Discussion

In May 2019, Boeing informed the FAA that alteration of thrust reverser upper locking actuators, in accordance with unapproved data in the Boeing AMM, could cause a locking mechanism failure of a thrust reverser upper locking actuator to remain undetected for thousands of flights.

Boeing informed the FAA of the risk that operators could use an existing AMM procedure that was intended for use in rigging a newly installed thrust reverser upper locking actuator to instead alter the functioning of a worn upper locking actuator's lock indication. That procedure removes material from the upper locking actuator's lock sensor target until the upper locking actuator's unlocked indication (the “REVERSER” light on the flight deck aft overhead panel, which is illuminated when the upper locking actuator is unlocked or when other system failures are detected) is no longer illuminated. However, that procedure does not require a check to verify that the thrust reverser upper locking actuator locking mechanism is operative or that the unlocked indication functions normally after removal of the material. As a result, it is possible that use of this procedure could prevent actuator unlocked indications to the flight crew if the thrust reverser upper locking actuator locking mechanism has already failed or subsequently fails.

An undetected unlocked thrust reverser upper locking actuator in flight significantly increases the likelihood of an in-flight deployment of the thrust reverser. In-flight thrust reverser deployment in some phases of flight would likely result in loss of airplane control.

The FAA is issuing this AD because the agency evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD requires revising the existing maintenance or inspection program to remove certain text from all locations in the existing maintenance and inspection program that instructs the maintainers to remove material from or grind or trim the sensor target of the thrust reverser upper locking actuator. For Model 737-600, -700, -700C, -800, -900, and -900ER series (737 NG) airplanes, this AD also requires repetitive integrity tests of the thrust reverser upper locking actuator.

The Model 737-8 and -9 (737 MAX) airplane fleet is a young fleet and those airplanes have not been subjected to enough wear to warrant the use by any operator of the sensor target trimming procedure that leads to the upper locking actuator lock indication failure that may exist on 737 NG airplanes. The FAA therefore has determined that the integrity test is not necessary for the 737 MAX fleet.

The FAA considers this AD interim action. The manufacturer is currently developing a modification that will address the unsafe condition identified in this AD. Once this modification is developed, approved, and available, the FAA might consider additional rulemaking.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C.) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without seeking comment prior to the rulemaking. Similarly, Section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies forgoing notice and comment prior to adoption of this rule because alteration of thrust reverser upper locking actuators in accordance with certain unapproved AMM data could cause a thrust reverser upper locking actuator that is unlocked in flight to remain undetected, which could significantly increase the likelihood of an in-flight deployment of the thrust reverser and consequent loss of airplane control. The compliance time for the required action is shorter than the time necessary for the public to comment and for publication of the final rule.

Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the reasons stated above, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, the FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2019-0696 and Product Identifier 2019-NM-136-AD at the beginning of your comments. The FAA specifically invites comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to http://www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact received about this final rule.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Christopher Baker, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3552; email: Christopher.R.Baker@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 2,149 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA has determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. In the past, the FAA has estimated that this action takes 1 work-hour per airplane. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the FAA estimates the total cost per operator to be $7,650 (90 work-hours x $85 per work-hour).

The FAA estimates the following costs to do any necessary replacement that would be required based on the results of the integrity test. The FAA has no way of determining the number of aircraft that might need this replacement:

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 the Class E airspace extending upward from 700 feet above the surface at Posey Field Airport, Haleyville, AL, and Marion County-Rankin Fite Airport, Hamilton, AL, to support IFR operations at these airports.

The FAA published a notice of proposed rulemaking in the Federal Register (84 FR 33022; July 11, 2019) for Docket No. FAA-2019-0502 to amend the Class E airspace extending upward from 700 feet above the surface at Posey Field Airport, Haleyville, AL, and Marion County-Rankin Fite Airport, Hamilton, AL. 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 7400.11D, dated August 8, 2019, and effective September 15, 2019, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019. FAA Order 7400.11D is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11D 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:

Amends the Class E airspace extending upward from 700 feet above the surface to within a 6.5-mile radius (increased from a 6.4-mile radius) at Posey Field Airport, Haleyville, AL; removes the city associated with the airport in the airspace legal description to comply with a change in FAA Order 7400.2M, Procedures for Handling Airspace Matters; removes the Hamilton VORTAC and associated extension from the airspace legal description; and adds an extension 2 miles each side of the 002° bearing from the airport extending from the 6.5-mile radius to 11 miles north of the airport;

And amends the Class E airspace extending upward from 700 feet above the surface to within a 6.5-mile radius (reduced from a 6.6-mile radius) of Marion County-Rankin Fite Airport, Hamilton, AL; removes the city associated with the airport in the airspace legal description to comply with a change in FAA Order 7400.2M; removes the Hamilton VORTAC and associated extension from the airspace legal description; adds an extension 4 miles each side of the 002° bearing from the airport extending from the 6.5-mile radius to 11.8 miles north of the airport; adds an extension 4 miles each side of the 182° bearing from the airport extending from the 6.5-mile radius to 11.4 miles south of the airport; and updates the name and geographic coordinates of the Marion County-Rankin Fite Airport (formerly Marion County Airport) to coincide with the FAA's aeronautical database.

This action is the result of an airspace review caused by the decommissioning of the Hamilton VOR, which provided navigation information for the instrument procedures at these airports, as part of the VOR MON Program.

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 the Class E airspace extending upward from 700 feet above the surface at Coles County Memorial Airport, Mattoon/Charleston, IL, and removes the Class E airspace extending upward from 700 feet above the surface at Piatt County Airport, Monticello, IL, to support IFR operations at the Coles County Memorial Airport.

The FAA published a notice of proposed rulemaking in the Federal Register (84 FR 33191; July 12, 2019) for Docket No. FAA-2019-0529 to amend the Class E airspace extending upward from 700 feet above the surface at Coles County Memorial Airport, Mattoon/Charleston, IL, and remove the Class E airspace extending upward from 700 feet above the surface at Piatt County Airport, Monticello, IL. 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 7400.11D, dated August 8, 2019, and effective September 15, 2019, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019. FAA Order 7400.11D is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11D 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:

Amends the Class E airspace extending upward from 700 feet above the surface to within a 6.6-mile radius (decreased from a 7-mile radius) of the Coles County Memorial Airport, Mattoon, IL; updates the name of the city to Mattoon/Charleston, IL (previously Mattoon, IL) to coincide with the FAA's aeronautical database; removes the city associated with the airport in the airspace legal description to comply with FAA Order 7400.2M, Procedures for Handling Airspace Matters; and updates the geographic coordinates of the airport to coincide with the FAA's aeronautic database;

And removes the Class E airspace extending upward from 700 feet above the surface at Piatt County Airport, Monticello, IL, due to the instrument procedures being cancelled and the airport being closed, so the airspace is no longer required.

Subsequent to publication, the FAA discovered a typographic error in the header of the airspace legal description removing the Monticello, IL, airspace. The header is corrected from “AGL MN E5 Monticello, IL [Removed]” to “AGL IL E5 Monticello, IL [Removed].” All else remains the same.

This action is the result of an airspace review caused by the decommissioning of the Mattoon VOR, which provided navigation information for the instrument procedures at these airports, as part of the VOR MON Program.

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 the Class E surface airspace and the Class E airspace extending upward from 700 feet above the surface at Fairmont Municipal Airport, Fairmont, MN, to support IFR operations at this airport.

The FAA published a notice of proposed rulemaking in the Federal Register (84 FR 33194; July 12, 2019) for Docket No. FAA-2019-0471 to amend the Class E surface airspace and the Class E airspace extending upward from 700 feet above the surface at Fairmont Municipal Airport, Fairmont, MN. 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 6002 and 6005 of FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019. FAA Order 7400.11D is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11D 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:

Amends the Class E surface airspace to within a 4.1-mile radius (increased from a 4-mile radius) of the Fairmont Municipal Airport, Fairmont, MN; removes the extensions to the airspace, as they are no longer needed; updates the geographic coordinates of the airport to coincide with the FAA's aeronautic database; and updates the outdated term “Airport/Facility Directory” with “Chart Supplement”;

And amends the Class E airspace extending upward from 700 feet above the surface to within a 6.6-mile radius (increased from a 6.5-mile radius) of the Fairmont Municipal Airport; removes the extensions, as they are no longer required; and updates the geographic coordinates of the airport to coincide with the FAA's aeronautical database.

This action is the result of an airspace review caused by the decommissioning of the Fairmont VOR, which provided navigation information for the instrument procedures at these airports, as part of the VOR MON Program.

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:

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 the Class E surface airspace and the Class E airspace extending upward from 700 feet above the surface and establishes a Class E airspace area designated as an extension to a Class C surface area at Huntsville International-Carl T. Jones Field, Huntsville, AL, to support instrument flight rule operations at this airport.

The FAA published a notice of proposed rulemaking in the Federal Register (84 FR 33196; July 12, 2019) for Docket No. FAA-2019-0530 to amend the Class E surface airspace and the Class E airspace extending upward from 700 feet above the surface and establish a Class E airspace area designated as an extension to a Class C surface area at Huntsville International-Carl T. Jones Field, Huntsville, AL. 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 6002, 6003, and 6005, respectively, of FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019. FAA Order 7400.11D is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11D 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:

Amends the Class E surface airspace at Huntsville International-Carl T. Jones Field, Huntsville, AL, by updating the city in the airspace legal description to Huntsville, AL (previously Huntsville International-Carl T. Jones Field, AL), to comply with a change to FAA Order 7400.2M, Procedures for Handling Airspace Matters; updates the geographic coordinates of the Huntsville International-Carl T. Jones Field; updates the names of Huntsville International-Carl T. Jones Field (previously Huntsville International-Carl T. Jones Field Airport) and Redstone AAF (previously Redstone Army Air Field) to coincide with the FAA's aeronautical database; and replaces the outdated term “Airport/Facility Directory” with “Chart Supplement”;

Establishes a Class E airspace area designated as an extension to a Class C surface area at Huntsville International-Carl T. Jones Field extending 1 mile each side of the 181° bearing from the Huntsville International-Carl T. Jones Field: RWY 36L-LOC extending from the 5-mile radius of Huntsville International-Carl T. Jones Field to 6.3 miles south of the Huntsville International-Carl T. Jones Field: RWY 36L-LOC;

And amends the Class E airspace extending upward from 700 feet above the surface to within a 7.5-mile radius (reduced from an 8.2-mile radius) of Huntsville International-Carl T. Jones Field; adds an extension 3 miles each side of the 001° bearing from Huntsville International-Carl T. Jones Field extending from the 7.5-mile radius to 12.3 miles north of the Huntsville International-Carl T. Jones Field; adds an extension 1.3 miles each side of the 181° bearing from the Huntsville International-Carl T. Jones Field: RWY 36L-LOC extending from the 7.5-mile radius to 8.3 miles south of the Huntsville International-Carl T. Jones Field: RWY 36L-LOC; updates the names of Huntsville International-Carl T. Jones Field (previously Huntsville International-Carl T. Jones Airport), Pryor Field Regional Airport (previously Pryor Field), Decatur, AL, and Huntsville Executive Tom Sharp Jr. Field (previously Huntsville Airport North), Huntsville, AL, to coincide with the FAA's aeronautical database; and updates the geographic coordinates of Huntsville International-Carl T. Jones Field, Pryor Field Regional Airport, and Huntsville Executive Tom Sharp Jr. Field to coincide with the FAA's aeronautical database.

This action is the result of an airspace review caused by the decommissioning of the Decatur VOR, which provided navigation information for the instrument procedures at these airports, as part of the VOR MON Program.

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:

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking PATCOM Coast Guard Patrol Commander § Section U.S.C. United States Code II. Background Information and Regulatory History

OPA Racing LLC of Brick Township, NJ, notified the Coast Guard that it will be conducting the Ocean City Grand Prix between 9:00 a.m. and 5:00 p.m. on September 29, 2019, along a designated, marked racetrack-type course located in the North Atlantic Ocean, at Ocean City, MD. In response, on August 23, 2019, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Special Local Regulation; North Atlantic Ocean, Ocean City, MD” (84 FR 44263). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this power boat racing event. During the comment period that ended September 9, 2019, we received one comment.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable and contrary to public interest because it would delay the safety measures necessary to respond to potential safety hazards associated with this marine event. Immediate action is needed protect participants, spectators, and other persons and vessels during the high-speed race event on these navigable waters.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70041. The Captain of the Port Maryland-National Capital Region (COTP) has determined that potential hazards associated with the power boat racing event will be a safety concern for anyone intending to operate in or near the event area. The purpose of this rule is to protect event participants, spectators, and transiting vessels on specified waters of the North Atlantic Ocean before, during, and after the scheduled event.

As noted above, we received one comment on our NPRM published August 23, 2019. We thank the commenter for taking time to review the NPRM and submitting a comment regarding this action.

The commenter stated that the high-speed power boat racing event should be cancelled in order to not obstruct normal waterway operations and waste precious energy.

With few exceptions, normal waterway operations in the event area are recreational in nature that will be able to take place safely outside the regulated area. Waterway users that may be affected by the regulated area are well informed of this annually occurring offshore power boat racing event. Methods include Code of Federal Regulations, internet websites ( http://www.oparacing.org/oc.html, https://oceancitymd.gov/oc/event/ocean-city-powerboat-grand-prix/ ), regional boating publications ( i.e., PropTalk), social media ( i.e., Facebook), and local media outlets ( i.e., The Dispatch), which include newspaper, radio and television. The part of the comment regarding energy is outside the scope of the rulemaking; the regulated area is established to provide for waterway safety.

There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule establishes a special local regulation to be enforced from 8:30 a.m. to 5:30 p.m. on September 29, 2019. The regulated area will cover all navigable waters of the North Atlantic Ocean, within an area bounded by the following coordinates: Commencing at a point near the shoreline at latitude 38°21′42″ N, longitude 075°04′11″ W, thence east to latitude 38°21′33″ N, longitude 075°03′10″ W, thence southwest to latitude 38°19′25″ N, longitude 075°04′02″ W, thence west to the shoreline at latitude 38°19′35″ N, longitude 075°05′02″ W, at Ocean City, MD. The duration of the special local regulations and size of the regulated area are intended to ensure the safety of life on these navigable waters before, during, and after the power boat racing event, scheduled from 9:00 a.m. until 5:00 p.m. on September 29, 2019.

Except for participants and vessels already at berth, a vessel or person will be required to get permission from the COTP or PATCOM before entering the regulated area. Vessel operators can request permission to enter and transit through the regulated area by contacting the PATCOM on VHF-FM channel 16. Vessel traffic will be able to safely transit the regulated area once the PATCOM deems it safe to do so. A person or vessel not registered with the event sponsor as a participant or assigned as official patrols will be considered a spectator. Official Patrols are any vessel assigned or approved by the Commander, Coast Guard Sector Maryland-National Capital Region with a commissioned, warrant, or petty officer on board and displaying a Coast Guard ensign.

If permission is granted by the COTP or PATCOM, a person or vessel will be allowed to enter the regulated area or pass directly through the regulated area as instructed. Vessels will be required to operate at a safe speed that minimizes wake while within the regulated area. Official patrol vessels will direct spectator vessels while within the regulated area. Only participant vessels and official patrol vessels will be allowed to enter the race area.

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

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

This regulatory action determination is based on the size, duration and location of the regulated area. Vessel traffic will be able to safely transit around this regulated area, which would impact a small designated area of the North Atlantic Ocean for 9 hours. The Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the status of the regulated area. Moreover, the rule will allow vessels to seek permission to enter the regulated area, and vessel traffic will be able to safely transit the regulated area once the PATCOM deems it safe to do so.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves implementation of regulations within 33 CFR part 100 applicable to organized marine events on the navigable waters of the United States. The temporary regulated area will be in effect for nine hours. It is categorically excluded from further review under paragraph L61 in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. A Memorandum for the Record supporting this determination is available in the docket where indicated under ADDRESSES .

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

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

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

The M/V ZHEN HUA 26 is transporting post-Panamax gantry cranes to ports within the United States. These large cranes extend beyond the width of M/V ZHEN HUA 26 on both sides of the vessel and create a navigational hazard to vessels operating within a certain proximity. The cranes are fastened in a manner that facilitates passage through the open ocean. Upon arrival to the Delaware River, M/V ZHEN HUA 26 will transit to anchorage and begin an approximately four day process of removing the sea fastenings. The M/V ZHEN HUA 26 will then proceed, conditions permitting, to berth at the Port of Philadelphia Greenwich Terminal to deliver the cranes. To ensure a safe transit during its inbound transit from its initial anchorage to the Greenwich Terminal, the vessel may stop to anchor along the way in a designated anchorage area, as set forth in 33 CFR 110.157, for a short time if needed due to weather and tidal requirements.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable and contrary to the public interest. There is insufficient time to allow for a reasonable comment period prior to the anticipated arrival of M/V ZHEN HUA 26 to the Delaware Bay Captain of the Port zone. The rule must be in force by September 14, 2019, to ensure the safety of waterway users and the general public from hazards associated with the transport of post-Panamax gantry cranes within the Delaware Bay Captain of the Port Zone.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is needed to mitigate the potential safety hazards associated with transportation of post-Panamax gantry cranes from anchorage in Delaware Bay to its berth at Greenwich Terminal in Philadelphia, PA.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The COTP has determined that there are potential hazards associated with the transportation of post-Panamax gantry cranes. The COTP Delaware Bay has determined that the potential hazards will be a safety concern for anyone within a 200-yard radius of the vessel except when the vessel is moored at Greenwich Terminal in Philadelphia, Pennsylvania. This rule is needed to protect personnel and vessels in the navigable waters within the safety zone while the cranes are being transported.

The safety zone includes all navigable waters within 200 yards of M/V ZHEN HUA 26 when the vessel first anchors within the Delaware Bay Captain of the Port Zone until it completes its inbound transit to and mooring operations at Greenwich Terminal in Philadelphia. Because the vessel will not be carrying cranes on its outbound transit, this rule will not apply to its outbound transit. The anticipated date of arrival for the M/V ZHEN HUA 26 is September 14, 2019. However, inclement weather and other unforeseen circumstances may necessitate a change in the date of transit upriver. Sector Delaware Bay will notify the maritime community of the date of transit, at a minimum, via marine safety information bulletin and broadcast notice to mariners.

To ensure a safe transit during the inbound transit from the initial anchorage to Greenwich Terminal, the vessel may stop to anchor along the way in a designated anchorage area, as set forth in 33 CFR 110.157, for a short time if needed due to weather and tidal requirements. The safety zone will remain in place during the time(s) the vessel is anchored. Vessels will be allowed to transit through the safety zone without seeking advance permission from the COTP Delaware Bay while the M/V ZHEN HUA 26 is anchored in a designated anchorage area if they meet the following requirements: transit through the safety zone at the minimum safe speed to reduce wake and maintain steerage, and, except for towing vessels designated as assist tugs and operating in such capacity, do not overtake, meet, or otherwise pass any other unmoored or unanchored vessel while transiting through the safety zone. Vessels which do not meet all of the requirements listed above are prohibited from entering or transiting the safety zone without prior approval of the COTP Delaware Bay. Additionally, vessels must ask permission to enter or transit the safety zone any time the M/V ZHEN HUA 26 is underway. Vessels requesting to enter or transit the safety zone may contact the Sector Delaware Bay Command Center via VHF-FM channel 16. The Coast Guard anticipates that most vessels will be able to freely transit around the safety zone and will not need to seek permission to enter the zone while the M/V ZHEN HUA 26 is underway.

There will be a pre-designated safety vessel escorting the ZHEN HUA 26 while it is underway to monitor the flow of traffic and inform mariners that the gantry crane transit is in progress.

The Coast Guard is establishing a second safety zone through a separate rulemaking found in Docket number USCG-2019-0784 to ensure the safety of vessels and persons transiting the area during offloading operations once the vessel is moored at the terminal.

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

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

This regulatory action determination is based on the short duration and traffic management of the safety zone. The safety zone will allow for vessels to transit through the safety zone with permission while the M/V ZHEN HUA 26 is underway or in a designated anchorage without permission if certain requirements are met. The Coast Guard anticipates that most vessels will be able to freely transit around the safety zone and will not need to seek permission to enter the zone while the M/V ZHEN HUA 26 is underway. For these reasons, the impact on waterway traffic is expected to be minimal.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a moving safety zone lasting only the duration of transit of a vessel carrying post-Panamax gantry cranes. It is categorically excluded from further review under paragraph L60(a) in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES .

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

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

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port New York DHS Department of Homeland Security FR Federal Register LNM Local Notice to Mariners NPRM Notice of proposed rulemaking NYSDOT New York State Department of Transportation § Section U.S.C. United States Code II. Background Information and Regulatory History

Shoreside construction for Unionport Bridge replacement project started on July 17, 2017, and is tentatively scheduled for completion on, or about, July 13, 2021. During this project, removal and replacement of the original structure will take place. To accomplish these tasks, a temporary vertical lift bridge will be installed upstream, and downstream, of the original structure to facilitate construction and maintain shoreside vehicle traffic.

On November 27, 2018, Lane Construction, the contractor selected for the Unionport Bridge construction project, submitted their regulation request to the Waterways Management Division of U. S. Coast Guard Sector New York. Lane Construction requested a temporary safety zone be established, possibly lasting up to 96 hours, within a 500-foot radius of the New York State Department of Transportation (NYSDOT) I-95 bridge structures to the north, and south, of the Unionport (Bruckner Expressway) Bridge, construction vessels, and machinery, at mile 1.7 over Westchester Creek during the float-in, erection, and installation of two temporary vertical lift spans by barge. We anticipate enforcing the safety zone during the heavy lift operations, occurring between approximately February 25, 2019 and February 28, 2019. The safety zone is expected to be enforced for approximately one 96-hour period when vessels are preparing for and conducting the temporary bridge installation operations. The duration of enforcement for the safety zone is intended to protect personnel, vessels, and the marine environment in these waters while the temporary bridge is being installed. During the enforcement period, all vessels and persons must obtain permission from the Captain of the Port New York or a designated representative before entering the safety zone.

The temporary bridge installation operations could take place anytime between February 25, 2019 and May 1, 2019. However, we anticipated the installation operations to begin on February 25, 2019 sta. The Coast Guard is publishing this rule to be effective through May 01, 2019 in case the project is delayed due to unforeseen circumstances.

The Coast Guard will issue a LNM and/or a Broadcast Notice to Mariners via marine channel 16 (VHF-FM) with as much advance notice as possible for any period of waterway closure or as soon as practicable in response to unforeseen circumstances. Upon completion of temporary bridge installation bridges, enforcement of the safety zone will be suspended and notice given via Broadcast Notice to Mariners and LNM.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The late finalization of project details did not give the Coast Guard enough time to issue a modified bridge permit, publish an NPRM, take public comments, and issue a final rule before the installation of the two temporary vertical lift bridges is set to begin. It would be impracticable and contrary to the public interest to delay promulgating this rule as it is necessary to establish this safety zone before the temporary vertical lift bridge installations begin on, or about, February 25, 2019, to protect the safety of the waterway users, construction crew, and other personnel associated with the bridge replacement project. A delay of the replacement project to accommodate a full notice and comment period would delay necessary operations, result in increased costs, delay the date when the replacement project is expected to be completed, and open the new bridge for normal operations.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . For reasons stated in the preceding paragraph, delaying the effective date of this rule would be impracticable and contrary to the public interest because timely action is needed to respond to the potential safety hazards associated with the construction project.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP has determined that potential hazards associated with floating in of two, temporary vertical lift bridges starting on or about February 25, 2019. This rule is needed to protect personnel, vessels, and the marine environment on the navigable waters of Westchester Creek within the safety zone while the bridge replacement project is ongoing.

This rule establishes a safety zone from February 25, 2019 through May 31, 2019. The safety zone will cover all navigable waters from surface to bottom within a 500-foot radius of the New York State Department of Transportation (NYSDOT) I-95 bridge structures to the north, and south, of the Unionport (Bruckner Expressway) Bridge, construction vessels, and machinery at mile 1.7 over Westchester Creek. Chartlets of the area are available in the docket. When enforced, no vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

The Coast Guard will notify the public and local mariners of this safety zone through appropriate means, which may include, but are not limited to, publication in the LNM or Broadcast Notice to Mariners via marine Channel 16 (VHF-FM) in advance of any enforcement.

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

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

This regulatory action determination is based on the following reasons: (1) The safety zone only impacts a small designated area of Westchester Creek, (2) the safety zone will only be enforced for approximately 96 hours during the float-in, erection, and installation of two temporary vertical lift spans by barge or if there is an emergency or other unforeseen circumstance, (3) persons or vessels desiring to enter the safety zone may do so with permission from the COTP or a designated representative. The Coast Guard will notify the public of the enforcement of this rule via appropriate means, such as via LNM or Broadcast Notice to Mariners via marine channel 16 (VHF-FM).

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting up to 96 hours that will prohibit entry within a 500-foot radius of the New York State Department of Transportation (NYSDOT) I-95 bridge structures to the north, and south, of the Unionport (Bruckner Expressway) Bridge, construction vessels, and machinery at mile 1.7 over Westchester Creek. Channel openings may be requested by mariners before, or after, each work day when requested 24-hours in advance by mariners. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES .

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

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

The M/V ZHEN HUA 26 is transporting post-Panamax gantry cranes to ports within the United States. These large cranes extend beyond the width of M/V ZHEN HUA 26 on both sides of the vessel and create a navigational hazard to vessels operating within a certain proximity. The cranes are fastened in a manner which facilitates passage through the open ocean. Upon arrival to the Delaware River, M/V ZHEN HUA 26 will transit to anchorage and begin an approximately four day process of removing the sea fastenings. The M/V ZHEN HUA 26 will then proceed, conditions permitting, to berth at the Port of Philadelphia Greenwich Terminal where it will offload the cranes. Because offloading the cranes requires precise environmental conditions which passing traffic could disrupt, and with the consequences of failure being catastrophic to those in proximity to the operation, the facility, and the waterway, we are establishing a safety zone around the vessel while it is preparing for and conducting the operation to offload the cranes.

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable and contrary to the public interest. There is insufficient time to allow for a reasonable comment period prior to the anticipated arrival of M/V ZHEN HUA 26 to the Delaware Bay Captain of the Port zone. The rule must be in force by September 14, 2019, to serve its purpose of ensuring the safety of waterway users and the general public from hazards associated with the offloading of post-Panamax gantry cranes with the Delaware Bay Captain of the Port Zone.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable and contrary to the public interest because immediate action is needed to mitigate the potential safety hazards associated with the offloading of the post-Panamax gantry cranes.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The COTP has determined that there are potential hazards associated with the offloading of the post-Panamax gantry cranes. These potential hazards will be a safety concern for anyone transiting navigable waters of the Delaware River bounded to the south by a line drawn from the southeast corner of Pier 124S at 39°53′41″ N, 075°08′19″ W, thence east-southeast to the New Jersey Shoreline at 39°53′34″ N, 075°07′49″ W, and bounded to the north by the southernmost edge of the Walt Whitman Bridge.

This rule establishes a temporary safety zone on all waters of the Delaware River bounded to the south by a line drawn from the southeast corner of Pier 124S at 39°53′41″ N, 075°08′19″ W, thence east-southeast to the New Jersey Shoreline at 39°53′34″ N, 075°07′49″ W, and bounded to the north by the southernmost edge of the Walt Whitman Bridge. This safety zone is needed to protect personnel and vessels, in the navigable waters within the safety zone as well as persons on the adjacent shoreline during offloading of two Post-Panamax gantry cranes. This safety zone will be enforced for approximately seven days beginning from the time the M/V ZHEN HUA 26 arrives at berth at Greenwich Terminal until the vessel departs from the terminal, unless cancelled earlier by the COTP Delaware Bay. Enforcement of the safety zone will be announced via broadcast notice to mariners.

Vessels will be able to transit through the safety zone without permission from the COTP Delaware Bay if they meet the following requirements: (1) Transit through the safety zone at the minimum safe speed to reduce wake and maintain steerage, (2) except for towing vessels designated as assist tugs and operating in such capacity, do not overtake, meet, or otherwise pass any other unmoored or unanchored vessel while transiting through the safety zone, and (3) regardless of travel direction, vessels shall remain east of the centerline of the main navigation channel. The centerline is depicted on U. S. Electronic Navigational Chart US5PA12M and is a line drawn approximately from 39°53′39″ N, 075°08′11″ W, thence north-northeast to approximate position 39°54′20″ N, 075°07′54″ W. Vessels which do not meet all of the requirements listed above will be prohibited from entering or transiting the safety zone without prior approval of the COTP Delaware Bay. Vessels requesting to enter or transit the safety zone may contact the Sector Delaware Bay Command Center via VHF-FM channel 16.

Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.

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

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

This regulatory action determination is based on the short duration and traffic management of the safety zone. This rule will allow for vessels to transit through the safety zone while the M/V ZHEN HUA 26 moored at Greenwich Terminal in Port of Philadelphia, Pennsylvania if certain requirements are met, and the Coast Guard anticipates that most vessels will be able to freely transit around the safety zone and will not need to seek permission to enter the zone. For these reasons, the impact on waterway traffic is expected to be minimal.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment This rule involves a safety zone to be enforced only during the offload of a vessel carrying post-Panamax gantry cranes. It is categorically excluded from further review under paragraph L60(a) in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES .

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

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

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

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. 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:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after October 18, 2019 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

EPA is finalizing these SNURs under TSCA section 5(a)(2) for 19 substances which were the subject of PMNs. These SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.

In the Federal Register of August 27, 2018, (83 FR 43607) (FRL-9982-25), EPA proposed a SNUR for these 19 chemical substances in 40 CFR part 721 subpart E. More information on the specific chemical substances subject to this final rule can be found in the Federal Register documents for the direct final SNUR of August 27, 2019 (83 FR 43538)(FRL-9982-24). The record for the SNUR was established in the docket under docket ID number EPA-HQ-OPPT-2017-0464. That docket includes information considered by the Agency in developing the proposed and final rules.

EPA received public comments on the proposed rule. Those comments and EPA's responses are found in Unit IV.

TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). In the case of a determination other than not likely to present unreasonable risk, the applicable review period must also expire before manufacturing or processing for the new use may commence.

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. In the case of a determination other than not likely to present unreasonable risk, the applicable review period must also expire before manufacturing or processing for the new use may commence. If EPA determines that the use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings.

When the Agency issues an order under TSCA section 5(e), TSCA section 5(f)(4) requires that the Agency consider whether to promulgate a SNUR for any use not conforming to the restrictions of the TSCA section 5(e) Order or publish a statement describing the reasons for not initiating the rulemaking. TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four TSCA section 5(a)(2) factors listed in this unit.

EPA received public comments from 8 entities on the proposed rule. The Agency's responses are described in this unit.

EPA received 5 anonymous comments on the proposed rule. All of these comments were general in nature and not specific to or relevant to any of the proposed SNURs. No response is required.

One commenter commented on proposed SNURs for these isocyanate-based polymers or prepolymers: Polyethylene glycol polymer with aliphatic polycarbodiimide bis(alkoxysilylpropyl) amine blocked (generic) (PMN P-16-99, 40 CFR 721.11098); Blocked polyester polyurethane, neutralized (generic) P-16-363, 40 CFR 721.11101); Alkanediol, 2,2-bis (substituted alkyl)- polymer with substituted alkane, heteromonocycles, alkenoate (generic) (P-17-170, 40 CFR 721.11107); 1,3,5-Triazine-2,4-diamine, 6-phenyl-, reaction products with polyalkylene glycol mono- alkyl ether and 2,4-toluene diisocyanate (generic) (P-17-222, 40 CFR 721.11111); and Fatty acids, polymers with benzoic acid, cyclohexanedicarboxylic acid anhydride, aliphatic diisocyanate, alkyl diol, alkyl triol, pentaerythritol, phthalic anhydride, polyalkylene glycol amine, and aromatic dicarboxylate sulfonic acid sodium salt (generic) (P-17-231, 40 CFR 721.11112).

Comment. The commenter stated that EPA should clarify the proposed SNURs to the extent it is basing them on concerns with excess or residual isocyanate monomers in mixture with an isocyanate-based polymer or prepolymer SNUR chemical. The commenter also stated that EPA has not transparently identified those monomers as being subject to the proposed SNURs and, besides, EPA may not use its SNUR authority to address ongoing uses of the existing isocyanate monomers and must use its TSCA section 6 authority instead.

Response. EPA is concerned about the health effects of any residual monomer as well as unreacted isocyanate groups on a polymer when assessing the risks for new chemical substances. EPA has the authority under TSCA section 5 to address any risks associated with the manufacture, processing, and use of the new chemical substances. The SNUR applies to activities associated with the new chemical substances. Activities associated with the new chemical substance are not ongoing activities of the existing chemical substance. EPA did not receive specific, quantitative information that demonstrates the chemical substance subject to these proposed SNURs exhibit a lower potential for the hazards and potential risks or that they will specifically replace a chemical substance with a higher potential for hazards and risks. EPA is issuing the SNUR as proposed to provide the Agency with the opportunity to review any new uses for potential unreasonable risks. The diisocyanates, MDI and TDI, are well-known dermal and inhalation sensitizers and have been documented to cause asthma, lung damage, and in severe cases, fatal reactions. EPA is concerned about potential health effects that may result from exposures of consumers or self-employed workers while using products containing uncured (unreacted) MDI and TDI and its related polyisocyanates ( e.g., spray- applied foam sealants, adhesives, and coatings) or incidental exposures to the general population. Due to the nature of the potential risk posed by these chemicals, EPA believes it is prudent to emphasize its concern through respiratory protection requirements where there is potential for inhalation exposure, in addition to proposing significant new uses such as consumer use and application method. Accordingly, the regulatory actions for new diisocyanates reflects EPA's policy of consistent treatment of the entire class of potentially hazardous chemicals, regardless of their statutory status as “new” or “existing” chemicals. EPA continues to work to lessen the apparent inequity between regulations of new and existing chemicals.

Comment. The same commenter stated that EPA should clarify its basis for the imposed limitations on total residual isocyanates, because varying limitations on residual isocyanates appear in the regulatory text for these SNURs, i.e., greater than: 0.2% residual isocyanate (P-16-99), 0.1% residual isocyanate (P-16-363, P-17-170, P-17-222, and P-17-231), and 0.15% residual toluene isocyanate (P-17-222).

Response. For each PMN substance, where there is potential risk from residual chemicals or lower molecular weights if the polymer is manufactured differently, EPA attempts to minimize exposure based on information in the notification. Each of these PMNs contained information that the polymer was manufactured at a certain molecular weight and residual isocyanate level. EPA included restrictions for residual isocyanate in the TSCA section 5(e) Order and the proposed SNUR to prevent potential health risks.

Comment. The same commenter stated that EPA should clarify the basis for the derived New Chemical Exposure Limit (NCEL) of 0.9 mg/m 3 (as an 8-hour time weighted average) for P-16-99. The commenter added that the requirement to develop a validated airborne monitoring method is overly burdensome and unnecessary and EPA should allow company industrial hygienists to use professional judgment instead.

Response. This substance is an alkoxysilane, with some residual isocyanate. The NCEL of 0.9 mg/m 3 was derived using a No Observed Adverse Effect Level from a 90-day study on vinyltrimethoxysilane, as described in the new chemicals program category document for alkoxysilanes at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/new-chemicals-program-under-tsca. The SNUR does not require manufacturers or processors to develop validated monitoring methods or techniques. A manufacturer would be required to develop validated monitoring methods or techniques if they choose use the NCEL.

Comment. The same commenter stated that EPA should defer personal protective equipment (PPE) and hazard communication provisions to the applicable OSHA requirements.

Response. The TSCA section 5(e) Orders for the chemicals in this SNUR contain worker protection requirements, EPA proposed and is issuing a final SNUR retaining those requirements so that all manufacturers and processors are subject to the same requirements. If the underlying TSCA section 5(e) Orders are modified EPA would consider modifying the SNUR.

Comment. The same commenter stated that EPA should delete the provisions incorporating the recordkeeping requirements in 40 CFR 721.125, as it did in the proposed TDI SNUR, 80 FR 2068 (January 15, 2015), and some others.

Response. The SNURs cited by the commenter are existing chemical SNURs, where EPA determined recordkeeping was not needed. For example, when the significant new use for an existing chemical is “any use” there is typically no recordkeeping required because there are no records to be maintained that would inform EPA inspection or enforcement. Because the SNURs in this current rule are new chemical SNURs, EPA will continue to require recordkeeping for all new chemical SNUR to better allow EPA to inspect and enforce SNUR requirements at facilities where chemicals subject to SNURs are manufactured and processed.

Comment. One commenter suggests that EPA has deviated from its Persistent, Bioaccumulative, and Toxic (PBT) New Chemical Substances Testing Policy (see final policy statement at 64 FR 60194; November 4, 1999) and failed to explain those deviations. Comments relate to the chemical substances described in PMNs P-15-719, P-16-221, P-17-177, P-17-247, and P-17-248, which met criteria identified in the 1999 Policy Statement for persistence, bioaccumulation potential, and toxicity that would indicate they should be controlled more stringently, up to a ban on commercialization pending development of certain testing.

Response. These comments constitute challenges to certain TSCA section 5(a)(3) determinations rather than to the basis for or the content of the SNURs. EPA is not responding to these comments in this notice and declines to withdraw the SNURs on the basis of these comments, since they are not relevant to this rulemaking. The 1999 policy statement, which is not a rule, provides guidance criteria for persistence, bioaccumulation, and toxicity for new chemicals and advises the industry about our regulatory approach for chemicals meeting the criteria. Establishment of a PBT category alerts potential PMN submitters to possible assessment or regulatory issues associated with PBT new chemicals review. It also provides a vehicle by which the Agency may gauge the flow of PBT chemical substances through the TSCA New Chemicals Program and measure the results of its risk screening and risk management activities for PBT new chemical substances; as such, it is a major element in the Agency's overall strategy to further reduce risks from PBT pollutants.

The TSCA section 5(e) Orders for these PMNs do state that EPA estimates that the substances will persist in the environment for more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. The policy statement notes that even for “very” P (persistence in the environment for more than six months) and “very” B cases (bioaccumulation factor of greater than 5,000), where “because of the increased concern, more stringent control action would be a likely outcome, . . . it would not be appropriate to automatically trigger a “ban pending testing” at these cutoffs given the uncertainties about substance properties, release, and environmental behavior that normally characterize PMN review.” Accordingly, the Agency evaluates each PMN based on the use, exposure and release information submitted, and makes a case by case risk management decision. The proposed SNUR terms for these substances reflect the Agency's determination under their respective TSCA section 5(e) Orders, that the controls stipulated in those TSCA section 5(e) Orders are protective or human health and environment, pending submission of further information that is identified in the TSCA section 5(e) Orders.

Comment. One commenter noted that EPA has instituted an ad hoc testing policy change without acknowledging it has done so and without meeting TSCA's requirements. With these proposed SNURs, the commenter continues, EPA has implemented a significant departure from past policy and practice by ceasing to include any testing requirements or identifying any recommended testing. Instead, the commenter states, each chemical-specific description in Unit IV. of the proposed rule only identifies “potentially useful information” that EPA indicates is only being “provided for informational purposes;” EPA has not defined what it means for information to be only potentially useful and why EPA does not identify the information as useful or necessary. Finally, the commenter states that, moreover, EPA provides no explanation for why it no longer identifies testing as “recommended testing,” as it previously did, and instead only describes the associated information as “potentially useful.”

Response. The comment pertains to the preamble of each SNUR, which are not requirements for testing. EPA has modified language in its regulatory documents to ensure consistency with TSCA section 4(h) requirements to reduce testing on vertebrates to the extent practicable. TSCA section 5(e) Orders will now contain a statement of need that explains the basis for any decision that requires the use of vertebrate animals. In addition, EPA is modifying language in its legal documents describing test requirements to reflect a preference for tiered testing and use of non-vertebrate testing strategies first and using that test data to inform whether higher tiered testing (including testing of vertebrates) is necessary. Similarly, EPA is modifying language in its SNURs to more generally describe the information EPA believes would help characterize chemical properties, fate and/or the potential human health and environmental effects associated with a significant new use of the chemical substance, rather than list specific recommended tests. EPA is encouraging companies to consult with the Agency on the potential for use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs) to generate data to inform risk assessment. EPA encourages dialogue with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h).

Comment. One commenter noted that for P-16-0533, P-16-0570, P-16-0363, P-17-0170, P-17-0179, and P-17-0247-48, the corresponding TSCA section 5(e) Orders prohibit distribution of the substance until it has been completely cured, while the proposed SNURs do not contain a corresponding notification requirement applicable to a company that intends to distribute the uncured substance. The commenter concludes that the final SNURs must do so. The commenter further notes that for P-16-0595 and P-17-0260 the proposed SNURs state that “[t]he requirements of this section do not apply to quantities of the substance after they have been reacted (cured),” while the underlying TSCA section 5(e) Order contains no such provision to lift its restrictions. The commenter concludes that the final SNURs should not provide an exemption from the requirements of the SNUR where such an exemption is not provided in the TSCA section 5(e) Orders.

Response. For P-16-370 (P-16-570 is not contained in the proposed SNUR), P-16-363, P-17-170, P-17-179, and P-17-247-248, the TSCA section 5(e) Orders do not prohibit distribution of the substances until they are completely reacted (cured). The TSCA section 5(e) Orders allow distribution under certain conditions. The terms of the TSCA section 5(e) Orders including the distribution requirements are exempted for these PMNs when they have been fully reacted (cured). The final SNURs for these substances will contain the same exemption. Manufacturers and processors distributing chemicals in commerce subject to SNURs are subject to the notification requirements found in 40 CFR 721.5(a)(2). The TSCA section 5(e) Orders for P-16-533, P-16-595, and P-17-260 do not contain an exemption if the substance is completely reacted (cured). To be consistent with the TSCA section 5(e) Order, the final SNURs for these three substances will not contain that exemption.

Comment. One commenter noted that prior to finalizing the SNUR for certain chemical substances identified, EPA must ensure that the generic names for these chemicals comply with the law and conform to EPA's Generic Name Guidance (83 FR 30173; June 27, 2018). The commenter continued that despite TSCA's requirement for generic names to be specific as practicable, and EPA's stated preference in its guidance for masking only a single structural element, we have identified a number of generic names covered by proposed SNURs that are or appear to be far from sufficiently specific. The specific chemical substances identified in this batch proposed SNUR were P-16-0221: Fluorinated organopolysilazane; P-16-0370: Methoxy-terminated polysiloxanes; P-16-0376: Hydroxystyrene resin; P-17-0179: Modified carboxypolyamine salt; P-17-0247: Branched alkyl (C=17) carboxylic acid; and P-17-0248: Branched alkyl (C=18) alcohol.

Response. The statute, regulations, and guidance stipulate that generic names should be as specific as practicable and reveal the specific chemical identity to the maximum extent possible. See TSCA section 14(c)(1)(C), 40 CFR 720.85(a)(2-3), and “ Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under TSCA” (see 83 FR 30173; June 27, 2018). EPA declares PMNs incomplete if they include generic names for confidential substances that are overly generic. However, EPA more thoroughly examines generic names provided after commencement of manufacture or import ( i.e., in a Notice of Commencement, or NOC), in accordance with 40 CFR 720.85(b)(6). Because this may occur after finalization of a SNUR, a generic name provided in a SNUR may be improved upon regarding its specificity at a later date when the NOC is submitted to the Agency. Persons should also keep in mind that they do not have the benefit of seeing the full chemical identities of confidential substances which is necessary for determining the acceptability of generic names for such substances. Generic names that may appear overly generic may be acceptable for simple chemical substances that have very few functional groups or structural features.

Comment. One commenter noted that despite EPA having provided PMN submitters instructions to the contrary, many of these generic use descriptions are overly broad or vague. The commenter provided these examples in this batch proposed SNUR: P-16-363: open, non-dispersive use; P-16-595: polymer; P-17-260: resin modifier; P-17-222: additive open non-dispersive use; and these described by the commenter as “slightly better”: P-16-99: additive for industrial coatings; P-16-359: pigment additive for industrial coatings; P-16-376: photolithography; and P-17-247/48: chemical raw materials. The commenter stated that these generic use descriptions do not comply with EPA's own 2015 “Instruction Manual for Reporting under the TSCA § 5 New Chemicals Program,” which calls for the generic use description to include both (1) a description of the category of use, which “should reveal the intended category of use to the maximum extent possible;” and (2) a characterization of the “degree of containment,” with examples cited such as “destructive use” or “open, non-dispersive use.” Both components are needed; EPA's manual states: “a generic use description that solely describes the degree of containment such as `open, non-dispersive use' is not acceptable.” While a few of the examples cited previously come closer than others, the commenter concludes, none of them comply with the instructions.

Response. EPA notes the generic use description issue, with regards to PMN reporting. However, this comment does not pertain to the findings or requirements of the proposed SNURs. Accordingly, EPA is not making any changes to the final SNURs based on these comments.

Comment. One commenter suggested that EPA should generally designate as a significant new use any use of a chemical substance other than the specific uses EPA evaluated in its PMN review and determined are not likely to present an unreasonable risk. The commenter identified P-17-247/248 as SNURs where the specific use is claimed as confidential by the PMN submitter, but the TSCA section 5(e) Order and SNURs restrict generically to use only as an intermediate, and it is not clear that EPA examined other intermediate uses beyond the specific use identified in the PMNs. The commenter believes that EPA must also require notification for any type of chemical intermediate use other than that which EPA has reviewed. The commenter also noted that the SNURs for P-16-359 and 16-370 do not include designation of any use that would require notification (only process restrictions, no consumer use, application method, etc.).

Response. The commenter suggested approach is overly broad. TSCA requires that EPA evaluate new chemicals under their conditions of use, including the intended, known and reasonably foreseen circumstances of manufacture, processing, distribution in commerce, use and disposal. Based upon EPA's review of the relevant PMNs, the Agency identified uses that are appropriate for designation as “significant new uses” in order to ensure that EPA has an opportunity to review those uses in a SNUN submission at a later date and address any unreasonable risks at that time. TSCA section 5(a)(2) does not require EPA to take the broad approach advocated by the commenter. EPA believes a more tailored approach is warranted to avoid unduly burdensome regulations.

Comment. One commenter noted that certain proposed SNURs state that a significant new use related to Industrial, commercial, and consumer activities is listed as “requirements as specified in § 721.80” without specifying one of the 25 possible restrictions in that section.

Response. EPA understands the confusion and has deleted reference to 40 CFR 721.80 where no specific section is cited and simply writes the applicable significant new use, i.e., “ Industrial, commercial, and consumer activities. It is a significant new use to . . . .”

Comment. One commenter stated that the provisions in many of the proposed SNURs that address “protection in the workplace” are not consistent with the underlying TSCA section 5(e) Orders, and unlike the TSCA section 5(e) Orders, do not accurately and sufficiently invoke the Industrial Hygiene Hierarchy of Controls (HOC), which is a foundational element of OSHA and NIOSH policy. The commenter also cites two TSCA section 5(e) Orders or preambles to the SNURs for P-16-221 and P-16-370 that either fail to include language requiring preference for engineering and administrative controls over PPE or only include a general statement that encourages such controls.

Response. EPA believes that although the SNURs may not precisely mimic the language in the underlying TSCA section 5(e) Orders, the SNURs do incorporate the same requirements for HOC as found in the TSCA section 5(e) Orders. The commenter refers to this language generally used in TSCA section 5(e) Orders: “Engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible to each person who is reasonably likely to be [dermally exposed/exposed by inhalation] in the work area to the PMN substance * * *. Where engineering, work practice, and administrative controls are not feasible or, if feasible, do not prevent exposure, each person subject to this exposure must be provided with, and is required to wear, [personal protective equipment]. * * * ” The corresponding SNUR language is shortened to this: “engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible”. The language in the specific references under 40 CFR 721.63(a) regarding establishing a program to protect workers incorporates both the HOC and worker protection requirements of the SNUR. EPA believes that the intent and requirements are identical between the TSCA section 5(e) Orders and SNURs and that adding a phrase referring to PPE where engineering controls are not feasible would not serve to further clarify this SNUR notification requirement.

Comment. The same commenter noted that many of the SNURs do not include specific provisions to incorporate requirements for protection in the workplace regulations codified at 40 CFR 721.63. Specific SNURs cited were for PMNs P-16-376, P-16-595, P-17-172, P-17-222, P-17-231, and P-17-260. None of the TSCA section 5(e) Orders contained workplace controls.

Response. For the TSCA section 5(e) Orders listed, EPA achieved the necessary risk reduction in the workplace via provisions other than specific worker protection requirements. For P-16-376, the TSCA section 5(e) Order requires manufacture of the substance at a certain molecular weight and molecular weight distribution that effectively controls risk “upstream,” for the inherent hazard of the substance. For P-16-595, the TSCA section 5(e) Order requires certain (confidential) conditions of use that address potential risk. A bona fide and SNUN would be required before any other conditions of use can be evaluated and approved. For P-17-172, P-17-222, and P-17-260, lung toxicity concerns are addressed by prohibition on inhalation exposures, plus (in the case of P-17-222, a limitation on isocyanate residuals). P-17-231 achieves risk reduction solely via restriction on residual isocyanate in the manufactured substance.

Comment. One commenter favored the idea that EPA should leave workplace protection to OSHA and NIOSH. Another commenter argued against that view, stating that nothing in the TSCA statute supports the assertion that EPA should rely on OSHA to regulate new chemicals in the workplace, see 15 U.S.C. 2604(f)(5); and due to the limitations on OSHA's authority, the protections for workers would not meet TSCA's requirement to “protect against an unreasonable risk of injury to health or the environment.” 15 U.S.C. 2604(e).

Response. To the extent these comments argue that the Agency should or should not have issued orders under sections 5(e) or 5(f) of TSCA that include worker protection conditions, EPA believes they are beyond the scope of the SNUR for which EPA specifically solicited comments and are properly directed to the TSCA section 5(a)(3) determinations that pertain to the underlying PMNs for the SNUR. EPA is therefore not responding to these comments.

However, EPA in response to comments that pertain specifically to the SNUR, i.e., those regarding the uses that should be subject to the SNUR, as well as the assertion that EPA must include certain worker protection provisions in the SNURs on the basis of TSCA section 5(f)(4), EPA disagrees with the comment that, with respect to scenarios where EPA expects that worker protection requirements under other federal/state authorities would mitigate risks to workers, EPA must designate all uses without those protections as “significant new uses”. TSCA section 5(a)(2) does not mandate that any specific uses be designated as significant. Instead, EPA has discretion as to which new uses to designate as significant. In exercising its discretion under TSCA section 5(a)(2), EPA expects compliance with federal and state laws, such as worker protection standards or disposal restrictions, unless case-specific facts indicate otherwise. Further, any workplace risks will be mitigated if exposures are appropriately controlled, and EPA expects that employers will require and workers will use the appropriate controls ( e.g., personal protective equipment such as impervious gloves and/or respirators), consistent with the Safety Data Sheet prepared by the PMN submitter, in a manner adequate to protect them.

Comment. One commenter noted that in this proposed SNUR, EPA placed a notification requirement based on the concentration of residual isocyanate in the chemical as imported but has failed to include a similar express notification requirement on manufacturing. Specifically, the proposed SNUR (and the corresponding TSCA section 5(e) Order) states that “[i]t is a significant new use to import the chemical substance containing greater than 0.15 percent residual isocyanate.” As written, the commenter continues, the TSCA section 5(e) Order and SNUR appear to allow domestic manufacture of the chemical without any limit on the residual level of isocyanate.

One commenter also noted that for P-17-222, the TSCA section 5(e) Order restricts the chemical to be imported “to contain maximum residual of toluene diisocyanate (TDI) no greater than 0.15 weight percent.” In contrast, the proposed SNUR states that a significant new use is “import [of] the chemical substance containing greater than 0.15 percent residual isocyanate.” The TSCA section 5(e) Order also prohibits processing and use of the chemical if it “contain[s] residual of toluene diisocyanate (TDI) greater than 0.15 weight percent.” In contrast, the SNUR applies that numerical residual limit only to import of the substance. In order to be consistent with the TSCA section 5(e) Order, the commenter states, the final SNUR must designate as a significant new use any import, processing, or use of the chemical containing greater than 0.15 percent residual toluene diisocyanate (TDI).

Response: The Agency agrees that there was an oversight in the proposed rule. The final SNUR for that chemical substance is corrected to read “It is a significant new use to manufacture, process, or use the chemical substance containing greater than 0.15 percent residual toluene isocyanate.” Note that manufacture includes import. In addition, the previous sentence in the same proposed SNUR will be corrected to read “It is a significant new use to modify the manufacture, process or use activities if it results in inhalation exposure to vapor, mist, aerosol, or dust of (replacing to ) the substance.”

Comment. One commenter stated that TSCA does not extend CBI protection to any health and safety study which is submitted under TSCA, including underlying information and occupational exposure studies. In addition to the scientific analyses developed by EPA ( e.g., engineering reports, Structure Activity Team reports), which fall under this definition, other information that is generally required to be submitted with PMNs, such as toxicity studies, information on worker exposure, and the majority of information in Safety Data Sheets, also fall under this definition. EPA must disclose this information to the public. Despite these mandates, the commenter argues that EPA has failed to disclose this health and safety information. The comment states that EPA's SAT reports, engineering reports, and exposure reports all constitute or contain health and safety information that EPA must disclose, yet for P-16-359 (as an example provided by the commenter) EPA has largely redacted these documents.

Response. EPA recognizes that TSCA section 14 does not protect from disclosure certain confidential information described in TSCA section 14(b), including health and safety information. However, TSCA section 14 does not require that EPA make a final confidentiality determination for all information submitted under TSCA and claimed as CBI as part of a PMN review, and EPA has not made a determination regarding the eligibility for confidential treatment of the information referenced in the comment. Here, EPA balanced the need for sufficient information in the public record to fully explain the bases for its decisions with the protections for CBI in TSCA section 14. With regard to EPA technical support reports underlying the section 5 determination, they are not covered by TSCA section 14(b)(2), which specifically refers to health and safety studies submitted to EPA. EPA provided sufficient information in the public record to fully explain the bases for its decisions while preserving the submitter's confidentiality claims.

Comment. A commenter cited the TSCA section 5(e) Orders for P-15-719, P-16-99, P-16-221, P-16-370, P-16-487, P-16-533, P-17-170, P-17-179, and P-17-247 that require animal testing by a specified production volume. The commenter requested that wherever EPA require vertebrate animal testing, it include the statutorily-mandated explanation of the bases for the such decision in each particular case. In addition, the commenter requested that EPA contact the PMN submitters for P-16-533, P-17-170, and P-17-247 to inform them that the local lymph node assay for skin sensitization should be replaced with a defined approach as identified in section 5 of the draft EPA policy document Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program (see https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/strategic-plan-reduce-use-vertebrate-animals-chemical).

Response. A request to review compliance with TSCA section 4(h)(3) for PMNs and TSCA section 5(e) Orders is not relevant to the proposed SNUR. Because SNURs do not require testing and only suggest the type of information that could address hazards identified by EPA, they include opportunities for EPA to engage submitters considering conducting testing. For SNURs with time or production volume limits, or if a SNUN submitter is required to conduct testing, EPA will include consideration of TSCA section 4(h)(3). When a company consults with EPA before submitting any SNUN as recommended by EPA when issuing SNURs, EPA will also have an opportunity to consider what testing if any should be conducted including consideration of TSCA section 4(h)(3).

EPA is establishing significant new use and recordkeeping requirements for 19 chemical substances in 40 CFR part 721, subpart E. In Unit IV. of the original August 27, 2018 direct final rule (83 FR 43538) (9982-24), EPA provides the following information for each chemical substance:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).

• Basis for the TSCA section 5(e) Order.

• Potentially Useful Information. This is information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substance in support of a request by the PMN submitter to modify the TSCA section 5(e) Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.

• CFR citation assigned in the regulatory text section of this rule.

The regulatory text section of each rule specifies the activities designated as significant new uses. Certain new uses, including exceedance of production volume limits ( i.e., limits on manufacture volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.

These final rules include 19 PMN substances that are subject to Orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those TSCA section 5(e) Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA section 5(e) Orders, consistent with TSCA section 5(f)(4).

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) Order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) Orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the 40 CFR 721.63 respirator requirements may request to do so under 40 CFR 721.30. EPA expects that persons whose 40 CFR 721.30 requests to use the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) Order for the same chemical substance.

During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for all 19 chemical substances regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow TSCA section 5(e) Orders with a SNUR that identifies the absence of those protective measures as Significant New Uses to ensure that all manufacturers and processors—not just the original submitter—are held to the same standard.

EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:

• To identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA section 5(e) Orders, consistent with TSCA section 5(f)(4).

• To receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.

• To have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.

• To be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at http://www.epa.gov/opptintr/ existingchemicals/pubs/tscainventory/index.html.

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.

When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) Orders have been issued for all the chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which will be designated as significant new uses. The identities of all 19 chemical substances subject to this rule have been claimed as confidential and EPA has not received any post-PMN bona fide submission (per 40 CFR 720.25 and 721.11) for a chemical substance covered by this action. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

Furthermore, EPA designated August 27, 2018 (the date of public release of the proposed and direct final rules) as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the final rule.

In the unlikely event that a person began commercial manufacture or processing of the chemical substances for a significant new use identified as of August 27, 2018, that person will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons will have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.

EPA recognizes that TSCA section 5 does not require developing any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception:

If a person is required to submit information for a chemical substance pursuant to a rule, order or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. of the original direct final SNUR (83 FR 43538) lists potentially useful information for all SNURs listed here. Descriptions of this information is provided for informational purposes. The potentially useful information identified will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance, which may assist with EPA's analysis of the SNUN.

EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing on vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h).

In certain of the TSCA section 5(e) Orders for the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of specified tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. The SNURs contain the same production volume limits as the TSCA section 5(e) Orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing.

Any request by EPA for the triggered and pended testing described in the TSCA section 5(e) Orders was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models.

The potentially useful information identified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data or other information may increase the likelihood that EPA will take action under TSCA section 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1).

Under these procedures a manufacturer or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.1725(b)(1) with that under 40 CFR 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2017-0366.

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

This action establishes SNURs for several new chemical substances that were the subject of PMNs and TSCA section 5(e) Orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

According to PRA (44 U.S.C. 3501 et seq. ), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

Pursuant to RFA section 605(b) (5 U.S.C. 601 et seq. ), the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 and only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq. ).

This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this action.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of Executive Order 13045 has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks disproportionately affecting children.

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on energy supply, distribution, or use.

Since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).

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 parts 9 and 721 are amended as follows:

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

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. 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:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and Orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after October 18, 2019 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

EPA is finalizing these SNURs under TSCA section 5(a)(2) for 26 substances which were the subject of PMNs. These SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. EPA is not finalizing the proposed SNUR at 40 CFR 721.11082 on the chemical substance that is the subject of PMN P-16-543, because the Agency is currently reviewing data submitted in support of a request to modify the underlying TSCA 5(e) Order that forms the basis for the proposed SNUR.

In the Federal Register of August 17, 2018 (83 FR 41039) (FRL-9981-82), EPA proposed a SNUR for 27 chemical substances in 40 CFR part 721, subpart E and reopened the public comment period in the Federal Register of October 15, 2018 (83 FR 51911) (FRL-9984-69). This reopened comment period closed on October 30, 2018. A direct final rule was also published on August 17, 2018 (83 FR 40986) (9971-37) but withdrawn on October 11, 2018 (83 FR 51360) (9984-71) when EPA received notices of intent to submit adverse comments on these SNURs. More information on the specific chemical substances subject to this final rule can be found in the Federal Register documents proposing the SNUR. The record for the SNUR was established under docket ID number EPA-HQ-OPPT-2017-0414. That docket includes information considered by the Agency in developing the proposed and final rules.

EPA received public comments on the proposed rule. Those comments and EPA's responses are found in Unit IV.

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)).

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. In the case of a determination other than not likely to present unreasonable risk, the applicable review period must also expire before manufacturing or processing for the new use may commence. If EPA determines that the use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings.

When the Agency issues an Order under TSCA section 5(e), TSCA section 5(f)(4) requires that the Agency consider whether to promulgate a SNUR for any use not conforming to the restrictions of the Order or publish a statement describing the reasons for not initiating the rulemaking. Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.

EPA received public comments from 12 entities on the proposed rule. The Agency's responses are described in this unit.

Comment. EPA received two anonymous comments on the proposed rule. One of these comments was general in nature and did not pertain to the proposed rule.

Response: No response is required. The second anonymous comment—also repeated by another commenter—related to the proposed SNUR for a chlorofluorocarbon (P-16-150, 40 CFR 721.11078). This will be covered separately in this unit, under the subheading: “ Protection of groundwater and source water from CFC contamination ”.

EPA received comments from six entities related to the proposed SNURs for chlorinated paraffins (CPs): 40 CFR 721.11068 (P-12-277), 40 CFR 721.11069 (P-12-278), 40 CFR 721.11070 (P-12-280), 40 CFR 721.11071 (P-12-281), 40 CFR 721.11072 (P-12-282 and P-14-684), 40 CFR 721.11073 (P-12-283 and P-14-683), 40 CFR 721.11074 (P-12-284), 40 CFR 721.11075 (P-12-433), 40 CFR 721.11076 (P-12-453), and 40 CFR 721.11077 (P-12-505).

Comment: The commenters stated that manufacturers of these chemicals are already engaging in ongoing uses; new CAS registry numbers have been given to chemicals already in use and these new CAS registry numbers take time to be shared downstream and for companies to figure out if the SNUR substances are present in supply chains. The commenters add that CPs should be moved to TSCA section 6 (EPA's existing chemicals program) for a long-term regulatory remedy.

Response: The Agency is aware that CPs have been in commerce globally for over 70 years. However, in 2009, EPA informed the U.S. manufacturers of CPs that they were using the wrong CAS numbers for the CPs that are the subject of these SNURs. Those CPs were not properly listed on the TSCA Inventory, and thus remained “new chemical” substances as defined under TSCA. In 2012, the major domestic manufacturers and importers of CPs agreed to immediately cease domestic manufacture and import of short-chain CPs. Additionally, the companies agreed to submit PMNs for the medium-and long-chain CPs for EPA to review under TSCA section 5. Around the same time, EPA added medium- and long-chain CPs to the TSCA Work Plan for existing chemical substances. However, given that these CPs were not listed on the TSCA Inventory, EPA determined it was more appropriate to manage them under the TSCA New Chemicals Program. The CPs in this SNUR were subsequently reviewed under the New Chemicals Program, and the PMN submitters were held to certain restrictions in TSCA section 5(e) Orders. Consistent with its responsibilities under TSCA section 5(f)(4), EPA is finalizing these SNURs to ensure that other manufacturers, importers and processors of these CPs are held to the same standards as the original PMN submitters. EPA notes that suppliers have been on notice of this issue for over 10 years and would have an additional 5 years to come into compliance under the terms of this SNUR.

Comment: Several commenters said that five years was too short a time period by which to require SNUN notification, and that the short time period reignites market uncertainty on availability of these CPs. Commenters focused on the proposed time-based SNUR triggers and the potential negative impacts on the regulated community, including downstream processors and users of substances. The commenters encouraged EPA to clarify the obligations of manufacturers and processors of these substances under the SNURs, and the timeline for those obligations. The commenters also encouraged EPA to consider whether the SNURs could be revised to mitigate uncertainty for downstream users. One commenter also asked if this time-based notification requirement applies even if the chemical is being used for the uses allowed under the SNUR.

Response: The five-year time-trigger notification requirement is consistent with the underlying TSCA section 5(e) Orders for the CPs. Processors (who are not also manufacturers/importers) are exempt from this notification requirement. A manufacturer (including importer) of the CPs subject to the SNURs has five years following their commencement of manufacture to submit a SNUN . This SNUR ensures that the PMN submitters and other entrants to the marketplace are treated uniformly. The TSCA 5(e) Orders limit the submitters to a five-year production limit. Following the effective date of the SNUR, there will be ample time for other manufacturers (those not currently subject to the TSCA section 5(e) Orders) to submit SNUNs and for the Agency to complete its review. If an entity decides to discontinue manufacture within that five-year period, there is no need for a SNUN submission requesting to go beyond that time limit. The time limit is independent of the specific use restrictions; notification is required within that five-year period even if the chemical is manufactured for an allowed end use.

Separately, in response to a comment on another batch SNUR (public docket OPPT-2017-0366), to avoid confusion EPA is modifying the proposed SNUR to eliminate specific reference to 40 CFR 721.80 requirements and instead stating the significant new use in plain English: “It is a significant new use to manufacture (including import) the substance more than five years.”

Comment: A commenter asked if processors or users who want to use a substance for uses other than those allowed under the SNUR must submit a SNUN for that use.

Response: Only manufacturers and processors are subject to SNUR notification requirements. A processor can either co-submit a SNUN with a manufacturer for the new use (an actual use, not the production limit, which applies only to manufacturers) or submit a SNUN on their own. After review of a SNUN, if EPA makes a finding allowing the significant new use, the submitter can engage in that new use but must wait for the SNUR to be modified accordingly before distributing the substance for the new use.

Comment: A commenter asked if, pursuant to 40 CFR 721.5, notification of downstream customers and processors of the existence of the SNUR is required prior to expiration of the 5-year time production limit or only after submission of a SNUN to exceed that limit.

Response: The downstream notification requirements at 40 CFR 721.5 are in force without regard to the specific SNUR requirements once the SNUR is effective and continues until the SNUR is revoked.

Comment: One commenter stated that the uses allowed under the SNUR for the CP submitted as PMN P-12-277 (40 CFR 721.11068) would hinder the ability to use the substance for a certain confidential (adhesives) use that is currently ongoing.

Response: Because this is an ongoing use, EPA has revised the regulatory text of the SNUR at 40 CFR 721.11068 to add this use to those currently allowed uses in the proposed SNUR.

Comment: One commenter claims that industry may be using the CP substances subject to the SNUR for critical uses without alternatives, but with the short timeframe for comments and the lack of clarity surrounding the assignment of the CAS registry numbers, we have not been able to ascertain our uses. In the cases that alternatives may exist, transition takes beyond five years to qualify, certify, and implement. There is also the challenge of finding substances with an equivalent technical performance and proliferation within a complex supply base.

Response: The Agency notes that companies have been on notice since 2009 that EPA has been taking actions to regulate these chemical substances. As stated previously, EPA has publicly documented its concerns over these chemicals through multiple actions taken over the last decade: By initiating the enforcement action in 2009, publishing an “Action Plan” in 2009, reaching legal settlements with the manufacturers in 2012, initiating the TSCA section 5 process in 2012, listing the chemicals on the 2012 Work Plan, and publishing risk assessments in 2015 that identified environmental concerns. There is, therefore, no basis for EPA to further extend the five-year timeline in the proposed SNURs.

Comment: One commenter stated that—generally for isocyanate SNURs, but in this rule specifically the proposed SNUR for PMN P-17-10 (721.11084), in which EPA proposed that exceeding the specified weight of residual isocyanates in the PMN chemical substance would be a significant new use—EPA should clarify the extent it is basing the SNUR on concerns with excess or residual isocyanate monomers. EPA appears to be basing the proposed SNURs on the potential for the hazards or risks of excess or residual isocyanate monomer in mixture with this isocyanate-based polymer or prepolymer. These isocyanate monomers are existing chemicals with many ongoing uses, including use as a monomer or use in excess or residual monomer. EPA has not transparently identified those monomers as being subject to the proposed SNURs. EPA may not use its SNUR authority to address ongoing uses of the isocyanate monomers.

In response to this commenter, another commenter stated that regardless of whether there are separate ongoing uses for these isocyanates, their presence here as residuals is directly associated with the manufacture of a new chemical substance that EPA has reviewed and for which it has determined that the PMN substance may present an unreasonable risk. That commenter continued that it is therefore appropriate in this and other such cases that EPA promulgates SNURs that would require notification and EPA review of potential risks posed by the residual isocyanates present in the PMN substance prior to allowing expanded manufacture or use. In addition, the commenter states that these isocyanates have never been used to produce the PMN substance before; this particular significant new use identified by EPA— i.e., manufacture of the PMN substance with a residual isocyanate level above 0.1%—would constitute a significant new use of both the relevant isocyanates and the PMN substance requiring notification under TSCA section 5.

Response: EPA is concerned about the health effects of any residual monomer as well as unreacted isocyanate groups on a polymer when assessing the risks for the new chemical substances. EPA has the authority under TSCA section 5 to address any risks associated with the manufacture, processing, and use of the new chemical substances even if those risks are based on the presence of existing chemical substances. The SNUR only applies to activities associated with the new chemical substances. Activities associated with the new chemical substance are not ongoing activities of the existing chemical substance. EPA did not receive specific, quantitative information that demonstrates the chemical substance subject to these proposed SNURs exhibit a lower potential for the hazards and potential risks described in the proposed SNUR or that they will specifically replace a chemical substance with a higher potential for hazards and risks. EPA is issuing the SNUR as proposed to provide the Agency with the opportunity to review any new uses for potential unreasonable risks. As described in the Agency's ongoing Action Plan for MDI and TDI, diisocyanates are well-known dermal and inhalation sensitizers in the workplace and have been documented to cause asthma, lung damage, and in severe cases, fatal reactions. EPA is concerned about potential health effects that may result from exposures of consumers or self-employed workers while using products containing uncured (unreacted) MDI and TDI and its related polyisocyanates ( e.g., spray-applied foam sealants, adhesives, and coatings) or incidental exposures to the general population while such products are used in or around buildings including homes or schools. While workers may already be using protective controls in occupational settings, due to the nature of the potential risk posed by these chemicals, EPA believes it is prudent to emphasize its concern through respiratory protection requirements where there is potential for inhalation exposure, in addition to proposing significant new uses such as consumer use and application method. Accordingly, the regulatory actions for new diisocyanates reflects EPA's policy of consistent treatment of the entire class of potentially hazardous chemicals, regardless of their statutory status as “new” or “existing” chemicals.

Comment: One commenter stated that EPA should clarify the basis, scope, and provisions of the proposed SNURs. In particular, EPA should clarify its basis for both the imposed limitations on residual isocyanates and molecular weight limitations. In addition, the commenter added that EPA should defer personal protective equipment (PPE) and hazard communication provisions to the applicable OSHA requirements.

Response: With regards to the basis for imposed limitations on residual isocyanates and molecular weight limitations, for each PMN substance such as P-17-10 where there is potential risk from residual chemicals or lower molecular weights if the polymer is manufactured differently, EPA attempts to minimize exposure based on information in the notification about how the chemical is manufactured. The PMN for P-17-10 contained information that the polymer was manufactured at a certain molecular weight and residual isocyanate level less than 0.1%. EPA included these as restrictions in the TSCA section 5(e) Order and the proposed SNUR to prevent potential health risks. Regarding deferring PPE and hazard communication requirements to OSHA, because the TSCA section 5(e) Orders for the chemicals in this SNUR contain worker protection requirements, EPA proposed and is issuing a final SNUR retaining those requirements so that all manufacturers and processors are subject to the same requirements. If the underlying TSCA section 5(e) Orders are modified EPA would consider modifying the SNUR. For PMNs currently in review EPA will continue to determine when PPE and hazard communication provisions can be addressed by other applicable requirements or if a specific finding for a PMN requires PPE and hazard communication provisions under TSCA.

Comment: The same commenter states that EPA should also clarify the proposed regulatory text and the preamble of the proposed SNURs, which include inconsistent language regarding when respiratory and dermal protection is needed.

Response: The regulatory text for 40 CFR 721.63 states that workers who are “reasonably likely to be exposed” are required to use the personal protective equipment identified in the SNUR. The preamble language is a summary of SNUR requirements and is not intended to describe every detail of the SNUR requirements. Persons manufacturing or processing a chemical substance subject to a SNUR should follow the requirements cited in the regulatory text of the SNUR.

Comment: The same commenter stated that EPA should delete the provisions incorporating the recordkeeping requirements in 40 CFR 721.125, as it did in the proposed TDI SNUR, 80 FR 2068 (Jan. 15, 2015), and some others.

Response: The SNURs cited by the commenter are existing chemical SNURs where EPA determined recordkeeping was not needed. For example, when the significant new use for an existing chemical is “any use” there is typically no recordkeeping required because there are no records to be maintained that would inform EPA inspection or enforcement. Because these are new chemical SNURs EPA will continue to require recordkeeping for all new chemical SNUR to better allow EPA to inspect and enforce SNUR requirements at facilities where chemicals subject to SNURs are manufactured and processed.

Comment: One commenter stated that EPA has deviated from its Persistent, Bioaccumulative, and Toxic (PBT) New Chemical Substances Testing Policy (see final policy statement at 64 FR 60194; November 4, 1999) and failed to explain those deviations. Comments relate to the previously mentioned CPs, plus two other chemicals (P-17-228, 40 CFR 721.11092) and P-17-229, 40 CFR 721.11093).

Response: The policy statement, which is not a rule and accordingly has no binding effect, provides guidance criteria for persistence, bioaccumulation, and toxicity for new chemicals and advises the industry about our regulatory approach for chemicals meeting the criteria. Establishment of a PBT category alerts potential PMN submitters to possible assessment or regulatory issues associated with PBT new chemicals review. It also provides a vehicle by which the Agency may gauge the flow of PBT chemical substances through the TSCA New Chemicals Program and measure the results of its risk screening and risk management activities for PBT new chemical substances; as such, it is a major element in the Agency's overall strategy to further reduce risks from PBT pollutants.

The TSCA section 5(e) Orders for the CPs do state that at least some congener groups present in the PMN substances may be “persistent to very persistent, with estimated half-lives in air exceeding 2 days and estimated half-lives in water or sediments exceeding 2 months” and “bioaccumulative to very bioaccumulative based on multiple lines of evidence, including: Log Kow values, modeled BCFs, laboratory-measured BCFs, field-measured BAFs, field-measured BMFs, laboratory-measured biota-sediment bioaccumulation factors (BSAFs) and the presence of MCCPs in human and wildlife biota.” The TSCA section 5(e) Order for the other two substances (P-17-228, 40 CFR 721.11092 and P-17-229, 40 CFR 721.11093), identifies PBT concerns as well, based on physical chemical properties of those substances. The policy statement notes that even for “very” P and “very” B cases, where “because of the increased concern, more stringent control action would be a likely outcome, . . . it would not be appropriate to automatically trigger a “ban pending testing” at these cutoffs given the uncertainties about substance properties, release, and environmental behavior that normally characterize PMN review.” Accordingly, the Agency evaluates each PMN based on the use, exposure and release information submitted, and makes a case by case risk management decision. In fact, the TSCA section 5(e) Orders for the CPs state that EPA has determined that because medium-chain CPs similar to the PMN substances have been manufactured, processed and used for the uses described in the PMN for more than 40 years, manufacture, processing, distribution in commerce, use and disposal of the PMN substances in accordance with the provisions of the TSCA section 5(e) order do not create an unreasonable risk of injury to health or the environment. The proposed SNUR terms for the CPs and the other 2 substances (P-17-228, 40 CFR 721.11092; and P-17-229, 40 CFR 721.11093) reflect the Agency's determination under their respective TSCA section 5(e) Orders, that the controls stipulated in the underlying TSCA section 5(e) Orders are protective or human health and environment, pending submission of further information that is identified in the TSCA section 5(e) Orders.

Comment: One commenter stated that the TSCA section 5(e) Order and Risk Assessment for the CP PMNs P-14-683 and P-14-684, plus the testing strategy for all the CP PMNs included in a previous docket, are not in the docket for this SNUR.

Response: This is an oversight. The TSCA section 5(e) Order and risk assessment for P-14-683 and P-14-684 have now been added to the docket. Note, however, that the chemical identities, risk assessment, and terms of the TSCA section 5(e) Order are identical to those for P-12-283 and P-12-282, respectively, which are already in the docket. As a result, EPA has not reopened the public comment period, because the public had an opportunity to review the available risk assessment and TSCA section 5(e) Order requirements that apply to P-16-683 and P-14-684. Each CP PMN 5(e) Order contains the current iteration of the testing strategy as specific testing requirements required by a certain date. EPA refers the public to the docket for the December 23, 2015 (80 FR 79886) “Chlorinated Paraffins; Request for Available Information on PMN Risk Assessments” (EPA-HQ-OPPT-2015-0789) for the original testing strategy for CPs.

Comment: One commenter stated that the provisions in many of the proposed SNURs that address “protection in the workplace” are not consistent with the underlying TSCA section 5(e) Orders, and unlike the TSCA section 5(e) Orders, do not accurately and sufficiently invoke the Industrial Hygiene Hierarchy of Controls (HOC), which is a foundational element of OSHA and NIOSH policy. The commenter referred to this language generally used in TSCA section 5(e) Orders: “Engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible to each person who is reasonably likely to be [dermally exposed/exposed by inhalation] in the work area to the PMN substance . . . Where engineering, work practice, and administrative controls are not feasible or, if feasible, do not prevent exposure, each person subject to this exposure must be provided with, and is required to wear, [personal protective    equipment] . . .” The corresponding SNUR language is shortened to this: “engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible”.

Response: Although the SNURs may not precisely mimic the language in the underlying TSCA section 5(e) Orders, the SNURs do incorporate the same requirements for HOC as found in the TSCA section 5(e) Orders. The language in the specific references under 40 CFR 721.63(a) regarding establishing a program to protect workers incorporates both the HOC and worker protection requirements of the SNUR. The requirements are identical between the TSCA section 5(e) Orders and SNURs. Adding a phrase referring to PPE where engineering controls are not feasible would not serve to further clarify this SNUR notification requirement.

Comment: A commenter noted the following inconsistencies between certain proposed SNUR and underlying TSCA section 5(e) Order restrictions. For P-17-218, the TSCA section 5(e) Order requires that the substance not be manufactured or processed “involving a method that generates a vapor, mist, aerosol, or dust,” whereas the proposed SNUR does not contain the same restrictions, and rather only has an analogous restriction regarding the use of the PMN substance. For P-17-154, the TSCA section 5(e) Order calls for chemical goggles or equivalent eye protection, while the SNUR does not. For the CP PMNs, the TSCA section 5(e) Orders state that the 5-year time limit is on manufacturing, processing, distribution in commerce, use, and disposal, while the proposed SNUR simply states it is a limit on manufacturing.

Response: For the SNUR for P-17-218, the Agency agrees that there was an oversight in the proposed rule. The final SNUR for that chemical substance no longer cites 40 CFR 721.80(y)(1) and (2), but rather include the overarching statement “It is a significant new use to manufacture, process or use the substance involving a method that generates a vapor, mist, aerosol, or dust.” For the SNUR for P-17-154, the Agency agrees that there was an oversight in the proposed rule. The final SNUR for that chemical substance will include the restriction found at 40 CFR 721.63(a)(2)(iii), which corresponds to chemical goggles or equivalent eye protection. For the CP PMNs, even though the 5-year time limit in the TSCA section 5(e) Order prohibited manufacture, processing, distribution in commerce, use, and disposal for the Company submitting the PMN, EPA's previous practice for all other SNURS and intent for these SNURs was not to prohibit activities other than manufacturing by other entities based on a testing requirement for manufacturers. The SNUR requirement will continue to apply only to manufacturers or importers.

Comment: A commenter notes that the preamble to the proposed SNUR for P-16-543 lists one of the TSCA section 5(e) Order restrictions as “Manufacture, process, or use of the substance without the engineering controls required by the Order to control dermal and inhalation exposure,” where it should say “No manufacture . . . etc.”

Response: The Agency is deferring final action on this SNUR due to ongoing review of data to support a modification to the underlying TSCA 5(e) Order that forms to basis for the SNUR.

Comment: A commenter noted that the preamble to the SNUR for P-17-226 has an incomplete listing of engineering controls contained in the underlying TSCA section 5(e) Order. In particular, bullet 5 in the preamble states “No processing without appropriate engineering controls to prevent inhalation exposure, including dust removal with 99.9% efficiency when loading or unloading the substance in powder form.”

Response: The referenced bullet 5 is the only TSCA section 5(e) Order requirement regarding engineering controls. The SNUR and preamble will remain as proposed.

Comment: A commenter suggested that EPA should add provisions addressing protection in the workplace to proposed SNURs that currently do not—and the underlying TSCA section 5(e) Orders do not—include any such provision. The commenter also states that EPA should not defer workplace protections to OSHA or NIOSH.

Response: EPA disagrees with the comment that, with respect to scenarios where EPA expects that worker protection requirements under other federal/state authorities would mitigate risks to workers, EPA must designate all uses without those protections as “significant new uses”. As discussed in a previous response to comment, because the TSCA section 5(e) Orders for the chemicals in this SNUR contain certain requirements to address unreasonable risks, EPA proposed and is issuing a final SNUR retaining the same requirements so that all manufacturers and processors are subject to similar requirements. If the underlying TSCA section 5(e) Orders are modified to include worker protection requirements, EPA would consider modifying the SNUR. When exercising its discretion regarding which new uses should be designated as significant under TSCA section 5(a)(2), EPA expects compliance with federal and state laws, such as worker protection standards or disposal restrictions, unless case-specific facts indicate otherwise. Further, EPA expects that employers will require and workers will use the appropriate controls ( e.g., personal protective equipment such as impervious gloves and/or respirators), consistent with the Safety Data Sheet prepared by the PMN submitter, in a manner adequate to protect them.

Comment: One commenter noted that the proposed SNURs for P-17-154, P-17-155, and P-17-156 contain no limits on water releases, even though the underlying TSCA section 5(e) Order for these chemical substances mention an aquatic toxicity Concentration of Concern (CoC) of 240 ppb. By comparison, another proposed rule (P-17-226, 721.11091) does contain a surface water limit of the same amount.

Response: Based on review of the available information available for these four PMNs, the Agency made different determinations. While the hazards for the PMN substances that the commenter compared are similar, their predicted environmental fate was not. EPA estimates for removal during wastewater treatment for P-17-154, P-17-155, and P-17-156 was 90%. Wastewater treatment removal for the reaction products of P-17-226 during wastewater treatment was estimated to be as low as 0% and to contain some chemical components that are very persistent and bioaccumulative. Based on this information EPA decided to include a surface water limit for P-17-226 but not for P-17-154, P-17-155, and P-17-156.

Comment: Two commenters—one anonymous—raised concerns related to the proposed SNUR for a substance generically described as “chlorofluorocarbon” (P-16-150, 40 CFR 721.11078), which includes proposed significant new uses involving workplace protection, restriction to use as a chemical intermediate and a water discharge limit. The commenters suggested that chlorofluorocarbons (CFCs) in general should not be approved under SNURs, as CFCs already contaminates certain groundwater drinking water supplies, which increases the costs and difficulty to remove this containment to provide safe drinking water, and there are potential health problems and future environmental issues.

Response: EPA's review of this chemical did identify potential for health and environmental effects if this chemical is limited to certain concentrations in surface waters or drinking water. EPA's assessment of the chemical as an intermediate only identified limited releases to air after incineration and water releases to surface waters after wastewater treatment. These releases would be significantly below any levels of concern for health and environmental effects for the chemical. Because of the potential hazards, the TSCA section 5(e) Order did not allow, and the SNUR contains reporting requirements before, levels in surface waters exceed 240 ppb or any use of the chemical other than as a chemical intermediate. EPA would receive notification of and evaluate any new uses of the chemical that could result in releases causing health and environmental effects.

Subsequent to the publication of the proposed SNUR for P-16-410 (721.11080), the PMN submitter requested a modification to the underlying TSCA section 5(e) Order to increase the allowable percent concentration of the PMN substance from 0.2% to 23% as an automotive engine fluid additive in imported product formulations for industrial use only. EPA evaluated the information submitted by the PMN submitter and determined that increasing the concentration of the PMN substance in imported product to 23% will not result in risk to workers or consumers. As a result, EPA modified the TSCA section 5(e) Order to allow this increase in percent concentration and has accordingly modified that provision in the associated final SNUR.

EPA is establishing significant new use and recordkeeping requirements for 26 chemical substances in 40 CFR part 721, subpart E. In Unit IV of the original direct final rule in the Federal Register of August 17, 2018 (83 FR 40986), EPA provides the following information for each chemical substance:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).

• Basis for the TSCA section 5(e) Order.

• Potentially Useful Information. This is information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.

• CFR citation assigned in the regulatory text section of this rule.

The regulatory text section of each rule specifies the activities designated as significant new uses. Certain new uses, including exceedance of production volume limits ( i.e., limits on manufacture volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.

These final rules include 26 PMN substances that are subject to Orders under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). Those Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) Order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) Orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the 40 CFR 721.63 respirator requirements may request to do so under 40 CFR 721.30. EPA expects that persons whose 40 CFR 721.30 requests to use the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) Order for the same chemical substance.

During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for all 26 chemical substances regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV of the original direct final rule in the Federal Register of August 17, 2018 (83 FR 40986). Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow TSCA section 5(e) Orders with a SNUR that identifies the absence of those protective measures as Significant New Uses to ensure that all manufacturers and processors—not just the original submitter—are held to the same standard.

EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:

• To receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.

• To have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.

• To be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.

• To identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA section 5(e) Orders, consistent with TSCA section 5(f)(4).

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.

When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) Orders have been issued for all of the chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which will be designated as significant new uses. The identities of 12 of the 26 chemical substances subject to this final rule have been claimed as confidential and EPA has received one post-PMN bona fide submission (per 40 CFR 720.25 and 721.11) for a chemical substance covered by this action. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

EPA designated August 17, 2018 (the date of publication of the direct final and proposed rules in the Federal Register ) as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the final rule.

In the unlikely event that a person began commercial manufacture or processing of the chemical substances for a significant new use identified as of August 17, 2018, that person will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons will have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.

EPA recognizes that TSCA section 5 does not require developing any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, order or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV of the original direct final rule in the Federal Register of August 17, 2018 (83 FR 40986) lists potentially useful information for all SNURs listed here. Descriptions of this information is provided for informational purposes. The potentially useful information identified in Unit IV of the original direct final rule will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance, which may assist with EPA's analysis of the SNUN.

EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h).

In certain of the TSCA section 5(e) Orders for the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of specified tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. The SNURs contain the same production volume limits as the TSCA section 5(e) Orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing.

Any request by EPA for the triggered and pended testing described in the TSCA section 5(e) Orders was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models.

The potentially useful information identified in Unit IV. of the original direct final rule may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data or other information may increase the likelihood that EPA will take action under TSCA section 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1).

Under these procedures a manufacturer or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.1725(b)(1) with that under 40 CFR 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2017-0414.

This action establishes SNURs for several new chemical substances that were the subject of PMNs and TSCA section 5(e) Orders. 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).

According to PRA (44 U.S.C. 3501 et seq. ), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 and only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq. ).

This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).

This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action.

This action is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

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), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Pursuant to the CRA (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 parts 9 and 721 are amended as follows:

Throughout this document “we,” “us,” and “our” means the EPA.

The background for this action is discussed in detail in our proposal published on April 18, 2019 (84 FR 16226). In that notice we proposed to approve the November 1, 2018, and September 24, 2018, i-SIP certifications submitted by the State of New Mexico and Albuquerque-Bernalillo County, respectively. The November 1, 2018, and September 24, 2018, submittals addressed the implementation, maintenance, and enforcement of the 2015 O 3 NAAQS in New Mexico, including two of the four interstate transport requirements (CAA section 110(a)(2)(D)(i)(II)). We also proposed to approve a SIP revision submitted on November 16, 2018, by the State of New Mexico that pertains to the repeal of the air quality standards for TSP in New Mexico. The November 16, 2018, submital included a demonstration that the repeal of the TSP NMAAQS will not interfere with the attainment and maintenance of the NAAQS or any other CAA requirement.

We received comments on the April 18, 2019, proposal from two commenters on the infrastructure portion of the action. One commenter was anonymous and submitted adverse comments on several elements of the New Mexico i-SIPs. The other commenter was the City of Albuquerque Environmental Health Department (EHD), who submitted a comment letter to correct certain statements made in the proposal. We did not receive any comments regarding the repeal of the TSP NMAAQS. Our response to the comments is provided in the section below.

Comment: The commenter stated that the EPA should disapprove the current infrastructure SIP as it relates to prevention of significant deterioration (PSD) elements. The current approved version of the New Mexico regulation does not require ammonia as a precursor to fine particulate matter (PM 2.5 ) evaluations. The commenter stated that the EPA claims the State and County have a “comprehensive” program, but the approved regulation does not include ammonia as a precursor. The commenter stated that New Mexico must update its permitting programs for both the State and the counties.

Response: The EPA disagrees with the comment. The EPA's minimum requirements for a state PSD program at 40 CFR 51.166 do not regulate ammonia as either a precursor or a presumed precursor for PM 2.5 for PSD permitting. Regulated precursors for PM 2.5 for PSD permitting are defined at 40 CFR 51.166(b)(49)(i)( b )( 2 ) and ( 3 ) as sulfur dioxide and nitrogen oxides, respectively. 1 The State of New Mexico and Albuquerque-Bernalillo County PSD programs were SIP-approved for the regulation of PM 2.5 and its precursors on January 22, 2013, and September 19, 2012, respectively (78 FR 4339 and 77 FR 58032). The New Mexico State and County SIP-approved PSD programs are comprehensive PSD programs that cover all regulated pollutants, including PM 2.5 and its applicable precursors.

Comment: The commenter stated that New Mexico's permitting program requires ambient air quality modeling to be performed “as specified in EPA's Guideline on Air Quality Models (EPA-450/2-78-027R, July 1986), its revisions, or any superseding document, and approved by the Department.” The commenter stated that this text in the regulation restricts the State from requiring the most up-to-date modeling as required in 40 CFR part 52, Appendix W, which is not a “superseding document”, as it is a regulation promulgated by the EPA and not a document.

The commenter also stated that the State's rule appears to give the State inappropriate director's discretion in the use of what air quality modeling is used as the language “and approved by the department” appears to allow the department to disregard EPA-required modeling if the department does not approve of it. The commenter stated that director's discretion was outlawed by the Courts in NRDC v. EPA in 2013 and was affirmed by the EPA in its startup, shutdown, and malfunction SIP call. The commenter additionally stated that this modeling problem should also require the EPA to disapprove Element K as well, since that also has to do with modeling.

Response: The EPA disagrees with the commenter that the text in the New Mexico regulation, which the commenter cited from 20.2.74.305 of the New Mexico Administrative Code (NMAC), restricts the State from requiring the most up-to-date modeling. The EPA notes that the commenter likely meant to refer to 40 CFR part 51 rather than 40 CFR part 52 as there is no Appendix W in 40 CFR part 52, and the EPA's Guideline on Air Quality Models is codified at 40 CFR part 51, Appendix W.

The general definition of the term “document” can mean any written, printed, or electronic material that provides information or conveys thoughts or ideas. Any regulation in the CFR is considered a document. The EPA's Guideline on Air Quality Models (40 CFR part 51, Appendix W) also refers to itself as a document at several instances throughout its text. The most recent version of the Guideline on Air Quality Models is therefore a “superseding document” to the July 1986 Guideline on Air Quality Models cited in the New Mexico regulations at 20.2.74.305 NMAC.

Additionally, the text in the New Mexico regulations at 20.2.74.305 NMAC also includes any “revisions” to the EPA's Guideline on Air Quality Models. The January 17, 2017, final rule for the most recent update to Appendix W is titled “Revisions to the Guideline on Air Quality Models: Enhancements to the AERMOD Dispersion Modeling System and Incorporation of Approaches To Address Ozone and Fine Particulate Matter” and contains a description of the action in the summary, which states that “[i]n this action, the Environmental Protection Agency (EPA) promulgates revisions to the Guideline on Air Quality Models” (82 FR 5182). The January 17, 2017, final rule also describes in the background section the past revisions of the Guideline on Air Quality Models ( Id. ). Therefore, the most recent version of the Guideline on Air Quality Models is clearly a “revision” to older versions, including the July 1986 version cited in the New Mexico regulation, of the EPA's Guideline on Air Quality Models.

The EPA also disagrees with the commenter that the provisions at 20.2.74.305 NMAC provide inappropriate director's discretion to the State of New Mexico. This provision clearly requires that modeling be conducted pursuant to the latest version of the EPA's Guideline on Air Quality Models. According to 20.2.74.305 NMAC, “[a]ny substitution or modification of a model must be approved by the Department”, and “[n]otification shall be given by the Department of such a substitution or modification and the opportunity for public comment provided for in fulfilling the public notice requirements in subsection B of 20.2.74.400 NMAC”. Additionally, 20.2.74.305 NMAC states that the New Mexico Environment Department (NMED) “will seek EPA approval of such substitutions or modifications”. The provisions at 20.2.74.305 NMAC, the EPA's regulations at 40 CFR 51.166(l) and the Guideline on Air Quality Models itself provide that alternative models, modeling scenarios, or model substitutions may be used if approved by the EPA. The New Mexico rule requires an additional approval from the state air director in addition to the EPA before an applicant can use such an alternative model or model substitution for permitting.

The New Mexico regulations at 20.2.74.305 NMAC, therefore, do not restrict the State from requiring the most recent modeling for permitting as required by 40 CFR 51.166(l) nor do they provide inappropriate director's discretion to the State of New Mexico.

Comment: The commenter asked, with respect to adequate funding, whether the EPA has done a full accounting of the department's finances. The commenter also asked how the EPA can be sure that New Mexico is collecting the correct amount in fees from major title V sources to adequately fund the department and stated that there is no accounting or financial evaluation in the docket that proves New Mexico or the County is adequately funded. The commenter also asked if they are supposed to take the State's word at face value.

Response: A “full accounting of the NMED's finances” is not required. Section 110(a)(2) does not require a specific quantitative metric or methodology for determining adequate resources. Section 110(a)(2)(E) requires that the state provide necessary assurances that the state will have adequate funding under state law to carry out the SIP. As mentioned in our TSD for the proposal, to address adequate funding, the NMED and the EHD have the resources necessary to carry out the SIP, which are provided through general funds, permit fees, and the CAA section 103 and 105 grant processes. NMSA 1978, § 74-2-5.1(F) provides the NMED and the EHD with the power to accept, receive and administer grants or other funds or gifts from public and private agencies, including the federal government, or from any person. NMSA 1978, § 74-2-7 authorizes and requires the State and County to adopt regulations to include for the collection of permit fees.

The State of New Mexico's Permit Fee System implements a fee system for all preconstruction air permits issued by the NMED and can be found at 20.2.75 NMAC, Construction Permit Fees. The provisions in 20.2.75 NMAC were most recently approved by the EPA on March 29, 2012 (77 FR 18923). In the March 29, 2012, final rule, the EPA found that the rule and revisions to 20.2.75 NMAC met the applicable fee-related requirements in section 110(a)(2) of the CAA (77 FR 18923). Under the provisions of 20.2.75 NMAC, the NMED assesses fees when an owner or operator applies for a notice of intent, a permit to construct or modify a source, or a revision to a construction permit. Additionally, annual fees are assessed for sources that have been issued a permit under 20.2.72 NMAC, Construction Permits.

Albuquerque-Bernalillo County's provisions for permit fees are codified in 20.11.2 NMAC, Fees, and 20.11.41, Construction Permits, which were most recently approved by the EPA on May 24, 2012, and June 29, 2017, respectively (77 FR 30900 and 82 FR 29421). The EPA found that the submitted rules and revisions to 20.11.2 NMAC met the applicable fee-related requirements of section 110(a)(2) of the CAA (76 FR 68385, November 4, 2011; 77 FR 30900, May 24, 2012). Under the provisions of 20.11.2 NMAC, the EHD assesses fees when an owner or operator applies for an air permit, air permit renewal, or air permit amendment. Annual fees are also assessed for sources with existing source registrations or permits.

The State of New Mexico and Albuquerque-Bernalillo County each concluded in their i-SIP submittals that they do not anticipate a need for additional resources to implement their respective plans for the 2015 O 3 NAAQS beyond those which have been utilized for the preparation of said plans, plan revisions submitted to the EPA, and other current programmatic demands.

Additionally, section 110(a)(2)(L) requires SIPs to require each major stationary source to pay permitting fees to the permitting authority to cover the cost of reviewing, approving, implementing and enforcing a permit. Section 110(a)(2) falls under title I of the CAA and governs the implementation, maintenance, and enforcement of the NAAQS, in this instance 2015 O 3 , through the federally approved SIP. Section 110 and 40 CFR part 51 also provide mechanisms for programmatic remedies with respect to the SIP. Furthermore, title I addresses minor and major new source review SIP preconstruction permits. The title V program, by contrast, governs operating permits and is addressed by CAA sections 502 through 507. Any evaluation of the title V program and any consequent programmatic remedies must be done pursuant to CAA section 502 and 40 CFR part 70. The scope of this action is limited to determining whether the New Mexico SIP meets certain infrastructure requirements of CAA 110(a)(2) with respect to the 2015 O 3 NAAQS. The State of New Mexico and Albuquerque-Bernalillo County's title V programs are not part of the New Mexico SIP but were approved by the EPA on November 26, 1996 (61 FR 60032). Title V fees are separate from title I fees. As mentioned earlier in this action, title V is subject to evaluation under different statutory and regulatory mechanisms provided for outside the SIP parameters for evaluation under CAA section 110 and 40 CFR part 51. Therefore, the part of the comment that questions whether New Mexico collected the correct amount in fees from major title V sources (Element L) to adequately fund the department is irrelevant to the approval of Element E.

As described in our proposal, TSD, and previously in this response, the EPA's evaluation and approval of adequate resources for the State of New Mexico and Albuquerque-Bernalillo County are based upon various sources of funding, state statutes and rules pursuant to section 110(a)(2). The EPA has not identified sufficient information to support the necessary finding for disapproval with regard to adequate funding. Also, the commenter has not identified any flaws or specific program deficiencies in the State's or County's accounting or fee system, or description of why we would question such. The EPA noted no significant deficiencies, thus indicating that both the State of New Mexico and Albuquerque-Bernalillo County have sufficient resources to implement their respective SIPs. Therefore, the EPA is approving Element E for the State of New Mexico and Albuquerque-Bernalillo County for meeting infrastructure requirements for the 2015 O 3 NAAQS.

Comment: The commenter stated that in Table 1 of the proposed action, the EPA notes that Element J as it pertains to visibility is “not germane to infrastructure SIPs”. The commenter stated that this statement is incorrect as Element J is a necessary element that needs to be addressed in each and every SIP.

Response: The EPA disagrees with the commenter that the visibility sub-element of Element J needs to be addressed in these infrastructure SIPs from the State of New Mexico and Albuquerque-Bernalillo County for the 2015 O 3 NAAQS. Under 40 CFR part 51 subpart P, implementing the visibility requirements of CAA title I, part C, states are subject to requirements for reasonably attributable visibility impairment, new source review for possible impacts on air quality related values in Class I areas, and regional haze planning. These include timeframes for SIP submittals related to visibility requirements. See, e.g., 40 CFR 51.308(b) (establishing a deadline for initial SIPs to meet regional haze requirements of December 17, 2007). As the EPA recognized in the 2013 Infrastructure SIP Guidance, generally speaking, when the EPA establishes or revises a NAAQS, the visibility requirements under part C of title I of the Clean Air Act do not change. See Guidance at pages 54-55. 2 There are no new visibility protection requirements under part C as a result of the revised NAAQS here. Therefore, there are no newly applicable visibility protection obligations pursuant to Element J applicable in or to New Mexico, and this sub-element is therefore not being addressed in this action. We note that the State of New Mexico and Albuquerque-Bernalillo County each currently have a fully approved SIP under subpart P, addressing best available retrofit technology (BART) and reasonable progress requirements as part of their long-term strategy for improving visibility during the first planning period. For the State of New Mexico, see 77 FR 70693 (November 27, 2012) and 79 FR 60985 (October 9, 2014) for the final approval of the State's regional haze SIP, and see 82 FR 27127 (June 14, 2017) for the final approval of the State's five-year progress report. For Albuquerque-Bernalillo County, see 77 FR 71119 (November 29, 2012) for the final approval of the County's regional haze SIP, and see 82 FR 58347 (December 12, 2017) for the final approval of the County's five-year progress report. New Mexico and other states are in the process of developing SIPs for the second planning period, which are due to the EPA on July 31, 2021. See Final Rule, Protection of Visibility: Amendments to Requirements for State Plans, 82 FR 3078 (January 10, 2017).

Comment: The commenter stated that the EPA should also issue a federal plan for the interstate transport elements, as these elements were due in October 2018, and it is now (at the time the comment was submitted) seven months late, and both the EPA and New Mexico have stated that the State does not have an interstate transport submission (section 110(a)(2)(D)(i)(I)) prepared by stating “as a sufficient basis for a submittal addressing these requirements does not yet exist”. The commenter stated that since the EPA is formally recognizing in the proposed notice that the State has not made a submission for the interstate transport elements, this should be considered a finding of failure to submit, and finalization of this regulation should start a 24-month clock for the EPA to issue a federal implementation plan.

Response: In this action, the EPA is only evaluating whether the SIP submissions under review have met the statutory requirements they purport to address. Whether or not the State of New Mexico or Albuquerque-Bernalillo County have otherwise made a timely submission addressing the interstate transport elements (section 110(a)(2)(D)(i)(I)) for the 2015 O 3 NAAQS infrastructure requirements is outside the scope of this rulemaking because the EPA is not addressing these elements in this action. The EPA interprets its authority under CAA section 110(k) as affording the Agency the discretion to approve, disapprove, or conditionally approve, individual elements of the New Mexico infrastructure and transport SIP submissions for the 2015 O 3 NAAQS. The EPA views discrete infrastructure SIP requirements, such as the requirements of 110(a)(2)(D)(i)(I), as severable from other infrastructure SIP elements and interprets section 110(k) as allowing it to act on individual severable elements or requirements in a SIP submission. In short, the EPA has the discretion under CAA section 110(k) to act upon the various individual elements of a state's infrastructure SIP submission, separately or together, as appropriate. Here, the EPA has focused its evaluation on the individual infrastructure SIP elements addressed in the SIP submissions under review. The EPA will evaluate whether it is necessary to issue a separate notice to formally address the requirements of section 110(a)(2)(D)(i)(I) in the future.

Comment: We received one comment from the City of Albuquerque Environmental Health Department (EHD) stating that the EPA incorrectly made two statements which misstate New Mexico law in the April 18, 2019, proposal. The EHD provided proposed corrections to the two statements and clarified the EHD's authority under New Mexico law as well as the EHD's relation to the New Mexico Environmental Improvement Board (EIB) and the Albuquerque and Bernalillo County Joint Air Quality Control Board (Air Board).

The EHD stated that the first incorrect statement is: “The AQCA [New Mexico Air Quality Control Act] and Ordinances [Albuquerque and Bernalillo County Joint Air Quality Control Board Ordinances] also state that the EHD is the administrative agency for the EIB and give the EHD authority to enforce air quality regulations.” The EHD stated that the statement would be correct if changed to: “The AQCA and Ordinances also state that the EHD is the administrative agency for the Air Board and give the EHD authority to enforce the Air Board's air quality regulations.”

The EHD stated that the second incorrect statement is: “[T]he AQCA provides authority for the NMED and the EHD to enforce the requirements of the AQCA and any regulations of the EIB, permits, or final compliance orders.” The EHD stated that the statement would be correct if changed to: “[T]he AQCA provides authority for the NMED and the EHD to enforce the requirements of the AQCA and, within their respective jurisdiction, any applicable regulations, or permits, or final compliance orders each agency (NMED and EHD) has issued.”

Response: The EPA agrees with the EHD's corrected statements of its authority under New Mexico law.

We are approving the November 1, 2018, and September 24, 2018, i-SIP submittals pertaining to the implementation, maintenance, and enforcement of the 2015 O 3 NAAQS, including two of the transport sub-elements (CAA section 110(a)(2)(D)(i)(II)), in the State of New Mexico and Albuquerque-Bernalillo County. Table 1 below outlines the final action EPA is taking on specific infrastructure elements.

We are also approving the November 16, 2018, submittal which consists of a revision to 20.2.3 NMAC (Ambient Air Quality Standards) . The approved SIP revision removes section 109 (Total Suspended Particulates) from 20.2.3 NMAC, as the EPA found that such a revision will not adversely affect the attainment of applicable CAA requirements.

In this document, 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 a revision to 20.2.3 NMAC. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 6 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 the EPA for inclusion in the SIP, have been incorporated by reference by the 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 the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.

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

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

• 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, described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

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

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

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

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 18, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

I. Background

On October 26, 2015, EPA issued a final rule revising both the primary and secondary NAAQS for ozone to 0.070 parts per million (ppm) based on 8-hour average concentrations. Pursuant to section 110(a)(1) of the CAA, states are required to make SIP submissions to meet the applicable requirements of section 110(a)(2) within three years after EPA promulgates a new or revised NAAQS, or within a shorter period as EPA may prescribe. Section 110(a)(2) requires states to address basic SIP elements such as requirements for monitoring, basic program requirements and legal authority that are designed to assure implementation, maintenance, and enforcement of the new or revised NAAQS. EPA refers to this type of SIP submission as an “infrastructure SIP submission” because it focuses on the basic requirements that a state must have to provide for implementation, maintenance, and enforcement of the NAAQS at issue in the submission.

On October 11, 2018, EPA received from the State of Maryland, through the Maryland Department of the Environment (MDE), a formal SIP submission (#18-06) to satisfy the requirements of section 110(a) of the CAA for the 2015 ozone NAAQS. EPA reviewed Maryland's submittal and, subsequently on April 24, 2019, published a notice of proposed rulemaking (NPRM) regarding this submittal. See 84 FR 17125. The SIP submission addressed the following infrastructure elements, or portions thereof, for the 2015 ozone NAAQS: CAA section 110(a)(2)(A), (B), (C), (D)(i)(II), D(ii), (E), (F), (G), (H), (J), (K), (L), and (M).

The rationale supporting EPA's proposed rulemaking action, including the scope of infrastructure SIP submissions in general, is explained in the published NPRM and the technical support document (TSD) and will not be restated here. The NPRM and TSD are available in the docket for this rulemaking at https://www.regulations.gov, Docket ID Number EPA-R03-OAR-2019-0036.

EPA received comments from one commenter in response to the April 24, 2019 proposed approval of Maryland's 2015 ozone NAAQS infrastructure SIP. The commenter did not provide any personal information, such as a name or group affiliation, and therefore is considered anonymous. The commenter opposed EPA's proposed approval of the SIP submission on several grounds. The full text of the comment is in the docket for this rulemaking action.

Comment 1: The commenter claims that EPA was incorrect in proposing to find that Maryland's 2015 ozone NAAQS infrastructure SIP submittal met the requirements of section 110(a)(2)(A) of the CAA, because Maryland is not attaining the 2015 ozone NAAQS of 70 parts per billion (ppb). 1 The commenter cites and includes data from MDE's website showing 16 days when monitor data showed exceedances of the NAAQS in 2018, and notes that the number of exceedances increased from 11 in 2014.

EPA Response: EPA disagrees with the commenter regarding the approvability of Maryland's infrastructure SIP submittal with respect to the requirements of CAA section 110(a)(2)(A) for the 2015 ozone NAAQS. First, in this action, EPA is evaluating the State's infrastructure SIP submission. In this context, EPA is not determining whether or not Maryland has met all of the potential emissions control requirements that may or may not ultimately be necessary in order to comply with CAA section 110(a)(2)(I), and part D, subpart 2 SIP requirements for nonattainment areas. In the context of evaluating an infrastructure SIP submission, EPA interprets section 110(a)(2)(A) of the CAA at this early stage of planning for a new or revised NAAQS only to require a state to identify the existing control measures already in the existing SIP that provide for implementation, maintenance, and enforcement of the 2015 ozone NAAQS. Section 110(a)(2) requires that each SIP “include enforceable emission limitations and other control measures, means, or techniques . . . as well as schedules and timetables for compliance, as may be necessary or appropriate to meet the applicable requirements of [the CAA],” which in this case is the 2015 ozone standard. In later phases of SIP planning, in particular to meet requirements for nonattainment plan SIP submissions in designated nonattainment areas, states are required to adopt additional measures to provide for attainment of the NAAQS, as applicable. EPA has provided guidance explaining that nonattainment plan SIP submission requirements are separate from infrastructure SIP submission requirements. 2

Second, to the extent that Maryland needs to adopt and submit any additional emission controls in nonattainment areas in order to attain the 2015 ozone NAAQS, the State will need to do so in a different type of SIP submission that it must submit later. EPA reviews an infrastructure SIP submittal to verify that the state's SIP provides for the implementation, maintenance, and enforcement of the NAAQS and that any additional requirements for a new NAAQS is met, but not to evaluate whether the state has met any potential nonattainment area plan requirements that apply separately and later. Under subpart 2 of part D of title I of the CAA, state planning and emissions control requirements in a nonattainment area for ozone are determined, in part, by the area's classification. Under subpart 2, EPA initially classified ozone nonattainment areas based on the severity of their ozone levels, as determined by the area's design value relative to the lower and upper design value thresholds for each classification. Nonattainment areas with a lower classification, such as “marginal,” have ozone levels at the time of designation that are closer to the standard than areas with a higher classification. Ozone nonattainment areas in the lower classification levels have fewer initial mandatory air quality planning and control requirements than those in higher classifications. EPA designated several areas within Maryland as marginal nonattainment areas for the 2015 ozone NAAQS. 83 FR 25776, 25812 (June 4, 2018); 40 CFR 81.321. Section 182 of the CAA requires states with ozone nonattainment areas to submit various SIP elements within specified time frames. States with areas designated as marginal nonattainment have two years from the effective date of designation to submit SIP revisions addressing emissions inventories (required by CAA section 182(a)(1)), reasonably available control technology (CAA section 182(b)(2)) and certain emissions statement regulations. 3 Maryland's effective date for the initial nonattainment designation for the 2015 ozone NAAQS was August 3, 2018, so the nonattainment SIP elements for Maryland for the 2015 ozone NAAQS are not due until August 3, 2020. CAA section 181 provides an increasing amount of maximum time from the date of designation to attain the standards for the progressively higher classifications: Marginal—3 years, moderate—6 years, serious—9 years, severe—15 or 17 years, and extreme—20 years. Under EPA's interpretation of section 181 of the CAA, marginal nonattainment areas have up to three years after the effective date of the nonattainment designation to attain the 2015 ozone NAAQS. 40 CFR 51.1302. Thus, Maryland's marginal nonattainment areas for the 2015 ozone NAAQS have until June 4, 2021 to come into attainment. EPA's review of Maryland's infrastructure SIP submittal indicated that the State has numerous SIP approved regulations in place to control and reduce emissions of the ozone precursors nitrogen oxides (NO X ) and volatile organic compounds (VOCs).

Third, regarding the ambient ozone measurements referenced by the commenter, EPA agrees that some of these preliminary 8-hour concentrations exceed the 0.070 ppm numerical level of the 2015 ozone NAAQS. However, an individual 8-hour average measurement at an individual monitor is not indicative of whether the 2015 ozone NAAQS has been violated in an area. The standard is met at an air quality monitor when the 3-year average of the annual fourth-highest daily maximum 8-hour average ozone concentration is less than or equal to the 2015 ozone NAAQS (0.070 ppm). 40 CFR 50.19(b). Thus, three full years of data for each monitor is required, and more specifically, it is the 3-year average of the annual fourth-highest daily maximum 8-hour average ozone concentration that is needed to ascertain if a monitor is attaining or not. None of the numerical values cited by the commenter, by themselves, can be used to determine if the monitor or area is violating the NAAQS. The commenter referred several times to preliminary daily ozone values and seemed to infer that these daily values could be compared to the 2015 ozone standard. This is misleading as the 2015 ozone standard is not measured by a singular day's reading. Therefore, the daily monitor readings are not comparable. Finally, EPA disagrees with the commenter that the Agency stated in the proposed approval notice that Maryland is currently attaining the 2015 ozone NAAQS. However, as mentioned previously, the State has until 2021 to attain.

Comment 2: The commenter questioned EPA's proposed finding that Maryland has the necessary funding and personnel to implement the SIP, as required by CAA section 110(a)(2)(E)(i), and EPA's proposed finding that the SIP required major stationary sources to pay adequate permit fees to cover the cost of reviewing and acting upon a permit application, and that it was adequate to cover the cost of ensuring the permits are followed, as required by CAA section 110(a)(2)(L). The commenter questioned whether EPA has a formula for making these determinations, or hired a qualified forensic accountant to comb through MDE's finances to determine the financial stability of MDE. The commenter questions EPA's methods for evaluating the adequacy of Maryland's staffing and budget levels.

EPA Response: As stated in the proposed approval for this action, EPA's evaluation indicates that the State of Maryland has the staffing and funding resources to meet SIP obligations in accordance with section 110(a)(2)(E) of the CAA. Maryland's infrastructure SIP submission for the 2015 ozone NAAQS (SIP submittal) indicated that MDE's Air and Radiation Division has a budget of $19.5 million for fiscal year 2019, which is on par with its budgets in 2017 and 2018, and currently has 167 personnel in the Air and Radiation Division. SIP submittal, pp. 7-8. These budget and staff levels have been consistent over the past number of years and over these years Maryland has been able to meet its statutory commitments, including submitting the required air quality data, attainment plans, and monitoring network plans.

In addition, the SIP submittal cited the state law allowing MDE to seek funding, as well as the various funding sources for its programs, including CAA section 103 and 105 grants, the Maryland Clean Air Fund, permit fees, fees from vehicle emission inspections, and funds received from the Maryland Department of Transportation to help fund transportation-related air pollution programs. SIP submittal, pp. 7-8. Maryland also has an EPA-approved fee program under CAA title V which is used to support title V program elements such as permitting, monitoring, testing, inspections, and enforcement. EPA conducts periodic title V fee and program audits in accordance with generally accepted government auditing standards. Maryland regulation COMAR 26.11.02.19 provides fee schedules and other relevant fee information regarding title V permits and state permits to operate. Regarding Maryland's CAA section 105 funding, Maryland's use of the funds is evaluated through the evaluation process requirements of 40 CFR part 35, subpart A, which call for the State and EPA to jointly evaluate and report progress and accomplishments under the work plan. 4 Maryland also has various permit programs that are self-funded as they apply fees for permit applications. Most of these permit program fees can be adjusted if the State determines that the fee does not cover the reasonable costs of reviewing and acting upon the permit applications. Based on EPA's various reviews of these existing resources, EPA reasonably concluded that Maryland has adequate funding and personnel to implement its SIP.

Comment 3: The commenter asserts that EPA cannot find this infrastructure SIP meets CAA section 110(a)(2)(B) because EPA had to issue a Data Requirements Rule (DRR) for sulfur dioxide (SO 2 ) because Maryland did not have enough SO 2 monitors to adequately measure SO 2 .

EPA Response: EPA disagrees with the commenter's assertion that the SO 2 Data Requirements Rule is proof that Maryland currently does not have an adequate monitoring network for SO 2 , and therefore cannot meet the section 110(a)(2)(B) requirements. EPA disagrees with the commenter for three reasons.

First, in this action, EPA is evaluating the state's infrastructure SIP submission for the 2015 ozone NAAQS. Accordingly, for purposes of section 110(a)(2)(B), EPA is evaluating whether Maryland has SIP provisions that provide for things such as required air quality monitoring and submission of required data with respect to the ozone NAAQS, not the SO 2 NAAQS. The scope of EPA's evaluation of section 110(a)(2)(B) is described in the agency's guidance for infrastructure SIP submissions. 5

Second, EPA has determined that Maryland has met the requirements of section 110(a)(2)(B) for the 2015 ozone NAAQS. Section 110(a)(2)(B) of the CAA requires that each plan shall provide for the establishment and operation of appropriate devices, methods, systems, and procedures necessary to monitor, compile, and analyze data on ambient air quality, and upon request, make such data available to EPA. As part of its determination, EPA verified the scope and continuing validity of the State law authority cited in Maryland's October 11, 2018 infrastructure SIP submission. Additionally, Maryland has SIP approved regulations located under COMAR 26.11.04.02 specifying that methods of measuring ambient air quality levels shall be aligned with those specified in 40 CFR parts 50, 51, 53 and 58, as amended. In addition, the State has submitted, and EPA has approved, annual network monitoring plans that specifically address the monitoring network requirements for the ozone NAAQS throughout Maryland. Most recently, EPA approved the 2018 annual network monitoring plan and concluded that Maryland's network of monitors meets regulatory requirements and is consistent with applicable guidance. 6

Finally, the commenter is also incorrect with respect to the current status of SO 2 monitoring in Maryland. Although not relevant in the context of this action on an infrastructure SIP submission for the 2015 ozone NAAQS, EPA notes that the DRR cited by the commenter did not specifically find that Maryland lacked sufficient SO 2 monitors to monitor adequately for purposes of the SO 2 NAAQS. Instead, the DRR required that states identify to EPA by January 15, 2016, those sources of SO 2 within their jurisdiction emitting more than 2,000 tons per year (tpy) of SO 2 , or other SO 2 sources or clusters of SO 2 sources warranting evaluation. The DRR then gave states three options for characterizing SO 2 concentrations around these sources: (1) By installing and using SO 2 monitors; (2) by modelling SO 2 concentrations; or (3) by adopting SO 2 limits for the source to keep it below the 2,000 tpy threshold. States were required to choose an option for each source by July 1, 2016. For installation of a new SO 2 monitor(s), states were to include information about the new monitor in the annual network monitoring plan by July 1, 2016. Maryland's 2016 annual monitoring plan identified any new SO 2 monitors to be installed, and EPA's approval of that plan confirmed that the placement of any new SO 2 monitors was acceptable. 7 More importantly, Maryland was not even required to install monitors if it chose to do SO 2 modeling instead, so any perceived lack of SO 2 monitors could be remedied by modeling. EPA has no information that Maryland is not at this time meeting its obligations under the DRR, even if that were relevant in the context of EPA's evaluation of the State's compliance with section 110(a)(2)(B) in the context of an infrastructure SIP submission for the 2015 ozone NAAQS, which it is not.

EPA is approving Maryland's October 11, 2018 infrastructure SIP submission which addresses the basic program elements, or portions thereof, specified in sections 110(a)(2)(A), (B), (C), (D)(i)(II), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M) of the CAA, necessary to implement, maintain, and enforce the 2015 ozone NAAQS. This rulemaking does not address section 110(a)(2)(I), or the NNSR permitting program requirements of section 110(a)(2)(C), which pertain to the nonattainment planning requirements of part D of the CAA. States are required to make other SIP submissions to meet those nonattainment area requirements later, after completion of designations, and, if required, would be due to EPA by the dates statutorily prescribed in CAA part D, subpart 2. Because the CAA directs states to make SIP submissions to address nonattainment plan requirements on a separate schedule, EPA does not interpret the CAA to require states to address these requirements in the infrastructure SIP submission due three years after adoption of a new or revised NAAQS.

Additionally, this rulemaking does not address CAA section 110(a)(2)(D)(i)(I) (significant contribution to nonattainment or interference of maintenance through interstate transport of air emissions) for the 2015 ozone NAAQS because Maryland's infrastructure SIP submission did not include these elements. EPA will take later, separate action on these requirements once they have been submitted.

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

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 18, 2019. 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 pertaining to Maryland's section 110(a)(2) infrastructure elements for the 2015 ozone NAAQS may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2019 Pacific cod total allowable catch (TAC) allocated to catcher/processors using pot gear in the BSAI is 2,410 metric tons (mt) as established by the final 2019 and 2020 harvest specifications for groundfish in the BSAI (84 FR 9000; March 13, 2019).

In accordance with § 679.20(d)(1)(iii), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2019 Pacific cod TAC allocated as a directed fishing allowance to catcher/processors using pot gear in the BSAI will soon be reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by pot catcher/processors in the BSAI.

While this closure is effective the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for Pacific cod by pot catcher/processors in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of September 12, 2019.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2019 total allowable catch (TAC) of sablefish allocated to vessels using trawl gear in the Western Regulatory Area of the GOA is 316 metric tons (mt) as established by the final 2019 and 2020 harvest specifications for groundfish of the GOA (84 FR 9416, March 14, 2019).

In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2019 TAC of sablefish allocated to vessels using trawl gear in the Western Regulatory Area of the GOA will be reached. Therefore, NMFS is requiring that sablefish caught by vessels using trawl gear in the Western Regulatory Area of the GOA be treated as prohibited species in accordance with § 679.21(a).

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay prohibiting the retention of sablefish by vessels using trawl gear in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of September 12, 2019.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and § 679.21 and is exempt from review under Executive Order 12866.

NMFS manages the groundfish fishery in the Bering Sea and Aleutian Islands management area (BSAI) according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2019 flathead sole, rock sole, and yellowfin sole Amendment 80 allocations of the total allowable catch (TAC) specified in the BSAI are 13,149 metric tons (mt); 30,860 mt; and 117,171 mt; respectively, as established by the final 2019 and 2020 harvest specifications for groundfish in the BSAI (84 FR 9000, March 13, 2019) and flatfish exchange (84 FR 34070, July 17, 2019).

The 2019 flathead sole, rock sole, and yellowfin sole Amendment 80 ABC reserves are 43,348 mt; 69,317 mt; and 95,516 mt; respectively, as established by the final 2019 and 2020 harvest specifications for groundfish in the BSAI (84 FR 9000; March 13, 2019) and flatfish exchange (84 FR 34070, July 17, 2019).

The Alaska Seafood Cooperative has requested that NMFS exchange 2,900 mt of rock sole and 700 mt of yellowfin sole Amendment 80 allocation of the TAC for 3,600 mt of flathead sole Amendment 80 ABC reserves under § 679.91(i). Therefore, in accordance with § 679.91(i), NMFS exchanges 2,900 mt of rock sole and 700 mt of yellowfin sole Amendment 80 allocation of the TAC for 3,600 mt of flathead sole Amendment 80 ABC reserves in the BSAI. This action also decreases and increases the TACs and Amendment 80 ABC reserves by the corresponding amounts. Tables 11 and 13 of the final 2019 and 2020 harvest specifications for groundfish in the BSAI (84 FR 9000, March 13, 2019) and as revised (84 FR 34070; July 17, 2019) are further revised as follows:

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the flatfish exchange by the Alaska Seafood Cooperative in the BSAI. Since these fisheries are currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of September 9, 2019.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.