Federal Register Vol. 83, No.62,

The Food and Nutrition Service published a final rule and interim final rule on January 6, 2017, (82 FR 2010), which implements provisions of the Food, Conservation and Energy Act of 2008 (FCEA) affecting the eligibility, benefits, certification, and employment and training (E&T) requirements for applicant or participant households in the Supplemental Nutrition Assistance Program (SNAP). Certain existing provisions were inadvertently removed from 7 CFR 273.2(b)(1). This document makes the technical correction to reinsert the provisions.

Accordingly, 7 CFR part 273 is corrected by making the following correcting amendments:

Sections 1832 and 1833 of the National Defense Authorization Act for Fiscal Year 2017, Public Law 114-328, 130 Stat. 2000 (Dec. 23, 2016) authorize the SBA's OHA to determine protests and appeals related to inclusion in the CVE database. In order to implement these sections, this rule amends OHA's jurisdiction in subparts A and B of 13 CFR part 134 to include protests of eligibility for inclusion in the CVE database, and appeals of denials and cancellations of inclusion in the CVE database. In addition, this rule creates a new subpart J in 13 CFR part 134 to set detailed rules of practice for protests of eligibility for inclusion in the VA CVE database, and a new subpart K to set detailed rules of practice for appeals of denials and cancellations of verification for inclusion in the VA CVE database.

On September 28, 2017, SBA published in the Federal Register (82 FR 45212) a proposed rule to implement sections 1832 and 1833 of the NDAA 2017 and to amend OHA's jurisdiction and procedures in order to accommodate protests of eligibility for inclusion in the CVE database and appeals of denials and cancellations of inclusion in the CVE database. The proposed rule allowed for a comment period ending on October 30, 2017. During the comment period, SBA received thirteen comments.

SBA proposed amending § 134.102, which defines OHA's jurisdiction, to add protests of eligibility for inclusion in the CVE database and appeals of denials and cancellations of inclusion in the CVE database as two new types of proceedings over which OHA would have jurisdiction. SBA also proposed adding new paragraphs (8) and (9) to § 134.201(b) to identify the location of the regulations concerning protests of eligibility for inclusion in the CVE database and appeals of denials and cancellations of inclusion in the CVE database. As a result of these new paragraphs, SBA also proposed to redesignate existing § 134.201(b)(8) as § 134.201(b)(10). There were no comments on these specific revisions, and SBA is adopting them exactly as proposed.

SBA received four comments that were generally supportive of transferring the protests and appeals at issue from VA to OHA for adjudication. In addition, four other comments described the commenters' views and experiences with existing processes. SBA is unable to respond to these comments as they did not address the proposed regulations at issue here.

SBA proposed to add a new subpart J, consisting of §§ 134.1001 through 134.1013, to establish the rules of practice before OHA for protests of eligibility for inclusion in the CVE database (CVE Protests). The new rules of practice for CVE Protests mirror SBA's existing rules for protests of service-disabled veteran-owned small businesses, found in 13 CFR part 125, subpart D.

SBA received no comments regarding the proposed new §§ 134.1001 (Scope of rules), 134.1002 (Who may file a CVE Protest?), 134.1004 (Commencement of CVE Protests), 134.1005 (Contents of the CVE Protest), 134.1006 (Service and filing requirements), 134.1008 (Discovery), 134.1009 (Oral hearings), 134.1010 (Standard of review and burden of proof), 134.1011 (Weight of evidence), 134.1012 (The record), and 134.1013 (Request for reconsideration). Except for § 134.1001, which SBA is amending to delete a duplicative sentence, SBA is adopting these provisions exactly as proposed. As discussed below, SBA received comments on proposed §§ 134.1003 and 134.1007.

The penultimate sentence in proposed § 134.1001(c) stated that “All protests relating to a concern's status as a SDVO SBC for a non-VA procurement are subject to part 125 of this chapter and must be filed in accordance with that part.” This sentence is duplicative with language in § 134.1001(d), so SBA is amending § 134.1001(c) to remove the sentence. No other changes were made to § 134.1001.

Proposed § 134.1003 outlined the grounds for filing a CVE Protest. Proposed paragraph (c) required the Judge to determine a protested concern's eligibility for inclusion in the CVE database as of the date the protest was filed. SBA received one comment on paragraph (c). The commenter states that proposed § 134.1003(c) is inconsistent with VA Acquisition Regulation (VAAR) clause 852.219-10(b), VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside, which indicates that offers received that are not from service-disabled veteran-owned small businesses will not be considered and that award must be made to a service-disabled veteran-owned small business. The commenter adds that this clause has been interpreted by CVE to mean that eligibility is determined both at the time a bid or initial proposal containing price has been submitted, and at time of award. In addition, the commenter observes that 13 CFR 125.18(a) requires service-disabled veteran-owned small business concerns to self-certify their status at time of initial offer, including price, and also that similar language is found at Federal Acquisition Regulation 19.1403(b). The commenter further maintains that a concern's status may change between the date of proposal submission and the date of award. The commenter urges SBA to revise proposed § 134.1003(c) so that eligibility is determined as of the date the initial proposal with pricing, or bid, was submitted.

In response, SBA agrees with the commenter that, if the CVE Protest pertains to a procurement, SBA should examine eligibility at two separate points: (1) As of the date the concern submits its bid or initial offer, which includes price; and (2) as of the date the CVE Protest was filed. Such an approach would restrict concerns that became ineligible after their initial bid or proposal from being awarded contracts. However, SBA notes that, under 38 U.S.C. 8127(f)(8)(B), the Secretary of the VA or his/her designee may initiate a CVE Protest that does not involve a procurement. In this situation, there would be no bid or proposal, so eligibility can be assessed only as of the date of the CVE Protest. Accordingly, the commenter's recommendation is accepted in part, and SBA is revising the language of § 134.1003(c).

Section 134.1007 proposed to establish the process for CVE Protests as follows: Paragraph (a) required OHA to issue a notice and order if the protest is found to be timely, specific, and based on protestable allegations; paragraph (b) required dismissal of a protest if the Judge determines the protest to be premature, untimely, nonspecific, or based on non-protestable allegations; paragraph (c) required the Director of the CVE (D/CVE) to send the case file to OHA by the deadline specified in the notice and order; paragraph (d) described the process for requesting a protective order; paragraph (e) allowed for supplemental arguments after a protester reviews the CVE case file; paragraph (f) allowed for a response to a protest within 15 days of the date the protest was filed; and paragraph (g) required the Judge to base the decision on the case file and information provided by the parties or information requested by the Judge. The proposed rule also authorized the Judge to investigate issues beyond those raised by the parties. Paragraph (h) proposed to allow a contracting officer to award the contract after a protest is filed but before a decision is reached if the contracting officer determines the public interest will be protected and notifies the Judge of his/her decision; paragraph (i) required OHA to serve all parties with the decision, which would be a final agency decision; paragraph (j) set out the effects of the decision upon the protested concern and the contract at issue.

SBA received no public comments on § 134.1007. However, VA recommended that § 134.1007(j)(2) be amended to be consistent with VA's existing regulation in VAAR 819.307(h). Specifically, the proposed § 134.1007(j)(2) stated that “A contracting officer shall not award a contract to a protested concern that the Judge has determined is not eligible for inclusion in the CVE database. If the contracting officer has already made an award under paragraph (h), the contracting officer shall either terminate the contract or not exercise the next option.” VA recommended that the provision instead read: “A contracting officer shall not award a contract to a protested concern that the Judge has determined is not eligible for inclusion in the CVE database. If the contract has already been awarded, then the awarded contract shall be deemed void ab initio and the contracting officer shall rescind the contract and award the contract to the next [eligible concern] in line for the award.” SBA believes this change is minor because, under the proposed § 134.1007(h), a contracting officer normally would not have made an award by the time a CVE Protest is decided. Furthermore, VA's suggestion removes a potential inconsistency between the two agencies' regulations. Therefore, SBA is adopting the comment and revising § 134.1007(j)(2) to mirror VA's existing regulation at VAAR 819.307(h).

SBA proposed to add a new subpart K, consisting of §§ 134.1101 through 134.1112, promulgating the rules of practice before OHA for appeals of denials and cancellations of verification for inclusion in the VA CVE database (CVE Appeals). SBA received no comments regarding the proposed §§ 134.1101 (Scope of rules), 134.1102 (Who may file a CVE Appeal?), 134.1103 (Grounds for filing a CVE Appeal), 134.1105 (The appeal petition), 134.1106 (Service and filing requirements), 134.1107 (Transmission of the case file), 134.1108 (Response to an appeal petition), 134.1109 (Discovery and oral hearings), and 134.1111 (Standard of review and burden of proof). Therefore, SBA is adopting these provisions exactly as proposed. SBA, however, received comments on proposed § 134.1104 (Commencement of CVE Appeals), § 134.1110 (New evidence), and § 134.1112 (The decision).

Proposed § 134.1104 required CVE Appeals to be filed within 10 business days of being notified that the CVE status has been denied or cancelled. Paragraph (b) proposed to adopt the rules for counting days found at § 134.202(d). Paragraph (c) proposed to require OHA to dismiss any untimely appeal.

SBA received three comments on § 134.1104. All three commenters stated that 10 business days to file a CVE Appeal is too short a timeframe. The commenters contend that preparing the appeals requires gathering a significant amount of documents and developing responses to legal issues. The three commenters recommend a 30 calendar day time period for filing a CVE Appeal.

In response, SBA notes that CVE Appeals will be based on the documentation provided to the VA by the business concern. In turn, VA will be responsible for producing this record to OHA. The commenters' concern that a 10 business day timeline is too short because documents will need to be provided on appeal is thus unwarranted. On appeal, a business concern will not be required to compile the record or produce new documents. SBA is thus adopting § 134.1104 exactly as proposed.

Proposed § 134.1110 prohibited the introduction of new evidence in CVE Appeals, unless good cause is shown. SBA received one comment on this section. The commenter stated that the section should be revised to allow a denied concern to resubmit its application, thus restarting the verification process, if new evidence is available.

SBA responds that under proposed § 134.1112(c), “Decisions under this part will be based primarily on the evidence in the CVE case file, arguments made on appeal, and any response(s) thereto.” Thus, SBA does not anticipate that new evidence will typically be necessary to decide a CVE Appeal. Nevertheless, a party that can establish good cause for the introduction of new evidence may do so under proposed § 134.1110. SBA believes that allowing new evidence to be introduced and allowing the Judge to consider the evidence will negate the necessity of restarting the verification process. The limitations on the introduction of new evidence in proposed § 134.1110 are consistent with OHA's restrictions on the use of new evidence in other types of proceedings. See 13 CFR 134.308 (limitations on the use of new evidence in size appeals). Therefore, SBA will not alter § 134.1110 and is adopting it exactly as proposed.

Under proposed § 134.1112(a) the Judge would decide a CVE Appeal, if practicable, within 60 calendar days after the close of record. SBA received one comment on this section. The commenter argues the decisions should be rendered within 30 calendar days, because 60 days is too long to wait for a decision. The commenter further argues the appeal should be automatically granted if OHA does not issue the decision by the deadline.

In response, SBA notes that CVE Appeals under subpart K are not tied to a particular procurement. These appeals are of denials and cancellations of verification for inclusion in the VA CVE database, so there is no pending procurement at stake. Further, the 60 day timeframe is similar to that used by OHA in deciding 8(a) eligibility cases (13 CFR 134.409). As a result, SBA does not agree that a more expedited timeframe is warranted. In addition, SBA does not agree that it would be appropriate to automatically reinstate a concern in the CVE database due to a delay in issuing a decision, because such an approach might enable ineligible concerns to bid on VA contracts. SBA will not alter § 134.1112(a) and is adopting it exactly as proposed.

Proposed § 134.1112(g) allowed any party that has appeared in the proceeding, or the Secretary of VA or his or her designee, to file a petition for reconsideration. As proposed, the petition must be filed within twenty (20) calendar days after service of the written decision, upon a clear showing of an error of fact or law material to the decision. The Judge also may reconsider a decision on his or her own initiative.

SBA received one comment on this paragraph. The commenter states that 20 calendar days allowed for filing a petition for reconsideration is too long, and suggests changing it to 10 calendar days.

SBA responds that 20 calendar days is the standard for other OHA proceedings, as set forth under OHA's rules in 13 CFR 134.227(c). Thus, SBA will not alter its timelines and adopts § 134.1112(g) exactly as proposed. There were no comments on the remaining paragraphs of § 134.1112 and SBA is adopting them exactly as proposed.

OMB has determined that this final rule does not constitute a “significant regulatory action” under Executive Order 12866. This final rule is also not a major rule under the Congressional Review Act, 5 U.S.C. 800. This final rule amends the rules of practice for the SBA's OHA in order to implement procedures for protests of eligibility for inclusion in the CVE database, and appeals of denials and cancellations of inclusion in the CVE database. As such, the rule has no effect on the amount or dollar value of any Federal contract requirements or of any financial assistance provided through SBA or VA. Therefore, the rule is not likely to have an annual economic effect of $100 million or more, result in a major increase in costs or prices, or have a significant adverse effect on competition or the United States economy. In addition, this rule does not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency, materially alter the budgetary impact of entitlements, grants, user fees, loan programs or the rights and obligations of such recipients, nor raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

This action meets applicable standards set forth in section 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. The action does not have retroactive or preemptive effect.

This final rule does not have Federalism implications as defined in Executive Order 13132. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in the Executive Order. As such it does not warrant the preparation of a Federalism Assessment.

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

The SBA has determined that this final rule does not impose additional reporting or recordkeeping requirements under the Paperwork Reduction Act, 44 U.S.C. Chapter 35.

The Regulatory Flexibility Act of 1980, as amended (RFA), 5 U.S.C. 601-612, requires Federal agencies to consider the effect of their actions on small entities, small non-profit businesses, and small local governments. Pursuant to the RFA, when an agency issues a final rule, the agency must prepare a final regulatory flexibility analysis (FRFA). The FRFA describes whether the impact of the rule will have a significant economic impact on a substantial number of small entities, which includes small businesses, small not-for-profit organizations, and small governmental jurisdictions. However, Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an FRFA, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities.

This final rule revises the regulations governing cases before SBA's Office of Hearings and Appeals, SBA's administrative tribunal. These regulations are procedural by nature. Specifically, this final rule establishes rules of practice for the SBA's OHA in order to implement protests of eligibility for inclusion in the CVE database and appeals of denials and cancellations of inclusion in the CVE database, new types of administrative litigation mandated by sections 1832 and 1833 of the National Defense Authorization Act for Fiscal Year 2017. This legislation provides a new statutory right to challenge eligibility for inclusion in the CVE database, as well as denials and cancellation of inclusion in the CVE database. This final rule merely provides the rules of practice at OHA for the orderly hearing and disposition of protests of CVE database inclusion and appeals of denials and cancellations of CVE database inclusion. At the proposed stage, SBA did not anticipate that this final rule would have a significant economic impact on any small businesses (the only small entities that would be affected by this rule); we did request comments from any small business on how and to what degree this final rule would affect it economically. No comments were received regarding RFA issues. Therefore, the Administrator of SBA certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.

For the reasons stated in the preamble, SBA amends 13 CFR part 134 as follows:

I. Approval Actions

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during July, August, and September 2017, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

SmartVet USA, Inc., 22201 West Innovation Dr., suite 170A, Olathe, KS 66061-1304 has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215:

Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:

The following sponsors requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed:

Following this withdrawal of approval, Watson Laboratories, Inc. is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in § 510.600(c).

Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 047-055, 104-606, and 139-633, and all supplements and amendments thereto, is withdrawn, effective April 9, 2018. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.

Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248 has informed FDA that it has changed its name and address to Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248. ADM Alliance Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115 has informed FDA that it has changed its name to ADM Animal Nutrition, Inc. Accordingly, we are amending § 510.600(c) to reflect these changes.

We are also making technical amendments to update the scientific name of a pathogenic bacterium, to accurately list the concentrations of ingredients in a combination new animal drug, and to correctly list the assay limits and maximum drug concentration in Type B medicated feeds for a combination new animal drug used in feed. These actions are being taken to improve the accuracy of the regulations.

This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires Federal Register publication of “notice[s] . . . effective as a regulation,” of the conditions of use of approved new animal drugs. This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities.

Although denominated a rule pursuant to the FD&C Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as “an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 510, 520, 522, 524, 556, and 558 are amended as follows:

During July and August 2017, the following sponsors requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed:

Therefore, under authority delegated to the Commissioner of Food and Drugs, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADAs 047-055, 104-606, and 139-633, and all supplements and amendments thereto, is hereby withdrawn, effective April 9, 2018.

Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications.

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The Coast Guard did not receive the final details of this rowing event until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be impracticable because it would inhibit the Coast Guard's ability to protect participants, mariners and vessels from the hazards associated with this event. We are issuing this rule under 5 U.S.C. 553(d)(3), as the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register for the same reason noted above.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The Captain of the Port Detroit (COTP) has determined that the likely combination of recreation vessels, commercial vessels, and an unknown number of spectators in close proximity to a youth rowing regatta along the water pose extra and unusual hazards to public safety and property. Therefore, the COTP is establishing a Special Local Regulation around the event location to help minimize risks to safety of life and property during this event.

This rule establishes a temporary special local regulation from 8 a.m. until 11 a.m. on April 21, 2018. In light of the aforementioned hazards, the COTP has determined that a special local regulation is necessary to protect spectators, vessels, and participants. The special local regulation will encompass the following waterway: All waters of the Detroit River, Trenton Channel between the following two lines going from bank-to-bank: The first line is drawn directly across the channel from position 42°11.0′ N, 083°09.4′ W (NAD 83); the second line, to the north, is drawn directly across the channel from position 42°11.7′ N, 083°08.9′ W (NAD 83).

An on-scene representative of the COTP may permit vessels to transit the area when no race activity is occurring. The on-scene representative may be present on any Coast Guard, state, or local law enforcement vessel assigned to patrol the event. Vessel operators desiring to transit through the regulated area must contact the Coast Guard Patrol Commander to obtain permission to do so. The COTP or his designated on-scene representative may be contacted via VHF Channel 16 or at 313-568-9560.

The COTP or his designated on-scene representative will notify the public of the enforcement of this rule by all appropriate means, including a Broadcast Notice to Mariners and Local Notice to Mariners.

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

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

This regulatory action determination is based on the size, location, duration, and time-of-year of the special local regulation. Vessel traffic will be able to safely transit around this special local regulation zone which will impact a small designated area of the Detroit River from 8 a.m. to 11 a.m. April 21, 2018. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the special local regulation and the rule allows vessels to seek permission to enter the area.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, 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 special local regulation lasting four hours that will prohibit entry into a designated area. It is categorically excluded from further review under paragraph L[61] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

The California Department of Transportation has requested a temporary change to the operation of the Tower Drawbridge, mile 59.0, over the Sacramento River, at Sacramento, CA. The drawbridge navigation span provides a vertical clearance of 30 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.189(a). Navigation on the waterway is commercial and recreational.

The drawspan will be secured in the closed-to-navigation position 7 a.m. to 12:30 p.m. on April 21, 2018, to allow the community to participate in the Sacramento Giant Race 5K/10K run/walk. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

The owner of the bridge, the MTA Long Island Railroad, requested a temporary deviation to facilitate the replacement of bridge timbers. The Long Island Railroad Bridge across the Reynolds Channel, mile 4.4, has a vertical clearance in the closed position of 14 feet at mean high water. The existing bridge operating regulations are found at 33 CFR 117.5.

This temporary deviation allows the Long Island Railroad Bridge to remain in the closed position as follows:

12:01 a.m. on April 7 to 4 a.m. on April 9;

12:01 a.m. on April 14 to 4 a.m. on April 16;

12:01 a.m. on April 21 to 12:01 a.m. on April 23; and

12:01 a.m. on April 28 to 12:01 a.m. on April 30.

The waterway is transited by commercial and recreational traffic. Coordination with the waterway users has indicated no objection to the proposed closure of the drawbridge. Vessels that are able to pass under the bridge in the closed position and may do so at any time. Although the bridge will not be able to open for emergencies, there is an alternate route for vessels to pass.

The Coast Guard will also inform waterway users of the closure through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

I. Background, Purpose and Legal Basis

On December 19, 2017, the Coast Guard published a temporary deviation entitled “Drawbridge Operation Regulation; Newark Bay, Newark, NJ” in the Federal Register (82 FR 60116). That temporary deviation allows the bridge to test a change to the drawbridge operation schedule to determine whether a permanent change to the schedule is needed from January 1, 2018 to March 31, 2018.

The owner of the bridge, Consolidated Rail Corporation, requested a change to the Drawbridge Operation Regulations because the volume of train traffic and maneuvering of train movements from the adjacent rail yard across the bridge cause significant delays to marine traffic.

The Lehigh Valley Bridge across the Newark Bay, mile 4.3, at Newark, New Jersey is a lift bridge with a vertical clearance of 35 feet at mean high water and 39 feet at mean low water in the closed position. The existing drawbridge operating regulations are listed at 33 CFR 117.5 and 33 CFR 117.735.

The waterway users are seasonal recreational vessels and commercial vessels of various sizes. Coordination with waterway users indicated no objection to extend the test period.

The Coast Guard is publishing this modified temporary deviation to test the proposed regulation change to determine whether a permanent change to the schedule is necessary to better balance the needs of marine and rail traffic.

Under this modified deviation, in effect from 12:01 a.m. on April 1, 2018 to 11:59 p.m. on June 29, 2018, the Lehigh Valley Bridge will open on signal if at least one hour advance notice is given.

Vessels able to pass through the bridge in the closed position may do so at any time. There are no alternate routes. The bridge will be able to open for emergencies.

The Coast Guard contacted the waterway users regarding extending the current temporary deviation in order to continue testing a proposed change to the Drawbridge Operation Regulations. No objections were received. The Coast Guard will inform the users of the waterways through our Local and Broadcast Notices to Mariners and other appropriate local media of the change in operating schedule for the bridge so that vessel operators may arrange their transits to minimize any impact caused by the temporary deviation.

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

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

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

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

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

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule due to the short time period between when Sector Delaware Bay received complete details of this operation, March 8, 2018, and the date when this safety zone needs to go into effect by. It is impracticable and contrary to the public interest to publish an NPRM before issuing this rule because we must establish this safety zone by March 20, 2018 to ensure the safety of persons and vessels participating in or transiting near the transit operations.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is needed to mitigate the hazards presented to safety of life in the Delaware Bay and River presented by the transit of equipment of this size.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231.

The COTP Delaware Bay has determined that potential hazards are associated with the transit of the motor vessel (M/V) ZHEN HUA 16 beginning when the vessel arrives at the Delaware Bay Pilot's Station. There will be a continuing safety concern for anyone within a 200-yard radius of the vessel until it is moored at Greenwich Terminal in Philadelphia, Pennsylvania.

This rule establishes a temporary traveling safety zone in the Delaware River and Bay in order to facilitate the delivery of two post-Panamax gantry cranes to the Greenwich Terminal in Philadelphia, Pennsylvania. The safety zone includes all navigable waters within 200 yards of the M/V ZHEN HUA 16 during its transit from the Delaware Bay Pilot's Station to Greenwich Terminal in Philadelphia, Pennsylvania. Enforcement of the safety zone will begin when the M/V ZHEN HUA 16 arrives at the Delaware Bay Pilot's Station and terminate when the vessel completes mooring operations at the Greenwich Terminal in Philadelphia, Pennsylvania. The anticipated date of arrival for the M/V ZHEN HUA 16 at the Delaware Bay Pilot's Station is March 20, 2018, with alternate dates of March 21, 22, 23, 24, 25, or 26, 2018. The exact timeframe that will be required to complete the transit is unable to be known in advance, but the Coast Guard estimates that it may take up to 48 hours to complete the journey from the Delaware Bay Pilot's Station to Greenwich Terminal (with additional time possibly needed to complete mooring).

To ensure a safe transit between the station and the terminal, the vessel may stop in a designated anchorage area, as set forth in 33 CFR 110.157, for a short time if necessary due to weather and tidal requirements. The safety zone will remain in place during any time the vessel spends anchored. Vessels may transit through the safety zone while the M/V ZHEN HUA 16 is anchored in a designated anchorage area if they meet the following requirements: Transit through the safety zone at the minimum safe speed to reduce wake and maintain steerage, and, except for towing vessels designated as assist tugs and operating in such capacity, do not overtake, meet, or otherwise pass any other unmoored or unanchored vessel while transiting through the safety zone. Vessels which do not meet all of the requirements listed above are prohibited from entering or transiting the safety zone without prior approval of the COTP Delaware Bay. Vessels requesting to enter or transit the safety zone may contact the Sector Delaware Bay Command Center via VHF-FM channel 16. The Coast Guard anticipates that most vessels will be able to freely transit around the safety zone and will not need to seek permission to enter the zone while the M/V XHEN HUA 16 is underway.

There will be a pre-designated safety vessel escorting the ZHEN HUA 16 while it is underway to monitor the flow of traffic and inform mariners that the gantry crane transit is in progress.

The Coast Guard will be establishing a second safety zone through a separate rulemaking to ensure the safety of vessels and persons transiting the area during offloading operations once the vessel reaches the terminal.

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

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

This regulatory action determination is based on the short duration of the rule. The rule also allows for vessels to transit through the safety zone while the M/V XHEN HUA 16 is in a designated anchorage if certain requirements are met, and the Coast Guard anticipates that most vessels will be able to freely transit around the safety zone and will not need to seek permission to enter the zone while the M/V XHEN HUA 16 is underway. For these reasons the impact on waterway traffic is expected to be minimal.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, 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 moving safety zone lasting only the duration of transit from the Delaware Bay Pilot's station to Greenwich Terminals and a stationary safety zone, which allows vessels to transit if certain requirements are met, lasting approximately six days. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

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

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule due to the short time period between when Sector Delaware Bay received complete details of this operation, March 8, 2018, and the date when this safety zone needs to go into effect by. It is impracticable and contrary to the public interest to publish an NPRM before issuing this rule because we must establish this safety zone by March 23, 2018, to ensure the safety of persons and vessels participating in or transiting near the offloading operations of two Post-Panamax gantry cranes at the Port of Philadelphia.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is needed to mitigate the hazards presented to safety of life in the Delaware River presented by the offloading of equipment of this size.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP Delaware Bay has determined that potential hazards are associated with the offloading of the two Post-Panamax gantry cranes from the motor vessel (M/V) ZHEN HUA 16.

The Coast Guard is establishing a temporary safety zone on the Delaware River bounded to the south by a line drawn from the southeast corner of Pier 124S at 39°53′41.751″ N, 075°08′19.1419″ W, thence east-southeast to the New Jersey Shoreline at 39°53′34″ N, 075°07′49″ W, and bounded to the north by the southernmost edge of the Walt Whitman Bridge. This safety zone is needed to protect personnel and vessels, in the navigable waters within the safety zone as well as persons on the adjacent shoreline during offloading of the gantry cranes. This safety zone is needed for seven days beginning from the time of the M/V ZHEN HUA 16 arrives at Greenwich Terminal, unless cancelled earlier via Marine Safety Information Bulletin and Broadcast Notice to Mariners.

Vessels may not enter, remain in, or transit the safety zone unless authorized by the COTP or the COTP's designated representative. To seek permission to enter or remain in the zone, unless moored or anchored outside the main navigational channel, contact the COTP or the COTP's representative via VHF-FM Channel 16.

Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative. Vessels transiting the zone must maintain the minimum safe speed to reduce wake and maintain steerage. Except towing vessels designated as assist tugs and operating in such capacity, no vessel may meet, overtake or otherwise pass another unmoored or unanchored vessel within the safety zone. Regardless of travel direction, vessels shall remain east of the centerline of the main navigation channel. The navigable waters west of the centerline of the main navigation channel (on the green side of the centerline) is closed to navigation for the duration of the enforcement of this safety zone.

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

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

This regulatory action determination is based on the short duration of the rule. The rule also allows for vessels to transit through the safety zone if certain requirements are met, thus minimizing the impact on waterway traffic.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, 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 stationary safety zone, which allows vessels to transit if certain requirements are met, lasting approximately six days. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

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

The Forest Service will consider revising this rule based on public comments received. If the Forest Service determines that no changes to the rule are warranted, the Forest Service will publish a notice affirming this final rule by September 26, 2018. If the Forest Service seeks to incorporate changes based on the public comments, the final rule will be revised as appropriate.

This final rule is promulgated pursuant to section 14(a) of the FRRRPA (16 U.S.C. 1612(a)), which provides that the Secretary, in exercising his authority [under the Act] and other laws applicable to the Forest Service, by regulation, shall establish procedures, including public hearings where appropriate, to give the Federal, State, and local governments and the public adequate notice and an opportunity to comment upon the formulation of standards, criteria, and guidelines applicable to Forest Service programs.

This provision of law has been implemented through 36 CFR part 216, published on April 23, 1984. The purpose of that provision is to ensure that Federal, State, and local governments and the public have adequate notice and opportunity to comment upon the formulation of standards, criteria, and guidelines applicable to Forest Service programs.

Currently, 36 CFR part 216 only applies to directives published in the Forest Service Manual, which are policies and guidance for Forest Service staff. Part 216 reflects an Agency assumption that the Forest Service Handbook—which contains detailed instructions on how to implement the Forest Service Manual—is administrative or technical in nature, and does not include standards, criteria or guidelines. Over the past three decades, however, the complexity of management of the National Forest System (NFS) has increased, and the Agency has realized that the Forest Service Handbook may contain directives subject to the notice and comment requirements of section 14(a) of FRRRPA.

This final rule revises part 216 to require public notice and comment on the formulation of standards, criteria or guidelines applicable to Forest Service programs, regardless of whether they are published in the Forest Service Manual or Handbook. The part 216 requirements would not apply to Forest Service directives pertaining to law enforcement and investigations; personnel matters; procurement; administrative support activities such as budget and finance; business operations; and activities undertaken by the Forest Service on behalf of other Federal agencies.

The revision of part 216 will also require the Forest Service to establish an internet-based notice and comment system, as notice of proposed changes to directives will be posted on a Forest Service-administered schedule on the agency's national website. While interim and final directives are available to the public on the internet, revision of part 216 will allow the public to have notice of, and ready access to, proposed, directives issued by the Forest Service. By utilizing modern technology, the public will be presented with several options for submitting comments, including at least one electronic means of submittal such as email or through a web form, as well as the traditional means of submitting comments by post-mailed letters. The process for submitting comments will be specified on the schedule. Several supplemental notification methods may also be employed in order to communicate about such notice to a broader segment of the public, including publishing notices of proposed, interim, and final directives in the Federal Register, issuing press releases, or holding public meetings. Other similar processes could also be utilized when appropriate.

These revisions are issued as a final rule as provided for in 5 U.S.C. 553(a)(2) and 553(b)(3)(A) and (B) and (d)(1). The final rule does not impose additional burdens on any governmental entity or the public but significantly expands the opportunity for all parties to comment more readily on Forest Service policies set forth in Forest Service directives. These revisions maintain the public's right to participate in the formulation of internal standards, criteria, and guidelines and expands the options available to the Forest Service as it manages this procedural process. These revisions are intended to expand the public's awareness and ability to comment upon these directives.

Since certain situations require implementation of standards, criteria, and guidelines applicable to Forest Service programs prior to completion of the public notice and comment process, this final rule continues to allow the use of interim directives that are effective upon publication. The same public participation process for proposed directives applies to interim directives.

Use of the Forest Service website for providing notice and comment opportunities results in both expanded capacity and actual savings (estimated at $72,000-$110,000 over 10 years). The revision has many non-economic and non-quantifiable benefits. It will allow the Forest Service to reach a broader cross-section of the interested public when publishing notice of proposed directives, fostering robust public participation.

The Forest Service solicited input from the public to inform the content of this final rule. These outreach efforts included direct engagements with State natural resource agencies, Federally-recognized Indian Tribes and Alaska Native Corporations, agencies within the Department of Agriculture (USDA), and other Federal land management agencies. In addition, the Forest Service published a Request for Information in the Federal Register, inviting interested members of the public to attend an informational webinar and to submit questions, comments, and suggestions to a dedicated agency email address (80 FR 74740 (Nov. 30, 2015)).

Collectively, the feedback provided in these conversations indicated broad support for the use of web-based technology, in addition to maintaining traditional, postal-based commenting, to improve public participation in the formulation of Forest Service directives. No outright opposition to this approach was expressed. Several stakeholder groups reiterated the importance of ensuring that the web platform used to facilitate the notice and comment process for Forest Service directives be accessible, reliable, and user-friendly.

Several specific provisions were also suggested for inclusion in this final rule. For example, representatives from certain State agencies requested that the comment period for any directives involving an issue of overlapping State and Federal jurisdiction be at least 60 days to provide States sufficient opportunity to explore the questions and formulate meaningful input. To support engagement of representatives of public agencies, as well as other communities of interest, the revised Part 216 notes that the Forest Service will maintain generally on a quarterly basis a schedule of pending and proposed directives in a centralized repository on the Forest Service website.

In addition, several stakeholders asked that criteria be established to guide the Forest Service's determination as to whether point-by-point responses must be issued to individual comments or whether issuance of a single summary response to all timely and relevant comments is sufficient for a given directive. The Forest Service intends to provide a framework, consistent with the Office of Management and Budget's Good Guidance Practice Bulletin, for responding to comments through revision of the directives that will include more detailed guidance on managing public notice and comment.

For example, Agency response should reflect the nature of public comment provided; a high volume of very similar comments may need to be handled differently than a small number of very detailed comments. There may be situations where no comments are within the scope of the proposed policy so no Agency response is needed. The directives will ensure that the Agency's approach to responding to comments is consistent with FRRRPA requirements and supports transparency, public participation and collaboration. While the directives will provide a flexible approach to responding to comments, it should be noted that it is the Agency's intent that all comments received will be viewable through the Forest Service website.

This final rule updates the process the Forest Service will use in implementing section 14(a) of the FRRRPA. Forest Service regulations at 36 CFR 220.6(d)(2) exclude “rules, regulations, or policies to establish service-wide administrative procedures, program processes, or instructions” from documentation in an environmental assessment or environmental impact statement. The Department's assessment is that this final rule falls within this category of actions, and that no extraordinary circumstances exist that would require preparation of an environmental assessment or environmental impact statement.

This final rule has been reviewed under applicable USDA procedures, as well as Executive Order (E.O.) 12866 on regulatory planning and review. The Office of Management and Budget (OMB) has designated this rule to be significant based on its applicability to a wide segment of the public.

This final rule is not subject to the requirements of E.O. 13771 (82 FR 9339, February 3, 2017) because this final rule is related to agency organization, management or personnel. This final rule will have no costs to the public, and result in fiscal savings in the long-run. Cost savings will result from expected reductions in utilizing the Federal Register for publication; moreover, the final rule allows the Forest Service to expand its ability to provide notice and opportunity for public comment on directives by posting them on the Agency website, even as it reduces publication costs. The Agency estimates it spent nearly $39,000 over the last three years on the publication of directives in the Federal Register, whereas setting up an email subscription service will incur a one-time cost of $24,766. The new regulations will result in an annualized cost savings of between $7,431 to $13,371 per year at 3%, and between $6,807 to $13,157 at 7% using the low and high ends of the three years of data on Federal Register costs and the annualized cost of CARA over 10 years of $2,904 at 3% and $3,528 at 7%.

The Agency expects to recoup the costs associated with setting up the internal software that allows publications of such notices, and commenting functionality within 3-4 years and achieve significant long term savings, thereafter. Additional cost savings would be realized through improved staff efficiency in the time and effort required to review and issue directives. Details on the estimated cost savings of this final rule can be found in the rule's economic analysis.

This final rule has been considered in light of the Regulatory Flexibility Act (5 U.S.C. 601-612). The final rule updates the process used by the Forest Service in implementing section 14(a) of the FRRPRA with regard to the issuance of Forest Service Directives. This final rule will not have a significant economic impact on a substantial number of small entities as defined by the Act, because the Rule will not impose recordkeeping requirements on them. Neither will it affect small entities' competitive position in relation to large entities, nor would it not affect their cash flow, liquidity, or ability to remain in the market.

This final rule has been analyzed in accordance with the principles and criteria contained in E.O. 12630. It has been determined that the rule would not pose a risk of a taking of private property.

This final rule has been reviewed under E.O. 12988 on civil justice reform. Upon publication of the final rule, (1) all State and local laws and regulations that conflict with this Rule or impede its full implementation are preempted; (2) no retroactive effect is given to this Rule; and (3) no exhaustion of administrative proceedings before parties may file suit in court challenging its provisions is required.

The Forest Service has considered this final rule under the requirements of E.O. 13132 on federalism, and has determined that the rule: Conforms with the principles of federalism set out in the E.O.; will not impose any compliance costs on the States; and will not have substantial direct effects on the States, the relationship between the Federal Government and the States, or the distribution of power and responsibilities among the various levels of government. Therefore, the Agency, has determined that no further assessment of federalism implications is necessary. This final rule has been considered under the requirements of E.O. 13175, Consultation and Coordination with Indian Tribal Governments. The Forest Service's Office of Tribal Relations has conducted the 120 day consultation period, which ended on May 31, 2016.

Only one Tribe commented on this rule. The comment expressed support for expanding the public notification procedures through a centralized, internet-based schedule, and reiterated the desire of Tribes to receive early and meaningful consultation opportunities on applicable policy changes that are separate and distinct from the general public participation requirements. It recommended that Tribal consultation occur before notice and comment procedures are initiated to ensure the general public is commenting on polices that are not in conflict with Tribal interests.

In response to these comments, the Forest Service reiterates its commitment to ensuring that consultation procedures are maintained according to existing authorities. This regulatory revision makes no change to any Tribal consultation policy. This revision seeks to update and expand outreach, engagement, and notice of changes to the Directives System; as such, the Forest Service is developing electronic engagement platforms, and it intends to link to the online Forest Service Tribal Relations Consultation Schedule whenever appropriate and practicable.

This final rule has been reviewed under E.O. 13211 of May 18, 2001, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. It has been determined that this rule does not constitute a significant energy action as defined in E.O. 13211.

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Agency has assessed the effects of this final rule on State, local, and Tribal governments and the private sector. This rule will not compel the expenditure of $100 million or more by any State, local, or Tribal government, or any entity in the private sector. Therefore, a statement under section 202 of the Act is not required.

This final rule does not contain any recordkeeping or reporting requirements or other information collection requirements as defined in 5 CFR part 1320 that are not already required by law or are not already approved for use. Accordingly, the review provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521), and its implementing regulations at 5 CFR part 1320, do not apply.

The authority for this rulemaking is 5 U.S.C. 552a, the Privacy Act of 1974, as amended, which requires the implementation of the Act by Federal agencies.

This action ensures that ABMC's collection, use, maintenance, or dissemination of information about individuals for purposes of discharging its statutory responsibilities will be performed in accordance with the Privacy Act of 1974 and applicable OMB guidance. This rule:

• Establishes rules of conduct for ABMC personnel and ABMC contractors involved in the design, development, operation, or maintenance of any system of records.

• Establishes appropriate administrative, technical, and physical safeguards to ensure the security and confidentiality of records and to protect against any anticipated threats or hazards to their security or integrity that could result in substantial harm, embarrassment, inconvenience, or unfairness to any individual about whom information is maintained.

• Ensures that guidance, assistance, and subject matter expert support are provided ABMC staff, contractors and the public as needed in the implementation and execution of and compliance with the ABMC Privacy Program.

• Ensures that laws, policies, procedures, and systems for protecting individual privacy rights are implemented throughout ABMC.

The proposed rule was published at 82 FR 39067 (August 17, 2017). ABMC received one comment that was not germane. Accordingly this rule is being finalized with no changes.

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 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule benefits the public and the United States Government by providing clear procedures for members of the public, contractors, and employees to follow with regard to the ABMC privacy program. This rule has been designated a not significant regulatory action.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1532) requires agencies to assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2016, that threshold is approximately $146 million. This rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.

The ABMC certifies this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. Ch. 6) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require ABMC to prepare a regulatory flexibility analysis.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This rule will not have a substantial effect on the States; the relationship between the National Government and the States; or the distribution of power and responsibilities among the various levels of Government.

It has been determined that this rule does not impose reporting or record keeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

For the reasons set forth in the Preamble, the American Battle Monuments Commission amends 36 CFR chapter IV by adding part 407 to read as follows:

Regulatory Review Information

This rule is not a significant regulatory action for the purposes of E.O. 12866 and a significance determination was requested from the Office of Management and Budget (OMB). It is also not a major rule as defined in 5 U.S.C. Chapter 8, Congressional Review of Agency Rulemaking. As a result, this rule is also not subject to deregulatory requirements contained in E.O. 13771. As required by the Regulatory Flexibility Act, we certify that this rule will not have a significant impact on a substantial number of small entities; it simply updates contact, office, and agency online site information to reflect organizational changes. This rule also does not have any Federalism implications.

This rule is effective upon publication for good cause as permitted by the Administrative Procedure Act (5 U.S.C. 553(d)(3)). NARA believes that a public comment period is unnecessary as this rule merely makes minor administrative updates to reflect NARA organizational changes.

For the reasons stated in the preamble, NARA amends 36 CFR parts 1220, 1223, 1225, 1226, 1227, 1228, 1229, 1230, 1231, 1232, 1233, 1234, 1235, 1237, 1238, and 1239 as follows:

Each state has a SIP containing the control measures and strategies used to attain and maintain the national ambient air quality standards (NAAQS). The SIP is extensive, containing such elements as air pollution control regulations, emission inventories, monitoring networks, attainment demonstrations, and enforcement mechanisms.

Each state must formally adopt the control measures and strategies in the SIP after the public has had an opportunity to comment on them and then submit the proposed SIP revisions to EPA. Once these control measures and strategies are approved by EPA, after notice and comment, they are incorporated into the federally-approved SIP and are identified in part 52 “Approval and Promulgation of Implementation Plans,” Title 40 of the Code of Federal Regulations (40 CFR part 52). The full text of the state regulation approved by EPA is not reproduced in its entirety in 40 CFR part 52, but is “incorporated by reference.” This means that EPA has approved a given state regulation with a specific effective date. The public is referred to the location of the full text version should they want to know which measures are contained in a given SIP. The information provided allows EPA and the public to monitor the extent to which a state implements a SIP to attain and maintain the NAAQS and to take enforcement action if necessary.

The SIP is a living document which the state can revise as necessary to address the unique air pollution problems in the state. Therefore, EPA from time to time must take action on proposed revisions containing new and/or revised state regulations. A submission from a state can revise one or more rules in their entirety or portions of rules, or even change a single word. The state indicates the changes in the submission (such as, by using redline/strikethrough) and EPA then takes action on the requested changes. EPA establishes a docket for its actions using a unique Docket Identification Number. which is listed in each action. These dockets and the complete submission are available for viewing on www.regulations.gov.

On May 22, 1997, (62 FR 27968), EPA revised the procedures for incorporating by reference, into the Code of Federal Regulations, materials approved by EPA into each state SIP. These changes revised the format for the identification of the SIP in 40 CFR part 52, streamlined the mechanisms for announcing EPA approval of revisions to a SIP, and streamlined the mechanisms for EPA's updating of the IBR information contained for each SIP in 40 CFR part 52. The revised procedures also called for EPA to maintain “SIP Compilations” that contain the federally-approved regulations and source specific permits submitted by each state agency. These SIP Compilations are contained in 3-ring binders and are updated primarily on an annual basis. Under the revised procedures, EPA must periodically publish an informational document in the rules section of the Federal Register notifying the public that updates have been made to a SIP Compilation for a particular state. EPA applied the 1997 revised procedures to Alabama on December 22, 1998 (63 FR 70669).

This action represents EPA's publication of the Alabama SIP Compilation update, appearing in 40 CFR part 52: specifically, the materials of paragraphs (c) and (d) at 40 CFR 52. In addition, notice is provided of the following corrections to paragraph (c) of section 52.50, as described below:

A. Under the “State effective date” and “EPA approval date” changing the 2-digit year to reflect a 4-digit year (for consistency) and correcting numerous Federal Register citations to reflect the first page of the preamble as opposed to the regulatory text page.

B. Section 335-3-1-.05: revising entry to read “Sampling and Testing Methods.”

C. Section 335-3-3-.01: State effective date is revised to read “1/22/2008” and EPA approval date is revised to read “9/15/2008; 73 FR 53134.”

D. Section 335-3-4-.01: State effective date is revised to read “9/30/2008” and EPA approval date is revised to read “10/15/2008; 73 FR 60957.”

E. Section 335-3-4-.16: entry is removed from the table because the rule was reserved.

F. Section 335-3-5-.10: revising entry to read “TR SO2 Trading Program—computation of Time.

G. Section 335-3-5-.20: entry is removed from the table because the rule was reserved.

H. Section 335-3-5-.30: entry is removed from the table because the rule was reserved.

I. Section 335-3-6-.02: State effective date is revised to read “4/15/1987” and EPA approval date is revised to read “9/27/1993; 58 FR 50262.”

J. Section 335-3-6-.03: State effective date is revised to read “4/15/1987” and EPA approval date is revised to read “9/27/1993; 58 FR 50262.”

K. Section 335-3-6-.19: entry is removed from the table because the rule was reserved.

L. Section 335-3-6-.26: State effective date is revised to read “4/15/1987” and EPA approval date is revised to read “9/27/1993; 58 FR 50262.”

M. Section 335-3-6-.31: State effective date is revised to read “4/15/1987” and EPA approval date is revised to read “9/27/1993; 58 FR 50262.”

N. Section 335-3-6-.33: State effective date is revised to read “10/15/1996” and EPA approval date is revised to read “6/6/1997; 62 FR 30991.”

O. Section 335-3-6-.35: State effective date is revised to read “4/15/1987” and EPA approval date is revised to read “9/27/1993; 58 FR 50262.”

P. Section 335-3-6-.40: entry is removed from the table because the rule was reserved.

Q. Section 335-3-6-.43: State effective date is revised to read “10/15/1996” and EPA approval date is revised to read “6/6/1997; 62 FR 30991.”

R. Section 335-3-6-.49: State effective date is revised to read “10/15/1996” and EPA approval date is revised to read “6/6/1997; 62 FR 30991.”

S. Section 335-3-6-.53: State effective date is revised to read “10/15/1996” and EPA approval date is revised to read “6/6/1997; 62 FR 30991.”

T. Section 335-3-8-.04: Title/subject is changed to remove the word “(Reserved)”.

U. Section 335-3-8-.15: entry is removed from the table because the rule was reserved.

V. Section 335-3-8-.19: removing the explanation because EPA inadvertently inserted this explanation in its August 31, 2016 (81 FR 59869) approval of this section. There is only one section of 335-3-8-.19 in the approved SIP.

W. Section 335-3-8-.22: entry is removed from the table because the rule was reserved.

X. Section 335-3-8-.47: entry is removed from the table because the rule was reserved.

Y. Section 335-3-8-.54: entry is removed from the table because the rule was reserved.

Z. Section 335-3-8-.64: entry is removed from the table because the rule was reserved.

AA. Section 335-3-14-.04: revising entry to read “Air Permits Authorizing Construction in Clean Air Areas (Prevention of Significant Deterioration (PSD))

BB. Chapter 335-3-20 heading and Sections 335-3-20-.01 through 335-3-20-.03: entries are removed from the table because the rule was reserved.

EPA has determined that this action falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedure Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation and section 553(d)(3) which allows an agency to make an action effective immediately (thereby avoiding the 30-day delayed effective date otherwise provided for in the APA). This administrative action simply codifies provisions which are already in effect as a matter of law in Federal and approved state programs and corrects typographical errors appearing in the CFR. Under section 553(b)(3)(B) of the APA, an agency may find good cause where procedures are “impracticable, unnecessary, or contrary to the public interest.” Public comment for this administrative action is “unnecessary” and “contrary to the public interest” since the codification (and typographical corrections) only reflect existing law. Immediate notice of this action in the Federal Register benefits the public by providing the public notice of the updated Alabama SIP Compilation and notice of typographical corrections to the Alabama “Identification of Plan” portion of the Federal Register. Further, pursuant to section 553(d)(3), making this action immediately effective benefits the public by immediately updating both the SIP compilation and the CFR “Identification of plan” section (which includes table entry corrections).

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 previously EPA-approved regulations promulgated by Alabama and federally effective prior to October 1, 2017. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

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, this notification of administrative change 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 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).

EPA also believes that the provisions of section 307(b)(1) of the CAA pertaining to petitions for judicial review are not applicable to this action. This is because prior EPA rulemaking actions for each individual component of the Alabama SIP compilations previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action. Thus, EPA believes judicial review of this action under section 307(b)(1) of the CAA is not available.

40 CFR part 52 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On November 14, 2017 (82 FR 52683), EPA published a Notice of Proposed Rulemaking (NPRM) for the State of New Hampshire. The NPRM proposed approval of a revised single source order limiting emissions of volatile organic compounds (VOCs) from Sturm Ruger & Company, and a revised state regulation identified as Env-A 900, Owner or Operator Recordkeeping and Reporting Obligations. During the public comment period we received four comment letters. Two of the comment letters did not contain information that was specific or germane to our proposed actions for New Hampshire. One comment letter noted that approving New Hampshire's SIP revisions was “a bad idea,” but did not explain why or how New Hampshire's SIP revisions should be changed. One letter did contain relevant adverse comments and those comments are responded to below. In light of these relevant adverse comments, on January 11, 2018 (83 FR 1302) we published a withdrawal of the direct final rule we published in conjunction with our November 14, 2017 NPRM (82 FR 52664).

A comment was received indicating that EPA should not approve the “reasonably available control technology” (RACT) order for Sturm Ruger & Company for the following reasons. First, the commenter notes that Table 1 of the order illustrates that the company is able to meet a more stringent emission limit for topcoats than the order requires, and therefore the order should not be approved because this emission limit does not represent the lowest emission limit the source can meet for that coating. Additionally, the commenter notes that EPA should not approve sections of the order that involve SIP-approved rules because doing so is redundant, and may create conflicting requirements if the state changes the SIP-approved rule at some point in the future.

With regard to the commenter's first point, we note that the RACT order that we are approving into the New Hampshire SIP, Order ARD-03-001 issued to Sturm Ruger & Company, is divided into four parts as follows: Section A, Introduction; Section B, Parties; Section C, Statement of Fact and Law; and Section D, Order. Section D, Order, contains the RACT requirements New Hampshire has tailored to the facility. Table 1, which the commenter alludes to as being indicative that the order contains insufficient requirements for RACT because the emission limit contained within it does not represent the lowest emission limit the source can meet for that coating, is found within Section C, Statement of Fact and Law, and the volatile organic compound (VOC) limits cited within it are from a state regulation previously approved into the New Hampshire State Implementation Plan (SIP).1 Section C is provided as informative background as to what air pollution control regulations the source is subject to. Table 1 of Section C indicates that the source at issue in this SIP action uses coatings with VOC contents that are lower than allowed by the State's regulation, which illustrates that the source is in compliance with those existing state requirements. New Hampshire adopted the regulation in question, Env-A 1213, Wood Furniture, Burial Caskets, and Gunstock Coatings, to meet, in part, its obligation to ensure that RACT is required at major, and some non-major, sources of VOC emissions. EPA approved the State's regulation as meeting RACT on March 10, 1998 (63 FR 11600). EPA is not taking any action on those previously-approved SIP provisions in this action. The fact that the source has found coatings with VOC content limits that are lower than required by the State's regulation does not dictate that New Hampshire revise its regulation to make it more stringent; rather, as noted previously, it indicates that the source is in compliance with the State's RACT requirements for such facilities. The commenter's assertion that the levels shown in Table 1 can't be RACT because it is not the lowest emission limit the source can meet appear to confuse RACT, which requires “reasonably available control technology,” with the requirements of a more rigorous regulatory tool of “lowest achievable emission rate” (LAER). LAER, as defined at 40 CFR 51.165(a)(1)(xiii), could in some instances require a more stringent level of control than RACT.

In response to the commenter's second point regarding the Sturm Ruger & Company order, we do agree that some portions of Section D of the order are currently part of the New Hampshire SIP, and are therefore duplicative and not needed within the order. We have included in the Docket for this action a version of the State's order that excludes the portions of Section D of the order that are duplicative of existing, SIP-approved requirements, and are incorporating that version into the NH SIP. A copy of the version of RACT Order ARD-03-001, as amended February 2, 2017, that we are approving into the New Hampshire SIP has been placed into the Docket for this rulemaking.

A comment was received requesting that EPA not approve New Hampshire's recordkeeping and reporting rule, Env-A 900, until the state clarifies the applicability section of the rule. The commenter asserted that, as currently structured, the rule would apply to many small sources, including individual users of consumer products, and is therefore far too burdensome. The commenter cites Env-A 902.01 and 903.01 as examples of the asserted broad reach of the rule's authority.

The applicability criteria of New Hampshire's Env-A 900 differ by section of the regulation, and are structured such that they would not apply to the small entities noted by the commenter. The provisions at Env-A 902.01 are not applicability provisions; rather, they provide the record retention and record availability requirements for sources that are subject to the rule. Env-A 903.01 does contain applicability criteria. For example, Env-A 903.01(a) provides applicability criteria as follows: “Except as provided in (b),2 below, this part shall apply to any stationary source, area source, or device that is subject to Env-A 600” (underlined emphasis added). Env-A 600 is applicable to sources required to obtain a permit from the New Hampshire Department of Environmental Services (NH DES), and there are various, specific applicability criteria within that regulation identifying who needs to do so. For example, Env-A 607, Temporary Permits, applies to the sources identified within Env-A 607.01, including those noted in paragraph (a) of that section: external combustion devices with a heat input of greater than or equal to 10 million British Thermal Units (BTUs) per hour burning gas, liquid propane, distillate fuel, or any combination of these fuels. Env-A 607.01 continues with specific applicability criteria for other types of equipment, and in no case would apply to the small entities noted by the commenter. In addition, Env-A 900, section 904.01 provides applicability criteria for equipment that has “. . . actual VOC emissions greater than or equal to 10 tons in any calendar year or that is subject to Env-A 1200 `VOC RACT'. . . .” Here, as within Env-A 600, the specific applicability criteria of New Hampshire's regulations preclude their application to the small entities contemplated by the commenter, and no part of the regulation we are approving, Env-A 900, provides the state with such authority.

EPA is approving portions of New Hampshire's revised regulation Env-A 900, Owner or Operator Recordkeeping and Reporting Obligations, and certain parts of the RACT Order ARD-03-001 issued to Sturm Ruger & Company, as revisions to the New Hampshire SIP. This rule, which responds to the adverse comments received, finalizes our proposed approval of these SIP revisions.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of portions of Env-A 900, Owner or Operator Recordkeeping and Reporting Obligations, and portions of Order ARD-03-001, as amended February 2, 2017, as described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available through www.regulations.gov, and at the EPA Region 1 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information.

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, 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 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 May 29, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0660, EPA-HQ-OPP-2015-0720 and EPA-HQ-OPP-2015-0723 are in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before May 29, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0660, EPA-HQ-OPP-2015-0720 and EPA-HQ-OPP-2015-0723 are, by one of the following methods:

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

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

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

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

In the Federal Register of November 23, 2015 (80 FR 72941) (FRL-9936-73), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of pesticide petitions IN-10791, IN-10805, and IN-10806 by Technology Sciences Group, (1150 18th Street NW, Suite 1000 Washington, DC 20036) on behalf of Stepan Company (22 West Frontage Road, Northfield, Illinois 60093). The petitions requested that 40 CFR 180.910 be amended by establishing exemptions from the requirement of a tolerance for residues of N,N-dimethyl 9-decenamide (CAS Reg No. 1356964-77-6) (IN-10791); N,N-dimethyldodecanamide (CAS Reg No. 3007-53-2) (IN-10806); and N,N-dimethyltetradecanamide (CAS Reg No. 3015-65-4) (IN-10805) when used as inert ingredients (surfactant/solvent) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest. That document referenced summaries of the petitions prepared by Technology Sciences Group on behalf of Stepan Company, the petitioner, which are available in the corresponding dockets, http://www.regulations.gov. A comment was received on the notice of filing. EPA's response to this comment is discussed in Unit V.C.

Based upon review of the data supporting the petitions, EPA has limited the maximum concentration of N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide to not more than 20% by weight in pesticide formulations. The reason for this change is explained in Unit V.B. below.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

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

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

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide and N,N-dimethyltetradecanamide as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

N,N-dimethyl 9-decenamide is very similar in structure to N,N-dimethyldecanamide (differing only in the presence of a single double bond), and to N,N-dimethyloctanamide (differeing only in alkyl group carbon chain length and the presence of a terminal double bond). N,N-dimethyldodecanamide is very similar in structure to N,N-dimethyldecanamide and N,N-dimethyloctanamide, differing only in alkyl group carbon chain length. Similarly, N,N-dimethyltetradecanamide is very similar in structure to N,N-dimethyldecanamide and N,N-dimethyloctanamide, differing only in alkyl group carbon chain length. Based upon these close structural similarities, N,N-dimethyldecanamide and N,N-dimethyloctanamide are considered suitable surrogates to characterize toxicity due to exposure to N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide.

N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide are not sensitizers. Based on the acute toxicity data on surrogate chemicals N,N-dimethyldecanamide and N,N-dimethyloctanamide, they are expected to be of low oral acute toxicity; the lethal dose, (LD50) in rats is 1,770 milligrams/kilogram (mg/kg). The acute dermal LD50 is greater than 400 mg/kg and the acute inhalation lethal concentration, LC50 is greater than 3.55 milligrams/liter (mg/L). They are expected to be a severe irritant to the skin and corrosive to the eyes.

Following subchronic exposure in the diet of the rat, toxicity is manifested as an increased incidence of basophilic regenerative tubules in the renal cortex as well as a slight increase in the amount of protein excreted in the urine at 10,000 parts per million (ppm) (787.6 mg/kg/day). The no-observed-adverse effect level (NOAEL) is 2,000 ppm (136.8 mg/kg/day). In the 6-weeks toxicity study in dogs via gavage, decreased food consumption was seen at 1,000 mg/kg/day, the highest dose tested. The NOAEL was 500 mg/kg/day.

No fetal susceptibility is observed in developmental studies in rats or rabbits. In rats, maternal and developmental toxicity are observed at 450 mg/kg/day. In rats, maternal toxicity is manifested as clinical signs, food consumption and increased post-implantation loss. Developmental toxicity is manifested as decreased fetal body weight and increased incidence of skeletal malformations/variations. In the rabbit, neither maternal nor developmental toxicity is observed at dose levels up to 1,000 mg/kg/day.

In a 5-day repeat dose inhalation toxicity study in rats (nose only, 6-hour exposure per day), marginally reduced body weight gains and goblet cell hyperplasia in the nasal and paranasal cavities were seen at 521.2 mg/m3 (approximately 426.8 mg/kg/day), the highest dose tested. The NOAEL is 111.2 mg/m3).

N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide are negative for gene mutations and clastogenicity in the Ames test and the micronucleus assay, respectively.

A Derek Nexus structural alert analysis was conducted with N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide and indicated no structural alerts for carcinogenicity or mutagenicity. Therefore, N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide are not expected to be carcinogenic.

No neurotoxicity or immunotoxicity studies are available for review with N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide. However, evidence of potential neurotoxicity or immunotoxicity was not observed in the submitted studies.

Based on the chemical structure and known mammalian enzymatic activities, N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide are expected to undergo carboxyamide hydrolysis by amidase enzymes that have broad substrate specificity, resulting in the corresponding carboxylic acid with a fatty acid structure.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

The chronic reference dose (cRfD) as well as all dermal exposure scenarios, was based on the 90-day toxicity study in the rat. In this study, the LOAEL was 10,000 ppm (equivalent to 787.6 mg/kg/day) based on an increased incidence of basophilic regenerative tubules in the renal cortex as well as a slight increase in the amount of protein excreted in the urine. The NOAEL was 2,000 ppm (equivalent to 136.8 mg/kg/day). This represents the lowest NOAEL in the most sensitive species in the toxicity database. The standard uncertainty factors were applied to account for interspecies (10x) and intraspecies (10x) variations. The additional uncertainty factor was reduced to 3x to account for extrapolation from subchronic to chronic exposures scenarios because the kidney effects were reversible and observed in male rats only. Additionally, in the dog following 6 weeks of oral exposure, no signs of toxicity were observed up to 500 mg/kg/day and the only sign of toxicity (decreased food consumption) was observed at the limit dose of 1,000 mg/kg/day. The 5-day inhalation toxicity study in rats was not selected for inhalation exposure assessment because oral end point and inhalation end points yielded comparable NOAEL. In addition, the nasal effects seen in this study is primarily due to irritation and marginally decreased in reduced body weight would have observed in the oral study. A dermal absorption factor of 85% was applied based on a dermal penetration study in rats and an in vitro dermal absorption study with human skin. The default value of 100% absorption was used for the inhalation absorption factor. The resultant chronic population adjusted dose (cPAD) is 0.456 mg/kg/day. The MOEs for short-term and intermediate-term occupational and residential exposures are 100.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide in food as follows:

Dietary exposure (food and drinking water) to N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide can occur following ingestion of foods with residues from treated crops. Because no adverse effects attributable to a single exposure of N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; or N,N-dimethyltetradecanamide are seen in the toxicity databases, an acute dietary risk assessment is not necessary. For the chronic dietary risk assessment, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCIDTM, Version 3.16, and food consumption information from the U.S. Department of Agriculture's (USDA's) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, no residue data were submitted for N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; or N,N-dimethyltetradecanamide. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high use insecticides, herbicides, and fungicides. One hundred percent crop treated was assumed, default processing factors, and tolerance-level residues for all foods and use limitations of not more than 20% in pesticide formulations. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide, a conservative drinking water concentration value of 100 ppb based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide may be used as inert ingredients in products that are registered for specific uses that may result in residential exposure, such as pesticides used in and around the home. The Agency conducted a conservative assessment of potential residential exposure by assessing N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide in pesticide formulations (outdoor scenarios) and in disinfectant-type uses (indoor scenarios). The Agency's assessment of adult residential exposure combines high-end dermal and inhalation handler exposure from liquids/trigger sprayer/home garden and indoor hard surface, wiping with a high-end post application dermal exposure from contact with treated lawns. The Agency's assessment of children's residential exposure includes total post-application exposures associated with total exposures associated with contact with treated lawns and surfaces (dermal and hand-to-mouth exposures).

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

EPA has not found N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide to share a common mechanism of toxicity with any other substances, and N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide do not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. The toxicity database for N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide contains subchronic and developmental toxicity studies conducted with surrogate chemicals. Increased fetal susceptibility is not observed in either of the developmental toxicity studies in rats or rabbits. In rats, maternal (clinical signs, food consumption and increased post-implantation loss) and developmental (fetal body weight, increased incidence of skeletal malformations/variations) toxicity were observed at 450 mg/kg/day. In the rabbit, neither maternal nor developmental toxicity was observed up to 1,000 mg/kg/day. Reproduction toxicity studies were not available; however, increased post-implantation loss is observed at 450 mg/kg/day in the developmental toxicity study in rats. The established cRfD will be protective of the observed effect. In addition, the Agency used conservative exposure estimates, with 100 percent crop treated, tolerance-level residues, conservative drinking water modeling numbers, and a conservative assessment of potential residential exposure for infants and children. Based on the adequacy of the toxicity database, the conservative nature of the exposure assessment, and the lack of concern for prenatal and postnatal sensitivity, the Agency has concluded that there is reliable data to determine that infants and children will be safe if the FQPA SF of 10x is reduced to 1x for short and intermediate-term exposure and 3 x for chronic exposure assessment.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide are not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide from food and water will utilize 62.3% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide may be used as inert ingredients in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide.

Using the exposure assumptions described above for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 680 for both adult males and females. EPA has concluded the combined short-term aggregated food, water, and residential pesticide exposures result in an aggregate MOE of 359 for children. Because EPA's level of concern for N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; and N,N-dimethyltetradecanamide is a MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide may be used as inert ingredients in pesticide products that are registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide.

Using the exposure assumptions described above for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate MOEs of 1475 for adult males and females. EPA has concluded the combined intermediate-term aggregated food, water, and residential exposures result in an aggregate MOE of 394 for children. Because EPA's level of concern for N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide is a MOE of 100 or below, these MOEs are not of concern.

5. Aggregate cancer risk for U.S. population. Based on the lack of structural alerts in a DEREK structural alert analysis and the lack of mutagenicity, N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide residues.

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide and N,N-dimethyltetradecanamide in or on any food commodities. EPA is establishing limitations on the amount of N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide and N,N-dimethyltetradecanamide that may be used in pesticide formulations applied to growing crops. These limitations will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for use on growing crops or raw agricultural commodities after harvest for sale or distribution that exceeds 20% by weight of N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide unless additional data are submitted that demonstrate a higher concentration would be safe.

Based upon an evaluation of the data included in the petition, EPA is establishing an exemption from the requirement of a tolerance for residues of N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide,and N,N-dimethyltetradecanamide when used in pesticide formulations as inert ingredients (surfactant/solvent), not to exceed 20% by weight of the formulation, instead of the unlimited use requested. Because unlimited use of N,N-dimethyl 9-decenamide; N,N-dimethyldodecanamide; or N,N-dimethyltetradecanamide resulted in aggregate risks of concern, EPA is establishing a 20% limitation in formulation to support the safety finding of these tolerance exemptions. The concern for unlimited use of theses inert ingredients is documented on page 4 of the Agency's risk assessment documents “N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations,” which can be found at http://www.regulations.gov in in docket ID number EPA-HQ-OPP-2015-0660, EPA-HQ-OPP-2015-0720 and EPA-HQ-OPP-2015-0723, respectively.

The comment was received from a private citizen who opposed the authorization to sell any pesticide that leaves a residue on food. The Agency recognizes that some individuals believe that no residue of pesticides should be allowed. However, under the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) EPA is authorized to establish pesticide tolerances or exemptions where persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by the statute. EPA has evaluated all the available data and concluded that there is a reasonable certainty of no harm from the limited use of N,N-dimethyl 9-decenamide, N,N-dimethyldodecanamide, and N,N-dimethyltetradecanamide as inert ingredients in pesticide formulations. The commenter has not provided any information supporting a conclusion that such exposure will not be safe.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for residues of N,N-dimethyl 9-decenamide (CAS Reg No. 1356964-77-6), N,N-dimethyldodecanamide (CAS Reg No. 3007-53-2), and N,N-dimethyltetradecanamide (CAS Reg No. 3015-65-4) when used as inert ingredients (surfactant, solvent) at a maximum concentration not to exceed 20% by weight in any pesticide formulation applied to growing crops or raw agricultural commodities after harvest.

This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

I. Background

In the December 30, 2015 final rule (80 FR 81674) titled “Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies,” we implemented section 1834(a)(15) of the Social Security Act (the Act) by establishing an initial Master List (called the Master List of Items Frequently Subject to Unnecessary Utilization) of certain DMEPOS that the Secretary determined, on the basis of prior payment experience, are frequently subject to unnecessary utilization and by establishing a prior authorization process for these items. The Master List includes items that meet the following criteria:

• Appear on the DMEPOS Fee Schedule list.

• Have an average purchase fee of $1,000 or greater (adjusted annually for inflation) or an average monthly rental fee schedule of $100 or greater (adjusted annually for inflation). (These dollar amounts are referred to as the “payment threshold”.)

• Meet either of the following criteria:

++ Identified in a Government Accountability Office (GAO) or Department of Health and Human Services Office of Inspector General (OIG) report that is national in scope and published in 2007 or later as having a high rate of fraud or unnecessary utilization.

++ Listed in the 2011 or later Comprehensive Error Rate Testing (CERT) program's Annual Medicare Fee-For-Service (FFS) Improper Payment Rate Report DME and/or DMEPOS Service Specific Report(s).

The rule described the maintenance process of the Master List as follows:

• The Master List is self-updating annually. That is, items on the DMEPOS Fee Schedule that meet the “payment threshold” are added to the list when the item is listed in a future OIG or GAO report of a national scope or listed in a future CERT DME and/or DMEPOS Service Specific Report(s).

• Items remain on the Master List for 10 years from the date the item was added to the Master List.

• Items are updated on the Master List when the Healthcare Common Procedure Coding System (HCPCS) codes representing an item have been discontinued and cross-walked to an equivalent item.

• Items are removed from the list sooner than 10 years if the purchase amount drops below the “payment threshold”.

• Items that age off the Master List because they have been on the list for 10 years can remain on or be added back to the Master List if a subsequent GAO/OIG, or CERT DME and/or DMEPOS Service Specific Report(s) identifies the item to be frequently subject to unnecessary utilization.

• Items already on the Master List that are identified by a GAO/OIG, or CERT DME and/or DMEPOS Service Specific Report(s) will remain on the list for 10 years from the publication date of the new report(s).

• We will notify the public annually of any additions and deletions from the Master List by posting the notification in the Federal Register and on the CMS Prior Authorization website.

In the December 30, 2015 final rule (80 FR 81674), we stated that we would notify the public annually of any additions and deletions from the Master List by posting the notification in the Federal Register and on the CMS Prior Authorization website.

This document is to provide the annual update to the Master List of Items Frequently Subject to Unnecessary Utilization.

As noted previously, we adjust the “payment threshold” each year for inflation. More specifically, we stated in the preamble to the December 2015 final rule (80 FR 81679) that we will apply the same percentage adjustment to the “payment threshold” as we do to the DMEPOS fee schedule. In accordance with section 1834(a)(14) of the Act, certain DMEPOS fee schedule amounts are updated annually by the percentage increase in the consumer price index for all urban consumers (United States city average) or CPI-U for the 12-month period ending June 30 of the previous year, adjusted by the change in the economy-wide productivity equal to the 10-year moving average of changes in annual economy-wide private non-farm business multifactor productivity (MFP). We use this same methodology to adjust the Master List Payment Threshold for inflation.

For calendar year (CY) 2017, the MFP adjustment is 0.3 percent and the CPI-U percentage increase is 1 percent. Thus, the 1 percentage increase in the CPI-U is reduced by the 0.3 percentage increase in the MFP resulting in a net increase of 0.7 percent to be used as the update factor. We applied the 0.7 percent update factor to the average purchase fee of $1,000, resulting in a CY 2017 adjusted “payment threshold” of $1,007 ($1,000 × 1.007). We also applied the 0.7 percent update factor to the average monthly rental fee of $100, resulting in an adjusted “payment threshold” of $100.70 ($100 × 1.007). Rounding this figure to the nearest whole dollar amount resulted in a CY 2017 adjusted monthly rental fee threshold amount of $101.

For CY 2018, the MFP adjustment is 0.5 percent and the CPI-U percentage increase is 1.6 percent. Thus, the 1.6 percentage increase in the CPI-U is reduced by the 0.5 percentage increase in the MFP resulting in a net increase of 1.1 percent to be used as the update factor. We applied the 1.1 percent update factor to the CY 2017 average purchase fee of $1,007, resulting in a CY 2018 adjusted “payment threshold” of $1,018.07 ($1,007 × 1.011). Rounding this figure to the nearest whole dollar amount resulted in a CY 2018 adjusted “payment threshold” amount of $1,018. We also applied the update factor of 1.1 percent to the CY 2017 average monthly rental fee of $101, resulting in an adjusted “payment threshold” of $102.11 ($101 × 1.011). Rounding this figure to the nearest whole dollar amount resulted in a CY 2018 adjusted monthly rental fee threshold of $102.

This update does not reflect any additions because there are no new items that meet the updated “payment threshold” that are listed in an OIG or GAO report of a national scope or a CERT DME and/or DMEPOS Service Specific Report(s). The following four HCPCS codes are removed from the Master List of Items Frequently Subject to Unnecessary Utilization because they no longer have a DMEPOS Fee Schedule price of $1,018 or greater or an average monthly rental fee schedule of $102 or greater:

The full updated list is also available in the download section of the following CMS website: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/DMEPOS/Prior-Authorization-Process-for-Certain-Durable-Medical-Equipment-Prosthetic-Orthotics-Supplies-Items.html.

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

We have examined the impact of this action as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), 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). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This document does not reach the economic threshold and thus is not considered a major rule.

The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and states are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this document will not have a significant economic impact on a substantial number of small entities.

In addition, section 1102(b) of the Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this action will not have a significant impact on the operations of a substantial number of small rural hospitals.

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 1 year of $100 million in 1995 dollars, updated annually for inflation. Currently, that threshold is approximately $148 million. This action will have no consequential effect on state, local, or tribal governments or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this action does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.

Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017 and requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” OMB's interim guidance, issued on April 5, 2017, https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2017/M-17-21-OMB.pdf, explains that for Fiscal Year 2017 the above requirements only apply to each new “significant regulatory action that imposes costs.” It has been determined that this document is not a “significant regulatory action” and thus does not trigger the aforementioned requirements of Executive Order 13771.

In accordance with the provisions of Executive Order 12866, this document was reviewed by the Office of Management and Budget.

This is a summary of the Commission's Report and Order (Order), FCC 18-16, adopted and released on February 20, 2018. The full text of this document is available electronically via the FCC's Electronic Document Management System (EDOCS) website at http://fjallfoss.fcc.gov/edocs_public/ or via the FCC's Electronic Comment Filing System (ECFS) website at http://fjallfoss.fcc.gov/ecfs2/. (Documents will be available electronically in ASCII, Microsoft Word, and/or Adobe Acrobat.) This document is also available for public inspection and copying during regular business hours in the FCC Reference Information Center, which is located in Room CY-A257 at FCC Headquarters, 445 12th Street SW, Washington, DC 20554. The Reference Information Center is open to the public Monday through Thursday from 8:00 a.m. to 4:30 p.m. and Friday from 8:00 a.m. to 11:30 a.m. The complete text may be purchased from the Commission's copy contractor, 445 12th Street SW, Room CY-B402, Washington, DC 20554. Alternative formats are available for people with disabilities (Braille, large print, electronic files, audio format), by sending an email to [email protected] or calling the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

1. In this Order, we eliminate rules that require certain broadcast and cable entities to maintain paper copies of the Commission's regulations. As part of our initiative to modernize our media regulations, we issued a Notice of Proposed Rulemaking (NPRM) proposing to eliminate requirements that regulatees maintain copies of certain portions of the Code of Federal Regulations (CFR). We received unanimous support for this proposal. As set forth below, we conclude that eliminating these requirements, which apply to low power TV, TV and FM translators, TV and FM booster stations, cable television relay station (CARS) licensees, and certain cable operators, will advance the Commission's goal of reducing outdated regulations and unnecessary regulatory burdens that can impede competition and innovation in media markets.

2. We adopt the proposal to eliminate the requirement, set forth in § 74.769 of our rules, that licensees or permittees of low power TV, TV translators, and TV booster stations maintain “a current copy of Volume I and Volume III of the Commission's rules.” We also adopt the proposal to eliminate the requirement in § 74.1269 of our rules that licensees and permittees of FM translator and FM booster stations maintain “a current copy of Volumes I (parts 0, 1, 2 and 17) and III (parts 73 and 74) of the Commission's rules.” As we noted in the NPRM, the Commission adopted these requirements more than 40 years ago as part of its regulation of then recently established broadcast translator services. We agree with NAB that, “given licensees' ability today to immediately access FCC rules via the internet, requiring broadcasters to retain hard copies of the rules is no longer necessary.” Indeed, the electronic version of the CFR available on the internet is often more current than the printed version, which is published only once a year. Removing this requirement also would help small broadcasters in particular by enabling them to cut unnecessary costs.

3. Additionally, as proposed in the NPRM, we eliminate the requirement in § 76.1714(a) that cable operators serving 1,000 or more subscribers maintain a current copy of part 76 of the Commission's rules and, if subject to the Emergency Alert System (EAS) rules contained in part 11, an EAS Operating Handbook. As noted in the NPRM, we recognize the public safety benefits of keeping the EAS Handbook in close proximity, but we see no need to duplicate the requirement in section 11.15—which this order does not impact—that a copy of the handbook “be located at normal duty positions or EAS equipment locations when an operator is required to be on duty and be immediately available to staff responsible for authenticating messages and initiating actions.” We agree with NCTA that this “requirement wastes resources and is unjustified today given that the materials are readily available for free to anyone with access to the internet.” Moreover, because the most up-to-date version of the Commission's rules is accessible via the internet, a requirement to keep a hard copy of part 76 of the Commission's rules has outlived its usefulness.

4. We also eliminate from §§ 76.1714(c) and 78.67 of the Commission's rules the requirement that CARS licensees maintain a current copy of part 78 of the Commission's rules and, in cases where aeronautical obstruction markings of antennas are required, a current copy of part 17. The Commission adopted these rules several decades ago as part of a comprehensive regulatory framework to govern then-nascent cable television service. We agree with ACA and other commenters that, because the Commission's rules are now easily accessible via the internet, requirements to keep hard copies of those rules have outlived their purpose.

5. For these reasons, we find that these pre-internet era rules requiring certain broadcast and cable entities to keep hard copies of Commission rules are outdated and impose an unnecessary burden on regulates. As such, we find that removing them is in the public interest. At the same time, we note that our action today does not eliminate the portions of §§ 74.769, 74.1269, 76.1714, and 78.67 that obligate the subject broadcast and cable entities to be familiar with the rules governing their respective operations.

6. This document does not contain any new or revised information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3501-3520). In addition, therefore, it does not contain any new or modified “information burden for small business concerns with fewer than 25 employees” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, 44 U.S.C. 3506(c)(4).

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

8. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Notice of Proposed Rulemaking (NPRM) in MB Docket 17-231. The Commission sought written public comments on proposals in the NPRM, including comment on the IRFA. The Commission received no comments on the IRFA, although some commenters discussed the effect of the proposals on smaller entities, as discussed below. The present Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.

9. Need for, and Objectives of, the Report and Order. The Report and Order (Order) stems from a Public Notice issued by the Commission in May 2017, launching an initiative to modernize the Commission's media regulations. The parties that filed comments in the proceeding unanimously agree that the recordkeeping requirements at issue are outdated and unnecessary and should be eliminated. The Order adopts the NPRM's proposal to eliminate provisions of the Commission's rules that obligate certain broadcasters and cable entities to maintain paper copies of Commission rules.

10. Specifically, the Order eliminates: (i) The requirement that licensees or permittees of low power TV, TV translator, and TV booster stations maintain a copy of Volume I and Volume III of the Commission's rules; (ii) the requirement that licensees or permittees of FM translator and FM booster stations maintain a copy of Volumes I (parts 0, 1, 2 and 17) and III (parts 73 and 74) of the Commission's rules; (iii) the requirement that certain cable operators maintain a copy of part 76 of the Commission's rules and, if subject to the Emergency Alert System (EAS) rules contained in part 11 of such rules, an EAS Operating Handbook; and (iv) the requirements that cable television relay station (CARS) licensees maintain a copy of part 76 of the Commission's rules and, in cases where aeronautical obstruction markings of antennas are required, part 17 of such rules. The Order finds that eliminating these recordkeeping requirements will remove an outdated and unnecessary regulatory burden that may impede competition and innovation in media markets.

11. Summary of Significant Issues Raised by Public Comments in Response to the IRFA. No comments were filed in response to the IRFA.

12. Response to Comments by the Chief Counsel for Advocacy of the Small Business Administration. Pursuant to the Small Business Jobs Act of 2010, which amended the RFA, the Commission is required to respond to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA), and to provide a detailed statement of any change made to the proposed rules as a result of those comments.1 The Chief Counsel did not file any comments in response to the proposed rules in this proceeding.

13. Description and Estimate of the Number of Small Entities to Which the Rules Will Apply. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the rules adopted in the Order.2 The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” 3 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.4 A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.5 Below, we provide a description of such small entities, as well as an estimate of the number of such small entities, where feasible.

14. Television Broadcasting. This Economic Census category “comprises establishments primarily engaged in broadcasting images together with sound.” These establishments operate television broadcast studios and facilities for the programming and transmission of programs to the public. These establishments also produce or transmit visual programming to affiliated broadcast television stations, which in turn broadcast the programs to the public on a predetermined schedule. Programming may originate in their own studio, from an affiliated network, or from external sources. The SBA has created the following small business size standard for such businesses: Those having $38.5 million or less in annual receipts. The 2012 Economic Census reports that 751 firms in this category operated in that year. Of that number, 656 had annual receipts of $25,000,000 or less, 25 had annual receipts between $25,000,000 and $49,999,999, and 70 had annual receipts of $50,000,000 or more. Based on this data, we estimate that the majority of commercial television broadcasters are small entities under the applicable SBA size standard.

15. In addition, the Commission has estimated the number of licensed commercial television stations to be 1,384. Of this total, 1,264 stations had revenues of $38.5 million or less, according to Commission staff review of the BIA Kelsey Inc. Media Access Pro Television Database (BIA) on February 24, 2017. Such entities, therefore, qualify as small entities under the SBA definition. The Commission has estimated the number of licensed noncommercial educational (NCE) television stations to be 394. The Commission, however, does not compile and does not have access to information on the revenue of NCE stations that would permit it to determine how many such stations would qualify as small entities.

16. We note, however, that in assessing whether a business concern qualifies as “small” under the above definition, business (control) affiliations 6 must be included. Our estimate, therefore likely overstates the number of small entities that might be affected by our action, because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies. In addition, another element of the definition of “small business” requires that an entity not be dominant in its field of operation. We are unable at this time to define or quantify the criteria that would establish whether a specific television broadcast station is dominant in its field of operation. Accordingly, the estimate of small businesses to which the proposed rules would apply does not exclude any television station from the definition of a small business on this basis and therefore could be over-inclusive.

17. There are also 1,968 LPTV stations, 417 Class A stations, and 3,776 TV translator stations. Given the nature of these services, we will presume that all of these entities qualify as small entities under the above SBA small business size standard.

18. Radio Stations. This economic Census category “comprises establishments primarily engaged in broadcasting aural programs by radio to the public.” The SBA has created the following small business size standard for this category: those having $38.5 million or less in annual receipts. Census data for 2012 shows that 2,849 firms in this category operated in that year. Of this number, 2,806 firms had annual receipts of less than $25,000,000, and 43 firms had annual receipts of $25,000,000 or more. Because the Census has no additional classifications that could serve as a basis for determining the number of stations whose receipts exceeded $38.5 million in that year, we conclude that the majority of television broadcast stations were small under the applicable SBA size standard.

19. Apart from the U.S. Census, the Commission has estimated the number of licensed commercial AM radio stations to be 4,486 stations 7 and the number of commercial FM radio stations to be 6,755, for a total number of 11,241. Of this total, 9,898 stations had revenues of $38.5 million or less, according to Commission staff review of the BIA Kelsey Inc. Media Access Pro Television Database (BIA) in October 2014. In addition, the Commission has estimated the number of noncommercial educational FM radio stations to be 4,111. NCE stations are non-profit, and therefore considered to be small entities. Therefore, we estimate that the majority of radio broadcast stations are small entities.

20. Low Power FM Stations. The same SBA definition that applies to radio stations would apply to low power FM stations. As noted above, the SBA has created the following small business size standard for this category: Those having $38.5 million or less in annual receipts. The Commission has estimated the number of licensed low power FM stations to be 1,966. In addition, as of June 30, 2017, there were a total of 7,453 FM translator and FM booster stations. Given the nature of these services, we will presume that these licensees qualify as small entities under the SBA definition.

21. We note again, however, that in assessing whether a business concern qualifies as “small” under the above definition, business (control) affiliations 8 must be included. Because we do not include or aggregate revenues from affiliated companies in determining whether an entity meets the applicable revenue threshold, our estimate of the number of small radio broadcast stations affected is likely overstated. In addition, as noted above, one element of the definition of “small business” is that an entity not be dominant in its field of operation. We are unable at this time to define or quantify the criteria that would establish whether a specific radio broadcast station is dominant in its field of operation. Accordingly, our estimate of small radio stations potentially affected by the proposed rules includes those that could be dominant in their field of operation. For this reason, such estimate likely is over-inclusive.

22. Cable Companies and Systems (Rate Regulation). The Commission has developed its own small business size standards for the purpose of cable rate regulation. Under the Commission's rules, a “small cable company” is one serving 400,000 or fewer subscribers nationwide.9 In addition, under the Commission's rate regulation rules, a “small system” is a cable system serving 15,000 or fewer subscribers.10 Industry data indicate that there are currently 4,300 active cable systems in the United States.11 Of this total, 3,550 cable systems have fewer than 15,000 subscribers, and 750 systems have 15,000 or more subscribers.12 Thus, we estimate that most cable systems are small entities.

23. Cable System Operators (Telecom Act Standard). The Communications Act of 1934, as amended, also contains a size standard for small cable system operators, which is “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than 1 percent of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenues in the aggregate exceed $250 million.” 13 There are approximately 52,107,104 cable video subscribers in the United States today. Accordingly, an operator serving fewer than 521,071 subscribers shall be deemed a small operator if its annual revenues, when combined with the total annual revenues of all its affiliates, do not exceed $250 million in the aggregate. Based on available data, we find that all but six incumbent cable operators are small entities under this size standard. We note that the Commission neither requests nor collects information on whether cable system operators are affiliated with entities whose gross annual revenues exceed $250 million.14 Although it seems certain that some of these cable system operators are affiliated with entities whose gross annual revenues exceed $250 million, we are unable at this time to estimate with greater precision the number of cable system operators that would qualify as small cable operators under the definition in the Communications Act.

24. We also note that there currently are 182 cable antenna relay service (CARS) licensees.15 The Commission, however, neither requests nor collects information on whether CARS licensees are affiliated with entities whose gross annual revenues exceed $250 million. Although some CARS licensees may be affiliated with entities whose gross annual revenues exceed $250 million, we are unable at this time to estimate with greater precision the number of CARS licensees that would qualify as small cable operators under the definition in the Communications Act.

25. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements. The Report and Order eliminates rules that require certain broadcast and cable entities to maintain paper copies of sections of the Commission's regulations. Accordingly, the Report and Order does not impose any new reporting, recordkeeping, or other compliance requirements.

26. Because no commenter provided information specifically quantifying the costs and administrative burdens of complying with the existing recordkeeping requirements, we cannot precisely estimate the impact on small entities of eliminating them. The rule revisions adopted in the Order will afford all affected Commission regulatees, including small entities, greater flexibility in the manner by which they access and stay familiar with Commission rules governing their services. Additionally, as NAB notes, removing this obligation will also help small entities in particular to cut unnecessary costs related to maintaining updated paper copies of Commission rules.16 No party in the proceeding has opposed the proposals set forth in the NPRM. We thus find it reasonable to conclude that the benefits of eliminating the rules at issue outweigh any costs.

27. Steps Taken to Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered. The RFA requires an agency to describe any significant, specifically small business, alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.17

28. The Report and Order eliminates the obligation, imposed on certain broadcasters and cable regulatees, to maintain paper copies of Commission rules. Eliminating these requirements is intended to modernize the Commission's regulations and reduce costs and recordkeeping burdens for affected entities, include small entities. Under the revised rules, affected entities no longer will need to expend time and resources maintaining and updating hard copies of Commission rules, but rather, will be able to stay familiar with Commission rules by accessing those rules online. As noted, no party has opposed the rule revisions we adopt in the Order. Thus, we anticipate that affected small entities will benefit from such revisions.

29. Report to Congress. The Commission will send a copy of the Report and Order, including this FRFA, in a report to be sent to Congress pursuant to the Congressional Review Act.18 In addition, the Commission will send a copy of the Report and Order, including this FRFA, to the Chief Counsel for Advocacy of the SBA. A copy of the Report and Order and FRFA (or summaries thereof) will also be published in the Federal Register.

30. It is ordered that, pursuant to the authority found in sections 1, 4(i), and 4(j) of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), and 154(j), this Report and Order is hereby adopted.

31. It is further ordered that, pursuant to the authority found in sections 1, 4(i), and 4(j) of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), and 154(j), the Commission's rules are amended as set forth in Rules Appendix A of the Report and Order, effective as of the date of publication of a summary in the Federal Register.19

32. It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Report and Order, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

33. It is further ordered that the Commission shall send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

34. It is further ordered that, should no petitions for reconsideration or petitions for judicial review be timely filed, MB Docket No. 17-231 shall be terminated and its docket closed.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 74, 76 and 78 as follows:

Why is this rulemaking necessary?

This rulemaking is necessary because, by law, the migratory bird harvest season is closed unless opened by the Secretary of the Interior, and the regulations governing subsistence harvest of migratory birds in Alaska are subject to public review and annual approval. This rule establishes regulations for the taking of migratory birds for subsistence uses in Alaska during the spring and summer of 2018. This rule also sets forth a list of migratory bird season openings and closures in Alaska by region.

Background information, including past events leading to this rulemaking, accomplishments since the Migratory Bird Treaties with Canada and Mexico were amended, and a history, were originally addressed in the Federal Register on August 16, 2002 (67 FR 53511) and most recently on April 4, 2017 (82 FR 16298).

Recent Federal Register documents and all final rules setting forth the annual harvest regulations are available at http://www.fws.gov/alaska/ambcc/regulations.htm or by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

The U.S. Fish and Wildlife Service is establishing migratory bird subsistence-harvest regulations in Alaska for the 2018 season. These regulations allow for the continuation of customary and traditional subsistence uses of migratory birds in Alaska and prescribe regional information on when and where the harvesting of birds may occur. These regulations were developed under a co-management process involving the Service, the Alaska Department of Fish and Game, and Alaska Native representatives.

The Alaska Migratory Bird Co-management Council (Co-management Council) held meetings on April 5-6, 2017, to develop recommendations for changes that would take effect during the 2018 harvest season. The Co-management Council recommended no changes for the 2018 regulations.

On February 1, 2018, we published in the Federal Register a proposed rule (83 FR 4623) to amend 50 CFR part 92 to propose regulations for the 2018 spring and summer subsistence harvest of migratory birds in Alaska at subpart D, and to amend subpart C. We accepted public comments on the proposed rule for 30 days, ending March 5, 2018. A summary of the comments we received, and our responses to them, is provided below, under Summary of Comments and Responses.

This final rule contains no changes from the proposed regulation amendments published on February 1, 2018 (83 FR 4623).

Eligibility to harvest under the regulations established in 2003 was limited to permanent residents, regardless of race, in villages located within the Alaska Peninsula, Kodiak Archipelago, the Aleutian Islands, and in areas north and west of the Alaska Range (50 CFR 92.5). These geographical restrictions opened the initial migratory bird subsistence harvest to about 13 percent of Alaska residents. High-populated, roaded areas such as Anchorage, the Matanuska-Susitna and Fairbanks North Star boroughs, the Kenai Peninsula roaded area, the Gulf of Alaska roaded area, and Southeast Alaska were excluded from eligible subsistence harvest areas.

In response to petitions requesting inclusion in the harvest in 2004, we added 13 additional communities consistent with the criteria set forth at 50 CFR 92.5(c). These communities were Gulkana, Gakona, Tazlina, Copper Center, Mentasta Lake, Chitina, Chistochina, Tatitlek, Chenega, Port Graham, Nanwalek, Tyonek, and Hoonah, with a combined population of 2,766. In 2005, we added three additional communities for glaucous-winged gull egg gathering only in response to petitions requesting inclusion. These southeastern communities were Craig, Hydaburg, and Yakutat, with a combined population of 2,459, according to the latest census information at that time.

In 2007, we enacted the Alaska Department of Fish and Game's request to expand the Fairbanks North Star Borough excluded area to include the Central Interior area. This action excluded the following communities from participation in this harvest: Big Delta/Fort Greely, Healy, McKinley Park/Village, and Ferry, with a combined population of 2,812.

In 2012, we received a request from the Native Village of Eyak to include Cordova, Alaska, for a limited season that would legalize the traditional gathering of gull eggs and the hunting of waterfowl during spring. This request resulted in a new, limited harvest of spring waterfowl and gull eggs starting in 2014.

Under subpart C, General Regulations Governing Subsistence Harvest, we are amending § 92.22, the list of birds open to subsistence harvest, by adding emperor goose (Chen canagica) and by amending cackling goose to allow egg gathering. These changes were originally made in the 2017 regulations (82 FR 16298; April 4, 2017), but were mistakenly set to expire August 31, 2017. We intended these changes to subpart C to be permanent as emperor goose hunting would be based on the total bird index; therefore, we are setting them forth again in this rule to make them permanent. The Service, Alaska Department and Fish and Game, and the Native Caucus agreed to an emperor goose management plan designed to allow a sustainable subsistence harvest concurrent with population protection. If the emperor goose population falls below the level for which subsistence harvest is allowed, the emperor goose subsistence harvest season will be closed and the species removed from the list of permanent species allowed for harvest.

We have monitored subsistence harvest for the past 25 years through the use of household surveys in the most heavily used subsistence harvest areas, such as the Yukon-Kuskokwim Delta. In recent years, more intensive surveys combined with outreach efforts focused on species identification have been added to improve the accuracy of information gathered from regions still reporting some subsistence harvest of listed or candidate species.

Based on our monitoring of the migratory bird species and populations taken for subsistence, we find that this rule will provide for the preservation and maintenance of migratory bird stocks as required by the Migratory Bird Treaty Act (Act; 16 U.S.C. 703 et seq.). The Act's 16 U.S.C. 712(1) provision states that the Service, “is authorized to issue such regulations as may be necessary to assure that the taking of migratory birds and the collection of their eggs, by the indigenous inhabitants of the State of Alaska, shall be permitted for their own nutritional and other essential needs, as determined by the Secretary of the Interior, during seasons established so as to provide for the preservation and maintenance of stocks of migratory birds.” Communication and coordination between the Service, the Co-management Council, and the Pacific Flyway Council have allowed us to set harvest regulations to ensure the long-term viability of the migratory bird stocks. In addition, Alaska migratory bird subsistence harvest rates have continued to decline since the inception of the subsistence-harvest program, reducing concerns about the program's consistency with the preservation and maintenance of stocks of migratory birds.

As for the ensuring the conservation of Endangered Species Act (ESA; 16 U.S.C. 1531 et seq.) listed species, spectacled eiders (Somateria fischeri) and the Alaska-breeding population of Steller's eiders (Polysticta stelleri) are listed as threatened species. Their migration and breeding distribution overlap with areas where the spring and summer subsistence migratory bird hunt is open in Alaska. Both species are closed to hunting, although harvest surveys and Service documentation indicate both species are taken in several regions of Alaska. We have determined that this rule complies with the ESA (see Endangered Species Act Consideration discussion, below).

The Service has dual objectives and responsibilities for authorizing a subsistence harvest while protecting migratory birds and threatened species. Although these objectives continue to be challenging, they are not irreconcilable, provided that: (1) Regulations continue to protect threatened species, (2) measures to address documented threats are implemented, and (3) the subsistence community and other conservation partners commit to working together. With these dual objectives in mind, the Service, working with North Slope partners, developed measures in 2009 to further reduce the potential for shooting mortality or injury of closed species. These conservation measures included: (1) Increased waterfowl hunter outreach and community awareness through partnering with the North Slope Migratory Bird Task Force; and (2) continued enforcement of the migratory bird regulations that are protective of listed eiders.

This rule continues to focus on the North Slope from Utqiagvik (formerly known as Barrow) to Point Hope because Steller's eiders from the listed Alaska breeding population are known to breed and migrate there, and harvest survey data and direct observations indicate take during subsistence harvest has occurred there. These regulations are designed to address several ongoing eider-management needs by clarifying for subsistence users that (1) Service law enforcement personnel have authority to verify species of birds possessed by hunters, and (2) it is illegal to possess any species of bird closed to harvest. This rule also describes how the Service's existing authority of emergency closure will be implemented, if necessary, to protect Steller's eiders. We are always willing to discuss regulations with our partners on the North Slope to ensure protection of closed species while providing subsistence hunters an opportunity to maintain the culture and traditional migratory bird harvest of the community. These regulations pertaining to bag checks and possession of illegal birds are deemed necessary to monitor take of closed eider species during the subsistence hunt.

In collaboration with North Slope partners, a number of conservation efforts have been implemented to raise awareness and educate hunters in and around Utqiagvik on Steller's eider conservation via the local bird outreach festival, meetings, radio shows, signs, school visits, and one-on-one contacts. Limited intermittent monitoring on the North Slope, focused primarily at Utqiagvik, found no evidence that listed eiders were shot in 2009 through 2012; one Steller's eider and one spectacled eider were found shot during the summer of 2013; one Steller's eider was found shot in 2014; and no listed eiders were found shot in 2015 through 2017. Elsewhere in Alaska, one spectacled eider that appeared to have been shot was found dead on the Yukon-Kuskokwim Delta in 2015. The Service acknowledges progress made with the other eider conservation measures, including partnering with the North Slope Migratory Bird Task Force, for increased waterfowl-hunter awareness, continued enforcement of the regulations, and in-season verification of the harvest. To reduce the threat of shooting mortality of threatened eiders, we continue to work with North Slope partners to conduct education and outreach. In addition, the emergency-closure authority provides another level of assurance if an unexpected number of Steller's eiders are killed by shooting (50 CFR 92.21 and 50 CFR 92.32).

The longstanding general emergency-closure provision at 50 CFR 92.21 specifies that the harvest may be closed or temporarily suspended upon finding that a continuation of the regulation allowing the harvest would pose an imminent threat to the conservation of any migratory bird population. With regard to Steller's eiders, the regulations at 50 CFR 92.32, carried over from the past 7 years, clarify that we would take action under 50 CFR 92.21 as is necessary to prevent further take of Steller's eiders, and that action could include temporary or long-term closures of the harvest in all or a portion of the geographic area open to harvest. When and if mortality of threatened eiders is documented, we would evaluate each mortality event by criteria such as cause, quantity, sex, age, location, and date. We would consult with the Co-management Council when we are considering an emergency closure. If we determine that an emergency closure is necessary, we would design it to minimize its impact on the subsistence harvest.

Section 7 of the Endangered Species Act (16 U.S.C. 1536) requires the Secretary of the Interior to “review other programs administered by him and utilize such programs in furtherance of the purposes of the Act” and to “insure that any action authorized, funded, or carried out * * * is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of [critical] habitat. * * *” We conducted an intra-agency consultation with the Service's Fairbanks Fish and Wildlife Field Office on this harvest as it will be managed in accordance with this final rule and the conservation measures. The consultation was completed with a biological opinion dated March 2, 2018, that concluded the final rule and conservation measures are not likely to jeopardize the continued existence of Steller's and spectacled eiders or result in the destruction or adverse modification of designated critical habitat.

On February 1, 2018, we published in the Federal Register a proposed rule (83 FR 4623) to amend 50 CFR part 92 to establish regulations in Alaska for the 2018 subsistence season. We accepted public comments on the proposed rule for 30 days, ending March 5, 2018. We posted an announcement of the comment-period dates for the proposed rule, as well as the rule itself and related historical documents, on the Co-management Council's internet homepage. By facsimile (fax), we issued a press bulletin, announcing our request for public comments and the pertinent deadlines for such comments, to the media Statewide in Alaska. Additionally, we made all relevant documents available on http://www.regulations.gov. In response to the proposed rule, the Service received eight comments, but five of these did not address topics specific to our proposed rule. The three on-topic comments we received are below by topic. The comments are addressed below by topic.

Comment (1): We received one general comment that expressed opposition to the concept of allowing subsistence hunting of migratory birds in Alaska on the grounds that it sanctions the murdering of birds for food.

Service Response: For centuries, indigenous inhabitants of Alaska have harvested migratory birds for subsistence purposes during the spring and summer months. The Canada and Mexico migratory bird treaties were amended for the express purpose of allowing subsistence hunting for migratory birds during the spring and summer. The amendments indicate that the Service should issue regulations allowing such hunting as provided in the Migratory Bird Treaty Act; see 16 U.S.C. 712(1). See also Statutory Authority, below, for more details.

Comment (2): We received one general comment on the need for agencies to develop regulations in a manner consistent with the principles of Executive Order (E.O.) 13563.

Service Response: This rule complies with both E.O. 13563 and E.O. 12866. Details of our compliance are discussed under Regulatory Planning and Review (Executive Orders 12866 and 13563), below.

Comment (3): We received one comment opposing the addition of emperor geese, which the commenter refers to as a near threatened species, to subsistence hunting. The commenter also expressed concern over the lack of bag limits for hunting emperor geese, as the species is vulnerable to overharvest due to aspects of its natural history.

Service Response: Emperor geese were opened to subsistence harvest starting in April 2017; however, the new regulations were mistakenly set to expire August 31, 2017 (see 82 FR 16298; April 4, 2017). In this rule, we are publishing the same changes we made to the list of birds open for harvest in April 2017 to make them permanent, including the addition of emperor goose to the list. In the April 4, 2017 final rule, we provided justification for opening emperor geese to subsistence harvest, and to make this change permanent based on the total bird index. In summary, in September 2016, a Co-management Council emperor goose management plan was signed as a companion document to the 2016 revision of the Pacific Flyway management plan for the emperor goose. The Co-management Council's plan for the emperor goose establishes a population objective of 34,000 bird consistent with the population abundance achieved in 2016 (34,109) after about 30 years of hunting season closures. This equates to a total range-wide population size of about 177,000 geese based on current model estimates. The Co-management Council's plan allows for a customary and traditional subsistence harvest (i.e., no bag limits) when the Yukon-Kuskokwim Delta Coastal Zone Survey index equals or exceeds 28,000 geese, which equates to a total range-wide population size of about 145,000 geese. Should the population index decline below 28,000 geese, harvest restrictions will be considered to reduce the probability for a subsequent closed season. The harvest season will be closed if the population index declines below 23,000 emperor geese, which equates to a total range-wide population size of about 120,000 geese. The population index thresholds for hunting season restrictions (28,000) and closure (23,000) represent 82 percent and 68 percent of the population objective (34,000), respectively. The Alaska Native Caucus opposed bag limits during the spring-summer subsistence season. The Service, together with the Alaska Department of Fish and Game and the Co-management Council's Native Caucus, agreed to a harvest strategy that incorporated customary and traditional subsistence practices (i.e., no bag limits) but ensured the protection of the emperor goose population. The 2016 emperor goose population index was 34,109 (95% Confidence Interval = 29,229 − 38,989). The 2017 emperor goose population index was 30,087 (95% Confidence Interval = 26,108−34,066). The term of this harvest strategy is 5 years with agreement of an annual review during the first three years (2017-2019) following implementation to assess all data including population survey information, harvest survey data, and other relevant information to determine the need for conservation measures. Therefore, we are not making any changes to this rule in response to this comment.

We derive our authority to issue these regulations from the Migratory Bird Treaty Act of 1918, at 16 U.S.C. 712(1), which authorizes the Secretary of the Interior, in accordance with the treaties with Canada, Mexico, Japan, and Russia, to “issue such regulations as may be necessary to assure that the taking of migratory birds and the collection of their eggs, by the indigenous inhabitants of the State of Alaska, shall be permitted for their own nutritional and other essential needs, as determined by the Secretary of the Interior, during seasons established so as to provide for the preservation and maintenance of stocks of migratory birds.”

The amendments to subparts C and D of 50 CFR part 92 will take effect on April 2, 2018 (see DATES, above). If there were a delay in the effective date of these regulations after this final rulemaking, subsistence hunters would not be able to take full advantage of their subsistence hunting opportunities. We therefore find that “good cause” exists justifying the earlier start date, within the terms of 5 U.S.C. 553(d)(3) of the Administrative Procedure Act, and under authority of the Migratory Bird Treaty Act (July 3, 1918), as amended (16 U.S.C. 703 et seq.).

This rule is not subject to the requirements of Executive Order 13771 (82 FR 9339, February 3, 2017) because this rule establishes annual harvest limits related to routine hunting or fishing.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) will review all significant rules. OIRA has determined that this rule is not significant.

Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). A regulatory flexibility analysis is not required. Accordingly, a Small Entity Compliance Guide is not required. This rule legalizes a pre-existing subsistence activity, and the resources harvested will be consumed.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

(a) Will not have an annual effect on the economy of $100 million or more. It legalizes and regulates a traditional subsistence activity. It will not result in a substantial increase in subsistence harvest or a significant change in harvesting patterns. The commodities that will be regulated under this rule are migratory birds. This rule deals with legalizing the subsistence harvest of migratory birds and, as such, does not involve commodities traded in the marketplace. A small economic benefit from this rule derives from the sale of equipment and ammunition to carry out subsistence hunting. Most, if not all, businesses that sell hunting equipment in rural Alaska qualify as small businesses. We have no reason to believe that this rule will lead to a disproportionate distribution of benefits.

(b) Will not cause a major increase in costs or prices for consumers; individual industries; Federal, State, or local government agencies; or geographic regions. This rule does not deal with traded commodities and, therefore, will not have an impact on prices for consumers.

(c) Will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This rule deals with the harvesting of wildlife for personal consumption. It will not regulate the marketplace in any way to generate substantial effects on the economy or the ability of businesses to compete.

We have determined and certified under the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.) that this rule will not impose a cost of $100 million or more in any given year on local, State, or tribal governments or private entities. The rule will not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act is not required. Participation on regional management bodies and the Co-management Council requires travel expenses for some Alaska Native organizations and local governments. In addition, they assume some expenses related to coordinating involvement of village councils in the regulatory process. Total coordination and travel expenses for all Alaska Native organizations are estimated to be less than $300,000 per year. In a notice of decision (65 FR 16405; March 28, 2000), we identified 7 to 12 partner organizations (Alaska Native nonprofits and local governments) to administer the regional programs. The Alaska Department of Fish and Game also incurs expenses for travel to Co-management Council and regional management body meetings. In addition, the State of Alaska would be required to provide technical staff support to each of the regional management bodies and to the Co-management Council. Expenses for the State's involvement may exceed $100,000 per year, but should not exceed $150,000 per year. When funding permits, we make annual grant agreements available to the partner organizations and the Alaska Department of Fish and Game to help offset their expenses.

Under the criteria in Executive Order 12630, this rule will not have significant takings implications. This rule is not specific to particular land ownership, but applies to the harvesting of migratory bird resources throughout Alaska. A takings implication assessment is not required.

Under the criteria in Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. We discuss effects of this rule on the State of Alaska in the Unfunded Mandates Reform Act section, above. We worked with the State of Alaska to develop these regulations. Therefore, a federalism summary impact statement is not required.

The Department, in promulgating this rule, has determined that it will not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of Executive Order 12988.

Consistent with Executive Order 13175 (65 FR 67249; November 6, 2000), “Consultation and Coordination with Indian Tribal Governments,” and Department of Interior policy on Consultation with Indian Tribes (December 1, 2011), we sent letters via electronic mail to all 229 Alaska Federally recognized Indian tribes. Consistent with Congressional direction (Pub. L. 108-199, div. H, Sec. 161, Jan. 23, 2004, 118 Stat. 452, as amended by Pub. L. 108-447, div. H, title V, Sec. 518, Dec. 8, 2004, 118 Stat. 3267), we also sent letters to approximately 200 Alaska Native corporations and other tribal entities in Alaska soliciting their input as to whether or not they would like the Service to consult with them on the 2018 migratory bird subsistence harvest regulations.

We implemented the amended treaty with Canada with a focus on local involvement. The treaty calls for the creation of management bodies to ensure an effective and meaningful role for Alaska's indigenous inhabitants in the conservation of migratory birds. According to the Letter of Submittal, management bodies are to include Alaska Native, Federal, and State of Alaska representatives as equals. They develop recommendations for, among other things: seasons and bag limits, methods and means of take, law enforcement policies, population and harvest monitoring, education programs, research and use of traditional knowledge, and habitat protection. The management bodies involve village councils to the maximum extent possible in all aspects of management. To ensure maximum input at the village level, we required each of the 11 participating regions to create regional management bodies consisting of at least one representative from the participating villages. The regional management bodies meet twice annually to review and/or submit proposals to the Statewide body.

This rule does not contain any new collections of information that require Office of Management and Budget (OMB) approval under the PRA (44 U.S.C. 3501 et seq.). We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number. OMB has reviewed and approved our collection of information associated with:

• Voluntary annual household surveys that we use to determine levels of subsistence take (OMB Control Number 1018-0124, expires October 31, 2019).

• Permits associated with subsistence hunting (OMB Control Number 1018-0075, expires June 30, 2019).

• Emperor Goose Spring Subsistence Harvest Survey (to include number of geese harvested, age, sex, and mass of birds harvested associated) (OMB Control Number 1090-0011, expires August 31, 2018).

The annual regulations and options are considered in an October 2017 environmental assessment, “Managing Migratory Bird Subsistence Hunting in Alaska: Hunting Regulations for the 2018 Spring/Summer Harvest.” Copies are available from the person listed under FOR FURTHER INFORMATION CONTACT or at http://www.regulations.gov.

Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This is not a significant regulatory action under this Executive Order; it allows only for traditional subsistence harvest and improves conservation of migratory birds by allowing effective regulation of this harvest. Further, this rule is not expected to significantly affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action under Executive Order 13211, and a Statement of Energy Effects is not required.

For the reasons set out in the preamble, we amend title 50, chapter I, subchapter G, of the Code of Federal Regulations as follows: