be the regulated entities. Individually permitted vessels may hold permits for several fisheries, harvesting species of fish that are regulated by several different FMPs, even beyond those affected by this action. Furthermore, multiple-permitted vessels and/or permits may be owned by entities affiliated by stock ownership, common management, identity of interest, contractual relationships, or economic dependency. Because of this, some individually permitted vessels may be part of the same firm because they have the same owner for the purpose of this analysis.

In terms of the RFA, a business primarily engaged in for-hire fishing activity is classified as a small business if it has combined annual receipts not in excess of $7.5 million. The current ownership data set used for this analysis is based on calendar year 2016 (the most recent complete year available) and contains average gross sales associated with those permits for calendar years 2014 through 2016. According to the ownership database, there were 406 for-hire permits that generated revenues from recreational fishing for various species during the 2014-2016 period. Of these permits, there were 328 that were not affiliated with any other ownership group. The remaining 78 for-hire vessels were comprised of affiliated ownership groups with between two and six for-hire vessels for a total of 359 for-hire affiliate firms; all of which are categorized as small businesses. Although it is not possible to derive what proportion of the overall revenues came from specific fishing activities, further analysis conducted by the Council and NMFS during the development of this action identified that in 2016 there were 291 for-hire entities that recreationally caught black sea bass. In 2013, the last year that a recreational black sea bass fishery was open in January and February, 331 for-hire firms caught black sea bass recreationally; however, only 39 of those were active during the Wave 1 (January and February) period. While these are the best available estimates of potential participation in the February season implemented by this action, these numbers are not necessarily indicative of the number of entities that will actually participate. Overall, participation is expected to be low as only Virginia and North Carolina declared into the fishery, and general comments on the proposed rule suggest that businesses are primarily promoting and planning for the busier summer and fall seasons.

No additional reporting, recordkeeping, or other compliance requirements are included in this final rule.

NMFS is implementing the Council-recommended final rule to open a February recreational season in the 2018 black sea bass fishery to satisfy the Magnuson-Stevens Act requirements to ensure that fish stocks are not subject to overfishing, while allowing the greatest access to the fishery, and opportunity to achieve optimum yield. The objective of this action is to increase fishing opportunity while maintaining catch within the recreational harvest limit and annual catch limit.

As described in the proposed rule for this action, two other alternatives to the approved action were considered. Maintaining the status quo with no winter fishing did not take advantage of the favorable stock status or provide any additional access or opportunity in the recreational black sea bass fishery. Opening the fishery for both January and February could have created more recreational fishing opportunity in 2018; however, given the lack of recreational data available, the time constraints involved, and the potential disproportionate impacts to state recreational fisheries later in the year, this alternative was not selected. The action described in this final rule was chosen as the best feasible way to increase recreational fishing opportunity in the black sea bass fishery in 2018 with the lowest potential negative impact.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a letter to permit holders that also serves as small entity compliance guide was prepared and will be sent to all holders of Federal charter/party permits issued for the black sea bass fishery. In addition, copies of this final rule and guide (i.e., permit holder letter) are available from NMFS (see ADDRESSES) and at the following website: www.greateratlantic.fisheries.noaa.gov.

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