Federal Register Vol. 83, No.176,

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain RRD Tay 620-15 turbofan engines. The NPRM published in the Federal Register on April 30, 2018 (83 FR 18758). The NPRM was prompted by reports of LPC fan blade retention lug failures. The NPRM proposed to require reviewing the engine maintenance records and replacing the LPC fan blade with a part eligible for installation if the DFL treatment limit is exceeded. We are issuing this AD to address the unsafe condition on these products.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2018-0013, dated January 17, 2018 (referred to after this as “the MCAI”), to address the unsafe condition on these products. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0235.

We gave the public the opportunity to participate in developing this final rule. We received no comments on the NPRM or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting this final rule as proposed except for minor editorial changes.

• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

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

We reviewed RRD ALERT NMSB TAY-72-A1834, dated November 17, 2017. The Alert NMSB describes procedures for reviewing the maintenance records and replacing the LPC fan blade with a serviceable part. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We reviewed RRD NMSB TAY-70-1050, Revision 9, dated July 14, 2010. The NMSB defines a basic engine life management program suitable for RRD Tay engines in aircraft that are engaged in non-airline operations.

We estimate that this AD affects 25 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 is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.

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 this AD:

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

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

(3) Will not affect intrastate aviation in Alaska, 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:

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 proposed 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 establishes Class E airspace at Chebeague Island Heliport, Chebeague Island, ME, to support IFR operations in standard instrument approach procedures at this heliport.

The FAA published a notice of proposed rulemaking in the Federal Register (83 FR 29064, June 22, 2018) for Docket No. FAA-2018-0475 to establish Class E airspace extending upward from 700 feet above the surface at Chebeague Island Heliport, Chebeague Island, ME. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

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

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

This amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface within a 6-mile radius of Chebeague Island Heliport, Chebeague Island, ME, providing the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures. These changes are necessary for continued safety and management of IFR operations at Chebeague Island Heliport.

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

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

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

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 E airspace at Bloomsburg Municipal Airport, Bloomsburg, PA, to support IFR operations at the airport.

The FAA published a notice of proposed rulemaking in the Federal Register for Docket No. FAA-2017-1043 (83 FR 29066, June 22, 2018) proposing to amend Class E airspace extending upward from 700 feet or more above the surface within an 11.8-mile radius at Bloomsburg Municipal Airport, Bloomsburg, PA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

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

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

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by amending Class E airspace extending upward from 700 feet or more above the surface within an 11.8-mile radius (increased from a 6.3-mile radius) of Bloomsburg Municipal Airport, Bloomsburg, PA, due to the decommissioning of the Milton VORTAC, and cancellation of the VOR approach. These changes enhance the safety and management of IFR operations at the airport.

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

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

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

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

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 will amend Class D airspace, at Appleton International Airport, Appleton, WI, to support instrument flight rules (IFR) operations at the airport.

The FAA published a notice of proposed rulemaking (NPRM) in the Federal Register (83 FR 11445; March 15, 2018) for Docket No. FAA-2018-0006 to modify Class D airspace at Appleton International Airport, Appleton, WI. 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 airspace designations are published in paragraph 5000 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class D airspace designations listed in this document will be published subsequently in the Order.

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

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class D airspace extending upward from the surface to and including 3,400 feet MSL within a 4.2-mile radius (decreased from a 4.4-mile radius) of Appleton International Airport (formerly Outagamie County Airport), Appleton, WI. Airspace reconfiguration is necessary due to the decommissioning of the GAMIE LOM/OM.

This action also updates the airport name and geographic coordinates of the airport to coincide with the FAA's aeronautical database.

Additionally, this action makes an editorial change to the Class D airspace legal description replacing “Airport/Facility Directory” with the term “Chart Supplement”.

Finally, an editorial change would be made removing the name of the city associated with the airport name in the airspace designation to comply with a recent change to FAA Order 7400.2L, Procedures for Handling Airspace Actions, dated October 12, 2017.

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:

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 Olive Branch Airport, Olive Branch, MS, to support IFR operations at the airport.

The FAA published a final rule in the Federal Register (83 FR 36402; July 30, 2018) for Docket No. FAA-2017-0866 amending Class D airspace, removing Class E airspace, and establishing Class E airspace at Olive Branch Airport, Olive Branch, MS.

Subsequent to publication, the FAA discovered the Memphis Class B airspace exclusionary language was omitted from the Class D legal description of the airport. This rule adds the Class B exclusionary language back into the legal description.

Class D airspace designations are published in paragraph 5000, of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR part 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.

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

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by adding to the Class D legal description for Olive Branch Airport, Olive Branch, MS, the following text that reads “excluding that airspace within the Memphis Class B airspace area.”

Accordingly, action is take herein to add this exclusion of Memphis Class B airspace to the legal description in the interest of flight safety. Therefore, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest.

To avoid confusion on the part of pilots flying in the vicinity of Olive Branch Airport, Olive Branch, MS, the FAA finds good cause, pursuant to 5 U.S.C. 553(d), for making this rule effective in less than 30 days in order to promote the safe and efficient handling of air traffic in the area.

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

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

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

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 E airspace at Williamsport Regional Airport, Williamsport, PA, and Williamsport Hospital Medical Center Heliport, to support standard instrument approach procedures for IFR operations in the area.

The FAA published a notice of proposed rulemaking (NPRM) in the Federal Register (83 FR 25967, June 5, 2018) for Docket No. FAA-2018-0322 to amend Class D airspace, Class E surface airspace, Class E airspace designated as an extension to a Class D surface area, and Class E airspace extending upward from 700 feet or more above the surface at Williamsport Regional Airport, Williamsport, PA.

Subsequent to publication, the FAA found that the name of Williamsport Hospital has changed to Williamsport Hospital Medical Center Heliport, and is corrected in this rule.

Also, we are not retaining the proposal as stated, and only going forward with amending Class E airspace extending upward from 700 feet above the surface at Williamsport Regional Airport. The previous amendments proposed in the NPRM have been executed in a final rule published August 3, 2018 (83 FR 38016).

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

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

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

This amendment to Title 14 Code of Federal Regulations (14 CFR) amends part 71 by amending Class E airspace extending upward from 700 feet or more above the surface at Williamsport Regional Airport to within a 12.6-mile radius of the airport due to the decommissioning of the Picture Rocks NDB, and cancellation of the NDB approach. The Williamsport Regional Airport ILS localizer is removed as it is no longer needed to define the boundary. Also, the name of Williamsport Hospital is changed to Williamsport Hospital Medical Center Heliport.

We have removed the amendments that were made for Williamsport Regional Airport noted in Class D airspace, Class E surface airspace, and Class E airspace designated as an extension to a Class D surface area, as they were addressed in a separate rulemaking (FR 83 38016).

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

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

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, 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 makes a clerical correction removing the NOTAM part-time status from the Class E airspace area designated as an extension at Lynchburg Regional Airport-Preston Glenn Field, Lynchburg, VA.

The FAA Aeronautical Information Services branch found the Class E airspace area designated as an extension to a Class D surface area at Lynchburg Regional Airport-Preston Glenn Field Airport, Lynchburg, VA, was incorrectly identified as part time. This action also changes the airport name to Lynchburg Regional Airport-Preston Glenn Field.

Class E airspace designations are published in paragraph 6004 of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

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

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by removing the NOTAM part-time status from the Class E airspace area designated as an extension to a Class D airspace at Lynchburg Regional Airport-Preston Glenn Field Airport, Lynchburg, VA. The airport name also is changed from Lynchburg Regional-Preston Glenn Field to Lynchburg Regional Airport-Preston Glenn Field.

This is an administrative change and does not affect the boundaries, or operating requirements of the airspace, therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.

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

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.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:

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 and Class E airspace at Bowman Field Airport, Louisville, KY, to support IFR operations at the airport.

The FAA published a final rule in the Federal Register (82 FR 50506; November 1, 2017) for Docket No. FAA-2016-9499 amending Class D airspace, and Class E surface airspace at Bowman Field Airport, Louisville, KY.

Subsequent to publication, the FAA discovered the Louisville Standiford Field Class C airspace exclusionary language was omitted from the Class D legal description of the airport. This rule adds the Class C exclusionary language into the legal descriptions, noting the airport name change to Louisville International Airport.

An editorial change is made that removes the airport name from the Louisville, KY, airspace designation, and the city from the airport name.

Class D airspace and Class E surface airspace designations are published in paragraph 5000, and 6002 of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR part 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.

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

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by adding to the Class D and Class E surface area legal descriptions for Bowman Field Airport, Louisville, KY, the following text that reads “excluding that portion within the Louisville International Airport Class C airspace area, and excluding that portion south of the 081° bearing from Louisville International Airport, and also excluding that portion north of the Louisville International Airport Class C airspace area and west of a line drawn from lat. 38°11′28″ N long. 85°42′01″ W direct thru the point where the 030° bearing from Louisville International Airport intersects the 5-mile radius from Louisville International Airport to the point of intersection with the 3.9-mile radius from Bowman Field Airport.” This action makes an editorial change to the Louisville, KY, airspace designation by removing the airport name of Bowman Field. This action also removes the city name (Louisville) from the airport name of Bowman Field Airport, to comply with FAA Order 7400.2L, Procedures for Handling Airspace Matters.

Accordingly, action is take herein to add this exclusion of Louisville International Airport Class C airspace to the legal description for Bowman Field Airport, Louisville, KY, in the interest of flight safety. Therefore, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest.

To avoid confusion on the part of pilots flying in the area of Bowman Field Airport, Louisville, KY, the FAA finds good cause, pursuant to 5 U.S.C. 553(d), for making this rule effective in less than 30 days in order to promote the safe and efficient handling of air traffic in the area.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The final regulations (TD 9836) that are the subject of this correction are under section 170 of the Internal Revenue Code.

As published July 30, 2018 (83 FR 36417), the final regulations (TD 9836) contain an error that needs to be corrected.

Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:

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

The drawspan will be secured in the closed-to-navigation position from 7 a.m. to 10 a.m. on October 6, 2018, to allow the community to participate in the Sacramento Century Challenge bicycle race. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised. Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

I. Background

In an action published on June 21, 2018 (83 FR 28789), EPA proposed to approve changes to the North Carolina SIP, submitted by the NC DEQ to EPA through a letter dated October 17, 2017.1 The details of North Carolina's submittal and the rationale for EPA's actions are explained in the proposal notice and briefly summarized below. EPA did not receive any adverse comments on the proposed action.

EPA is approving two actions with regard to North Carolina's SIP submittal updating the State's PSD regulations found at 15A North Carolina Administrative Code (NCAC) 02D .0530. First, EPA is approving North Carolina's October 17, 2017, SIP submittal with regard to changes to the State's regulation at 15A NCAC 02D .0530 because EPA has determined that the State's changes fully meet the requirements of EPA's rulemaking, “Prevention of Significant Deterioration (PSD) for Particulate Matter Less Than 2.5 Micrometers (PM2.5)—Increments, Significant Impact Levels (SILs) and Significant Monitoring Concentration (SMC),” Final Rule, 75 FR 64864 (October 20, 2010) (hereafter referred to as the “2010 PSD PM2.5 Rule”). Second, as a result of the approval of North Carolina's October 17, 2017, SIP submittal for these PSD requirements, EPA is approving this submittal for portions of the infrastructure SIP PSD elements for the following NAAQS: 1997 Annual and 24-hour PM2.5; 2006 24-hour PM2.5; 2008 lead; 2008 8-hour ozone; 2010 SO2; 2010 NO2; and 2012 Annual PM2.5.2 3

North Carolina's October 17, 2017, SIP submittal adopts changes in the State's PSD permitting program at 15A NCAC 02D .0530 by incorporating by reference EPA's PSD regulations as of July 1, 2014. This incorporation by reference includes the federally-required provisions of EPA's 2010 PSD PM2.5 Rule needed to implement the PSD PM2.5 program in North Carolina. Adopting the federal rule as of July 1, 2014, has the effect of adding to the North Carolina SIP the required definitions of “major source baseline date,” “minor source baseline date,” and “baseline area” that were lacking in the State's previous PM2.5 submittals. This incorporation by reference as of July 1, 2014, also captures EPA's October 25, 2012 (77 FR 65107), amendment to the definition of “regulated NSR pollutant” concerning condensable particulate matter. North Carolina's incorporation by reference of EPA's PSD regulations as of July 1, 2014, is not only consistent with the current federal rule, but it also will not interfere with North Carolina's efforts to prevent significant deterioration of air quality and to attain and maintain compliance with the PM2.5 NAAQS.

Because North Carolina's October 17, 2017, SIP submittal addresses certain NSR/PSD requirements, it thereby meets the related infrastructure SIP requirements of section 110(a)(2)(C), 110(a)(2)(D)(i)(II) and 110(a)(2)(J). As finalized, North Carolina's SIP includes a complete PSD program that addresses all structural PSD requirements due under the CAA and EPA regulations. Therefore, because EPA is approving North Carolina's SIP revisions for the PSD program, it is also approving the October 17, 2017, submittal for the PSD infrastructure SIP requirements of sections 110(a)(2)(C), 110(a)(2)(D)(i)(II), and 110(a)(2)(J) for the 2008 lead NAAQS, 2008 ozone NAAQS, 2010 SO2 NAAQS, 2010 NO2 NAAQS, and 1997, 2006 and 2012 PM2.5 NAAQS.4

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of North Carolina's regulations 15A NCAC 02D .0530, entitled “Prevention of Significant Deterioration,” which modify the NSR permitting regulations, effective September 1, 2017. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 Office (please contact the person identified in the “For Further Information Contact” section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.5

EPA is approving changes to the North Carolina SIP, provided by the NC DEQ, to EPA through a letter dated October 17, 2017. Specifically, EPA is approving changes to North Carolina's NSR permitting regulations codified at 15A 02D .0530—Prevention of Significant Deterioration, which relate to the requirements to comply with EPA's 2010 PSD PM2.5 Rule. EPA also notes that North Carolina's incorporation by reference of EPA's PSD regulations as of July 1, 2014, includes EPA's amendment to the definition of “regulated NSR pollutant” concerning condensable PM promulgated on October 25, 2012. EPA is approving the version of 15A NCAC 02D .0530 (PSD) that became effective in the State on September 1, 2017, which will be incorporated into North Carolina's SIP. As a result of this approval, EPA is also approving portions of the PSD elements of North Carolina's infrastructure SIP submittals (i.e., CAA sections 110(a)(2)(C), 110(a)(2)(D)(i)(II), and 110(a)(2)(J)) for the 1997 Annual and 24-hour PM2.5, 2006 24-hour PM2.5, 2008 lead, 2008 8-hour ozone, 2010 SO2, 2010 NO2 and the 2012 Annual PM2.5 NAAQS. This final action removes EPA's obligation under section 110(c) to promulgate a FIP to address the PM2.5 increments requirements of EPA's 2010 PSD PM2.5 Rule PSD and the related PSD elements for the above listed infrastructure SIPs.

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

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 13, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, it is intended to refer to the EPA.

On May 11, 2018, the EPA proposed to approve the redesignation request and limited maintenance plan (LMP) submitted by the Idaho Department of Environmental Quality (IDEQ) on September 29, 2017, for the City of Pinehurst PM10 Nonattainment Area and the Pinehurst PM10 Expansion Nonattainment Area, collectively referred to as the Pinehurst PM10 Nonattainment Area (Pinehurst PM10 NAA).

Related to this action, the EPA is taking final agency action on the EPA's concurrence with the IDEQ's request for exclusion of data measured on September 15, 2013, as a high wind exceptional event at the Pinehurst monitoring station, as set forth in the March 2, 2017 letter to the IDEQ, included in the docket. The Clean Air Act (CAA) allows for the exclusion of air quality monitoring data from design value calculations when there are exceedances caused by events, such as wildfires or high wind events, that meet the criteria for an exceptional event identified in the EPA's implementing regulations, the Exceptional Events Rule at 40 CFR 50.1, 50.14 and 51.930. In 2013, emissions from a high wind event entrained dust and impacted PM10 concentrations recorded at the Pinehurst monitor. The EPA evaluated the IDEQ's exceptional event demonstration for the flagged values of the 24-hour PM10 NAAQS for September 15, 2013, at the monitor in Pinehurst, Idaho, with respect to the requirements of the EPA's Exceptional Events Rule and determined that IDEQ met the rule requirements.

Separately, the EPA also proposed approval of the base year emissions inventory for the West Silver Valley (WSV) PM2.5 Nonattainment Area (NAA). Section 172(c)(3) of the CAA requires a state with an area designated as nonattainment to submit a “comprehensive, accurate, current inventory of actual emissions from all sources of the relevant pollutant” for the NAA. The IDEQ developed a 2013 base year emissions inventory for the WSV annual PM2.5 NAA. The base year emissions inventory includes data from 2013 and 2014 and in large part was extracted from the 2014 periodic emissions inventory which is used to populate the EPA's National Emissions Inventory. The 2013 base year inventory is one of the three years used to designate the area as nonattainment. This base year inventory presents direct PM2.5 emissions (condensable and filterable) and emissions of all PM2.5 precursors (NOX, VOCs, NH3, and SO2) to meet the emissions inventory requirements of CAA section 172(c)(3) and 40 CFR 51.1008(a)(1). The EPA has reviewed the results, procedures, and methodologies for the WSV Annual PM2.5 NAA base year emissions inventory. The EPA determined that the 2013 base year emissions inventory for the WSV annual PM2.5 NAA met the requirements of CAA section 172(c)(3) and 40 CFR 51.1008(a)(1).

An explanation of the CAA requirements, a detailed analysis of the submittal, and the EPA's reasons for proposing approval were provided in the notice of proposed rulemaking (83 FR 21976), and will not be restated here. The public comment period for this proposed rule ended on June 11, 2018. The EPA received adverse comments on the proposal.

The Idaho Conservation League (ICL) submitted adverse comments on our proposed approval of the Pinehurst PM10 NAA redesignation request and LMP. Within this section, we have summarized the adverse comments and provided our responses. A full copy of comments received is available in the docket for this final action.

Summary—The ICL comment letter asserts the “EPA must reject Idaho DEQ's request for redesignation of the Pinehurst NAA” because the state has not met the redesignation requirements in CAA section 107(d)(3)(E)(iii). The ICL cites the EPA's September 4, 1992, guidance, which, among other things, addresses emissions reductions based on permanent and enforceable measures (Memorandum from John Calcagni, Director, Air Quality Management Division, EPA Office of Air Quality Planning and Standards, entitled “Procedures for Processing Requests to Redesignate Areas to Attainment” (Calcagni Memo)). The ICL comment letter provides examples of nonattainment areas redesignated for PM10 and ozone in Ohio, Colorado, and Idaho, which use local rules, laws, and ordinances to provide for permanent and enforceable emissions reductions. The comment letter states that the IDEQ and City of Pinehurst were aware of the need for permanent and enforceable measures, citing discussion notes taken during a 2016 advisory committee session for the West Silver Valley PM2.5 NAA, an overlapping area designated nonattainment for the 2012 annual PM2.5 NAAQS. The ICL comment letter concludes that the control measures and associated emissions reductions are not permanent nor enforceable.

Response—We disagree with the commenter. Measures to attain the 24-hour PM10 NAAQS were submitted by IDEQ on April 14, 1992, and approved into the SIP on August 25, 1994 (59 FR 43745). In the August 25, 1994 action, the EPA evaluated the IDEQ's submittal with respect to the CAA section 172 requirements, including the Reasonably Available Control Measures and their enforceability. The EPA approved the control measures into the SIP at 40 CFR part 52, subpart N as meeting CAA requirements and making them, along with the attainment plan itself, federally enforceable (59 FR 43745). Once approved, the state is subject to CAA section 179(a)(4), which provides that a state can be subject to federal sanctions for not implementing any requirement of an approved plan or part of an approved plan, unless the deficiency is corrected within 18 months.

Reviewing the specific plan measures, the IDEQ has implemented woodstove replacements and home weatherization since the early 1990s in the Pinehurst PM10 NAA. As identified in Table 9 of the IDEQ submittal, the woodstove changeout program resulted in 76 uncertified woodstoves being replaced by 1994, with an additional 87 between 1995 and 2014 and 40 more between 2015 and 2017. These measures have been implemented through a variety of programs and agencies. Changeouts of uncertified woodstoves were completed through a combined Federal assistance grant and state and local loan program. This combined program was administered by the Northern Idaho Community Action Agency. The home weatherization program was run through the Idaho Economic Opportunity Office with loan and grant funding supplied by the Idaho Department of Water Resources, Farmers Home Administration, Washington Water Power, and North Idaho Community Action Agency. In terms of emissions reductions, when comparing the emissions inventories from residential wood combustion from 1988 to 2013, they dropped 80.25 lb/day (27.45%) during the winter season when particulate matter emissions are often the highest (Table 8 of the IDEQ submittal). These reductions are permanent in that both the woodstove replacement and the reduced energy needs from improved home energy efficiency via weatherization generally last and extend throughout the life of the home.1 Any subsequent home modification would likely improve, if not maintain, emissions reductions, and benefits are expected to be net positive given that emissions of EPA-certified stoves are estimated to be on average three to four times lower than uncertified stoves.2 The remaining measures, including the public awareness campaign focused on clean burning practices and the voluntary woodsmoke curtailment programs are all helpful in supporting the reduction of woodsmoke emissions in the area.

Additionally, the EPA recently awarded IDEQ a 2015 Targeted Airshed Grant for the West Silver Valley PM2.5 NAA. As a condition of the grant agreement with the EPA, the IDEQ committed to replace 183 uncertified wood heating devices and provide the associated emissions reductions. Each homeowner receiving a changeout must sign a certification document to ensure that they will remove an uncertified wood heating device from their home and agree to have two follow-up home inspections on the new certified device, commit to proper wood burning practices, and commit to not replacing the device with another solid fuel burning device. All removed stoves are rendered permanently and irreversibly inoperable and are properly disposed. We believe the grant terms and conditions and the homeowner certifications provide additional enforceability for purposes of maintaining the PM10 standard in the area.

While not specifically taken credit for in the original attainment plan nor the LMP, road dust control has played an important part in the area. It is the second largest source of pollution according to the emissions inventory, and the area has taken measures to reduce emissions through paving roads, maintenance of roads, and adjusting street sweeping to reduce particulate matter. With respect to permanence of road controls, once paved their associated emissions will be reduced and road maintenance will ensure lasting emissions reductions. We received clarification from the IDEQ that since 2016, the majority of roads (over 10 miles in a city roughly 1 square mile) in the Pinehurst area have been rebuilt or sealed.

We have reviewed monitoring data for the area with respect to the permanence of the emissions reductions. In Table 2 of the IDEQ submittal, monitoring data is provided from 1986 through 2015. From 1986 through 1993, the Pinehurst PM10 NAA was regularly recording values above 100 µg/m3, and exceeded the 3-year expected exceedances design value of 1.0. From 1994 through 2015, Table 2 shows that the area has consistently met the 24-hour PM10 standard, and the EPA has reviewed and confirmed the data. As noted in the submittal, the area came into attainment in the same timeframe as the IDEQ's completion of the first batch of woodstove changeouts (76 by 1994). The area has continued to meet the 24-hour PM10 NAAQS design value since 1994, and it has also shown a continued decrease in maximum annual 24-hr PM10 concentrations. Additionally, the EPA has determined that the Pinehurst PM10 NAA meets the 5-year average design value for LMP qualification as identified in the proposal.

Since the proposal, the IDEQ has submitted and the EPA has reviewed and concurred on the IDEQ's demonstration that elevated PM10 concentrations on three days in September 2017 were attributable to wildfire exceptional events and qualify for exclusion under EPA's Exceptional Events Rule. The August 24, 2018 concurrence letter to the IDEQ is included in the docket. With the exceptional event days excluded, the area continues to meet the LMP average design value for the most recent 5-year period, through 2017. The EPA intends to propose final agency action on these 2017 exceptional events in a forthcoming action.

Based on the IDEQ PM10 LMP submission and the EPA's review of air quality monitoring data, it is reasonable to conclude that the measures to reduce PM10 in the Pinehurst PM10 NAA have contributed to permanent emissions reductions. Emissions reductions in the area have been maintained since 1994, and enforceable control measures remain in place as approved into the SIP. We therefore conclude that the area has met its obligations with regard to permanent and enforceable measures to maintain the 24-hour PM10 standard and that no further action is required.

Summary—The ICL requests that the EPA explain why the LMP and the EPA's subsequent analysis only evaluated the 24-hour PM10 LMP design value and not the annual PM10 LMP design value. The commenter asserts that both are required.

Response—On August 9, 2001, the EPA issued guidance on streamlined maintenance plan provisions for certain moderate PM10 nonattainment areas seeking redesignation to attainment (Memorandum from Lydia Wegman, Director, Air Quality Standards and Strategies Division, entitled “Limited Maintenance Plan Option for Moderate PM10 Nonattainment Areas” (LMP Option Memo)). Section IV of the LMP Option Memo discusses LMP qualification and qualifying design values specifically. It states that “[t]he area should be attaining the NAAQS and the average PM10 design value for the area, based on the most recent 5 years of air quality data at all monitors in the area, should be at or below 40 μg/m3 for the annual PM10 NAAQS and 98 μg/m3 for the 24-hr PM10 NAAQS with no violations at any monitor in the nonattainment area.”

To qualify for the LMP option, the area must meet the design value test with respect to the standard for which the area was designated nonattainment.3 The Pinehurst PM10 NAA was designated nonattainment for the 24-hr PM10 NAAQS and therefore the appropriate statistical test is with respect to the 98 µg/m3 5-year average design value. The EPA has confirmed that the area meets the 5-year average design value of 98 µg/m3. We believe that the IDEQ has met the requirements of the LMP with regards to the 24-hr PM10 standard and the IDEQ does not need to address the annual PM10 standard.

Summary—The ICL states that they are concerned about recent actions and statements by federal agencies that may affect vehicle emissions reductions in the future, and how that may affect the Pinehurst PM10 NAA ability to attain and its permanence. The ICL comment letter specifically points to the IDEQ's reference to Tier 3 vehicle standards and the EPA's proposal to reduce Corporate Average Fuel Economy (CAFE) standards. The comment then requests that the EPA “identify any and all of its models and analyses that may be impacted by current and proposed deregulation of vehicle emissions. Furthermore, we request that any vehicle emission model or emission factor for PM10 be revised such that the models and factors are not based on any federal emission regulation currently under judicial or administrative review.”

Response—We do not agree with the commenter's assertion regarding the impact of current or proposed changes to motor vehicle emissions standards on the proposed action, because the Pinehurst PM10 NAA does not rely on motor vehicle emissions reductions for attainment or its continued maintenance of the NAAQS. Additionally, there are no proposed changes to Tier 3 vehicle standards and proposed CAFE standards have minimal effect on criteria pollutants, their focus instead being on greenhouse gas emissions reductions.

When reviewing the submitted Pinehurst PM10 2013 Emissions Inventory in Table 7 of the IDEQ's submittal, the primary source of PM10 is residential wood combustion at 17.75 tons per year (TPY), which is 44.5% of the PM10 emissions in the area. Road dust, paved and unpaved, is the next largest contributor at a cumulative 8.91 TPY, or 22.3% of emissions. Cumulatively, residential wood combustion and road dust make up 66.8% of the emissions inventory. During winter days when particulate matter levels are often higher, residential wood combustion is 212.05 lb/day, which is 82.17% of the PM10 emissions in the area (Table 8). Paved road dust (unpaved is no longer part of the emissions inventory), is the next largest contributor at a 25.38 lb/day, or 9.83% of emissions. Residential wood combustion currently makes up the majority of the emissions inventory. Motor vehicle emissions by comparison make up a very small portion of the emissions inventory at 1.84 TPY(annual) and 11.09 lb/day(winter), or less than 5% of both the annual and winter emissions inventories. This is expected as motor vehicle emissions do not contribute large quantities of PM10.

As described in section 3.4 Control Measures and section 3.2.2 Emissions Inventory Results and Adequacy Determination, the Pinehurst PM10 LMP focuses primarily on the reduction of PM10 emissions from residential woodsmoke and from road dust from paved and unpaved roads. The Pinehurst PM10 LMP itself does not take credit for emissions reductions from motor vehicle emissions reductions nor does it rely on it for continued attainment of the PM10 NAAQS.

As mentioned in the proposal, the Pinehurst area has met the PM10 3-year design value of expected exceedance of 1.0 or less since 1994. Additionally, the Pinehurst area has only recorded one value (in 2010) above 98 µg/m3 since 1999 that was not the result of an exceptional event. The area has demonstrated, and EPA has confirmed, that the 3-yr and 5-yr design values qualify for the LMP option. Additionally, the area has demonstrated that it meets the LMP motor vehicle regional analysis, which assesses increases in emissions based on the area's growth rate as applied to paved road dust emissions, unpaved road dust emissions, and mobile source emissions. It is this last category where the ICL comment questions if any changes in federal emissions requirements would affect the area's ability to attain. As explained above, motor vehicle emissions in the Pinehurst NAA are not expected to affect the areas ability to continue to attain as they are less than 5% and were not taken credit for in the attainment plan, nor the redesignation request and LMP.

While we do not believe that any changes to motor vehicle emissions are relevant to the area's ability to attain, we did a basic evaluation to determine if the area would continue to meet the LMP motor vehicle regional analysis. The only portion of the calculation that would change would be the on-road mobile source. Currently, that value is calculated using the formula in the LMP Option Memo: DV mobile * VMT paved, where the DV mobile provides a 3.6509 μg/m3 contribution to the design value and VMT paved is the 0.0166 percent growth rate (3.6509 * 0.0166 = 0.06 μg/m3 contribution). Given that the growth rate in Pinehurst is very small, any potential changes to the emissions standards would have a small effect on the design value. Taking a conservative assumption and doubling the DV mobile from 3.6509 μg/m3 to 7.3018 μg/m3, and applying the 0.0166 growth rate would only increase the mobile contribution from 0.06 µg/m3 contribution to 0.12 µg/m3 contribution and the Pinehurst area would still be able meet the motor vehicle regional analysis test. Given the small contribution of motor vehicle emissions and low growth rate in the Pinehurst area, we believe the Pinehurst PM10 NAA LMP is sufficient and no further action is required.

The ICL's request that the EPA identify and revise all of its models, analyses, and emissions factors that may be impacted by current or proposed changes to vehicle emissions standards is outside of the scope of this action.

Summary—The ICL requested that the EPA confirm that all woodstoves replaced were “Phase II,” and to require that the IDEQ revise calculations in the case that any of the replacements were not Phase II. The ICL asserts that the IDEQ used incorrect emissions factors based on a comparison of AP-42 emissions factors to those used by IDEQ in the Pinehurst PM10 LMP, and requests an explanation for this or revision, whichever is more appropriate.

Response—We disagree that the IDEQ used incorrect emissions factors and do not believe that any further calculations are needed. In 1988, the EPA finalized the residential wood heaters new source performance standards (NSPS) that required performance standards for woodstoves. These performance standards were released in two phases; Phase I went into effect immediately in 1988, and Phase II went into effect in 1990. The Phase II performance standards required that catalytic stoves have an emission rate of 4.1g/hr or less and non-catalytic stoves have an emissions rate of 7.5 g/hr or less. All stoves that have been replaced in Pinehurst occurred after Phase II standards were in place. Additionally, we have received confirmation from IDEQ that these changeouts were completed and that they were Phase II EPA certified stoves.

With regard to the ICL's request for explanation of the emissions factors used, we reviewed the emissions factors (EFs) for residential wood combustion that IDEQ used and found them consistent with the EPA EFs and methodology used in the 2014 National Emissions Inventory. The IDEQ used EFs derived from EPA's Residential Wood Combustion Emissions Estimation Tool version 3.1 (October 2016) that are more up to date than the EFs in AP-42, which were last updated in 1996 for this source category. We have included in the docket the documentation for v3.1 and 3.2 of the Residential Wood Combustion Emissions Estimation Tool, which has the emissions factors used and the references for those EFs. Both versions of the tool use the same EFs.

In response to the comment, we have confirmed with the IDEQ that the changeouts were with phase II or better EPA certified stoves. We have also confirmed that the IDEQ emissions inventory assumptions and calculations are correct and that the appropriate EFs were used.

Summary—The ICL requested that the EPA further explain how the IDEQ's Contingency Plan is compliant with section 175A of the CAA. The comment provides a summary with references to CAA section 175A, the Calcagni Memo that provides guidance for maintenance plans, and the LMP Option Memo that provides guidance for LMPs.

Response—While the commenter correctly identifies that CAA section 175A provides the statutory requirements for maintenance plan requirements, and that the LMP Option Memo provides guidance for contingency provisions under the LMP option, the ICL's contention that contingency provisions 4 must be fully adopted and take effect within one year and without further legislative action is incorrect. These requirements do not appear in the CAA section 175A requirements nor the LMP Option Memo, and are contradicted by the Calcagni Memo, EPA's long-standing interpretation of redesignation and maintenance plan requirements. There, it states, “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 Memo at 12; see also Greenbaum v. EPA, 370 F.3d 527, 541 (6th Cir. 2004) (upholding this portion of the Calcagni Memo).

CAA section 175A(d) and EPA's interpretation of that provision as set out in the Calcagni Memo and the LMP Option Memo provide the standards by which the EPA must evaluate contingency plans. Section 175A(d) states that “[e]ach plan revision submitted under this section shall contain such contingency provisions as the Administrator deems necessary to assure that the State will promptly correct any violation of the standard which occurs after the redesignation of the area as an attainment area. Such provisions shall include a requirement that the State will implement all measures with respect to the control of the air pollutant concerned which were contained in the State implementation plan for the area before redesignation of the area as an attainment area.” The Calcagni Memo and the LMP Option memo further elaborate that “Section 175A of the Act states that a maintenance plan must include contingency provisions, as necessary, to promptly correct any violation of the NAAQS which may occur after redesignation of the area to attainment. These contingency measures do not have to be fully adopted at the time of redesignation. However, the contingency plan is considered to be an enforceable part of the SIP and the State should ensure that the contingency measures are adopted as soon as possible once they are triggered by a specific event. The contingency plan should identify the measures to be adopted, and provide a schedule and procedure for adoption and implementation of the measures if they are required. Normally, the implementation of contingency measures is triggered by a violation of the NAAQS but the State may wish to establish other triggers to prevent a violation of the NAAQS, such as an exceedance of the NAAQS.”

The EPA has determined that the IDEQ's contingency plan meets the requirements of Section 175A(d) and the EPA's guidance memos. Section 3.5 of the IDEQ's submittal confirms that all measures relied upon for attainment, including woodstove changeouts, voluntary curtailment program, home weatherization, and public awareness campaign continue to be in place and will be strengthened if the PM10 standard is exceeded. If the Pinehurst area exceeds the standard, Section 3.5.1 identifies the Annual Network Plan monitoring data as the triggering mechanism for contingency provisions. A violation cited in the Annual Network Plan would trigger a schedule and process for IDEQ to examine the data, assess the source of the problem, and identify which contingency provision to adopt and implement. The submitted plan lists potential provisions focused on control of woodsmoke and road dust, the two primary sources of PM10 in the nonattainment area. The submitted contingency provisions meet the CAA section 175A requirement to continue implementing measures relied upon for attainment. There is an automatic process on a set schedule by which the Pinehurst area's design value is evaluated annually (i.e., the Annual Network Plan submittal-review-approval), and a violation would trigger the state to be required to evaluate, identify, adopt, and implement contingency provisions best suited towards bringing the area back into attainment. Therefore, the EPA is finalizing approval of the IDEQ's plan as meeting the requirements of section 175A.

The EPA is approving the Pinehurst PM10 NAA LMP submitted by the IDEQ and concurrently redesignating the area to attainment for the PM10 NAAQS. Related to this action, the EPA is taking final agency action on the September 15, 2013, high wind exceptional event at the Pinehurst monitoring station. Additionally, the EPA is approving the West Silver Valley annual PM2.5 base year emissions inventory as meeting CAA section 172(c)(3) requirements.

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 Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 13, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

For the reasons set forth in the preamble, 40 CFR parts 52 and 81 are amended as follows:

I. Background

On November 12, 2008 (73 FR 66964), EPA promulgated a revised primary and secondary lead NAAQS of 0.15 micrograms per cubic meter (µg/m3). Under EPA's regulations at 40 CFR part 50, the 2008 lead NAAQS are met when the maximum arithmetic 3-month mean concentration for a 3-year period, as determined in accordance with appendix R of 40 CFR part 50, is less than or equal to 0.15 µg/m3. See 40 CFR 50.16. Ambient air quality monitoring data for the 3-year period must meet a data completeness requirement.

EPA designated the Hillsborough Area as a nonattainment area for the 2008 lead NAAQS on November 22, 2010 (75 FR 71033), effective December 31, 2010, using 2007-2009 ambient air quality data. On March 26, 2018, Florida submitted a request for EPA to redesignate the Hillsborough Area to attainment for the 2008 lead NAAQS and submitted an associated SIP revision containing a maintenance plan for the Area. In a notice of proposed rulemaking (NPRM), published June 19, 2018 (83 FR 28402), EPA proposed to determine that the Hillsborough Area is attaining the 2008 lead NAAQS, based on complete, quality-assured, and certified ambient monitoring data for the 2014-2016 time period and continues to attain based on complete, quality-assured, and certified ambient monitoring data for the 2015-2017 time period; proposed to approve the SIP revision containing the State's maintenance plan for maintaining attainment of the 2008 lead standard; and proposed to redesignate the Hillsborough Area to attainment for the 2008 lead NAAQS.1 The details of Florida's SIP revision and redesignation request, as well as the rationale for EPA's actions, are further explained in the NPRM. Comments on the proposed rulemaking were due on or before July 19, 2018. EPA did not receive any adverse comments on the proposed actions.

Approval of Florida's redesignation request changes the legal designation of the portion of Hillsborough County, Florida, that is designated as nonattainment, found at 40 CFR 81.310, from nonattainment to attainment for the 2008 lead NAAQS. Approval of Florida's associated SIP revision also incorporates a plan into the SIP for maintaining the 2008 lead NAAQS in the Hillsborough Area through 2029.

EPA is taking three separate but related final actions regarding Florida's March 26, 2018, redesignation request and associated SIP revision for the Hillsborough Area.

First, EPA is determining that the Area attained the 2008 lead NAAQS based on complete, quality-assured, and certified ambient monitoring data for the 2014-2016 period and that the Area continues to attain the standard based on complete, quality-assured, and certified ambient monitoring data for the 2015-2017 period.

Second, EPA is approving the maintenance plan for the Area and incorporating it into the Florida SIP. As described in the NPRM, the maintenance plan demonstrates that the Area will continue to maintain the 2008 lead NAAQS through 2029.

Third, EPA is approving Florida's request for redesignation of the Area from nonattainment to attainment for the 2008 lead NAAQS. This final rule approves the redesignation request for the Hillsborough Area and changes the official designation of the portion of Hillsborough County, Florida, bounded by a 1.5 km radius centered at UTM coordinates 364104 meters East, 3093830 meters North, Zone 17, which surrounds Envirofocus, as found at 40 CFR part 81, from nonattainment to attainment for the 2008 lead NAAQS.

Under the CAA, redesignation of an area to attainment and the accompanying approval of a maintenance plan under section 107(d)(3)(E) are actions that affect the status of a geographical area and do not impose any additional regulatory requirements on sources beyond those imposed by state law. A redesignation to attainment does not in and of itself create any new requirements, but rather results in the applicability of requirements contained in the CAA for areas that have been redesignated to attainment. Moreover, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, these actions merely approve state law as meeting Federal requirements and do not impose additional requirements beyond those imposed by state law. For this reason, these actions:

• Are not significant regulatory actions 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);

• Are not Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory actions because SIP approvals and redesignations are exempted under Executive Order 12866;

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

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

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

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

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

• Are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

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

• Will not have disproportionate human health or environmental effects under Executive Order 12898 (59 FR 7629, February 16, 1994).

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 13, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR parts 52 and 81 are amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2018-0263 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 November 13, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2018-0263, 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 June 14, 2018 (83 FR 27743) (FRL-9978-41), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a(d)(3), announcing the receipt of a pesticide petition (PP IN-11151) filed by Spring Trading Company on behalf of BASF Corporation, 100 Park Avenue, Florham Park, New Jersey 07932. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate; CAS Reg. No. 58499-26-6. That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any comments.

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

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

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

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

2. The polymer does contain as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur.

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

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

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

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

7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as listed in 40 CFR 723.250(d)(6).

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

8. The polymer's number average MW of 3,600 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.

Thus, 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate.

For the purposes of assessing potential exposure under this exemption, EPA considered that 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate is 3,600 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

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

EPA has not found 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate to share a common mechanism of toxicity with any other substances, and 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

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

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate.

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

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

The Codex has not established a MRL for 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate.

Accordingly, EPA finds that exempting residues of 2-propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate from the requirement of a tolerance will be safe.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 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-2017-0591 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 November 13, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0591, 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 March 21, 2018 (83 FR 12311) (FRL-9974-76), 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 IN-11030) by the Interregional Research Project No. 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.560 be amended by establishing tolerances for residues of the cloquintocet-mexyl (acetic acid, [(5-chloro-8-quinolinyl)oxy]-, 1-methylhexyl ester) (CAS Reg. No. 99607-70-2) and its acid metabolite (5-chloro-8-quinlinoxyacetic acid), for use as an inert ingredient (safener) in combination with the active ingredients florasulam, fluroxypyr 1-methylhelptyl ester and pyroxsulam in or on teff, forage at 0.2 ppm; teff, grain at 0.1 ppm; teff, hay at 0.5 ppm; and teff, straw at 0.1 ppm parts per million (ppm). That document referenced a summary of the petition prepared by the Interregional Research Project No. 4 (IR-4), the petitioner, which is available in the docket, http://www.regulations.gov. There were no relevant comments received in response to the notice of filing.

Based upon the fact that tolerances for cloquintocet-mexyl when used with the active ingredient pyroxsulam have previously been established under 40 CFR 180.560, the Agency's evaluation of the subject tolerance petition is limited to the use of cloquintocet-mexyl with the active ingredients florasulam and fluroxypyr 1-methylhelptyl ester on teff only.

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 cloquintocet-mexyl (acetic acid, [(5-chloro-8-quinolinyl)oxy]-, 1-methylhexyl ester) and its acid metabolite (5-chloro-8-quinolinoxyacetic acid) in or on teff forage, grain, hay and straw, consistent with FFDCA section 408(b)(2).

In the Federal Register of August 2, 2016 (81 FR 50630) (FRL-9947-78), EPA established tolerances for residues of cloquintocet-mexyl and its acid metabolite (5-chloro-8-quinolinoxyacetic acid) when used in pesticide formulations containing the active ingredient halauxifen-methyl, in or on barley grain, barley hay, barley straw, and wheat forage, wheat grain, wheat hay, and wheat straw. EPA is relying upon the risk assessments that supported the findings made in the August 2, 2016, Federal Register document in support of this action. The toxicity profile of cloquintocet-mexyl has not changed, and the previous risk assessments that supported the establishment of those tolerances remain valid.

The Agency evaluated the request to establish tolerances in or on teff forage, grain, hay, and straw. Teff is prepared like other whole grains, such as rice and barley, and may also be used to make flour in a manner similar to wheat and other cereal grains. In considering likely residue levels on teff, EPA concludes that because of the similarity in application rates for pesticides containing cloquintocet-mexyl between teff and wheat, the likely decline in residue levels as teff moves through commerce, and the similarities to other small grains in terms of morphology, taxonomy and cultural practices, residue levels of cloquintocet-mexyl on teff will be similar to residue levels on wheat. The lack of teff consumption data being reported in the available food consumption data indicates a very low overall consumption of teff in the United States. When teff is consumed in the U.S., it is typically consumed in place of wheat. Using these assumptions regarding likely residue levels and consumption, EPA concludes that aggregate exposure and risk estimates resulting from cloquintocet-mexyl residues in/on teff would not be substantially different than those presented in the most recent human health risk assessment and published in the August 2, 2016 final rule. As those risk estimates were not of concern to the Agency, 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 cloquintocet-mexyl residues. For a detailed discussion of the aggregate risk assessments and determination of safety for these tolerances, please refer to the August 2, 2016, Federal Register document and its supporting documents, available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2012-0843. Further information about EPA's determination that an updated risk assessment was not necessary may be found in the document, “Cloquintocet-mexyl-Human Health Risk Assessment of Tolerances without a U.S. Registration for Use on Teff” in docket ID number EPA-HQ-OPP-2016-0299.

For specific information on the studies received and the nature of the adverse effects caused by cloquintocet-mexyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies, the reader is referred to the final rule published in the Federal Register of December 16, 2005 (70 FR 74679) (FRL-7753-4); Docket ID number EPA-HQ-OPP-2005-0234.

Adequate enforcement methodology, chromatography with ultraviolet detection (HPLC-UV for cloquintocet-mexyl and its acid metabolite, are available to enforce the tolerance expression.

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 cloquintocet-mexyl (acetic acid, [(5-chloro-8-quiniolinyl)oxy]-, 1-methylhexyl ester) and its acid metabolite (5-chloro-8-quinlinoxyacetic acid) on teff.

Therefore, tolerances are established for residues of cloquintocet-mexyl (acetic acid, [(5-chloro-8-quiniolinyl)oxy]-, 1-methylhexyl ester) and its acid metabolite (5-chloro-8-quinlinoxyacetic acid), for use as an inert ingredient (safener) when used in formulations with the active ingredients florasulam and fluroxypyr 1-methylhelptyl ester in or on teff, forage at 0.2 ppm; teff, grain at 0.1 ppm; teff, hay at 0.5 ppm; and teff, straw at 0.1 ppm.

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), nor is it a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” ((82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

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

Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 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-2017-0505 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 November 13, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0505, 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 27, 2018 (83 FR 8408) (FRL-9972-17), 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 7E8584) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of spiromesifen; 2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate, and its enol metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one calculated as the stoichiometric equivalent of spiromesifen in or on the raw agricultural commodities: Coffee bean, green at 0.20 parts per million (ppm); coffee, instant at 0.20 ppm; and coffee bean, roasted at 0.20 ppm. That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has modified the commodities for which tolerances are being established. The reason for these changes is explained in Unit IV.D.

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 spiromesifen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with spiromesifen 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.

Following oral administration of spiromesifen, the target organs included the thyroid gland for rats and dogs (increased thyroid-stimulating hormone (TSH), increased thyroxine binding capacity, decreased triiodothyronine (T3) and thyroxine (T4) levels, colloidal alteration, and thyroid follicular cell hypertrophy), the liver for rats and dogs (increased alkaline phosphatase, alanine transaminase (ALT), and decreased cholesterol and triglycerides), the spleen for rats (atrophy, decreased spleen cell count, and increased macrophages), and the adrenal gland for mice (discoloration, decrease in fine vesiculation, and the presence of cytoplasmic eosinophilia in zona fasciculata cells). For rats, additional effects included reduced body weights and clinical signs (piloerection, reduced motility, spastic gait, and increased reactivity when touched).

There were no adverse effects in rats following dermal exposure up to the limit dose (1,000 milligrams/kilograms/day (mg/kg/day)). Decreased spleen weights were also observed for rats in a 5-day inhalation toxicity study, along with gross pathological findings in the lung (dark red areas or foci) and clinical signs (e.g., tremors, clonic-tonic convulsions, reduced activity, bradypnea, etc.).

While the clinical signs observed in rats following oral and inhalation exposures could indicate neurotoxicity, there was no evidence of neurotoxicity in the rest of the toxicological database, including the acute neurotoxicity study up to the limit dose (2,000 milligrams/kilograms (mg/kg)) and the subchronic neurotoxicity study; however, the doses tested in the subchronic neurotoxicity study were lower than the doses causing clinical signs in the 90-day dietary study in rats. There was no evidence of immunotoxicity in an antibody plaque-cell forming assay.

There was no evidence of increased pre- or post-natal susceptibility. In the developmental toxicity studies in rats and rabbits, maternal effects were observed in the absence of fetal effects. In the rat two-generation reproductive toxicity study, the reported parental effects, consisting of decreased spleen weights (relative and absolute) and a decreasing number of ovarian follicles, occurred at a dose level that also caused pup body weight decrements during lactation.

Spiromesifen is classified as “Not likely to be Carcinogenic to Humans” based on the absence of treatment-related tumors in two adequate rodent carcinogenicity studies. There was no concern for mutagenicity or genotoxicity.

Specific information on the studies received and the nature of the adverse effects caused by spiromesifen 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 the document titled, “Spiromesifen. Human Health Risk Assessment in Support of Proposed Tolerance for Residues of in/on Imported Coffee” in docket ID number EPA-HQ-OPP-2017-0505.

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 the NOAEL and the LOAEL are identified. 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 spiromesifen used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to spiromesifen, EPA considered exposure under the petitioned-for tolerances as well as all existing spiromesifen tolerances in 40 CFR 180.607. EPA assessed dietary exposures from spiromesifen 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. No such effects were identified in the toxicological studies for spiromesifen; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA; 2003-2008). As to residue levels in food, the chronic (food and water) analysis assumed 100 percent crop treated (PCT) and tolerance-level residues or tolerance-level residues adjusted to account for the residue of concern.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that spiromesifen does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for spiromesifen. Tolerance level residues or tolerance-level residues adjusted to account for the residue of concern and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for spiromesifen in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of spiromesifen. 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 Provisional Cranberry model and Pesticide Water Calculator—Groundwater (PWC-GW) model, the estimated drinking water concentrations (EDWCs) of spiromesifen for chronic exposures are estimated to be 188 parts per billion (ppb) for surface water and 116 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the chronic dietary risk assessment, the water concentration of value 188 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).

Spiromesifen is currently registered for the following uses that could result in residential exposures: Ornamentals. EPA assessed residential exposure using the following assumptions: Short-term inhalation exposure to residential handlers is expected. A dermal assessment (handler and post-application) was not conducted since no hazard was identified via the dermal route. Post-application inhalation exposures were not assessed due to the low vapor pressure and the expected dilution in outdoor sites. Post-application incidental oral exposure is considered unlikely since the use is restricted to ornamental plants (turf treatment is not permitted). Therefore, only short-term inhalation exposure to handlers was assessed. 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.”

EPA has not found spiromesifen to share a common mechanism of toxicity with any other substances, and spiromesifen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that spiromesifen does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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

2. Prenatal and postnatal sensitivity. There was no evidence of increased pre- or post-natal susceptibility. In the developmental toxicity studies in rats and rabbits, maternal effects were observed in the absence of fetal effects. In the rat two-generation reproductive toxicity study, the reported parental effects, consisting of decreased spleen weights (relative and absolute) and a decreasing number of ovarian follicles, occurred at a dose level that also caused pup body weight decrements during lactation.

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 spiromesifen is complete.

ii. There is no indication that spiromesifen is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.

iii. There is no evidence that spiromesifen 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.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to spiromesifen in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by spiromesifen.

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

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

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to spiromesifen from food and water will utilize 68% of the cPAD for children 1 to 2 years 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 spiromesifen 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). Spiromesifen 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 spiromesifen.

Because the level of concern (LOC) for inhalation (LOC for MOEs <30) and oral (LOC for MOEs <100) exposure differ, the aggregate assessment was calculated using the aggregate risk index (ARI) approach. The ARI was devised as a way to aggregate MOEs that have dissimilar uncertainty factors. The ARI is an extension of the MOE concept and as with the MOE, risk increases as the ARI decreases. An ARI that is greater than or equal to 1 is not of concern.

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 an aggregate ARI of 1.87. Because EPA's level of concern for spiromesifen is an ARI of 1 or below, this ARI is 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, spiromesifen 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 spiromesifen.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, spiromesifen 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 spiromesifen residues.

Adequate enforcement methodology (liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS)) is available to enforce the tolerance expression.

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.

Codex has a MRL for residues of only spiromesifen in/on coffee beans of 0.05 ppm. Since the residue expression for the U.S. and Codex tolerances differ and since the maximum combined residues of spiromesifen and BSN 2060-enol in/on coffee green bean from the field trials was greater than 0.1 ppm, harmonization with the Codex expression/value is not possible. Note that BSN 2060-enol is included in the tolerance expression due to the demonstrated degradation of parent to BSN 2060-enol during storage.

Three comments were submitted to the docket for this action. Two comments, one about “China's ongoing economic war against the United States” and another about air and water pollution in China relative to that of the United States, are not relevant to this action. The third comment stated in part that “the people drinking coffee should not have this toxic chemical as part of its drink.”

The Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops; however, the existing legal framework provided by section 408 of the FFDCA states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework nor have they provided any specific information or allegation that would support a finding that these tolerances are unsafe.

The green coffee bean tolerance being established is identical to that proposed by the petitioner. EPA has determined that separate tolerances for the processed commodities of roasted coffee bean and instant coffee are unnecessary because the processing data indicates that combined residues of spiromesifen and BSN 2060-enol do not concentrate in roasted or instant coffee.

Therefore, a tolerance is established for residues of spiromesifen, including its metabolites and degradates, in or on coffee, green bean at 0.20 ppm.

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), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

U.S. purse seine fishing in the area of application of the Convention, or Convention Area, is managed, in part, under the Western and Central Pacific Fisheries Convention Implementation Act (16 U.S.C. 6901 et seq.). Regulations implementing the Act are at 50 CFR part 300, subpart O. On behalf of the Secretary of Commerce, NMFS promulgates regulations under the Act as may be necessary to carry out the obligations of the United States under the Convention, including implementation of the decisions of the Commission.

Pursuant to WCPFC Conservation and Management Measure 2017-01, NMFS issued regulations that established a limit of 1,370 fishing days that may be used by U.S. purse seine fishing vessels on the high seas between the latitudes of 20° N and 20° S in the Convention Area in calendar year 2018 (see final rule at 83 FR 33851, published July 18, 2018, codified at 50 CFR 300.223). A fishing day means any day in which a fishing vessel of the United States equipped with purse seine gear searches for fish, deploys a fish aggregating device (FAD), services a FAD, or sets a purse seine, with the exception of setting a purse seine solely for the purpose of testing or cleaning the gear and resulting in no catch (see definition at 50 CFR 300.211).

Based on data submitted in logbooks and other available information, NMFS expects that the 2018 limit of 1,370 fishing days will be reached, and in accordance with the procedures established at 50 CFR 300.223(a), announces that the purse seine fishery on the high seas between the latitudes of 20° N and 20° S in the Convention Area will be closed starting at 00:00 on September 18, 2018 UTC, and will remain closed until 24:00 on December 31, 2018 UTC. Accordingly, it shall be prohibited for any fishing vessel of the United States equipped with purse seine gear to be used for fishing on the high seas between the latitudes of 20° N and 20° S in the Convention Area from 00:00 on September 18, 2018 UTC until 24:00 December 31, 2018 UTC, except that such vessels will not be prohibited from bunkering in that area during that period (50 CFR 300.223(a)). Fishing means using any vessel, vehicle, aircraft or hovercraft for any of the following activities, or attempting to do so: (1) Searching for, catching, taking, or harvesting fish; (2) engaging in any other activity which can reasonably be expected to result in the locating, catching, taking, or harvesting of fish for any purpose; (3) placing, searching for, or recovering fish aggregating devices or associated electronic equipment such as radio beacons; (4) engaging in any operations at sea directly in support of, or in preparation for, any of the activities previously described in elements (1) through (3) of this definition, including, but not limited to, bunkering; or (5) engaging in transshipment at sea, either unloading or loading fish (see definition at 50 CFR 300.211). As noted above, bunkering will not be prohibited in the closure area during the closure period. This rule does not prohibit lawful fishing with purse seine gear within the U.S. Exclusive Economic Zone within the Convention Area.

There is good cause under 5 U.S.C. 553(b)(B) to waive prior notice and opportunity for public comment on this action. Compliance with the notice and comment requirement would be impracticable and contrary to the public interest, since NMFS would be unable to ensure that the 2018 limit on purse seine fishing effort on the high seas between the latitudes of 20° N and 20° S in the Convention Area is not exceeded. This action is based on the best available information on U.S. purse seine fishing effort in the limit area. The action is necessary for the United States to comply with its obligations under the Convention and is important for the conservation and management of bigeye tuna, yellowfin tuna, and skipjack tuna in the western and central Pacific Ocean. For the same reasons, there is good cause under 5 U.S.C. 553(d)(3) to establish an effective date less than 30 days after the date of publication of this notice.

This action is required by 50 CFR 300.223(a) and is exempt from review under Executive Order 12866.