Federal Register Vol. 82, No.188,

I. Summary of Changes A. Background

NCPC's 2004 Policies were adopted in 2004 (69 FR 41299, July 8, 2004) and generally remain appropriate. However certain portions of the 2004 Policies require revision to simplify, streamline, and improve the effectiveness of NCPC's process for complying with NEPA. Accordingly, this document adopts a complete new rule.

One of the most significant changes reflected in the new rule is the elimination of procedures for complying with Section 106 of the National Historic Preservation Act (NHPA). In 2004, when it adopted the 2004 Policies, NCPC opted to issue combined NEPA and NHPA guidance to ensure coordinated implementation of both procedures. However, regulations promulgated by the Advisory Council on Historic Preservation (ACHP) do not require agencies to adopt agency specific processes and procedures (see 36 CFR chapter VIII). Instead ACHP regulations establish the processes and procedures all Federal Agencies must follow. This resulted in the inclusion of duplicative information in NCPC's 2004 Policies. While this information proved helpful, it diverted attention away from NCPC's agency-specific NEPA procedures mandated by the Council on Environmental Quality (CEQ). Accordingly, this rule does not include detailed references to the Section 106 consultation process. It does include a reference to coordination between NEPA and NHPA and consideration of historic resources in the NEPA process.

To clarify roles and responsibilities, these Regulations distinguish between Federal Agency applicants and Non-Federal Agency applicants. Federal Agency applicants include cabinet level departments and executive agencies such as the U.S. General Services Administration (GSA). Non-Federal Agency applicants include, without limitation, the Smithsonian Institution, the John F. Kennedy Center for the Performing Arts, the National Gallery of Art, the U.S. Institute of Peace, the Government of the District of Columbia, the Maryland National Capital Park and Planning Commission (MNCPPC), and private parties and entities implementing projects on Federal land. NCPC's jurisdiction extends to Non-Federal Agency applicants when they undertake projects on federally-owned land. Under this rule, NCPC serves as the Lead Agency for Non-Federal Agency applications. This is necessitated by the fact the Non-Federal Agencies are not subject to NEPA. However, if the Commission takes an approval action on a Non-Federal Agency application, the requirements of NEPA apply to the Commission's decision-making process. This means NCPC must undertake the requisite steps of the NEPA process for a Non-Federal Agency application to meet its legal obligation.

These Regulations also alter the timing and sequencing of an applicant's submission of NEPA documentation for applications governed by the National Capital Planning Act and the Commemorative Works Act. Under the 2004 Policies, an applicant was required to complete the NEPA process at the time of preliminary review. Under this rule, an applicant must complete its NEPA process at the time of final review. This revised approach allows the Commission an opportunity to provide input on a project when it is still in the developmental phase. It also provides a NEPA sequencing consistent with Federal Agency project development schedules. This eliminates the pressure on Federal Agency applicants to expedite its NEPA process to meet NCPC's current sequencing requirements.

NCPC's rule also includes changes to the list of projects eligible for application of a Categorical Exclusion (CATEX). The Regulations include several new CATEXs. NCPC eliminated several existing CATEXs because they were based on old, antiquated authorities which have little to no relationship to NCPC's present day review roles. The rule also increase the number of extraordinary circumstances which negate the application of a CATEX.

NCPC published a Proposed Rule (82 FR 42570, May 30, 2017) addressing revisions to its 2004 Policies, establishing a 45-day public comment period. The public comment period closed on July 14, 2017.

NCPC received a little under 100 comments on its proposed NEPA rule Regulations. Comments were submitted by the General Services Administration, the U.S. Department of the Interior and it's National Park Service, and the National Aeronautics and Space Administration; the Smithsonian Institution; the Washington Area Metropolitan Transit Authority; the National Trust for Historic Preservation; The Committee of 100 on the Federal City; approximately 21 members of the general public; and two private consulting firms. A summary chart of all the comments received and NCPC's response thereto can be found on NCPC's Web site at www.ncpc.gov/subnepa.

The major comments can be grouped into six categories: (1) The elimination of detailed reference to compliance with Section 106 of the NHPA; (2) the treatment of Non-Federal Agencies in the Regulations; (3) the timing and sequencing of submitting NEPA Documents/Co-Signing a Finding of No Significant Impact (FONSI) or a Record of Decision (ROD); (4) NCPC's reliance on the CATEX of other government agencies; and (5) the minimal focus on public participation in the NEPA process/lack of public knowledge of process for administering CATEXs.

NCPC decided to rename its NEPA requirements the National Environmental Policy Act Regulations (Regulations). This title is more descriptive of the true nature of the Regulations versus the title of Environmental Policies and Procedures conferred on the 2004 Policies.

Several comments addressed the elimination of NHPA Section 106 procedures from the Regulations. The National Trust for Historic Preservation generally agreed with the elimination, but it suggested designating the NEPA Lead and Cooperating Agencies as the Lead and Consulting Parties for the Section 106 process. NCPC disagrees with this suggestion. NCPC maintains it is inappropriate to designate roles for the Section 106 process in its NEPA Regulations. To compensate for the elimination, a member of the public suggested reference to ACHP guidance on the ACHP for integrating NEPA and the Section 106 processes. While NCPC found merit to this comment and initially inserted an endnote to the ACHP Web site and the CEQ Web site for general NEPA guidance, CEQ believed the references unnecessary. Finally, the Committee of 100 on the Federal City maintained the elimination of references to the Section 106 process sent a negative message about the connection between the two processes. NCPC notes this was not its intention as evidenced by the clearly articulated policy in § 601.2(d) to integrate the requirements of NEPA with, among others, the requirements of the NHPA.

The role of Non-Federal Agencies in the NEPA process generated a number of comments. The Smithsonian Institution (designated a Non-Federal Agency in the Regulations) recommended the re-designation of Federal and Non-Federal Agencies as Executive and Non-Executive Agencies on the theory that this might be less confusing. NCPC declined to make this change because of the repeated use of the term “federal” in the National Capital Planning Act (40 U.S.C. 8701 et seq.). However, for clarification purposes, NCPC revised the definition of Non-Federal Agencies to indicate this designation applies only for purposes of NEPA.

One member of the public challenged the legality of designating Non-Federal Agencies as “Cooperating Agencies” given that the CEQ regulatory definition only designates “federal agencies” as capable of serving in this capacity. NCPC notes this statement is only partially correct. The definition of Cooperating Agency in 40 CFR 1508.5 also extends to state or local agencies rendering such agencies eligible to serve as Cooperating Agencies. This makes Cooperating Agency status appropriate for the Government of the District of Columbia and the Maryland National Capital Park and Planning Commission. As to the others listed in the definition—Smithsonian Institution, the John F. Kennedy Center for the Performing Arts, the National Gallery of Art, the U.S. Institute of Peace, and private parties undertaking development on Federal land—NCPC agrees an alternative approach is necessary.

NCPC also agrees with the same individual's multiple comments that NCPC does not undertake NEPA “on behalf” of Non-Federal Agencies. NCPC recognizes that the NEPA obligation for a Non-Federal Agency application belongs to NCPC. NCPC believes a minor wording change to “undertakes NEPA for a Non-Federal Agency application” solves this concern.

Turning to an alternative approach for NEPA compliance for Non-Federal Agency applications, NCPC notes it is not alone in confronting the issue of Non-Federal Agency applications to which NEPA applies because of the Federal Agency's approval/permitting authority. NCPC looked at the NEPA regulations for similarly situated Federal Agencies to ascertain how they handle the issue. One Federal Agency lists in its regulations the information that the Non-Federal Agency (permittee and owner of the project) must submit to facilitate staff's preparation of the requisite NEPA document. Because this approach increased the complexity of the agency's regulations, and NCPC's goal is to streamline its regulations consistent with the Administration's articulated regulatory reduction goals, NCPC adopted a modified version of this approach.

NCPC will enter into a Memorandum of Agreement (MOA) (renamed from a Memorandum of Understanding or MOU in the proposed rule) with Non-Federal Agencies. The MOA will specify, among others, the information the Non-Federal Agency must submit to enable preparation of the requisite environmental document by NCPC staff and the timing of the information's submission. Contrary to the comments on one individual, NCPC disagrees the MOA approach is legally insufficient. This comment implies NCPC is relinquishing its NEPA responsibilities by entering into a MOA. This is not the case. NCPC considers the MOA an internal operating procedure within its authority to implement. It is also an efficient and effective way to fulfill its NEPA obligation and avoid some of the pitfalls associated with the prior approach of Cooperating Agency status. The problems avoided include budgetary issues if the Non-Federal Agency provides money to NCPC to retain a contractor, Non-Federal Agency participation in NCPC's retention of the Non-Federal Agency funded contractor, and the potential for two A&E contractors working on different aspects of the same project. To facilitate public awareness, NCPC will post the completed MOA on the NCPC's Web site.

NCPC notes that in a follow-up conversation with the commenter to explore the rationale for opposing an MOA, the commenter agreed the MOA approach as outlined above is legally sufficient. NCPC conducted the follow-up conversation after the comment period closed, and no new comments were discussed during the conversation.

All the government agencies supported NCPC's process change of moving NEPA completion to coincide with the Commission's final approval. There was one concern expressed about the sequencing of NEPA and the Commemorative Works Act's review process, but NCPC believes the comment was the result of a misunderstanding of the process.

Multiple Federal Agencies also advised against incorporation of a provision allowing NCPC to co-sign another agency's FONSI or ROD. NCPC notes that the Regulations render this practice discretionary. However, if both agencies agree on the contents of a FONSI or ROD, it makes no sense for NCPC to prepare a duplicated document for NCPC to sign. Obviously, if the two agencies have different reasons for reaching a FONSI or a ROD, co-signature is not an option, and each agency will have to prepare its own document. Co-signature is also not an option if there is disagreement over the ability to reach a FONSI or ROD. This disagreement points to problems with the Environmental Document that must be resolved before the project can be presented to the Commission. Finally, NCPC reminds Federal Agencies that co-signing a FONSI or ROD is entirely consistent with the Administration's efforts to streamline regulatory processes especially NEPA.

The inclusion of five Categorical Exclusions that allowed NCPC to use the exclusion of another agency when it had no corresponding CATEX generated a number of comments pro and con. Federal Agencies supported the concept because it removed the possible need for them to prepare an EA if they used a Categorical Exclusions for their project but NCPC had no exclusion it could apply. The National Trust for Historic preservation and a member of the general public objected to the approach noting it was inconsistent with CEQ's long standing policy to disallow such an approach.

As required, NCPC submitted an administrative record to CEQ for all of its proposed CATEX, most of which are carry-overs from several iterations of prior regulations. The administrative record noted that the five CATEXs predicated upon use of another agency's exclusion had not been enlarged in scope and the CATEX continued to be appropriately limited by extraordinary circumstances, the number of which has been significantly increased in the Regulations.

NCPC's Administrative Record for the five CATEXs at issue was initially accepted, but upon further reflection CEQ has decided to adhere to its long standing policy to disallow such an approach. Consequently, NCPC has removed all five of the CATEXs at issue. Since four of the five CATEX at issue have been put to little use for a prolonged period of time, NCPC does not believe its implementation of NEPA will be unduly burdened by this removal. The addition of new CATEX may also fill the gap.

The Committee of 100 on the Federal City commented on the silence of the proposed regulation on the goals, criteria and process for meaningful public participation. They encouraged the incorporation of meaningful public participation policy and goals to rectify this deficiency.

NCPC is fully committed to open government and transparency and believes its past actions amply substantiate this commitment not only in the NEPA and Section 106 processes but to all of its significant planning activities. Accordingly, the Regulations clearly articulate a policy of using the NEPA process to “. . . foster meaningful public involvement in NCPC's decisions.” Moreover, throughout the Regulations, there are repeated opportunities for public participation to include in the EIS scoping process with an option for NCPC to conduct a public scoping process for Environmental Assessments as well; in the review of draft Environmental Assessments (EAs) (at NCPC's option) and Environmental Impact Statements (EISs); and in the review of FONSIs and RODs. Moreover, at the suggestion of another commenter, documents required to be published in the Federal Register (Notice of Intent to Prepare an EIS and Notice of Availability of an EIS) will also be published on the NCPC Web site where parties interested in NCPC activities are more likely to go to stay abreast of current NCPC events.

The Committee of 100 on the Federal City also expressed concern about the Regulation's silence on the administrative process for the application of a CATEX. NCPC notes that among the Commission's official delegations is one conferring administrative responsibility for NEPA on the Executive Director. In the future, owing to the recent redesign of NCPC's Web site, the delegations will be listed on the Web site. However, NCPC notes this responsibility, how and when it is made, and how the public is notified of the decision is set forth in §§ 601.11(c) and 601.12(b) of the Regulations.

As required by CEQ Regulations, NCPC submitted a draft of this final rule to CEQ for its review and approval following revisions to the Regulations to reflect comments received during the public comment period. CEQ responded with a number of recommendations. Most of the recommendations were minor in nature and involved language clarifications, addition of cross-references to relevant sections of CEQ's regulations, and inclusion of additional language.

The one recommendation falling outside the minor category related to the timing of the signing FONSIs and RODs by Federal Agency applicants and NCPC for Non-Federal Agency applications. NCPC has in the past accepted signed FONSIs and RODs at the time an application for final approval is submitted to the Commission. This practice reflects the close coordination between NCPC and its applicants and the likelihood that the Commission, with rare exceptions, will approve the final application. CEQ (and one commenter) pointed out that notwithstanding the high probability the signed FONSI or ROD would reflect the Commission's decision, it was technically incorrect. The signature of a FONSI or ROD can only occur after the Commission takes a final action and cannot precede a future, anticipated decision of approval.

In response to CEQ's comment, the rule requires NCPC to sign its decision documents following Commission final approval of an application. As to Federal Agencies, the rule is silent as to when the Federal Agency may sign its FONSI or ROD. However, there is now an express provision that places the burden on Federal Agency applicants to review their Environmental Documents and their FONSI or ROD to determine if revisions are necessary if at the time of final approval the Commission disapproves an application and requires changes to the project.

Following incorporation of all of CEQ's recommended changes into the regulations, NCPC received final CEQ sign off on September 21, 2017.

By Memorandum dated October 12, 1993 from Sally Katzen, Administrator, Office of Information and Regulatory Affairs (OIRA) to Heads of Executive Departments and Agencies, and Independent Agencies, OMB rendered the NCPC exempt from the requirements of Executive Order 12866 (See, Appendix A of cited Memorandum). Nonetheless, NCPC endeavors to adhere to the provisions of the Executive Order.

NCPC is exempt from this Executive Order because it is exempt from E.O. 12866, NCPC confirmed this fact with OIRA.

As required by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the NCPC certifies that the rule will not have a significant economic effect on a substantial number of small entities.

This is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. It does not have an annual effect on the economy of $100 million or more; will not cause a major increase in costs for individuals, various levels of governments or various regions; and does not have a significant adverse effect on completion, employment, investment, productivity, innovation or the competitiveness of U.S. enterprises with foreign enterprises.

A statement regarding the Unfunded Mandates Reform Act is not required. The rule neither imposes an unfunded mandate of more than $100 million per year nor imposes a significant or unique effect on State, local or tribal governments or the private sector.

In accordance with Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. The rule does not substantially and directly affect the relationship between the Federal and state governments.

The General Counsel of NCPC has determined that the rule does not unduly burden the judicial system and meets the requirements of Executive Order 12988 3(a) and 3(b)(2).

The rule does not contain information collection requirements, and it does not require a submission to the Office of Management and Budget under the Paperwork Reduction Act.

The rule is of an administrative nature, and its adoption does not constitute a major Federal action significantly affecting the quality of the human environment. NCPC's adoption of the rule will have minimal or no effect on the environment; impose no significant change to existing environmental conditions; and will have no cumulative environmental impacts.

Executive Order 12866, Executive Order 12988, and the Presidential Memorandum of June 1, 1998 requires the NCPC to write all rules in plain language. NCPC maintains the rule meets this requirement.

Be advised that personal information such as name, address, phone number electronic address, or other identifying personal information contained in a comment may be made publically available. Individuals may ask NCPC to withhold the personal information in their comment, but there is no guarantee the agency can do so.

I. Delegation of Authority—Commission Regulation § 38.1051

Section 38.1051 of the Commission's regulations, 17 CFR 38.1051, governs the system safeguards requirements for DCMs. Pursuant to § 38.1051(n), DCMs are required to provide the Commission with their annual total trading volume by January 31 each calendar year. Section 38.1051(n)(2) also requires the Commission to provide each DCM with their percentage of the combined annual total trading volume among all DCMs regulated by the Commission by February 28 each calendar year. This annual Commission notification informs each DCM whether it is a “covered DCM” as that term is defined in § 38.1051(h)(1). A covered DCM is a DCM whose annual trading volume in a given year is five percent or more of the combined annual trading volume of all DCMs regulated by the Commission. Covered DCMs are required to comply with enhanced requirements with respect to the frequency of cybersecurity testing and the use of independent contractors. The Commission is amending § 38.1051 by adding paragraph (n)(3) to delegate authority to the Director of the Division of Market Oversight and designated staff to notify DCMs of their annual trading volume percentage.

As the revisions to the Commission's regulations in this rulemaking will not cause any party to undertake efforts to comply with the regulations as revised, the Commission has determined to make this rulemaking effective upon publication in the Federal Register.1

The Commission may not conduct or sponsor, and a respondent is not required to respond to, a collection of information contained in a rulemaking unless the information collection displays a currently valid control number issued by the Office of Management and Budget (“OMB”) pursuant to the Paperwork Reduction Act.2 This rulemaking contains no collection of information for which the Commission is obligated to obtain a control number from OMB.

For the reasons stated in the preamble, the Commodity Futures Trading Commission amends 17 CFR part 38 as follows:

We are adopting an updated EDGAR Filer Manual, Volume I and Volume II. The Filer Manual describes the technical formatting requirements for the preparation and submission of electronic filings through the EDGAR system.1 It also describes the requirements for filing using EDGARLink Online and the Online Forms/XML Web site.

The revisions to the Filer Manual reflect changes within Volume I, entitled EDGAR Filer Manual, Volume I: “General Information,” Version 29 (September 2017), and Volume II, entitled EDGAR Filer Manual, Volume II: “EDGAR Filing,” Version 43 (September 2017). The updated manual will be incorporated by reference into the Code of Federal Regulations.

The Filer Manual contains all the technical specifications for filers to submit filings using the EDGAR system. Filers must comply with the applicable provisions of the Filer Manual in order to assure the timely acceptance and processing of filings made in electronic format.2 Filers may consult the Filer Manual in conjunction with our rules governing mandated electronic filing when preparing documents for electronic submission.3

The EDGAR system will be upgraded to Release 17.3 on September 11, 2017, and will introduce the following changes:

In Release No. 33-10231 (October 13, 2016) [81 FR 81870], the Commission adopted changes to the reporting requirements for investment companies. Among the changes was the adoption of Form N-PORT, which requires investment companies to report information about portfolio holdings monthly in a structured format. EDGAR Release 17.3 will provide a pilot program whereby filers may submit TEST versions of the following form types:

• Public Monthly Portfolio Investments Report on Form N-PORT (NPORT-P).

• Amended Public Monthly Portfolio Investments Report on Form N-PORT (NPORT-P/A).

• Non-Public Monthly Portfolio Investments Report on Form N-PORT (NPORT-NP).

• Amended Non-Public Monthly Portfolio Investments Report on Form N-PORT (NPORT-NP/A).

• Portfolio Holdings Exhibit to Form N-PORT (NPORT-EX).

• Amended Portfolio Holdings Exhibit to Form N-PORT (NPORT-EX/A).

In Release No. 33-10231 the Commission also adopted new Form N-CEN, which will require investment companies, other than face amount certificate companies, to provide an annual report of census-type information in a structured format. EDGAR Release 17.3 will permit investment companies to submit TEST versions of the following form types:

• Annual Report for Registered Investment Companies (N-CEN).

• Amendment to Annual Report for Registered Investment Companies (N-CEN/A).

• EDGAR Release 17.3 will also introduce two additional submission form types:

• Notice under Exchange Act Rule 12b-25 of the inability to timely file Form N-CEN (NT-NCEN).

• Amendment to Notice under Exchange Act Rule 12b-25 of the inability to timely file Form N-CEN (NT-NCEN/A).

EDGAR will only accept TEST submissions of form types NPORT-P, NPORT-P/A, NPORT-NP, NPORT-NP/A, NPORT-EX, NPORT-EX/A, N-CEN, and N-CEN/A from September 11, 2017, through December 31, 2017, and then again from March 1, 2018 until May 31, 2018. Beginning June 1, 2018, EDGAR will accept both TEST and LIVE submissions of form types NPORT-P, NPORT-P/A, NPORT-NP, NPORT-NP/A, NPORT-EX, NPORT-EX/A, N-CEN, and N-CEN/A. The EDGAR Filer Manual will be revised to provide instructions for making TEST N-PORT and N-CEN filings. Corresponding changes will be made to Chapter 8 (Preparing and Transmitting Online Submissions) of the EDGAR Filer Manual, Volume II: “EDGAR Filing.”

In Release No. 33-10332 (March 31, 2017) [82 FR 17545] the Commission made rule and form changes to effectuate inflation adjustments and other technical amendments required under Titles I & III of the JOBS Act. Among the technical changes was the revision to Commission forms so that registrants can designate whether they are an Emerging Growth Company and whether they have elected not to use the extended transition period for complying with any new or revised financial accounting standards.

Updates are being made in EDGAR Release 17.3 so that the same disclosures can be provided for any co-registrants. The following EDGARLink Online submission form types will be revised to reflect the two fields for each co-registrant: S-1, S-1/A, S-3, S-3/A, S-4, S-4/A, S-8, S-11, S-11/A, F-1, F-1/A, F-3, F-3/A, F-4, F-4/A, 10-12B, 10-12B/A, 10-12G, 10-12G/A, 8-K, 8-K/A, 8-K12B, 8-K12B/A, 8-K12G3, 8-K12G3/A, 8-K15D5, 8-K15D5/A, 10-Q, 10-Q/A, 10-QT, 10-QT/A, 10-K, 10-K/A, 10-KT, 10-KT/A, 20-F, 20-F/A, 20FR12B, 20FR12B/A, 20FR12G, 20FR12G/A, 40-F, 40-F/A, 40FR12B, 40FR12B/A, 40FR12G, and 40FR12G/A. Corresponding changes will be made to Chapter 7 (Preparing and Transmitting EDGARLink Online Submissions) of the EDGAR Filer Manual, Volume II: “EDGAR Filing.”

The “Balance Information” and “Account Activity Statement” screen of the EDGAR Filing Web site will be updated with the following text: “A negative balance amount indicates that money is owed to the SEC and the account is past due. For more information on making filing fee payments, see https://www.sec.gov/paymentoptions.” Corresponding changes will be made to Chapter 5 (Maintenance of Company Data) of the EDGAR Filer Manual Volume I: “General Information.”

Along with the adoption of the Filer Manual, we are amending Rule 301 of Regulation S-T to provide for the incorporation by reference into the Code of Federal Regulations of today's revisions. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

The updated EDGAR Filer Manual will be available for Web site viewing and printing; the address for the Filer Manual is https://www.sec.gov/info/edgar/edmanuals.htm. You may also obtain paper copies of the EDGAR Filer Manual from the following address: Public Reference Room, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m.

Since the Filer Manual and the corresponding rule changes relate solely to agency procedures or practice, publication for notice and comment is not required under the Administrative Procedure Act (“APA”).4 It follows that the requirements of the Regulatory Flexibility Act 5 do not apply.

The effective date for the updated Filer Manual and the rule amendments is September 29, 2017. In accordance with the APA,6 we find that there is good cause to establish an effective date less than 30 days after publication of these rules. The EDGAR system upgrade to Release 17.3 is scheduled to become available on September 11, 2017. The Commission believes that establishing an effective date less than 30 days after publication of these rules is necessary to coordinate the effectiveness of the updated Filer Manual with these system upgrades.

We are adopting the amendments to Regulation S-T under Sections 6, 7, 8, 10, and 19(a) of the Securities Act of 1933,7 Sections 3, 12, 13, 14, 15, 23, and 35A of the Securities Exchange Act of 1934,8 Section 319 of the Trust Indenture Act of 1939,9 and Sections 8, 30, 31, and 38 of the Investment Company Act of 1940.10

In accordance with the foregoing, title 17, chapter II of the Code of Federal Regulations is amended as follows:

Pursuant to 21 U.S.C. 811(a)(2), the Attorney General may, by rule, “remove any drug or other substance from the schedules if he finds that the drug or other substance does not meet the requirements for inclusion in any schedule.” The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the Drug Enforcement Administration (DEA). 28 CFR 0.100.

The Controlled Substances Act (CSA) provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on his own motion, (2) at the request of the Secretary of the Department of Health and Human Services (HHS) 1, or (3) on the petition of any interested party. 21 U.S.C. 811(a). This action was initiated at the request of the Acting Assistant Secretary for Health of the HHS and by a petition by the drug sponsor to DEA to remove naldemedine from the list of scheduled controlled substances of the CSA, and is supported by, inter alia, a recommendation from the Assistant Secretary of the HHS and an evaluation of all relevant data by the DEA. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle or propose to handle naldemedine.

Naldemedine, known chemically as (4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,7,9-trihydroxy-N-(2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl)-2,3,4,4a,5,7a-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-6-carboxamide, is an opium alkaloid derivative. Naldemedine is a high-affinity antagonist at the mu, kappa, and delta opioid receptors. On March 23, 2016, a new drug application (NDA) was submitted by Shionogi Inc. (Sponsor) to the Food and Drug Administration (FDA) for approval of naldemedine for the treatment of opioid induced constipation in patients with chronic non-cancer pain. The FDA approved naldemedine for marketing on March 23, 2017, under the trade name Symproic® (0.2 mg tablets).2 Naldemedine is indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Opioid-induced constipation is caused by an activation of mu-opioid receptors in the gastrointestinal tract. Naldemedine, a peripheral acting mu-opioid antagonist, can prevent OIC.

On June 8, 2016, the DEA received a petition from the drug sponsor requesting that the DEA amend 21 CFR 1308.12(b)(1) to exclude naldemedine as a schedule II substance from the Controlled Substances Act (CSA). The petitioner stated that naldemedine is a potent peripherally acting mu-opioid receptor antagonist. In accordance with 21 CFR 1308.43(c), the DEA accepted the petition for filing on August 5, 2016.

On March 22, 2017, the HHS provided the DEA with a scientific and medical evaluation document prepared by the FDA entitled “Basis for the Recommendation to Decontrol Naldemedine and its Salts from the Controlled Substances Act.” After considering the eight factors in 21 U.S.C. 811(c), including consideration of the substance's abuse potential, legitimate medical use, and dependence liability, the Assistant Secretary of the HHS recommended that naldemedine and its salts be removed from schedule II of the CSA. In response, the DEA conducted its own eight factor analysis of naldemedine pursuant to 21 U.S.C. 811(c). Both the DEA and HHS analyses are available in their entirety in the public docket of this rule (Docket Number DEA-468) at http://www.regulations.gov under “Supporting and Related Material.”

After a review of the available data, including the scientific and medical evaluation and the recommendation to decontrol naldemedine from HHS, the DEA published in the Federal Register a notice of proposed rulemaking (NPRM) entitled “Schedules of Controlled Substances: Removal of Naldemedine from Control” which proposed removal of naldemedine including its salts from the schedules of the CSA. 82 FR 32153, July 12, 2017. The proposed rule provided an opportunity for interested persons to file a request for a hearing in accordance with DEA regulations by August 11, 2017. No requests for such a hearing were received by the DEA. The NPRM also provided an opportunity for interested persons to submit written comments on the proposal on or before August 11, 2017.

The DEA received six comments on the proposed rule to remove naldemedine from control. Five commenters supported the decontrol of naldemedine. One commenter submitted a comment not related to the proposed decontrol action.

One commenter stated that naldemedine does not induce euphoria therefore limiting its potential for abuse. Another commenter stated that naldemedine can help alleviate constipation which will reduce the amount of time a patient is absent from work or the need for placement on disability. Further, another commenter stated that since naldemedine is a naltrexone derivative, it should be unscheduled.

One commenter stated that senators and representatives should support the removal of naldemedine to allow for safe and efficacious use of the drug due to its lack of abuse potential in clinical use. This commenter further suggested that naldemedine be made available to the public without the need for a prescription to treat individuals overdosed on opioids.

DEA Response: The DEA appreciates the comments in support of this rulemaking. The comment about making naldemedine available without prescription does not relate to the factors determinative of control of a substance (21 U.S.C. 811(c)) or the criteria for placement of a substance in a particular schedule (21 U.S.C. 812(b)).

A commenter expressed concerns about reports on “opioid epidemic” without consideration of the need for opioids by chronic pain patients. This commenter felt “patients are being denied, dismissed and overlooked by our drs (sic) due to all the scrutiny associated with treating chronic pain disease.”

DEA Response: Because naldemedine is not an opioid analgesic, this comment about the use of opioid analgesic in the management of pain is unrelated to the current decontrol action. Further it does not relate to the factors determinative of control of a substance (21 U.S.C. 811(c)) or the criteria for placement of a substance in a particular schedule (21 U.S.C. 812(b)).

The drug sponsor (Shionogi Inc.) requested that the effective date of this decontrol action correspond to the date of publication of the Final Rule.

DEA Response: Generally, DEA scheduling actions are effective 30 days from the date of publication of the final rule in the Federal Register. 21 CFR 1308.45; see also 5 U.S.C. 553(d). In accordance with 21 CFR 1308.45, the DEA finds that the limited availability of effective therapeutic treatments for opioid induced constipation (OIC), coupled with the fact that this is an action for decontrol, supports the finding that conditions of public health require this action to be effective immediately upon publication in the Federal Register. Due to adverse side effects, the majority of treatment alternatives currently available for OIC have restricted clinical application. By comparison, in clinical studies, naldemedine was well tolerated and exhibited a good safety profile in patients with opioid-induced bowel dysfunction.

In making the determination to make this rule effective immediately, the DEA took into consideration the effects of immediate implementation. The DEA agrees that making this rule immediately effective is in the best interest of the public health and will not burden registrants, the healthcare system or law enforcement. The DEA notes that its decision to make this rule effective immediately aligns with the exceptions to the 30-day effective date requirement of the Administrative Procedure Act (APA). One of the APA's exceptions to the 30-day effective date is for a substantive rule granting or recognizing an exemption or which relieves a restriction. 5 U.S.C. 553(d)(1).

Based on the consideration of all comments, the scientific and medical evaluation and accompanying recommendation of the HHS, and based on the DEA's consideration of its own eight-factor analysis, the Administrator finds that these facts and all relevant data demonstrate that naldemedine does not meet the requirements for inclusion in any schedule, and will be removed from control under the CSA.

In accordance with 21 U.S.C. 811(a), this scheduling action is subject to formal rulemaking procedures performed “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563.

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

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

This rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612) (RFA), has reviewed this rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. The purpose of this rule is to remove naldemedine from the list of schedules of the CSA. This action removes regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances for handlers and proposed handlers of naldemedine. Accordingly, it has the potential for some economic impact in the form of cost savings.

This rule will affect all persons who handle, or propose to handle, naldemedine. Due to the wide variety of unidentifiable and unquantifiable variables that potentially could influence handling of naldemedine, the DEA is unable to determine the number of entities and small entities which might handle naldemedine. However, the DEA estimates that all persons who handle, or propose to handle naldemedine, are currently registered with the DEA to handle controlled substances. Therefore, the 1.7 million (1,683,023 as of April 2017) controlled substance registrations, representing approximately 436,761 entities, would be the maximum number of entities affected by this rule. The DEA estimates that 425,856 (97.5%) of 436,761 affected entities are “small entities” in accordance with the RFA and Small Business Administration size standards.

The DEA estimates all controlled substance registrants handle both controlled and non-controlled substances and these registrants are expected to continue to handle naldemedine. Additionally, since prospective naldemedine handlers are likely to handle other controlled substances, the cost benefits they would receive as a result of the de-control of naldemedine is minimal. As naldemedine handlers continue to handle other controlled substances, they will need to maintain their DEA registration and keep the same security and recordkeeping processes, equipment, and facilities in place and would experience only minimal reduction in security, inventory, recordkeeping, and labeling costs. Physical security control requirements are the same for controlled substances listed in schedules II, III, IV, and V for the vast majority of registrants (practitioners).

While the DEA does not have a basis to estimate the number of affected entities, the DEA estimates that the maximum number of affected entities is 436,761 of which 425,856 are estimated to be small entities. Since the affected entities are expected to handle other controlled substances and maintain security and recordkeeping facilities and processes consistent with controlled substances, the DEA estimates any economic impact will be minimal. Because of these facts, this rule will not have a significant economic impact on a substantial number of small entities.

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., the DEA has determined and certifies that this action would not result in any Federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year * * *.” Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.

This action does not impose a new collection of information requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign based enterprises in domestic and export markets. However, pursuant to the CRA, the DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.

For the reasons set out above, 21 CFR part 1308 is amended as follows:

In implementing section 701 and partially implementing several other sections of NDAA-17, this interim final rule advances all four components of the Military Health System's quadruple aim of improved readiness, better care, better health, and lower cost. The aim of improved readiness is served by reinforcing the vital role of the TRICARE Prime health plan to refer patients, particularly those needing specialty care, to military medical treatment facilities (MTFs) in order to ensure that military health care providers maintain clinical currency and proficiency in their professional fields. The objective of better care is enhanced by a number of improvements in beneficiary access to health care services, including increased geographical coverage for the TRICARE Select provider network, reduced administrative hurdles for TRICARE Prime enrollees to obtain urgent care services and specialty care referrals, and promotion of high value services and medications. The goal of better health is advanced by expanding TRICARE coverage of preventive care services, treatment of obesity, high-value care, and telehealth. And the aim of lower cost is furthered by refining cost-benefit assessments for TRICARE plan specifications that remain under DoD's discretion and adding flexibilities to incentivize high-value health care services.

This interim final rule is required to implement or partially implement several sections of NDAA-17, including 701, 706, 715, 718, and 729. The legal authority for this rule also includes chapter 55 of title 10, United States Code.

The major provisions of the interim final rule are:

The establishment of TRICARE Select as a self-managed, PPO option under the TRICARE program. TRICARE Select replaces the TRICARE Extra and Standard programs and adopts a number of improvements, including fixed copayments rather than cost shares for covered benefits provided by a civilian network provider. TRICARE Select beneficiaries can choose any provider for their healthcare; however, they will enjoy lower out-of-pocket costs if they choose preferred providers within the TRICARE civilian network.

The continuation of TRICARE Prime as a managed care, HMO-like option under the TRICARE program. TRICARE Prime adopts a number of changes to conform to specifications in the new law, including categories of health care services applicable to the determination of copayment amounts (such as primary care, specialty care, emergency care).

Improved access to care, including a codified requirement that the TRICARE Select health care plan is available in all locations and at least 85% of the U.S. beneficiary TRICARE Select population is covered by the TRICARE network. Also, for TRICARE Prime enrollees, there are new procedures to ensure timely appointments for health care services and to authorize some or all urgent care visits without the need for referral from a primary care manager.

Promotion of high value services and medications, telehealth services, preventive health care, and healthy lifestyles.

A new design for the health care enrollment system, including mandatory enrollment to maintain TRICARE coverage, an annual open season enrollment period, and hassle-free enrollment procedures.

Other features include preservation of benefits for active duty dependents and TRICARE-for-Life beneficiaries, and changes to the TRICARE Young Adult (TYA), TRICARE Reserve Select (TRS), TRICARE Retired Reserve (TRR), Continued Health Care Benefit Program (CHCBP), and TRICARE Retiree Dental Program (TRDP) to conform with new statutory requirements.

The rule implements the new law (section 701 of NDAA-17) that establishes TRICARE Select as a self-managed, PPO program. It allows beneficiaries to use the TRICARE civilian provider network, with reduced out-of-pocket costs compared to care from non-network providers, as well as military treatment facilities (when space is available). Similar to the long-operating “TRICARE Extra” and “TRICARE Standard” plans, which TRICARE Select replaces, a major feature is that enrollees will not have restrictions on their freedom of choice with respect to health care providers. TRICARE Select is based primarily on 10 U.S.C. 1075 (as added by section 701 of NDAA-17) and 10 U.S.C. 1097. With respect to beneficiary cost sharing, the statute introduces a new split of beneficiaries into two groups: One group (which the rule refers to as “Group A”) consists of sponsors and their family members who first became affiliated with the military through enlistment or appointment before January 1, 2018, and the second group (referred to as “Group B”) who first became affiliated on or after January 1, 2018. In general, beneficiary out-of-pocket costs for Group B are higher than for Group A.

In addition to implementing the statutory specifications, the interim final rule also makes improvements for TRICARE Select Group A enrollees, compared to the features of the old TRICARE Extra plan. One such improvement is to convert the current cost-sharing requirement of 15% for active duty family members and 20% for retirees and their family members of the allowable charge for care from a network provider to a fixed dollar copayment calculated to approximately equal 15% or 20% of the average allowable charge for the category of care involved. Consistent with prevailing private sector health program practices, the fixed dollar copayment is more predictable for the patient and easier for the network health care provider to administer. The breakdown of categories of care (such as outpatient primary care visit, specialty care visit, emergency room visit, etc.) contained in the rule is the same as the categories now specified in the statute for Group B Select enrollees.

A second improvement in TRICARE Select (for both Group A and Group B) is that additional preventive care services that previously were only offered to TRICARE Prime beneficiaries will now (under the authority of 10 U.S.C. 1097 and NDAA-17) also be covered for Select enrollees when furnished by a network health care provider. These are services recommended by the United States Preventive Services Task Force and the Health Resources and Services Administration of the Department of Health and Human Services.

These improvements are based partly on the statutory provision (10 U.S.C. 1075(c)(2)) that Group A Select enrollee cost-sharing requirements are calculated as if TRICARE Extra were still being carried out by DoD. TRICARE Extra specifications are based on the underlying authority of 10 U.S.C. 1097, which allows DoD to adopt special rules for the PPO plan. This statute was the basis for the original set of rules for TRICARE Extra, which were adopted in 1995, and is the authority for these improved rules for TRICARE Select Group A, adopted as if TRICARE Extra were still being carried out by DoD.

Under the interim final rule, the cost sharing rules applicable to TRICARE Select Group B are those specified in 10 U.S.C. 1075. For TRICARE Select Group A, in addition to the copayment rules noted above, consistent with 10 U.S.C. 1075, an enrollment fee of $150 per person or $300 per family will begin January 1, 2021, for most retiree families, with annual updates thereafter based on the cost of living adjustment (COLA) applied to retired pay. At the same time, the catastrophic cap will increase from $3,000 to $3,500 for these retiree families. These changes, however, will not apply to TRICARE Select Group A active duty families, survivors of members who died while on active duty, or disability retiree families; that is, no enrollment fee will be applicable to this group and the applicable catastrophic cap will continue to be $1,000 for active duty families as established under 10 U.S.C. 1079(b) and $3,000 for survivors of members who died while on active duty or disability retiree families as established under 10 U.S.C. 1086(b).

A second major feature of this interim final rule, based primarily on 10 U.S.C. 1075a (also added by section 701 of NDAA-17), is the continuation of TRICARE Prime as a managed care, HMO-like program. It generally features use of military treatment facilities (MTFs) and substantially reduced out-of-pocket costs for authorized care provided outside MTFs. Beneficiaries generally agree to use military treatment facilities and designated civilian provider networks and to follow certain managed care rules and procedures. Like with TRICARE Select, with respect to beneficiary cost sharing, the statute introduces a new split of beneficiaries into two groups (again referred to in the rule as Group A and Group B) based on the military sponsor's initial enlistment or appointment before January 1, 2018 (Group A), or on or after that date (Group B). Beneficiary cost sharing for Group B is slightly higher than for Group A.

As with TRICARE Select, the cost sharing specifications for TRICARE Prime Group B are set forth in the statute, and those for Group A are calculated in accordance with other health care provisions of title 10 (rather than the new section 1075a). The primary original statutory authority for the TRICARE Prime health plan, established by DoD regulation in 1995, was 10 U.S.C. 1097, and this continues to be relied upon for the continued operation of TRICARE Prime for Group A. Also relevant to the original terms of TRICARE Prime was section 731 of the National Defense Authorization Act for Fiscal Year 1994. That law required DoD to include, to the maximum extent practicable, the HMO-like option under TRICARE. That law also required that the HMO-like option “shall be administered so that the costs incurred by the Secretary under the TRICARE program are no greater than the costs that would otherwise be incurred”, to provide health care to beneficiaries. The extent to which this “cost neutrality” requirement has not been maintained was recently highlighted by the Congressional Budget Office: “CBO estimates that under current law, a typical retiree household enrolled in TRICARE Prime as a `family' in 2018, and for whom TRICARE is the primary payer of health benefits, will cost DoD about $17,400, and a typical family that uses Standard/Extra will cost DoD about $12,700.” 1

Based on the TRICARE Prime cost neutrality provision in NDAA-1994, the original 1995 TRICARE Prime regulation included (at 32 CFR 199.18(g)) that cost sharing requirements “may be updated for subsequent years to the extent necessary to maintain compliance with statutory requirements pertaining to government costs.” Since NDAA-1994, Congress took away DoD's discretion for enrollment fee increases, which are now tied by law to the retired pay COLA. However, DoD continues to have discretion to update copayment amounts—which have not changed since 1995—and this discretion is confirmed by the newly enacted 10 U.S.C. 1075a(a)(3).

This discretion to update copayment amounts is continued in the interim final rule, but the framework for setting Prime Group A copayment amounts is being revised. Specifically, DoD is adopting for Group A the same structure of categories of care that Congress adopted for Group B. Thus, for example, while the current TRICARE Prime copayment amount makes no distinction between primary care and specialty care services, the new Group B structure under the statute does have a different copayment for primary care and specialty care. Under the rule, copayment amounts for Group A beneficiaries will be set for each of those categories, as well as the other categories of care the statute now specifies for Group B enrollees. The interim final rule does not specify the amount for each category of care. Rather, consistent with DoD's discretion under current statute and regulation, the actual amount will be set each year prior to open season enrollment. The interim final rule does, however, specify that the amount for each category of care for Group A enrollees may not exceed the amount that Congress set for Group B enrollees. In this way, the Prime copay structure would be in alignment with proposed legislative changes recommended by the Department to Congress for enactment this year to eliminate the “grandfathering” of Group A retiree families and return to a single TRICARE Prime model for all working-age retiree families. Again, it should be noted that this applies only to per-service copayments; enrollment fee increases for Group A enrollees will continue to be based on the retired pay COLA.

The interim final rule also continues the point-of-service provision of the current TRICARE Prime plan. Any health care services obtained by a Prime enrollee not in accordance with the rules and procedures of Prime (e.g. failure to obtain a primary care manager referral when such a referral is required or seeing a non-network provider when a network provider is available) will not be paid for under Prime rules, but may be covered by the point-of-service option. This results in higher cost sharing—specifically, a deductible of $300 per person and $600 per family, and a copayment of 50 percent of the allowable charges after the deductible. Point-of-service charges do not count against the annual catastrophic cap. These point-of-service rules continue for TRICARE Prime Group A and are also applicable to Group B. For Group B, the rules for point-of-service charges are specified in 10 U.S.C. 1075a(c), which clarifies that point-of-service cost sharing is “notwithstanding” the usual cost sharing rules of Prime Group B enrollees.

One other matter on which the interim final rule preserves DoD discretion, similar to that in the current regulation, is with respect to the locations where TRICARE Prime is offered. This is noted in the current regulation at 32 CFR 199.17(a)(5). Under the interim final rule, the locations where TRICARE Prime will be offered will be determined by the Director, Defense Health Agency (DHA) and announced prior to the annual open season enrollment period. The guiding principle for this decision is that the purpose of TRICARE Prime is to support the medical readiness of the armed forces and the readiness of medical personnel. Codification in regulation of this guiding principle is a corollary to the codification by Congress in statute, specifically sections 703 and 725 of NDAA-17 that MTFs exist to support the medical readiness of the armed forces and the readiness of medical personnel.

TRICARE Prime, especially for working age retirees and family members, provides MTFs clinical workload, including for a range of medical specialty areas that permit military health care providers to maintain currency and proficiency in their respective clinical fields. This important support of a ready medical force is what justifies the higher government cost of Prime (which CBO estimates at $17,400 per retiree family), notwithstanding the original statutory requirement of cost neutrality between TRICARE Prime and TRICARE Standard. This cost-benefit assessment supports the conclusion that it is practicable to offer TRICARE Prime in areas where it supports the medical readiness of one or more MTFs. Additionally, where TRICARE Prime is offered, it may be limited to active duty family members if the Director, DHA determines it is not practicable to offer TRICARE Prime to retired beneficiaries as well—a determination that again would take into account the nature of the supported MTF and the range of services it offers.

A third significant change in the interim final rule is a set of improvements in standards for access to care. The TRICARE Select plan replaces TRICARE Standard as the generally applicable plan in all areas. Under TRICARE Select, eligible beneficiaries can choose any provider for their healthcare, and they will enjoy lower out-of-pocket costs if they choose providers within the TRICARE civilian network. The vast majority of TRICARE beneficiaries located in the United States will have access to TRICARE network providers (it is DoD's plan that at least 85% of the U.S. beneficiary population under TRICARE Select will be covered by the network upon implementation), similar to the current TRICARE Extra option, but with the benefit of predictable fixed dollar copayments. In cases in which a network provider is not available to a TRICARE Select enrollee, such as in remote locations where there are very few primary or specialty providers, enrollees will still have access to any TRICARE authorized provider, with cost sharing comparable to the current TRICARE Standard plan (i.e. 25% for retired category beneficiaries).

A second interim final rule enhancement for access to care is that if a TRICARE Prime enrollee seeks to obtain an appointment for care from the managed care support contractor but is not offered an appointment within the applicable access time standards from a network provider, the enrollee will be authorized to receive care from any authorized provider without incurring the additional fees associated with point-of-service care.

A third access to care improvement under the interim final rule is that the TRICARE Prime referral requirement may be waived for urgent care visits for Prime enrollees other than active duty members. This is similar to the current pilot program, which waives the referral requirement (other than for active duty members) for up to two urgent care visits per year. The specific number of urgent care visits without a referral will be determined annually prior to the beginning of the open season enrollment period.

A fourth access to care improvement is adoption of the new statutory provision that a primary care manager who believes a referral to a specialty care network provider is medically necessary and appropriate need not obtain pre-authorization from the managed care support contractor. Managed care support contractor preauthorization is only required with respect to a primary care manager's referral for inpatient hospitalization, inpatient care at a skilled nursing facility, inpatient care at a residential treatment center and inpatient care at a rehabilitation facility.

In addition to the expansion noted above concerning preventive care services, the interim final rule makes a number of other improvements in TRICARE Prime and TRICARE Select based on provisions of sections 701(h), 706, 718, and 729 of NDAA-17. Section 701(h), among other things, provides for a four-year pilot program to encourage use by patients of high value services and medications. Section 706, among other things, authorizes special arrangements with provider groups that will improve population-based health outcomes and focus more on preventive care. Section 729 calls for special actions to incentivize medical intervention programs to address chronic diseases and other conditions and healthy lifestyle interventions. Section 718, among other things, requires actions to promote greater use of telehealth services under TRICARE. While these sections of NDAA-17 also require actions outside the scope of this interim final rule (such as contracting actions) they can be partially implemented, consistent with Congressional intent, in this rule. The interim final rule does this in several ways.

First, the interim final rule authorizes coverage under TRICARE Prime and TRICARE Select for medically necessary treatment of obesity even if it is the sole or major condition treated. Under 10 U.S.C. 1079(a)(10), this is disallowed under the basic program. However, it is DoD's conclusion that the underlying authority of 10 U.S.C. 1097, together with section 729 of NDAA-17 (which specifically authorizes medical intervention for obesity), allow the Department to cover these services when provided by a network provider for a TRICARE Prime or TRICARE Select enrollee.

Second, the interim final rule codifies authority of the Director, DHA to waive or reduce copayment requirements for TRICARE Prime and TRICARE Select enrollees for care received from network providers for certain health care services that provide especially high value in terms of better health outcomes for patients. Authority for this includes section 706 and 729 of NDAA-17. This is also consistent with the four-year pilot program authority of section 701(h), but does not necessarily rely on that time-limited authority. Consistent with the intent of these sections, the Department also intends to use the authority of § 199.21(j)(3) of the TRICARE Pharmacy Benefits Program section of the TRICARE regulations to encourage use of high value medications by reducing or eliminating the copayment of selected medicines.

Third, consistent with section 718 of NDAA-17, the interim final rule provides that health care services covered by TRICARE and provided through the use of telehealth modalities are covered services to the same extent as if provided in person at the location of the patient if those services are medically necessary and appropriate for such modalities. The Director, DHA will establish standardized payment methods to reimburse for such services, and shall reduce or eliminate, as appropriate, beneficiary copayments or cost-shares for such services in cases in which a copayment would otherwise apply. This may be done by designating some telehealth services as high value services for which lower copays apply as well as the elimination of any beneficiary cost-sharing related to originating site fees when used to support the provision of telehealth services.

A fourth major change in the interim final rule is its implementation of the new statutory design for the health care enrollment system. Starting in calendar year 2018, beneficiaries other than active duty members and TRICARE-for-Life beneficiaries must elect to enroll in TRICARE Select or TRICARE Prime in order to be covered by the private sector care portion of TRICARE. While TRICARE-for-Life beneficiaries under the age of 65 are permitted to enroll in TRICARE Prime under limited circumstances, their failure to enroll will not affect their coverage by the private sector care portion of TRICARE. Enrollment will be done during an open season period prior to the beginning of each plan year, which operates with the calendar year. An enrollment choice will be effective for the plan year. As an exception to the open season enrollment rule, enrollment changes can be made during the plan year for certain qualifying events, such as a change in eligibility status, marriage, divorce, birth of a new family member, relocation, loss of other health insurance, or other events.

Eligible Prime or Select beneficiaries who do not enroll will no longer have private sector care coverage under the TRICARE program (including the TRICARE retail pharmacy and mail order pharmacy programs) until the next open enrollment season or they have a qualifying event, except that they do not lose any statutory eligibility for space-available care in military medical treatment facilities. There is a limited grace period exception to this enrollment requirement for calendar year 2018, as provided in section 701(d)(3) of NDAA-17, to give beneficiaries another chance to adjust to this new requirement for annual enrollment. For the administrative convenience of beneficiaries, there are also procedures for automatic enrollment in Prime and Select for most active duty family members, and automatic renewal of enrollments of covered beneficiaries, subject to the opportunity to decline or cancel.

Due to a compressed implementation schedule that precludes an annual open season enrollment period in calendar year 2017 for existing TRICARE beneficiaries to elect or change their TRICARE coverage, the Department will convert existing TRICARE Standard coverage to TRICARE Select coverage effective January 1, 2018. All other existing TRICARE coverages will be renewed effective January 1, 2018. As noted previously, beneficiaries may elect to change their TRICARE coverage anytime during the limited grace period in calendar year 2018.

The interim final rule has several other noteworthy provisions. First, there are no changes in benefits for TRICARE-for-Life beneficiaries, or generally in cost sharing levels for active duty family members. Second, although “TRICARE Standard” is terminated as a distinct TRICARE plan as of December 31, 2017, basic program benefits (as established under 32 CFR 199.4) continue under both TRICARE Prime and TRICARE Select. In addition, when a TRICARE Select beneficiary receives services covered by the basic program benefits from an authorized health care provider who is not part of the TRICARE provider network, that care is covered by TRICARE as “out-of-network” care under terms that match the old TRICARE Standard plan. Third, in order to transition enrollment fees, deductibles, and catastrophic caps from a fiscal year basis to a calendar year basis, special rules apply for the last quarter of calendar year 2017, including that a Prime enrollee's enrollment fee for the quarter is one-fourth of the enrollment fee for fiscal year 2017, and the deductible amount and the catastrophic cap amount for fiscal year 2017 will be applicable to the 15-month period of October 1, 2016, through December 31, 2017. A similar transition rule will apply to TRICARE for Life, TYA, TRR and TRS to align remaining program deductibles and/or catastrophic caps from a fiscal year to calendar year basis for consistency and ease of administration.

Additionally, the interim final rule adopts several changes to regulatory provisions applicable to the TYA, TRS, TRR, and TRDP programs to conform with new statutory requirements. In implementing section 701(a) of NDAA-17, together with section 701(j)(1)(F), the rule conforms the TYA regulation to the statutory language which established the eligibility of TYA under 10 U.S.C. 1110b to enroll in TRICARE Select and provided that the TYA premium shall apply instead of the otherwise applicable TRICARE Prime or Select enrollment fee. In implementing section 701(j)(1)(B), the rule conforms the TRICARE Reserve Select plan regulation to the statutory language which defines “TRICARE Reserve Select” as the TRICARE Select self-managed, preferred-provider network option under 10 U.S.C. 1075 made available to beneficiaries under 10 U.S.C. 1076d and requires payment of a premium for coverage instead of the TRICARE Select enrollment fee. In implementing section 701(j)(1)(C), the rule conforms the TRICARE Retired Reserve plan regulation to the statutory language which defines “TRICARE Retired Reserve” as the TRICARE Select self-managed, preferred-provider network option under 10 U.S.C. 1075 made available to beneficiaries under 10 U.S.C. 1076e and requires payment of a premium for coverage instead of the TRICARE Select enrollment fee. In implementing section 701(a) and 701(e), the rule conforms the CHCBP regulation to replace TRICARE Standard with TRICARE Select as the continuation health care benefit for Department of Defense and the other uniformed services beneficiaries losing eligibility. In implementing section 715, the rule conforms the TRDP regulation to the statutory language which authorizes an interagency agreement between the Department of Defense and the Office of Personnel Management to allow beneficiaries otherwise eligible for the TRDP to enroll in a dental insurance plan offered under the Federal Employees Dental and Vision Insurance Program. Under the statute, TRDP beneficiaries will have the opportunity to access a dental plan with significantly higher annual maximum benefit and a lower premium cost than available under the current TRDP, while giving the Department an opportunity to eliminate costs associated with procuring and administering a separate TRDP contract.

Also, the interim final rule adopts several changes to regulatory provisions applicable to benefit coverage of medically necessary food and vitamins. Section 714 of NDAA-17 confirms long-standing TRICARE policy authorizing benefit coverage of medically necessary vitamins when prescribed for management of a covered disease or condition. In addition, while section 714 confirms long-standing TRICARE policy authorizing medical nutritional therapy coverage of medically necessary food and medical equipment/supplies necessary to administer such food when prescribed for dietary management of a covered disease or condition, the law also allows the medically necessary food benefit to include coverage of low protein modified foods. Consistent with this we also recognize the role of Nutritionists and Registered Dieticians in the appropriate planning for the use of medically necessary foods.

Additionally, the interim final rule adopts several conforming changes to regulatory provisions applicable to general TRICARE administration, the TRICARE Pharmacy Benefits Program and the Extended Health Care Option to reflect transition of deductibles, catastrophic caps, and program reimbursement limitations, as applicable, from a fiscal year basis to a calendar year basis for consistency and ease of administration. Simultaneously, technical corrections are being made to the TRICARE Pharmacy Benefits Program to conform regulation provisions to statutory provisions enacted by section 702 of the National Defense Authorization Act for Fiscal Year 2016.

Finally, the interim final rule includes authority for the Director, DHA to establish preferred provider networks in areas outside the United States where it is determined to be economically in the best interests of the Department of Defense. As a result of the TRICARE Philippines Demonstration Project, which commenced in January 1, 2013, the Department has determined that the TRICARE contracted preferred provider network established in designated locations in the Philippines provided adequate access to beneficiaries with 97 percent of care delivered by network providers. It also successfully achieved the demonstration goals of reducing aberrant billing activities, reduced out-of-pocket expenses for beneficiaries, and increased overall beneficiary satisfaction while leading to a net savings to the government. Although the demonstration was projected to continue through December 31, 2018, the Philippines preferred provider network is determined to be economically in the interests of the Department of Defense and the demonstration shall terminate effective December 31, 2017, with transition of the demonstration's approved preferred provider network to a TRICARE Select preferred provider network effective January 1, 2018.

The following two tables summarize beneficiary fees (including enrollment fees, deductibles, cost sharing amounts, and catastrophic loss protection limits) under TRICARE Select and TRICARE Prime for calendar year 2018. For future calendar years, all fees are subject to review and annual updating in accordance with sections 1075, 1075a, and 1097 of title 10, United States Code. Table 1 is for active duty family members (ADFMs); Table 2 is for retiree families. As a guide for understanding the tables:

For services listed as “to be determined (TBD)”, the Director, DHA will ensure the applicable fee for calendar year 2018 will be available at www.health.mil/rates before December 1, 2017.

For services not specifically addressed in these tables, applicable cost-sharing requirements shall be established by the Director, DHA and published annually.

For services designated as “IN”, the listed fee is for covered services or supplies obtained “in-network,” meaning received from TRICARE authorized network providers.

For TRICARE Prime beneficiaries, if covered services or supplies are not obtained in accordance with the rules and procedures of Prime (e.g., failure to obtain a required referral or unauthorized use of a non-network provider), the services or supplies will be reimbursed under a point-of-service option for which there is a deductible of $300 per person or $600 per family and a cost share of 50 percent of the allowable charges after the deductible.

For services designated as “OON”, the listed fee for TRICARE Select beneficiaries is for covered services or supplies obtained “out-of-network”, meaning received from non-network TRICARE authorized providers.

Certain preventive services have no cost sharing whether received from network or non-network providers. However, certain preventive services are not covered services for TRICARE Prime or Select beneficiaries unless obtained from network providers. Additionally, TRICARE Prime beneficiaries are required to obtain services in accordance with the rules and procedures of Prime to avoid point-of-service charges.

Enrollment fees and deductibles are listed in the tables as individual/family, indicating the dollar amounts applicable per individual or per family.

The criteria for fees associated with High Value Primary Care Outpatient Care and High Value Specialty Outpatient Care are under development but will be designed to encourage beneficiaries to receive health care services from high-value providers as highlighted in the contractor's network provider directory. When finalized, the fees will be made available at www.health.mil/rates.

Inpatient subsistence refers to the rate charged for inpatient care obtained in a military treatment facility.

“COLA” is the cost-of-living adjustment for retired pay under 10 U.S.C. 1401a by which certain fees are required to be annually indexed.

“<” means less than; ≤ means less than or equal to.

This is being issued as an interim final rule in order to comply with statutory specifications regarding effective dates of changes to TRICARE as a health care entitlement program. For example, the change from a fiscal year-based TRICARE plan year for purposes of enrollment fees, deductibles, and catastrophic caps to a calendar year-based TRICARE plan year requires that this regulation be in place by October 1, 2017. Many other changes must be in place by January 1, 2018, including the operation of TRICARE Select to replace TRICARE Extra and TRICARE Standard, which DoD no longer has authority to operate as of that date. In view of the statutory effective dates of the substantial changes in TRICARE, the Department finds that obtaining public comment in advance of issuing this rule is impracticable, unnecessary, and contrary to the public interest. Nonetheless, DoD invites public comments on this rule and is committed to considering all comments and issuing a final rule as soon as practicable.

E.O. 13771 seeks to control costs associated with the government imposition of private expenditures required to comply with Federal regulations and to reduce regulations that impose such costs. Consistent with the analysis of transfer payments under OMB Circular A-4, this interim final rule does not involve regulatory costs subject to E.O. 13771.

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

Under the Congressional Review Act, a major rule may not take effect until at least 60 days after submission to Congress of a report regarding the rule. A major rule is one that would have an annual effect on the economy of $100 million or more or have certain other impacts. This interim final rule is not a major rule under the Congressional Review Act.

The Regulatory Flexibility Act requires that each Federal agency analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. This interim final rule is not an economically significant regulatory action, and it will not have a significant impact on a substantial number of small entities. Therefore, this rule is not subject to the requirements of the RFA.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any one year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $140 million. This interim final rule will not mandate any requirements for state, local, or tribal governments or the private sector.

This rulemaking does not contain a “collection of information” requirement, and will not impose additional information collection requirements on the public under Public Law 96-511, “Paperwork Reduction Act” (44 U.S.C. Chapter 35).

This interim final rule has been examined for its impact under E.O. 13132, and it does not contain policies that have federalism implications that would have substantial direct effects on the States, on the relationship between the national Government and the States, or on the distribution of powers and responsibilities among the various levels of Government. Therefore, consultation with State and local officials is not required.

For the reasons stated in the preamble, the Department of Defense amends 32 CFR part 199 as set forth below:

I. Table of Abbreviations BLS Bureau of Labor Statistics COTP Captain of the Port DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section symbol OMB Office of Management and Budget RFA Regulatory Flexibility Act SNPRM Supplemental notice of proposed rulemaking TFR Temporary final rule U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is extending, for an additional six months, an existing temporary safety zone for the navigable waters surrounding the entry of lava from the Kilauea Volcano into the Pacific Ocean on the southeast side of the Island of Hawaii, HI. Extending this safety zone ensures mariners remain safe from the potential hazards associated with molten lava entering the ocean while the proposed rule is being reviewed. This safety zone will continue to encompass all waters within 300 meters (984 feet) of all entry points of lava flow into the ocean. Because the entry points of the lava vary, the safety zone location will also vary. Entry of persons or vessels into this safety zone remains prohibited, unless specifically authorized by the Captain of the Port (COTP) Honolulu, or his designated representative.

Lava flow that enters the ocean can be potentially hazardous to anyone near it, particularly when lava deltas collapse. A lava delta is new land that forms when lava accumulates above sea level, and extends from the existing base of a sea cliff. Persons near active lava flow entry sites incur potential hazards, particularly when lava deltas collapse. These hazards include, but are not limited to, plumes of hot, corrosive seawater laden with hydrochloric acid, and fine volcanic particles that can irritate the skin, eyes, and lungs; explosions of debris and eruptions of scalding water from hot rock entering the ocean; sudden lava delta collapses; and waves associated with these explosions and collapses.

Lava has been entering the ocean at the Kamokuna lava delta on Kilauea Volcano's south coast since July 2016. On December 31, 2016, a large portion of lava delta collapsed into the ocean at the Kamokuna entry point. Following this collapse, portions of the adjacent sea cliff fell into the ocean, producing localized waves, and showers of debris. As of March 2017, a new delta has begun to form at the Kamokuna ocean entry point. This lava delta continues to grow and collapse, and cracks parallel to the sea cliff surrounding it persist, indicating further collapses may occur with little or no warning.

On March 28, 2017, the Coast Guard established a temporary final rule (TFR) and put into place a safety zone for mariners near lava entry points to address the hazards of the lava entering the ocean. The TFR discussed Sector Honolulu's review of nearly 30 years of delta collapse and ejecta distance observations from the Hawaii Volcano Observatory records. The TFR was published in the April 3, 2017 Federal Register (82 FR 16109).

On April 3, 2017, the Coast Guard also published a notice of proposed rulemaking (NPRM) to establish a permanent safety zone that would encompass all waters extending 300 meters (984 feet) in every direction around all entry points of lava flow into the navigable waters surrounding the entry of lava from the Kilauea Volcano into the Pacific Ocean on the southeast side of the Island of Hawaii, HI (82 FR 16142). We determined that a radius of 300 meters was a reasonable, minimum high-hazard zone around a point of active lava flow entering the ocean. The safety zone allows the Coast Guard to impose and enforce restrictions on vessels operating closely to the lava entry area, which protects persons and vessels from the potential hazards associated with molten lava entering the ocean. The NPRM addressed this concern and invited the public to comment on the safety zone. The comment period, which ended on June 2, 2017, received 67 comments. On May 8, 2017, at a public meeting held in Hilo, HI, meeting participants discussed the proposed rule and NPRM's public comments.

During the period of the TFR, four tour operators and one photographer with economic ties to lava tourism petitioned the COTP Honolulu for entry within 300 meters of the high-hazard zone. They also requested and petitioned for various levels of entry distances—ranging from a close, safe distance to 50 meters—based on sea conditions resulting from the lava entry. The COTP Honolulu granted express authorization for entry within 300 meters to the five operators. The authorization included operational restrictions and other vessel safety criteria requirements considered by the COTP Honolulu and will continue under the extended period of this TFR.

In order to review the overall impact of the final rule, a supplemental notice of proposed rulemaking (SNPRM) will be published, providing an additional 60 days for public comments and input. This TFR is necessary to promote navigational safety, provide for the safety of life and property, and facilitate the reasonable demands of commerce relating to tourism surrounding the lava entry points. It also provides an opportunity for further comment from the public. Upon publication of the SNPRM, we will invite additional public comments on this rulemaking.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Although we expect to review the SNPRM within 30 days of publication of this TFR, it would be impractical to delay the effective date of this rule. Immediate action is necessary to protect persons, vessels, and the public from the potential safety hazards associated with the ocean lava entry.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP Honolulu has determined that potential hazards associated with Kilauea's active lava flow entry into the Pacific Ocean on the southeast side of the Island of Hawaii, HI is a safety concern for anyone within 300 meters (984 feet) in every direction around the entry of lava flow. The purpose of this rule is to ensure the safety of the public and vessels traveling in the navigable waters covered by the safety zone.

This TFR extends the existing safety zone from September 28, 2017 through March 28, 2018, or until it is no longer necessary. If the safety zone terminates prior to March 28, 2018, the Coast Guard will provide notice via established notice to mariners.

In order to review the overall impact of the rule, the Coast Guard will publish an SNPRM providing an additional 60 days for comments on the proposed final rule. This TFR is necessary to promote navigational safety, provide for the safety of life and property, and facilitate the reasonable demands of commerce relating to tourism surrounding the lava entry points.

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

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

Under Executive Order 12866, this rule has not been designated a “significant regulatory action. Accordingly, the Office of Management and Budget (OMB) has not reviewed it. As this rule is a non-significant regulatory action, it is exempt from the requirements of Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017). A regulatory analysis follows.

This TFR extends, for an additional six months, the existing safety zone for the navigable waters surrounding the entry of lava from Kilauea volcano into the Pacific Ocean. The safety zone will remain to include waters within 300 meters (984 feet) of where lava enters the ocean. Entry of persons or vessels into the safety zone may only occur if granted permission by the COTP Honolulu, or his designated representative.

Lava has been entering the ocean at Kamokuna on Kilauea Volcano's south coast since July of 2016 and will continue to do so in the future. When lava enters the ocean, new hazards emerge: Plumes of corrosive seawater can irritate the skin, eyes, and lungs; explosions of debris and scalding water can injure passengers; sudden collapse of lava deltas can cause large waves potentially capsizing vessels. This TFR establishes a minimum safe operating distance in order to protect individuals and operators from the hazards of the Kilauea lava flow at sea.

This rule affects any vessel that would normally travel within 300 meters of points where lava reaches the ocean. Currently, four lava tour-boat operators have state licenses to operate from the Pohoiki Boat Ramp, the closest location to pick up passengers for tours of the Kilauea lava flow. The Coast Guard is also aware of one photographer who photographs the Kilauea lava flow. Since the implementation of the temporary safety zone, the COTP granted prior approval to these parties to enter the safety zone, so long as they comply with the conditions set by the COTP. These entities are required to notify the COTP by phone before each tour when entering the 300-meter safety zone.

When the Coast Guard published the original TFR on April 3, 2017, owners and operators were required to prepare and submit a written request to the COTP to enter the safety zone. The TFR is a continuation of the requirements extending the safety zone for an additional six months, and therefore, we are presenting the costs associated with this TFR.

First, the captain of a lava tour boat will initiate the request to enter the safety zone through an initial written request to the COTP. Based on waiver requests from the four state-licensed operations, the Coast Guard estimates it takes about 4-hours for an owner or operator to submit a written request to enter the safety zone. This includes the time it would take lava tour-boat owners or operators to respond to questions from the COTP concerning the waiver request. Lava tour-boat owners or operators are only required to make this written waiver request once for consideration by the COTP.

We obtained the mean hourly wage rate for a Captain of a lava tour boat from the Bureau of Labor Statistics (BLS) Occupational Employment Statistics National Occupational Employment and Wage Estimates for May 2016. Based on BLS's data, the mean hourly wage rate for Captains, Mates, and Pilots of Water Vessels with the North American Industry Classification System (NAICS) occupational code of 53-5021 in the “Scenic and Sightseeing Transportation, Water” industry is $24.42. Because this is an unloaded hourly wage rate, we added a load factor of 1.52 derived from the BLS March 2017 “Employer Cost for Compensation” databases to obtain a loaded hourly wage rate of $37.12. We estimate the one-time initial cost for an owner or operator to prepare a written request and respond to comments from the Coast Guard to be about $148.47 ($37.12 per hour × 4 hours). We estimate the total cost of the temporary final rule to be about $593.88 ($148.47 × 4 lava tour-boat owners or operators).

Since all four tour operators and the photographer were each granted permission to enter the safety zone through an initial waiver request, the only potential cost to these tour operators is the cost of the initial request. Each owner or operator also will be required to notify the COTP before entering the safety zone. These entities shall notify the Coast Guard by phone; however, we do not estimate a cost for the call because the equipment already exists onboard the vessel and operators will make their calls in the normal course of a Captain's duty.

The Federal Government also will incur costs of this temporary final rule. Government costs to implement the rule include the one-time cost of reviewing the waiver requests (we do not estimate a cost for the time to receive a call from an owner or operator to when entering a safety zone because the COTP conducts this review in the normal course of the COTP duties). To process the written request, we estimate one non-commissioned officer with a rank of E-7, and three officers with ranks of O-4, O-5, and O-6 will take about one hour each to review the written request. Based on the labor rates in table 1, we estimate the total cost to the Government of the temporary final rule to be about $378.00. Table 1 below summarizes these Government costs.1

We estimate the total cost of this temporary final rule to industry and the Government to be about $972 ($593.88 for lava tour-boat owners or operators + $378 for the Government).

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. Rules that are exempt from the Administrative Procedures Act include interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice; or when the agency for good cause finds that notice and comment are impracticable, unnecessary, or contrary to the public interest. When an agency is not required to publish an NPRM for a rule, the RFA does not require an agency to prepare a regulatory flexibility analysis. The Coast Guard was not required to publish an NPRM for this rule for the reasons stated in section II. “Background Information and Regulatory History” and therefore is not required to publish a regulatory flexibility analysis.

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary safety zone lasting 6 months that will prohibit persons and vessels from entry into the 300 meters (984 feet) safety zone extending in all directions around the entry of lava flow into the Pacific Ocean. This safety zone is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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

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

The Coast Guard will enforce the Safety Zone for the Pittsburgh Downtown Partnership/Light Up Night Fireworks on the Allegheny River, listed in 33 CFR 165.801 Table 1, Sector Ohio Valley, No. 37 on November 17, 2017. Entry into the safety zone is prohibited unless authorized by the COTP or a designated representative. Persons or vessels desiring to enter into or passage through the safety zone must request permission from the COTP or a designated representative. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.

This notice of enforcement is issued under authority of 33 CFR 165.801 and 5 U.S.C. 552(a). In addition to this notice in the Federal Register, the Coast Guard will provide the maritime community with advance notification of this enforcement period via Local Notice to Mariners and updates via Marine Information Broadcasts.

Please refer to the notice of enforcement published in the Federal Register on August 7, 2017 (82 FR 36688), FR Doc. 2017-16506.

In a document published in the Federal Register on December 12, 2003 (68 FR 69312), the Secretary exercised the authority under the HEROES Act (Pub. L. 108-76, 20 U.S.C. 1098bb(b)) and announced waivers and modifications of statutory and regulatory provisions designed to assist “affected individuals.” Under 20 U.S.C. 1098ee(2), the term “affected individual” means an individual who:

• Is serving on active duty during a war or other military operation or national emergency;

• Is performing qualifying National Guard duty during a war or other military operation or national emergency;

• Resides or is employed in an area that is declared a disaster area by any Federal, State, or local official in connection with a national emergency; or

• Suffered direct economic hardship as a direct result of a war or other military operation or national emergency, as determined by the Secretary.

Please note that these waivers and modifications do not apply to an individual who resides or is employed in an area declared a disaster area by any Federal, State, or local official unless that declaration has been made in connection with a national emergency.

Under the HEROES Act, the Secretary's authority to provide the waivers and modifications would have expired on September 30, 2005. However, Public Law 109-78, enacted on September 30, 2005, extended the expiration date of the Secretary's authority to September 30, 2007. Accordingly, in a document in the Federal Register published on October 20, 2005 (70 FR 61037), the Secretary extended the expiration of the waivers and modifications published on December 12, 2003, to September 30, 2007.

Public Law 110-93, enacted on September 30, 2007, eliminated the September 30, 2007, expiration date of the HEROES Act, thereby making permanent the Secretary's authority to issue waivers and modifications of statutory and regulatory provisions.

On December 26, 2007, the Secretary published a document in the Federal Register (72 FR 72947) extending the waivers and modifications published on December 12, 2003, to September 30, 2012. In that document, the Secretary also indicated an intent to review the waivers and modifications published on December 12, 2003, in light of statutory and regulatory changes and to consider whether to change some or all of the published waivers and modifications.

In a document in the Federal Register published on September 27, 2012 (77 FR 59311), the Secretary published updated waivers and modifications to reflect the results of the review. Under that document, the updated waivers and modifications expire on September 30, 2017.

The Secretary is updating the waivers and modifications to reflect statutory and regulatory changes that have occurred since the September 27, 2012, document was published. The waivers and modifications in this document will expire on September 30, 2022. With a few limited exceptions, the waivers and modifications in this document are the same waivers and modifications published in the September 27, 2012, Federal Register document. However, the 2012 waivers and modifications have been updated in the following areas:

(1) The Secretary updated the need analysis modification to reflect the change in which tax year's information is collected on the Free Application for Federal Student Aid (FAFSA) and used to calculate the applicant's expected family contribution (EFC). Previously when completing a FAFSA, a student provided income information from the most recently completed tax year prior to the beginning of the financial aid application cycle (e.g., 2015 income information for the 2016-2017 FAFSA). Beginning with the 2017-2018 FAFSA, income information is collected from one tax year earlier—referred to as the “prior-prior year.” This change was made under the authority of section 480(a)(1)(B) of the HEA. This modification was also updated to make it consistent with the modification to professional judgment included in this document, which provides three options that a financial aid administrator (FAA) may use to make adjustments to the values of the items used to calculate the EFC to reflect a student's special circumstances.

(2) For the professional judgment modification, the Secretary clarified that in addition to using income information from the first or second calendar year of the award year, an institution may use another annual income that more accurately reflects the family's current financial circumstances.

(3) The Secretary updated the modifications related to verification of adjusted gross income (AGI) and U.S. income tax paid so that affected individuals under this category are no longer required to provide a signature on the statement certifying that he or she has not filed an income tax return or a request for a filing extension because he or she was called up for active duty or for qualifying National Guard duty during a war or other military operation or national emergency; or certifying the amount of AGI and U.S. income tax paid for the specified year.

(4) The Secretary extended the waiver assisting affected individuals with regard to the annual reevaluation requirements for FFEL and Direct Loan borrowers who are repaying loans under the Income-Based Repayment (IBR) plan, and Direct Loan borrowers who are repaying loans under the Income-Contingent Repayment (ICR) plan to include borrowers who are repaying Direct Loans under the Pay As You Earn (PAYE) or Revised Pay As You Earn (REPAYE) repayment plans.

(5) For the fourth category of affected individuals to which waivers and modifications apply, as described later in this document, the Secretary removed the reference to spouses of affected individuals who are serving on active duty or performing qualifying National Guard duty during a war or other military operation or national emergency, since the waivers under this category only pertain to the dependent student of such affected individuals.

(6) The Secretary updated the waiver related to verification signature requirements to waive the requirement for a parental signature on any verification documentation required for title IV eligibility for a dependent student because of the parent's status as an affected individual.

(7) The Secretary made a technical change to the waiver related to the section on required signatures on the FAFSA, the Student Aid Report (SAR), and the Institutional Student Information Record (ISIR), replacing the reference to “ISIR” with “or submitting corrections electronically”. The Secretary also changed the reference to “responsible parent” to “relevant parent” to mean the parent whose information is reported on the FAFSA.

The Secretary is issuing these waivers and modifications under the authority of the HEROES Act, 20 U.S.C. 1098bb(a). In accordance with the HEROES Act, the Secretary is providing the waivers and modifications of statutory and regulatory requirements applicable to the student financial assistance programs under title IV of the HEA that the Secretary believes are appropriate to ensure that:

• Affected individuals who are recipients of student financial assistance under title IV are not placed in a worse position financially in relation to that financial assistance because they are affected individuals;

• Affected individuals who are recipients of student financial assistance are not unduly subject to administrative burden or inadvertent, technical violations or defaults;

• Affected individuals are not penalized when a determination of need for student financial assistance is calculated;

• Affected individuals are not required to return or repay an overpayment of grant funds based on the HEA's Return of Title IV Funds provision; and

• Entities that participate in the student financial assistance programs under title IV of the HEA and that are located in areas that are declared disaster areas by any Federal, State, or local official in connection with a national emergency, or whose operations are significantly affected by such a disaster, receive temporary relief from administrative requirements.

In 20 U.S.C. 1098bb(b)(1), the HEROES Act further provides that section 437 of the General Education Provisions Act (20 U.S.C. 1232) and section 553 of the Administrative Procedure Act (5 U.S.C. 553) do not apply to the contents of this document.

The following terms used in this document are defined in 20 U.S.C. 1098ee: Active duty, military operation, national emergency, qualifying National Guard duty during a war or other military operation or national emergency, and serving on active duty during a war or other military operation or national emergency.

The following waivers and modifications are grouped into four categories, according to the affected individuals to whom they apply.

Category 1: The Secretary is waiving or modifying the following requirements of title IV of the HEA and the Department of Education's (Department's) regulations for ALL affected individuals.

Section 480 of the HEA provides that, in the calculation of an applicant's EFC, the term “total income,” which is used in the determination of “annual adjusted family income” and “available income,” is equal to the applicant's, the applicant's spouse's, or the applicant's parent's AGI plus untaxed income and benefits for the second preceding tax year minus excludable income. The HEROES Act allows an institution to substitute AGI plus untaxed income and benefits received in the first calendar year of the award year for which such determination is made for any affected individual, and for his or her spouse and dependents, if applicable, in order to reflect more accurately the financial condition of an affected individual and his or her family. The Secretary has determined that an institution has the option of using the applicant's original EFC (the EFC based on the income and tax information reported on the FAFSA), the EFC based on the data from the first calendar year of the award year, or the EFC based on another annual income that more accurately reflects the family's current financial circumstances.

If an institution chooses to use anything other than the original EFC, it should use the administrative professional judgment options discussed in the following section.

Section 479A of the HEA specifically gives the FAA at an institution the authority to use professional judgment to make, on a case-by-case basis, adjustments to the cost of attendance or to the values of the items used in calculating the EFC to reflect a student's special circumstances. The Secretary is modifying this provision by removing the requirement that adjustments be made on a case-by-case basis for affected individuals. The use of professional judgment in Federal need analysis is discussed in the Federal Student Aid Handbook available at www.ifap.ed.gov.

The Secretary encourages FAAs to use professional judgment to reflect more accurately the financial need of affected individuals. To that end, the Secretary encourages institutions to determine an affected individual's need using one of the options listed below:

• Using the AGI plus untaxed income and benefits received in the first calendar year of the award year;

• Using another annual income that more accurately reflects the family's current financial circumstances; or

• Making no modifications.

The FAA must clearly document the reasons for any adjustment and the facts supporting the decision. In almost all cases, the FAA should have documentation from a third party with knowledge of the student's special circumstances. As usual, any professional judgment decisions made by an FAA that affect a student's eligibility for a subsidized student financial assistance program must be reported to the Central Processing System.

Section 484B(b)(2) of the HEA and 34 CFR 668.22(h)(3)(ii) require a student to return or repay, as appropriate, unearned grant funds for which the student is responsible under the Return of Title IV Funds calculation. For a student who withdraws from an institution because of his or her status as an affected individual, the Secretary is waiving these statutory and regulatory requirements so that a student is not required to return or repay any overpayment of grant funds based on the Return of Title IV Funds provisions.

For these students, the Secretary also waives 34 CFR 668.22(h)(4), which:

• Requires an institution to notify a student of a grant overpayment and the actions the student must take to resolve the overpayment;

• Denies eligibility to a student who owes a grant overpayment and does not take an action to resolve the overpayment; and

• Requires an institution to refer a grant overpayment to the Secretary under certain conditions.

Therefore, an institution is not required to contact the student, notify the National Student Loan Data System, or refer the overpayment to the Secretary. However, the institution must document in the student's file the amount of any overpayment as part of the documentation of the application of this waiver.

The student is not required to return or repay an overpayment of grant funds based on the Return of Title IV Funds provision. Therefore, an institution must not apply any title IV credit balance to the grant overpayment prior to: Using a credit balance to pay authorized charges; paying any amount of the title IV credit balance to the student or parent, in the case of a parent PLUS loan; or using the credit balance to reduce the student's title IV loan debt (with the student's authorization) as provided in Dear Colleague Letter GEN-04-03 (February 2004; revised November 2004).

Pursuant to 34 CFR 668.57(a)(3)(ii), for an individual who is required to file a U.S. income tax return and has been granted a filing extension by the Internal Revenue Service (IRS), an institution must accept, in lieu of an income tax return for verification of AGI or U.S. income tax paid:

• A copy of IRS Form 4868, “Application for Automatic Extension of Time to File U.S. Individual Income Tax Return,” that the individual filed with the IRS for the specified year, or a copy of the IRS's approval of an extension beyond the automatic six-month extension if the individual requested an additional extension of the filing time; and

• A copy of each IRS Form W-2 that the individual received for the specified year or, for a self-employed individual, a statement signed by the individual certifying the amount of AGI and U.S. income tax paid for the specified year.

The Secretary is modifying the requirement of this provision so that the submission of a copy of IRS Form 4868 or a copy of the IRS's approval of an extension beyond the six-month extension is not required if an affected individual has not filed an income tax return by the filing deadline.

For these individuals, an institution must accept, in lieu of an income tax return for verification of AGI and U.S. income tax paid:

• A statement from the individual certifying that he or she has not filed an income tax return or a request for a filing extension because he or she was called up for active duty or for qualifying National Guard duty during a war or other military operation or national emergency; and

• A copy of each W-2 received for the specified year or, for a self-employed individual, a statement by the individual certifying the amount of AGI and U.S. income tax paid for the specified year.

An institution may request that an individual granted a filing extension submit tax information using the IRS Data Retrieval Tool, or by obtaining a tax return transcript from the IRS that lists tax account information for the specified year after the income tax return is filed. If an institution receives the tax information, it must verify the income information of the tax filer(s).

Category 2: The Secretary is waiving or modifying requirements in the following provisions of title IV of the HEA and the Department's regulations for affected individuals who are serving on active duty or performing qualifying National Guard duty during a war or other military operation or national emergency, or who reside or are employed in a disaster area.

Under 34 CFR 668.22(a)(6)(iii)(A)(5) and (D), a student (or parent for a parent PLUS loan) must be provided a post-withdrawal disbursement of a title IV loan if the student (or parent) responds to an institution's notification of the post-withdrawal disbursement within 14 days of the date that the institution sent the notice, or a later deadline set by the institution. If a student or parent submits a late response, an institution may, but is not required to, make the post-withdrawal disbursement.

The Secretary is modifying this requirement so that, for a student who withdraws because of his or her status as an affected individual in this category and who is eligible for a post-withdrawal disbursement, the 14-day time period in which the student (or parent) must normally respond to the offer of the post-withdrawal disbursement is extended to 45 days, or to a later deadline set by the institution. If the student or parent submits a response after the designated period, the institution may, but is not required to, make the post-withdrawal disbursement. As required under the current regulations, if the student or parent submits the timely response instructing the institution to make all or a portion of the post-withdrawal disbursement, or the institution chooses to make a post-withdrawal disbursement based on receipt of a late response, the institution must disburse the funds within 180 days of the date of the institution's determination that the student withdrew.

Under 34 CFR 668.22(d)(3)(iii)(B), a student is required to provide a written, signed, and dated request, which includes the reason for that request, for an approved leave of absence prior to the leave of absence. However, if unforeseen circumstances prevent a student from providing a prior written request, the institution may grant the student's request for a leave of absence if the institution documents its decision and collects the written request at a later date. It may be appropriate in certain limited cases for an institution to provide an approved leave of absence to a student who must interrupt his or her enrollment because he or she is an affected individual in this category. Therefore, the Secretary is waiving the requirement that the student provide a written request for affected individuals who have difficulty providing a written request as a result of being an affected individual in this category. The institution's documentation of its decision to grant the leave of absence must include, in addition to the reason for the leave of absence, the reason for waiving the requirement that the leave of absence be requested in writing.

Under 34 CFR 668.164(h)(2), an institution must pay any title IV credit balance to the student, or parent in the case of a parent PLUS loan, as soon as possible, but no later than: 14 days after the balance occurred if the balance occurred after the first day of class of a payment period; or 14 days after the first day of class of a payment period if the balance occurred on or before the first day of class of that payment period. If the student (or parent) has provided authorization, an institution may use a title IV credit balance to reduce the borrower's total title IV loan debt, not just the title IV loan debt for the period for which the Return of Title IV Funds calculation is performed.

For students who withdraw because they are affected individuals in this category, the Secretary finds that the institution has met the 14-day requirement under 34 CFR 668.164(h)(2) if, within that timeframe, the institution attempts to contact the student (or parent) to suggest that the institution be authorized to return the credit balance to the loan program(s).

Based upon the instructions of the student (or parent), the institution must promptly return the funds to the title IV loan programs or pay the credit balance to the student (or parent).

In addition, if an institution chooses to attempt to contact the student (or parent) for authorization to apply the credit balance to reduce the student's title IV loan debt, it must allow the student (or parent) 45 days to respond. If there is no response within 45 days, the institution must promptly pay the credit balance to the student (or parent) or return the funds to the title IV programs if the student (or parent) cannot be located.

Consistent with the guidance provided in Dear Colleague Letter GEN-04-03 (February 2004; revised November 2004), the institution may also choose to pay the credit balance to the student (or parent) without first requesting permission to apply the credit balance to reduce the student's title IV loan debt.

Under 34 CFR 668.165(a)(4)(ii), an institution must return loan or TEACH Grant proceeds, cancel the loan or TEACH Grant, or do both, if the institution receives a loan or TEACH Grant cancellation request from a student or parent:

• By the later of the first day of a payment period or 14 days after the date the institution notifies the student or parent of his or her right to cancel all or a portion of a loan or TEACH Grant, if the institution obtains affirmative confirmation from the student under 34 CFR 668.165(a)(6)(i); or

• Within 30 days of the date the institution notifies the student or parent of his or her right to cancel all or a portion of a loan, if the institution does not obtain affirmative confirmation from the student under 34 CFR 668.165(a)(6)(i).

Under 34 CFR 668.165(a)(4)(iii), if an institution receives a loan cancellation request from a borrower after the period specified in 34 CFR 668.165(a)(4)(ii), the institution may, but is not required to, comply with the request. For a student or parent who is an affected individual in this category, the Secretary is modifying this requirement so that an institution must allow at least 60 days for the student or parent to request the cancellation of all or a portion of a loan or TEACH Grant for which proceeds have been credited to the account at the institution. If an institution receives a loan or TEACH Grant cancellation request after the 60-day period, the institution may, but is not required to, comply with the request.

Under 34 CFR 668.165(b)(1), an institution must obtain a written authorization from a student or parent, as applicable, to:

• Use title IV funds to pay for educationally related charges incurred by the student at the institution other than charges for tuition and fees and, as applicable, room and board; and

• Hold on behalf of the student or parent any title IV funds that would otherwise be paid directly to the student or parent.

The Secretary is modifying these requirements to permit an institution to accept an authorization provided by a student (or parent for a parent PLUS loan) orally, rather than in writing, if the student or parent is prevented from providing a written authorization because of his or her status as an affected individual in this category. The institution must document the oral consent or authorization.

Institutions may, in cases where a student failed to meet the institution's satisfactory academic progress standards as a direct result of being an affected individual in this category, apply the exception provision of “other special circumstances” contained in 34 CFR 668.34(a)(9)(ii).

Sections 428(b)(7)(D) and 464(c)(7) of the HEA and 34 CFR 674.31(b)(2)(i)(C), 682.209(a)(5), and 685.207(b)(2)(ii) and (c)(2)(ii) exclude from a Federal Perkins Loan, FFEL, or Direct Loan borrower's (title IV borrower's) initial grace period any period during which a borrower who is a member of an Armed Forces reserve component is called or ordered to active duty for a period of more than 30 days. The statutory and regulatory provisions further require that any single excluded period may not exceed three years and must include the time necessary for the borrower to resume enrollment at the next available regular enrollment period. Lastly, any borrower who is in a grace period when called or ordered to active duty is entitled to another six- or nine-month grace period, as applicable, upon completion of the excluded period of service.

The Secretary is modifying these statutory and regulatory requirements to exclude from a title IV borrower's initial grace period, any period, not to exceed three years, during which a borrower is an affected individual in this category. Any excluded period must include the time necessary for an affected individual in this category to resume enrollment at the next available enrollment period.

A title IV borrower is considered to be in an “in-school” status and is not required to make payments on a title IV loan that has not entered repayment as long as the borrower is enrolled at an eligible institution on at least a half-time basis. Under sections 428(b)(7) and 464(c)(1)(A) of the HEA and 34 CFR 674.31(b)(2), 682.209(a), and 685.207(b), (c), and (e)(2) and (3), when a title IV borrower ceases to be enrolled at an eligible institution on at least a half-time basis, the borrower is obligated to begin repayment of the loan after a six- or nine-month grace period, depending on the title IV loan program and the terms of the borrower's promissory note. The Secretary is modifying the statutory and regulatory requirements that obligate an “in-school” borrower who has dropped below half-time status to begin repayment if the borrower is an affected individual in this category, by requiring the holder of the loan to maintain the loan in an “in-school” status for a period not to exceed three years, including the time necessary for the borrower to resume enrollment in the next regular enrollment period, if the borrower is planning to go back to school. The Secretary will pay interest that accrues on a subsidized Stafford Loan as a result of the extension of a borrower's in-school status under this modification.

Under sections 427(a)(2)(C)(i), 428(b)(1)(M)(i), 428B(a)(2) and (d)(1), 428C(b)(4)(C), 455(f)(2)(A), and 464(c)(2)(A)(i) of the HEA and 34 CFR 674.34(b)(1), 682.210(b)(1)(i), (ii), and (iii), 682.210(s)(2), (3), and (4), 685.204(b), 685.204(d), and 685.204(e), a title IV borrower is eligible for a deferment on the loan during periods after the commencement or resumption of the repayment period on the loan when the borrower is enrolled and in attendance as a regular student on at least a half-time basis (or full-time, if required by the terms of the borrower's promissory note) at an eligible institution; enrolled and in attendance as a regular student in a course of study that is part of a graduate fellowship program; engaged in an eligible rehabilitation training program; or, for Federal Perkins Loan borrowers, engaged in graduate or post-graduate fellowship-supported study outside the United States. The borrower's deferment period ends when the borrower no longer meets one of the above conditions.

The Secretary is waiving the statutory and regulatory eligibility requirements for this deferment for title IV borrowers who were required to interrupt a graduate fellowship or rehabilitation training program deferment, or who were in an in-school deferment but who left school, because of their status as an affected individual in this category. The holder of the loan is required to maintain the loan in the graduate fellowship, rehabilitation training program, or in-school deferment status for a period not to exceed three years during which the borrower is an affected individual in this category. This period includes the time necessary for the borrower to resume his or her graduate fellowship program, resume a rehabilitation training program, or resume enrollment in the next regular enrollment period if the borrower returns to school. The Secretary will pay interest that accrues on a FFEL subsidized Stafford Loan or not charge interest on a Direct subsidized Stafford Loan as a result of extending a borrower's eligibility for deferment under this waiver.

Under section 464(e) of the HEA and 34 CFR 674.33(d)(2), there is a three-year cumulative limit on the length of forbearances that a Federal Perkins Loan borrower can receive. To assist Federal Perkins Loan borrowers who are affected individuals in this category, the Secretary is waiving these statutory and regulatory requirements so that any forbearance based on a borrower's status as an affected individual in this category is excluded from the three-year cumulative limit.

Under section 464(e) of the HEA and 34 CFR 674.33(d)(2) and (3), a school must receive a request and supporting documentation from a Federal Perkins Loan borrower before granting the borrower a forbearance, the terms of which must be in the form of a written agreement. The Secretary is waiving these statutory and regulatory requirements to require an institution to grant forbearance based on the borrower's status as an affected individual in this category for a one-year period, including a three-month “transition period” immediately following, without supporting documentation or a written agreement, based on the written or oral request of the borrower, a member of the borrower's family, or another reliable source. The purpose of the three-month transition period is to assist borrowers so that they will not be required to reenter repayment immediately after they are no longer affected individuals in this category. In order to grant the borrower forbearance beyond the initial twelve- to fifteen-month period, supporting documentation from the borrower, a member of the borrower's family, or another reliable source is required.

Under 34 CFR 682.211(i)(1), a FFEL borrower who requests forbearance because of a military mobilization must provide the loan holder with documentation showing that he or she is subject to a military mobilization. The Secretary is waiving this requirement to allow a borrower who is not otherwise eligible for the military service deferment under 34 CFR 682.210(t), 685.204(h), and 674.34(h) to receive forbearance at the request of the borrower, a member of the borrower's family, or another reliable source for a one-year period, including a three-month transition period that immediately follows, without providing the loan holder with documentation. To grant the borrower forbearance beyond this period, documentation supporting the borrower's military mobilization must be submitted to the loan holder.

The Secretary will apply the forbearance waivers and modifications in this section to loans held by the Department.

In accordance with 34 CFR part 674, subpart C—Due Diligence, and 682.410(b)(6), schools and guaranty agencies must attempt to recover amounts owed from defaulted Federal Perkins Loan and FFEL borrowers, respectively. The Secretary is waiving the regulatory provisions that require schools and guaranty agencies to attempt collection on defaulted loans for the time period during which the borrower is an affected individual in this category and for a three-month transition period. The school or guaranty agency may stop collection activities upon notification by the borrower, a member of the borrower's family, or another reliable source that the borrower is an affected individual in this category. Collection activities must resume after the borrower has notified the school or guaranty agency that he or she is no longer an affected individual and the three-month transition period has expired. The loan holder must document in the loan file why it has suspended collection activities on the loan, and the loan holder is not required to obtain evidence of the borrower's status while collection activities have been suspended. The Secretary will apply the waivers described in this paragraph to loans held by the Department.

Depending on the loan program, borrowers may qualify for loan cancellation if they are employed fulltime in specified occupations, such as teaching or in law enforcement, pursuant to sections 428J, 460(b)(1), and 465(a)(2)(A)-(M) and (3) of the HEA, and 34 CFR 674.53, 674.55, 674.55(b), 674.56, 674.57, 674.58, 674.60, 682.216, and 685.217. Generally, to qualify for loan cancellation, borrowers must perform uninterrupted, otherwise qualifying service for a specified length of time (for example, one year) or for consecutive periods of time, such as five consecutive years.

For borrowers who are affected individuals in this category, the Secretary is waiving the requirements that apply to the various loan cancellations that such periods of service be uninterrupted or consecutive, if the reason for the interruption is related to the borrower's status as an affected individual in this category. Therefore, the service period required for the borrower to receive or retain a loan cancellation for which he or she is otherwise eligible will not be considered interrupted by any period during which the borrower is an affected individual in this category, including the three-month transition period. The Secretary will apply the waivers described in this paragraph to loans held by the Department.

A borrower of a Direct Loan or FFEL Loan must make nine voluntary on-time, monthly payments over ten consecutive months to rehabilitate a defaulted loan in accordance with section 428F(a) of the HEA and 34 CFR 682.405 and 685.211(f). Federal Perkins Loan borrowers must make nine consecutive, on-time monthly payments to rehabilitate a defaulted Federal Perkins Loan in accordance with section 464(h)(1)(A) of the HEA and 34 CFR 674.39. To assist title IV borrowers who are affected individuals in this category, the Secretary is waiving the statutory and regulatory requirements that payments made to rehabilitate a loan must be consecutive or made over no more than ten consecutive months. Loan holders should not treat any payment missed during the time that a borrower is an affected individual in this category, or during the three-month transition period, as an interruption in the number of monthly, on-time payments required to be made consecutively, or the number of consecutive months in which payment is required to be made, for loan rehabilitation. If there is an arrangement or agreement in place between the borrower and loan holder and the borrower makes a payment during this period, the loan holder must treat the payment as an eligible payment in the required series of payments. When the borrower is no longer an affected individual in this category, and the three-month transition period has expired, the required sequence of qualifying payments may resume at the point they were discontinued as a result of the borrower's status. The Secretary will apply the waivers described in this paragraph to loans held by the Department.

Under sections 428F(b) and 464(h)(2) of the HEA and under the definition of “satisfactory repayment arrangement” in 34 CFR 668.35(a)(2), 674.2(b), 682.200(b), and 685.102(b), a defaulted title IV borrower may make six consecutive, on-time, voluntary, full, monthly payments to reestablish eligibility for title IV student financial assistance. To assist title IV borrowers who are affected individuals in this category, the Secretary is waiving statutory and regulatory provisions that require the borrower to make consecutive payments to reestablish eligibility for title IV student financial assistance. Loan holders should not treat any payment missed during the time that a borrower is an affected individual in this category as an interruption in the six consecutive, on-time, voluntary, full, monthly payments required for reestablishing title IV eligibility. If there is an arrangement or agreement in place between the borrower and loan holder and the borrower makes a payment during this period, the loan holder must treat the payment as an eligible payment in the required series of payments. When the borrower is no longer an affected individual or in the three-month transition period for purposes of this document, the required sequence of qualifying payments may resume at the point they were discontinued as a result of the borrower's status. The Secretary will apply the waivers described in this paragraph to loans held by the Department.

Under the definition of “satisfactory repayment arrangement” in 34 CFR 685.102(b), a defaulted FFEL or Direct Loan borrower may establish eligibility to consolidate a defaulted loan in the Direct Consolidation Loan Program by making three consecutive, voluntary, on-time, monthly, full payments on the loan. The Secretary is waiving the regulatory requirement that such payments be consecutive. FFEL loan holders should not treat any payment missed during the time that a borrower is an affected individual in this category as an interruption in the three consecutive, voluntary, monthly, full, on-time payments required for establishing eligibility to consolidate a defaulted loan in the Direct Consolidation Loan Program. If there is an arrangement or agreement in place between the borrower and loan holder and the borrower makes a payment during this period, the loan holder must treat the payment as an eligible payment in the required series of payments. When the borrower is no longer an affected individual in this category or in the three-month transition period, the required sequence of qualifying payments may resume at the point they were discontinued as a result of the borrower's status as an affected individual. The Secretary will apply the waivers described in this paragraph to loans held by the Department.

Section 493C(c) of the HEA requires the Secretary to establish procedures for annually determining a borrower's eligibility for the IBR plan, including verification of a borrower's annual income and the annual amount due on the total amount of the borrower's loans. Section 455(e)(1) of the HEA provides that the Secretary may obtain such information as is reasonably necessary regarding the income of a borrower for the purpose of determining the annual repayment obligation of the borrower under an income-contingent repayment plan. Under 34 CFR 682.215(e), 685.209(a)(5), (b)(3), and (c)(4), and 685.221(e), borrowers repaying under the IBR, PAYE, REPAYE, or ICR plans must annually provide their loan holder with documentation of their income and family size so that the loan holder may, if necessary, adjust the borrower's monthly payment amount based on changes in the borrower's income or family size. Borrowers are required to provide information about their annual income and family size to the loan holder each year by a deadline specified by the holder. If a borrower who is repaying his or her loans under the IBR, PAYE, or ICR plans fails to provide the required information by the specified deadline, the borrower's monthly payment amount is adjusted and is no longer based on the borrower's income. This adjusted monthly payment amount is generally higher than the payment amount that was based on the borrower's income.

The Secretary is waiving these statutory and regulatory provisions to require loan holders to maintain an affected borrower's payment at the most recently calculated IBR, PAYE, REPAYE, or ICR monthly payment amount for up to a three-year period, including a three-month transition period immediately following the three-year period, if the borrower's status as an affected individual in this category has prevented the borrower from providing documentation of updated income and family size by the specified deadline.

Category 3: The Secretary is waiving or modifying the following provisions of title IV of the HEA and the Department's regulations for affected individuals who are serving on active duty or performing qualifying National Guard duty during a war or other military operation or national emergency.

The HEROES Act encourages institutions to provide a full refund of tuition, fees, and other institutional charges for the portion of a period of instruction that a student was unable to complete, or for which the student did not receive academic credit, because he or she was called up for active duty or for qualifying National Guard duty during a war or other military operation or national emergency. Alternatively, the Secretary encourages institutions to provide a credit in a comparable amount against future charges.

The HEROES Act also recommends that institutions consider providing easy and flexible reenrollment options to students who are affected individuals in this category. At a minimum, an institution must comply with the requirements of 34 CFR 668.18, which addresses the readmission requirements for service members serving for a period of more than 30 consecutive days under certain conditions. Some institutions must also abide by the protections provided by the Principles of Excellence (Executive Order 13607, issued April 27, 2012) to service members who are absent for shorter periods of service. Institutions agree to comply with the Principles of Excellence through arrangements with the Department of Defense and the Department of Veterans Affairs. Executive Order 13607 is available at www.whitehouse.gov/the-press-office/2012/04/27/executive-order-establishing-principles-excellence-educational-instituti.

Of course, an institution may provide such treatment to affected individuals other than those who are called up to active duty or for qualifying National Guard duty during a war or other military operation or national emergency.

Before an institution makes a refund of institutional charges, it must perform the required Return of Title IV Funds calculations based upon the originally assessed institutional charges. After determining the amount that the institution must return to the title IV Federal student aid programs, any reduction of institutional charges may take into account the funds that the institution is required to return. In other words, we do not expect that an institution would both return funds to the Federal programs and also provide a refund of those same funds to the student.

Category 4: The Secretary is waiving or modifying the following provisions of the HEA and the Department's regulations for dependents of affected individuals who are serving on active duty or performing qualifying National Guard duty during a war or other military operation or national emergency.

The Department's regulations in 34 CFR 668.57(b), (c), and (d) require signatures to verify the number of family members in the household, the number of family members enrolled in postsecondary institutions, or other information specified in the annual Federal Register document that announces the FAFSA information that an institution and an applicant may be required to verify, as well as the acceptable documentation for verifying that FAFSA information. The Secretary is waiving the requirement for a parent's signature on any verification documentation required for title IV eligibility for a dependent student when no relevant parent can provide the required signature because of the parent's status as an affected individual in this category.

Generally, when a dependent applicant for title IV aid submits the FAFSA or submits corrections to a previously submitted FAFSA, at least one parent's signature is required on the FAFSA, SAR, or in connection with submitting corrections electronically. The Secretary is waiving this requirement so that an applicant need not provide a parent's signature when there is no relevant parent who can provide the required signature because of the parent's status as an affected individual in this category. In these situations, a student's high school counselor or the FAA may sign on behalf of the parent as long as the applicant provides adequate documentation concerning the parent's inability to provide a signature due to the parent's status as an affected individual in this category.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site. You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

I. Background

Under the Regional Haze Rule,1 each state was required to submit its first implementation plan addressing regional haze visibility impairment to the EPA no later than December 17, 2007. See 40 CFR 51.308(b). New Jersey submitted its regional haze plan on July 28, 2009. On January 3, 2012, the EPA approved New Jersey's regional haze SIP submittal addressing the requirements of the first implementation period for regional haze. 77 FR 19 (Jan.3, 2012).

Each state is also required to submit a progress report in the form of a SIP revision that evaluates progress towards the reasonable progress goals (RPGs) for each mandatory Class I Federal area within the state and for each mandatory Class I Federal area outside the state which may be affected by emissions from within the state. See 40 CFR 51.308(g). Each state is also required to submit, at the same time as the progress report, a determination of the adequacy of its existing regional haze SIP. See 40 CFR 51.308(h). The progress report SIP was due five years after submittal of the initial regional haze SIP.

On June 28, 2016, New Jersey submitted to the EPA, as a revision to its SIP, a report on progress made towards the RPGs for Class I areas in the State and for Class I areas outside the State that are affected by emissions from sources within the State. In its progress report SIP, New Jersey concludes the elements and strategies relied on in its original regional haze SIP are sufficient to enable New Jersey and neighboring states to meet all established RPGs. In a notice of proposed rulemaking (NPRM) published on August 1, 2017 (82 FR 35734), the EPA proposed to approve New Jersey's progress report as satisfying the requirements of 40 CFR 51.308(g) and 51.308(h). No comments were received on the August 1, 2017 proposed rulemaking.

EPA is finalizing approval of New Jersey's Regional Haze Progress Report SIP revision, submitted by New Jersey on June 28, 2016, as meeting the requirements of 40 CFR 51.308(g) and 51.308(h).

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

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

• 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 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, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 28, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

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

I. Background

On December 14, 2004, and March 1, 2016, the State of North Carolina, through NCDEQ, submitted revisions to the North Carolina SIP. The March 1, 2016, submission which adds a new rule—15A NCAC 02Q .0809 Concrete Batch Plants—and a portion of the December 14, 2004, submission which adds two new rules—15A NCAC 02Q .0901, Purpose and Scope and .0902 Portable Crushers. In a proposed rulemaking published on July 10, 2017 (82 FR 31739), EPA proposed to approve these SIP revisions. The details of North Carolina's SIP revision and the rationale for EPA's action are explained in the proposed rulemaking. Comments on the proposed rulemaking were due on or before August 9, 2017. EPA did not receive any comments on the proposed action.

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 North Carolina Rules 15A NCAC 02Q .0809 entitled “Concrete Batch Plants” effective April 1, 2004, a new exclusionary rule for concrete batch that excludes from Title V permitting requirements such facilities that operate below a specified annual production rate; 15A NCAC 02Q .0901 entitled “Purpose and Scope” effective January 1, 2005, a new exclusionary rule which provides for exclusions from construction and operating permits for certain types of sources and activities; and 15A NCAC 02Q .0902 entitled “Portable Crushers” effective January 1, 2005, an exclusionary rule which provides for exclusions from construction and operating permits for portable crusher operations.

Therefore, these materials have been approved by EPA for inclusion in the State implementation plan, 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 EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region 4 Office (please contact the person identified in the “For Further Information Contact” section of this preamble for more information).

EPA is approving North Carolina's March 1, 2016, submission and a portion of the December 14, 2004, submission. The changes pertain to the addition of two new rules under a new section “Permit Exemptions” and a new rule to the “Exclusionary Rules” of the North Carolina SIP. These rule adoptions do not contravene federal permitting requirements or existing EPA policy, nor will they impact the NAAQS or interfere with any other applicable requirement of the Act. See 42 U.S.C. 7410(l).

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

• Are 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);

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 28, 2017. 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:

I. Background

On May 8, 2017, the Maryland Department of the Environment (MDE) submitted on behalf of the State of Maryland a formal revision, requesting EPA's approval for the SIP of its NNSR Certification for the 2008 Ozone Standard (Revision 17-01). The SIP revision is in response to EPA's final 2008 8-hour ozone NAAQS Findings of Failure to Submit for NNSR requirements. See 82 FR 9158 (February 3, 2017). Specifically, Maryland is certifying that its existing NNSR program, covering the Baltimore Nonattainment Area (which includes Anne Arundel, Baltimore, Carroll, Harford, and Howard Counties and the city of Baltimore), the Philadelphia-Wilmington-Atlantic City Nonattainment Area (which includes Cecil County in Maryland), and the Washington, DC Nonattainment Area (which includes Calvert, Charles, Frederick, Montgomery, and Prince Georges Counties in Maryland) for the 2008 8-hour ozone NAAQS, is at least as stringent as the requirements at 40 CFR 51.165, as amended by the final rule titled “Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements” (SIP Requirements Rule), for ozone and its precursors.1 See 80 FR 12264 (March 6, 2015).

On March 12, 2008, EPA promulgated a revised 8-hour ozone NAAQS of 0.075 parts per million (ppm). See 73 FR 16436 (March 27, 2008). Under EPA's regulations at 40 CFR 50.15, the 2008 8-hour ozone NAAQS is attained when the 3-year average of the annual fourth-highest daily maximum 8-hour average ambient air quality ozone concentrations is less than or equal to 0.075 ppm.

Upon promulgation of a new or revised NAAQS, the CAA requires EPA to designate as nonattainment any area that is violating the NAAQS based on the three most recent years of ambient air quality data at the conclusion of the designation process. The Philadelphia-Wilmington-Atlantic City Area and the Washington, DC Area were classified as marginal nonattainment areas, and the Baltimore Area was classified as a moderate nonattainment for the 2008 8-hour ozone NAAQS on May 21, 2012 (effective July 20, 2012) using 2008-2010 ambient air quality data. See 77 FR 30088. On March 6, 2015, EPA issued the final SIP Requirements Rule, which establishes the requirements that state, tribal, and local air quality management agencies must meet as they develop implementation plans for areas where air quality exceeds the 2008 8-hour ozone NAAQS. See 80 FR 12264. Areas that were designated as marginal ozone nonattainment areas were required to attain the 2008 8-hour ozone NAAQS no later than July 20, 2015, based on 2012-2014 monitoring data. See 40 CFR 51.1103. The Philadelphia-Wilmington-Atlantic City Area and the Washington, DC Area did not attain the 2008 8-hour ozone NAAQS by July 20, 2015; however, these areas did meet the CAA section 181(a)(5) criteria, as interpreted in 40 CFR 51.1107, for a 1-year attainment date extension. See 81 FR 26697 (May 4, 2016). Therefore, on April 11, 2016, the EPA Administrator signed a final rule extending the Philadelphia-Wilmington-Atlantic City Area and the Washington, DC Area 2008 8-hour ozone NAAQS attainment date from July 20, 2015 to July 20, 2016.2

Moderate areas, such as the Baltimore Area, are required to attain the 2008 8-hour ozone NAAQS no later than July 20, 2018, six years after the effective date of the initial nonattainment designations.3 See 40 CFR 51.1103. The statutorily required DOA, for the Baltimore Area, which is due prior to the attainment date for the Area, has not passed and will be addressed in a future rulemaking action.

Based on initial nonattainment designations for the 2008 8-hour ozone standard, as well as the March 6, 2015 final SIP Requirements Rule, Maryland was required to develop a SIP revision addressing certain CAA requirements for the Philadelphia-Wilmington-Atlantic City, Washington, DC, and Baltimore Areas, and submit to EPA a NNSR Certification SIP or SIP revision no later than 36 months after the effective date of area designations for the 2008 8-hour ozone NAAQS (i.e., July 20, 2015). See 80 FR 12264 (March 6, 2015). EPA is taking action on Maryland's May 8, 2017 NNSR Certification SIP revision. EPA's analysis of how this SIP revision addresses the NNSR requirements for the 2008 8-hour ozone NAAQS is provided in Section II below.

Areas designated nonattainment for the ozone NAAQS are subject to the general nonattainment area planning requirements of CAA section 172 and also to the ozone-specific planning requirements of CAA section 182.4 States in the ozone transport region (OTR), such as Maryland, are additionally subject to the requirements outlined in CAA section 184.

Ozone nonattainment areas in the lower classification levels have fewer and/or less stringent mandatory air quality planning and control requirements than those in higher classifications. For a marginal area, such as the Philadelphia-Wilmington-Atlantic City Area and the Washington, DC Area, a state is required to submit a baseline emissions inventory, adopt a SIP requiring emissions statements from stationary sources, and implement a NNSR program for the relevant ozone standard. See CAA section 182(a). For a moderate area, such as the Baltimore Area, a state needs to comply with the marginal area requirements, plus additional requirements, including the requirement to submit a demonstration that the area will attain in 6 years, the requirement to adopt and implement certain emissions controls, such as reasonably available control technology (RACT), and the requirement for greater emissions offsets for new or modified major stationary sources under the state's NNSR program. For each higher ozone nonattainment classification, a state needs to comply with all lower area classification requirements, plus additional emissions controls and more expansive NNSR offset requirements.

The CAA sets out specific requirements for states in the OTR.5 Upon promulgation of the 2008 8-hour ozone NAAQS, states in the OTR were required to submit a SIP revision for RACT. See 40 CFR 51.1116. This requirement is the only recurring obligation for an OTR state upon revision of a NAAQS, unless that state also contains some portion of a nonattainment area for the revised NAAQS. In that case, the nonattainment requirements described previously also apply to those portions of that state.

In the March 6, 2015 SIP Requirements Rule, EPA detailed the requirements applicable to ozone nonattainment areas, as well as requirements that apply in the OTR, and provided specific deadlines for SIP submittals.

On February 3, 2017, EPA found that 15 states and the District of Columbia failed to submit SIP revisions in a timely manner to satisfy certain requirements for the 2008 8-hour ozone NAAQS that apply to nonattainment areas and/or states in the OTR. See 82 FR 9158. As explained in that rulemaking action, consistent with the CAA and EPA regulations, these findings of failure to submit established certain deadlines for the imposition of sanctions, if a state does not submit a timely SIP revision addressing the requirements for which the finding is being made, and for the EPA to promulgate a federal implementation plan (FIP) to address any outstanding SIP requirements.

EPA found that the State of Maryland failed to submit SIP revisions in a timely matter to satisfy NNSR requirements for its marginal and moderate nonattainment areas, specifically the Philadelphia-Wilmington-Atlantic City Area, the Washington, DC Area, and the Baltimore Area.6 Maryland submitted its May 8, 2017 SIP revision to address the specific NNSR requirements for the 2008 8-hour ozone NAAQS, located in 40 CFR 51.160-165, as well as its obligations under EPA's February 3, 2017 Findings of Failure to Submit. EPA's analysis of how this SIP revision addresses the NNSR requirements for the 2008 8-hour ozone NAAQS and the Findings of Failure to Submit is provided in Section II below.

This rulemaking action is specific to Maryland's NNSR requirements. NNSR is a preconstruction review permit program that applies to new major stationary sources or major modifications at existing sources located in a nonattainment area.7 The specific NNSR requirements for the 2008 8-hour ozone NAAQS are located in 40 CFR 51.160-165. The SIP Requirements Rule explained that, for each nonattainment area, a NNSR plan or plan revision was due no later than 36 months after the effective date of area designations for the 2008 8-hour ozone standard (i.e., July 20, 2015).8

The minimum SIP requirements for NNSR permitting programs for the 2008 8-hour ozone NAAQS are located in 40 CFR 51.165. See 40 CFR 51.1114. These NNSR program requirements include those promulgated in the “Phase 2 Rule” implementing the 1997 8-hour ozone NAAQS (75 FR 71018 (November 29, 2005)) and the SIP Requirements Rule implementing the 2008 8-hour ozone NAAQS. Under the Phase 2 Rule, the SIP for each ozone nonattainment area must contain NNSR provisions that: Set major source thresholds for oxides of nitrogen (NOX) and volatile organic compounds (VOC) pursuant to 40 CFR 51.165(a)(1)(iv)(A)(1)(i)-(iv) and (2); classify physical changes as a major source if the change would constitute a major source by itself pursuant to 40 CFR 51.165(a)(1)(iv)(A)(3); consider any significant net emissions increase of NOX as a significant net emissions increase for ozone pursuant to 40 CFR 51.165(a)(1)(v)(E); consider certain increases of VOC emissions in extreme ozone nonattainment areas as a significant net emissions increase and a major modification for ozone pursuant to 40 CFR 51.165(a)(1)(v)(F); set significant emissions rates for VOC and NOX as ozone precursors pursuant to 40 CFR 51.165(a)(1)(x)(A)-(C) and (E); contain provisions for emissions reductions credits pursuant to 40 CFR 51.165(a)(3)(ii)(C)(1)-(2); provide that the requirements applicable to VOC also apply to NOX pursuant to 40 CFR 51.165(a)(8); and set offset ratios for VOC and NOX pursuant to 40 CFR 51.165(a)(9)(i)-(iii) (renumbered as (a)(9)(ii)-(iv) under the SIP Requirements Rule for the 2008 8-hour ozone NAAQS). Under the SIP Requirements Rule for the 2008 8-hour ozone NAAQS, the SIP for each ozone nonattainment area designated nonattainment for the 2008 8-hour ozone NAAQS and designated nonattainment for the 1997 ozone NAAQS on April 6, 2015, must also contain NNSR provisions that include the anti-backsliding requirements at 40 CFR 51.1105. See 40 CFR 51.165(a)(12).

Maryland's longstanding SIP approved NNSR program, established in Code of Maryland Regulations (COMAR) Air Quality Rule COMAR 26.11.17—Nonattainment Provisions for Major New Sources and Major Modifications, applies to the construction and modification of major stationary sources in nonattainment areas. In its May 8, 2017 SIP revision, Maryland certifies that the version of the Air Quality Rule COMAR 26.11.17 in the SIP is at least as stringent as the federal NNSR requirements for the Philadelphia-Wilmington-Atlantic City Area, the Washington, DC Area, and the Baltimore Area. EPA last approved revisions to the SIP approved version of Maryland's NNSR rule in 2012 addressing, among other things, NSR Reform and NOX as a precursor to ozone. See 77 FR 45949 (August 2, 2012).9

EPA notes that neither COMAR 26.11.17 nor Maryland's approved SIP have the regulatory provision for any emissions change of VOC in extreme nonattainment areas, specified in 40 CFR 51165(a)(1)(v)(F), because Maryland has never had an area designated extreme nonattainment for any of the ozone NAAQS. Thus, the Maryland SIP is not required to have this requirement for VOC in extreme nonattainment areas until such time as Maryland has an extreme ozone nonattainment area. Additionally, there are no anti-backsliding provisions found in 40 CFR 51.165(a)(12) in either COMAR 26.11.17 or the Maryland SIP because Maryland's major stationary source thresholds were established for the 1997 8-hour ozone NAAQS nonattainment designations, which were and continue to be more stringent. Thus, antibacksliding requirements are not required. Maryland has not changed these major stationary source threshold provisions in COMAR 26.11.17.01(17), so they remain in Maryland's federally-approved SIP.10 All of the sources located in the 2008 8-hour ozone nonattainment areas in Maryland are required to meet a major stationary source threshold of 25 tons or more per year of VOC or NOX.

The version of COMAR 26.11.17 that is contained in the current SIP has not changed since the 2012 rulemaking where EPA last approved Maryland's NNSR provisions. This version of the rule covers the Philadelphia-Wilmington-Atlantic City, Washington, DC, and Baltimore Nonattainment Areas and remains adequate to meet all applicable NNSR requirements for the 2008 8-hour ozone NAAQS in 40 CFR 51.165, the Phase 2 Rule and the SIP Requirements Rule. A detailed description of the state submittal and EPA's evaluation is included in a technical support document (TSD) prepared in support of this rulemaking action. A copy of the TSD is available, upon request, from the EPA Regional Office listed in the ADDRESSES section of this document or is also available electronically within the Docket for this rulemaking action.

EPA is approving Maryland's May 8, 2017 SIP revision addressing the NNSR requirements for the 2008 ozone NAAQS for the Philadelphia-Wilmington-Atlantic City, Washington, DC, and Baltimore Areas. EPA has concluded that the State's submission fulfills the 40 CFR 51.1114 revision requirement, meets the requirements of CAA sections 110 and 172 and the minimum SIP requirements of 40 CFR 51.165, as well as its obligations under EPA's February 3, 2017 Findings of Failure to Submit. EPA is publishing this rule without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse comment. However, in the “Proposed Rules” section of today's Federal Register, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on November 28, 2017 without further notice unless EPA receives adverse comment by October 30, 2017. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

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);

• 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, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 28, 2017. 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking action. This action approving Maryland's 2008 8-hour ozone NAAQS Certification SIP revision for NNSR 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 “we,” “us,” and “our” refer to EPA. This section provides additional information by addressing the following:

EPA is approving elements of the 2012 PM2.5 NAAQS infrastructure SIP submission from the State of Iowa, dated December 15, 2015, and received on December 22, 2015. Specifically, EPA is approving the following elements of section 110(a)(2): (A), (B), (C), (D)(i)(II)—prevent significant deterioration of air quality (prong 3), (D)(ii) (E) through (H), and (J) through (M).

A Technical Support Document (TSD) is included as part of the docket to discuss the details of this action, including analysis of how the SIP meets the applicable 110 requirements for infrastructure SIPs.

The state submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The state held a 30-day comment period, and a public hearing on November 16, 2015. No oral or written comments were received. This submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, as explained above and in more detail in the technical support document which is part of this docket, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.

EPA is approving elements of the December 15, 2015, infrastructure SIP submission from the State of Iowa, which addresses the requirements of CAA sections 110(a)(1) and (2) as applicable to the 2012 PM2.5 NAAQS. As stated above, EPA is approving the following elements of section 110(a)(2): (A), (B), (C), (D), (D)(i)(II)—prevent significant deterioration of air quality (prong 3), (D)(ii), (E) through (H), and (J) through (M). Details of the submission are addressed in a TSD as part of the docket to discuss this approval action.

EPA is not taking action on section 110(a)(2)(I). Section 110(a)(2)(I) requires that in the case of a plan or plan revision for areas designated as nonattainment areas, states must meet applicable requirements of part D of the CAA, relating to SIP requirements for designated nonattainment areas. EPA does not expect infrastructure SIP submissions to address element (I). The specific SIP submissions for designated nonattainment areas, as required under CAA title I, part D, are subject to different submission schedules than those for section 110 infrastructure elements. EPA will take action on part D attainment plan SIP submissions through a separate rulemaking governed by the requirements for nonattainment areas, as described in part D.

EPA is not taking action on section 110(a)(2)(D)(i)(I) prongs 1 and 2, and section 110(a)(2)(D)(i)(II) prong 4.

We are publishing this direct final rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. However, in the “Proposed Rules” section of this issue of the Federal Register, we are publishing a separate document that will serve as the proposed rule to approve the SIP revision if adverse comments are received on this direct final rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document. If EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. We will address all public comments in any subsequent final rule based on the proposed rule.

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, 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);

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

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

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

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

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

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

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

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

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications 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 November 28, 2017. 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).)

For the reasons stated in the preamble, EPA amends 40 CFR part 52 as set forth below:

Regulated Entities. Entities regulated under CSAPR are fossil fuel-fired boilers and stationary combustion turbines that serve generators producing electricity for sale, including combined cycle units and units operating as part of systems that cogenerate electricity and other useful energy output. Regulated categories and entities include:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated. To determine whether your facility is affected by this action, you should carefully examine the applicability provisions in 40 CFR 97.404 and 97.704. If you have questions regarding the applicability of CSAPR to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section above.

The EPA promulgated CSAPR in 2011 in order to address the obligations of states—and of the EPA when states have not met their obligations—under CAA section 110(a)(2)(D)(i)(I) to prohibit air pollution contributing significantly to nonattainment in, or interfering with maintenance by, any other state with regard to several NAAQS, including the 1997 annual PM2.5 NAAQS.1 To address Texas' transport obligation under CAA section 110(a)(2)(D)(i)(I) with regard to this NAAQS, CSAPR established FIP requirements for affected EGUs in Texas, including statewide emissions budgets that apply to the EGUs' collective annual emissions of SO2 and NOX.

In 2012, the EPA promulgated an amendment to the Regional Haze Rule allowing a state whose EGUs participate in one of the CSAPR trading programs for a given pollutant to rely on its sources' participation in CSAPR as an alternative to source-specific BART requirements—the so-called CSAPR-better-than-BART rule, codified at 40 CFR 51.308(e)(4).2 This rule relied on a regional analytic demonstration that included an air quality modeling analysis comparing the projected visibility impacts of CSAPR implementation and BART implementation. To project emissions under CSAPR, the EPA assumed that the geographic scope and state emissions budgets for CSAPR would be implemented as finalized and amended in 2011 and 2012.3

In July 2015, the D.C. Circuit issued a decision on a range of challenges to CSAPR in EME Homer City Generation, L.P. v. EPA (EME Homer City II), denying most claims but remanding several CSAPR emissions budgets to the EPA for reconsideration, including the Phase 2 SO2 budget for Texas.4 Because the remand created the potential for changes in the geographic scope and stringency of CSAPR as evaluated for purposes of the 2012 comparison to BART implementation, the EPA recognizes that how the Agency addresses the remand could raise questions as to whether states and the EPA should continue to rely on the CSAPR-better-than-BART rule.

The EPA issued a proposal to address the remand of the Texas Phase 2 SO2 budget and to resolve any questions about continued reliance on the CSAPR-better-than-BART rule on November 3, 2016, and solicited comment on the proposal.5 Four commenters provided substantive comments, and this final rule takes those comments into consideration. The Agency's responses to the principal comments are provided below. The remaining comments are addressed in the Response to Comments document available in the docket for this action.

In this final action, as proposed, the EPA is withdrawing the FIP provisions requiring Texas EGUs to participate in the CSAPR SO2 Group 2 Trading Program and the CSAPR NOX Annual Trading Program during Phase 2 of these programs, which began with 2017 emissions.6 Removal of Texas EGUs from Phase 2 of these CSAPR trading programs renders it necessary to evaluate whether EPA should use other means to address any remaining transport obligation for Texas under CAA section 110(a)(2)(D)(i)(I) with regard to the 1997 annual PM2.5 NAAQS. However, the EPA is finalizing its proposed determination that Texas does not have any such remaining 1997 annual PM2.5 NAAQS transport obligation as of the beginning of Phase 2 of the CSAPR trading programs for SO2 and annual NOX. Accordingly, the EPA is also determining that the Agency has no obligation to issue new FIP requirements for Texas sources to address transported PM2.5 pollution under CAA section 110(a)(2)(D)(i)(I) with regard to this NAAQS.

Also in this action, the EPA is concluding, based on consideration of the sensitivity analysis included in the proposal and additional analysis included in this final action, that the 2012 analytic demonstration supporting the conclusion that CSAPR participation qualifies as a BART alternative is not adversely affected by the actions being taken to respond to the D.C. Circuit's remand of CSAPR Phase 2 budgets.7 As a result, no revisions are needed to the CSAPR-better-than-BART rule.

At the same time, however, because Texas EGUs will no longer participate in a CSAPR SO2 trading program, Texas will no longer be eligible to rely on CSAPR participation as an alternative to the application of source-specific SO2 BART for its BART-eligible EGUs under 40 CFR 51.308(e)(4). That obligation and any other remaining regional haze obligations for Texas are not addressed in this action and will need to be addressed through other actions as appropriate.8

This final rule is effective immediately upon publication in the Federal Register. As discussed in section VI.L below, the EPA is issuing this rule under CAA section 307(d). While Administrative Procedure Act (APA) section 553(d)9 generally provides that rules may not take effect earlier than 30 days after they are published in the Federal Register, CAA section 307(d)(1) clarifies that “[t]he provisions of [APA] section 553 . . . shall not, except as expressly provided in this section, apply to actions to which this subsection applies.” Thus, APA section 553(d) does not apply to this rule. Nevertheless, in making this rule effective immediately upon publication, the EPA has considered the purposes underlying APA section 553(d). The primary purpose of the prescribed 30-day waiting period is to give affected parties a reasonable time to adjust their behavior and prepare before a final rule takes effect. This rule does not impose any new regulatory requirements and therefore does not necessitate time for affected sources to adjust their behavior or otherwise prepare for implementation. Further, APA section 553(d) expressly allows an effective date less than 30 days after publication for a rule that “grants or recognizes an exemption or relieves a restriction.” This rule relieves Texas EGUs of certain FIP requirements that would otherwise apply. Consequently, making this rule effective immediately upon publication is consistent with the purposes of APA section 553(d).

The EPA initially promulgated CSAPR in 2011 to address the obligations of states—and of the EPA when states have not met their obligations—under CAA section 110(a)(2)(D)(i)(I), often referred to as the “good neighbor” provision, to prohibit transported air pollution contributing significantly to nonattainment in, or interfering with maintenance by, any other state with regard to the 1997 annual PM2.5 NAAQS, the 2006 24-hour PM2.5 NAAQS, and the 1997 8-hour ozone NAAQS.10 To reduce transported PM2.5 pollution, CSAPR sets limits on annual emissions of NOX and SO2 as precursors to PM2.5. To reduce transported ozone pollution during the May-September ozone season, CSAPR sets limits on seasonal emissions of NOX as a precursor to ozone. The CSAPR requirements were initially established in FIPs, but states can voluntarily replace the CSAPR FIPs with CSAPR state implementation plans (SIPs) that include equally stringent budgets.11 Upon approval of such a CSAPR SIP, the corresponding CSAPR FIP is automatically withdrawn.12

As explained in the proposal, a number of petitioners challenged CSAPR, and in 2015 the D.C. Circuit issued a decision remanding the Phase 2 SO2 emissions budgets for Alabama, Georgia, South Carolina, and Texas and the Phase 2 seasonal NOX budgets for eleven states to the EPA for reconsideration.13 In response to the remand of the Phase 2 SO2 emissions budgets, the EPA has engaged the affected states to determine appropriate next steps to address the decision with regard to each state. As discussed in the proposal and also in section III below, the EPA expects that EGUs in Alabama, Georgia, and South Carolina will continue to participate in CSAPR trading programs for SO2 and annual NOX pursuant to approved SIP revisions (with equally stringent emissions budgets), making Texas the only state whose EGUs will no longer participate in these programs to reduce transported PM2.5 pollution as a result of actions taken to address the remand.

Also as explained in the proposal, in the CSAPR Update rule issued in 2016, the EPA responded to the remand of eleven states' original Phase 2 seasonal NOX budgets (which had been established to address transport obligations with regard to the 1997 8-hour ozone NAAQS) by withdrawing the FIP provisions requiring EGUs to comply with those budgets for emissions after 2016.14 The EPA determined that none of those eleven states has a remaining transport obligation under CAA section 110(a)(2)(D)(i)(I) with regard to the 1997 8-hour ozone NAAQS, but for eight of those states, including Texas, the CSAPR Update rule also established new budgets to address transport obligations with regard to the more stringent 2008 8-hour ozone NAAQS.15 EGUs in the three states with remanded Phase 2 seasonal NOX budgets for which the EPA did not establish new budgets—Florida, North Carolina, and South Carolina—are no longer required to participate in a CSAPR trading program for seasonal NOX emissions to address ozone transport obligations after 2016. However, because EGUs in North Carolina and South Carolina16 are expected to continue to participate in a CSAPR trading program for annual NOX emissions in order to address PM2.5-related transport obligations, Florida is expected to be the only state originally covered by CSAPR for NOX emissions for which all such coverage is ending as a result of the EPA's set of actions to address the remand.17

Prior to this action, Texas EGUs have been subject to CSAPR FIP provisions requiring participation in the CSAPR SO2 Group 2 Trading Program and the CSAPR NOX Annual Trading Program. With this action, the EPA is withdrawing the FIP provisions requiring Texas EGUs to participate in these CSAPR federal trading programs. (Although the court's decision specifically remanded only Texas' Phase 2 SO2 budget, the court's rationale for remanding that budget also implicates Texas' Phase 2 annual NOX budget because the SO2 and annual NOX budgets were developed through an integrated analysis and were promulgated to meet a common PM2.5 transport obligation under CAA section 110(a)(2)(D)(i)(I).) This action has no effect on the separate CSAPR requirements applicable to Texas EGUs relating to seasonal NOX emissions, which, as discussed in the preceding paragraph, were promulgated in the CSAPR Update rule and are not subject to the D.C. Circuit's remand.

The proposal provides a detailed explanation of the Regional Haze Rule requirements for best available retrofit technology (BART) and the criteria for demonstrating that an alternative measure achieves greater reasonable progress than source-specific BART.18

In 2012, the EPA amended the Regional Haze Rule to provide that participation by a state's EGUs in a CSAPR trading program for a given pollutant—either a CSAPR federal trading program implemented through a CSAPR FIP or a CSAPR state trading program implemented through an approved CSAPR SIP revision—qualifies as a BART alternative for those EGUs for that pollutant.19 In promulgating this CSAPR-better-than-BART rule, the EPA relied on an analytic demonstration of the improvement in visibility from CSAPR implementation relative to BART implementation based on an air quality modeling study.20 Since the EPA promulgated this amendment, numerous states covered by CSAPR have come to rely on the provision through either SIPs or FIPs.21 Additionally, many states have submitted or are planning to submit SIPs relying on the CSAPR-better-than-BART rule for BART or visibility transport purposes, or to replace regional haze FIPs with SIPs.

As explained in the proposal, the 2012 analytic demonstration that CSAPR provides for greater reasonable progress than BART included Texas EGUs as subject to CSAPR for SO2 and annual NOX (as well as seasonal NOX) and included Florida EGUs as subject to CSAPR for seasonal NOX. The EPA recognizes that the treatment of these EGUs in the analysis would have been different if the Florida FIP withdrawal finalized in the CSAPR Update rule and the Texas FIP withdrawal finalized in this action had been known at the time of the demonstration. In order to address any potential concern about continuing to rely on CSAPR participation as a BART alternative for EGUs in the remaining CSAPR states, in the proposal for this action the EPA provided a sensitivity analysis explicitly addressing the potential effect on that demonstration of the removal of Texas and Florida EGUs from the relevant CSAPR trading programs in response to the D.C. Circuit's remand. As discussed in section IV, the sensitivity analysis indicates clearly that the demonstration remains valid despite these changes in CSAPR's geographic scope, supporting the continued validity of EPA's 2012 conclusion that CSAPR participation meets the Regional Haze Rule's criteria for a BART alternative.22 Consequently, in this action the EPA is affirming the current Regional Haze Rule provision at 40 CFR 51.308(e)(4) authorizing the use of CSAPR participation as a BART alternative for BART-eligible EGUs for a given pollutant in states whose EGUs continue to participate in a CSAPR trading program for that pollutant.

In this action, as proposed, the EPA is responding to the remand of the CSAPR Phase 2 SO2 budget for Texas by withdrawing the FIP provisions requiring Texas EGUs to participate in the CSAPR SO2 Group 2 Trading Program and the CSAPR NOX Annual Trading Program with regard to emissions during Phase 2 of those programs, which began in 2017. In EME Homer City II, the court remanded the CSAPR Phase 2 SO2 budget for Texas to the EPA for reconsideration on the grounds that the budget may be more stringent than necessary to address the state's obligation under CAA section 110(a)(2)(D)(i)(I) to reduce transported pollution with respect to the 1997 annual PM2.5 NAAQS.23 Upon review of options for responding to the remand, the EPA has determined, for the reasons discussed in this section, that withdrawal of the FIP provisions identified above, rather than issuance of revised FIP provisions for Texas with a higher (i.e., less stringent) Phase 2 SO2 budget as advocated by some commenters, is the appropriate response. Withdrawal of the FIP provisions related to the CSAPR SO2 trading program encompasses withdrawal of the requirement for Texas EGUs to comply with the remanded Phase 2 SO2 budget, thereby addressing the specific rule provision remanded by the court. The EPA is withdrawing the FIP provisions related to annual NOX (in addition to the requirements related to SO2) because the CSAPR FIP requirements for SO2 and annual NOX were determined through an integrated analysis and were promulgated in combination to remedy covered states' PM2.5 transport obligations; the court's finding that CSAPR's Phase 2 requirements may be more stringent than necessary to address Texas' PM2.5 transport obligation therefore implicates the state's Phase 2 budgets for both SO2 and annual NOX.

Withdrawal of the previous CSAPR FIP requirements revives the need to consider Texas' transport obligation under CAA section 110(a)(2)(D)(i)(I) with regard to the 1997 annual PM2.5 NAAQS and to address any remaining obligation through other means. However, as proposed, the Agency is further determining that Texas has no remaining transport obligation under this CAA provision with regard to this NAAQS following withdrawal of the previous FIP requirements, and consequently is also determining that the EPA has no obligation to issue new FIP requirements as to Texas's transport obligation under CAA section 110(a)(2)(D)(i)(I) with regard to the 1997 annual PM2.5 NAAQS.

In the CSAPR final rule, the EPA determined that 23 states, including Texas, had transport obligations with regard to the 1997 annual PM2.5 NAAQS, the 2006 24-hour PM2.5 NAAQS, or both, and established SO2 and annual NOX emissions budgets for each of the states.24 The budgets were implemented through FIP provisions requiring the affected EGUs in each covered state to participate in CSAPR allowance trading programs. In the case of Texas, the PM2.5-related FIP requirements were imposed based solely on the state's transport obligations with regard to the 1997 annual PM2.5 NAAQS.25

Following issuance of the D.C. Circuit's decision in EME Homer City II remanding the CSAPR Phase 2 SO2 budget for Texas, the EPA reevaluated its earlier conclusions regarding Texas' PM2.5 transport obligations by reexamining the data in the final CSAPR record in light of the D.C. Circuit's holdings in the decision, including the holdings regarding the CSAPR Phase 2 seasonal NOX budgets for several states, as explained in the proposal.26 The final CSAPR record contained “base case” modeling projections of air quality at monitoring locations throughout the country both for 2012, the intended start year of Phase 1 of the CSAPR trading programs, and for 2014, the intended start year of Phase 2 of the programs. The base case projections were designed to represent projected air quality at these monitoring locations without any emission reductions from CSAPR. In the CSAPR rulemaking, the EPA used the 2012 base case air quality projections for purposes of identifying ozone receptors projected to have air quality problems and determining states that were linked to those receptors and that therefore might have transport obligations under both Phase 1 and Phase 2 of the CSAPR trading programs. However, in EME Homer City II, the D.C. Circuit agreed with petitioners27 that the EPA should also have considered the 2014 base case air quality projections for these purposes, and that in instances of receptors where the 2014 base case projections did not show air quality problems, the EPA lacked authority to require any emission reductions in Phase 2 of the CSAPR trading programs based on linkages to those receptors only occurring in Phase 1 of the programs. On these grounds, the court found that EPA lacked authority to establish Phase 2 seasonal NOX emission limitations for EGUs in ten states linked solely to ozone receptors whose 2014 air quality projections did not show air quality problems.28

While not discussed in the court's decision, the projections of 2014 air quality for a PM2.5 receptor in Madison County, Illinois (the only PM2.5 receptor with projected air quality problems to which Texas was linked) in the final CSAPR record are analogous to the 2014 air quality projections for the ozone receptors described above, in that the air quality problems at the Madison County receptor were projected to be resolved in 2014 before any emission reductions from CSAPR. In light of the court's holding as to the legal import of the 2014 base case air quality projections for the ozone receptors described above, the EPA considered the legal import of the analogous 2014 base case air quality projections for the Madison County PM2.5 receptor with respect to Texas' PM2.5-related obligations under CSAPR. There are three relevant record data elements. First, the record indicates that the only PM2.5 receptor to which Texas is linked for purposes of determining possible obligations under the good neighbor provision is the receptor in Madison County, Illinois.29 Second, the projected maximum design value 30 for annual PM2.5 at the Madison County receptor is 15.02 micrograms per cubic meter (µg/m3) in the 2014 base case.31 Finally, the value that the EPA used to determine whether a particular PM2.5 receptor should be identified as having air quality problems that may trigger transport obligations with regard to the 1997 annual PM2.5 NAAQS is 15.05 µg/m3, which is higher than the Madison County maximum design value in the 2014 base case.32 Thus, the reevaluation of the final CSAPR record in light of the D.C. Circuit's holding indicates that the record does not support a finding of a transport obligation for Texas under CAA section 110(a)(2)(D)(i)(I) with regard to this NAAQS as of the beginning of Phase 2 of the CSAPR trading programs for SO2 and annual NOX, and the Agency accordingly finds that the state's obligation is resolved without a need for further emission reductions, including the emission reductions from CSAPR. The finding that Texas's transport obligation with regard to this NAAQS is resolved as of the start of Phase 2 of the CSAPR trading programs without the need for any emission reductions from CSAPR removes the EPA's authority to issue new FIP requirements for purposes of responding to the court's remand of the state's CSAPR Phase 2 SO2 budget. The finding likewise eliminates any obligation of the EPA to issue new FIP requirements addressing a remaining transport obligation of the state with regard to this NAAQS following withdrawal of the existing CSAPR FIP requirements, because the state has no such remaining transport obligation following the withdrawal.

As noted in the proposal, the modeling for the CSAPR final rule also linked Texas to a downwind air quality problem with regard to the 2006 24-hour PM2.5 NAAQS, but the EPA did not rely on the linkage with regard to this NAAQS as a basis for establishing CSAPR FIP requirements for Texas EGUs. In the proposal, the EPA indicated that data in the final CSAPR record, reevaluated in light of EME Homer City II, would show that Texas no longer has a transport obligation with regard to the 2006 24-hour PM2.5 NAAQS as of the beginning of Phase 2 of the CSAPR trading programs for SO2 and annual NOX, but that because Texas was not subject to CSAPR requirements with regard to this NAAQS, the EPA was not proposing to make a determination in this action as to any obligation of Texas with regard to this NAAQS. Nevertheless, because commenters raise the 2006 24-hour PM2.5 NAAQS in their comments, the EPA will explain how the court's reasoning would apply with respect to the data for this NAAQS. The analysis for the 2006 24-hour PM2.5 NAAQS is essentially identical to the analysis described above with regard to the 1997 annual PM2.5 NAAQS. Specifically, the Madison County receptor is the only PM2.5 receptor to which Texas was linked for this NAAQS; 33 the projected maximum design value for 24-hour PM2.5 at the Madison County receptor is 35.3 µg/m3 in the 2014 base case; 34 and the value that the EPA used to determine whether a particular PM2.5 receptor should be identified as having air quality problems that may trigger transport obligations with regard to the 2006 24-hour PM2.5 NAAQS is 35.5 µg/m3, which is higher than the Madison County maximum design value in the 2014 base case.35 Thus, the reevaluation of the final CSAPR record in light of the D.C. Circuit's holding also indicates that the record would not support a finding of a transport obligation for Texas with regard to the 2006 24-hour PM2.5 NAAQS as of the beginning of Phase 2 of the CSAPR trading programs for SO2 and annual NOX.

Overall, on the subject of the proposed withdrawal of the FIP provisions and the proposed finding that Texas will no longer have a transport obligation following withdrawal of the FIP provisions, the EPA received substantive comments from two parties.36 The remainder of this section summarizes these commenters' principal comments on this topic and provides the Agency's response.

The commenters state that the Agency's explanation for the proposed finding that Texas no longer has a transport obligation under CAA section 110(a)(2)(D)(i)(I) with regard to the 1997 annual PM2.5 NAAQS as of the beginning of Phase 2 of the CSAPR trading programs for SO2 and annual NOX is inadequate or confusing, and that the Agency must provide additional explanation for changing its position on the continued existence of a Texas transport obligation from the contrary position taken by the Agency when promulgating the CSAPR final rule.

The EPA disagrees with these comments. The proposal contained a complete explanation of the Agency's basis for this finding, including all necessary supporting data and documentation.37 As fully explained in the proposal and reiterated above, the Agency's change in position as to Texas' transport obligation between the CSAPR final rule and this action is readily attributable to the D.C. Circuit's holding in EME Homer City II with regard to the legal import of the 2014 base case air quality projections in the final CSAPR record. The court's holding clarifies the legal standard the Agency should have used when considering the information in the final CSAPR record, which includes those air quality projections.

The commenters assert that withdrawal of the remanded Texas SO2 budget without issuance of a presumably less stringent replacement budget is not responsive to the D.C. Circuit's remand instructions. According to the commenters, the court directed the EPA to develop a revised CSAPR FIP SO2 budget for Texas EGUs that does not over-control, and the EPA must either do so or, alternatively, must allow Texas to submit a CSAPR SIP with a higher SO2 budget. The commenters' argument is intended to provide a continued basis for reliance on CSAPR participation as an SO2 BART alternative for Texas EGUs. Underlying the commenters' arguments is an apparent belief that a revised, higher CSAPR budget, whether issued through a FIP or approved through a SIP, would automatically enable Texas to rely on CSAPR participation as an alternative to source-specific SO2 BART requirements for the State's EGUs under 40 CFR 51.308(e)(4).

The EPA disagrees with these comments. As an initial matter, the D.C. Circuit in fact did not direct the Agency to develop replacement budgets for the Texas SO2 budget or any of the other remanded CSAPR Phase 2 budgets. Rather, the court found that certain budgets were invalid and remanded to the EPA to “reconsider” them,38 a general instruction that encompasses a range of possible Agency actions upon reconsideration. The commenters cite no statement from the court's opinion that requires the establishment of replacement budgets, but assert that such a requirement must be inferred from the court's other statements or determinations. For example, the commenters suggest that because the court remanded the budgets without vacatur instead of vacating the budgets outright, the court must have intended for the Agency to replace rather than simply withdraw the budgets. However, the court actually provided a different rationale for remanding without vacatur, including the statement that “some good neighbor obligations may be appropriate for some of the relevant states.” 39 The reference to “some” of the states indicates that the court considered it likely that replacement budgets would not be established in every instance, and the use of the word “may” indicates that the court considered it possible that replacement budgets would not be established in any instance. Thus, contrary to the commenters' claims, the court's opinion clearly affords the Agency the discretion to determine the appropriate response to the remand and does not prevent the Agency from determining upon reconsideration that the program is no longer needed for a particular state with respect to a particular pollutant and consequently not establishing a replacement budget.

The commenters make several additional arguments in support of their contention that the FIP withdrawal is not responsive to the D.C. Circuit's instructions. One commenter asserts that because the court stated that the Agency could consider new information in responding to the remand, the court must have intended for the Agency's response to involve the establishment of replacement budgets. This claim is a non sequitur—the court's acknowledgement that additional information may be considered says nothing about what the Agency may or must conclude from consideration of that information. The same commenter also asserts that the Agency may not rely on lack of FIP authority as the basis for not establishing a revised budget because lack of FIP authority was not the basis cited by the court for remanding the budget. This claim is also a non sequitur—the Agency lacks authority to issue a revised budget and therefore may not do so, regardless of what additional defects the court may have cited in ordering the remand.

The other commenter asserts that the FIP withdrawal would disrupt allowance markets, contrary to the concern expressed by the D.C. Circuit that outright vacatur, rather than remand without vacatur, could have that impact. While the EPA agrees with the concern expressed by the court and the commenter regarding the potentially disruptive effects of outright vacatur on allowance markets, the Agency does not agree that the court's concern regarding unintended consequences of a judicial vacatur provides a basis for not taking final action at this time to withdraw the Texas FIP requirements, for two reasons. First, the EPA believes that the court did not intend for its expression of concern to constrain the Agency's range of possible responses to the remand. As discussed above, it is clear from the opinion that the court anticipated the possibility that upon reconsideration the EPA would determine that some, or even all, of the remanded budgets should be withdrawn and not replaced. Second, in this instance, emissions data reported by the EGUs covered by the CSAPR trading programs for SO2 and annual NOX demonstrate that withdrawal of the FIP provisions requiring Texas EGUs to participate in these programs will not cause allowance market disruption for the programs' remaining participants. Under both programs, the totals of the emissions reported by participating EGUs for both 2015 and 2016 in states other than Texas were less than the sums of the Phase 2 emissions budgets for these other states.40 Likewise, under both programs the totals of the emissions reported by Texas EGUs for both 2015 and 2016 were less than the Texas Phase 2 budgets.41 The elimination from the programs of Texas EGUs and the allowances allocated to Texas EGUs is therefore not expected to cause either shortages of allowances available for purchase by EGUs in the other states or the loss of an important market for sale of surplus allowances by EGUs in the other states. In these circumstances, the EPA anticipates that the FIP withdrawal will have little impact on the allowance market in either trading program.

With regard to the two commenters' preferred response to the remand—that the EPA establish a revised, less stringent SO2 budget for Texas EGUs and implement that budget through a revised FIP—such an action is infeasible because the Agency lacks the necessary legal authority. In this action, the EPA is finalizing the proposed finding that Texas no longer has a transport obligation under CAA section 110(a)(2)(D)(i)(I) for the 1997 annual PM2.5 NAAQS. That finding addresses the deficiency in the Texas SIP that was the basis for issuance of the withdrawn FIP requirements and, therefore, because there is no longer a deficiency, the Agency no longer has authority to issue revised FIP requirements.42 The reasons for the finding are discussed above and were discussed at length in the proposal.43

With regard to the commenters' suggested alternative response to the remand—that the EPA allow Texas to submit a CSAPR SIP with a higher SO2 budget in order to allow the state to rely on CSAPR participation as an SO2 BART alternative even if the state's EGUs are no longer subject to a CSAPR FIP SO2 budget—the comment is not properly directed to the EPA, because Texas has not expressed interest in submitting a CSAPR SIP.44 Moreover, even if consideration of Texas' BART obligations were relevant for our action on remand, reliance on CSAPR participation with a higher budget would not automatically qualify as an SO2 BART alternative under the terms of the CSAPR-better-than-BART rule. That rule allows a state to rely on its EGUs' participation in a CSAPR SIP trading program only if the EPA approves the SIP as “meeting the requirements of” the CSAPR regulations at 40 CFR 52.38 and 52.39.45 As relevant here, the CSAPR regulations at § 52.39 expressly preclude a state's SO2 emissions budget from exceeding the SO2 emissions budget established under the CSAPR FIP trading program that the CSAPR SIP trading program would replace.46 Thus, even if the D.C. Circuit's remand could serve as a basis for the EPA to approve a SIP revision that does not satisfy § 52.39 on the grounds that the state's transport obligations can be addressed by a less stringent budget, the CSAPR-better-than-BART rule at 40 CFR 51.308(e)(4) would not be satisfied. A SIP approved on such a basis could in theory provide a mechanism for Texas EGUs to participate in CSAPR with a higher SO2 budget than the remanded FIP budget despite the Agency's lack of authority to set a revised SO2 budget through a revised FIP. However, because of the increased SO2 budget, such a SIP would not “meet[] the requirements of . . . § 52.39” and therefore would not allow the state to rely on its EGUs' participation in the CSAPR SIP trading program as an alternative to source-specific BART for SO2.47

One commenter states that by withdrawing the FIP requirements the EPA is arbitrarily singling Texas out as the only state with a remanded CSAPR budget whose EGUs will lose the ability to rely on CSAPR participation as a BART alternative. The commenter further asserts that the Agency's “sole purpose” in withdrawing the FIP requirements is to facilitate the imposition of source-specific SO2 BART requirements on Texas EGUs through a different action.

The EPA disagrees with these comments, which are entirely contrary to the record. First, on the question of uniform application of the CSAPR-better-than-BART regulations, no state whose EGUs do not participate in a CSAPR trading program for a given pollutant can rely on CSAPR participation as a BART alternative for that pollutant. In response to the D.C. Circuit's remand of CSAPR Phase 2 budgets, the EPA has withdrawn or expects to withdraw all fifteen remanded budgets. As explained in the proposal, in thirteen instances, the state will retain eligibility to rely on the CSAPR-better-than-BART rule for the pollutant in question through either the EPA's establishment of a new CSAPR budget to address a more stringent NAAQS (eight seasonal NOX budgets), the state's sources' continued participation in a different CSAPR trading program for the same pollutant (two seasonal NOX budgets), or the state's voluntary adoption in a SIP revision of a CSAPR state budget as stringent as the remanded CSAPR FIP budget (three SO2 budgets).48 In the remaining two instances where a remanded budget is being withdrawn and none of the three options for preserving eligibility to rely on CSAPR-better-than-BART applies—Texas' SO2 budget and Florida's seasonal NOX budget—the state is losing the opportunity to rely on CSAPR participation as a BART alternative for that pollutant.49 Thus, Texas is being treated the same as every other state with respect to use of the CSAPR-better-than-BART rule.50

Second, on the question of the EPA's purpose in withdrawing the FIP requirements, that purpose is to address the court's remand. As explained in the proposal, before initiating this action, the EPA communicated with officials in all four states with remanded SO2 budgets—Alabama, Georgia, South Carolina, and Texas—regarding the EPA's intent to respond to the remand of the Phase 2 SO2 budgets by withdrawing the FIP provisions requiring the states' EGUs to participate in the CSAPR federal trading programs for SO2 and annual NOX.51 The EPA explained that each state would lose its ability to rely on CSAPR participation as a BART alternative for SO2 and/or NOX if its EGUs no longer participated in the CSAPR trading programs, but that the state could preserve that ability, if desired, by submitting a CSAPR SIP revision replacing the CSAPR federal trading programs with CSAPR state trading programs applying state-established budgets no less stringent than the remanded federally-established budgets (i.e., budgets consistent with the 2012 CSAPR-better-than-BART analytic demonstration).52 Alabama, Georgia, and South Carolina indicated their preference to pursue the SIP revision option. The EPA approved Alabama's CSAPR SIP revision in 2016 and, accordingly, the FIP provisions requiring its EGUs to participate in the CSAPR federal trading programs for SO2 and annual NOX have been automatically withdrawn.53 Georgia and South Carolina committed to the EPA in 2016 to submit similar CSAPR SIP revisions by deadlines falling in September 2017 and August 2017, respectively.54 Georgia has in fact now submitted its SIP to the EPA for approval,55 South Carolina has submitted its proposed state CSAPR trading program rules and has requested that the EPA begin the SIP approval process under the Agency's parallel processing procedure,56 and the EPA has proposed to approve both SIP revisions.57 The CSAPR FIP provisions remain in place for the time being for EGUs in Georgia and South Carolina, and the EPA is not proposing their withdrawal at this time based on the reasonable expectation that such withdrawal will be automatically accomplished as a result of the Agency's action on those states' SIP submittals, just as with Alabama.58 Because Texas has indicated that it will not submit a CSAPR SIP revision, the EPA is proceeding with this action to withdraw the FIP requirements for Texas EGUs, consistent with the intended approach previously communicated to officials for all four states. Texas has had the same set of options available to all four states with remanded SO2 budgets and has selected a different option than the other three states.

One commenter asserts that the EPA has not analyzed whether other states covered by CSAPR are linked only to receptors for which the 2014 base case projections do not show air quality problems, and that “[b]y not performing that analysis, the EPA is arbitrarily singling Texas out for removal from the CSAPR program.”

The EPA disagrees with these comments. With respect to the budgets that were not remanded by the court, the Agency has confirmed for each such budget that the state is linked to at least one receptor for which the base case 2014 air quality projections showed air quality problems. The court's holding as to lack of authority to establish Phase 2 emission reduction requirements for a state in the absence of any linkage to a projected air quality problem in the 2014 base case therefore does not extend to these budgets.59

With respect to the remanded budgets, the EPA again rejects the suggestion that Texas is being treated differently than any other state. As noted in the response above to the comments concerning the consistency of the Agency's responses to the remand, the FIP requirements to comply with all the remanded budgets, not just the remanded Texas SO2 budget, have been withdrawn or are expected to be withdrawn. Further, as discussed above, in the cases of ten of the eleven remanded seasonal NOX budgets, the absence of air quality problems at the relevant receptors in the 2014 base case projections was expressly cited by the court as the basis for remanding the budgets. The EPA's reliance on the court's holding as applied to those states' ozone-related transport obligations with regard to the 1997 8-hour ozone NAAQS is indistinguishable from the EPA's reliance on the same holding as applied to Texas' PM2.5-related transport obligations with regard to the 1997 annual PM2.5 NAAQS.60

Finally, the commenters state that the EPA should consider Texas's obligations to address interstate transport with respect to the 2006 24-hour PM2.5 NAAQS and/or the 2012 annual PM2.5 NAAQS before withdrawing Texas' FIP obligations. As noted in the proposal and discussed above, in the case of Texas, CSAPR FIP obligations related to PM2.5 pollution were established with respect to the 1997 annual PM2.5 NAAQS only, even though for other states the CSAPR FIPs were based on the states' transport obligations with respect to both the 1997 annual PM2.5 NAAQS and the 2006 24-hour PM2.5 NAAQS.61 The commenters assert that failure to consider Texas' potential transport obligations with respect to the 2006 24-hour PM2.5 NAAQS now before withdrawing the FIP obligations would be inconsistent with the manner in which the EPA responded to the D.C. Circuit's remand of seasonal NOX budgets and inconsistent with data in the CSAPR record that links Texas to downwind air quality problems with respect to the 2006 24-hour PM2.5 NAAQS.62

The EPA disagrees with this comment for three reasons. First, as noted above, the Agency is responding to the court's remand of all fifteen CSAPR Phase 2 SO2 and seasonal NOX budgets in the same way, namely by withdrawing the FIP provisions requiring affected EGUs to comply with the remanded budgets.63 The differences noted by the commenters are differences only in the actions that are being coordinated with the responses, not differences in the responses themselves.

Second, the differences in the coordinated actions are reasonable given the differences in other regulatory activities being undertaken for the two pollutants. The EPA coordinated the withdrawal of the eleven remanded seasonal NOX budgets addressing the 1997 8-hour ozone NAAQS with the establishment of new budgets for eight of those states addressing the 2008 8-hour ozone NAAQS because a rulemaking to address transported pollution with respect to the 2008 8-hour ozone NAAQS was actively under development at the time of the court's decision.64 Under this circumstance, such coordination was efficient and fully consistent with the court's expressed intent to minimize market disruption and to continue to address statutory obligations to reduce transported pollution where appropriate. In contrast, no analogous opportunity is available to coordinate withdrawal of the remanded SO2 budgets with another rulemaking addressing a more recent PM2.5 NAAQS because states' transport obligations with respect to the 2006 24-hour PM2.5 NAAQS have already been largely addressed through either SIPs or the CSAPR rulemaking, and the Agency has not identified interstate transport problems with respect to the 2012 annual PM2.5 NAAQS sufficient to justify a new national rulemaking at this time.

Third, the EPA lacks authority to rely on a transport obligation for Texas with respect to either the 2006 24-hour PM2.5 NAAQS or the 2012 annual PM2.5 NAAQS as the legal basis to support imposing an SO2 budget for the state via a FIP. Under CAA section 110(c), the Agency's authority to issue a FIP with respect to a particular state obligation arises either when the Agency finds that a state has failed to submit a required SIP or when the Agency disapproves a submitted SIP. Neither of these predicate events has occurred with regard to Texas' transport obligations under either the 2006 24-hour PM2.5 NAAQS or the 2012 annual PM2.5 NAAQS.65 Commenters are correct that data in the final CSAPR record, as evaluated by the Agency when CSAPR was promulgated, showed that PM2.5 pollution transported from Texas to downwind states exceeded the minimum threshold level used to establish which states might have transport obligations for the 2006 24-hour PM2.5 NAAQS. However, as noted in the proposal 66 and discussed above, the 2014 base case air quality projections in the final CSAPR record, when reevaluated in light of the D.C. Circuit's holdings in EME Homer City II, would support a finding that as of the beginning of Phase 2 of the CSAPR trading programs for SO2 and annual NOX, Texas does not have an ongoing transport obligation with respect to the 2006 24-hour PM2.5 NAAQS. Thus, even if the EPA had taken final action disapproving Texas' outstanding SIP submission addressing transported pollution with regard to the 2006 24-hour PM2.5 NAAQS, such a disapproval would no longer provide a basis for the Agency to issue a FIP in this instance, because without any remaining transport obligation, there is no remaining SIP deficiency to address through a FIP.

Throughout this document “we,” “us,” and “our” refer to EPA. This section provides additional information by addressing the following:

EPA is approving elements of the 2010 SO2 NAAQS infrastructure SIP submission from the State of Iowa received on July 29, 2013. Specifically, EPA is approving the following elements of section 110(a)(2): (A),(B),(C),(D)(i)(II)—prevent of significant deterioration of air quality (prong 3), and (D)(ii), (E) through (H), and (J) through (M). A Technical Support Document (TSD) is included as part of the docket to discuss the details of this action, including analysis of how the SIP meets the applicable 110 requirements for infrastructure SIPs.

The state submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The state initiated public comment from April 6, 2013, to May 8, 2013. One comment was received and adequately addressed in the final SIP submission. This submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, as explained in above preamble and in more detail in the TSD which is part of this docket, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.

EPA is approving elements of the July 23, 2013, infrastructure SIP submission from the State of Iowa, which addresses the requirements of CAA sections 110(a)(1) and (2) as applicable to the 2010 SO2 NAAQS. As stated above, EPA is approving the following elements of section 110(a)(2): (A),(B),(C),(D)(i)(II)—prevent of significant deterioration of air quality (prong 3), and (D)(ii), (E) through (H), and (J) through (M). Details of the submission are addressed in the TSD, included as part of the docket, and discuss this approval action.

EPA is not taking action on section 110(a)(2)(I). Section 110(a)(2)(I) requires that in the case of a plan or plan revision for areas designated as nonattainment areas, states must meet applicable requirements of part D of the CAA, relating to SIP requirements for designated nonattainment areas. EPA does not expect infrastructure SIP submissions to address element (I). The specific SIP submissions for designated nonattainment areas, as required under CAA title I, part D, are subject to different submission schedules than those for section 110 infrastructure elements. EPA will take action on part D attainment plan SIP submissions through a separate rulemaking governed by the requirements for nonattainment areas, as described in part D.

EPA is not taking action on section 110(a)(2)(D)(i)(I) prongs 1 and 2, and section 110(a)(2)(D)(i)(II) prong 4.

We are publishing this direct final rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. However, in the “Proposed Rules” section of this issue of the Federal Register, we are publishing a separate document that will serve as the proposed rule to approve the SIP revision if adverse comments are received on this direct final rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document. If EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. We will address all public comments in any subsequent final rule based on the proposed rule.

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, 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);

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

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

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

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

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

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

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

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

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications 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 November 28, 2017. Filing a petition for reconsideration by the Administrator of this direct 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)).

For the reasons stated in the preamble, EPA amends 40 CFR part 52 as set forth below:

I. Background

Under the Regional Haze Rule,1 each state was required to submit its first implementation plan addressing regional haze visibility impairment to the EPA no later than December 17, 2007. See 40 CFR 51.308(b). New York submitted its regional haze plan on March 15, 2010. On August 28, 2012, the EPA approved New York's regional haze SIP submittal addressing the requirements of the first implementation period for regional haze. 77 FR 51915 (Aug. 28, 2012).

Each state is also required to submit a progress report, in the form of a SIP revision that evaluates progress towards the reasonable progress goals (RPGs) for each mandatory Class I Federal area within the state and for each mandatory Class I Federal area outside the state which may be affected by emissions from within the state. See 40 CFR 51.308(g). Each state is also required to submit, at the same time as the progress report, a determination of the adequacy of its existing regional haze SIP. See 40 CFR 51.308(h). The first progress report was due five years after submittal of the initial regional haze SIP.

On June 16, 2015, New York submitted to the EPA, as a revision to its SIP, a report on progress made towards the RPGs for Class I areas outside the State that are affected by emissions from sources within the State. There are no Class I areas in New York State. In its progress report SIP, New York concludes the elements and strategies relied on in its original regional haze SIP are sufficient for neighboring states affected by emissions from New York to meet all established RPGs. In a notice of proposed rulemaking (NPRM) published on August 1, 2017 (82 FR 35738), the EPA proposed to approve New York's progress report as satisfying the requirements of 40 CFR 51.308(g) and 51.308(h). No comments were received on the August 1, 2017 proposed rulemaking.

EPA is finalizing approval of New York's Regional Haze Progress Report SIP revision, submitted by New York on June 16, 2015, as meeting the requirements of 40 CFR 51.308(g) and 51.308(h).

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

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

• 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 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, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 28, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

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

Executive Summary

The FOIA, 5 U.S.C. 552, establishes basic procedures for public access to agency records. The FOIA requires federal agencies to issue regulations to establish procedures to implement the FOIA. The CSB's current FOIA rule is codified at 40 CFR part 1601.

This interim rule revises 40 CFR part 1601 to implement provisions of the FOIA Improvement Act of 2016 and to make additional legal updates. Specifically, this interim rule implements changes to conform to the requirements of the following amendments to the FOIA since the adoption of the CSB's current FOIA rule: The OPEN Government Act of 2007, Public Law 110-175, the OPEN FOIA Act of 2009, Public Law 111-83, and the FOIA Improvement Act of 2016, Public Law 114-185.

For example, the FOIA Improvement Act of 2016 introduced several changes to current law, including, but not limited to the following: An increase in the minimum time for an administrative appeal to ninety (90) day; increased opportunities for dispute resolution services at various times throughout the FOIA process; waiver of fees if agencies do not meet mandated time limits; proactive disclosure of records of general interest to the public that are appropriate for such disclosure; and application of the Department of Justice's “foreseeable harm” standard as the basis for withholding information pursuant to a FOIA exemption, 5 U.S.C. 552(a)(8)(A)(i)(I).

The CSB is issuing an interim final rule to revise its current FOIA regulation because these changes are required by statutory amendments to FOIA since the adoption of the CSB's original FOIA rule in 2000. By issuing an interim final rule, these regulatory changes will take effect sooner than would be possible with the publication of a Notice of Proposed Rulemaking. Even though the CSB has issued an interim final rule, the CSB welcomes public comments from interested persons regarding any aspect of the changes made by this interim final rule. Please refer to the ADDRESSES section above for guidance on submitting comments. The CSB will consider all public comments in drafting the final rule.

All comments must be submitted in English, or if not, accompanied by an English translation.

Please note that all comments received are considered part of the public record and will be made available for public inspection online at http://www.csb.gov/disclaimers/legal-affairs-foia. Posted information made available on the CSB Web site will include personal identifying information (such as name and address) voluntarily submitted by the commenter, unless the CSB receives a specific request as described below to withhold such information.

If you want to submit personal identifying information (such as your name and address) as part of your comment, but do not want it to be posted online, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You also must locate all the personal identifying information you do not want posted online in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be posted online, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You also must prominently identify any confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted on http://www.csb.gov/.

Personal identifying information and confidential business information identified and located as set forth above will be placed in the agency's records, but not posted online.

The CSB reserves the right, but has no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from http://www.csb.gov/ that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the rulemaking will be retained in the rulemaking record and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the FOIA.

The CSB's implementation of this rule as an interim final rule, with provision for post-promulgation public comment, is based on section 553(b) of the Administrative Procedure Act. 5 U.S.C. 553(b). Under section 553(b), an agency may issue a rule without notice of proposed rulemaking and the pre-promulgation opportunity for public comment, with regard to “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice.” The CSB has determined that many of the revisions are to interpretive rules issued by the CSB, as they merely advise the public of the CSB's implementation of recent amendments to the FOIA. Moreover, the CSB has determined that the remaining revisions are rules of agency procedure or practice, as they do not change the substantive standards the agency applies in implementing the FOIA. The CSB has also concluded that there is good cause to find that a pre-publication public comment period is unnecessary. These revisions to the existing regulations in 40 CFR part 1601 merely implement statutory changes, align the CSB's regulations with controlling judicial decisions, and clarify agency procedures.

This interim final rule is not subject to the Unfunded Mandates Reform Act because it does not contain a Federal mandate that may result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000.00 or more in any one year. Nor will it have a significant or unique effect on small governments.

This interim final rule is not subject to the Regulatory Flexibility Act. The CSB has reviewed this regulation and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities. The rule implements the procedures for processing FOIA requests within the CSB. Under the FOIA, agencies may recover only the direct costs of searching for, reviewing, and duplicating the records processed for the requesters. Thus, fees accessed by CSB will be nominal. Further, the “small entities” that make FOIA requests, as compared with individual and other requesters, are relatively few in number.

This interim final rule does not impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995. The Paperwork Reduction Act imposes certain requirements on Federal agencies in connection with the conducting or sponsoring of any collection of information. This interim rule does not contain any new collection of information requirement within the meaning of the Act.

This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996 (as amended), 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100,000,000.00 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.

This interim final rule will not have significant effect on the human environment. Accordingly, this rule is categorically excluded from environmental analysis under 43 CFR 46.210(i).

Section 206 of the E-Government Act requires agencies, to the extent practicable, to ensure that all information about that agency required to be published in the Federal Register is also published on a publicly accessible Web site. All information about the CSB required to be published in the Federal Register may be accessed at http://www.csb.gov/. This Act also requires agencies to accept public comments “by electronic means.” See the “Public Participation” heading of the SUPPLEMENTARY INFORMATION section of this document, for directions on the electronic submission of public comments on this interim final rule.

Finally, the E-Government Act requires, to the extent practicable, that agencies ensure that a publicly accessible Federal Government Web site contains electronic dockets for rulemakings under the Administrative Procedure Act of 1946 (5 U.S.C. 551 et seq.). Under this Act, an electronic docket consists of all submissions under section 553(c) of title 5, United States Code; and all other materials that by agency rule or practice are included in the rulemaking docket under section 553(c) of title 5, United States Code, whether or not submitted electronically. The Web site http://www.csb.gov/ will contain an electronic dockets for this rulemaking.

Under this Act, the term “plain writing” means writing that is clear, concise, well-organized, and follows other best practices appropriate to the subject or field and intended audience. To ensure that this rulemaking has been written in plain and clear language so that it can be used and understood by the public, the CSB has modeled the language of this interim final rule on the Federal Plain Language Guidelines.

For the reasons stated in the preamble, the CSB revises 40 CFR part 1601 to read as follows:

I. Background

On September 30, 2010, HHS published an advanced notice of proposed rulemaking (ANPRM) in the Federal Register, “340B Drug Pricing Program Manufacturer Civil Monetary Penalties” (75 FR 57230, September 20, 2010). HHS subsequently published a notice of proposed rulemaking (NPRM) on June 17, 2015, to implement CMPs for manufacturers that knowingly and intentionally charge a covered entity more than the ceiling price for a covered outpatient drug; to provide clarity regarding the requirement that manufacturers calculate the 340B ceiling price on a quarterly basis; and to establish the requirement that a manufacturer charge $.01 (penny pricing) for drugs when the ceiling price calculation equals zero (80 FR 34583, June 17, 2015). The public comment period closed on August 17, 2015, and HRSA received 35 comments. After review of the initial comments, HHS reopened the comment period (81 FR 22960, April 19, 2016) to invite additional comments on the following areas of the NPRM: 340B ceiling price calculations that result in a ceiling price that equals zero (penny pricing); the methodology that manufacturers use when estimating the ceiling price for a new covered outpatient drug; and the definition of the “knowing and intentional” standard to be applied when assessing a CMP for manufacturers that overcharge a covered entity. The comment period closed May 19, 2016, and HHS received 72 comments.

On January 5, 2017, HHS published a final rule in the Federal Register (82 FR 1210, January 5, 2017); comments from both the original comment period established in the NPRM and the reopened comment period announced in the April 19, 2016 notice were considered in the development of the final rule. The provisions of that final rule were to be effective March 6, 2017; however, HHS issued a subsequent final rule (82 FR 12508, March 6, 2017) delaying the effective date to March 21, 2017, in accordance with a January 20, 2017, memorandum from the Assistant to the President and Chief of Staff, titled “Regulatory Freeze Pending Review.” 1 In the January 5, 2017, final rule, HHS acknowledged that the effective date fell during the middle of a quarter and stakeholders needed time to adjust systems and update their policies and procedures. As such, HHS stated that it intended to enforce the requirements of the final rule at the start of the next quarter, which began April 1, 2017.

After further consideration and to provide affected parties sufficient time to make needed changes to facilitate compliance, and because questions were raised, HHS issued an interim final rule (82 FR 14332, March 20, 2017), to delay the effective date of the final rule to May 22, 2017, and solicited additional comments on whether that date should be further extended to October 1, 2017. HHS received 51 comments on the interim final rule, some supporting and some opposing the delay of the effective date to May 22, 2017, or alternatively to October 1, 2017. After careful consideration of the comments received, HHS delayed the effective date of the January 5, 2017, final rule to October 1, 2017 (82 FR 22893, May 19, 2017).

HHS subsequently published a proposed rule (82 FR 39553, August 21, 2017) to further delay the effective date of the final rule to July 1, 2018. The further delay allows necessary time to fully consider the substantial questions of fact, law, and policy raised by the rule, consistent with the aforementioned “Regulatory Freeze Pending Review,” memorandum. Requiring manufacturers to make targeted and potentially costly changes to pricing systems and business procedures in order to comply with a rule that is under further consideration and for which substantive questions have been raised would be disruptive. The further delay allows HHS to consider objections regarding the timing of the effective date and challenges associated with complying with the rule, as well as other objections to the rule.

In addition, Executive Order 13765 (82 FR 8351) titled, “Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal,” specifically instructs HHS and all other heads of executive offices to utilize all authority and discretion available to delay the implementation of certain provisions or requirements of the Patient Protection and Affordable Care Act.2 HHS based the January 5, 2017, final rule on changes made to the 340B Program by the Patient Protection and Affordable Care Act. HHS proposed to delay the effective date of the January 5, 2017, final rule to July 1, 2018, to allow for a sufficient amount of time to consider the regulatory burdens that may be posed by this final rule. HHS continues to examine important substantive issues in matters covered by the rule and intends to engage in additional rulemaking on these issues.

HHS received a number of comments on the proposed rule both supporting and opposing the delay of the effective date to July 1, 2018. After careful consideration of the comments received, HHS has decided to delay the effective date of the January 5, 2017, final rule to July 1, 2018. As HHS changed the effective date of the final rule to July 1, 2018, enforcement will be delayed to July 1, 2018. HHS continues to believe that the delay of the effective date provides regulated entities sufficient time to implement the requirements of the rule, as well as allowing a more deliberate process of considering alternative and supplemental regulatory provisions, and to allow for sufficient time for additional rulemaking.

Section 553(d) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq.) requires that Federal agencies provide at least 30 days after publication of a final rule in the Federal Register before making it effective, unless good cause can be found not to do so. HHS finds good cause for making this final rule effective less than 30 days after publication in the Federal Register given that failure to do so would result in the final rule published on January 5, 2017, going into effect on October 1, 2017, for several weeks before a final rule delaying the effective date until July 1, 2018, would go into effect. To preclude this uncertainty in the marketplace and to ease the burdens of stakeholders, HHS believes that a clear effective date is an important goal and one that becomes particularly important when it is paired with potential civil monetary penalties. The additional time provided to the public before the rule takes effect will assist stakeholders in preparing to comply with these new program requirements.

In the proposed rule, HHS solicited comments regarding whether we should delay the January 5, 2017, final rule to July 1, 2018. We received 97 comments containing a number of issues from covered entities, manufacturers, and groups representing these stakeholders. In this final rule, we will only respond to comments related to whether HHS should delay the January 5, 2017, final rule to July 1, 2018. We did not consider and do not address comments that raised issues beyond the narrow scope of the proposed rule, including comments related to withdrawal of the rule or comments related to broader policy matters. However, HHS intends to engage in further rulemaking on issues covered in the January 5, 2017, final rule. We have summarized the relevant comments received and provided our responses below.

Comment: Some commenters supported HHS's proposed delay of the effective date of the final rule until not only July 1, 2018, but until HHS fulfills its commitment to engage in additional rulemaking that cures the substantive legal and practical concerns with the final rule. These commenters recommend that HRSA tie the further delay of the effective date of the final rule to the completion of such rulemaking, as opposed to a certain date.

Response: HHS has decided to delay the effective date to July 1, 2018, to provide affected parties sufficient time to make needed changes to facilitate compliance and because HHS continues to examine important substantive issues arising from the January 5, 2017, final rule. After reviewing the comments received from stakeholders regarding objections on the timing of the effective date and challenges associated with complying with the final rule, HHS has determined that delaying the effective date to July 1, 2018, is necessary to consider some of the issues raised. HHS believes that delaying the effective date to July 1, 2018, provides sufficient time to address these issues and does not believe a further delay is necessary at this time.

Comment: Some commenters stated that the January 5, 2017, final rule contains several policies that are inconsistent with the 340B statute and imposes needless burdens on manufacturers. These commenters urge HHS to delay the effective date to July 1, 2018, and use the additional time to reconsider the policies included in the final rule.

Responses: HHS intends to engage in further rulemaking and believes that this delay will provide HHS with time to consider the substantial questions of fact, law, and policy raised by the rule.

Comment: Several commenters explained that a delay in the effective date of the final rule is also necessary to align with the Administration priorities of analyzing final, but not yet effective, regulations, and removing or minimizing unwarranted economic and regulatory burdens related to the Affordable Care Act, the law that added the provisions of the 340B statute that are the subject of the final rule.

Response: HHS agrees with the commenters. Executive Order 13765 instructs agencies to use discretion to delay the implementation of certain provisions of requirements of the Patient Protection and Affordable Care Act. As previously mentioned, HHS based the January 5, 2017, final rule on changes made to the 340B Program by the Patient Protection and Affordable Care Act. As such, HHS is complying with Executive Order 13765 to delay implementation on provisions of that law that “. . . impose a fiscal burden on any State or a cost, fee, tax, penalty, or regulatory burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications.” The policies finalized in the January 5, 2017, final rule will require targeted and potentially costly changes to pricing systems and business procedures for manufacturers affected by the rule. Thus, HHS is delaying the effective date to July 1, 2018.

Comment: Some commenters recommend that HHS delay the effective date of the final rule until HHS concurrently addresses 340B covered entity compliance obligations and penalties under the 340B statute, which is necessary to strengthen the integrity of the 340B Program.

Response: HHS plans to issue separate policy documents for the different areas of the 340B program integrity provisions in the 340B statute and disagrees with the commenters advising HHS to address these issues concurrently.

Comment: Many commenters opposed delaying the effective date to July 1, 2018. Commenters recommended that HHS use its statutory rulemaking authority to balance the scales of enforcement and oversight in the 340B Program, and expressed concern that drug manufacturers have engaged in discriminatory pricing strategies due to a lack of oversight and enforcement with respect to manufacturer behavior. They explained that various factors, including extensive data regarding overcharging covered entities, HHS's inability to address overcharges, and HHS's admission that many manufacturers are still out of compliance highlight the need for the final rule to go into effect immediately. They further explained that the January 5, 2017, final rule is critical to ensuring that drug manufacturers uphold the intent of the 340B Program. The commenters also disagreed that “a more deliberative process is needed” as there have been multiple delays and stakeholders were given various opportunities to comment.

Response: HHS does not agree that that we should enforce the final rule immediately. We are delaying the effective date of the January 5, 2017, final rule to July 1, 2018, because the delay will provide stakeholders with additional time to come into compliance and provide time to consider the substantial questions of fact, law, and policy raised by the rule. The final rule does not represent the only method for HHS to address manufacturer overcharges. In addition to the final rule, HHS performs audits of manufacturers, investigates all allegations of overcharging, and participates in settlements that have returned millions of dollars to covered entities. HHS believes that it would be disruptive to require stakeholders to make potentially costly changes to pricing systems and business procedures in order to comply with a rule that is under further consideration and for which substantive questions have been raised.

While stakeholders had the opportunity to provide comments on the final rule, the 340B Program is a complex program that is affected by changes in other areas of health care. HHS has determined that this complexity and changing environment warrants further review of the final rule.

Comment: Many commenters supported further delaying the effective date to July 1, 2018, at a minimum, and agreed with HHS that more time was needed for stakeholders to come into compliance and to consider substantial questions of fact, law and policy raised by the January 5, 2017, final rule.

Response: HHS agrees with the commenters and will delay the effective date of the January 5, 2017, final rule to July 1, 2018.

HHS examined the effects of this final rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 8, 2011), the Regulatory Flexibility Act (Pub. L. 96-354, September 19, 1980), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act, and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866, emphasizing the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year), and a “significant” regulatory action is subject to review by the Office of Management and Budget (OMB) and is therefore, not a major rule under the Congressional Review Act.

HHS does not believe that a delay of the effective date of the January 5, 2017, final rule will have an economic impact of $100 million or more, and is, therefore, not designated as an “economically significant” rule under section 3(f)(1) of the Executive Order 12866. Therefore, the economic impact of having no rule in place related to the policies addressed in the final rule is believed to be minimal, as the policies would not yet be required or enforceable.

Executive Order 13771, titled “Reducing Regulation and Controlling Regulatory Costs,” was issued on January 30, 2017. This final rule is not expected to be an EO 13771 regulatory action because this final rule is not significant under EO 12866.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) and the Small Business Regulatory Enforcement and Fairness Act of 1996, which amended the RFA, require HHS to analyze options for regulatory relief of small businesses. If a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of the rule on small entities and analyze regulatory options that could lessen the impact of the rule. HHS will use an RFA threshold of at least a 3 percent impact on at least 5 percent of small entities.

For purposes of the RFA, HHS considers all health care providers to be small entities either by meeting the Small Business Administration (SBA) size standard for a small business, or by being a nonprofit organization that is not dominant in its market. The current SBA size standard for health care providers ranges from annual receipts of $7 million to $35.5 million. As of January 1, 2017, over 12,000 covered entities participate in the 340B Program, which represent safety-net health care providers across the country. HHS has determined, and the Secretary certifies that this final rule will not have a significant impact on the operations of a substantial number of small manufacturers; therefore, we are not preparing an analysis of impact for this RFA. HHS estimates that the economic impact on small entities and small manufacturers will be minimal.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year.” In 2017, that threshold is approximately $148 million. HHS does not expect this rule to exceed the threshold.

HHS has reviewed this final rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have “federalism implications.” This final rule would not “have substantial direct effects on the States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that OMB approve all collections of information by a federal agency from the public before they can be implemented. This final rule is projected to have no impact on current reporting and recordkeeping burden for manufacturers under the 340B Program. This final rule would result in no new reporting burdens. Comments are welcome on the accuracy of this statement.

Background on the IATTC

The United States is a member of the IATTC, which was established under the 1949 Convention for the Establishment of an Inter-American Tropical Tuna Commission. In 2003, the IATTC took the first step to dramatically revise the 1949 Convention by adopting the Convention for the Strengthening of the IATTC Established by the 1949 Convention between the United States of America and the Republic of Costa Rica (Antigua Convention), which did not enter into force until 2010 when the requite number of members agreed to the revisions. After the Antigua Convention had entered into force in 2010, the United States acceded to the Antigua Convention on February 24, 2016. The full text of the Antigua Convention is available at: https://www.iattc.org/PDFFiles2/Antigua_Convention_Jun_2003.pdf.

The IATTC consists of 21 member nations and four cooperating non-member nations and facilitates scientific research into, as well as the conservation and management of, tuna and tuna-like species in the IATTC Convention Area. The IATTC Convention Area is defined as waters of the EPO within the area bounded by the west coast of the Americas and by 50° N. latitude, 150° W. longitude, and 50° S. latitude. The IATTC maintains a scientific research and fishery monitoring program and regularly assesses the status of tuna, sharks, and billfish stocks in the EPO to determine appropriate catch limits and other measures deemed necessary to promote sustainable fisheries and prevent the overexploitation of these stocks.

As a Party to the Antigua Convention and a member of the IATTC, the United States is legally bound to implement decisions of the IATTC. The Tuna Conventions Act (16 U.S.C. 951 et seq.) directs the Secretary of Commerce, in consultation with the Secretary of State and, with respect to enforcement measures, the U.S. Coast Guard, to promulgate such regulations as may be necessary to carry out the United States' obligations under the Antigua Convention, including recommendations and decisions adopted by the IATTC. The authority of the Secretary of Commerce to promulgate such regulations has been delegated to NMFS.

The IATTC adopted Resolution C-17-02 by consensus at its 92nd meeting in July 2017. While the Resolution contains management measures for tropical tuna in the Convention Area for 2018-2020, it also contains amendments to C-17-01, which is applicable in 2017 only. The measures for 2018-2020 will be implemented in a different rulemaking. In contrast, this rule implements only the amendments to C-17-01 because they are applicable immediately and therefore need to be expeditiously implemented.

The IATTC adopted Resolution C-17-01 in February 2017. C-17-01 included a provision not previously utilized in recent IATTC resolutions: Convention Area-wide TACs for yellowfin and bigeye tuna caught by purse seine vessels. As the 92nd Meeting of the IATTC approached in July 2017, the purse seine catch levels were monitored by the IATTC staff, who notified the IATTC that the TAC for class size 4 to 6 purse seine vessels fishing on floating objects (97,711 metric tons) was near its limit. Due to the negative impacts an August closure would have on several countries, the Commission formulated an alternative solution that would relieve those social-financial impacts to industry while still protecting the stocks from overfishing. The IATTC scientific staff analyzed the conservation benefit of various alternatives for 2017 management of tropical tunas and recommended, as they had during previous meetings, extending the 62-day purse seine closure period.

Accordingly, the Commission agreed to amend C-17-01 to eliminate the TACs and extend the two closure period options from 62 days to 72 days. Two additional provisions of the amendment include:

• Allowing vessels that harvest tunas by encircling dolphins 1 to fish with that method during the 10-day extension of the closure period (because the separate TAC for that fishery was not close to being reached at the time of agreement to Resolution C-17-02), and

• shifting the dates of the time/area closure known as the corralito so that it does not overlap with the new dates of the closure periods.

Most provisions of Resolution C-17-01 remain unchanged by the amendments, including: Full retention of tropical tunas on purse seine vessels, an opportunity to apply for exemption to the purse seine closure periods due to force majeure, and a country-specific bigeye tuna catch limit for longline vessels greater than 24 meters in length.

This final rule is implemented under the Tuna Conventions Act (16 U.S.C. 951 et seq.), as amended on November 5, 2015, by title II of Public Law 114-81.

This rule removes the two TACs for yellowfin and bigeye tuna codified at 50 CFR 300.25(d): Class size 4 to 6 purse seine vessels that fish on floating objects—97,711 mt, and class size 6 vessels fishing in association (chasing and encircling) with dolphins—162,182 mt. Under 50 CFR 300.25(e), the two closure period options for class 4 to 6 purse seine vessels (each vessel must choose only one by which it will abide) are extended from 62 days to 72 days as follows: July 29, 2017-October 8, 2017, or November 9, 2017-January 19, 2018. Purse seine vessels with a dolphin mortality limit may fish during the 10 days that are being added to the extended closure period they are observing, provided the vessels are not used to make sets on floating objects during those 10 days. Those periods are respectively September 29, 2017-October 8, 2017, or November 9, 2017-November 18, 2017. Lastly, the corralito area remains unchanged, but the dates of the closure are shifted to October 9, 2017-November 8, 2017.

The NMFS Assistant Administrator has determined that this final rule is consistent with the Tuna Conventions Act of 1950 and other applicable laws.

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

There are no new collection-of-information requirements associated with this action that are subject to the Paperwork Reduction Act (PRA), and the existing collection-of-information requirements still apply under Control Number 0648-0387. Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number. All currently approved NOAA collections of information may be viewed at: http://www.cio.noaa.gov/services_programs/prasubs.html.

The Assistant Administrator for Fisheries finds good cause, pursuant to 5 U.S.C. 553(b)(B), to waive advance notice and comment. The decision by the IATTC that is being implemented by this rule was made on July 28, 2017. NMFS has no discretion to change this decision. This decision is binding under international law, and failure to ensure domestic implementation would render the nation out of compliance with our international treaty obligations, as well as failing to adequately conserve and manage target stocks of tropical tuna. Therefore, providing advance notice and consideration of public comments before implementing this decision would be impracticable because the first closed period (described above) under the existing regulations ends on September 27, 2017, but under the newly adopted international treaty obligations, the United States must ensure that vessels subject to that first closed period are prevented from fishing beginning on September 28 for an additional 10 days. The public interest dictates that the nation adheres to international legal obligations and continues to adequately conserve and manage tropical tunas in the Pacific. Therefore, it would be impracticable and contrary to the public interest to publish a proposed rule and provide advance notice and comment before implementing the revisions to IATTC Resolution C-17-01.

The Assistant Administrator for Fisheries also finds good cause, pursuant to 5 U.S.C. 553(d)(3), to waive the 30-day delay in effectiveness of the rule. Since the binding IATTC resolution makes these measures effective immediately, and the extended closure dates begin on September 28, 2017, this rule must be enforceable at least by that date. As explained above, this date is set in a binding resolution and cannot be changed by NMFS. Failure to implement the resolution by this date would risk putting the United States out of compliance with our international Treaty obligations, as well as failing to adequately conserve and manage tropical tuna stocks in the Pacific.

Ensuring conservation of tropical tuna stocks in the EPO, and remaining in compliance with binding international obligations of the United States, by expedient domestic implementation of Resolution C-17-02 through issuing this final rule now rather than risking violation of our obligations or the health of tuna stocks is in the public's interest. Therefore, there is good cause to waive the otherwise applicable requirement for a 30-day delay in effectiveness.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 605(b), requires an RFA analysis only for rules subject to notice and comment rulemaking under Section 553(b) of the Administrative Procedure Act or any other law. Because notice and comment are not required for this rule, as described above, no regulatory flexibility analysis is required and none has been prepared.

For the reasons set out in the preamble, 50 CFR part 300, subpart C is amended as follows: