Federal Register Vol. 82, No.134,

On June 9, 2017 (82 FR 26739), OSC published a final rule revising its regulations regarding the filing of complaints and disclosures with OSC and updating OSC's prohibited personnel practice provisions. This document indefinitely delays the effective date of that final rule.

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain CFM CFM56-3, -3B, and -3C turbofan engines. The NPRM published in the Federal Register on March 9, 2017 (82 FR 13077). The NPRM was prompted by a report of dual-engine LOTC that resulted in an air turn back. The NPRM proposed to require initial and repetitive checks of the VSV actuation system in the HPC. We are issuing this AD to maintain the actuators ability to fully reach commanded position, and prevent LOTC and reduced control of the airplane.

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

CFM, Boeing, Anonymous, and Jet2.com requested that the Applicability paragraph be limited to engines operating in the tropical regions specified in CFM Service Bulletin (SB) CFM56-3 S/B 72-1169, rather than fleet-wide. A change of applicability to specific regions would avoid unnecessary burden for operators that do not fly in tropical zones and do not fly less than 150 hours per month.

We disagree. Operators may experience high moisture environments outside of the specified tropical zone that is described in CFM SB CFM56-3 S/B 72-1169. Operators that are outside of the specified tropical zone have experienced restricted VSV movement events. We did not change this AD.

Milan Pavlovic requested that we include the CFM CFM56-3 Engine Shop Manual (ESM) 72-32-00 procedure for VSV pull force checks, as an acceptable method of compliance, in paragraph (f)(2) of this AD. The change is requested to allow the pull force check at the modular level, using the ESM procedure.

We partially agree. We agree that performing the pull force check of the VSV system per the ESM is acceptable. We disagree with including a statement in paragraph (f)(2) because paragraph (f)(2) does not refer to any service information.

Milan Pavlovic requested that we allow the replacement of an affected stator case with an HPC stator case (that passes the pull force check) in lieu of a repaired case. The proposed Compliance paragraph (f)(2)(i) states: “If any stage requires more than 100 lbs. force to move the actuation ring, ream the VSV bores and apply anti-corrosion coating to stage 1, 2 and 3, prior to further flight.” This statement is interpreted as incorporation of CFM CFM56-3 ESM 72-32-01, Repair 031 is the mandated action and therefore the only acceptable action to satisfy the AD compliance requirements. Would replacement of the stator case assembly with a serviceable stator case assembly, that has not had CFM CFM56-3 ESM 72-32-01, Repair 031 performed, be considered an acceptable alternate action providing the pull force check is performed on the replacement stator case assembly and is found to be less than 75 lbs. in each stage?

The commenter feels that replacement with a stator case that passes the pull force check is an additional action that would satisfy the AD requirements. The replacement case would be subject to the repetitive checks specified in paragraph (f)(3).

We partially agree. We disagree that using any specific service information to comply this AD is mandated. We agree that the installation of a replacement HPC stator case that passes the VSV pull force check with measurements of 75 lbs. or less is acceptable. We changed paragraph (f)(2)(i) of this AD accordingly.

CFM requested that we cite the latest revision date of CFM SB CFM56-3 S/B 72-1169, in the Service Information section.

We agree. The NPRM included an earlier revision date. This AD now references CFM SB CFM56-3 S/B 72-1169, Revision 01, dated November 4, 2016.

CFM requested that we refer to the latest revision of CFM CFM56-3 ESM 72-32-01, Repair 031, in the Service Information section. The latest CFM CFM56-3 ESM 72-32-01, Repair 031, revision is dated December 15, 2016.

We agree. The NPRM referenced an out of date ESM repair. This AD now references CFM CFM56-3 ESM 72-32-01, Repair 031, dated December 15, 2016.

CFM and Milan Pavlovic noted that early configurations of the CFM56-3 engines were released with titanium HPC stator cases, which are not susceptible to corrosion in VSV bores. An additional commenter asks if the AD should affect steel stator cases only. CFM recommends applicability be noted as CFM56-3 engines with steel HPC cases with P/Ns 1499M30G01, 1499M30G02, 1499M30G03, or 1676M88G01. CFM's experience indicates that the titanium HPC cases do not experience VSV bore corrosion, and therefore do not experience restricted VSV movement due to bore corrosion.

We agree. Titanium HPC cases do not experience restricted VSV movement due to VSV bore corrosion. We changed this AD to specify that it is applicable to CFM56-3, -3B, and -3C turbofan engines with steel HPC stator cases,P/Ns 1499M30G01, 1499M30G02, 1499M30G03, or 1676M88G01, installed.

CFM proposes that we change the language in the Discussion section to state that the VSV resistance due to the corrosion may lead to an inability of the actuator to fully reach commanded position. The description should more accurately describe the problem. VSV actuators do not fail due to corrosion, but do exhibit limited range of movement.

We agree. The statement of “failure of VSV actuators” is an incomplete description of the problem. We revised the Discussion section and paragraph (e) of this AD to clarify.

CFM requested that we change the Related Service Information section, which highlights that CFM SB CFM56-3 S/B 72-1169, Revision 01, dated November 4, 2016, describes a procedure to examine the VSV bore on the inside of the HPC case. While this is correct, CFM proposes that this section highlight that CFM SB CFM56-3 S/B 72-1169 describes a procedure to check the resistance of the VSV system as this portion of the SB is most relevant.

We agree. This AD requires a pull force check of VSV actuators. We changed the Related Service Information section to state that CFM SB CFM56-3 S/B 72-1169, Revision 01, dated November 4, 2016 describes a procedure to check the resistance of the VSV system.

Boeing recommends allowing a ferry flight instead of requiring repair prior to further flight, if a pull force check exceeds 100 lb on one engine. They stated that a ferry flight should be allowed if take-off rated thrust can be achieved during a ground run, and the sister engine is within SB VSV pull force limits.

We partially agree. We agree with allowing special flight permits because a dual engine LOTC due to VSV restricted movement is unlikely to occur if the sister engine is within the pull force limit. We disagree with changing this AD, because as written, this AD does not limit or prohibit special flight permits. Special flight permits are allowed under 14 CFR 39.23. We did not change this AD.

A commenter asked why the Bahrain region is not listed as an affected zone for applicability of CFM SB CFM56-3S/B 72-1169, Revision 01, dated November 4, 2016. The commenter stated that regions other than tropical climate zones listed in the SB may also expose an engine to humid environments.

We agree. We recognize that operation in more than one climate zone may contribute to VSV bore corrosion. However, this AD is applicable to all CFM56-3, -3B, and -3C turbofan engines with a steel HPC stator case, part numbers (P/Ns) 1499M30G01, 1499M30G02, 1499M30G03, or 1676M88G01, installed, regardless of their operating environment. We did not change this AD.

The Air Line Pilots Association expressed support for the NPRM as written.

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

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

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

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

We reviewed CFM SB CFM56-3 S/B 72-1169, Revision 01, dated November 4, 2016. This SB describes a procedure to check the resistance of the VSV system. We also reviewed CFM CFM56-3 ESM 72-32-01, Repair 031, dated December 15, 2016. This ESM repair describes procedures for reaming and applying anti-corrosion paint to the VSV bores.

We estimate that this AD affects 460 engines installed on airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

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

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

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

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

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and

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

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class D airspace at North Texas Regional Airport/Perrin Field, Sherman, TX; Class E airspace designated as a surface area at Draughon-Miller Central Texas Regional Airport, Temple, TX; Class E airspace extending upward from 700 feet above the surface at North Texas Regional Airport/Perrin Field and Draughon-Miller Central Texas Regional Airport; and establishes Class E airspace designated as an extension at Draughon-Miller Central Texas Regional Airport, in support IFR operations at these airports.

On April 20, 2017, the FAA published in the Federal Register (82 FR 18596) Docket No. FAA-2016-9544, a notice of proposed rulemaking (NPRM) to amend Class D airspace at North Texas Regional Airport/Perrin Field, Sherman, TX; amend Class E airspace designated as a surface area at Draughon-Miller Central Texas Regional Airport, Temple, TX; amend Class E airspace extending upward from 700 feet above the surface at North Texas Regional Airport/Perrin Field and Draughon-Miller Central Texas Regional Airport; and establish Class E airspace designated as an extension at Draughon-Miller Central Texas Regional Airport. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class D and E airspace designations are published in paragraph 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies:

Class D airspace within a 4.7-mile radius (reduced from a 5.0-mile radius) at North Texas Regional Airport/Perrin Field (formerly Grayson County Airport), Sherman/Denison, TX, and updates the name of the airport to coincide with the FAA's aeronautical database;

Class E airspace designated as a surface area within a 4.2-mile radius (increased from a 4.1-mile radius) at Draughon-Miller Central Texas Regional Airport (formerly Draughon-Miller Municipal Airport), Temple, TX, eliminating the extension southeast of the airport, and updates the name and geographic coordinates of the airport to coincide with the FAA's aeronautical database;

Class E airspace extending upward from 700 feet above the surface:

Within a 7.2-mile radius (increased from a 6.9-mile radius) of North Texas Regional Airport/Perrin Field (formerly Grayson County Airport), Sherman/Denison, TX, and updates the name and geographic coordinates of the airport to coincide with the FAA's aeronautical database;

Within a 6.7-mile radius of Draughon-Miller Central Texas Regional Airport (formerly Draughon-Miller Municipal Airport), Temple, TX, eliminates the extensions north and southeast of the airport, amends the extension northwest of the airport from the 6.7-mile radius to 14.4 miles (reduced from 19.5 miles), adds an extension south of the airport from the 6.7-mile radius to 10.1 miles, adds an extension southwest of the airport from the 6.7-mile radius to 9.7 miles, and updates the name and geographic coordinates of the airport and the name of the Draughon-Miller Central Texas Regional Localizer (formerly Draughon-Miller Localizer) to coincide with the FAA's aeronautical database;

And establishes Class E airspace designated as an extension to Class E surface airspace within a 4.2-mile radius of Draughon-Miller Central Texas Regional Airport, Temple, TX, with an extension southeast 7.7 miles.

Cancellation of standard instrument approach procedures at these airports prompted the FAA to conduct a review of the airspace. Controlled airspace is necessary for the safety and management of standard instrument approach procedures for IFR operations at these airports.

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

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

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

Background

Pursuant to the provisions of the 1970 United Nations Educational, Scientific and Cultural Organization (UNESCO) Convention, codified into U.S. law as the Convention on Cultural Property Implementation Act (hereinafter, “the Cultural Property Implementation Act” or “the Act”) (Pub. L. 97-446, 19 U.S.C. 2601 et seq.), the United States entered into a bilateral agreement with the Republic of Cyprus on July 16, 2002, to impose import restrictions on certain archaeological materials representing the Pre-Classical and Classical periods ranging in date from approximately the 8th Millennium B.C. to approximately 330 A.D. of Cyprus (“the 2002 Agreement”). On July 19, 2002, the former United States Customs Service (U.S. Customs and Border Protection's predecessor agency) published Treasury Decision (T.D.) 02-37 in the Federal Register (67 FR 47447), which amended 19 CFR 12.104g(a) to reflect the imposition of these restrictions and included a list designating the types of articles covered by the restrictions. These restrictions were to be effective through July 16, 2007.

On August 17, 2006, the Republic of Cyprus and the United States amended the 2002 Agreement (covering Pre-Classical and Classical archeological materials) to include a list of Byzantine ecclesiastical and ritual ethnological materials dating from approximately the 4th century A.D. through approximately the 15th century A.D. that had been (and, at that time, were still) protected pursuant to an emergency action which was published in the Federal Register (64 FR 17529) on April 12, 1999. The amendment of the 2002 Agreement to cover both the archaeological materials and the ethnological materials was reflected in CBP Dec. 06-22, which was published in the Federal Register (71 FR 51724) on August 31, 2006. CBP Dec. 06-22 contains the list of Byzantine ecclesiastical and ritual ethnological materials from Cyprus previously protected pursuant to the emergency action and announced that import restrictions, as of August 31, 2006, were imposed on this cultural property pursuant to the amended Agreement (19 U.S.C. 2603(c)(4)). Thus, as of that date, the import restrictions covering materials described in CBP Dec. 06-22 were set to be effective through July 16, 2007.

On July 13, 2007, CBP published CBP Dec. 07-52 in the Federal Register (72 FR 38470) which further extended the import restrictions to July 16, 2012. The Designated List was published with this decision.

On July 13, 2012, CBP published CBP Dec. 12-13 in the Federal Register (77 FR 41266), effective on July 16, 2012, amending CBP regulations to reflect the extension of import restrictions and also to cover Post-Byzantine ecclesiastical and ritual ethnological materials ranging from approximately 1500 A.D. to approximately 1850 A.D. of Cyprus. The amended Designated List was published with the decision in CBP Dec. 12-13, which includes the unrevised list of covered archaeological objects, as well as Byzantine and post-Byzantine ecclesiastical and ritual ethnological materials. The import restrictions are due to expire on July 16, 2017.

On August 1, 2012, CBP published a correcting amendment to CBP Dec. 12-13 in the Federal Register (77 FR 45479) as the amended Designated List and the regulatory text in that document contained language which was inadvertently not consistent with the rest of the document as to the historical period that the import restrictions cover for ecclesiastical and ritual ethnological materials from Cyprus.

Import restrictions listed in the Code of Federal Regulations (CFR) at 19 CFR 12.104g(a) are effective for no more than five years beginning on the date on which the agreement enters into force with respect to the United States. This period may be extended for additional periods of not more than five years if it is determined that the factors which justified the initial agreement still pertain and no cause for suspension of the agreement exists. (19 CFR 12.104g(a)).

On July 12, 2016, the Department of State received a request by the Republic of Cyprus to extend the Agreement. The Department of State proposed to extend the import restrictions for an additional five years in a notice published in the Federal Register (81 FR 52946) on August 10, 2016. On March 22, 2017, the Assistant Secretary for Educational and Cultural Affairs, State Department, after consultation with and recommendations by the Cultural Property Advisory Committee, determined that the cultural heritage of Cyprus continues to be in jeopardy from pillage of certain archaeological objects and certain ethnological materials and that the import restrictions should be extended for an additional five-year period to July 16, 2022. Diplomatic notes have been exchanged reflecting the extension of those restrictions for an additional five-year period. Accordingly, CBP is amending 19 CFR 12.104g(a) to reflect the extension of the import restrictions.

The Amended Designated List of archaeological objects and Byzantine and post-Byzantine ecclesiastical and ritual ethnological materials is set forth in CBP Dec. 12-13. The herein mentioned Agreements and the Designated List and amended Designated Lists may be found at the following Web site address: https://eca.state.gov/cultural-heritage-center/cultural-property-protection/bilateral-agreements by clicking on “Cyprus.”

The restrictions on the importation of these archaeological, and ecclesiastical and ritual ethnological materials from Cyprus are to continue in effect through July 16, 2022. Importation of such materials from Cyprus continues to be restricted through that date unless the conditions set forth in 19 U.S.C. 2606 and 19 CFR 12.104c are met.

This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure under 5 U.S.C. 553(a)(1). In addition, CBP has determined that such notice or public procedure would be impracticable and contrary to the public interest because the action being taken is essential to avoid interruption of the application of the existing import restrictions (5 U.S.C. 553(b)(B)). For the same reason, a delayed effective date is not required under 5 U.S.C. 553(d)(3).

Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply.

Because this rule involves a foreign affairs function of the United States, it is not subject to either Executive Order 12866 or Executive Order 13771.

This regulation is being issued in accordance with 19 CFR 0.1(a)(1).

For the reasons set forth above, part 12 of title 19 of the Code of Federal Regulations (19 CFR part 12), is amended as set forth below:

Legal Authority

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

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

Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of his intention to temporarily place a substance into Schedule I of the CSA.2 The Administrator transmitted the notice of intent to place acryl fentanyl into Schedule I on a temporary basis to the Assistant Secretary by letter dated April 17, 2017. The Assistant Secretary responded to this notice by letter dated May 2, 2017, and advised that based on review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications or approved new drug applications for acryl fentanyl. The Assistant Secretary also stated that the HHS has no objection to the temporary placement of acryl fentanyl into Schedule I of the CSA. The DEA has taken into consideration the Assistant Secretary's comments as required by 21 U.S.C. 811(h)(4). Acryl fentanyl is not currently listed in any schedule under the CSA, and no exemptions or approvals are in effect for acryl fentanyl under section 505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of acryl fentanyl in Schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety, and as required by 21 U.S.C. 811(h)(1)(A), a notice of intent to issue a temporary order to schedule acryl fentanyl was published in the Federal Register on June 2, 2017. 82 FR 25564.

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

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

Available data and information for acryl fentanyl, summarized below, indicate that this synthetic opioid has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. The DEA's three-factor analysis, and the Assistant Secretary's May 2, 2017, letter, are available in their entirety under the tab “Supporting Documents” of the public docket of this action at www.regulations.gov under FDMS Docket ID: DEA-2017-0005 (Docket Number DEA-460).

The recreational abuse of fentanyl-like substances continues to be a significant concern. These substances are distributed to users, often with unpredictable outcomes. Acryl fentanyl has recently been encountered by law enforcement and public health officials and the adverse health effects and outcomes are demonstrated by fatal overdose cases. The documented negative effects of acryl fentanyl are consistent with those of other opioids.

On October 1, 2014, the DEA implemented STARLiMS (a web-based, commercial laboratory information management system) to replace the System to Retrieve Information from Drug Evidence (STRIDE) as its laboratory drug evidence data system of record. DEA laboratory data submitted after September 30, 2014, are reposited in STARLiMS. Data from STRIDE and STARLiMS were queried on May 5, 2017. STARLiMS registered 36 reports containing acryl fentanyl, from Alabama, Connecticut, Illinois, Indiana, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, South Carolina, Tennessee, Texas, and West Virginia. According to STARLiMS, the first laboratory submission of acryl fentanyl occurred in July 2016 in Texas.

The National Forensic Laboratory Information System (NFLIS) is a national drug forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by other federal, state and local forensic laboratories across the country. NFLIS registered 74 reports containing acryl fentanyl from state or local forensic laboratories in Arkansas, California, Connecticut, Iowa, Kentucky, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin (query date: May 5, 2017).3 The first report of acryl fentanyl was reported in Wisconsin in May 2016. The DEA is not aware of any laboratory identifications of acryl fentanyl prior to 2016.

Evidence suggests that the pattern of abuse of fentanyl analogues, including acryl fentanyl, parallels that of heroin and prescription opioid analgesics. Seizures of acryl fentanyl have been encountered in powder form, in solution, and packaged similar to that of heroin. Acryl fentanyl has been encountered as a single substance as well as in combination with other substances of abuse, including heroin, fentanyl, 4-fluoroisobutyryl fentanyl, and furanyl fentanyl. Acryl fentanyl has been connected to fatal overdoses, in which insufflation and intravenous routes of administration were documented.

Reports collected by the DEA demonstrate acryl fentanyl is being abused for its opioid properties. This abuse of acryl fentanyl has resulted in morbidity and mortality (see DEA 3-Factor Analysis for full discussion). The DEA has received reports for at least 83 confirmed fatalities associated with acryl fentanyl. Information on these deaths, occurring as early as September 2016, was collected by the DEA from post-mortem toxicology and medical examiner reports. These deaths were reported from, and occurred in, Illinois (27), Maryland (22), New Jersey (1), Ohio (31), and Pennsylvania (2). NFLIS and STARLiMS have a total of 110 drug reports in which acryl fentanyl was identified in drug exhibits submitted to forensic laboratories in 2016 and 2017 from law enforcement encounters in Alabama, Arkansas, California, Connecticut, Illinois, Indiana, Iowa, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, West Virginia, and Wisconsin. It is likely that the prevalence of acryl fentanyl in opioid analgesic-related emergency room admissions and deaths is underreported as standard immunoassays may not differentiate this substance from fentanyl.

The population likely to abuse acryl fentanyl overlaps with the population abusing prescription opioid analgesics, heroin, fentanyl, and other fentanyl-related substances. This is evidenced by the routes of drug administration and drug use history documented in acryl fentanyl fatal overdose cases and encounters of the substance by law enforcement officials. Because abusers of acryl fentanyl are likely to obtain this substance through unregulated sources, the identity, purity, and quantity are uncertain and inconsistent, thus posing significant adverse health risks to the end user. Individuals who initiate (i.e., use a drug for the first time) acryl fentanyl abuse are likely to be at risk of developing substance use disorder, overdose, and death similar to that of other opioid analgesics (e.g., fentanyl, morphine, etc.).

Acryl fentanyl exhibits pharmacological profiles similar to that of fentanyl and other µ-opioid receptor agonists. The toxic effects of acryl fentanyl in humans are demonstrated by overdose fatalities involving this substance. Abusers of acryl fentanyl may not know the origin, identity, or purity of this substance, thus posing significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone.

Based on information reviewed by the DEA, the misuse and abuse of acryl fentanyl leads to the same qualitative public health risks as heroin, fentanyl and other opioid analgesic substances. As with any non-medically approved opioid, the health and safety risks for users are high. The public health risks attendant to the abuse of heroin and opioid analgesics are well established and have resulted in large numbers of drug treatment admissions, emergency department visits, and fatal overdoses.

Acryl fentanyl has been associated with numerous fatalities. At least 83 confirmed overdose deaths involving acryl fentanyl abuse have been reported from Illinois, Maryland, New Jersey, Ohio, and Pennsylvania in 2016 and 2017. As the data demonstrates, the potential for fatal and non-fatal overdoses exists for acryl fentanyl; thus, acryl fentanyl poses an imminent hazard to the public safety.

In accordance with 21 U.S.C. 811(h)(3), based on the data and information summarized above, the continued uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of acryl fentanyl pose an imminent hazard to the public safety. The DEA is not aware of any currently accepted medical uses for this substance in treatment in the United States. A substance meeting the statutory requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed into Schedule I. Substances in Schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for acryl fentanyl indicate that this substance has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. As required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through a letter dated April 17, 2017, notified the Assistant Secretary of the DEA's intention to temporarily place this substance into Schedule I. A notice of intent was subsequently published in the Federal Register on June 2, 2017. 82 FR 25564.

In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, herein sets forth the grounds for his determination that it is necessary to temporarily schedule acryl fentanyl into Schedule I of the CSA, and finds that placement of this synthetic opioid into Schedule I of the CSA is necessary to avoid an imminent hazard to the public safety.

Because the Administrator hereby finds it necessary to temporarily place this synthetic opioid into Schedule I to avoid an imminent hazard to the public safety, this temporary order scheduling acryl fentanyl will be effective on the date of publication in the Federal Register, and will be in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular (permanent) scheduling process. 21 U.S.C. 811(h)(1) and (2).

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

Upon the effective date of this temporary order, acryl fentanyl will become subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, engagement in research, and conduct of instructional activities or chemical analysis with, and possession of Schedule I controlled substances including the following:

1. Registration. Any person who handles (manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses), or who desires to handle, acryl fentanyl must be registered with the DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21 CFR parts 1301 and 1312, as of July 14, 2017. Any person who currently handles acryl fentanyl, and is not registered with the DEA, must submit an application for registration and may not continue to handle acryl fentanyl as of July 14, 2017, unless the DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312. Retail sales of Schedule I controlled substances to the general public are not allowed under the CSA. Possession of any quantity of this substance in a manner not authorized by the CSA on or after July 14, 2017 is unlawful and those in possession of any quantity of this substance may be subject to prosecution pursuant to the CSA.

2. Disposal of stocks. Any person who does not desire or is not able to obtain a Schedule I registration to handle acryl fentanyl, must surrender all quantities of currently held acryl fentanyl.

3. Security. Acryl fentanyl is subject to Schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of July 14, 2017.

4. Labeling and packaging. All labels, labeling, and packaging for commercial containers of acryl fentanyl must be in compliance with 21 U.S.C. 825, 958(e), and be in accordance with 21 CFR part 1302. Current DEA registrants shall have 30 calendar days from July 14, 2017, to comply with all labeling and packaging requirements.

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

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

7. Reports. All DEA registrants who manufacture or distribute acryl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312 as of July 14, 2017.

8. Order Forms. All DEA registrants who distribute acryl fentanyl must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of July 14, 2017.

9. Importation and Exportation. All importation and exportation of acryl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, 958, and in accordance with 21 CFR part 1312 as of July 14, 2017.

10. Quota. Only DEA registered manufacturers may manufacture acryl fentanyl in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303 as of July 14, 2017.

11. Liability. Any activity involving acryl fentanyl not authorized by, or in violation of the CSA, occurring as of July 14, 2017, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

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

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

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

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

This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

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

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

The Controlled Substances Act (CSA) gives the Attorney General the authority to specify, by regulation, chemicals as list I or list II chemicals. 21 U.S.C. 802 (34) and (35). A “list I chemical” is a chemical that is used in manufacturing a controlled substance in violation of title II of the CSA, and is important to the manufacture of the controlled substance. 21 U.S.C. 802(34). A “list II chemical” is a chemical (other than a list I chemical) that is used in manufacturing a controlled substance in violation of title II of the CSA. 21 U.S.C. 802(35). The current list of all listed chemicals is published at 21 CFR 1310.02. Pursuant to 28 CFR 0.100(b), the Attorney General has delegated his authority to designate list I and list II chemicals to the Administrator of the Drug Enforcement Administration.

In addition, the United States is a Party to the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988 Convention). When the United States receives notification that a chemical has been added to Table I or Table II of the 1988 Convention pursuant to article 12, the United States is required to take measures it deems appropriate to monitor the manufacture and distribution of that chemical within the United States and to prevent its diversion. In addition, the 1988 Convention requires the United States to take other specified measures related to that chemical, including measures related to its international trade.

By a letter dated April 9, 2014, the Secretary-General of the United Nations informed the United States Government that the chemical alpha-phenylacetoacetonitrile (APAAN) was added to Table I of the 1988 Convention. This letter was prompted by a March 19, 2014, decision at the 57th Session of the United Nations Commission on Narcotic Drugs (CND) to add APAAN to Table I. As a Party to the 1988 Convention, the United States is obligated, pursuant to article 12, to take measures it deems appropriate to monitor the manufacture and distribution of APAAN within the United States and to prevent its diversion. Article 12 also obligates the United States to take other specified measures related to APAAN, including measures related to its international trade. By designating APAAN, which is a primary precursor for the manufacture of phenylacetone (also known as phenyl-2-propanone (P2P) or benzyl methyl ketone), methamphetamine, and amphetamine, as a list I chemical, the United States will fulfill its obligations under the 1988 Convention.

On December 12, 2016, DEA published a Notice of Proposed Rulemaking (NPRM) proposing control of APAAN, due to its use in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine. 81 FR 89402. In response to the NPRM, only one comment was received. This comment was supportive of the DEA's proposed control of APAAN. As such, this rulemaking finalizes the control of APAAN as a list I chemical.

On the effective date of this final rule, handlers of APAAN shall be subject to the chemical regulatory provisions of the CSA, including 21 CFR parts 1309, 1310, 1313, and 1316. Since even a small amount of APAAN can make a significant amount of P2P, this action does not establish a threshold for domestic and import transactions of APAAN in accordance with the provisions of 21 CFR 1310.04(g). Therefore, all APAAN transactions, regardless of size, will be regulated transactions as defined in 21 CFR 1300.02(b). As such, all APAAN transactions will be subject to recordkeeping, reporting, import and export controls, and other CSA chemical regulatory requirements. In addition, each regulated bulk manufacturer shall submit manufacturing, inventory, and use data on an annual basis.

Under this final rulemaking, chemical mixtures containing APAAN shall not be exempt from regulatory requirements at any concentration, unless an application for exemption of a chemical mixture is submitted by an APAAN manufacturer, and the application is reviewed and accepted and the mixture exempted by the DEA under 21 CFR 1310.13. Therefore, all chemical mixtures containing any quantity of APAAN shall be subject to CSA control, unless the APAAN manufacturer is granted an exemption by the application process in accordance with 21 CFR 1310.13. This rule modifies the “Table of Concentration Limits” in 21 CFR 1310.12(c) to reflect the fact that chemical mixtures containing any amount of APAAN are subject to CSA chemical control provisions.

The DEA has implemented an application process to exempt certain chemical mixtures from the requirements of the CSA and its implementing regulations. 21 CFR 1310.13. Manufacturers may submit an application for exemption for those mixtures that do not qualify for automatic exemption. Exemption status may be granted if the DEA determines that the mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance, and that the listed chemical or chemicals cannot be readily recovered. 21 CFR 1310.13(a)(1)-(2).

The designation of APAAN as a list I chemical shall subject APAAN handlers (manufacturers, distributors, importers, and exporters) to all of the regulatory controls and administrative, civil, and criminal actions applicable to the manufacture, distribution, importing, and exporting of a list I chemical. Upon publication of this final rule, persons handling APAAN, including regulated chemical mixtures containing APAAN, shall be required to comply with the following list I chemical regulations:

1. Registration. Any person who manufactures, distributes, imports, or exports APAAN, or proposes to engage in the manufacture, distribution, importation, or exportation of APAAN, must obtain a registration pursuant to 21 U.S.C. 822, 823, 957, 958. Regulations describing registration for list I chemical handlers are set forth in 21 CFR part 1309.

Upon publication of this final rule, any person manufacturing, distributing, importing, or exporting APAAN or a chemical mixture containing APAAN will become subject to the registration requirement under the CSA. The DEA recognizes, however, that it is not possible for persons who are subject to the registration requirement to immediately complete and submit an application for registration and for the DEA to immediately issue registrations for those activities. Therefore, to allow continued legitimate commerce in APAAN, the DEA is establishing in 21 CFR 1310.09, a temporary exemption from the registration requirement for persons desiring to engage in activities with APAAN, provided that the DEA receives a properly completed application for registration or exemption of a chemical mixture on or before August 14, 2017. The temporary exemption for such persons will remain in effect until the DEA takes final action on their application for registration or application for exemption of a chemical mixture.

The temporary exemption applies solely to the registration requirement; all other chemical control requirements, including recordkeeping and reporting, would become effective on the effective date of this final rule. Therefore, all transactions of APAAN and chemical mixtures containing APAAN will be regulated while an application for registration or exemption is pending. This is necessary because not regulating these transactions could result in increased diversion of chemicals desirable to drug traffickers.

Additionally, the temporary exemption does not suspend applicable federal criminal laws relating to APAAN, nor does it supersede State or local laws or regulations. All handlers of APAAN must comply with applicable State and local requirements in addition to the CSA regulatory controls.

2. Records and Reports. Every DEA registrant must maintain records and reports with respect to APAAN pursuant to 21 U.S.C. 830 and in accordance with 21 CFR part 1310. Pursuant to 21 CFR 1310.04, a record must be made and maintained for two years after the date of a transaction involving a listed chemical, provided the transaction is a regulated transaction.

Each regulated bulk manufacturer of a listed chemical must submit manufacturing, inventory, and use data on an annual basis. 21 CFR 1310.05(d). Existing standard industry reports containing the required information will be acceptable, provided the information is separate or readily retrievable from the report.

21 CFR 1310.05(a) requires that each regulated person shall report to the DEA any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of the CSA and its corresponding regulations. Regulated persons are also required to report any proposed regulated transaction with a person whose description or other identifying characteristic the Administration has previously furnished to the regulated person; any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person; any in-transit loss in which the regulated person is the supplier; and any domestic regulated transaction in a tableting or encapsulating machine.

3. Importation and Exportation. All importation and exportation of APAAN must comply with 21 U.S.C. 957, 958, and 971 and be in accordance with 21 CFR part 1313.

4. Security. All applicants and registrants must provide effective controls against theft and diversion in accordance with 21 CFR 1309.71-1309.73.

5. Administrative Inspection. Places, including factories, warehouses, or other establishments and conveyances, where registrants or other regulated persons may lawfully hold, manufacture, distribute, or otherwise dispose of a list I chemical or where records relating to those activities are maintained, are controlled premises as defined in 21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA (21 U.S.C. 880) allows for administrative inspections of these controlled premises as provided in 21 CFR part 1316, subpart A.

6. Liability. Any activity involving APAAN not authorized by, or in violation of, the CSA, will be unlawful, and may subject the person to administrative, civil, and/or criminal action.

This final rulemaking, which adds APAAN as a list I chemical, has been developed in accordance with the principles of Executive Orders 12866 and 13563. The DEA followed the principles of these Executive Orders, even though it has been determined that this action is not a significant regulatory action.

To determine whether this action is a significant regulatory action, the DEA utilized a least cost option analysis. At the outset, the DEA determined that the primary costs of this rule would come from complying with the registration, recordkeeping, reporting, and export and import requirements set forth in the CSA. Therefore, under the least cost option, an entity would choose to discontinue the sale of APAAN if proceeds from the sale are less than the cost of complying with the rule.

The DEA has not identified any industrial uses of APAAN by domestic entities and its potential usage appears to be limited to research. Based on independent research following a 2013 United Nations Questionnaire/Survey on APAAN, the DEA identified three entities that have each imported APAAN. Two of the three entities had average annual sales of APAAN totaling $13 during the analysis period. The third entity had average annual sales of APAAN totaling $1,440 during the same period. Other chemical distributors list APAAN in their chemical catalogs. However, these entities do not manufacture APAAN, instead opting to purchase APAAN from international sources to fill special orders. These entities do not stock APAAN in inventory and the vast majority had no previous sales of APAAN.

The registration fee for importers of a list I chemical is $1,523 per year. Based on the least cost option, these three entities would choose to discontinue the sale of APAAN because complying with the rule is more costly. Thus, the annual economic impact of the rule is $1,467 (total annual sales of APAAN from the three affected entities). Therefore, this is evidence that this rule will not have an annual effect on the economy of $100 million or more and is not a significant regulatory action.

Executive Order 13771, titled “Reducing Regulation and Controlling Regulatory Costs,” was issued on January 30, 2017 and published in the Federal Register on February 3, 2017. 82 FR 9339. Section 2(a) of Executive Order 13771 requires an agency, unless prohibited by law, to identify at least two existing regulations to be repealed when the agency publicly proposes for notice and comment or otherwise promulgates a new regulation. In furtherance of this requirement, section 2(c) of Executive Order 13771 requires that the new incremental costs associated with new regulations, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations. The interim guidance from the Office of Management and Budget (OMB), issued on February 2, 2017, explains that for Fiscal Year 2017 the above requirements only apply to each new “significant regulatory action that imposes costs.” Because the DEA has determined that this final rulemaking is not a “significant regulatory action,” the requirements of Executive Order 13771 have not been triggered.

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

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

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

The Acting Administrator, in accordance with the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, has reviewed this rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. The purpose of this rule is to designate APAAN as a list I chemical under the CSA. No less restrictive measures (i.e., non-control or control in list II) would enable the DEA to meet its statutory obligation under the CSA and its international obligations of the 1988 Convention. The DEA estimates that this rule affects three small entities. As discussed above, the DEA compared the dollar value of APAAN sales to the cost of registration. Further, the DEA assumed that if the cost of registration is more than the dollar value of APAAN sales, then each entity would discontinue the sale of APAAN.

Two entities earned $13 in annual sales of APAAN while the third entity earned $1,440 in annual sales of APAAN. The cost of registration alone is $1,523 for each entity. Therefore, the DEA anticipates that each entity will discontinue the sale of APAAN because the cost of compliance is greater than the annual sales. As a result, the annual economic impact of the rule is $1,467.

Using 1% of annual revenue as the criteria for significant economic impact, the DEA estimates that none of the three small entities will experience a significant economic impact. The cost of the rule as a percentage of annual revenue for the three entities is, 0.00044%, 0.00036%, and 0.038%, respectively, which is less than 1% of the entities' annual income. Therefore, the rule will not have a significant effect on a substantial number of small entities.

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

This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. The DEA does not anticipate that it will receive new registration applications for the purpose of engaging in transactions involving this chemical. The transactions in this chemical of which the DEA is aware are very small, and it does not appear to the DEA that it would be economically justifiable because DEA believes there is no legitimate market for manufacturing or engaging in commercial transactions in this chemical. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100 million or more. It will not cause a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of the United States-based companies to compete with foreign based companies in domestic and export markets. However, the DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.

Accordingly, for the reasons set forth in the preamble, part 1310 of title 21 of the Code of Federal Regulations is amended as follows:

On July 29, 2016, HOTMA was signed into law (Pub. L. 114-201, 130 Stat. 782). HOTMA made numerous changes to statutes that govern HUD programs, including section 8 of the United States Housing Act of 1937 (1937 Act) (42 U.S.C. 1437f). HUD issued a notice on October 24, 2016, at 81 FR 73030, announcing to the public which of the statutory changes made by HOTMA could be implemented immediately, and which statutory changes required further guidance from HUD before owners, public housing agencies (PHAs), or other grantees may use the new statutory provisions.

On January 18, 2017, HUD published a second document at 82 FR 5458, making multiple HOTMA provisions impacting the HCV program effective and requesting comments. Several of the comments pointed out the need for technical corrections or clarifications to the January 18, 2017, implementation document. This document makes several technical corrections and clarifications to the January 18, 2017, implementation document, in part based on the public comments. HUD also received comments recommending changes that were not technical corrections or clarifications, but rather suggested alternative approaches to implementing the HOTMA provisions. HUD will take those comments under consideration.

HOTMA amended section 8(o) of the 1937 Act to provide a statutory definition of units owned by a PHA, overriding the regulatory definitions at 24 CFR 983.3 and 24 CFR 982.352. HOTMA establishes three categories under which a project is PHA-owned. A project is PHA-owned when the project is: (1) Owned by the PHA; (2) owned by an entity wholly controlled by the PHA; or (3) owned by a limited liability company (LLC) or limited partnership in which the PHA (or an entity wholly controlled by the PHA) holds a controlling interest in the managing member or general partner. The January 18, 2017, implementation document (page 5463, section B), used the phrase “50 percent or more” to define a level of control that constitutes a controlling interest and would thus indicate PHA ownership. The threshold for control should be “more than 50 percent” rather than “50 percent or more.”

This document also corrects a typographical error contained in the January 18, 2017, implementation document in the definition of “controlling interest” for purposes of establishing PHA ownership. Specifically, the implementation document incorrectly refers to equivalent levels of control in other “organizational” structures. This document corrects the definition to refer to “ownership” structures.

HOTMA amended the 1937 Act to except certain units from both the PHA program unit percentage limitation at section 8(o)(13)(B) and the income-mixing requirement at section 8(o)(13)(D). Specifically, HOTMA excepts units of project-based assistance that “are attached to units previously subject to federally required rent restrictions or receiving another type of long-term subsidy or project-based assistance provided by the Secretary.” The January 18, 2017, implementation document (page 5465, section C.2.C, and page 5467, section C.3.D, respectively) inadvertently excluded from the list of excepted units those units that have received assistance under section 201 of the Housing and Community Development Amendments of 1978. Therefore, HUD is correcting the January 18, 2017, implementation document to add the Flexible Subsidy Program in both lists.

In discussing the units that are not subject to the PBV program unit limitation, the January 18, 2017, implementation document describes the circumstances under which PBV new construction units will qualify as replacement housing for the covered units and likewise are exempt from the program limitation (page 5465, section C.2.C(2)). One of the requirements is that the newly constructed unit is located on the same site as the unit it is replacing. In describing this requirement, the January 18 2017, implementation document inadvertently referred to the “site of the original public housing development” instead of “site of the original development.” To avoid any indication that this requirement is only applicable to former public housing units as opposed to all the covered forms of HUD assistance listed earlier in the January 18, 2017, implementation document, C.2.C(2)(b) is revised to strike “public housing” from the paragraph.

HOTMA amends the 1937 Act with respect to the threshold for exemption from the income-mixing requirement. The income mixing requirement exception for supportive services now applies to dwelling units assisted under the contract that are exclusively made available to “households eligible for supportive services that are made available to the assisted residents of the project, according to the standards for such services the Secretary may establish.” HOTMA requires that families must be “eligible” for the supportive services, rather than “receiving” the supportive services, for the units made available to such families to be excluded from the income-mixing requirement. As clarified in the January 18, 2017, implementation document (page 5467, section C.3.B(2)), this HOTMA change means that a PHA may not require family participation in the supportive services as a condition of living in an excepted unit. Therefore, a PHA may not rely solely on a supportive services program that would require a family to engage in the supportive services once the family enrolls in the program, such as Family Self-Sufficiency (FSS), for the unit to meet the supportive services exception.

The January 18, 2017, implementation document states that “if the FSS family fails to successfully complete the FSS contract of participation or supportive services objective and consequently is no longer eligible for the supportive services, the family must vacate the unit . . . and the PHA shall cease paying housing assistance payments on behalf of the ineligible family.” Upon further consideration, HUD is concerned that the sentence may be misinterpreted to imply that a PHA could, under HOTMA, establish a supportive services exception based exclusively on participation in FSS (where participation in the supportive services is required as opposed to voluntary), rather than in combination with another supportive services option where participation in the supportive services is voluntary. Additionally, HUD has determined that this provision could be wrongly construed in a way that conflicts with current FSS requirements, which do not allow termination from the housing assistance program for failure to complete the FSS contract of participation. See the Federal Register notice entitled, “Waivers and Alternative Requirements for the Family Self-Sufficiency Program”, published on December 29, 2014, at 79 FR 78100.

Therefore, HUD is correcting the language on page 5467 to remove the ambiguities and better express the requirements of the HOTMA changes.

HOTMA amended the 1937 Act with respect to the types of units that are exempt from the income-mixing requirement. The January 18, 2017, implementation document (page 5467, section C.3.B(3)), noted that “projects that are in a census tract with a poverty rate of 20 percent or less” are excluded from the cap. However, the January 18, 2017, implementation document should have clarified that while PBV projects located in a census tract with a poverty rate of 20 percent or less are excluded from the 25 percent unit cap, those projects are subject to an alternative income mixing requirement that is the greater of 25 units or 40 percent of the units. HUD is adding a sentence to this section as a clarification.

There are two typographical errors in the last sentence of section C.3.C on page 5467. The word “contact” should be “contract” and the last word of the sentence should be “project” and not “unit”.

HOTMA amended the language in section 8(o)(13)(D) to exempt certain types of units receiving PBV assistance from having a project cap entirely. These are PBV units that were previously subject to certain federal rent restrictions or receiving another type of long-term housing subsidy provided by HUD. The January 18, 2017, implementation document (page 5468, section C.3.D(2)), provided an incorrect definition of new construction units that qualify for the exception as replacement housing. The definition in section C.3.D(2)(b) was supposed to match the definition provided on page 5465, section C.2.C(2)(b).

HOTMA amended the 1937 Act to add a new section 8(o)(13)(N), which allows a PHA that is engaged in an initiative to improve, develop, or replace a public housing property or site to attach PBVs to projects in which the PHA has an ownership or controlling interest, without following a competitive process. In the January 18, 2017, implementation document (page 5471, section C.6), HUD stated that, in order to avail itself of this exemption from the competitive award of PBVs, a PHA must “be planning rehabilitation or construction on the project with a minimum of $25,000 per unit in hard costs.” However, this minimum per unit cost would not be applicable in a situation where a PHA is replacing a public housing property or site with existing housing owned or controlled by the PHA.

Accordingly, in FR Doc. 2017-0091, beginning on page 5458 of the Federal Register of Wednesday, January 18, 2017, the following corrections are made:

1. On page 5463, in the first column, the final sentence of paragraph (3) is corrected to read as follows:

2. On page 5465, beginning in the first column, paragraph C(1)(b)(i) is corrected by adding at the end a new paragraph, to read as follows:

3. On page 5465, beginning in the second column, paragraph (b) is corrected by removing “public housing” in the second sentence.

4. On page 5467, in the second column, the last two paragraphs of paragraph B(2) are corrected to read as follows:

5. On page 5467, in the second column, paragraph B(3) is corrected by adding a new sentence at the end, to read as follows:

6. On page 5467, in the third column, the last sentence of paragraph (C) is corrected to read as follows:

7. On page 5467, beginning in the third column, paragraph D(1)(b)(i) is corrected by adding at the end a new paragraph, to read as follows:

8. On page 5468, in the second column, the second sentence of paragraph (b) is corrected by removing the parentheses and correcting it to read as follows:

9. On page 5471, in the third column, the second paragraph of section 6 is corrected to read as follows:

PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribes actuarial assumptions—including interest assumptions—for paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulation are also published on PBGC's Web site (http://www.pbgc.gov). PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.

The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for August 2017.1

The August 2017 interest assumptions under the benefit payments regulation will be 0.75 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for July 2017, these assumptions represent a decrease of 0.25 percent in the immediate rate and are otherwise unchanged.

PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

Because of the need to provide immediate guidance for the payment of benefits under plans with valuation dates during August 2017, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication. PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

In consideration of the foregoing, 29 CFR part 4022 is amended as follows:

The DelMoSports, LLC, on behalf of the New Jersey Department of Transportation, owner and operator of the US40-322 (Albany Avenue) Bridge that carries US 40 and US 322 across the NJICW (Inside Thorofare), mile 70.0, at Atlantic City, NJ, has requested a temporary deviation from the current operating regulations to ensure the safety of the increased volumes of cyclists and spectators that will be participating in the 7th Annual Atlantic City Triathlon on Saturday August 5, 2017. The bridge is a double bascule drawbridge. The bridge has a vertical clearance of 10 feet above mean high water in the closed position and unlimited vertical clearance in the open position.

The current operating regulation is set out in 33 CFR 117.733(f). Under this temporary deviation, the bridge will be maintained in the closed-to-navigation position from 6 a.m. to 1 p.m. on Saturday, August 5, 2017.

The NJICW (Inside Thorofare) is used by recreational vessels. The Coast Guard has carefully considered the nature and volume of vessel traffic on the waterway in publishing this temporary deviation.

Vessels able to pass through the bridge in the closed-to-navigation position may do so at any time. The bridge will be able to open for emergencies, if at least 10 minutes notice is given, and there is no immediate alternative route for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

I. Table of Acronyms CFR  Code of Federal Regulations 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 final 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)(3)(B), the Coast Guard finds that good cause exists for not publishing an NPRM with respect to this rule because doing so would be impracticable. The Coast Guard received the safety zone request on March 9, 2017. The Coast Guard did not receive the final details of the requested safety zone with sufficient time for a comment period to run before the start of the fireworks display. Thus, delaying this rule to wait for a notice and comment period to run would be impracticable because it would inhibit the Coast Guard's ability to protect the public from the potential hazards associated with the fireworks display.

We are issuing this final rule, and under 5 U.S.C. 553(d)(3), 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 reasons discussed in the preceding paragraph, a 30 day notice period would be impracticable.

The legal basis for the rule is the Coast Guard's authority to establish safety zones: 33 U.S.C. 1231; 33 CFR 1.05-1, 160.5; Department of Homeland Security Delegation No. 0170.1.

On every Saturday from June 24th to September 9th, 2017 and on July 4th 2017, St. Ignace will have fireworks displays at the end of the Arnold Transit Mill Slip. The state of Michigan regulates fireworks displays. This action is only for the safety zone. The Captain of the Port Sault Sainte Marie has determined that the pyrotechnics display will pose a significant risk to public safety and property. Such hazards include premature and accidental detonations, falling and burning debris, and collisions among spectator vessels. The special design of water shells requires a safety zone of at least 1,400 feet.

This rule is necessary to ensure the safety of vessels during the aforementioned displays. The temporary safety zone will encompass all U.S. waters of Lake Huron within a 1,400 foot radius from the end of Arnold Transit Mill Slip located at 45°52′24.6″ N., 084°43′18.1″ W. The safety zone will be enforced from 10:00 p.m. to 11:30 p.m. on June 24, 2017, from 10:00 p.m. to 11:30 p.m. on July 4, 2017, from 10:00 p.m. to 11:30 p.m. on July 8, 2017, from 9:45 p.m. to 11:15 p.m. on July 15, 2017, from 9:45 p.m. to 11:15 p.m. on July 22, 2017, from 9:30 p.m. to 11:00 p.m. on July 29, 2017, from 9:30 p.m. to 11:00 p.m. on August 5, 2017, from 9:30 p.m. to 11:00 p.m. on August 12, 2017, from 9:30 p.m. to 11:00 p.m. on August 19, 2017, from 9:30 p.m. to 11:00 p.m. on August 26, 2017, from 9:30 p.m. to 11:00 p.m. on September 2, 2017, from 9:00 p.m. to 10:00 p.m. on September 9, 2017. If the fireworks are cancelled on Saturday due to inclement weather, then this section will be enforced on the following day. The rule will be enforced with actual notice as-needed to mitigate risks associated with the display.

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Sault Sainte Marie, or a designated on-scene representative. The Captain of the Port or a designated on-scene representative may be contacted via VHF Channel 16 or telephone at 906-635-3233.

We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on these statutes and E.O.s 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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and promoting flexibility. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”), directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.” This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

We conclude that this rule is not a significant regulatory action because we anticipate that will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule is confined to area encompassing the potential firework fallout area and will be enforced only for the duration of the display. Under certain conditions, moreover, vessels may still transit through the safety zones when permitted by the Captain of the Port.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. 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.

This rule will affect the following entities, some of which might be small entities: The owners or operators of the vessels intending to transit or anchor in the vicinity of the safety zone.

This safety zone will not have a significant economic impact on a substantial number of small entities for the reasons identified in the Regulatory Planning and Review section. Further, the Coast Guard will give advance notice to the public via a Broadcast Notice to Mariners so the public can plan accordingly.

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 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 E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. 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 Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves establishment of a safety zone and, therefore, is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration (REC) supporting this determination is available in the docket where indicated in the ADDRESSES section of this preamble. However, we seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

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 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. The event sponsor did not submit notice to the Coast Guard with sufficient time remaining before the event to publish an NPRM. Delaying the effective date of this rule to wait for a comment period to run would be impracticable and contrary to the public interest by inhibiting the Coast Guard's ability to protect spectators and vessels from the hazards associated with a water ski show.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary rule effective less than 30 days after publication in the Federal Register because doing so would be impracticable and contrary to the public interest. Delaying the effective date would be contrary to the rule's objectives of ensuring safety of life on the navigable waters and protection of persons and vessels near the water ski show.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Buffalo (COTP) has determined that a water ski show presents significant risks to public safety and property. Such hazards include high speed craft and multiple water skiers performing in a relatively small area. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the water ski show is taking place.

This rule establishes a safety zone on July 29, 2017 and July 30, 2017 from 10:45 a.m. to 5:45 p.m. The safety zone will encompass all waters of the Oswego Harbor; Oswego, NY contained within the following points: 43°27′27.7″ N., 076°30′38.1″ W., then east to 43°27′28.6″ N., 076°30′34.0″ W., then northwest to 43°27′38.3″ N., 076°30′39.6″ W., then west to 43°27′38.5″ N., 076°30′44.8″ W., then back to the point of origin and 43°27′50.1″ N., 076°31′15.5″ W., then southwest to 43°27′42.2″ N., 076°31′36.0″ W., then northwest to 43°27′46.1″ N., 076°31′40.0″ W., then northeast to 43°27′55.2″ N., 076°31′17.2″ W., and returning to the point of origin (NAD 83).

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”), directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”

This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced only during the water ski performances. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within the particular areas are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

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 Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that it is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule establishes a temporary safety zone. It is categorically excluded under section 2.B.2, figure 2-1, paragraph 34(g) of the Instruction, which pertains to establishment of safety zones. A Record of Environmental Consideration (REC) supporting this determination is available in the docket where indicated in the ADDRESSES section of this preamble.

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 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 final 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 an NPRM with respect to this rule because doing so would be impracticable and contrary to the public interest. The Coast Guard did not receive the final details for this event until there was insufficient time remaining before the event to publish an NPRM. Specifically, the Coast Guard finalized the details regarding location and date for this display on June 6, 2017. Thus, delaying the effective date of this rule to wait for a comment period to run would be both impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect the public and vessels from the hazards associated with the Milwaukee Air and Water Show from July 13, 2017 through July 16, 2017, which is discussed further below.

We are issuing this final rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary rule effective less than 30 days after publication in the Federal Register. For the same reasons discussed in the preceding paragraph, waiting for a 30 day notice period to run would be impracticable and contrary to the public interest.

The legal basis for this rule is the Coast Guard's authority to establish safety zones: 33 U.S.C. 1231; 33 CFR 1.05-1, 160.5; Department of Homeland Security Delegation No. 0170.1.

In May of 2017 the Coast Guard confirmed that an extension of the safety zone for the Milwaukee Air and Water Show would provide increased safety for all participants, spectators and recreational waterway users. This extension will address boaters using the North gap of the Milwaukee Harbor and prevent them from unknowingly entering an unsafe area and the established safety zone from July 13, 2017 through July 16, 2017.

This air and water show is expected to draw a large group of waterborne spectators. The Captain of the Port Lake Michigan has determined that the likelihood of transiting vessels in the waters over which the air and water show participants will operate presents a significant risk of serious injuries or fatalities. Such hazards include flaming debris from dropped flares, and falling aircraft.

With the aforementioned hazards in mind, the Captain of the Port Lake Michigan has determined that this temporary safety zone is necessary to ensure the safety of persons and vessels during the air and water show. This zone is effective from 9 a.m. on July 13, 2017 through 5 p.m. on July 16, 2017. The safety zone will encompasses all waters of Milwaukee Harbor in the vicinity of Lakeshore State Park within an area bounded by the following coordinates, beginning at 43°02.455′ N., 087°52.880′ W.; then southeast to 43°02.230′ N., 087°52.061′ W.; then northeast to 43°04.451′ N., 087°50.503′ W.; then northwest to 43°04.738′ N., 087°51.445′ W.; then southwest to 43°02.848′ N., 087°52.772′ W.; then returning to the point of origin (NAD 83).

This rule will be only be enforced from 9:00 a.m. through 5:00 p.m. on each day from July 13, 2017 through July 16, 2017.

The Captain of the Port Lake Michigan will notify the public that the zone in this rule is or will be enforced in accordance with 33 CFR 165.7(a). Such means of notification may also include, but are not limited to Broadcast Notice to Mariners or Local Notice to Mariners.

All persons and vessels shall comply with the instructions of the Captain of the Port Lake Michigan or her designated on-scene representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or her designated on-scene representative. The Captain of the Port Lake Michigan or her designated on-scene representative may be contacted at 414-747-7182 or via VHF Channel 16.

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 cost and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and promoting flexibility. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”), directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.” This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. The safety zone created by this rule will be relatively small and enforced on an as-needed basis. Under certain conditions, vessels may still transit through the safety zone when permitted by the Captain of the Port. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone.

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

This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor within the waters of Milwaukee Harbor in Milwaukee, Wisconsin during the times in which the safety zone is enforced in July of 2017.

This safety zone will not have a significant economic impact on a substantial number of small entities for the reasons cited in the Regulatory Planning and Review section. Additionally, before the enforcement of this zone, we would issue a local Broadcast Notice to Mariners so vessel owners and operators can plan accordingly.

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

A rule has implications for federalism under 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 Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a safety zone and, therefore, is in the Milwaukee Harbor in Milwaukee, Wisconsin. Normally such actions are categorically excluded under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A preliminary Record of Environmental Consideration (REC) supporting this determination is available in the docket where indicated under the ADDRESSES section of this preamble. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

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

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

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

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. The event sponsor did not submit notice to the Coast Guard with sufficient time remaining before the event to publish an NPRM. Delaying the effective date of this rule to wait for a comment period to run would be impracticable and contrary to the public interest by inhibiting the Coast Guard's ability to protect spectators and vessels from the hazards associated with a fireworks display.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary rule effective less than 30 days after publication in the Federal Register because doing so would be impracticable and contrary to the public interest. Delaying the effective date would be contrary to the rule's objectives of ensuring safety of life on the navigable waters and protection of persons and vessels near the fireworks display.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Buffalo (COTP) has determined that a maritime fireworks show presents significant risks to public safety and property. Such hazards include premature and accidental detonations, dangerous projectiles, and falling or burning debris. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks show is taking place.

This rule establishes a safety zone on July 22, 2017 from 8:45 p.m. to 10:15 p.m. The safety zone will encompass all waters of the Saint Lawrence River, Ogden Island, Waddington, NY within a 560-foot radius of position 44°52′16.58″ N. and 075°12′18.08″ W. (NAD 83).

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.

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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”), directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”

This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs'” (February 2, 2017).

We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for a relatively short time. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the safety zone has been designed to allow vessels to transit around it. Thus, restrictions on vessel movement within that particular area are expected to be minimal. Under certain conditions, moreover, vessels may still transit through the safety zone when permitted by the Captain of the Port.

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 Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that it is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule establishes a temporary safety zone. It is categorically excluded under section 2.B.2, figure 2-1, paragraph 34(g) of the Instruction, which pertains to establishment of safety zones. A Record of Environmental Consideration (REC) supporting this determination is available in the docket where indicated in the ADDRESSES section of this preamble.

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:

On December 21, 2016, the Postal ServiceTM published a final rule replacing the product name “Standard Mail” with the new name “USPS Marketing Mail” throughout subchapter 240 of Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM). See, 81 FR 93606, 93613-93615. This rebranding is intended to enhance the public's perception of this service, and improve its position in the marketplace. Consistent with these objectives, we are amending our regulations as necessary to reflect that the product name “Standard Mail” has been changed to “USPS Marketing Mail.”

For the reasons stated in the preamble, the Postal Service amends 39 CFR part 233 as follows:

The Supplementary Information section is arranged as follows:

On November 12, 2008 (73 FR 66964), the Environmental Protection Agency (EPA) revised the Lead National Ambient Air Quality Standard (NAAQS), lowering the level from 1.5 micrograms per cubic meter (µg/m3) to 0.15 µg/m3 calculated over a three-month rolling average. The EPA established the 2008 Lead NAAQS based on significant evidence and numerous health studies demonstrating that serious health effects are associated with exposures to lead emissions.

Following promulgation of a new or revised NAAQS, the EPA is required by the Clean Air Act (CAA) to designate areas throughout the United States as attaining or not attaining the NAAQS; this designation process is described in CAA section 107(d)(1). On November 22, 2010 (75 FR 71033), the EPA promulgated initial air quality designations for the 2008 Lead NAAQS (first round of designations), which became effective on December 31, 2010, based on air quality monitoring data for calendar years 2007-2009, where there was sufficient data to support a nonattainment designation. On November 22, 2011 (76 FR 72097), the EPA promulgated its second round of designations for the 2008 Lead NAAQS, which became effective on December 31, 2011, based on air quality monitoring data for calendar years 2008-2010. The Arecibo Area was designated as nonattainment for the 2008 Lead NAAQS in the second round of designations, based on air quality monitoring data that exceeded the 2008 Lead NAAQS. This designation triggered a requirement for Puerto Rico to submit a State Implementation Plan (SIP) revision by June 30, 2013, with a plan for how the Area would attain the 2008 Lead NAAQS, as expeditiously as practicable, but no later than December 31, 2016. See 42 U.S.C. 7514(a), 7514a(a).

The Puerto Rico Environmental Quality Board (PREQB) initially submitted a lead SIP revision for the Arecibo Area on January 30, 2015. The EPA proposed to disapprove the January 30, 2015 submittal on February 29, 2016 (81 FR 10159). One comment was received from the Chairman of the PREQB, Weldin Ortiz Franco. The PREQB rescinded the January 30, 2015 submittal and replaced it with the August 30, 2016 lead SIP submittal for the Arecibo Area. The August 30, 2016 SIP submittal included the base year emissions inventory and the attainment demonstration. The EPA proposed to approve this submittal on November 7, 2016. (81 FR 78097). The EPA's analysis of the submitted attainment plan includes a review of the pollutant addressed, emissions inventory requirements, modeling demonstration of lead attainment, contingency measures and narrative on control measures that includes reasonably available control measures (RACM)/reasonably available control technology (RACT), and reasonable further progress (RFP) for the Arecibo Area. Today's rule represents the EPA's final action on Puerto Rico lead SIP attainment plan.

The public comment period for the November 7, 2016 proposed approval of the PREQB lead SIP revision closed on December 7, 2016. We received comments from Mr. Jesus Garcia Oyola and Mr. Wilfredo Velez Hernandez, Earthjustice, and Madres De Negro De Arecibo, Inc. In general, all three commenters stated that the EPA should disapprove Puerto Rico's proposed August 30, 2016 SIP revision.

A summary of the comments and the EPA's responses are provided below. Comments from Jesus Garcia Oyola and Wilfredo Velez Hernandez are referred to as “Garcia/Velez”, comments from Earthjustice are referred to as “Earthjustice” and comments from Madres De Negro De Arecibo, Inc. are referred to as “Madres De Negro.” These responses address “significant comments, criticisms, and new data” submitted during the comment period, pursuant to CAA section 307(d)(6)(B), 42 U.S.C. 7607(d)(6)(B). The EPA is not addressing those comments that do not relate to the underlying purpose of the November 17, 2016 proposed SIP approval of the attainment demonstration for the Arecibo Area, such as comments related to the Clean Water Act and Resource Conservation and Recovery Act.

1. Comment: In general, there were several comments that the Spanish and English versions of the lead SIP revision available for public comment by the PREQB were not identical (such as sections addressing the emissions inventory), and that the documents were too technical.

EPA Response: The EPA has reviewed, evaluated, and proposed action on the August 30, 2016 lead SIP revision submitted by PREQB to the EPA. The August 30, 2016 SIP submittal (lead SIP submittal or lead SIP revision), which is in English, is the official submittal. The PREQB followed the process set forth in CAA sections 110 and 172 and 40 CFR part 51, appendix V in preparing and submitting the lead SIP revision. Consistent with the relevant requirements, the official August 30, 2016 SIP submittal included the sources within the boundaries of the lead modeling domain (sources in Arecibo and its bordering municipalities, see pages 34-36 and pages 62-64 of the SIP submittal). Emissions from sources outside of the modeling domain were not included in the attainment demonstration modeling because their effect, if any, on the area within the lead modeling domain would be negligible. See Responses to Comments #4 and #5.

2. Comment: Garcia/Velez stated that the 2011 emissions inventory contains allowable emissions of lead but should contain actual emissions of lead, in accordance with 42 U.S.C. 7502(c)(3) which requires “a comprehensive, accurate, current inventory of actual emissions from all sources of the relevant pollutant.”

EPA Response: The lead SIP submittal provided the 2011 actual emissions and, for those sources where actual emissions could not be calculated due to lack of activity data, provided allowable emissions. The PREQB's use of allowable emissions for the 2011 calendar year, instead of actual emissions, is a more conservative approach which may result in the plan requiring additional controls to reach attainment in the future. As stated in Table 8.1 in 40 CFR part 51, appendix W (Guideline on Air Quality Models), this methodology is acceptable in attainment demonstrations instead of including a zero value due to lack of actual activity data.

3. Comment: Garcia/Velez stated that in 2011, Energy Answers and Sunbeam Synergy were not in operation, however, Energy Answers was included in the 2011 emissions inventory and Sunbeam Synergy was not.

EPA Response: The commenter is correct that on pages 18-19 of the lead SIP revision, the text stated that 2011 facility emissions for Energy Answers are included in the 2011 emissions inventory. However, although Energy Answers 2011 emissions are mentioned in the text on pages 18-19, the actual 2011 facility emissions numbers that are included in the air quality attainment demonstration do not include emissions from Energy Answers as it was not operating at that time. In fact, the facility has not been constructed yet. See the PREQB lead SIP submittal, page 32, Table A1, for 2011 emissions inventory numbers. The sources included in the air quality attainment demonstration were listed in the PREQB's 2011 emissions inventory at page 33, Table A1 of the submittal. These sources were included in Table 1 of the EPA's notice of proposed rulemaking, 81 FR at 78100. Although they are not included in the 2011 emissions inventory, as discussed in response #11 below, Energy Answers and Sunbeam Synergy are included in the 2016 projection inventory totals. See PREQB lead SIP submittal, page 57, Table B1.

4. Comment: Earthjustice stated that the EPA regulations mandate that “emissions inventories such as this one use the `[m]aximum allowable emission limit or federally enforceable permit limit' to model concentrations. But the AEROMOD Model in the lead SIP revision uses inputs that are lower than permit limits or maximum allowable emissions” for PREPA and Safetech facilities. Accordingly, Earthjustice stated that the PREQB must redo its model using maximum allowable emissions as required by the EPA regulations.

EPA Response: According to the EPA 2008 Lead NAAQS Implementation Questions and Answers Memorandum document dated July 8, 2011 (see page 7, answer to question 12), the emission rate input for attainment demonstrations should be based on maximum allowable or federally enforceable permit limits. The commenter is correct that the PREQB did not use the permit limits for PREPA and Safetech, which are 0.3 and 0.013 tons per year (tpy), respectively. However, in this particular instance, it is reasonable not to require the PREQB to remodel 2016 lead concentrations using maximum allowable emissions because doing so would not change the conclusion that the SIP submittal demonstrates attainment of the 2008 Lead NAAQS. The PREQB used 2016 emissions values for PREPA and Safetech of 0.28 and 0.009 tpy, respectively, resulting in a combined lead contribution for these two sources equal to 0.0178 percent of total cumulative lead contribution of 0.09352 μg/m3. Furthermore, the modeled 3-month rolling average cumulative lead concentration from all sources, 0.09352 μg/m3, is substantially below the 2008 Lead NAAQS of 0.15 μg/m3. Given the minimal contribution of these two sources to the overall lead contribution for this area, if the emissions for these two sources were increased to the permit levels of 0.3 tpy and 0.013 tpy, respectively, the increase would not impact the attainment demonstration of the 2008 Lead NAAQS. Consequently, the PREQB actions were within reason.

5. Comment: Madres de Negro and Earthjustice commented on the substance and approval status of permitted facilities in Arecibo and other municipalities. Specifically, commenters stated that the 2016 projected emissions inventory in the lead SIP revision does not match the permits inventory for the PREPA and Safetech facilities. Commenters suggested that these inconsistencies in information require the EPA to disapprove the lead SIP revision.

EPA Response: See the Responses to Comments #3 and #4. These enforceable limits were established pursuant to the Regulation for the Control of the Atmospheric Pollution (RCAP) Rules 203 (Permit to Construct a Source rule) and 204 (Permit to Operate a Source rule). RCAP Rules 203 and 204 require air emissions sources to obtain permits prior to the construction or operation of the source and also require the source to demonstrate compliance with all applicable rules and regulations prior to obtaining a construction permit. The EPA agrees that, for PREPA and Safetech, the emissions inventory in the lead SIP revision is slightly different from that in the permits included as Exhibits 3 and 4 to Earthjustice letter. The 2011 emissions inventory included the The Battery Recycling Company, Inc. (TBRCI) facility and the facilities in surrounding municipalities listed in the EPA's Emissions Inventory System (EIS)/National Emissions Inventory (NEI) database. TBRCI, a secondary lead smelter representing 85 percent of the 2011 emissions inventory, was the primary source of the high lead concentration, and the nonattainment area was established with this facility at its center. The other facilities contributed to lead concentrations representing a total of 13 percent of the 2011 emission inventory. As explained in the Responses to Comments #3 and #4, emissions from these sources contribute minimally to the cumulative lead concentration in the nonattainment area in the 2016 modeling, and slight differences between permitted and modeled emissions are unlikely to impact the attainment demonstration contained in the PREQB's SIP revision.

6. Comment: Several comments were made that the emissions included in the lead SIP revision were not inclusive of all TBRCI operations (including lead emissions to water and hazardous waste) and did not include all emissions of lead in the areas as far away as Camuy and Manati municipalities, including the airports.

EPA Response: The EPA disagrees that the emissions to water and hazardous waste as well as emissions from non-bordering municipalities should be included. PREQB's SIP emissions inventory included air lead emission sources consistent with the EPA guidance 2008 Lead NAAQS Implementation Questions and Answers. 1 Consistent with the Lead Guidance, any ambient air lead emissions recorded in the EPA EIS/NEI database for Arecibo and its bordering municipalities were included in this lead SIP revision. Emissions from Antonio Nery Juarbe Airport, which is located within the Arecibo Area, were also included. For additional facility emissions calculated and included in the inventory, see Responses to Comments #1-#4.

7. Comment: Madres de Negro states that the PREQB announced its intention to issue Energy Answers a construction permit in October 2014, and that authorizing construction of a new lead-emitting facility in a nonattainment area without a SIP violates 40 CFR 52.24.

EPA Response: The EPA disagrees that the timing of Energy Answers construction permit is relevant to the current rulemaking, which constitutes the EPA's action on the PREQB's attainment demonstration for the Arecibo lead nonattainment area. The PREQB has an approved nonattainment new source review program (NNSR) that includes lead and that meets the statutory requirements. Proposed facilities must, at the time of permit application, meet the requirements of the PREQB RCAP 203, the PREQB's NNSR program and any applicable federal requirements. As stated above, however, the permitting of new sources under this program is independent of considerations relevant to determining whether the PREQB has submitted an approvable attainment plan. Regardless, the 2016 modeling included in the Arecibo attainment demonstration shows that the new planned sources, including the Energy Answers facility, will not cause or contribute to lead concentrations in excess of the 2008 Lead NAAQS.

8. Comment: Earthjustice stated that the lead SIP revision does not include emissions limitations for any facility within or near the nonattainment area but rather sets forth general provisions of the PREQB regulations. Specifically, the commenter asserts that “[t]hese vague prohibitions on general pollution” do not comply with the CAA's requirement of particularized emission limits and control technologies applied to the emitting facilities within the nonattainment area.

EPA Response: The EPA disagrees that the attainment SIP does not provide for the statutorily required permanent and enforceable emissions limitations as may be necessary to provide for attainment. The lead SIP revision is a plan to control ambient air lead emissions from the primary sources (or, in this case, source) of emissions. The PREQB's attainment modeling took into account all ambient air lead emissions recorded in the EPA EIS/NEI database in Arecibo and its bordering municipalities, in addition to emissions from the primary source. The modeling also conservatively incorporated other planned facilities that emit lead to ensure that the area will attain the standard. The PREQB's modeling demonstration determined that TBRCI was the primary source of ambient air lead emissions contributing to nonattainment in the Arecibo Area and was thereby, the only source required to implement control technologies. On August 19, 2015, the PREQB rescinded the TBRCI operating and construction permits. Because TBRCI is no longer permitted to emit lead at the ambient air levels that contributed to nonattainment (or indeed at any level whatsoever), the permit rescission provides the permanent and enforceable emission reductions necessary to bring the Arecibo Area into attainment with the 2008 Lead NAAQS. As stated in both the lead SIP revision submitted by the PREQB and the EPA's proposed approval, should TBRCI or any other entity decide to start up business as a secondary lead smelter facility in the Arecibo Area, the company will need to obtain the appropriate permits to operate in accordance with all applicable laws and regulations of the Commonwealth of Puerto Rico and the EPA, including the Commonwealth of Puerto Rico RCAP, the Puerto Rico Environmental Public Policy Act, Act 416-2004 as amended (PREPPA Act 416) and CAA Section 112 requirements. These relevant laws and programs are intended, among other things, to ensure that emissions from new sources do not interfere with the attainment of the 2008 Lead NAAQS.

The EPA and the PREQB also considered fugitive emissions from the piles of lead slag and other materials stored on the facility property. It is noteworthy that the TBRCI site has been proposed for the Superfund National Priorities List 2 and that the EPA has been conducting activities on TBRCI property since September 2015. Additionally, RCAP Rule 404, which requires any person to take reasonable precautions to prevent fugitive emissions from becoming airborne has already been adopted, is approved into the Puerto Rico's SIP.3 The requirements of RCAP Rule 404 are, therefore, enforceable measures for controlling fugitive emissions from the TBRCI site.

9. Comment: Earthjustice stated that the Energy Answers and PREPA Cambalache Plant are the highest 2016 emitters and should be the subject of more stringent emissons limitations and control measures in the Arecibo SIP Revision.

EPA Response: The EPA disagrees. See Response to Comment #8. The PREQB's modeling indicates that the shutdown of TBRCI, coupled with the backstop of the fugitive emissions provisions in RCAP Rule 404, are sufficient for the Arecibo Area to achieve attainment of the 2008 Lead NAAQS.

10. Comment: Garcia/Velez stated that the PREQB should not have included facilities that are not operational in the 2016 projected emission inventory.

EPA Response: A projected emissions inventory is the basis for determining whether the area will attain and maintain the lead standard based on permitted allowances. As discussed in Response to Comment #3, the proposed sources Energy Answers and Sunbeam were added to the projected emissions inventory for 2016. This is a conservative approach for modeling the air quality in the Arecibo Area. By including the Energy Answers and Sunbeam Synergy facilities as part of the 2016 projected inventory for the attainment demonstration, the PREQB's lead SIP revision is demonstrating that future growth in lead emissions from these sources will not cause or contribute to a violation of the 2008 Lead NAAQS. The Arecibo ambient air lead attainment demonstration SIP is not required to address specific proposed facilities. Rather, consistent with RCAP Rule 203, pre-construction requirements, those proposed facilities are required to conduct a demonstration of compliance with all applicable rules and regulations at the time of permit application. In addition, proposed facilities will be required to comply with PREQB's approved NNSR program. The Arecibo attainment demonstration model demonstrates that the planned facilities will not cause an exceedance in the 2008 Lead NAAQS.

11. Comment: Several commenters questioned whether, if TBRCI is the cause of the ambient air lead problem in the area and its 2016 potential emissions of lead are 0.33538 tpy, then Energy Answers with slightly higher emissions may also be a problem.

EPA response: The 2016 projected emissions inventory for TBRCI in the January 30, 2015 lead SIP submittal was 0.33538 tpy. This number represented stack emissions from TBRCI. However, now that TBRCI's permits have been pulled and the facility has shut down, stack emissions from this facility are zero, as reflected in the more recent August 30, 2016 SIP revision. The lead SIP attainment demonstration in the 2015 submission assumed continued operation at TBRCI which includes fugitive emissions and materials handling and transport from TBRCI. When TBRCI was modeled in the previous submission, the modeling indicated that these low elevation fugitive emissions and materials handling and transport were the major contributor to overall emissions because they are subject to less dispersion, even exceeding the magnitude of the stack emissions. As modeled in the 2015 submission, TBRCI's cumulative emissions resulted in the Arecibo Area exceeding the 2008 Lead NAAQS of 0.15 μg/m 3. However, with the cessation of operations at TBRCI, the PREQB's updated modeling shows the area coming into attainment.

Regardless, while the emissions inventory number associated with the Energy Answers proposed incinerator may be similar to TBRCI's combined stack and fugitive/materials handling and transport emissions, the model in the Puerto Rico's SIP shows that the proposed incinerator's maximum air quality impact for lead is close to Energy Answer's fence-line and results in a lead concentration for the Arecibo Area that is 200 times less than the level of the 2008 Lead NAAQS. The model also shows that the proposed incinerator's impact in the Arecibo Area is 3000 times less than the 2008 Lead NAAQS and would have a negligible contribution to the lead emissions in the area. This information is included in Energy Answer's PSD permit application as well as EPA's Response to Comment document regarding its permit.

12. Comment: Earthjustice stated that even with TBRCI shutdown, the PREQB estimates that the other lead-emitting facilities in the area, collectively, will emit 0.78 tons of lead, a significant amount that is still about 65 percent of the 1.21 tons of lead that TBRCI emitted in 2011, leading to nonattainment.

EPA Response: The EPA disagrees that emissions from other lead-emitting facilities will result in nonattainment in the Arecibo Area. The attainment demonstration is not simply based on a summing of air lead emission values from all sources in the area, as presented by the commenter. Rather, the EPA's Lead Guidance requires that an attainment demonstration include an emissions inventory, ambient air monitoring data, and the EPA-approved air quality modeling dispersion analysis, which also takes into consideration atmospheric conditions, dispersion, chemical transformation in the area under analysis, emissions, background concentration, stack heights and stack down wash and building wake. The modeled attainment demonstration accounted for the collective ambient air lead emissions from sources in Arecibo and in bordering municipalities, including the emissions cited by the commenter, and shows that those emissions will not result in lead levels above the 2008 Lead NAAQS in the nonattainment area. See PREQB SIP Plan Appendix C.

13. Comment: Earthjustice stated that the EPA cannot approve a SIP revision when the air monitoring data does not demonstrate that attainment can be achieved until the end of 2018.

EPA Response: The EPA disagrees with this comment. As stated in the Lead Guidance, “[a]n attainment SIP may be approvable even if the state does not anticipate having 3 full years of clean data by the attainment date. See EDF v. EPA, 369 F.3d 193 (2d Cir. 2004); Sierra Club v. EPA, 356 F.3d 296 (D.C. Cir. 2004) amended 2004 WL 877850 (D.C. Cir. 2004).” Lead Guidance, page 4, Question 9. The ambient air monitoring data show clean data starting in September 2015, following the withdrawal of TBRCI permits on August 19, 2015; the closure of TBRCI will facilitate the attainment of the 2008 lead NAAQS by 2018. The fact that the area is unable to attain until 2018 does not abrogate either the PREQB's statutory obligation to submit a SIP demonstrating how it will reach attainment of the NAAQS as expeditiously as possible, or the EPA's responsibility to act on such a SIP submission. The EPA's approval of the attainment plan is based on the finding that the area meets all applicable lead NAAQS attainment plan requirements under CAA sections 172, 191, and 192, 42 U.S.C. 7502, 7514, and 7514a.

14. Comment: Earthjustice commented that one of the two lead air monitoring sites referenced in the SIP, Victor Santoni Cordero site, was not operational from October 3, 2015, to May 6, 2016, and that at the other lead air monitoring site, Road #2, there are data gaps between December 13, 2014, and January 12, 2015, and between July 5, 2015, and September 3, 2015. Earthjustice asserted that the EPA should ensure that both air monitoring sites are fully operational before approving the Arecibo Lead SIP Revision. Earthjustice stated that the PREQB has never published the air monitoring data relative to ambient air lead in Arecibo.

EPA Response: The EPA disagrees with Earthjustice's characterization of the PREQB's air monitoring network in the Arecibo Area. In accordance with 40 CFR part 58, appendix D section 4.5, the state is required to have at a minimum one source-oriented air monitoring site located to measure the maximum lead concentration in ambient air resulting from each non-airport lead source which emits 0.50 or more tpy. In Arecibo, the PREQB operates two monitoring sites, which is more than the required number. The data from both of the monitors is used to determine compliance with the NAAQS. Any 3-month period can show a violation of the standard, while a 36-month period can show attainment of the standard. While it is optimal to collect all the data points, mechanical issues may occur, thereby making sampling difficult. If an issue arises, the PREQB and the EPA work as expeditiously as possible to address it. Even though the Victor Santoni Cordero site was not operational from October 3, 2015, to May 6, 2016, the closer monitoring site, Road #2 was operational at that time. Similarly, the PREQB advised the EPA that, due to a mechanical issue, samples were not collected from July 11, 2015 to August 28, 2015 (nine samples) at the Road #2 site. However, the Victor Cordero site continued to operate during that time with sampling data ranging from 0.002 µg/m3 to 0.005 µg/m3. Consistent with 40 CFR part 58, appendix D section 4.5, one air monitoring site was operational. This data gap may affect the timeframe (three years of monitored clean data) by which the area can show attainment of the standard; however, it does not affect the SIP process of approving a plan to attain the standard.

The data is published in AQS as required by 40 CFR part 58. The public can access this data by visiting www.epa.gov/airdata.

15. Comment: Earthjustice stated that the proposed SIP action overlooks air quality monitoring data that clearly show continued exceedances of the lead NAAQS (0.15 μg/m3) even after the temporary shutdown of TBRCI and, therefore, the cessation of operations at TBRCI cannot serve as a basis for demonstrating attainment.

EPA Response: When TBRCI ceased lead smelter operations on June 2, 2014, the handling of the slag piles continued, causing the exceedances of the 2008 Lead NAAQS until July 2015. The air quality data measured after the PREQB rescinded TBRCI's permits (August 19, 2015) demonstrates that pulling the source's operating permit and terminating handling of slag piles, as opposed to just ceasing stack emissions, is an appropriate control measure that has a positive effect on the air quality. These slag piles, which generate the fugitive emissions, are part of a Superfund removal action. As identified in EPA's proposed approval, the existing SIP provision, Puerto Rico RCAP Rule 404, is in place as a control measure for fugitive emissions. RCAP Rule 404(E) provides that “[a]ny new or modified source, the construction of which causes or may cause fugitive emissions, shall apply for a permit as required in Rule 203.” All other control measures were discussed in the proposed approval. Also see Response to Comment #18.

16. Comment: Earthjustice stated that the contingency measures included in the lead SIP revision of increased monitoring, investigation, removal orders, air pollution alerts, etc., require `further action by the State' and therefore do not satisfy the CAA.

EPA Response: As Earthjustice indicates, CAA section 172(c)(9) provides that “contingency measures [are] to take effect in any such case without further action by the State or the Administrator.” In Greenbaum v. EPA, 370 F.3d 527 (6th Cir. 2004), in upholding a redesignation determination by the EPA, the court agreed with the EPA's interpretation that “without further action” means without further rulemaking by the State or the EPA. The court stated, citing to the EPA's Calcagni memo,4 “With respect to triggers, the EPA correctly argues that monitored violations of the NAAQS can be possible triggers. Calcagni Memo at 12. The contingency measures may be triggered upon notification by the Ohio EPA or the United States EPA of a determination by either agency that a violation has occurred. With respect to schedules, the EPA correctly explains that the contingency measures were initially developed pursuant to [CAA] § 172(c)(9), which requires that the measures take effect without further action by the State or the EPA, which the EPA interprets to mean `that no further rulemaking activities by the State or the EPA would be needed to implement the contingency measures.' State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990, 57 FR 13498, 13512 (April 16, 1992). The Calcagni Memorandum also states that `for the purposes of Section 175A, a State is not required to have fully adopted contingency measures that will take effect without further action by the State in order for the maintenance plan to be approved.' Calcagni Memorandum at 12. Thus, no pre-determined schedule for adoption of the measures is necessary in each specific case.” Greenbaum, 370 F.3d at 541.

The contingency measures in Puerto Rico's attainment plan can take effect without further rulemaking activities; thus, the EPA disagrees that the contingency measures included in the SIP revision do not satisfy the CAA.

17. Comment: Earthjustice stated that monitoring, by itself, does not satisfy the CAA's requirements for a control measure, and therefore cannot be a contingency measure.

EPA Response: The EPA disagrees that the PREQB intends for monitoring, by itself, to serve as a contingency measure. Monitoring is used as a trigger to activate contingency measures, not as a control measure and potential contingency measure itself. The substantive contingency measures the EPA is approving can be found in the PREQB SIP submittal at pages 24-27.

18. Comment: Earthjustice reviewed the EPA Air Quality Data and noted that exceedances of the lead NAAQS have been measured in Arecibo at least 26 times after the TBRCI shutdown, as recent as May 2016.

EPA Response: The data points Earthjustice referenced are not exceedances of the NAAQS. Compliance with the 2008 Lead NAAQS is assessed by averaging data points over a three month period, not on the basis of individual values. While the individual data points may be greater than 0.15 µg/m3, this does not mean there has been a violation of the NAAQS; once the relevant values averaged over three months, the data is still below the 2008 Lead NAAQS.

The EPA is approving into the SIP Puerto Rico's lead attainment plan for the Arecibo Area. Specifically, the EPA is taking final action to approve Puerto Rico's August 30, 2016 submittal, which includes the attainment demonstration, base year emissions inventory, modeling, and contingency measures, and addresses RACM/RACT and the RFP plan.5 Permits for the lead smelter, TBRCI, which was documented as the source of high lead emissions contributing to nonattainment of the NAAQS, have been withdrawn and TBRCI is no longer operating. The requirements for RACM/RACT and the RFP plan are satisfied because the Commonwealth of Puerto Rico demonstrated that the Area will attain the 2008 Lead NAAQS as expeditiously as practicable, and could not implement any additional measures to attain the NAAQS any sooner.

The EPA notes that since September 2015, the month after the PREQB withdrew the construction and operating permits for TBRCI, the data from the source oriented Arecibo air monitoring site indicates the lead concentration in the ambient air has been below the three-month rolling average for the 2008 Lead NAAQS and the 2016 modeling indicates the area will attain the NAAQS. The SIP for the Arecibo Area adequately demonstrates a trajectory towards attainment; thus, the EPA is approving the attainment demonstration, emissions inventory, modeling, control measures, RACM/RACT and RFP.

The EPA's review of the materials submitted indicates that Puerto Rico has developed the Lead attainment plan in accordance with the requirements of the CAA, 40 CFR part 51, and the EPA's technical requirements for a Lead SIP. Therefore, the EPA is approving into the SIP the Lead attainment plan for Arecibo, Puerto Rico.

A detailed analysis of the EPA's review and rationale for approving the lead SIP submittal as addressing these CAA requirements may be found in the November 7, 2016 proposed rulemaking action (81 FR 78097) which is available on line at www.regulations.gov, Docket ID Number EPA-R02-OAR-2016-0560.

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 12, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

For the reasons set forth in the preamble, the Environmental Protection Agency amends part 52 of chapter I, title 40 of the Code of Federal Regulations as follows:

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

On May 8, 2017 (82 FR 21348), EPA published a Notice of Proposed Rulemaking (NPR) for the State of Maine. The NPR proposed approval of Maine's revised Chapter 118, Gasoline Dispensing Facilities Vapor Control, that had been amended to allow for and require the decommissioning of all Stage II vapor recovery systems at GDFs in York, Cumberland, and Sagadahoc Counties. The updated regulation also strengthened the testing requirements for Stage I systems throughout the State. The formal SIP revision was submitted by the Maine DEP on April 13, 2016, and included a demonstration that decommissioning the Stage II vapor recovery systems is consistent with the Clean Air Act and EPA guidance.

A detailed discussion of Maine's April 13, 2016 SIP revision and EPA's rationale for proposing approval of the SIP revision were provided in the NPR and will not be restated in this notice. No public comments were received on the NPR.

EPA is approving Maine's April 13, 2016 SIP revision. Specifically, EPA is approving Maine's revised Chapter 118, Gasoline Dispensing Facilities Vapor Control, and incorporating it into the Maine SIP. EPA is approving this SIP revision because it meets all applicable requirements of the Clean Air Act and relevant EPA guidance, and it will not interfere with attainment or maintenance of the ozone NAAQS.

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 the of the State of Maine's revised Chapter 118 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 http://www.regulations.gov.

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 September 12, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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

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 EPA's tolerance regulations at 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-2016-0254 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 September 12, 2017. 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-2016-0254, 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 February 7, 2017 (82 FR 9555) (FRL-9956-86), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F8445) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.475 be amended by establishing tolerances for residues of the fungicide difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on cottonseed subgroup 20C at 0.40 parts per million (ppm); rice, grain at 7 ppm; and rice, wild, grain at 7 ppm. In addition, the petition requested that the existing tolerance for cotton, gin byproducts be increased from 0.05 ppm to 15 ppm; and requested the tolerance in/on cotton, undelinted seed at 0.05 ppm as a seed treatment be removed from 40 CFR 180.475 because the proposed new tolerance in/on cottonseed subgroup 20C reflecting foliar uses will be adequate to support the seed treatment uses. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 difenoconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with difenoconazole follows.

EPA has evaluated the available toxicity data and considered its 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.

Subchronic and chronic studies with difenoconazole in mice and rats showed decreased body weights, decreased body weight gains and effects on the liver (e.g. hepatocellular hypertrophy, liver necrosis, fatty changes in the liver). No systemic toxicity was observed at the limit dose in the most recently submitted rat dermal toxicity study.

The available toxicity studies indicated no increased susceptibility of rats or rabbits from in utero or postnatal exposure to difenoconazole. In prenatal developmental toxicity studies in rats and rabbits and in the 2-generation reproduction study in rats, fetal and offspring toxicity, when observed, occurred at equivalent or higher doses than in the maternal and parental animals.

In a rat developmental toxicity study, developmental effects were observed at doses higher than those which caused maternal toxicity. Developmental effects in the rat included increased incidence of ossification of the thoracic vertebrae and thyroid, decreased number of sternal centers of ossification, increased number of ribs and thoracic vertebrae, and decreased number of lumbar vertebrae. In the rabbit study, developmental effects (increases in post-implantation loss and resorptions and decreases in fetal body weight) were also seen at maternally toxic doses (decreased body weight gain and food consumption). Since the developmental effects are more severe than the maternal effects, qualitative susceptibility is indicated in the rabbit developmental study; however, the selected POD is protective of this effect. In the 2-generation reproduction study in rats, toxicity to the fetuses and offspring, when observed, occurred at equivalent or higher doses than in the maternal and parental animals.

In an acute neurotoxicity study in rats, reduced fore-limb grip strength was observed on day one in males at the lowest-observed-adverse-effect-level (LOAEL), and clinical signs of neurotoxicity were observed in females only at the highest dose tested. In a subchronic neurotoxicity study in rats, decreased hind limb strength was observed in males only at the mid- and high-doses. The effects observed in acute and subchronic neurotoxicity studies were considered transient.

Although there is some evidence that difenoconazole affects antibody levels at doses that cause systemic toxicity, there are no indications in the available studies that organs associated with immune function, such as the thymus and spleen, are affected by difenoconazole.

Difenoconazole is not mutagenic, and no evidence of carcinogenicity was seen in rats. Evidence for carcinogenicity was seen in mice (liver tumors), but statistically significant carcinoma tumors were only induced at excessively-high doses. Adenomas (benign tumors) and liver necrosis only were seen at 300 ppm (46 and 58 milligram/kilogram/day (mg/kg/day) in males and females, respectively); the NOAEL in that study was 30 ppm. EPA has concluded that the chronic point of departure (POD) for assessing chronic risk (0.96 mg/kg/day) will be protective of any cancer effects for the following reasons: (1) Tumors were seen in only one species; (2) carcinoma tumors were observed only at the two highest doses (2,500 and 4,500 ppm) in the mouse carcinogenicity study; (3) benign tumors and necrosis were observed at the mid-dose (300 ppm) ; (4) the absence of tumors at the study's lower doses (30 ppm); (5) the absence of genotoxic or mutagenic effects. The cRfD of 0.96 mg/kg/day is well below the no-observed-adverse-effect-level (NOAEL) of the mouse carcinogenicity study of 30 ppm (4.7 and 5.6 mg/kg/day in males and females, respectively), at which no effects on the biological endpoints relevant to tumor development (i.e., hepatocellular hypertrophy, liver necrosis, fatty changes in the liver and bile stasis) were seen. As a result, EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to difenoconazole and a separate quantitative cancer exposure assessment is unnecessary.

Specific information on the studies received and the nature of the adverse effects caused by difenoconazole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Difenoconazole: Human Health Risk Assessment for Proposed New Foliar Uses on Cotton, Rice and Wild Rice” at pp. 20-21 in docket ID number EPA-HQ-OPP-2016-0254.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for difenoconazole used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of April 2, 2015 (80 FR 17697) (FRL-9923-82).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to difenoconazole, EPA considered exposure under the petitioned-for tolerances as well as all existing difenoconazole tolerances in 40 CFR 180.475. EPA assessed dietary exposures from difenoconazole in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

Such effects were identified for difenoconazole. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. As to residue levels in food, EPA assumed tolerance-level residues, 100 percent crop treated (PCT), and available empirical or DEEM (ver. 7.81) default processing factors.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. As to residue levels in food, EPA used tolerance-level residues for some commodities, average field trial residues and USDA Pesticide Data Program monitoring samples for the remaining commodities, available empirical or DEEM (ver.7.81) default processing factors, and average PCT assumptions for some commodities.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to difenoconazole. Therefore, a separate quantitative cancer exposure assessment is unnecessary since the chronic dietary risk estimate will be protective of potential cancer risk.

iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

For the chronic dietary exposure assessment, the Agency used average PCT estimates for existing uses as follows: Almond 10%, apple 20%, apricot 10%, broccoli 2.5%, Brussels sprouts 2.5%, cabbage 5%, cantaloupe 2.5%, carrot 5%, cauliflower 2.5%, cherry 2.5%, cucumber 5%, garlic 5%, grape 10%, grapefruit 2.5%, hazelnut 1%, nectarine 2.5%, onions 5%, orange 2.5%, peach 2.5%, pear 10%, pecan 2.5%, pepper 5%, pistachio 5%, plum/prune 10%, potato 20%, pumpkin 2.5%, soybean 2.5%, squash 5%, strawberry 2.5%, sugar beet 15%, tangerine 2.5%, tomato 25%, walnut 1%, watermelon 5%, and wheat (seed treatment) 10%.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT value for chronic dietary risk analysis. The average PCT value for each existing use is derived by combining available public and private market survey data for that use and averaged across all observations and is rounded up to the nearest multiple of 5%, for use in the analysis unless the average PCT value is estimated at less than 2.5% or 1%, in which case the Agency uses 2.5% or 1%, respectively, as the average PCT value in the analysis. EPA uses a maximum PCT value for acute dietary risk analysis. The maximum PCT value is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5% for use in the analysis, unless the maximum PCT value is estimated at less than 2.5%, in which case the Agency uses 2.5% as the maximum PCT value in the analysis.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which difenoconazole may be applied in a particular area.

2. Dietary exposure from drinking water. The drinking water assessment was performed using a total toxic residue method, which considers both parent difenoconazole and its major metabolite, CGA 205375, in surface and groundwater. Therefore, the Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for difenoconazole and its major metabolite in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of difenoconazole and CGA 205375. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Tier II Pesticide in Water Calculator, the Revised Tier 1 Rice Model, the Surface Water Concentration Calculator, and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of total toxic residues of difenoconazole for acute exposures are estimated to be 33.4 parts per billion (ppb) for surface water and 2.0 ppb for ground water. For chronic exposures estimated drinking water concentrations (EDWCs) of total toxic residues of difenoconazole for non-cancer assessments are estimated to be 27.8 ppb for surface water and 0.60 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 33.4 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 27.8 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Difenoconazole is currently registered for the following uses that could result in residential exposures: Treatment of ornamental plants in commercial and residential landscapes and interior plantscapes. EPA assessed residential exposure using the following assumptions: For residential handlers, adult short-term dermal and inhalation exposure is expected from mixing, loading, and applying difenoconazole on ornamentals (gardens and trees). For residential post-application exposures, short-term dermal exposure is expected for both adults and children from post-application activities in treated residential landscapes.

The scenarios used in the aggregate assessment were those that resulted in the highest exposures. The highest exposures consist of the short-term dermal exposure to adults from post-application activities in treated gardens and short-term dermal exposure to children 6 to 11 years old from post-application activities in treated gardens. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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.”

Difenoconazole is a member of the conazole class of fungicides containing the 1,2,4-triazole moiety. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events (EPA, 2002).

In the case of conazoles, however, a variable pattern of toxicological responses is found; some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that difenoconazole shares a common mechanism of toxicity with any other conazole pesticide, and EPA is not following a cumulative risk approach for this tolerance action. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

This class of compounds can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazolylalanine and triazolylacetic acid). To support existing tolerances and to establish new tolerances for triazole-containing pesticides, including difenoconazole, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazolylalanine, and triazolylacetic acid resulting from the use of all current and pending uses of any triazole-containing fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). The Agency retained a 3X for the LOAEL to NOAEL safety factor when the reproduction study was used. In addition, the Agency retained a 10X for the lack of studies including a developmental neurotoxicity (DNT) study. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment is found in the propiconazole reregistration docket at http://www.regulations.gov, Docket ID Number EPA-HQ-OPP-2005-0497.

The Agency's latest updated aggregate risk assessment for the triazole-containing metabolites was finalized on November 15, 2016 and includes the new uses in this rule. It is titled, “Common Triazole Metabolites: Updated Aggregate Human Health Risk Assessment to Address the New Section 3 Registrations for Use of Difenoconazole on Rice and Cotton.” Aggregate risk estimates associated with 1,2,4-triazole (T) and the conjugated triazole metabolites (i.e., combined residues of triazolylalanine (TA) and triazolylacetic acid (TAA)), are below the Agency's level of concern. There are no human health risk issues for these metabolites that would preclude the new uses of difenoconazole. The assessment may be found at http://www.regulations.gov in document in docket ID number EPA-HQ-OPP-2016-0254.

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 FQPA Safety Factor (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 prenatal and postnatal toxicology database for difenoconazole includes rat and rabbit prenatal developmental toxicity studies and a 2-generation reproduction toxicity study in rats. The available Agency guideline studies indicated no increased qualitative or quantitative susceptibility of rats to in utero and/or postnatal exposure to difenoconazole. In the prenatal developmental toxicity studies in rats and rabbits and the 2-generation reproduction study in rats, toxicity to the fetuses/offspring, when observed, occurred at equivalent or higher doses than in the maternal/parental animals. In a rat developmental toxicity study developmental effects were observed at doses higher than those which caused maternal toxicity. In the rabbit study, developmental effects (increases in post-implantation loss and resorptions and decreases in fetal body weight) were also seen at maternally toxic doses (decreased body weight gain and food consumption). Since the developmental effects are more severe than the maternal effects, qualitative susceptibility is indicated in the rabbit developmental study; however, the selected POD is protective of this effect. In the 2-generation reproduction study in rats, toxicity to the fetuses/offspring, when observed, occurred at equivalent or higher doses than in the maternal/parental animals.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for difenoconazole is complete.

ii. There are no clear signs of neurotoxicity following acute, subchronic or chronic dosing in multiple species in the difenoconazole database. The effects observed in acute and subchronic neurotoxicity studies are transient and showed in one sex (males as reduced fore-limb grip strength with no histologic findings), and the selected endpoints of toxicity for risk assessment are protective of any potential neurotoxicity. Based on the toxicity profile, and lack of concern for neurotoxicity, there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.

iii. There is no evidence that difenoconazole results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. The qualitative susceptibility seen in the rabbit developmental study is adequately protected by the selected POD.

iv. There are no residual uncertainties identified in the exposure databases. The dietary risk assessment utilized tolerance-level residues and 100 PCT for the acute assessment; the chronic assessment was refined by using USDA PDP monitoring data, average field-trial residues for some commodities, tolerance-level residues for remaining commodities, and average PCT for some commodities. These assumptions will not underestimate dietary exposure to difenoconazole. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to difenoconazole in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children. These assessments will not underestimate the exposure and risks posed by difenoconazole.

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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to difenoconazole will occupy 53% of the aPAD for all infants less than 1 year old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to difenoconazole from food and water will utilize 50% of the cPAD for all infants less than 1 year old the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of difenoconazole is not expected.

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). Difenoconazole is currently 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 difenoconazole.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 250 for children and 180 for adults. Because EPA's level of concern for difenoconazole 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). An intermediate-term adverse effect was identified; however, difenoconazole is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for difenoconazole.

5. Aggregate cancer risk for U.S. population. Based on the data summarized in Unit III.A., the chronic dietary risk assessment is protective of any potential cancer effects. Based on the results of that assessment, EPA concludes that difenoconazole 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 difenoconazole residues.

Adequate enforcement methodology (gas chromatography with nitrogen phosphorus detection (GC/NPD) method AG-575B) is available for the determination of residues of difenoconazole in or on plant commodities. Liquid chromatography with tandem mass spectrometry (LC/MS/MS) method REM 147.07b is available for the determination of residues of difenoconazole and CGA-205375 in livestock commodities. Adequate confirmatory methods are also available.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

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

The Codex has not established a MRL for difenoconazole in or on cottonseed subgroup 20C; cotton gin byproducts; rice, grain; and rice, wild, grain.

Therefore, tolerances are established for residues of difenoconazole, 1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole, in or on cottonseed subgroup 20C at 0.40 ppm; rice, grain at 7.0 ppm; and rice, wild, grain at 7.0 ppm. Additionally, this regulation amends the current tolerance for cotton, gin byproducts from 0.05 ppm to 15 ppm. Finally, EPA is removing the established tolerance for residues of difenoconazole in or on cotton, undelinted seed at 0.05 ppm because residues on cotton, undelinted seed are covered by the new tolerance for cottonseed subgroup 20C.

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

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

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

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

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

If you discover a discrepancy between the manning or endorsements specified by the Certificate of Inspection/Safe Manning Documentation (COI/SMD) and the provisions of the MSM, Volume III, bring it to the attention of the OCMI with a view toward aligning with the revised MSM III. Documents discussed in this document should be available in the online docket within three business days of this publication. There will be no hardcopy distribution of this change. This change has been incorporated into the electronic copy of the manual available on the INTERNET at http://www.dcms.uscg.mil/Our-Organization/Assistant-Commandant-for-C4IT-CG-6-/The-Office-of-Information-Management-CG-61/aboutCGDS/cim/smdpage2823/4/.

Volume III of the Marine Safety Manual (MSM) provides information and interpretations on international conventions and U.S. statutes and regulations relating to marine industry personnel. The last updates to Volume III of the MSM were released on July 30, 2014 (79 FR 45451, Aug. 5, 2014). The Coast Guard published a notice in the Federal Register announcing the availability of a draft Change-2 and requested public comments (See 81 FR 46042). This document announces updates portions of Part B and C.

Specifically, substantive changes include: (1) Updated guidance to align with the Howard Coble Coast Guard and Maritime Transportation Act of 2014; (2) manning scales for towing vessels certificated under Subchapter M from recently published Inspection of Towing Vessels final rule (81 FR 40003, June 20, 2016); and (3) various policy updates impacting vessel manning. Further, all manning scales throughout Part B Chapters 2, 4, 6 and 7 are presented in a new standard format. Additionally, a Suggested Safe Manning Proposal Template, Coast Guard Work Instruction, Master's Field Guide, and Verification Check-sheet have been added to the Annex. These are intended to aid Coast Guard personnel as well as owners/operators, masters and persons in charge of U.S. vessels, respectively.

We received 10 public comment responses to the July 15, 2016 Federal Register document. These comment responses contained a total of approximately 31 specific recommendations, suggestions and other comments. We have created a change matrix that provides a summary of each comment and the corresponding Coast Guard response, as well as Coast Guard changes. A copy of this change matrix is available for viewing in the public docket for this notice. For more detailed information, please consult the actual public comment letters in the docket. You may access the docket going to http://www.regulations.gov, using “USCG-2016-0669” as your search term, and following the instructions in the ADDRESSES section above.

Some commenters included a DOT mailing address in their comments. The Coast Guard no longer receives mail at the DOT Docket Management Facility. Each Coast Guard notice soliciting public comment includes instructions on how to comment on the online docket at www.regulations.gov, and what to do if commenters are unable to submit comments online.

The basic ideas and principles encompassed in the initial and supplemental drafts remain. Some commenters proposed revisions to the MSM or requested additional clarification. In response to these comments, the Coast Guard has made some additional revisions. The Coast Guard notes, however, that the MSM (and any revisions made to the MSM) reflect current law and regulation and are intended to provide guidance and information to marine industry personnel. For an in-depth discussion of the individual comments submitted, please visit the docket for this notice to view submitted comments and the change matrix.

It should be noted that Change-2 is not intended to preempt or take the place of separate policy initiatives regarding specific decisions on appeal or future regulations. Future changes to the MSM may be released if the Coast Guard promulgates new regulations or issues appeal decisions, which may affect the guidance and information contained within the MSM.

This document is issued under authority of 5 U.S.C. 552(a).

In FR Doc. 2017-11418 appearing on page 25538 in the Federal Register of Friday, June 2, 2017, the following corrections are made:

On page 25538, in the third column, in part 36, in amendment 2, the instruction “In 47 CFR part 36, remove the date “June 30, 2017” and add, in its place, the date “December 30, 2018” in the following places:” is corrected to read as “In 47 CFR part 36, remove the date “June 30, 2017” and add, in its place, the date “December 31, 2018” in the following places:”

Atlantic shark fisheries are managed under the 2006 Consolidated Highly Migratory Species (HMS) Fishery Management Plan (FMP), its amendments, and implementing regulations (50 CFR part 635) issued under authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.).

Atlantic shark fisheries have separate regional (Gulf of Mexico and Atlantic) quotas for all management groups except for the shark research fishery for LCS and sandbar sharks, blue shark, porbeagle shark, and pelagic shark (other than porbeagle or blue sharks) management groups. The boundary between the Gulf of Mexico region and the Atlantic region is defined at § 635.27(b)(1) as a line beginning on the East Coast of Florida at the mainland at 25°20.4′ N. lat, proceeding due east. Any water and land to the north and east of that boundary is considered, for the purposes of quota monitoring and setting of quotas, to be within the Atlantic region. This inseason action only affects the aggregated LCS and hammerhead shark management groups in the Atlantic region.

Under § 635.24(a)(8), NMFS may adjust the commercial retention limits in the shark fisheries during the fishing season. Before making any adjustment, NMFS must consider specified regulatory criteria and other relevant factors (see § 635.24(a)(8)(i) through (vi)). After considering these criteria as discussed below, NMFS has concluded that increasing the retention limit of the Atlantic aggregated LCS and hammerhead management groups for directed shark limited access permit holders will allow use of available aggregated LCS and hammerhead shark management group quotas and will provide fishermen throughout the Atlantic region equitable fishing opportunities for the rest of the year. Therefore, NMFS is increasing the commercial Atlantic aggregated LCS and hammerhead shark retention limit in the Atlantic region from 3 to 36 LCS other than sandbar shark per vessel per trip. Based on public comments NMFS received during the rulemaking for the 2017 Atlantic Shark Commercial Fishing Season Rule (81 FR 84491; November 23, 2016), constituents preferred the historical retention limit of 36 LCS other than sandbars sharks per vessel per trip to the default retention limit of 45 LCS other than sandbars sharks per vessel per trip, because they believed it would ensure the quota lasted longer and the fishing season could stay open later in the year.

NMFS considered the inseason retention limit adjustment criteria listed at § 635.24(a)(8)(i) through (vi), which includes (broken down by bullet points):

• The amount of remaining shark quota in the relevant area, region, or sub-region, to date, based on dealer reports.

Based on dealer reports through June 16, 2017, 52.6 metric tons (mt) dressed weight (dw) (116,048 pounds (lb) dw), or 31 percent, of the 168.9 mt dw shark quota for aggregated LCS and 4.9 mt dw (10,836 lb dw), or 18 percent, of the 27.1 mt dw shark quota for the hammerhead management groups have been harvested in the Atlantic region. This means that approximately 69 percent of the aggregated LCS quota remains available and approximately 82 percent of the hammerhead shark quota remains available. NMFS took action previously this year to reduce retention rates, after considering the need for all regions to have an equitable opportunity to utilize the quota. Given the geographic distribution of the sharks at this time of year (i.e., they are heading north before moving south again later in the year), the retention limit needs to be adjusted upwards to ensure that fishermen in the Atlantic region have an opportunity to fully utilize the quotas in the region throughout the remainder of the year.

• The catch rates of the relevant shark species/complexes in the region or sub-region, to date, based on dealer reports.

Based on the current commercial retention limit and average catch rate of landings data from dealer reports, the amount of aggregated LCS and hammerhead sharks harvested in the Atlantic region on a daily basis is low. Using current catch rates, projections indicate that landings would not reach 80 percent of the quota before the end of the 2017 fishing season (December 31, 2017). In other words, this daily average catch rate means that aggregated LCS and hammerhead sharks are being harvested too slowly to promote fishing opportunities and ensure full utilization of the quota in the Atlantic region.

• Estimated date of fishery closure based on when the landings are projected to reach 80 percent of the quota given the realized catch rates.

Once the landings reach 80 percent of either the aggregated LCS or hammerhead shark quotas, NMFS would, as required by the regulations, close the aggregated LCS and hammerhead shark management groups since they are “linked quotas.” Current catch rates would likely result in the fisheries remaining open for the remainder of the year, but with the quotas being underutilized in the Atlantic region. The higher retention limit should help make it possible to more fully utilize the quota in the Atlantic region.

• Effects of the adjustment on accomplishing the objectives of the 2006 Consolidated HMS FMP and its amendments.

Increasing the retention limit on the aggregated LCS and hammerhead management group in the Atlantic region from 3 to 36 LCS other than sandbar sharks per vessel per trip would allow for fishing opportunities later in the year, consistent with the FMP's objective to ensure equitable fishing opportunities throughout the fishing season. The higher retention limit is also consistent with the FMP's objective to limit bycatch and discards of sharks, because fishermen will be able to retain sharks that currently must be disposed of as bycatch or discards under the current retention limit of 3 LCS other than sandbar sharks per vessel per trip.

• Variations in seasonal distribution, abundance, or migratory patterns of the relevant shark species based on scientific and fishery-based knowledge.

The directed shark fisheries in the Atlantic region exhibit a mixed species composition, with a high abundance of aggregated LCS caught in conjunction with hammerhead sharks. Migratory patterns of many LCS in the Atlantic region indicate the sharks move farther north in the summer and then return south in the fall. Increasing the retention limit in the Atlantic region at this time provides for fishing opportunities by fishermen farther north as the sharks are likely going to be in the northern areas of the region for only a short period of time before migrating south again. As a result, by increasing the harvest and landings on a per-trip basis, fishermen throughout the region will likely experience equitable fishing opportunities.

• Effects of catch rates in one part of a region or sub-region precluding vessels in another part of that region or sub-region from having a reasonable opportunity to harvest a portion of the relevant quota.

NMFS has previously provided notice to the regulated community (81 FR 84491; November 23, 2016, and 82 FR 17765; April 13, 2017) that a goal of this year's fishery is to ensure fishing opportunities throughout the fishing season and fishing region. While dealer reports indicate that, under current catch rates, the aggregated LCS and hammerhead shark management groups in the Atlantic region would remain open for the remainder of the year, the catch rates also indicate that the quotas would likely not be fully harvested under the current retention limit. If the harvest of these species is increased through an increased retention limit, NMFS estimates that the fishery would still remain open for the remainder of the year and fishermen throughout the Atlantic region would have a reasonable opportunity to harvest a portion of the quota.

On November 23, 2016 (81 FR 84491), NMFS announced in a final rule that the aggregated LCS and hammerhead shark fisheries management groups for the Atlantic region would open on January 1 with a quota of 168.9 mt dw (372,552 lb dw) and 27.1 mt dw (59,736 lb dw), respectively. We had published a proposed rule on August 29, 2016 (81 FR 59167) and accepted public comment. In the final rule, NMFS also announced that if it appeared that the quota is being harvested too quickly, thus precluding fishing opportunities throughout the entire region (e.g., if approximately 20 percent of the quota is caught at the beginning of the year), NMFS would consider reducing the commercial retention limit to 3 or fewer LCS other than sandbar sharks and then later consider increasing the retention limit, perhaps to 36 LCS other than sandbar sharks per vessel per trip around July 15, 2017, consistent with the applicable regulatory requirements. In April 2017, dealer reports indicated that landings had exceeded 20 percent of the quota, and NMFS therefore reduced the commercial Atlantic aggregated LCS and hammerhead shark retention limit from 25 to 3 LCS other than sandbar sharks per vessel per trip on April 6, 2017 (82 FR 17765; April 13, 2017) after considering the inseason retention limit adjustment criteria listed in § 635.24(a)(8). Based on dealer reports through June 16, 2017, approximately 69 percent and 82 percent of the aggregated LCS and hammerhead shark quotas remain, respectively. At this point in the season, fishermen in the Atlantic region may not have an opportunity to fully utilize the quotas in the region for the remainder of the year if the retention limits are not increased, and available quota will be underutilized.

Accordingly, as of July 16, 2017, NMFS is increasing the retention limit for the commercial aggregated LCS and hammerhead shark management groups in the Atlantic region for directed shark limited access permit holders from 3 LCS other than sandbar sharks per vessel per trip to 36 LCS other than sandbar sharks per vessel per trip. This retention limit adjustment does not apply to directed shark limited access permit holders if the vessel is properly permitted to operate as a charter vessel or headboat for HMS and is engaged in a for-hire trip, in which case the recreational retention limits for sharks and “no sale” provisions apply (§ 635.22(a) and (c)); or if the vessel possesses a valid shark research permit under § 635.32 and a NMFS-approved observer is onboard, in which case the restrictions noted on the shark research permit apply.

All other retention limits and shark fisheries in the Atlantic region remain unchanged. This retention limit will remain at 36 LCS other than sandbar sharks per vessel per trip for the rest of the 2017 fishing season, or until NMFS announces via a document in the Federal Register another adjustment to the retention limit or a fishery closure, if warranted.

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

Prior notice is impracticable because the regulatory criteria for inseason retention limit adjustments are intended to allow the agency to respond quickly to existing management considerations, including remaining available shark quotas, estimated dates for the fishery closures, the regional variations in the shark fisheries, and equitable fishing opportunities. Additionally, regulations implementing Amendment 6 of the 2006 Atlantic Consolidated HMS FMP (80 FR 50074, August 18, 2015) intended that the LCS retention limit could be adjusted quickly throughout the fishing season to provide management flexibility for the shark fisheries and provide equitable fishing opportunities to fishermen throughout a region. Based on available shark quotas and informed by shark landings in previous seasons, responsive adjustment to the LCS commercial retention limit from the incidental level is warranted as quickly as possible to allow fishermen to take advantage of available quotas while sharks are present in their region. For such adjustment to be practicable, it must occur in a timeframe that allows fishermen to take advantage of it.

Adjustment of the LCS fisheries retention limit in the Atlantic region will begin on July 16, 2017. Prior notice would result in delays in increasing the retention limit and would adversely affect those shark fishermen that would otherwise have an opportunity to harvest more than the current retention limit of 3 LCS other than sandbar sharks per vessel per trip and could result in low catch rates and underutilized quotas. Analysis of available data shows that adjustment of the LCS commercial retention limit upward to 36 would result in minimal risks of exceeding the aggregated LCS and hammerhead shark quotas in the Atlantic region based on our consideration of previous years' data, in which the fisheries have opened in July. With quota available and with no measurable impacts to the stocks expected, it would be contrary to the public interest to require vessels to wait to harvest the sharks otherwise allowable through this action. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. Adjustment of the LCS commercial retention limit in the Atlantic region is effective July 16, 2017, to minimize any unnecessary disruption in fishing patterns, to allow the impacted fishermen to benefit from the adjustment, and to not preclude fishing opportunities by fishermen farther north as the sharks are likely going to be in the northern areas of the region for only a short period of time before migrating south again. Foregoing opportunities to harvest the respective quotas could have negative social and economic impacts for U.S. fishermen that depend upon catching the available quotas. Therefore, the AA finds there is also good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness.

This action is being taken under § 635.24(a)(2) and is exempt from review under Executive Order 12866.