The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. Therefore, the FAA has determined that prior public notice and comment are unnecessary, and finds that, for the same reason, good cause exists for adopting these special conditions upon publication in the Federal Register .

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

On July 3, 2018, GDC Technics applied for a supplemental type certificate for the use of single-passenger side-facing seats equipped with multiple airbag systems in the Model 777-300ER airplane. The Model 777-300ER airplane is a derivative of the Boeing Model 777-300 airplane currently approved under Type Certificate No. T00001SE, and is a twin-engine, transport category airplane with a maximum takeoff weight of 775,000 pounds. The Model 777-300ER as modified by GDC Technics has a maximum seating capacity of 75 passengers and 11 flight attendants.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, GDC Technics must show that the Model 777-300ER airplane, as changed, continues to meet the applicable provisions of the regulations listed in Type Certificate No. T00001SE Rev 40 or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations ( i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Boeing Model 777-300ER airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 777-300ER airplane must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

The Boeing Model 777-300ER airplane will incorporate the following novel or unusual design features:

These special conditions are issued for the Boeing Model 777-300ER airplane. This airplane, as modified by GDC Technics, will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature as modified by GDC Technics, will be equipped with nine single-passenger, side-facing seats, each of which will be installed with an upper torso restraint equipped with an airbag system and a floor level airbag system to limit the axial rotation of the upper leg, due to leg flail, of occupants in single-place, side facing divans. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

The design and installation of side-facing seats, and their associated novel design features, utilized on the Boeing Model 777-300ER airplane will be certified by supplemental type certificate (STC), therefore the minimum acceptable testing and human injury criteria for these seats will be applied by special conditions developed using FAA Policy No. PS-ANM-25-03-R1, Technical Criteria for Approving Side-Facing Seats.

The FAA has issued special conditions in the past for airbag systems on lap belts for some forward-facing seats. These special conditions for the airbag systems in the shoulder belts as well as the leg flail arresting airbag systems are based on the previous special conditions for airbag systems on lap belts, with some changes to address the specific issues of side-facing seats. The special conditions are not an installation approval. Therefore, while the special conditions relate to each such system installed, the overall installation approval is a separate finding and must consider the combined effects of all such systems installed.

The FAA has considered the installation of airbag systems in the shoulder belts as well as the leg flail arresting airbag systems to have two primary safety concerns:

1. The systems perform properly under foreseeable operating conditions.

2. The systems do not perform in a manner or at such times as would constitute a hazard to the occupants. This latter point has the potential to be the more rigorous of the requirements, owing to the active nature of the system.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

As discussed above, these special conditions are applicable to the Boeing Model 777-300ER airplane. Should GDC Technics apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. T00001SE to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Boeing Model 777-300ER airplanes, as modified by GDC Technics.

In addition to the airworthiness standards in §§ 25.562 and 25.785, special conditions 1 and 2 apply are applicable to all side-facing seat installations, and special conditions 3 through 16 apply to side-facing seats equipped with an airbag system in the shoulder belt system and an airbag system in the leg flail arresting device.

1. Additional requirements applicable to tests or rational analysis conducted to show compliance with §§ 25.562 and 25.785 for side-facing seats:

a. The longitudinal test(s) conducted in accordance with § 25.562(b)(2) to show compliance with the seat-strength requirements of § 25.562(c)(7) and (8), and these special conditions must have an ES-2re Anthropomorphic Test Dummy (ATD) (49 CFR part 572 subpart U) or equivalent, or a Hybrid-II ATD (49 CFR part 572, subpart B as specified in § 25.562) or equivalent, occupying each seat position and including all items contactable by the occupant ( e.g., armrest, interior wall, or furnishing) if those items are necessary to restrain the occupant. If included, the floor representation and contactable items must be located such that their relative position, with respect to the center of the nearest seat place, is the same at the start of the test as before floor misalignment is applied. For example, if floor misalignment rotates the centerline of the seat place nearest the contactable item 8 degrees clockwise about the airplane x-axis, then the item and floor representations must be rotated by 8 degrees clockwise also to maintain the same relative position to the seat place. Each ATD's relative position to the seat after application of floor misalignment must be the same as before misalignment is applied. To ensure proper loading of the seat by the occupants, the ATD pelvis must remain supported by the seat pan, and the restraint system must remain on the pelvis and shoulder of the ATD until rebound begins. No injury-criteria evaluation is necessary for tests conducted only to assess seat-strength requirements.

b. The longitudinal test(s) conducted in accordance with § 25.562(b)(2), to show compliance with the injury assessments required by § 25.562(c) and these special conditions, may be conducted separately from the test(s) to show structural integrity. In this case, structural-assessment tests must be conducted as specified in paragraph 1a, above, and the injury-assessment test must be conducted without yaw or floor misalignment. Injury assessments may be accomplished by testing with ES-2re ATD (49 CFR part 572 subpart U) or equivalent at all places. Alternatively, these assessments may be accomplished by multiple tests that use an ES-2re at the seat place being evaluated, and a Hybrid-II ATD (49 CFR part 572, subpart B, as specified in § 25.562) or equivalent used in all seat places forward of the one being assessed, to evaluate occupant interaction. In this case, seat places aft of the one being assessed may be unoccupied. If a seat installation includes adjacent items that are contactable by the occupant, the injury potential of that contact must be assessed. To make this assessment, tests may be conducted that include the actual item, located and attached in a representative fashion. Alternatively, the injury potential may be assessed by a combination of tests with items having the same geometry as the actual item, but having stiffness characteristics that would create the worst case for injury (injuries due to both contact with the item and lack of support from the item).

c. If a seat is installed aft of structure ( e.g., an interior wall or furnishing) that does not have a homogeneous surface contactable by the occupant, additional analysis and/or test(s) may be required to demonstrate that the injury criteria are met for the area which an occupant could contact. For example, different yaw angles could result in different injury considerations and may require additional analysis or separate test(s) to evaluate.

d. To accommodate a range of occupant heights (5th percentile female to 95th percentile male), the surface of items contactable by the occupant must be homogenous 7.3 inches (185 mm) above and 7.9 inches (200 mm) below the point (center of area) that is contacted by the 50th percentile male size ATD's head during the longitudinal test(s) conducted in accordance with paragraphs a, b, and c, above. Otherwise, additional head-injury criteria (HIC) assessment tests may be necessary. Any surface (inflatable or otherwise) that provides support for the occupant of any seat place must provide that support in a consistent manner regardless of occupant stature. For example, if an inflatable shoulder belt is used to mitigate injury risk, then it must be demonstrated by inspection to bear against the range of occupants in a similar manner before and after inflation. Likewise, the means of limiting lower-leg flail must be demonstrated by inspection to provide protection for the range of occupants in a similar manner.

e. For longitudinal test(s) conducted in accordance with § 25.562(b)(2) and these special conditions, the ATDs must be positioned, clothed, and have lateral instrumentation configured as follows:

(1) ATD positioning—Lower the ATD vertically into the seat while simultaneously:

(a) Aligning the midsagittal plane (a vertical plane through the midline of the body; dividing the body into right and left halves) with approximately the middle of the seat place.

(b) Applying a horizontal x-axis direction (in the ATD coordinate system) force of about 20 lb (89 N) to the bottom of the feet of the ES-2re Hybrid-II, to compress the seat back cushion.

(c) Keeping the lower and upper legs nearly horizontal by supporting at the bottom of the feet.

(2) Once all lifting devices have been removed from the ATD:

(a) Rock it slightly to settle it in the seat.

(b) Bend the knees of the ATD.

(c) Separate the knees by about 4 inches (100 mm).

(d) Set the ES-2re's head at approximately the midpoint of the available range of z-axis rotation (to align the head and torso midsagittal planes).

(e) Position the ES-2re's arms at the joint's mechanical detent that puts them at approximately a 40-degree angle with respect to the torso. Position the Hybrid-II ATD hands on top of its upper legs.

(f) Position the feet such that the centerlines of the lower legs are approximately parallel to a lateral vertical plane (in the airplane coordinate system).

(3) ATD clothing: Clothe each ATD in form-fitting, mid-calf-length (minimum) pants and shoes (size 11E) weighing about 2.5 lb (1.1 kg) total. The color of the clothing should be in contrast to the color of the restraint system. The ES-2re jacket is sufficient for torso clothing, although a form-fitting shirt may be used in addition if desired.

(4) ES-2re ATD lateral instrumentation: The rib-module linear slides are directional, i.e., deflection occurs in either a positive or negative ATD y-axis direction. The modules must be installed such that the moving end of the rib module is toward the front of the airplane. The three abdominal-force sensors must be installed such that they are on the side of the ATD toward the front of the airplane.

f. The combined horizontal/vertical test, required by § 25.562(b)(1) and these special conditions, must be conducted with a Hybrid II ATD (49 CFR part 572 subpart B as specified in § 25.562), or equivalent, occupying each seat position.

g. Restraint systems:

(1) If inflatable shoulder and leg flail restraint systems are used, they must be active during all dynamic tests conducted to show compliance with § 25.562.

(2) The design and installation of seat-belt buckles must prevent unbuckling due to applied inertial forces or impact of the hands/arms of the occupant during an emergency landing.

2. Additional performance measures applicable to tests and rational analysis conducted to show compliance with §§ 25.562 and 25.785 for side-facing seats:

a. Body-to-body contact: Contact between the head, pelvis, torso, or shoulder area of one ATD with the adjacent-seated ATD's head, pelvis, torso, or shoulder area is not allowed. Contact during rebound is allowed.

b. Thoracic: The deflection of any of the ES-2re ATD upper, middle, and lower ribs must not exceed 1.73 inches (44 mm). Data must be processed as defined in Federal Motor Vehicle Safety Standards (FMVSS) 571.214.

c. Abdominal: The sum of the measured ES-2re ATD front, middle, and rear abdominal forces must not exceed 562 lbs (2,500 N). Data must be processed as defined in FMVSS 571.214.

d. Pelvic: The pubic symphysis force measured by the ES-2re ATD must not exceed 1,350 lbs (6,000 N). Data must be processed as defined in FMVSS 571.214.

e. Leg: Axial rotation of the upper-leg (femur) must be limited to 35 degrees in either direction from the nominal seated position.

f. Neck: As measured by the ES-2re ATD and filtered at CFC 600 as defined in SAE J211:

(1) The upper-neck tension force at the occipital condyle (O.C.) location must be less than 405 lbs (1,800 N).

(2) The upper-neck compression force at the O.C. location must be less than 405 lbs (1,800 N).

(3) The upper-neck bending torque about the ATD x-axis at the O.C. location must be less than 1,018 in-lbs (115 Nm).

(4) The upper-neck resultant shear force at the O.C. location must be less than 186 lbs (825 N).

g. Occupant (ES-2re ATD) retention: The pelvic restraint must remain on the ES-2re ATD's pelvis during the impact and rebound phases of the test. The upper-torso restraint straps (if present) must remain on the ATD's shoulder during the impact.

h. Occupant (ES-2re ATD) support:

This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary. This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

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

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

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

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

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

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

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

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

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

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

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

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

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

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

NESDIS published a final rule (84 FR 3101; February 11, 2019) to establish a new schedule of fees for special access to NOAA data, information and related products and services. As explained in greater detail in the original final rule, NOAA continues to make its environmental data available to the public without any fee in most instances, primarily via NOAA's Comprehensive Large Array-Data Stewardship System (CLASS). NESDIS is revising the fee schedule that has been in effect since 2015 to ensure that the fees accurately reflect the costs of providing access to the environmental data, information, and related products and services. NESDIS is authorized under 15 U.S.C. 1534 to assess fees, up to fair market value, depending upon the user and intended use, for access to environmental data, information, and products derived from, collected, and/or archived by NOAA. The changes to the table are minimal and within the scope of our statutory authority and the public's reasonable expectations.

In the Federal Register of February 11, 2019, (84 CFR 3101) NESDIS included a table, Appendix A to Part 950—Schedule of User Fees for Access to NOAA Environmental Data on page 3102. That table included several entries of services that NESDIS no longer provides.

This rule has been determined to be not significant for purposes of E.O. 12866. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking and the opportunity for public participation are inapplicable because this rule falls within the public property exception of subparagraph (a)(2) of section 553, as it relates only to the assessment of fees, as authorized by 15 U.S.C. 1534. Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under 5 U.S.C. 553 or by any other law, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are not applicable. Accordingly, no Regulatory Flexibility Analysis is required and none has been prepared.

For the reasons set forth above, 15 CFR part 950 is amended as follows:

The NAVREGS are issued by the Secretary of the Navy under 10 U.S.C. 6011 and delineate the duties, responsibilities, authorities, distinctions, and relationships between various commands, officials, and individuals within the Department of the Navy (DON). The NAVREGS are not applicable to, and do not impact, the public. Therefore, they are not required to be published in the CFR. Nevertheless, a current version of the NAVREGS is maintained on and available to the public for download from the DON Issuances website, https://doni.documentservices.dla.mil/default.aspx.

It has been determined that publication of this CFR part removal for public comment is impracticable, unnecessary, and contrary to public interest since it based upon removing internal DON information.

This rule is not significant under Executive Order (E.O.) 12866, “Regulatory Planning and Review.” Therefore, E.O. 13771, “Reducing Regulation and Controlling Regulatory Costs” does not apply.

On March 12, 2019, Heinz Field notified the Coast Guard that it would be holding a concert from 5 p.m. to 11 p.m. on May 18, 2019. Heinz Field is located in close proximity to the banks of the Ohio and Allegheny Rivers, which are high vessel traffic areas used by both commercial and recreational vessels. Due to the proximity of Heinz Field to these waterways, it will be a destination for many recreational vessels to anchor and loiter throughout the concert weekend of May 17, 2019 to May 19, 2019.

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 contrary to the public interest because immediate action is needed to respond to the potential safety concerns and hazards that could occur in this area during the concert.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70041(a). The COTP has determined that this special local regulation is necessary to maintain an open navigation channel and ensure the safety of vessels on these navigable waters during the concert weekend. Risk of collisions near Heinz Field is a safety concern for any vessel loitering, anchoring, stopping, or drifting more than 100 feet from a riverbank or in a manner that impedes the passage of another vessel to any launching ramp, marina, or fleeting area. The purpose of this rulemaking is to ensure the safety of vessels on the navigable waters adjacent to Heinz Field along the Allegheny, Monongahela, and Ohio Rivers before, during, and after the Garth Brooks concert weekend.

The Coast Guard will enforce the safety zones for the annual Pittsburgh Pirates Fireworks listed in 33 CFR 165.801, Table 1, line 1 from 8 p.m. through 11:59 p.m. each day on May 24, June 21, August 3, August 23, and September 27, 2019. Should inclement weather require rescheduling, the safety zone will be effective following games on a rain date to occur within 48 hours of the scheduled date. Entry into the safety zone is prohibited to all vessels not registered with the sponsor as participants or official patrol vessels, unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative. Persons or vessels desiring to enter into or pass through the safety zone must request permission from the COTP or a designated representative. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0194 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before May 28, 2019. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0194, by one of the following methods:

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

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

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

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

In the Federal Register of September 15, 2017 (82 FR 43352) (FRL-9965-43), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E8529) by E. I. du Pont de Nemours and Company, 974 Centre Road, Wilmington, Delaware 19805, now Corteva Agriscience after E.I. du Pont de Nemours and Company merged with Dow AgroScience. The petition requested that 40 CFR 180 be amended by establishing tolerances for residues of the herbicide sulfometuron-methyl, in or on sugarcane, cane; sugarcane, sugar, refined; and sugarcane, molasses at 0.01 parts per million (ppm). That document referenced a summary of the petition prepared by E. I. du Pont de Nemours and Company, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received in response to the notice of filing, and the Agency's response can be found in Unit IV.C.

Based upon review of the data supporting the petition, EPA has determined a tolerance of 0.1 sugarcane, cane is appropriate, but that tolerances on sugarcane, sugar, refined and sugarcane, molasses is not needed. The reasons for these changes are further explained in Unit IV.D.

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

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for sulfometuron-methyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with sulfometuron-methyl follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The primary toxic effect in the toxicological database is changes in hematological parameters and body weight decrements. There is no evidence that sulfometuron-methyl is a developmental toxicant based on a prenatal developmental study in rats and increased susceptibility was not commonly observed in the database for other registered sulfonylurea herbicides (SUs). There is no evidence of neurotoxicity or immunotoxicity in the toxicology databased for sulfometuron-methyl. Sulfometuron-methyl is classified as “not likely to be carcinogenic to humans” based on lack of treatment-related increases in tumor incidence compared to controls in the mouse carcinogenicity study and negative findings in the genotoxicity toxicity studies. Sulfometuron-methyl has low acute toxicity via oral, dermal, and inhalation routes of exposure. It shows minimal eye irritation and is not a dermal irritant or sensitizer. Specific information on the studies received and the nature of the adverse effects caused by sulfometuron-methyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Sulfometuron-Methyl. Human Health Risk Assessment for a Tolerance without a U.S. Registration for Residues in/on Imported Sugarcane” at pages 18-20 in docket ID number EPA-HQ-OPP-2017-0194.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the NOAEL and the LOAEL. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to sulfometuron-methyl, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from sulfometuron-methyl in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for sulfometuron-methyl; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United States Department of Agriculture (USDA) 2003-2008 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed 100% crop treated (CT) and used tolerance-level residues for the sugarcane commodities. The 2018 default processing factors were used (in this case, the factors were 1 for sugarcane commodities).

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

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for sulfometuron-methyl. Tolerance level residues and/or 100% CT were assumed for sugarcane.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for sulfometuron-methyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of sulfometuron-methyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Instead of generating chemical-specific estimated drinking water concentrations (EDWCs) for sulfometuron-methyl, EPA used model inputs (rate, soil mobility, persistence) from all the sulfonylurea herbicides (sulfometuron-methyl is a sulfonylurea herbicide) to determine coarse-screen estimates that should exceed upper-bound, chemical-specific EDWCs for any SU. The resulting coarse-screen EDWCs generated with the Pesticide Root Zone Model Ground Water (PRZM GW) were higher than the surface water estimates and were used as conservative estimates of potential residues from sulfometuron-methyl in drinking water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 0.492 ppm was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Sulfometuron-methyl is not registered for any specific use patterns that would result in residential exposure.

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

In 2016, EPA's Office of Pesticide Programs released a guidance document entitled, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework. EPA has utilized this framework for sulfometuron-methyl and determined that although sulfometuron-methyl shares some chemical and/or toxicological characteristics ( e.g., chemical structure or apical endpoint) with other pesticides, the toxicological database does not support a testable hypothesis for a common mechanism of action. No further data are required to determine that no common mechanism of toxicity exists for sulfometuron-methyl and other pesticides, and no further cumulative evaluation is necessary for sulfometuron-methyl.

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

2. Prenatal and postnatal sensitivity. There is no evidence that sulfometuron-methyl is a developmental toxicant based on a prenatal developmental study in rats and increased susceptibility was not commonly observed in the database for other registered SUs.

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

i. The toxicity database for sulfometuron-methyl is complete.

ii. There is no indication that sulfometuron-methyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that sulfometuron-methyl results in increased susceptibility in rabbits in a prenatal developmental study. EPA has concluded based on a weight-of-evidence approach that the rat developmental and reproduction toxicity studies are not required for sulfometuron-methyl at this time for the following reasons: (1) Increased susceptibility was not commonly observed in the SU database; and (2) the chronic oral dog study, which is the study used to establish points of departure for sulfometuron-methyl, provides similar or lower NOAEL/LOAEL values than the rat developmental and rat reproduction toxicity studies across the SU database.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to sulfometuron-methyl in drinking water. These assessments will not underestimate the exposure and risks posed by sulfometuron-methyl.

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

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

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to sulfometuron-methyl from food and water will utilize 9.7% of the cPAD for all infants (<1 year old), the population group receiving the greatest exposure. There are no residential uses for sulfometuron-methyl; therefore, the chronic aggregate risk assessment is equivalent to the chronic dietary assessment. There are no chronic dietary risks of concern.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there are no uses for sulfometuron-methyl that result in residential exposures, the short-term aggregate assessment is equivalent to the chronic dietary assessment. There are no chronic dietary risks of concern as described above.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there are no uses for sulfometuron-methyl that result in residential exposures, the intermediate-term aggregate assessment is equivalent to the chronic dietary assessment. There are no chronic dietary risks of concern as described above.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in the rodent mouse carcinogenicity study and negative findings in the mutagenicity/genetic toxicity studies, sulfometuron-methyl is not expected to pose a cancer risk to humans.

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

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

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

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for sulfometuron-methyl.

One comment was submitted insisting that no residues of sulfometuron-methyl be permitted in food, although no additional information was provided that would support a conclusion that the tolerances requested for sulfometuron-methyl are not safe. Although some individuals do not want pesticides to be used on food, the FFDCA authorizes EPA to establish tolerances that permit certain levels of pesticide residues in or on food when the Agency can determine that such residues are safe. EPA has made that determination for the tolerances subject to this action, and the commenter provided no information to support a determination that the tolerance is not safe.

The petitioner requested a tolerance for residues of 0.01 ppm in/on sugarcane, cane; sugarcane, sugar, refined; and sugarcane, molasses. The residue data support a tolerance on sugarcane, cane of 0.1 ppm. This value is also harmonized with the MRL established in the major exporting country, Brazil. A value of 0.01 ppm may create a perceived trade irritant if the U.S. tolerance is lower than the MRL in the major exporting country. Tolerances for residues in/on sugarcane, sugar, refined and sugarcane, molasses are not needed, since residues are not expected to concentrate in the processed commodities.

Therefore, a tolerance is established for residues of sulfometuron-methyl, in or on sugarcane, cane at 0.1 ppm.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

I. Executive Summary A. Does this action apply to me?

You may potentially be affected by this final action if you manufacture (including import), process, or distribute in commerce methylene chloride (CASRN 75-09-2). 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:

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Persons who import any chemical substance governed by a final TSCA section 6 rule are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that a shipment of the chemical substance (in this case, methylene chloride) complies with all applicable rules and orders under TSCA. 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 subject to regulation under section 6 (in this case, methylene chloride) are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

If you have any questions regarding the applicability of this final action to a particular entity, consult the technical information contact listed under FOR FURTHER INFORMATION CONTACT .

Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines that a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant, under the conditions of use, EPA must by rule apply one or more requirements to the extent necessary so that the chemical substance or mixture no longer presents such risk.

With respect to a chemical substance listed in the 2014 update to the TSCA Work Plan for Chemical Assessments for which a completed risk assessment was published prior to the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA section 26(l)(4) (15 U.S.C. 2625(l)(4)) provides that EPA “may publish proposed and final rules under [TSCA section 6(a)] that are consistent with the scope of the completed risk assessment and consistent with other applicable requirements of [TSCA section 6].” Methylene chloride is such a chemical substance. It is listed in the 2014 update to the TSCA Work Plan and the 2014 final risk assessment includes consumer uses of paint and coating removal, among other uses (Refs. 1 and 2). EPA is publishing this final rule under TSCA section 6(a) in accordance with that discretionary statutory authority.

EPA is making a final determination that the use of methylene chloride in consumer paint and coating removal presents an unreasonable risk of injury to health due to acute human lethality. Accordingly, EPA is issuing a final rule under section 6(a) of TSCA to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride for consumer paint and coating removal (including distribution to and by retailers). This final rule also requires manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride for any use to provide downstream notification of the prohibitions throughout the supply chain; and requires limited recordkeeping. More details on these requirements are in Unit III.B.

In the proposed rule for methylene chloride in paint and coating removal (Ref. 3), EPA proposed an unreasonable risk determination for methylene chloride in commercial paint removal uses. In addition, EPA proposed to regulate under TSCA section 6(a) manufacture (including import), processing, distribution in commerce and use of methylene chloride in paint and coating removal for certain commercial uses. As noted previously, exercising its discretion under section 26(l)(4), EPA is not finalizing the proposed unreasonable risk determination and the proposed regulation for commercial uses of methylene chloride in paint and coating removal in this final action. Rather, EPA is soliciting comment, through an ANPRM published elsewhere in this issue of the Federal Register , on questions related to a potential training, certification, and limited access program as an option for risk management for all of the commercial uses of methylene chloride in paint and coating removal. More details on the proposed rule are in Unit II.B.2.

In the proposed rule for methylene chloride in paint and coating removal, EPA also proposed to regulate under TSCA section 6(a) N-methylpyrrolidone (NMP) in paint and coating removal. EPA is not finalizing the proposed regulation for NMP as part of this action. NMP use in paint and coating removal will be incorporated into the risk evaluation currently being conducted under TSCA section 6(b). More information about the proposed rule and NMP is in Unit II.B.2.

Based on EPA's analysis of consumer exposures to methylene chloride in paint and coating removal, EPA is making a final determination that the use of methylene chloride in consumer paint and coating removal presents an unreasonable risk of injury to health due to acute human lethality. This final rule addresses the unreasonable risk, which may include death due to asphyxiation, in a manner that results in the chemical no longer presenting that unreasonable risk. Effects from acute exposure during use of methylene chloride in paint and coating removal may include neurological impacts such as dizziness, incapacitation, loss of consciousness, coma, and death (Ref. 2).

As noted in Unit III.A., EPA is regulating certain conditions of use of methylene chloride related to consumer paint and coating removal, which is estimated to comprise less than 10% of the total use of the chemical (Ref. 4).

As described in more detail in the Economic Analysis (Ref. 4), EPA's analysis of the cost of this rule is estimated to be $3.8 to $13.6 million annualized over 20 years at a 3% discount rate and $3.8 to $13.7 million annualized over 20 years at a 7% discount rate. Because the costs estimated in this rule are variable, the values at the different discount rates are similar. Unquantified costs include potential loss of producer and consumer surplus associated with possible reductions in paint and coating removal activity. There may also be unquantified costs associated with performance of alternatives including longer time for products to work and countervailing hazards from alternative chemicals including potentially higher flammability and exposure to other toxic chemicals.

Preventing exposure to methylene chloride in consumer paint and coating removal results in monetized benefits, as well as non-monetized benefits. Monetized benefits include the prevention of deaths resulting from acute adverse effects that occur at a known rate among consumer users. Non-monetized benefits result from the prevention of some non-cancer adverse effects to the nervous system. Thus, there is not a quantification or monetary valuation estimate for the overall total benefits. Based on the benefits that EPA can monetize, the benefits for this rule are approximately $3.5 million per year over 20 years at 3% and 7% discount rate (Ref. 4).

This action is consistent with the 1995 EPA Policy on Evaluating Health Risks to Children ( http://www.epa.gov/children/epas-policy-evaluating-risk-children ). In its TSCA Work Plan Risk Assessment for methylene chloride, EPA identified risks from inhalation exposure to children who may be present as bystanders in homes where consumer paint and coating removal occurs. These risks may include neurological effects such as cognitive impairment, sensory impairment, dizziness, incapacitation, and loss of consciousness (leading to risks of falls, concussion, and other injuries). Supporting information on the health effects of methylene chloride exposure to children is available in the Toxicological Review of Methylene Chloride (Ref. 5) and the Final Risk Assessment on Methylene Chloride (Ref. 2), as well as Unit II.A.

Methylene chloride (CASRN 75-09-2) is a solvent used in a variety of industrial, commercial and consumer use applications, including adhesives, pharmaceuticals, metal cleaning, chemical processing, and feedstock in the production of refrigerant hydrofluorocarbon-32 (Ref. 2). According to the 2016 Chemical Data Reporting (CDR) information, approximately 264 million pounds of methylene chloride were domestically manufactured or imported into the United States in 2015, with the bulk of the volume domestically manufactured (Ref. 6). Most methylene chloride is produced and used for purposes other than paint and coating removal, which represents less than 10% of total use of methylene chloride (Ref. 4). In terms of environmental releases, 271 facilities reported a total of 3.4 million pounds of releases of methylene chloride to the 2015 Toxics Release Inventory (Ref. 7). Individuals are exposed to methylene chloride from industrial/commercial and consumer sources in different settings, such as homes and workplaces, and through multiple routes (inhalation, dermal, and ingestion).

Methylene chloride is acutely lethal, a neurotoxicant, and a likely human carcinogen. This final rule is specifically intended to prevent the unreasonable risks of injury to health due to acute human lethality from use of methylene chloride for consumer paint and coating removal. The risk assessment presents a detailed description of the range of adverse acute and chronic health effects associated with methylene chloride (Ref. 2).

The primary target organ of methylene chloride acute toxicity is the brain, and neurological effects result from either direct narcosis or the formation of carbon monoxide. The accumulation of carboxyhemoglobin in the blood can lead to sensory impairment, dizziness, incapacitation, loss of consciousness, heart failure, and death. The neurotoxic and cardiovascular effects may be exacerbated in fetuses and in infants with higher residual levels of fetal hemoglobin when exposed to high concentrations of methylene chloride (Ref. 2).

Based on data from the Occupational Safety and Health Administration (OSHA), the Consumer Product Safety Commission (CPSC), state records, and publicly reported information, EPA identified 49 fatalities from 1976 to 2016 (Ref. 3 at p. 7482) resulting from consumer or commercial worker exposure to methylene chloride during paint and coating removal. However, this may be an underestimate of the deaths that have occurred (Refs. 7 and 8). More details are provided in the proposed rule (Ref. 3 at p. 7468).

Since the publication of the January 19, 2017, proposed rule, EPA has learned of four additional fatalities due to methylene chloride in paint and coating removal (Ref. 10). Two of the victims were independent contractors working for small or family-owned businesses, the third was a small business owner, and the fourth was a consumer who died while using a methylene chloride paint and coating removal product to remove paint (Ref. 10). Many of the victims used paint and coating removers easily available to consumers through retailers. This may not constitute an exhaustive list of fatalities, rather, those that were brought to the attention of the Agency since publication of the proposed rule.

The use of methylene chloride in paint and coating removal presents an increased risk of death and nervous system effects for many of the estimated 1.3 million consumers and residential bystanders who use or are exposed to methylene chloride through consumer paint and coating removal each year (Ref. 4). Of particular concern is the potential for acute neurological impairment (central nervous system depressant effects) for consumers using methylene chloride for paint and coating removal. In the risk assessment, the upper-end scenarios for consumer users had 4-hour exposures of 233 parts per million (ppm). As described in the risk assessment, the Acute Exposure Guideline (AEGL-2), which is the threshold for disability for an 8-hour exposure, is 60 ppm. In humans, acute exposure to methylene chloride above 200 ppm results in acute neurobehavioral deficits measured in psychomotor tasks including: Tests of hand-eye coordination, visual evoked response changes, and auditory vigilance. In a few cases, cardiotoxic effects ( i.e., evidenced by electrocardiogram changes) were reported in humans (Ref. 2).

Some populations are currently at disproportionate risk for the health effects associated with use of methylene chloride in paint and coating removal, including children present in homes where consumer paint and coating removal is conducted. EPA's full analysis, conducted as part of compliance with Executive Order 13166 (65 FR 50121, August 11, 2000) and Executive Order 12898 (59 FR 7629, February 16, 1994) is described in the proposed rule (Ref. 3 at pp. 7476, 7525).

While the primary concern has been human health, there is potential for methylene chloride exposures to adversely impact ecological receptors. Methylene chloride is mainly released to the environment in air, and to a lesser extent in water and soil, due to industrial/commercial and consumer uses as a solvent, in aerosol products, and in paint and coating removal. Methylene chloride is moderately persistent and its bioaccumulation potential is low. Though volatile, methylene chloride has negligible atmospheric photochemical reactions, and is therefore exempt from being classified as a volatile organic compound (VOC) as defined at 40 CFR 51.100(c).

The proposed rule presented a comprehensive overview of regulatory actions by EPA, other Federal agencies, and state and international agencies pertaining to methylene chloride use in paint and coating removal and actions addressing methylene chloride waste disposal, releases to air and contamination of groundwater, drinking water, and soils (Ref. 3 at p. 7469). EPA presents here a summary of those actions, with a focus on those that have changed since the proposed rule.

EPA has issued several final rules and notices pertaining to methylene chloride under EPA's various authorities. Under the Clean Air Act, which designates methylene chloride as a hazardous air pollutant (HAP), EPA has promulgated several National Emissions Standards for Hazardous Air Pollutants (NESHAPs) addressing specific sources for methylene chloride emissions, including area sources engaged in paint stripping, surface coating of motor vehicles and mobile equipment, and miscellaneous surface coating operations, and a 2015 update to a 1995 NESHAP for Aerospace Manufacturing and Rework Facilities (42 U.S.C. 7412(b)(1)) CAA). Methylene chloride is listed as a hazardous waste under the Resource Conservation and Recovery Act (RCRA) (Hazardous Waste No. U080, for discarded commercial products, and Waste Nos. F001, F002, for spent halogenated solvents including those halogenated solvents used in degreasing) and as a hazardous constituent in appendix VIII to 40 CFR part 261 (Ref. 2). The Emergency Planning and Community Right-to-Know Act, section 313, lists methylene chloride on the Toxics Release Inventory (TRI) (Ref. 2). The Safe Drinking Water Act requires EPA to determine the level of contaminants in drinking water at which no adverse health effects are likely to occur, with EPA setting a maximum contaminant level goal of zero and an enforceable maximum contaminant level for methylene chloride (dichloromethane) at 0.005 milligrams/Liter (mg/L) or 5 parts per billion (ppb) (57 FR 31776, July 17, 1992).

Other Federal agencies with regulations on methylene chloride include the Food and Drug Administration (FDA), which has banned methylene chloride as an ingredient in all cosmetic products (21 CFR 700.19); OSHA, which has a permissible exposure limit (PEL) of 25 ppm as an eight-hour time-weighted average (TWA) and a 15-minute short-term exposure limit (STEL) of 125 ppm; and CPSC, which has updated its labeling policy for household products containing methylene chloride.

In 2016, CPSC was petitioned by the Halogenated Solvents Industry Alliance to amend its guidance contained in the Statement of Interpretation and Enforcement Policy on the Labeling of Certain Household Products Containing Methylene Chloride; CPSC published that petition and requested public comments (81 FR 60298, September 1, 2016). In response to that petition, CPSC updated the cautionary labeling policy for paint strippers containing methylene chloride to recommend the inclusion of language on the principal display panel of the label and on the back or other panel to specifically describe the risk of fatality from acute exposure in enclosed spaces (83 FR 12254, March 21, 2018; 83 FR 18219, April 26, 2018). CPSC's recommendations also included providing specific examples of spaces in which the product should not be used, incorporating precautionary information for indoor use, and warning against foreseeable inappropriate actions that are not sufficiently protective, such as use of a dust mask to provide protection against vapors. More information on CPSC's updates are in Unit III.A.4.

Several states have taken actions to reduce or make the public aware of risks from methylene chloride. In November 2017, California EPA's Department of Toxic Substances Control (DTSC) proposed to list paint strippers with methylene chloride as a priority product under its Safer Consumer Products regulations (Ref. 11). Methylene chloride is on DTSC's list of candidate chemicals (Ref. 12). If finalized, California's regulation on methylene chloride in paint and coating removers would trigger notification requirements for responsible entities, such as manufacturers and importers to DTSC, and require those companies making paint strippers with methylene chloride to analyze alternatives to determine if methylene chloride is essential and whether there are available alternatives.

This rule finalizes certain parts of the regulation proposed on January 19, 2017 (Ref. 3) with respect to methylene chloride use for consumer paint and coating removal. The proposed rule followed EPA's 2014 final risk assessment of methylene chloride for paint and coating removal. The changes in this final rule from the proposal are discussed in Unit III.

1. TSCA Work Plan and Methylene Chloride Risk Assessment. In 2012, EPA released the initial list of TSCA Work Plan chemicals identified for further assessment under TSCA as part of its chemical safety program (Ref. 1). The process for identifying these chemicals was based on a combination of hazard, exposure, and persistence and bioaccumulation characteristics, and is described in the “TSCA Work Plan Chemicals: Methods Document” (Ref. 13). Under the TSCA Work Plan chemical criteria, methylene chloride ranked high for health hazards and exposure potential. Methylene chloride also appeared in the 2014 update of the TSCA Work Plan for Chemical Assessments.

EPA finalized a TSCA Work Plan Chemical Risk Assessment for methylene chloride in paint and coating removal (methylene chloride risk assessment) in August 2014, following the 2013 peer review of the 2012 draft methylene chloride risk assessment. The completed 2014 risk assessment and all documents from the peer review process are available in Docket Number EPA-HQ-OPPT-2012-0725.

The 2014 methylene chloride risk assessment evaluated health risks to consumers, among others, from inhalation exposures from methylene chloride use in paint and coating removal. A more detailed discussion of the risk assessment is included in the proposed rule (Ref. 3 at p. 7470). The risk assessment identified risks of concern following acute (short-term) exposures for consumers and others conducting paint removal with methylene chloride, as well as for exposed bystanders, including residents of homes in which paint removal is conducted. The acute risks identified include death; neurological impacts such as dizziness, incapacitation, loss of consciousness, and coma (Ref. 2).

The assessment identified risks from acute exposures to methylene chloride when used for consumer paint and coating removal, including (Ref. 2):

• Acute risks of neurological effects for consumer users of methylene chloride as a paint remover.

• Acute risks of neurological effects for bystanders (including children) in the location in which paint removers containing methylene chloride are used by residents ( i.e. consumer paint and coating removal). These risks are also present for exposures to methylene chloride in a location after the paint removal work is complete, because methylene chloride can remain in the air in spaces that are enclosed, confined, or lacking ventilation.

Among the comments on the proposed rule, an overview of which is given in Unit II.B.3., EPA received 28 comments related to the 2014 risk assessment. Twelve mass-mailing campaigns, resulting in over 100,000 public comments, and four individual comments reiterated or supported the conclusions of the risk assessment. A separate individual comment provided a list of additional references documenting the health effects and deaths from methylene chloride use. Other commenters identified what they believe were shortcomings in the risk assessment, such as an underestimation of risk; lack of proper consideration of available data; deficiencies in risk estimation; an overestimation of risk; and lack of verification of data and fatality incident reports. Other comments included additional information from local governments regarding fatalities and adverse effects from use of methylene chloride in paint removers. There were also comments related to carcinogenicity.

The Small Business Advocacy Review (SBAR) Panel convened in support of this action heard from several Small Entity Representatives (SERs) who expressed concerns about the underlying methylene chloride risk assessment (Ref. 14). Many of the concerns expressed by these SERs were already expressed in the public comments and the peer review comments on the methylene chloride risk assessment. The Summary of External Peer Review and Public Comments and Disposition document in the risk assessment docket (EPA-HQ-OPPT-2012-0725) explains how EPA responded to the comments received.

EPA appreciates the comments supporting the conclusions of the risk assessment and those providing additional information. Some commenters expressed concern about analytical shortcomings in the risk assessment. However, the risk assessment relied on previous assessments that used current hazard and risk assessment methodology documented in EPA guidance. In particular, the hazard and dose response information in the risk assessment were developed by reputable organizations and subject to peer review processes and the cancer descriptor “likely carcinogenic in humans” is based on EPA's Toxicological Review using a weight of evidence approach (Ref. 5). The methylene chloride risk assessment was also peer reviewed. The comments on the risk assessment that were received during the comment periods on the proposed rule, and EPA's responses, are in the Response to Comments document (Ref. 15).

2. EPA's proposed rule under TSCA Section 6(a) for methylene chloride. EPA proposed to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride for all consumer and most types of commercial paint removal, and to prohibit most commercial use of methylene chloride for paint and coating removal. Exercising its discretion under section 26(l)(4), EPA is not finalizing the portion of the proposal relating to commercial paint and coating removal today. EPA will address commercial paint and coating removal in the future after soliciting comment, through an ANPRM published elsewhere in this issue of the Federal Register , on questions related to a potential training, certification, and limited access program.

EPA proposed a determination of unreasonable risk from the use of NMP in paint and coating removal. However, exercising its discretion under section 26(l)(4), EPA is not finalizing the proposed unreasonable risk determination for NMP in paint and coating removal at this time. EPA intends to incorporate NMP use in paint and coating removal in the risk evaluation for NMP. EPA has concluded that the Agency's assessment of the potential risks from this widely used chemical will be more robust if the potential risks from these conditions of use are evaluated by applying standards and guidance under amended TSCA. In particular, this includes ensuring the evaluation is consistent with the scientific standards in Section 26 of TSCA, including using best available science and systematic review approaches. Additional information on the NMP risk evaluation process, including public meetings, supporting documents, and public comments, is available in Docket Number EPA-HQ-OPPT-2016-0743.

In the proposed rule, EPA described supplemental analyses used to inform certain aspects of risk management for methylene chloride in paint and coating removal (Ref. 3 at p. 7472). These analyses were consistent with the scope of the methylene chloride risk assessment and were based on the peer-reviewed methodology used in the risk assessment (Ref. 3 at p. 7521). While EPA stated in the proposed rule that these analyses would be peer reviewed prior to promulgation of a final rule and received one comment on the proposed rule to that effect, they will not be peer reviewed at this time because EPA is not finalizing regulatory approaches informed by the results of those analyses.

In the proposed rule for methylene chloride in paint and coating removal (Ref. 3), EPA proposed an unreasonable risk determination for commercial uses of methylene chloride in paint and coating removal, including commercial furniture refinishing. EPA, in collaboration with the Small Business Administration's Office of Advocacy, conducted a workshop on furniture refinishing in Boston, MA on September 12, 2017 (82 FR 41256, August 30, 2017) (FRL-9966-83). A transcript of the meeting and speaker presentations are available in Docket Number EPA-HQ-OPPT-2017-0139.

In the proposed rule, EPA requested comment on a process for receiving and evaluating petitions requesting EPA to promulgate statutory exemptions. While EPA is not finalizing an exemption process in this rule, EPA will take the commenters' suggestions into account as EPA considers how to proceed in the future with respect to exemptions under TSCA section 6(g).

3. Public comments and other public input. The proposed rule provided for a 90-day comment period, ending on April 19, 2017; this comment period was extended until May 19, 2017, in response to public requests (82 FR 20310, May 1, 2017) (FRL-9961-66). Even though EPA received requests for a lengthier extension of the comment periods, the Agency concluded that a 30-day extension of the initial comment period was sufficient.

EPA received more than 147,000 comments on the proposed rule. Commenters included private citizens, potentially affected businesses, trade associations, environmental and public health advocacy groups, state and local governments, and other Federal agencies. Most of the comments received through mass mail campaigns and individual public comments supported the rule and urged EPA to prohibit the use of methylene chloride in paint and coating removal to stop putting families, workers and communities at risk, citing the lethality of methylene chloride and fatalities due to paint and coating removal with methylene chloride. Other commenters opposed the rule, and questioned EPA's authority for issuing it. In this preamble, EPA has responded to many of the comments relevant to methylene chloride in consumer paint and coating removal; however, the more comprehensive version of EPA's response to comments related to this final action can be found in the Response to Comments document (Ref. 15). Public interest in the proposed rule extended beyond the comments received on the proposal and at a furniture refinishing workshop described earlier. EPA continued discussions with the public to receive clarification on comments received on the proposed rule. This included meetings requested by W. M. Barr, Breast Cancer Prevention Partners, Natural Resources Defense Council, and Safer Chemicals Healthy Families, to discuss their comments and by families who have lost relatives using methylene chloride in paint removal (Refs. 16, 17, 18 and 19). EPA staff also attended a demonstration hosted by W. M. Barr of various paint and coating removal products (Ref. 20). EPA also consulted with state officials to discuss methylene chloride deaths reported since the proposal. (Ref. 21 and. Ref. 15).

4. Risk evaluation of methylene chloride. EPA announced in December 2016 its designation of methylene chloride as one of the ten chemical substances that will undergo risk evaluation pursuant to section 6(b)(2)(A) of TSCA (81 FR 91927, December 19, 2016) (FRL-9956-47). The purpose of the risk evaluation under section 6(b)(4)(A) is to determine whether methylene chloride presents an unreasonable risk of injury to health or the environment under the conditions of use. The scope of the methylene chloride risk evaluation identifies, among other issues, the conditions of use, including manufacturing, processing, and other uses beyond paint removal, such as adhesives and degreasing. If EPA makes a determination of unreasonable risk in the final risk evaluation for any of the other methylene chloride conditions of use included in that risk evaluation, EPA will subsequently issue a section 6(a) rule applying risk management requirements to the extent necessary so that such unreasonable risk is no longer present.

With respect to this final rule for methylene chloride in consumer paint and coating removal, although some commenters questioned EPA's authority to issue a final rule on methylene chloride in paint and coating removal without finalizing the peer review of the supplemental analysis and other commenters urged EPA to use its discretion not to finalize the rule and instead re-evaluate the paint and coating removal use under the risk evaluation under section 6(b)(4)(A), the Agency is exercising its discretion to proceed with this final rule addressing unreasonable risk from methylene chloride in consumer paint and coating removal in accordance with TSCA section 26(l)(4). TSCA section 26(l)(4) (15 U.S.C. 2625(l)(4)) provides that, for a chemical substance listed in the 2014 update to the TSCA Work Plan for Chemical Assessments for which a completed risk assessment was published prior to the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA “may publish proposed and final rules” under TSCA section 6(a) that are consistent with the scope of the completed risk assessment and with other applicable requirements of TSCA section 6. Methylene chloride was listed in the 2014 update to the TSCA Work Plan and the completed risk assessment was published in 2014. EPA is publishing this final rule under TSCA section 6(a) in accordance with that discretionary authority.

EPA is conducting a risk evaluation of the other conditions of use of methylene chloride under TSCA section 6(b). Additional information regarding the risk evaluation for the other conditions of use of methylene chloride, including public meetings, supporting documents, and public comments, is available in Docket Number EPA-HQ-OPPT-2016-0742.

EPA carefully considered all the public comments related to consumer paint and coating removal, as well as other information reasonably available in order to develop this final rule. As indicated previously, in this final action EPA is only addressing methylene chloride in consumer paint and coating removal and will address methylene chloride in commercial paint and coating removal in the future after soliciting comment, through an ANPRM published elsewhere in this issue of the Federal Register , on questions related to a potential training, certification, and limited access program. The changes from the proposed action to this final action related to methylene chloride in consumer paint and coating removal are:

• Further clarification in the final rule that paint and coating removers containing methylene chloride cannot be distributed to or by retailers and clarification that a retailer includes a person that distributes in commerce or makes available a chemical substance, mixture or article to consumers, including via internet sales or distribution. Any distributor with at least one consumer client is considered a retailer;

• A decision not to finalize the proposal's requirement for the distribution in commerce of methylene chloride for paint and coating removal in containers with a volume of less than 55 gallons. This requirement would have imposed an additional mitigation measure to address the risks to consumers from methylene chloride in consumer paint and coating removal. However, in this final rule, by eliminating access to methylene chloride for consumer paint and coating removal, via the retailer distribution restrictions, the unreasonable risk from consumer paint and coating removal use is addressed:

• A change in the date that the requirements begin for recordkeeping and for downstream notification of the prohibitions in this rule, from 45 days to 90 days after the effective date of the rule;

• Clarification that the downstream notification requirement should be done through the safety data sheets (SDSs) and provision of language required in the SDSs; and

• A provision allowing required records to be kept either at a company's headquarters or at the facility for which the records were generated.

In addition, this action finalizes the general provisions related to definitions, exports and imports requirements, and enforcement and inspections. These provisions were originally presented in another proposed rule, entitled “Trichloroethylene; Regulation of Certain Uses Under TSCA section 6(a)” (Ref. 23). As EPA is newly establishing 40 CFR part 751 to address the regulation of certain chemical substances and mixtures under TSCA section 6, the Agency intended that the general provisions presented in Subpart A of the proposed rule on trichloroethylene apply to all TSCA section 6 chemical substance regulations presented in part 751 (Ref. 23 at p. 91623). EPA's proposed rule on methylene chloride and NMP use in paint and coating removal specifically proposed to build upon the proposed part 751 presented therein, stating that the “proposal relies on general provisions in the proposed part 751, subpart A, which can be found at 81 FR 91592 (December 16, 2016)” (Ref. 3 at p. 7519), and that “40 CFR part 751, as proposed to be added at 81 FR 91592 (December 16, 2016), is proposed to be further amended” by adding proposed regulatory provisions addressing paint and coating removal uses of methylene chloride and NMP in subparts B and C, respectively (Ref. 3 at p. 7529). Since the trichloroethylene rule has not been finalized, the proposed general provisions are included in this final action with two modifications:

1. Further elaboration of TSCA section 6(a) requirements; and

2. A minor modification to clarify that inspections will be conducted at EPA discretion in accordance with TSCA section 11 and are not required under that authority.

In this final action, EPA is regulating the manufacture (including import), processing and distribution in commerce of methylene chloride for consumer paint and coating removal, including distribution of methylene chloride for consumer paint and coating removal to and by retailers. The details of the prohibitions and requirements of this final rule are in Unit III.B.

1. Paint and coating removal products. Methylene chloride has been used for decades in paint and coating removal in products intended for both consumer and commercial uses. Paint and coating removal, also referred to as paint stripping, is the process of removing paint or other coatings from a surface. Coatings can include paint, varnish, lacquer, graffiti, polyurethane, or other high-performance or specialty coatings. Surfaces or substrates may be the interior or exterior of buildings, structures, vehicles, aircraft, marine craft, furniture, or other objects and include a variety of materials, such as wood, metals, plastics, concrete, and fiberglass. Paint and coating removal can be conducted in consumer or occupational settings (Ref. 2).

Paint and coatings can be removed by chemical, mechanical, or thermal means. Chemical paint removers can include solvents, such as methylene chloride, or caustic chemicals. Solvents permeate the top of the coating and dissolve the bond between the coating and the substrate (Ref. 22). Following the application of the chemical paint remover, the coating can be more easily peeled, scraped, or mechanically removed from the substrate. Techniques for applying the paint remover chemical include manual coating or brushing, tank dipping, flow-over systems, spray applications (manually or through automation), pouring, and wiping and rolling (manual or automated) (Ref. 2). Methylene chloride has been used to remove paint and coatings from walls, trim, furniture, architectural features, patios or decks, ceilings, bathtubs, floors, civilian aircraft, marine craft, cars, trucks, railcars, tankers, storage vessels, and other vehicles or their component parts to prepare for new coatings. Methylene chloride is typically applied to the surface using a hand-held brush, then left on to soften the old coating, and once curing has occurred, the old coating is scraped or brushed off to clean the surface. For bathtub refinishing, methylene chloride is poured and brushed onto a bathtub using a paintbrush and then scraped from the bathtub after leaving the remover to cure for 20 to 30 minutes (Ref. 4). Consumer use of methylene chloride in paint and coating removal occurs in consumer settings, such as homes, workshops, basements, garages, attics, and outdoors. More information on specific paint removal techniques is in the methylene chloride risk assessment (Ref. 2).

Though some users are switching to substitutes and alternative methods, methylene chloride use continues because it is readily available and works quickly and effectively on nearly all coatings without damaging most substrates. In addition, some users prefer methylene chloride because it is less flammable than some other solvents; however, paint and coating removal products formulated with methylene chloride tend to contain high concentrations of co-solvents that are flammable (Ref. 24). Also, methylene chloride is extremely volatile, has strong fumes, and evaporates quickly so that it must be reapplied for each layer of paint or coating to be removed.

Products intended for one specific type of paint removal project can be easily used in a different setting, including by consumers or hobbyists (Refs. 8, 9, 10, and 25). Additionally, consumers can easily use paint removal products intended for or marketed to professional users since paint removal products are readily available at many big box, local hardware, and paint specialty stores. It should be noted that, while voluntary, several retailers have committed to phase out methylene chloride paint and coating removal products. EPA identified 59 different products for paint and coating removal that contain methylene chloride, formulated by 10 different firms. This is approximately 54% of the total number of paint and coating removal products EPA identified (109 products) (Ref. 24). Paint and coating removers containing methylene chloride are frequently sold at stores that sell products to consumers as well as professional users. Additionally, due to the wide availability of products available on the internet and through various additional suppliers that serve commercial and consumer customers, consumers may foreseeably purchase a variety of paint and coating removal products containing methylene chloride. EPA estimated that approximately 1.3 million consumers and residential bystanders who use or are exposed to methylene chloride through consumer paint and coating removal each year (Ref. 4).

2. Regulatory considerations. To identify the regulatory approach that would address the unreasonable risk presented by methylene chloride in paint and coating removal, EPA analyzed a wide range of regulatory options under section 6(a) in the proposed rule (Ref. 3 at pp. 7472, 7479).

Section 6(c)(2)(A) of TSCA requires EPA, in proposing and promulgating section 6(a) rules, to include a statement addressing certain factors, including the costs and benefits and the cost effectiveness of the regulatory action and of the one or more primary alternative regulatory actions considered by the Administrator. In the proposed rule, EPA described its consideration of several alternative regulatory actions. One of the proposal's primary alternative regulatory actions consisted of: (i) An occupational respiratory protection program for the commercial uses proposed for regulation; (ii) a prohibition on distribution in commerce of methylene chloride for paint and coating removal in containers with a volume of less than 55 gallons and 5 gallons for certain formulations as a means of limiting consumer access to methylene chloride paint and coating removal products (though it did not include restrictions on manufacturing, processing, or distribution of methylene chloride for consumer paint and coating removal); and (iii) required downstream notification.

Since this final rule is not addressing commercial paint and coating removal, the primary alternative regulatory action considered in this final rule is slightly modified from the proposed rule, in that it does not include the occupational respiratory protection program for the commercial uses. Therefore, the primary alternative regulatory action for this final rule consists of: ( a ) Prohibition on distribution in commerce of methylene chloride for paint and coating removal in containers with a volume of less than 55 gallons and 5 gallons for certain formulations; and ( b ) downstream notification.

This final regulatory action is consistent with the regulatory action proposed, which includes a prohibition on the manufacture, processing and distribution in commerce of methylene chloride for consumer paint and coating removal. The primary alternative regulatory action considered would have imposed additional mitigation measures to address the risk to consumers ( i.e. 55-gallon containers) with additional burdens to processors and distributors; however, by eliminating access to methylene chloride for consumer paint and coating removal, via the retailer distribution restrictions, the unreasonable risk for consumer paint and coating removal use is addressed.

The cost of the final rule is less than the cost of the primary alternative regulatory action considered. EPA's assessment of the costs and benefits of the primary alternative regulatory action are described in the Economic Analysis (Ref. 4) and in Unit III.A.3.

3. TSCA section 6(c)(2) considerations. TSCA section 6(c)(2)(A) requires EPA to consider and publish a statement based on reasonably available information with respect to the chemical's effects on health and the magnitude of human exposure to the chemical. The following is EPA's statement with respect to this final rule.

i. Health effects, exposure, and environmental effects. Methylene chloride is a neurotoxicant that can be acutely lethal. Exposure to methylene chloride can result in a range of adverse health effects, including effects on the nervous system, liver, respiratory system, kidneys, and reproductive systems. Methylene chloride is also a likely human carcinogen. The magnitude of exposure of human beings to methylene chloride use in consumer paint and coating removal is characterized by the number of users, in the case of this final action is estimated to be 1.3 million consumers and residential bystanders who may not be engaged in paint and coating removal but who are exposed via inhalation to the chemical as a result of consumer paint and coating removal each year (Ref. 4). While methylene chloride is moderately persistent, given its low bioaccumulation and low hazard for aquatic toxicity (Ref. 2), the magnitude of potential environmental impacts on ecological receptors is judged to be low for the environmental releases associated with methylene chloride in consumer paint and coating removal (Ref. 3 at pp. 7468, 7489).

ii. The benefits of the chemical substance or mixture for various uses. Methylene chloride use in paint and coating removal provides benefits for some users because it is readily available and works quickly and effectively on nearly all coatings without damaging most substrates. In addition to paint and coating removal, methylene chloride is a solvent used in a variety of industrial, commercial and consumer use applications, including adhesives, pharmaceuticals, metal cleaning, chemical processing, and feedstock in the production of refrigerant hydrofluorocarbon-32 (Ref. 3 at p. 7467).

iii. The reasonably ascertainable economic consequences of the rule. The reasonably ascertainable economic consequences of this rule include several components, all of which are described in the Economic Analysis for this final rule (Ref. 4). With respect to the anticipated effects of this rule on the national economy, EPA considered the number of businesses and workers that would be affected and the costs and benefits to those businesses and workers and did not find that there would be a significant impact on the national economy. In addition, EPA considered the employment impacts of this final rule, and found that the direction of change in employment is uncertain, but EPA expects the short-term and longer-term employment effects to be small. EPA estimates that impacts on small businesses are insignificant; EPA estimates that this final rule would affect approximately 7 small entities, with all small businesses having a cost impact of less than 1% of the annual revenue.

With respect to this rule's effect on technological innovation, EPA expects this rule to spur innovation, not hinder it. A prohibition on the manufacture, processing, and distribution of this use of methylene chloride is likely to increase demand for chemical substitutes. This rule is not likely to have significant effects on the environment, though it does present the potential for small reductions in air emissions and soil contamination associated with improper disposal of paint and coating removers containing methylene chloride. The effects of this rule on public health are estimated to be positive, due to the prevention of deaths from consumer exposure to methylene chloride when engaging in paint and coating removal with these products.

The costs and benefits that can be monetized for this rule are described at length in Unit III.F and in the Economic Analysis (Ref. 4). The costs for this rule are estimated to range from $3.8 to $13.6 million annualized over 20 years at a 3% discount rate and $3.8 to $13.7 million annualized over 20 years at a 7% discount rate. The monetized benefits are estimated to be $3.5 million per year over 20 years at 3% and 7% discount rate. This reflects the benefit to consumers.

EPA considered the estimated costs to regulated entities as well as the cost to administer and enforce alternative regulatory actions. The primary alternative regulatory action would not include restrictions on manufacturing, processing, or distribution of methylene chloride for consumer paint and coating removal, but it would prohibit the distribution in commerce of methylene chloride for paint and coating removal in containers with a volume of less than 55 gallons, or 5 gallons for certain formulations. In addition, downstream notification and recordkeeping would be required. The estimated annualized costs of this alternative regulatory action are $5.8 to $16.8 million at 3% and $5.8 to $16.8 million at 7% over 20 years (Ref. 4). The estimated annualized benefits of this alternative regulatory action are $13.0 to $13.1 million at 3% and $12.8 million at 7% over 20 years (Ref. 4). This reflects the $3.5 million per year benefits to consumers noted above and additional benefits to commercial users not targeted by the rule.

The regulatory action finalized today is more cost effective than the primary alternative regulatory action because it achieves the necessary risk reduction for consumers and bystanders with estimated lower costs than the alternative regulatory action. The cost of the alternative regulatory action was estimated to be higher due to the cost of compliance with the container volume requirements which impact commercial users not targeted by the rule. However, the net benefits of the final regulatory action are estimated to be lower than the net benefits of the primary alternative regulatory action, since the primary alternative regulatory action includes benefits from preventing consumer users' exposure to methylene chloride in paint and coating removal, whereas the final regulatory action only includes benefits from eliminating consumer exposures to methylene chloride in paint and coating removal (Ref. 4).

iv. Consideration of alternatives. In addition to the statement of effects and analysis of alternative regulatory actions required under TSCA section 6(c)(2)(A), section 6(c)(2)(C) requires EPA to consider, in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use, whether technically and economically feasible alternatives ( e.g., substitute chemicals or alternative methods) that benefit health or the environment will be reasonably available as a substitute when the prohibition or restriction takes effect. In the proposed rule, EPA requested comment on the accuracy of its conclusion that identified substitutes for methylene chloride which are reasonably available and technically and economically feasible, and whether its consideration of chemical substitutes and alternative methods met the requirements of TSCA section 6(c)(2)(C). EPA received several comments on this subject. A majority of commenters indicated that effective, safer alternatives are already available for paint and coating removal, and that EPA has amply satisfied TSCA section 6(c)(2)(C) requirements by identifying a number of available, preferable substitutes, including non-chemical substitutes. Some commenters raised concerns regarding alternatives and claimed EPA failed to satisfy the requirements of TSCA section 6(c)(2)(C) because the Agency erroneously concluded that technically and economically feasible alternative paint strippers exist. EPA disagrees with the comments that for consumer users, available alternative formulations are less safe and more expensive than products with methylene chloride, although EPA does recognize that many factors need to be considered when choosing the appropriate alternative. Substitute products currently are available for consumer users of methylene chloride for paint and coating removal, for a variety of coatings on numerous substrates (Refs. 26 and 27). None of the substitute chemicals already available has the level of toxicity associated with methylene chloride (Ref. 24). As EPA stated in the proposed rule, EPA is aware of technically and economically feasible chemical substitutes or alternative methods that are reasonably available to a consumer for almost every situation in which methylene chloride is used to remove paints or coatings (Ref. 3 at p. 7485). A summary of comments related to substitute products, and EPA's response, is in the docket for this action (Ref. 15).

4. TSCA section 9(a) analysis. Section 9(a) of TSCA describes the steps EPA must take if the EPA Administrator determines in his discretion that an unreasonable risk may be prevented or reduced to a sufficient extent by an action taken under a Federal law not administered by EPA. These steps include submitting a report to the agency administering that other law that describes the risk and the activities that present such risk. EPA has not made such a determination, and, in the proposed rule, EPA explained its reasoning. TSCA section 9(d) further instructs the Administrator to consult and coordinate TSCA activities with other Federal agencies for the purpose of achieving the maximum enforcement of TSCA while imposing the least burden of duplicative requirements. In the proposed rule, EPA described its consultations with CPSC and with OSHA, and letters documenting this consultation are in the docket (Refs. 28 and 29).

CPSC's mission is to protect the public from unreasonable risks of injury or death associated with the use of consumer products under the agency's jurisdiction. CPSC recently updated its guidance on labeling for certain products containing methylene chloride to explain that covered products that do not bear a prominent warning about the risk of death in enclosed spaces are considered misbranded hazardous substances under the Federal Hazardous Substances Act, 15 U.S.C. 1261-1276. One of the specifically-stated purposes for the update was to provide more immediate guidance and clarity to consumers and industry regarding the acute hazards associated with using methylene chloride based paint removers while they remain on the market (83 FR 12254, March 21, 2018). In that guidance, CPSC specifically stated that, “we do not suggest that labeling will address all hazards EPA identified in its proposed rulemaking” regarding methylene chloride use in paint and coating removal products. While EPA believes that the updated CPSC labeling guidance, if properly implemented by industry, would prevent some users from using methylene chloride paint and coating removal products in an unsafe manner, for the reasons described in the proposal, it is unlikely to mitigate the unreasonable risks to consumers identified by EPA so that they are no longer unreasonable.

OSHA's mission is to assure safe and healthful working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance. OSHA's authority does not address unreasonable risk from methylene chloride in consumer paint and coating removal.

In this final rule, EPA has not used its discretion to make a determination that unreasonable risks from the use of methylene chloride in consumer paint and coating removal may be prevented or reduced to a sufficient extent by an action taken under a Federal law not administered by EPA, and therefore there is no need to submit a report to CPSC or OSHA under TSCA section 9(a).

More than 20 comments were received regarding issues generally related to TSCA section 9. Some commenters supported EPA's decision to not make a determination and submit a report to another agency under TSCA section 9(a). These commenters agreed with EPA's reasoning on the ability of other authorities to address the unreasonable risks identified by EPA. Other commenters contended that the OSHA regulations and the CPSC labeling guidance were sufficient to address the risks EPA identified, especially given the fact that CPSC was in the process of revising its labeling guidance for methylene chloride. Others thought that, to the extent that EPA had identified risks to consumers and others that were not adequately addressed by the current CPSC guidance or OSHA regulations, a report from EPA under TSCA section 9(a) would have alerted the other agencies to the potential deficiencies.

In this case, EPA disagrees with those commenters who thought that EPA must make a determination that other authorities administered by other agencies could address the unreasonable risks identified by EPA.

5. TSCA section 9(b) analysis. TSCA section 9(b) directs EPA to use other authorities administered by EPA to protect against a risk to health or the environment if EPA determines that such risk could be eliminated or reduced to a sufficient extent by actions taken under those authorities, unless EPA determines that it is in the public interest to protect against such risk by actions taken under TSCA.

Although several EPA statutes have been used to limit methylene chloride exposure, as described in the proposed rule, the acute unreasonable risks EPA has identified could not be addressed through these other statutes.

For this reason, the Administrator is not making a determination that the unreasonable risks of injury to health due to acute human lethality from the use of methylene chloride in consumer paint and coating removal could be eliminated or reduced to a sufficient extent by actions taken under other Federal laws administered in whole or in part by EPA. Another commenter stated that EPA failed to meet its obligations under TSCA section 9(b) because EPA did not compare the estimated costs and efficiencies of acting under TSCA or other statutes administered by EPA. EPA disagrees with this commenter's reading of TSCA section 9(b). The obligation to compare costs and efficiencies only arises after EPA has first determined that the identified unreasonable risks could be adequately addressed through action under another statute administered by EPA, and also determines that it is in the public interest to act under TSCA rather than the other statute. In this case, EPA has made neither of those determinations.

6. TSCA section 26(h) considerations. EPA has used scientific information, technical procedures, measures, methods, protocols, methodologies, and models consistent with the best available science at the time the risk assessment for methylene chloride was conducted. These information sources supply information relevant to whether the use of methylene chloride in paint and coating removal would present an acute unreasonable risk. For example, the 2014 risk assessment used best available science and methods, was peer reviewed, and went through a public comment process (Ref. 2).

The clarity and completeness of the data, assumptions, methods, quality assurance, and analyses employed in EPA's decision are documented, as applicable and to the extent necessary for purposes of this final rule, in the proposed rule (Ref. 3 at p. 7521) and in the references cited throughout the preamble of the proposed and this final rule. While EPA recognizes, based on the available information, that there is variability and uncertainty with regard to EPA's risk assessment of the use of methylene chloride in paint and coating removal, those uncertainties were identified in the proposed rule (Ref. 3 at p. 7491) and were characterized and documented in the methylene chloride risk assessment (Ref. 2). The extent to which the various information, procedures, measures, methods, protocols, methodologies or models, as applicable, used in EPA's decision have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for this rule. Additional information on the peer review and public comment process, such as the peer review plan, the peer review report, and EPA's response to comments, is in Docket Number EPA-HQ-OPPT-2012-0725.

EPA received several public comments on the proposed rule relating to the scientific information, technical procedures, measures, methods, protocols, methodologies, and models used by EPA. Commenters disagreed on whether EPA's assessment of methylene chloride was scientifically rigorous, with some praising EPA for a strong scientific underpinning for the regulation and others stating that EPA did not use best available science by incorporating exposure data that were out of date or by not correctly using a weight-of-evidence for some findings. EPA disagrees with commenters that the exposure data should not be used, or that weight-of-evidence was applied incorrectly. This action based on acute unreasonable risks is supported by a risk assessment that underwent peer review and a public comment process. More details on these comments and EPA's response is in the Response to Comments document (Ref. 15).

This final rule:

1. Prohibits the manufacturing, processing, and distribution in commerce of methylene chloride for paint and coating removal for all consumer uses;

2. Prohibits the distribution in commerce of methylene chloride in paint and coating removal products to and by retailers. A retailer is any person or business entity that distributes or makes available paint and coating removal products to consumers, including through ecommerce internet sales or distribution. If a person or business entity distributes or makes available any methylene chloride-containing paint or coating removal product to at least one consumer, then it is considered a retailer. For a distributor not to be considered a retailer, he/she must distribute or make available methylene chloride-containing paint and coating removal products solely to commercial or industrial end users or businesses. This additional provision clarifies the proposed regulation and ensures that retailers will not be able to purchase for sale or distribution to consumers, or to make available to consumers, paint and coating removal products containing methylene chloride;

3. Requires manufacturers, processors, and distributors of methylene chloride for any use, excluding retailers, to provide downstream notification of the prohibitions in this final rule through SDSs by adding to sections 1(c) and 15 of the SDS the following language: “This chemical/product is not and cannot be distributed in commerce (as defined in TSCA section 3(5)) or processed (as defined in TSCA section 3(13)) for consumer paint or coating removal.”; and

4. Requires recordkeeping relevant to these prohibitions.

The prohibition on manufacturing, processing, and distribution in commerce of methylene chloride for consumer paint and coating removal, including distribution to and by retailers, will take effect 180 days after the effective date of this final rule. EPA believes this is a reasonable transition period and will not result in additional costs of collecting and disposal of any stranded products. EPA recognizes that some individual retailers might not be as efficient with their inventory management and that could result in stranded products and some additional cost for disposal of such products.

Each person who manufactures, processes, or distributes in commerce methylene chloride is required to provide downstream notification of the restrictions in this rule through SDSs, effective 90 days following the effective date of this final rule. Downstream notification ensures that processors and distributors are aware of the restrictions for methylene chloride in paint and coating removal; enhances the likelihood that the risks associated with this use of methylene chloride are addressed throughout the supply chain; and also streamlines compliance and enhances enforcement, since compliance is improved when rules are clearly and simply communicated (Ref. 30).

After 90 days following the effective date of this final rule, each person who manufactures, processes, or distributes in commerce methylene chloride must retain documentation of the entities to whom methylene chloride was shipped, a copy of the downstream notification provided, and the amount of methylene chloride shipped. The documentation must be retained for 3 years from the date of shipment. Based on a public comment, EPA added to the final rule a provision to keep the required records either at the company's headquarters or at the facility for which the records were generated.

This final rule also includes a definition of retailers and consumer paint and coating removal in order to be responsive to comments received requesting EPA to provide more clarity regarding the regulated distribution to consumers.

EPA received four comments related to downstream notification of methylene chloride restrictions, one of which took issue with EPA's approach. This commenter stated that EPA lacks the authority to require downstream notification and recordkeeping beyond the scope of the conditions of use identified in its unreasonable risk finding. While EPA recognizes there are companies likely manufacturing, processing, or distributing methylene chloride or products containing methylene chloride for uses that will not be regulated under this final rule, EPA disagrees with the commenter's reading of the statute that section 6(a)(3) downstream notification requirements do not apply to conditions of use other than those for which EPA is addressing the unreasonable risk for a chemical substance.

TSCA section 6(a) requires EPA to impose one or more of the specified requirements to the extent necessary so that a chemical substance no longer presents an unreasonable risk identified by EPA. Here, EPA has determined that the downstream notification provisions are necessary to prevent the identified unreasonable risk. Without downstream notification, manufacturers, processors, and distributors, are likely to be unfamiliar with the prohibitions against distribution of methylene chloride-containing paint and coating removal products to and by retailers. As such, the notification helps ensure that all downstream entities are aware of the prohibitions. Further, notification throughout the supply chain streamlines compliance and enhances enforcement, since compliance can be improved when rules are clearly and simply conveyed. Moreover, under section 6, EPA has authority to require reporting and recordkeeping related to the regulatory requirements imposed by EPA under section 6. See, e.g., 55 FR 222 (EPA's section 6 action on hexavalent chromium in cooling towers).

Some commenters requested more clarity from EPA regarding how to use the SDS for downstream notification. In this final rule, EPA is specifying the changes to the SDS needed for the downstream notification. Specifically, EPA is requiring the addition of the following language to sections 1(c) and 15 of the SDS: “This chemical/product is not and cannot be distributed in commerce (as defined in TSCA section 3(5)) or processed (as defined in TSCA section 3(13)) for consumer paint or coating removal.”

The effective date of the requirement for this notification and the associated recordkeeping is 90 days after the effective date of this action. The proposed rule would have had these requirements take effect 45 days after the effective date of this final rule. On further reflection, EPA has determined that 90 days is a more reasonable transition period. Regulated entities need only to provide additional information on their SDS, which is routinely produced and updated.

Persons who import any chemical substance governed by a final TSCA section 6 rule are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. To comply with the import certification requirements, importers (or their agents) will be required to certify that the shipment of methylene chloride complies with all applicable rules and orders under TSCA. 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 methylene chloride are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

Section 15 of TSCA makes it unlawful to fail or refuse to comply with any provision of a rule promulgated under TSCA section 6. Therefore, any failure to comply with this rule when it becomes effective would be a violation of section 15 of TSCA. In addition, section 15 of TSCA makes it unlawful for any person to: (1) Fail or refuse to establish and maintain records as required by this rule; (2) fail or refuse to permit access to or copying of records, as required by TSCA; or (3) fail or refuse to permit entry or inspection as required by section 11 of TSCA.

Violators may be subject to both civil and criminal liability. Under the penalty provision of section 16 of TSCA, any person who violates section 15 could be subject to a civil penalty for each violation. Each day in violation of this final rule, after the effective date could constitute a separate violation. Knowing or willful violations could lead to the imposition of criminal penalties for each day of violation and imprisonment. In addition, other remedies are available to EPA under TSCA.

Individuals, as well as corporations, could be subject to enforcement actions. Sections 15 and 16 of TSCA apply to “any person” who violates various provisions of TSCA. EPA may, at its discretion, proceed against individuals as well as companies. In particular, EPA may proceed against individuals who report false information or cause it to be reported.

EPA evaluated the costs and benefits of this final action, which is presented in the Economic Analysis (Ref. 4) and summarized in this unit.

1. Overview of public comments. Of the nine comments received related to the Economic Analysis, three comments supported EPA's Economic Analysis. One commenter stated that EPA conducted a thorough cost-benefit analysis, and appropriately provided an in depth qualitative description of health benefits. Other commenters pointed out perceived shortcomings of the Economic Analysis conducted by the Agency, with one commenter calling for the underlying Economic Analysis data to be more comprehensive, accurate, and reflective of current industry practices. These comments, and EPA's response, are in the Response to Comments document in this docket (Ref. 15).

2. Costs. The details of the costs of this final rule are summarized in Unit I.E and discussed in the Economic Analysis (Ref. 4). Under this final rule, costs to users of paint and coating removal products containing methylene chloride are approximately $3.8 to $13.6 million annualized for 20 years at a discount rate of 3% and $3.8 to $13.7 million at a discount rate of 7%. Costs to manufacturers of methylene chloride are $50 and $60 annualized for 20 years at a discount rate of 3% and 7% respectively. Costs for processors, including those associated with reformulation, downstream notification and label changes, on an annualized basis over 20 years are $ 15,000 to $25,000 using 3% and $20,000 to $34,000 using 7% discount rates. Agency costs for enforcement are estimated to be approximately $147,000 and $145,000 annualized over 20 years at 3% and 7%, respectively. Total costs of this final rule are estimated to be approximately $3.8 to $13.6 million annualized over 20 years at 3% and $3.8 to $13.7 million annualized over 20 years at 7%.

3. Benefits. EPA is not fully able to quantify the full monetary benefits that would accrue from preventing all consumer deaths due to methylene chloride in paint and coating removal and the impacts of the substitution effect by switching from methylene chloride to alternative chemicals and methods. Similarly, EPA is not able to monetize the benefits that would accrue from preventing non-fatal and non-cancer effects from exposure to methylene chloride in paint and coating removal. The subset of benefits that can be monetized from mitigating the risks from methylene chloride in paint and coating removal for consumers finalized by this rule are potential avoidance of fatalities and are estimated to be approximately $3.5 million (annualized at 3% and 7% over 20 years) (Ref. 4).

4. Comparison of benefits and costs. The monetized subset of benefits from preventing the risks resulting from methylene chloride in consumer paint and coating removal are less than the estimated monetary costs.

5. Impacts on the national economy, small businesses, technological innovation, the environment, and public health. As summarized in Unit I.E and III.A.3 and described in the Economic Analysis (Ref. 4), EPA considered the anticipated effects of this final rule. With respect to the national economy, as EPA indicated in the proposed rule (Ref. 3 at p. 7489), EPA considered the number of businesses and workers that would be affected and the costs and benefits to those businesses and workers. EPA did not find that there would be a significant impact on the national economy (Ref. 4). In addition, EPA considered the employment impacts of this final rule, and found that the direction of change in employment is uncertain, but EPA expects the short term and longer-term employment effects to be small (Ref. 4). EPA estimates that impacts on small businesses are insignificant; EPA estimates that this final rule would affect approximately 7 small entities, with all small businesses having a cost impact of less than 1% of the annual revenue, (Ref. 4). As EPA indicated in the proposed rule, with respect to this rule's effect on technological innovation, EPA expects this action to spur innovation, not hinder it. A prohibition on the manufacturing, processing, and distribution in commerce of methylene chloride for consumer paint and coating removal is likely to increase demand for alternatives (Ref. 4). This rule is not likely to have significant effects on the environment, though it does present the potential for small reductions in air emissions and soil contamination associated with improper disposal of paint and coating removers containing methylene chloride. The effects of this rule on public health are estimated to be positive, due to the prevention of deaths and nonlethal adverse health effects due to consumer exposure to methylene chloride when engaging in paint and coating removal (Ref. 3 at p. 7489).

6. Impacts of the final and alternative regulatory actions. The costs of this final rule are estimated to include costs to users of paint and coating removal products containing methylene chloride, product reformulation costs, downstream notification costs, recordkeeping costs, and Agency costs.

The primary alternative regulatory action considered by EPA would not include restrictions on manufacturing, processing, or distribution of methylene chloride for consumer paint and coating removal, but it would require the distribution in commerce of methylene chloride for paint and coating removal in containers with a volume of no less than 55 gallons, or 5 gallons for certain formulations. In addition, downstream notification and recordkeeping would be required. As required under TSCA section 6(c), EPA analyzed the costs and benefits of this primary alternative action and found that this approach would introduce additional burdens to processors and distributors who would bear the cost of ensuring products are in 55- and 5-gallon containers, as appropriate. In addition, the 55-gallon volume restriction would effectively bar most commercial users in the professional contractor, bathtub refinishing, and graffiti removal sectors given the increased cost and, for some users, impracticality of using large containers.

The regulatory action finalized today is more cost effective because it achieves the necessary risk reduction for consumers and bystanders with estimated lower costs than the alternative regulatory action. The cost of the alternative regulatory action was estimated to be higher due to the cost of compliance with the container volume requirements. However, the net benefits of the final regulatory action are estimated to be lower than the net benefits of the primary alternative regulatory action, since the primary alternative regulatory action includes benefits from preventing consumer users' exposure, whereas the final regulatory action only includes benefits from eliminating consumer exposures to methylene chloride in paint and coating removal. A summary of the findings of this analysis are in III.A.3 and in the Economic Analysis (Ref. 4).

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

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

This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Order 12866 (58 FR 51735, October 4, 1993) and Executive Order 13563 (76 FR 3821, January 21, 2011). Any changes made in response to OMB recommendations have been documented in the docket. EPA prepared an economic analysis of the potential costs and benefits associated with this action, which is available in the docket and summarized in Units I.E., III.A.3., and III.G. (Ref. 4).

This action is subject to the requirements for regulatory actions specified in Executive Order 13771 (82 FR 9339, February 3, 2017). Details on the estimated costs of this final rule can be found in EPA's analysis (Ref. 4) of the potential costs and benefits associated with this action, which is available in the docket and is summarized in Unit III.F.

The information collection requirements in this rule have been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document prepared by EPA has been assigned EPA ICR No. 2556.02 and OMB Control No. 2070-0204. You can find a copy of the ICR in the docket for this rule (Ref. 32), and it is briefly summarized here. This rule does not require the regulated entities to submit information to EPA.

The information collection activities required by this rule include a downstream notification requirement and a recordkeeping requirement. The downstream notification would require companies that ship methylene chloride to notify companies downstream in the supply chain through the SDS of the prohibitions described in this final rule. The recordkeeping requirement mandates companies that ship methylene chloride to retain certain information at the company headquarters, or at the facility for which the records were generated, for three years from the date of shipment. These information collection activities are necessary in order to enhance the prohibitions under this rule by ensuring awareness of the prohibitions throughout the methylene chloride supply chain, and to provide EPA with information upon inspection of companies downstream who purchased methylene chloride. This rule does not require confidential or sensitive information to be submitted to EPA or downstream companies. EPA believes that these information collection activities would not significantly impact the regulated entities as the downstream notification requirements is a simple modification to the SDS and recordkeeping requirements include information that is part of the normal course of business.

Respondents/affected entities: Methylene chloride manufacturers, processors, and distributors.

Respondent's obligation to respond: Respondents are not obligated to respond or report to EPA, but must notify downstream users and maintain required records.

Estimated number of respondents: 138.

Frequency of response: On occasion to third parties as needed.

Total estimated annual burden: 69 hours. Burden is defined at 5 CFR 1320.3(b).

Total estimated annual cost: $3,712.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The OMB control numbers for certain EPA regulations are listed in 40 CFR part 9.

Pursuant to sections 603 and 609(b) of the RFA, EPA prepared an initial regulatory flexibility analysis (IRFA) for the proposed rulemaking and convened a Small Business Advocacy Review (SBAR) Panel to obtain advice and recommendations from small entity representatives that potentially would be subject to the rule's requirements. Summaries of the IRFA and Panel recommendations are presented in the proposed rulemaking (Ref. 3).

As required by section 604 of the RFA, EPA prepared a final regulatory flexibility analysis (FRFA) for this action (Ref. 31). The FRFA addresses the issues raised by public comments on the IRFA for the proposed rulemaking. The complete FRFA is available for review in the docket and is summarized here.

1. Statement of need and rule objectives. The purpose of this action is to prevent acute fatalities from the use of methylene chloride in consumer paint and coating removal. Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines that a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant, under the conditions of use, EPA must by rule apply one or more requirements to the extent necessary so that the chemical substance no longer presents such risk.

With respect to a chemical substance listed in the 2014 update to the TSCA Work Plan for Chemical Assessments for which a completed risk assessment was published prior to the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (which includes methylene chloride), TSCA section 26(l)(4) (15 U.S.C. 2625(l)(4)) provides that EPA “may publish proposed and final rules” under TSCA section 6(a) that are consistent with the scope of the completed risk assessment and consistent with other applicable requirements of TSCA section 6. EPA is publishing this final rule under TSCA section 6(a) in accordance with that discretionary statutory authority.

Based on EPA's analysis of consumer population exposures to methylene chloride in paint and coating removal, EPA is making a final determination that the use of methylene chloride in consumer paint and coating removal presents an unreasonable risk of injury to health due to acute human lethality. This final rule addresses that unreasonable risk.

EPA believes this rule will be effective in preventing unreasonable risk from the use of methylene chloride in consumer paint and coating removal. This final rule is informed by the TSCA Work Plan Chemical Risk Assessment Methylene Chloride: Paint Stripping Use, as well as information gathered from the comments on the proposed rulemaking, SBAR panel, and public meetings. For more information on the proposed rulemaking, SBAR panel and outreach efforts for this action, see the docket for this rulemaking (Docket ID Number EPA-HQ-OPPT-2016-0231).

2. Significant comments on the IRFA. EPA received no comments on the IRFA. However, EPA did receive comments related to the regulatory options selected, alternative regulatory actions, and impacts on small businesses. The comments received on the proposed rule and EPA's responses as they relate to this final action are summarized in Unit II.B.3 and in further detail in the Response to Comment Document in the docket (Ref. 15).

3. SBA Office of Advocacy comments and EPA response. EPA received no comments from SBA on the IRFA. SBA, however, did provide comments on the proposed rule. Because EPA is not finalizing the proposed regulations on NMP, EPA is not responding to the comments received regarding NMP at this time and will take them into consideration during the risk evaluation for that chemical. SBA's comments which pertain to methylene chloride consumer paint and coating removal, and EPA's responses, are in the Response to Comments document for this rule (Ref. 15) and in the FRFA (Ref. 31).

4. Estimate of the number of small entities to which the final rule applies. EPA estimates that this final rule would affect approximately 7 small entities, specifically, a small number of formulators of paint and coating removal products that contain methylene chloride (Ref. 32). The cost to these small businesses will be the cost of reformulating products sold to consumer users and the cost of complying with the downstream notification requirements. In addition, cost impacts of a prohibition on sale of paint and coating remover products containing methylene chloride for consumer uses on retailers of such products is not included in this analysis, as EPA is uncertain about the effect of possible increased sales of alternative paint and coatings removal products. Some of the affected retailers may be small businesses and these retailers are not included in this discussion.

Some small business may be negatively affected by the rule. Negative impacts may include increasing production of substitute chemicals to replace some of the production of methylene chloride, or updating SDS sheets, etc. EPA does not expect these impacts to be costly but as they are tasks that will take time, effort, and resources the firms would not otherwise expend in such a manner, EPA sees them as negative impacts on the firms. Another negative impact may include a small business formulator exiting the paint and coating removal product market entirely.

5. Projected reporting, recordkeeping and other compliance requirements of the final rule. i. Compliance requirements. To address the unreasonable risks that EPA has identified for methylene chloride in consumer paint and coating removal, EPA is finalizing under section 6 of TSCA regulations that prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride for all consumer paint and coating removal. The prohibition on distribution in commerce of methylene chloride in paint and coating removal for all consumer uses includes a prohibition on the distribution of methylene chloride for paint and coating removal to and by retailers. EPA is also requiring manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride for any use to provide downstream notification of these requirements and prohibitions throughout the supply chain via simple modifications to the SDS; and requiring limited recordkeeping.

ii. Classes of small entities subject to the compliance requirements. The small entities that are potentially directly regulated by this rule are small entities that are formulators of paint and coating removal products that contain methylene chloride.

iii. Professional skills needed to comply. For this rule, complying with the prohibitions, the downstream notification, and the recordkeeping requirements involve no special skills.

6. Steps taken to minimize economic impact to small entities. i. Small Business Advocacy Review Panel. As required by section 609(b) of the RFA, EPA also convened an SBAR Panel during the development of the proposed rule to obtain advice and recommendations from small entity representatives that potentially would be subject to the rule's requirements. The SBAR Panel evaluated the assembled materials and small-entity comments on issues related to elements of an IRFA. A copy of the full SBAR Panel Report (Ref. 14) is available in the rulemaking docket. The Panel recommended that EPA seek additional information in five specific areas: Exposure information, regulatory options, alternatives, cost information, and risk assessment. The comments received on the proposed rule and EPA's responses as they pertain to consumer paint and coating removal are summarized in Unit II.B.3 and in further detail in the Response to Comments Document in the docket (Ref. 15).

ii. Alternatives considered. EPA considered a wide variety of risk reduction options. The primary alternative regulatory action would not include restrictions on manufacturing, processing, or distribution of methylene chloride for consumer paint and coating removal, but it would require the distribution in commerce of methylene chloride for paint and coating removal in containers with volumes no less than 55 gallons, or 5 gallons for certain formulations. In addition, downstream notification and recordkeeping would be required. As required under TSCA section 6(c), EPA analyzed the costs and benefits of the alternative regulatory action (Ref. 4). EPA finds that the primary alternative regulatory action would introduce additional burdens to processors and distributors who would bear the costs of ensuring products are in 55 and 5-gallon containers, as appropriate. In addition, the 55-gallon volume restriction would effectively bar most commercial users in the professional contractor, bathtub refinishing, and graffiti removal sectors given the increased cost. The final rule is more cost effective than the primary alternative regulatory action considered. A summary of the findings of this analysis are in III.A.3 and in the Economic Analysis (Ref. 4).

7. Small Business Compliance Guides. EPA is preparing a Small Entity Compliance Guide to help small entities comply with this rule. EPA expects that this guide will be made available on the EPA website prior to the effective date of this final rule.

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The requirements of this action would primarily affect manufacturers, processors, and distributors of methylene chloride. The total estimated annualized cost of this final rule are $3.8 to $13.6 million and $3.8 to $13.7 million annualized over 20 years at 3% and 7%, respectively (Ref. 4), which does not exceed the inflation-adjusted unfunded mandate threshold of $154 million.

EPA has concluded that this action does not have federalism implications, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This regulation will not preempt state law. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Neither pause preemption nor permanent preemption apply to the restrictions proposed or to this final regulation, because this TSCA section 6(a) rule is promulgated under TSCA section 26(l)(4). In accordance with section 26(l)(4), this rulemaking is consistent with the scope of the 2014 risk assessment of methylene chloride for paint and coating removal, as well as other applicable requirements of TSCA section 6, and is not based on a risk evaluation conducted under TSCA section 6(b). Therefore, EPA believes that this rule will not preempt a state law or action on methylene chloride for consumer paint and coating removal under either section 18(a)(1)(B) (under which the extent of permanent preemption is “consistent with the scope of the risk evaluation under section (6)(b)(4)(D)”) or section 18(b) (under which the extent of pause preemption is tied to the “scope of the risk evaluation pursuant to section 6(b)(4)(D)”).

Although this rule does not have federalism implications, the Agency consulted with state and local officials early in the process of developing the proposed action to permit them to have meaningful and timely input into its development. EPA invited the following national organizations representing state and local elected officials to a meeting on May 13, 2015, in Washington DC: National Governors Association; National Conference of State Legislatures, Council of State Governments, National League of Cities, U.S. Conference of Mayors, National Association of Counties, International City/County Management Association, National Association of Towns and Townships, County Executives of America, and Environmental Council of States. A summary of the meeting with these organizations, including the views that they expressed, is available in the docket (Ref. 33).

This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). This rulemaking would not have substantial direct effects on tribal government because methylene chloride is not manufactured, processed, or distributed in commerce by tribes. EPA did not receive any information during the public comment period to alter EPA's understanding that this action has no substantial direct effects on tribal governments. Tribes do not regulate methylene chloride, and this rulemaking would not impose substantial direct compliance costs on tribal governments. Thus, E.O. 13175 does not apply to this action. EPA nevertheless consulted with tribal officials during the development of this action, consistent with the EPA Policy on Consultation and Coordination with Indian Tribes (Ref. 34).

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not economically significant as defined in Executive Order 12866, and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action's health and risk assessment of exposure by children to methylene chloride in paint and coating removal is contained in the proposed rule (Ref. 3 at pp. 7462, 7476, and 7503). Supporting information on methylene chloride exposures and the health effects of methylene chloride exposure by children is available in the Toxicological Review of Methylene Chloride (Ref. 5) and the methylene chloride risk assessment (Ref. 2).

This final rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution in commerce, or use. This rule is intended to protect against risks from methylene chloride in paint and coating removal, and does not affect the use of oil, coal, or electricity.

This final rule does not involve technical standards, and is therefore not subject to considerations under NTTAA section 12(d), 15 U.S.C. 272.

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse health or environmental effects of their programs, policies and activities on minority populations and low-income populations in the U.S. EPA places particular emphasis on the public health and environmental conditions affecting minority populations, low-income populations, and indigenous peoples. In recognizing that these populations frequently bear a disproportionate burden of environmental harms and risks, EPA works to protect them from adverse public health and environmental effects (Ref. 35).

This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Background

The New England Fishery Management Council adopted Framework 30 to the Atlantic Sea Scallop Fishery Management Plan (FMP) on December 5, 2018, and submitted a final EA to NMFS on March 7, 2019, for approval. NMFS published a proposed rule for Framework 30 on February 20, 2019 (84 FR 5035). To help ensure that the final rule would be implemented before April 1, 2019, the start of the fishing year, the proposed rule included a 15-day public comment period that closed on March 7, 2019.

NMFS has approved all of the measures in Framework 30 recommended by the Council, as described below. This final rule implements Framework 30, which establishes scallop specifications and other measures for fishing years 2019 and 2020, including changes to the catch, effort, and quota allocations and adjustments to the rotational area management program for fishing year 2019, and default specifications for fishing year 2020. The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) allows NMFS to approve, partially approve, or disapprove measures proposed by the Council based on whether the measures are consistent with the FMP, the Magnuson-Stevens Act and its National Standards, and other applicable law. NMFS generally defers to the Council's policy choices unless there is a clear inconsistency with the law or the FMP. Details concerning the development of these measures were contained in the preamble of the proposed rule and are not repeated here.

The allocations incorporate updated biomass reference points that resulted from the Northeast Fisheries Science Center's most recent scallop stock benchmark assessment that was completed in August 2018. The assessment reviewed and updated the data and models used to assess the scallop stock and ultimately updated the reference points for status determinations. The scallop stock is considered overfished if the biomass is less than half of the biomass at maximum sustainable yield (B msy ), and overfishing is occurring if fishing mortality (F) is above the fishing mortality at maximum sustainable yield (F msy ). The assessment found that the scallop resource is not overfished and overfishing is not occurring, but the estimates for F msy and B msy have changed. A comparison of the old and new reference points is outlined in Table 1.

Due to these reference point updates, the fishing mortality rates that the Council uses to set OFL, ABC, and ACL are updated through this action. The OFL was set based on an F of 0.64, equivalent to the F threshold updated through the 2018 assessment. The ABC and the equivalent total ACL for each fishing year are based on an F of 0.51, which is the F associated with a 25-percent probability of exceeding the OFL. The Council's Scientific and Statistical Committee (SSC) recommended scallop fishery ABCs of 125.7 million lb (57,003 mt) for 2019 and 101.5 million lb (46,028 mt) for the 2020 fishing year, after accounting for discards and incidental mortality. The SSC will reevaluate and potentially adjust its ABC recommendation for 2020 when the Council begins to develop the next framework adjustment in the summer of 2019.

Table 2 outlines the scallop fishery catch limits derived from the ABC values and the projected landings of the fleet.

This action deducts 1.25 million lb (567 mt) of scallops annually for 2019 and 2020 from the ABC for use as the Scallop RSA to fund scallop research. Participating vessels are compensated through the sale of scallops harvested under RSA projects. Of the 1.25 million-lb (567-mt) allocation, NMFS has already allocated 103,418 lb (46,902 kg) to previously-funded multi-year projects as part of the 2018 RSA awards process. NMFS is reviewing proposals submitted for consideration of 2019 RSA awards and will be selecting and announcing projects for funding in the near future.

This action also deducts 1 percent of the ABC for the industry-funded observer program to help defray the cost to scallop vessels that carry an observer. The observer set-aside is 570 mt for 2019 and 460 mt for 2020. In fishing year 2019, the compensation rates for limited access vessels in open areas fishing under days-at-sea (DAS) is 0.12 DAS per DAS fished. For access area trips, the compensation rate is 250 lb (113 kg), in addition to the vessel's possession limit for the trip for each day or part of a day an observer is onboard. LAGC IFQ vessels may possess an additional 250 lb (113 kg) per trip when carrying an observer. NMFS may adjust the compensation rate throughout the fishing year, depending on how quickly the fleets are using the set aside. The Council may adjust the 2020 observer set-aside when it develops specific, non-default measures for 2020.

This action implements vessel-specific DAS allocations for each of the three limited access scallop DAS permit categories ( i.e., full-time, part-time, and occasional) for 2019 and 2020 (Table 3). The 2019 DAS allocations are the same as those allocated to the limited access fleet in 2018. Framework 30 sets 2020 DAS allocations at 75 percent of fishing year 2019 DAS allocations as a precautionary measure. This is to avoid over-allocating DAS to the fleet in the event that the 2020 specifications action is delayed past the start of the 2020 fishing year. The allocations in Table 3 exclude any DAS deductions that are required if, when calculating final landings for fishing year 2018, NMFS determines that the limited access scallop fleet exceeded its 2018 sub-ACL.

For fishing year 2019 and the start of 2020, Framework 30 keeps the Mid-Atlantic Access Area (MAAA), Nantucket Lightship-West Access Area (NLS-W), and Closed Area 1 Access Area (CA1) open as access areas. In addition, this action closes the Nantucket Lightship-South Access Area (NLS-S). However, vessels are still able to fish fishing year 2018 allocation in NLS-S during the first 60 days of the 2019 fishing year.

Framework 30 allocates a new type of flexible allocation in CA1. Limited access full-time and part-time vessels will be allocated 18,000 lb (8,165 kg) and 17,000 lb (7,711 kg), respectively, of flexible allocation (flex allocation) in CA1 (Table 4 and Table 5). Because of uncertainty about the condition of the resource in CA1, scallops allocated to the limited access fleet in CA1 can be landed in any available access area. For the 2019 fishing year and the first 60 days of the 2020 fishing year, limited access vessels may choose to land CA1 flex allocation from any access area available in fishing year 2019 ( i.e., CA1, MAAA, and/or NLS-W). For example, a full-time vessel can take a trip in the CA1 and land 10,000 lb (4,536 kg) from that area, leaving the vessel with 8,000 lb (3,629 kg) of the CA1 flex allocation available, which can be landed from CA1, MAAA, and/or NLS-W. Trips can be combined with allocation dedicated to other areas, provided the 18,000-lb (8,165-kg) possession limit is not exceeded on any one trip.

Table 4 provides the limited access full-time allocations for all of the access areas, which could be taken in as many trips as needed, so long as the vessels do not exceed the 18,000-lb (8,165-kg) possession limit on any one trip.

Table 5 provides the limited access part-time allocations for all of the access areas, which could be taken in as many trips as needed, so long as the vessels do not exceed the 17,000-lb (7,711-kg) possession limit on any one trip.

For the 2019 fishing year, an occasional limited access vessel is allocated 10,500 lb (4,763 kg) of scallops with a trip possession limit of 10,500 lb (4,763 kg) of scallops per trip. Occasional vessels can harvest 10,500 lb (4,763 kg) allocation from only one of three available access areas (CA1, NLS-W, or MAAA). For the 2020 fishing year, occasional limited access vessels are allocated 10,500 lb (4,763 kg) in the MAAA only with a trip possession limit of 10,500 lb (4,763 kg) per trip.

The owner of a vessel issued a limited access scallop permit may exchange unharvested scallop pounds allocated into one access area for another vessel's unharvested scallop pounds allocated to another access area. These exchanges may only be made for the amount of the current trip possession limit (18,000 lb (8,165 kg) for full-time vessels and 17,000 lb (7,711 kg) for part-time vessels). In addition, these exchanges can only be made between vessels in the same permit category. For example, a full-time vessel may not exchange allocations with a part-time vessel, and vice versa.

1. ACL and IFQ Allocation for LAGC Vessels with IFQ Permits. For LAGC vessels with IFQ permits, this action implements a 2,792-mt ACL for 2019 and a 2,249-mt default ACL for 2020 (see Table 2). These sub-ACLs have no associated regulatory or management requirements, but provide a ceiling on overall landings by the LAGC IFQ fleets. If the fleet were to reach this ceiling, any overages would be deducted from the following year's sub-ACL. The annual allocation to the LAGC IFQ-only fleet for fishing year 2019 is 1,360 mt and 1,020 mt for 2020 (see Table 2). Each vessel's IFQ is calculated from these allocations based on APL.

2. ACL and IFQ Allocation for Limited Access Scallop Vessels with IFQ Permits. For limited access scallop vessels with IFQ permits, this action implements a 279-mt ACL for 2019 and a default 225-mt ACL for 2020 (see Table 2). These sub-ACLs have no associated regulatory or management requirements, but provide a ceiling on overall landings by this fleet. If the fleet were to reach this ceiling, any overages would be deducted from the following year's sub-ACL. The annual allocation to limited access vessels with IFQ permits for fishing year 2019 is 136 mt and 102 mt for 2020 (see Table 2). Each vessel's IFQ is calculated from these allocations based on APL.

3. LAGC IFQ Trip Allocations for Scallop Access Areas. Framework 30 allocates LAGC IFQ vessels a fleet-wide number of trips in the CA1, NLS-W, and MAAA for fishing year 2019 and default fishing year 2020 trips in the MAAA (see Table 6). The scallop catch associated with the total number of trips for all areas combined (3,997) for fishing year 2019 is equivalent to the 5.5 percent of total catch from access areas.

4. Northern Gulf of Maine (NGOM) TAC. This action implements a 205,000-lb (92,986-kg) annual NGOM TAC for fishing year 2019 and a 170,000-lb (77,111-kg) default TAC for fishing year 2020. The NGOM portions of Framework 29 (83 FR 12857; March 26, 2018) developed a methodology for splitting the TAC between the LAGC and the limited access fleets. The limited access portion of the TAC may only be fished by vessels participating in the RSA program that are participating in a project that has been allocated NGOM RSA allocation. Table 7 describes the division of the TAC for the 2019 and 2020 (default) fishing years.

5. Scallop Incidental Catch Target TAC. This action implements a 50,000-lb (22,680-kg) scallop incidental catch target TAC for fishing years 2019 and 2020 to account for mortality from vessels that catch scallops while fishing for other species, and to ensure that F targets are not exceeded. The Council and NMFS may adjust this target TAC in a future action if vessels catch more scallops under the incidental target TAC than predicted.

This action allows vessels participating in RSA projects to harvest RSA compensation from NLS-W, MAAA, and the open area. All vessels are prohibited from harvesting RSA compensation pounds in CA1. Vessels are prohibited from fishing for RSA compensation in the NGOM unless the vessel is fishing an RSA compensation trip using NGOM RSA allocation that was awarded to an RSA project, as implemented in the NGOM portions of Framework 29. Finally, Framework 30 prohibits the harvest of RSA from any access areas under default 2020 measures. At the start of the 2020 fishing year, RSA compensation can only be harvested from open areas. The Council will likely re-evaluate this default prohibition measure in the action that will set final 2020 specifications.

The Scallop FMP allocates fishery specifications on an annual basis including open-area DAS and access area trips for the limited access component, IFQ to qualifying LAGC IFQ vessels, and access area trips to the LAGC IFQ fleet. Default specifications have been developed in this annual process so that the fishery may continue to operate at a conservative level if updated specifications are not in place by April 1 (start of the fishing year). This action standardizes the process for developing some default measures.

Framework 30 standardizes the default DAS allocations for the limited access fleet. During the specifications setting process, each limited access permit type receives 75 percent of Fishing Year 1 open area DAS to begin the subsequent fishing year. In addition, this action standardizes the default LAGC IFQ allocation. The LAGC IFQ component receives 75 percent of Fishing Year 1 quota allocation. This action does not allocate default access area trips for the limited access or LAGC IFQ component, and it does not standardize default allocations to the NGOM.

The LAGC IFQ fishery is allocated a fleetwide total number of access area trips. Individual vessels are not required to take trips in specific areas as is the case for access area trips allocated to the limited access fishery. Instead, a maximum number of trips are identified for each area and, once that limit is reached, the area closes to all LAGC IFQ vessels for the remainder of the fishing year. The level of allocation can vary and is specified in each framework action. Framework 30 standardizes overall access area allocations to the LAGC IFQ component by allocating the amount equivalent to 5.5 percent of total projected access area harvest by the limited access and LAGC IFQ components. The total projected access area harvest will be set by:

1. First, multiplying the number of full-time access area trips by the full-time limited access fleet's access area possession limit and the number of full-time equivalent permits in the fishery (327);

2. Next, dividing the expected limited access fleet's access area harvest by 0.945 to calculate total expected access area harvest; and

3. Finally, calculating the number of access area trips allocated to the LAGC IFQ fleet by dividing 5.5 percent of total expected access area harvest by the LAGC IFQ possession limit.

This final rule includes three revisions to address regulatory text that is unnecessary, outdated, or unclear. These revisions are consistent with section 305(d) of the Magnuson-Stevens Act, which provides authority to the Secretary of Commerce to promulgate regulations necessary to ensure that amendments to an FMP are carried out in accordance with the FMP and the Magnuson-Stevens Act. The first revisions, at § 648.52(g) and § 648.59(d), clarify that LAGC IFQ and limited access scallop vessels, respectively, cannot exceed the scallop possession limit unless they are carrying an observer. The second revision, at § 648.53(h)(4)(ii) and (iii), adjusts the specific timing for the LAGC IFQ Cost Recovery Program to more accurately reflect the realities and limitations of how the program has been operating. The current regulatory language states that NMFS shall mail out cost recovery bills on or about October 31 of each year, and that the fee must be paid by January 1 of each year. In practice, it is not possible for NMFS to prepare bills on or before October 31, because it does not provide enough time to collect any data from the last few weeks of the cost recovery year, run quality assurance and quality control checks on that data, determine total recoverable costs, and generate bills. We have determined that cost recovery can be accomplished more effectively and clearly by simply giving up to 60 days for the bill to be paid after it is mailed.

We did not receive any comments on the proposed rule.

We corrected a typographical error at § 648.62(b)(1) that listed the LAGC portion of the 2020 NGOM TAC in kilograms as 5,443 kg (12,000 lb). The actual LAGC portion of the 2020 NGOM TAC is 54,431 kg (120,000 lb). The pounds listed in the proposed rule were correct.

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is consistent with the FMP, other provisions of the Magnuson-Stevens Act and other applicable law.

OMB has determined that this rule is not significant pursuant to E.O. 12866.

This final rule does not contain policies with federalism or “takings” implications, as those terms are defined in E.O. 13132 and E.O. 12630, respectively.

This action does not contain any collection-of-information requirements subject the Paperwork Reduction Act (PRA).

The Assistant Administrator for Fisheries has determined that the need to implement the measures of this rule in an expedited manner are necessary to achieve conservation objectives for the scallop fishery and certain fish stocks, and to relieve other restrictions on the scallop fleet. This constitutes good cause, under authority contained in 5 U.S.C. 553(d)(3), to waive the 30-day delay in the date of effectiveness and to make the final Framework 30 measures effective on April 1, 2019.

The 2019 fishing year begins on April 1, 2019. If Framework 30 is delayed beyond April 1, certain default measures, including access area designations, DAS, IFQ, RSA and observer set-aside allocations, would automatically be put into place. These default allocations were set more conservatively than what would eventually be implemented under Framework 30. Under default measures, each full-time vessel has 18 DAS and one access area trip for 18,000 lb (8,165 kg) in the Mid-Atlantic Access Area. We have good cause to waive the 30-day delay in effectiveness because this action provides full-time vessels with an additional 6 DAS (24 DAS total) and 108,000 lb (48,988 kg) in access area allocation (126,000 lb (57,153 kg) total). Further, LAGC IFQ vessels will receive an additional 447-mt (1,497-mt total) of allocation and 3,426 access area trips spread out across 3 access areas (3,997 trips total). Accordingly, this action prevents more restrictive aspects of the default measures from going into place. Framework 30 could not have been put into place sooner to allow for a 30-day delayed effectiveness because the information and data necessary for the Council to develop the framework was not available in time for this action to be forwarded to NMFS and implemented by April 1, 2019, the beginning of the scallop fishing year.

Further, following the lapse in appropriations, NMFS published the proposed rule as quickly as possible, allowing for only a 15-day comment period, after receiving a draft of Framework 30 from the Council, and NMFS published the final rule as quickly as possible after the close of the comment period. Delaying the implementation of this action for 30 days would delay positive economic benefits to the scallop fleet and could negatively impact the access area rotation program by delaying fishing in access areas that should be available. Therefore, the Assistant Administrator for Fisheries has waived the 30-day delay in the date of effectiveness requirement of 5 U.S.C. 553(d).

Pursuant to section 604 of the Regulatory Flexibility Act (RFA), NMFS has completed a final regulatory flexibility analysis (FRFA) in support of Framework 30. The FRFA incorporates the IRFA, a summary of the significant issues raised by the public comments in response to the IRFA, NMFS responses to those comments, a summary of the analyses completed in the Framework 30 EA, and the preamble to this final rule. A summary of the IRFA was published in the proposed rule for this action and is not repeated here. A description of why this action was considered, the objectives of, and the legal basis for this rule is contained in Framework 30 and in the preambles to the proposed rule and this final rule, and is not repeated here. All of the documents that constitute the FRFA are available from NMFS and/or the Council, and a copy of the IRFA, the Regulatory Impact Review (RIR), and the EA are available upon request (see ADDRESSES ).

There were no specific comments on the IRFA.

These regulations affect all vessels with limited access and LAGC scallop permits, but there is no differential effect based on whether the affected entities are small or large. As explained in the proposed rule, the regulations are expected to result in slightly higher profits for small entities when compared to status quo. Framework 30 provides extensive information on the number and size of vessels and small businesses that will be affected by the regulations, by port and state (see ADDRESSES ). Fishing year 2017 data were used for this analysis because these data are the most recent complete data set for a fishing year. There were 307 vessels that held full-time limited access permits in 2017, including 247 dredge, 50 small-dredge, and 10 scallop trawl permits. In the same year, there were also 31 part-time limited access permits in the sea scallop fishery. No vessels were issued occasional scallop permits in 2017. NMFS issued 240 LAGC IFQ permits and 95 LAGC NGOM permits in 2017, of which, about 127 of the IFQ vessels and 32 NGOM vessels declared scallop trips in 2017. The remaining IFQ permits likely leased out scallop IFQ allocations with their permits in Confirmation of Permit History. Section 6.5 of Framework 30 provides extensive information on the number and size of vessels that will be affected by the regulations, their home and principal state, dependency on the scallop fishery, and revenues and profits (see ADDRESSES ).

For RFA purposes, NMFS defines a small business in a shellfish fishery as a firm that is independently owned and operated with receipts of less than $11 million annually (see 50 CFR 200.2). Individually-permitted vessels may hold permits for several fisheries, harvesting species of fish that are regulated by several different fishery management plans, even beyond those impacted by this rule. Furthermore, multiple permitted vessels and/or permits may be owned by entities with various personal and business affiliations. For the purposes of this analysis, ownership entities are defined as those entities with common ownership as listed on the permit application. Only permits with identical ownership are categorized as an ownership entity. For example, if five permits have the same seven persons listed as co-owners on their permit applications, those seven persons would form one ownership entity that holds those five permits. If two of those seven owners also co-own additional vessels, that ownership arrangement between the two owners for the additional vessels would be considered a separate ownership entity for the purpose of this analysis.

On June 1 of each year, ownership entities are identified based on a list of all permits for the most recent complete calendar year. The current ownership dataset is based on the calendar year 2017 permits. This analysis considers average gross sales associated with the permits in the current ownership dataset for calendar years 2015 through 2017 to provide a recent average. Matching the potentially impacted 2017 fishing year permits (limited access permits and LAGC IFQ permits) to calendar year 2017 ownership data results in 164 distinct ownership entities for the limited access fleet, and 101 distinct ownership entities for the LAGC IFQ fleet. Of these, based on the Small Business Administration guidelines, 157 of the limited access distinct ownership entities and 101 of the LAGC IFQ entities are categorized as small entities. The remaining seven of the limited access and none of the LAGC IFQ entities are categorized as large entities. There were 32 distinct small business entities with active NGOM permits in 2017.

This action contains no new collection-of-information, reporting, or recordkeeping requirements.

During the development of Framework 30, NMFS and the Council considered ways to reduce the regulatory burden on, and provide flexibility for, the regulated entities in this action. For instance, Framework 30 standardizes default specifications for limited access DAS and LAGC IFQ allocation and standardizes the approach used to set the number of access area trips available to for the LAGC. This reduces confusion for the fleet and allows them to better plan future scenarios. In addition, Framework 30 implements flexible allocation in CA1. This was intended to provide flexibility to the fleet by allowing them to fish this allocation in any available access. Alternatives to the measures in this final rule are described in detail in Framework 30, which includes an EA, RIR, and IRFA (see ADDRESSES ). The measures implemented by this final rule minimize the long-term economic impacts on small entities to the extent practicable. The only alternatives for the prescribed catch limits that were analyzed were those that met the legal requirements to implement effective conservation measures. Specifically, catch limits must be derived using SSC-approved scientific calculations based on the Scallop FMP. Moreover, the limited number of alternatives available for this action must also be evaluated in the context of an ever-changing FMP, as the Council has considered numerous alternatives to mitigating measures every fishing year in amendments and frameworks since the establishment of the FMP in 1982.

Overall, this rule minimizes adverse long-term impacts by ensuring that management measures and catch limits result in sustainable fishing mortality rates that promote stock rebuilding, and as a result, maximize optimal yield. The measures implemented by this final rule also provide additional flexibility for fishing operations in the short-term.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency will publish one or more guides to assist small entities in complying with the rule, and will designate such publications as “small entity compliance guides.” The agency will explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a letter to permit holders that also serves as a small entity compliance guide was prepared. Copies of this final rule are available from the Greater Atlantic Regional Fisheries Office, and the guide ( i.e., permit holder letter) will be sent to all holders of permits for the scallop fishery. The guide and this final rule will be available upon request.

For the reasons set out in the preamble, 50 CFR part 648 is amended as follows: