Federal Register Vol. 83, No.234,

The substance of these special conditions previously has been published in the Federal Register for public comment. These special conditions have been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. 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.

The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to prior opportunities for comment described above. 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 November 20, 2014, Textron applied for a type certificate for their new Model 700 airplane. The Model 700 airplane is a turbofan-powered executive-jet airplane with seating for 2 crewmembers and 12 passengers. This airplane will have a maximum takeoff weight of 39,500 pounds.

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.17, Textron must show that the Model 700 airplane meets the applicable provisions of part 25, as amended by Amendments 25-1 through 25-139, 25-141, and 25-143.

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 Textron Model 700 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 type certificate for that model be amended later to include any other model that incorporates 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 Textron Model 700 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 § 21.17(a)(2).

The Textron Model 700 airplane will incorporate the following novel or unusual design feature: A fly-by-wire rudder-control system that requires a continuous source of electrical power to maintain an operable rudder flight-control system. The loss of this system may result in loss of flight control and may be catastrophic to the airplane.

The Textron Model 700 airplane has a fly-by-wire rudder-control system that requires a continuous source of electrical power to maintain an operable flight-control system. Section 25.1351(d), operation without normal electrical power, requires safe operation in visual flight rule (VFR) conditions for at least 5 minutes after loss of normal electrical power, excluding the battery. This rule is structured around traditional designs that use mechanical control cables and linkages for flight control. These manual controls allow the crew to maintain aerodynamic control of the airplane for an indefinite time after loss of all electrical power. Under these conditions, a mechanical flight-control system provides the crew with the ability to fly the airplane while attempting to identify the cause of the electrical failure, restart engine(s) if necessary, and attempt to re-establish some of the electrical-power-generation capability.

A critical assumption in § 25.1351(d) is that the airplane is in VFR conditions at the time of an electrical failure. This is not a valid assumption in today's airline operating environment, where airplanes fly much of the time in instrument-meteorological conditions on air-traffic-control-defined flight paths. Another assumption in the existing rule is that the loss of all normal electrical power is the result of the loss of all engines. The 5-minute period in the rule is to allow at least one engine to be restarted, following an all-engines power loss, to continue the flight to a safe landing. However, service experience on airplanes with similar electrical-power-system architecture as the Textron Model 700 airplane has shown that at least the temporary loss of all electrical power for causes other than all-engine failure is not extremely improbable.

To maintain the same level of safety envisioned by the existing rule with traditional mechanical flight controls, the Textron Model 700 airplane design must not be time-limited in its operation under all reasonably foreseeable conditions, including loss of all normal sources of engine or auxiliary power unit (APU)-generated electrical power. Textron must demonstrate that the airplane can maintain safe flight and landing (including rollout and brake control through full stop) with the use of its emergency/alternate electrical-power systems. These electrical-power systems, or the minimum restorable electrical-power sources, must be able to power loads that are essential for continued safe flight and landing, including those required for the maximum length of approved flight diversion.

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

As discussed above, these special conditions are applicable to the Textron Model 700 airplane. Should Textron apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the 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.

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 Textron Model 700 airplanes.

In lieu of 14 CFR 25.1351(d), the following special condition applies:

Textron must show, by test or combination of test and analysis that the airplane is capable of continued safe flight and landing with all normal sources of engine- and APU-generated electrical power inoperative (electrical power sources excluding the battery and any other standby electrical sources). The airplane operation should be considered at the critical phase of flight, and should include the ability to restart the engines and maintain flight for the maximum diversion-time capability being certified.

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus SAS Model A318, A319, A320 and A321 series airplanes. The NPRM published in the Federal Register on June 14, 2018 (83 FR 27724). The NPRM was prompted by an evaluation by the DAH indicating that the principal structural elements and certain life-limited parts are subject to WFD. The NPRM proposed to require revising the existing maintenance or inspection program to incorporate new or more restrictive airworthiness limitations.

We are issuing this AD to address prevent fatigue cracking, accidental damage, or corrosion in principal structural elements, and WFD, which could result in reduced structural integrity of the airplane.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2017-0231, dated November 21, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus SAS Model A318, A319, A320 and A321 series airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0512.

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

Lufthansa Technik requested that we use the latest service information in the NPRM. Lufthansa Technik stated that Airbus issued A318/A319/A320/A321 Airworthiness Limitation Section Part 2—Damage Tolerant Airworthiness Limitation Items (DT-ALI), Revision 07, dated June 13, 2018, which is the latest revision of the document.

We disagree with the commenter's request. We, along with the EASA, have not determined that Airbus A318/A319/A320/A321 Airworthiness Limitation Section Part 2—Damage Tolerant Airworthiness Limitation Items (DT-ALI), Revision 07, dated June 13, 2018, is required for airplanes that do not include Revision 07 as part of the type design. In the future, should we determine that Revision 07 is required, we would consider issuing additional rulemaking at that time. However, operators may request approval to incorporate Revision 07 as an alternative method of compliance (AMOC) under the provisions of paragraph (j) of this AD. We have not changed this AD in this regard.

We have revised paragraph (j)(1)(ii) of this AD to state that AMOCs previously approved for AD 2015-05-02, Amendment 39-18112 (80 FR 15152, March 23, 2015) (“AD 2015-05-02”), as applicable to ALS Part 2, are approved as AMOCs for the corresponding provisions of this AD. In paragraphs (j)(1)(ii)(A), (j)(1)(ii)(B), (j)(1)(ii)(C), and (j)(1)(ii)(D) of the proposed AD, we had identified specific ALS documents. However, any previously approved AMOC for AD 2015-05-02, as applicable to ALS Part 2, is acceptable for the corresponding requirements of this AD.

We have removed paragraph (i)(1) of the proposed AD, which specified that accomplishing the action required by paragraph (g) of this AD terminates the requirements of paragraphs (g) and (j) of AD 2016-09-06. However, we have determined that the actions required by this AD, do not terminate the requirements specified in AD 2016-09-06. The actions specified in paragraph (g) of AD 2016-09-06 were not incorporated into Airbus A318/A319/A320/A321 Airworthiness Limitation Section Part 2—Damage Tolerant Airworthiness Limitation Items (DT-ALI), Revision 06, dated April 10, 2017, which is specified in paragraph (g) of this AD. We have coordinated this issue with EASA.

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

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

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

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

Airbus has issued A318/A319/A320/A321 Airworthiness Limitation Section Part 2—Damage Tolerant Airworthiness Limitation Items (DT-ALI), Revision 06, dated April 10, 2017. This service information describes damage tolerant airworthiness limitations.

Airbus has also issued the following variations to A318/A319/A320/A321 Airworthiness Limitation Section Part 2—Damage Tolerant Airworthiness Limitation Items (DT-ALI), Revision 06, dated April 10, 2017.

• A318/A319/A320/A321 Airworthiness Limitation Section Part 2—Damage Tolerant Airworthiness Limitation Items (DT-ALI), Variation 6.1, dated May 18, 2017. The service information describes ALI tasks applicable to certain Model A320-200 and A321-200 airplane configurations.

• A318/A319/A320/A321 Airworthiness Limitation Section Part 2—Damage Tolerant Airworthiness Limitation Items (DT-ALI), Variation 6.2, dated May 24, 2017. This service information describes ALI tasks applicable to Model A321-271N and -272N airplanes.

• A318/A319/A320/A321 Airworthiness Limitation Section Part 2—Damage Tolerant Airworthiness Limitation Items (DT-ALI), Variation 6.3, dated October 24, 2017. This service information describes ALI tasks associated with door stops for certain Model A318, A319, A320, and A321 series airplanes.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 1,180 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

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

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.

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

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

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

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

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

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

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

Discussion

We issued AD 2018-13-07, Amendment 39-19319 (83 FR 34758, July 23, 2018), (“AD 2018-13-07”), for all RR Trent 1000-A, Trent 1000-C, Trent 1000-D, Trent 1000-E, Trent 1000-G, and Trent 1000-H turbofan engine models. AD 2018-13-07 required inspecting the IPC stage 1 rotor blades, IPC stage 2 rotor blades, and IPC shaft stage 2 dovetail posts, and removing any cracked parts from service. AD 2018-13-07 resulted from crack findings on the IPC rotor blades and IPC shaft stage 2 dovetail posts, which could lead to rotor blade separations resulting in engine failures. We issued AD 2018-13-07 to prevent failure of the IPC, which could result in failure of one or more engines, loss of thrust control, and loss of the airplane.

Since we issued AD 2018-13-07, the manufacturer determined the need for repetitive inspections of the IPC stage 1 rotor blades, IPC stage 2 rotor blades, and IPC shaft stage 2 dovetail posts. Also, since we issued AD 2018-13-07, the European Aviation Safety Agency (EASA) issued AD 2018-0167R2, dated October 16, 2018, which requires initial and repetitive inspections of the IPC stage 1 rotor blades, IPC stage 2 rotor blades, and IPC shaft stage 2 dovetail posts. We are issuing this AD to address the unsafe condition on these products.

We reviewed RR Alert Non-Modification Service Bulletin (NMSB) Trent 1000 72-AK130, Revision 2, dated July 26, 2018, and RR Alert NMSB Trent 1000 72-K132, dated June 29, 2018. RR Alert NMSB Trent 1000 72-AK130 describes procedures for performing initial and repetitive inspections of the IPC stage 1 rotor blades, IPC stage 2 rotor blades, and IPC shaft stage 2 dovetail posts, and lists engine serial numbers. RR Alert NMSB Trent 1000 72-K132, describes procedures for replacement of the IPC stage 1 rotor blades, IPC stage 2 rotor blades, and the IP compressor drum during refurbishment. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We reviewed RR NMSB Trent 1000 72-K099, Initial Issue, dated June 11, 2018; RR NMSB Trent 1000 72-K099, Revision 1, dated July 3, 2018; RR NMSB Trent 1000 72-K100, Initial Issue, dated June 11, 2018; RR NMSB Trent 1000 72-K129, Initial Issue, dated June 11, 2018; and RR NMSB Trent 1000 72-K129, Revision 1, dated July 2, 2018. RR NMSB Trent 1000 72-K099, Initial Issue, and RR NMSB Trent 1000 72-K099, Revision 1, describe procedure for an ultrasonic inspection of the IPC stage 1 rotor blades. RR NMSB Trent 1000 72-K100 Initial Issue describes procedures for a visual borescope inspection of the IPC stage 2 rotor blades and IPC shaft stage 2 dovetail posts. RR NMSB Trent 1000 72-K129, Initial Issue, and RR NMSB Trent 1000 72-K129, Revision 1, describe procedures for an ultrasonic inspection of the IPC stage 2 rotor blades.

This product has been approved by EASA and is approved for operation in the United States. Pursuant to our bilateral agreement with the European Community, EASA has notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD requires initial and repetitive inspections of the IPC stage 1 rotor blades, IPC stage 2 rotor blades, and IPC shaft stage 2 dovetail posts, and removing any cracked parts from service.

This AD allows inspections of any affected IPC part to be completed within 15 days of the effective date of this AD. EASA AD 2018-0167R2, dated October 16, 2018, and RR Alert NMSB Trent 1000 72-AK130, Revision 2, dated July 26, 2018, allow certain affected IPC parts to be completed within 45 days of the effective date of EASA AD 2018-0167R1. We expect most operators to have already complied with EASA AD and find that completing the inspections within 15 days of the effective date of this AD provides an appropriate level of safety.

We consider this AD interim action. The manufacturer is still reviewing this unsafe condition and may develop follow-on actions.

No domestic operators use this product. Therefore, we find that notice and opportunity for prior public comment are unnecessary and that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments before it becomes effective. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2018-0871 and product identifier 2018-NE-24-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. We will consider all comments received by the closing date and may amend this final rule because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this final rule.

We estimate that this AD affects 0 engines installed on airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary replacements that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need these replacements:

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

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

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

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

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

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

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

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

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

Accordingly, under the authority delegated to me by the Administrator, the FAA amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

On November 7, 2018, we issued Emergency AD 2018-23-51, which requires revising certificate limitations and operating procedures of the AFM to provide the flight crew with runaway horizontal stabilizer trim procedures to follow under certain conditions. This emergency AD was sent previously to all known U.S. owners and operators of these airplanes. This action was prompted by analysis performed by the manufacturer showing that if an erroneously high single AOA sensor input is received by the flight control system, there is a potential for repeated nose-down trim commands of the horizontal stabilizer. This condition, if not addressed, could cause the flight crew to have difficulty controlling the airplane, and lead to excessive nose-down attitude, significant altitude loss, and possible impact with terrain.

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

This AD requires revising certificate limitations and operating procedures of the AFM to provide the flight crew with runaway horizontal stabilizer trim procedures to follow under certain conditions.

We consider this AD interim action. If final action is later identified, we might consider further rulemaking then.

An unsafe condition exists that requires the immediate adoption of Emergency AD 2018-23-51, issued on November 7, 2018, to all known U.S. owners and operators of these airplanes. The FAA found that the risk to the flying public justified waiving notice and comment prior to adoption of this rule because an erroneously high single AOA sensor input received by the flight control system can result in a potential for repeated nose-down trim commands of the horizontal stabilizer, which could cause the flight crew to have difficulty controlling the airplane, and lead to excessive nose-down attitude, significant altitude loss, and possible impact with terrain. These conditions still exist and the AD is hereby published in the Federal Register as an amendment to section 39.13 of the Federal Aviation Regulations (14 CFR 39.13) to make it effective to all persons. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason(s) stated above, we find that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2018-0960 and Product Identifier 2018-NM-151-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. We will consider all comments received by the closing date and may amend this final rule because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this final rule.

We estimate that this AD affects 45 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

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

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.

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

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

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

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

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

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

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to Pacific Aerospace Limited Model 750XL airplanes. The NPRM was published in the Federal Register on May 11, 2018 (83 FR 21962). The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by the Civil Aviation Authority of New Zealand (CAA). The MCAI states:

This AD requires inspecting the pitot static tubes for chafing damage, replacing tubing as necessary, installing an additional clamp for pitot static tube support, protecting plumbing with spiralwrap, and ensuring proper clearance between the pitot tubes and the primary support at the flame arrester intersection. The MCAI can be found in the AD docket on the internet at: https://www.regulations.gov/document?D=FAA-2018-0371-0002.

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

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes and changes to clarify the reference to the service information. We have determined that these minor changes:

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

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

We reviewed Pacific Aerospace Service Bulletin PACSB/XL/094, Issue 2, dated March 20, 2018. The service information contains procedures for inspecting the pitot static tubing for chafing, replacing tubing as necessary, installing an additional clamp for pitot static tube support, protecting plumbing with spiralwrap, and ensuring proper clearance between the pitot tubes and the primary support at the flame arrester intersection. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD will affect 22 products of U.S. registry. We also estimate that it would take about 1 work-hour per product to comply with the pitot static tubing inspection and installation of support clamps and spiral wrap required by this AD. The average labor rate is $85 per work-hour. Required parts would cost about $25 per product.

Based on these figures, we estimate the cost of the AD on U.S. operators to be $2,420, or $110 per product.

In addition, we estimate that any necessary follow-on actions to replace damaged tubing would take about 1 work-hour and require parts costing $25, for a cost of $110 per product. We have no way of determining the number of products that may need these actions.

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

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes, gliders, balloons, airships, domestic business jet transport airplanes, and associated appliances to the Director of the Policy and Innovation Division.

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

For the reasons discussed above, I certify this AD:

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

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

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

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

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

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:

Background on Viticultural Areas TTB Authority

Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), authorizes the Secretary of the Treasury to prescribe regulations for the labeling of wine, distilled spirits, and malt beverages. The FAA Act provides that these regulations should, among other things, prohibit consumer deception and the use of misleading statements on labels and ensure that labels provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the FAA Act pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). The Secretary has delegated various authorities through Treasury Department Order 120-01, dated December 10, 2013 (superseding Treasury Order 120-01, dated January 24, 2003), to the TTB Administrator to perform the functions and duties in the administration and enforcement of these laws.

Part 4 of the TTB regulations (27 CFR part 4) authorizes the establishment of definitive viticultural areas and regulate the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) sets forth standards for the preparation and submission of petitions for the establishment or modification of American viticultural areas (AVAs) and lists the approved AVAs.

Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region having distinguishing features, as described in part 9 of the regulations, and a name and a delineated boundary, as established in part 9 of the regulations. These designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to the wine's geographic origin. The establishment of AVAs allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may purchase. Establishment of an AVA is neither an approval nor an endorsement by TTB of the wine produced in that area.

Section 4.25(e)(2) of the TTB regulations (27 CFR 4.25(e)(2)) outlines the procedure for proposing an AVA and provides that any interested party may petition TTB to establish a grape-growing region as an AVA. Section 9.12 of the TTB regulations (27 CFR 9.12) prescribes standards for petitions for the establishment or modification of AVAs. Petitions to establish an AVA must include the following:

• Evidence that the area within the proposed AVA boundary is nationally or locally known by the AVA name specified in the petition;

• An explanation of the basis for defining the boundary of the proposed AVA;

• A narrative description of the features of the proposed AVA affecting viticulture, such as climate, geology, soils, physical features, and elevation, that make the proposed AVA distinctive and distinguish it from adjacent areas outside the proposed AVA boundary;

• The appropriate United States Geological Survey (USGS) map(s) showing the location of the proposed AVA, with the boundary of the proposed AVA clearly drawn thereon; and

• A detailed narrative description of the proposed AVA boundary based on USGS map markings.

TTB received a petition from Andrew and Kathleen Weber, owners of Northern Cross Vineyard, on behalf of local grape growers and vintners, proposing to establish the “Upper Hudson” AVA in all or portions of Albany, Montgomery, Rensselaer, Saratoga, Schenectady, Schoharie, and Washington Counties in New York. The proposed Upper Hudson AVA covers approximately 1,500-square miles and is not located within any other AVA. There are 19 commercial vineyards with attached wineries covering approximately 67.5 acres within the proposed AVA. According to the petition, several vineyard owners are planning to expand their vineyards by a total of an additional 14 acres in the near future, and 4 new vineyards are also planned.

According to the petition, the distinguishing feature of the proposed AVA is its climate, relying on the USDA plant hardiness zone map and the growing degree day accumulations (GDDs) 1 for the proposed AVA and the surrounding areas.

According to the USDA plant hardiness zone map, which ranges from the coolest zone 1 to the warmest zone 13, the proposed Upper Hudson AVA falls into zones 5a and 5b. Average minimum temperatures in these zones range from −20 to −15 degrees F. The petition states that these average minimum winter temperatures are cold enough to damage or even kill many varieties of grapes. Therefore, vineyard owners within the proposed AVA plant cold hardy varieties such as Marquette, Frontenac, La Crescent, and La Crosse, which have been developed to withstand temperatures as low as −30 degrees F. Regions to the immediate east and west of the proposed Upper Hudson AVA are also classified as zones 5a and 5b. Regions farther to the west and northwest of the proposed AVA are classified as zones 3b, 4a, and 4b, with average minimum temperatures between −35 and −25 degrees F. The region to the south of the proposed AVA is classified as zones 6a and 6b with average minimum temperatures between −10 and 0 degrees F, and able to grow a wider variety of grapes.

The petition states that the locations within the proposed AVA achieved GDD accumulations ranging between 2,300 and 2,700. A GDD accumulation of over 2,500 is generally considered to be the minimum GDD accumulations needed to ripen most varieties of grapes.2 According to the petition, the locations within the proposed AVA reach 2,500 GDDs late in September, meaning that the fruit typically has only a few weeks to continue maturing before the first frost sets in. The petition states that, as a result, wineries often must work with tart fruit and remove the tartness as part of the winemaking process through the use of malolactic fermentation, pH adjustment, or residual sugars.

Locations to the north and south of the proposed AVA have GDD accumulations over 2,700 due to the warming effects of Lake Champlain and the tidal portion of the Hudson River respectively. The petition states that grapes in these warmer regions have more time to mature before the first frost, so the grapes “have the tartness removed in the vineyard.”

The remaining locations, to the east, southeast, southwest, and west of the proposed Upper Hudson AVA, all have lower GDD accumulations than the proposed AVA. The petition claims that viticulture in these regions would be difficult because the GDD accumulations would not reach the levels necessary to reliably ripen most varieties of grapes.

As a result of its climate, the proposed Upper Hudson AVA is suitable for growing cold-hardy grape hybrids, but not the grape varieties that are commonly grown farther south within the established Hudson River Region AVA.

TTB published Notice No. 174 in the Federal Register on April 9, 2018 (83 FR 15091), proposing to establish the Upper Hudson AVA. In the notice, TTB summarized the evidence from the petition regarding the name, boundary, and distinguishing features for the proposed AVA. The notice also compared the distinguishing features of the proposed AVA to the surrounding areas. For a detailed description of the evidence relating to the name, boundary, and distinguishing features of the proposed AVA, and for a detailed comparison of the distinguishing features of the proposed AVA to the surrounding areas, see Notice No. 174. In Notice No. 174, TTB solicited comments on the accuracy of the name, boundary, and other required information submitted in support of the petition. The comment period closed on June 8, 2018.

In response to Notice No. 174, TTB received seven comments, all of which expressed support for the proposed AVA. Some of the commenters suggested that the proposed AVA will increase tourism and provide economic benefits to the region. Others suggested that the establishment of the proposed Upper Hudson AVA will help to showcase the uniqueness of this area based on its climate. TTB did not receive any comments opposing the proposed AVA.

After careful review of the petition and the comments received in response to Notice No. 174, TTB finds that the evidence provided by the petitioner supports the establishment of the Upper Hudson AVA. Accordingly, under the authority of the FAA Act, section 1111(d) of the Homeland Security Act of 2002, and parts 4 and 9 of the TTB regulations, TTB establishes the “Upper Hudson” AVA in in all or portions of Albany, Montgomery, Rensselaer, Saratoga, Schenectady, Schoharie, and Washington Counties in New York, effective 30 days from the publication date of this document.

See the narrative description of the boundary of the Upper Hudson AVA in the regulatory text published at the end of this final rule.

The petitioner provided the required maps, and they are listed below in the regulatory text.

Part 4 of the TTB regulations prohibits any label reference on a wine that indicates or implies an origin other than the wine's true place of origin. For a wine to be labeled with an AVA name or with a brand name that includes an AVA name, at least 85 percent of the wine must be derived from grapes grown within the area represented by that name, and the wine must meet the other conditions listed in 27 CFR 4.25(e)(3). If the wine is not eligible for labeling with an AVA name and that name appears in the brand name, then the label is not in compliance and the bottler must change the brand name and obtain approval of a new label. Similarly, if the AVA name appears in another reference on the label in a misleading manner, the bottler would have to obtain approval of a new label. Different rules apply if a wine has a brand name containing an AVA name that was used as a brand name on a label approved before July 7, 1986. See 27 CFR 4.39(i)(2) for details.

With the establishment of this AVA, its name, “Upper Hudson,” will be recognized as a name of viticultural significance under § 4.39(i)(3) of the TTB regulations (27 CFR 4.39(i)(3)). The text of the regulation clarifies this point. Consequently, wine bottlers using the name “Upper Hudson” in a brand name, including a trademark, or in another label reference as to the origin of the wine, will have to ensure that the product is eligible to use the AVA name as an appellation of origin. The establishment of the Upper Hudson AVA will not affect any existing AVA. The establishment of the Upper Hudson AVA will allow vintners to use “Upper Hudson” as an appellation of origin for wines made primarily from grapes grown within the Upper Hudson AVA if the wines meet the eligibility requirements for the appellation.

TTB certifies that this regulation will not have a significant adverse economic impact on a substantial number of small entities. The regulation imposes no new reporting, recordkeeping, or other administrative requirement. Any benefit derived from the use of an AVA name would be the result of a proprietor's efforts and consumer acceptance of wines from that area. Therefore, no regulatory flexibility analysis is required.

It has been determined that this final rule is not a significant regulatory action as defined by Executive Order 12866 of September 30, 1993. Therefore, no regulatory assessment is required.

Caroline Hermann of the Regulations and Rulings Division drafted this final rule.

For the reasons discussed in the preamble, TTB amends title 27, chapter I, part 9, Code of Federal Regulations, as follows:

The Coast Guard will enforce the safety zone established in 33 CFR 165.1191, Table 1, Item number 30, on December 8, 2018. The Coast Guard will enforce a 100-foot safety zone around the fireworks barge during the loading, transit, and arrival of the fireworks barge from the loading location to the display location and until the start of the fireworks display. From 10 a.m. until 4 p.m. on December 8, 2018, the fireworks barge will be loading pyrotechnics at Pier 50 in San Francisco, CA. The fireworks barge will remain at the loading location until its transit to the display location. From 5 p.m. to 6 p.m. on December 8, 2018 the loaded fireworks barge will transit from Pier 50 to the launch site near Sausalito Point in approximate position 37°51′29.23″ N, 122°28′25″ W (NAD 83) where it will remain until the conclusion of the fireworks display. At 7 p.m. on December 8, 2018, 30 minutes prior to the commencement of the 10-minute fireworks display, the safety zone will encompass the navigable waters surrounding the fireworks barge near Sausalito Point in Sausalito, CA within a radius of 1,000 feet from approximate position 37°51′29.23″N, 122° 28′25″ W (NAD 83) for the Sausalito Lighted Boat Parade Fireworks Display in 33 CFR 165.1191, Table 1, Item number 30. The safety zone shall terminate at 8:10 p.m. on December 8, 2018.

Under the provisions of 33 CFR 165.1191, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone during all applicable effective dates and times, unless authorized to do so by the PATCOM. Additionally, each person who receives notice of a lawful order or direction issued by an official patrol vessel shall obey the order or direction. The PATCOM is empowered to forbid entry into and control the regulated area. The PATCOM shall be designated by the Commander, Coast Guard Sector San Francisco. The PATCOM may, upon request, allow the transit of commercial vessels through regulated areas when it is safe to do so.

This notice is issued under authority of 33 CFR 165.1191 and 5 U.S.C. 552(a). In addition to this notice in the Federal Register, the Coast Guard will provide the maritime community with extensive advance notification of the safety zone and its enforcement period via the Local Notice to Mariners.

If the Captain of the Port determines that the regulated area need not be enforced for the full duration stated in this notice, a Broadcast Notice to Mariners may be used to grant general permission to enter the regulated area.

Purpose: As noted above, this final rule incorporates classification changes adopted by the Nice Agreement that will become effective on January 1, 2019. This rule benefits the public by providing notice regarding these changes.

Summary of Major Provisions: The USPTO is revising §  6.1 in part 6 of title 37 of the Code of Federal Regulations to incorporate classification changes and modifications that will become effective January 1, 2019, as listed in the International Classification of Goods and Services for the Purposes of the Registration of Marks (11th ed., 2019) (Nice Classification), published by WIPO.

The Nice Agreement is a multilateral treaty, administered by WIPO, which establishes the international classification of goods and services for the purposes of registering trademarks and service marks. As of September 1, 1973, this international classification system is the controlling system used by the United States, and it applies to all applications filed on or after September 1, 1973, and their resulting registrations, for all statutory purposes. See 37 CFR 2.85(a). Every signatory to the Nice Agreement must utilize the international classification system.

Each state party to the Nice Agreement is represented in the Committee of Experts of the Nice Union (Committee of Experts), which meets annually to vote on proposed changes to the Nice Classification. Any state that is a party to the Nice Agreement may submit proposals for consideration by the other members in accordance with agreed-upon rules of procedure. Proposals are currently submitted on an annual basis to an electronic forum on the WIPO website, commented upon, modified, and compiled by WIPO for further discussion and voting at the annual Committee of Experts meeting.

In 2013, the Committee of Experts began annual revisions to the Nice Classification. The annual revisions, which are published electronically and enter into force on January 1 each year, are referred to as versions and identified by edition number and year of the effective date (e.g., “Nice Classification, 10th edition, version 2013” or “NCL 10-2013”). Each annual version includes all changes adopted by the Committee of Experts since the adoption of the previous version. The changes consist of the addition of new goods and services to, and deletion of goods and services from, the Alphabetical List, and any modifications to the wording in the Alphabetical List, the class headings, and the explanatory notes that do not involve the transfer of goods or services from one class to another. New editions of the Nice Classification continue to be published electronically and include all changes adopted annually since the previous version, as well as goods or services transferred from one class to another or new classes that are created.

The annual revisions contained in this final rule consist of modifications to the class headings that were incorporated into the Nice Agreement during the 28th Session of the Committee of Experts, from April 30, 2018 through May 4, 2018. Under the Nice Classification, there are 34 classes of goods and 11 classes of services, each with a class heading. Class headings generally indicate the fields to which goods and services belong. Specifically, this rule adds new, or deletes existing, goods and services from 15 class headings. The changes to the class headings further define the types of goods and/or services appropriate to the class. As a signatory to the Nice Agreement, the United States adopts these revisions pursuant to Article 1.

The USPTO is revising §  6.1 as follows:

In Class 5, the wording “dietary supplements for humans and animals” is amended to “dietary supplements for human beings and animals.”

In Class 9, the wording “Scientific, nautical, surveying, photographic, cinematographic, optical, weighing, measuring, signalling, checking (supervision), life-saving and teaching apparatus and instruments” is amended to add “research” after “scientific,” amend “nautical” to “navigation,” add “audiovisual” after “cinematographic,” and amend “checking (supervision)” to “detecting, testing, inspecting.” The wording “apparatus and instruments for conducting, switching, transforming, accumulating, regulating or controlling electricity” is amended to add “the distribution or use of” after “controlling.” The wording “apparatus for recording, transmission or reproduction of sound or images” is amended to add “and instruments” after “apparatus,” amend “transmission or reproduction of” to “transmitting, reproducing or processing,” and amend “sound or images” to “sound, images or data.” The wording “magnetic data carriers, recording discs” is deleted and replaced with “recorded and downloadable media, computer software, blank digital or analogue recording or storage media.” The wording “compact discs, DVDs and other digital recording media” is deleted. The wording “cash registers, calculating machines, data processing equipment, computers” is amended to “cash registers, calculating devices.” The wording “computers and computer peripheral devices” is added thereafter. The wording “computer software” is deleted. The wording “diving suits, divers' masks, ear plugs for divers, nose clips for diver sand swimmers, gloves for divers, breathing apparatus for underwater swimming” is added thereafter.

In Class 11, “Apparatus for lighting” is amended to “Apparatus and installations for lighting,” and “cooling” is added before the wording “steam generating.” “Refrigerating” is deleted.

In Class 15, the wording “music stands and stands for musical instruments; conductors' batons” is added.

In Class 19, “Building materials (non-metallic)” is amended to “Materials, not of metal, for building and construction.” The wording “non-metallic rigid pipes for building” is amended to “rigid pipes, not of metal, for building.” The wording “asphalt, pitch and bitumen” is amended to add a comma after “pitch” and the wording “tar” thereafter. The wording “non-metallic transportable buildings” is amended to “transportable buildings, not of metal.”

In Class 23, “yarns and threads, for textile use,” is amended to delete the comma after “threads.”

In Class 25, the wording “headgear” is amended to “headwear.”

In Class 26, the wording “Lace and embroidery, ribbons and braid” is amended to add a comma after “Lace” and the wording “braid” thereafter, add “and haberdashery” before “ribbons,” and amend “braid” to “bows.”

In Class 27, the wording “wall hangings (non-textile)” is amended to “wall hangings, not of textile.”

In Class 29, “milk and milk products” is amended to “milk, cheese, butter, yoghurt and other milk products.”

In Class 30, “rice” is amended to add a comma and the wording “pasta and noodles” thereafter. The wording “chocolate;” is added after “bread, pastries and confectionery.” The wording “ice cream, sorbets and other” is added before “edible ices.” The wording “salt;” is amended to replace the semi-colon with a comma and add the wording “seasonings, spices, preserved herbs;” thereafter. The wording “mustard;” is deleted. The wording “vinegar, sauces (condiments);” is amended to add the wording “and other” before “condiments” and delete the parentheses. The wording “spices;” is deleted where it appears as a separate clause.

In Class 32, the wording “non-alcoholic beverages;” is added after “Beers.” The wording “mineral and aerated water and other non-alcoholic beverages” is amended to delete “and other non-alcoholic beverages.” The wording “syrups and other preparations for making beverages” is amended to add “non-alcoholic” before “preparations.”

In Class 33, the wording “Alcoholic beverages (except beers)” is amended to add a comma after “beverages” and delete the parentheses. The wording “alcoholic preparations for making beverages” is added thereafter.

In Class 34, “Tobacco” is amended to add “and tobacco substitutes” thereafter. The wording “cigarettes and cigars; electronic cigarettes and oral vaporizers for smokers;” is added before “smokers' articles.”

In Class 42, the wording “industrial analysis and research services” is amended to add “industrial” before “research.”

A. Administrative Procedure Act: The changes in this rulemaking involve rules of agency practice and procedure, and/or interpretive rules. See Perez v. Mortg. Bankers Ass'n, 135 S. Ct. 1199, 1204 (2015) (Interpretive rules “advise the public of the agency's construction of the statutes and rules which it administers.” (citation and internal quotation marks omitted)); Nat'l Org. of Veterans' Advocates v. Sec'y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (Rule that clarifies interpretation of a statute is interpretive.); Bachow Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 2001) (Rules governing an application process are procedural under the Administrative Procedure Act.); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001) (Rules for handling appeals were procedural where they did not change the substantive standard for reviewing claims.).

Accordingly, prior notice and opportunity for public comment for the changes in this rulemaking are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law. See Perez, 135 S. Ct. at 1206 (Notice-and-comment procedures are required neither when an agency “issue[s] an initial interpretive rule” nor “when it amends or repeals that interpretive rule.”); Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), does not require notice and comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice” (quoting 5 U.S.C. 553(b)(A))).

The 30-day delay in effectiveness is not applicable because this rule is not a substantive rule as the changes in this rule have no impact on the standard for reviewing trademark applications. As discussed above, the changes in this rulemaking involve rules of agency practice and procedure, and consist of modifications to the class headings that are used to classify goods and services in the trademark application process. These changes are administrative in nature and will have no substantive impact on the evaluation of a trademark application. The purpose of a delay in effectiveness is to allow affected parties time to modify their behaviors, businesses, or practices to come into compliance with new regulations. This rule imposes no additional requirements on the affected entities. Therefore, the requirement for a 30-day delay in effectiveness is not applicable, and the rule is made effective January 1, 2019.

B. Regulatory Flexibility Act: As prior notice and an opportunity for public comment are not required pursuant to 5 U.S.C. 553 or any other law, neither a Regulatory Flexibility Act analysis, nor a certification under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), is required. See 5 U.S.C. 603.

C. Executive Order 12866 (Regulatory Planning and Review): This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993).

D. Executive Order 13563 (Improving Regulation and Regulatory Review): The USPTO has complied with Executive Order 13563 (Jan. 18, 2011). Specifically, the USPTO has, to the extent feasible and applicable: (1) Made a reasoned determination that the benefits justify the costs of the rule; (2) tailored the rule to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector and the public as a whole, and provided on-line access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.

E. Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs): This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866.

F. Executive Order 13132 (Federalism): This rulemaking does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).

G. Executive Order 13175 (Tribal Consultation): This rulemaking will not: (1) Have substantial direct effects on one or more Indian tribes; (2) impose substantial direct compliance costs on Indian tribal governments; or (3) preempt tribal law. Therefore, a tribal summary impact statement is not required under Executive Order 13175 (Nov. 6, 2000).

H. Executive Order 13211 (Energy Effects): This rulemaking is not a significant energy action under Executive Order 13211 because this rulemaking is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211 (May 18, 2001).

I. Executive Order 12988 (Civil Justice Reform): This rulemaking meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden as set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996).

J. Executive Order 13045 (Protection of Children): This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (Apr. 21, 1997).

K. Executive Order 12630 (Taking of Private Property): This rulemaking will not affect a taking of private property or otherwise have taking implications under Executive Order 12630 (Mar. 15, 1988).

L. Congressional Review Act: Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), prior to issuing any final rule, the USPTO will submit a report containing the final rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this notice are not expected to result in an annual effect on the economy of 100 million dollars or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this notice is not expected to result in a “major rule” as defined in 5 U.S.C. 804(2).

M. Unfunded Mandates Reform Act of 1995: The changes set forth in this notice do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of 100 million dollars (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of 100 million dollars (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.

N. National Environmental Policy Act: This rulemaking will not have any effect on the quality of the environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq.

O. National Technology Transfer and Advancement Act: The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this rulemaking does not contain provisions that involve the use of technical standards.

P. Paperwork Reduction Act: This final rule does not involve information collection requirements which are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

For the reasons given in the preamble and under the authority contained in 15 U.S.C. 1112, 1123 and 35 U.S.C. 2, as amended, the USPTO is amending part 6 of title 37 as follows:

On July 30, 2018, the Copyright Royalty Judges (Judges) published a modified proposed rule that establishes affected cable operators' obligation to pay a Sports Surcharge royalty. 83 FR 36509.

The Judges solicited general comments for or against the proposal and specific comments on the following questions: Could the proposed provision in section 387.2 (e)(9) (“Nothing herein shall preclude any copyright owner of a live television broadcast, the secondary transmission of which would have been subject to deletion under the FCC Sports Blackout Rule, from receiving a share of royalties paid pursuant to this paragraph.”) apply to the secondary transmissions of the live television broadcasts of any entity other than a current member of the Joint Sports Claimants (JSC)? 1 If the answer is yes, which entities' transmissions would qualify for a share? If the answer is no (i.e., only JSC members could qualify), then is the current proposal nevertheless consistent with the section 111 license? If so, why? Id. at 36511.

The Judges received joint comments from the JSC, NCTA-The Internet & Television Association, and American Cable Association stating support for the modified proposed rule as consistent with the section 111 license, answering the question in the affirmative, and specifying that “non-JSC members (e.g., MLS)” 2 might qualify for a share of the royalties. Joint Comments of the Moving Parties at 5. The Judges received no other comments.

The joint commenters point out that the focus of the proposed rule is to specify the circumstances in which cable systems will owe and make Sports Surcharge royalty payments, i.e., a “pay-in” methodology. Id. at 4. The modified proposed language applies to Surcharge payments for events of JSC members and other entities, if any, who sought protection under the Sports Blackout Rule in the two years prior to its repeal. The joint commenters are not aware of any other protected entities, but they proposed removing the reference to the JSC in the rule to address the Judges' concern that the language in the rule as originally proposed appeared limiting and exclusionary. Although JSC members may be the only entities that invoked the protection, even entities who did not invoke the protection may be entitled to receive a share of the Surcharge funds in the future. Id. at 5-6. The modified proposed rule also eliminates the reference to “eligible” sports events as it only included by definition JSC-member events. Id. at 3-4.

The joint commenters believe the original proposed rule did not implicate any of the concerns the Judges expressed because distribution of shares is not a subject of this rule. Distribution of royalty fees will be determined by the Judges or by agreement of interested parties. The modified proposed rule nonetheless states expressly that copyright owners are not precluded from sharing in future payments for the regulated secondary transmissions. Id. at 4, 6.

The removal of the references to JSC-member events in the proposed rule and the addition of the section clarifying that no entity will be precluded from receiving shares based on this rule allay the concerns of the Judges.

For the reasons set forth in the preamble, and under the authority of chapter 8, title 17, United States Code, the Copyright Royalty Judges amend 37 CFR chapter III as follows:

The EPA is publishing this rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. However, in the “Proposed Rules” section of the Federal Register, we are publishing a separate document that will serve as the proposed rule to exempt a new system of records, EPA-63, the eDiscovery Enterprise Tool Suite, from certain requirements of the Privacy Act if adverse comments are received on this direct final rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document.

If EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. We would address all public comments in any subsequent final rule based on the proposed rule.

The EPA published a Privacy Act system of records notice for information collected using the eDiscovery Enterprise Tool Suite. Depending on the specific need, the Agency will use a combination of several electronic tools that together assist with the preservation, search, processing, review and production of electronically stored information (ESI). The tool suite will be used to preserve, search, collect, sort and review ESI including email messages, word processing documents, media files, spreadsheets, presentations, scanned documents and data sets in support of legal discovery. The Agency will also use these tools to search for ESI that is responsive to requests for information submitted under the Freedom of Information Act (FOIA), or other formal information requests.

The records in EPA's eDiscovery Enterprise Tool Suite are maintained for use in civil and criminal actions. The Agency's system of records, EPA-63, is maintained by the Office of Environmental Information, Office of Enterprise Information Programs, eDiscovery Division, on behalf of Agency offices that will require use of the eDiscovery tool suite for both civil and criminal actions. When information is maintained for the purpose of civil actions, the relevant provision of the Privacy Act is 5 U.S.C. 552a(d)(5) which states “nothing in this [Act] shall allow an individual access to any information compiled in reasonable anticipation of a civil action or proceeding.” 5 U.S.C. 552a(d)(5).

The system is also maintained for support of criminal enforcement activity by the EPA. In those cases, the system is maintained on behalf of the Criminal Investigation Division, Office of Criminal Enforcement, Forensics, and Training, Office of Enforcement and Compliance Assurance—a component of EPA that performs as its principal function, activities pertaining to the enforcement of criminal laws. When information is maintained for the purpose of criminal cases, the relevant provision of the Privacy Act is 5 U.S.C. 552a(j)(2), which states that the head of an agency may promulgate regulations to exempt the system from certain provisions of the Act if the system is “maintained by an agency or component thereof which performs as its principal function any activity pertaining to the enforcement of criminal laws, including police efforts to prevent, control, or reduce crime or to apprehend criminals, and the activities of prosecutors, courts, correctional, probation, pardon, or parole authorities, and which consists of: (A) Information compiled for the purpose of identifying individual criminal offenders and alleged offenders and consisting only of identifying data and notations of arrests, the nature and disposition of criminal charges, sentencing, confinement, release, and parole and probation status; (B) information compiled for the purpose of a criminal investigation, including reports of informants and investigators, and associated with an identifiable individual; or (C) reports identifiable to an individual compiled at any stage of the process of enforcement of the criminal laws from arrest or indictment through release from supervision.” 5 U.S.C. 552a(j)(2). Accordingly the EPA-63 is exempt from 5 U.S.C. 552a(c)(3), (c)(4), (d), (e)(1), (e)(2), (e)(3), (e)(4)(G), (e)(4)(H), (e)(5), (e)(8) and (f)(2)-(f)(5) and (g):

(1) From subsection (c)(3) because making available to a record subject the accounting of disclosures from records concerning him/her could reveal investigative interest on the part of EPA and/or the Department of Justice. This would permit record subjects to impede the investigation, e.g., destroy evidence, intimidate potential witnesses, or flee the area to avoid inquiries or apprehension by law enforcement personnel. Further, making available to a record subject the accounting of disclosures could reveal the identity of a confidential source.

(2) From subsection (c)(4) because no access to these records is available under subsection (d) of the Privacy Act.

(3) From subsection (d) because the records contained in these systems relate to official federal investigations. Individual access to these records could compromise ongoing investigations, reveal confidential informants and/or sensitive investigative techniques used in particular investigations, or constitute unwarranted invasions of the personal privacy of third parties who are involved in a certain investigation. Amendment of the records in either of these systems would interfere with ongoing law enforcement proceedings and impose an unworkable administrative burden by requiring law enforcement investigations to be continuously reinvestigated.

(4) From subsections (e)(1) and (e)(5) because in the course of law enforcement investigations information may occasionally be obtained or introduced the accuracy of which is unclear or which is not strictly relevant or necessary to a specific investigation. In the interests of effective law enforcement, it is appropriate to retain all information that may aid in establishing patterns of criminal activity. Moreover, it would impede any investigative process, whether civil or criminal, if it were necessary to assure the relevance, accuracy, timeliness and completeness of all information obtained.

(5) From subsection (e)(2) because to comply with the requirements of this subsection during the course of an investigation could impede the information gathering process, thus hampering the investigation.

(6) From subsection (e)(3) because to comply with the requirements of this subsection during the course of an investigation could impede the information gathering process, thus hampering the investigation.

(7) From subsections (e)(4)(G) and (H) because no access to these records is available under subsection (d) of the Privacy Act.

(8) From subsection (e)(8) because complying with this provision could prematurely reveal an ongoing criminal investigation to the subject of the investigation.

(9) From subsection (f)(2), (f)(3), (f)(4) and (f)(5) because this system is exempt from the access and amendment provisions of subsection (d).

(10) From subsection (g) because EPA is claiming that this system of records is exempt from subsections (c)(3) and (4), (d), (e)(1), (2), (3), (4)(G) and (H), (5), and (8), and (f)(2), (3), (4) and (5) of the Act, the provisions of subsection (g) of the Act are inapplicable and are exempted to the extent that this system of records is exempted from those subsections of the Act.

A final relevant provision of the Privacy Act is 5 U.S.C. 552a (k)(2), which states that the head of an agency may promulgate regulations to exempt the system from certain provisions of the Act if the system “contains investigatory material compiled for law enforcement purposes other than material within the scope of subsection (j)(2)” of 5 U.S.C. 552a. Accordingly EPA-63 is exempt from 5 U.S.C. 552a(c)(3), (d), (e)(1), (e)(4)(G), (e)(4)(H) and (f)(2)-(f)(5):

(1) From subsection (c)(3) because making available to a record subject the accounting of disclosures from records concerning him/her could reveal investigative interest on the part of EPA and/or the Department of Justice. This would permit record subjects to impede the investigation, e.g., destroy evidence, intimidate potential witnesses, or flee the area to avoid inquiries or apprehension by law enforcement personnel. Further, making available to a record subject the accounting of disclosures could reveal the identity of a confidential source.

(2) From subsection (d) because the records contained in these systems relate to official Federal investigations. Individual access to these records could compromise ongoing investigations, reveal confidential informants and/or sensitive investigative techniques used in particular investigations, or constitute unwarranted invasions of the personal privacy of third parties who are involved in a certain investigation. Amendment of the records in either of these systems would interfere with ongoing law enforcement proceedings and impose an impossible administrative burden by requiring law enforcement investigations to be continuously reinvestigated.

(3) From subsection (e)(1) because in the course of law enforcement investigations information may occasionally be obtained or introduced the accuracy of which is unclear or which is not strictly relevant or necessary to a specific investigation. In the interests of effective law enforcement, it is appropriate to retain all information that may aid in establishing patterns of criminal activity. Moreover, it would impede any investigative process, whether civil or criminal, if it were necessary to assure the relevance, accuracy, timeliness and completeness of all information obtained.

(4) From subsections (e)(4) (G) and (H), because no access to these records is available under subsection (d) of the Privacy Act.

(5) From subsection (f)(2), (f)(3), (f)(4) and (f)(5) because this system is exempt from the access and amendment provisions of subsection (d).

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

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

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

This action does not impose an information collection burden under the PRA. This action contains no provisions constituting a collection of information under the PRA.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments.

This action does not have federalism implications. 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.

This action does not have tribal implications as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

This rule is exempt from the CRA because it is a rule of agency organization, procedure or practice that does not substantially affect the rights or obligations of non-agency parties.

For the reasons stated in the preamble, title 40, chapter I, part 16 of the Code of Federal Regulations is amended as follows:

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

The background for this action is discussed in detail in our October 3, 2018 proposal (83 FR 49894). In that document we proposed to (1) approve the portions of the April 4, 2008 and May 1, 2008 Texas SIP submittals as they pertain to the requirements of CAA section 110(a)(2)(D)(i)(I) with respect to the 1997 ozone NAAQS, and (2) find that the conclusion in the state's SIP submittals is consistent with EPA's conclusion regarding Texas's good neighbor obligation, that emissions from Texas will not significantly contribute to nonattainment or interfere with maintenance of the 1997 ozone NAAQS in any other state.

We did not receive any adverse comments regarding our proposal. We received two supportive comments regarding the proposal. The first was a comment from the Texas Commission on Environmental Quality which supported the proposal; and the second comment was an anonymous comment stating general support for clean air regulations. The comments are available in the electronic docket for this action.

We are approving the portions of the April 4, 2008 and May 1, 2008 Texas SIP submittals as they pertain to the requirements of CAA section 110(a)(2)(D)(i)(I) with respect to the 1997 ozone NAAQS. We find that the conclusion in the state's SIP submittals is consistent with EPA's conclusion regarding the good neighbor obligation, that emissions from Texas will not significantly contribute to nonattainment or interfere with maintenance of the 1997 ozone NAAQS in any other state. This action is being taken under section 110 of the Act.

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 4, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

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

Section 553 of the APA, 5 U.S.C. 553(b)(3)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. The EPA has determined that there is good cause for taking this final agency action without prior proposal and opportunity for comment because no significant EPA judgment is involved in making a finding of failure to submit complete SIPs, or elements of SIPs, required by the CAA, where a state has made incomplete submissions, to meet the requirement. Thus, notice and public procedures are unnecessary. The EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

The EPA first promulgated NAAQS for PM2.5 on July 18, 1997, setting the primary and secondary annual standards at 15 micrograms per cubic meter (μg/m3) and the primary and secondary 24-hour standards at 65 μg/m3.1 Effective April 5, 2005, the EPA designated the San Joaquin Valley as nonattainment for the 1997 PM2.5 NAAQS.2 Following a January 4, 2013 decision of the U.S. Court of Appeals for the D.C. Circuit (“D.C. Circuit”) remanding the EPA's 2007 PM2.5 Implementation Rule for the 1997 PM2.5 NAAQS,3 the EPA published a final rule on June 2, 2014, classifying the San Joaquin Valley, among other areas, as a “Moderate” nonattainment area for the 1997 PM2.5 NAAQS under subpart 4, part D of title I of the Act.4

Effective May 7, 2015, the EPA reclassified the San Joaquin Valley as a “Serious” nonattainment area for the 1997 PM 2.5 NAAQS.5 Upon reclassification as a Serious Area, the San Joaquin Valley became subject to a December 31, 2015 deadline under CAA section 188(c)(2) for attaining the 1997 PM2.5 NAAQS. On February 9, 2016, the EPA proposed to grant the State's request for extensions of the December 31, 2015 attainment date under CAA section 188(e), to December 31, 2018, for the 1997 24-hour PM2.5 NAAQS and to December 31, 2020, for the 1997 annual PM2.5 NAAQS in the San Joaquin Valley.6 On October 6, 2016, after considering public comments, the EPA denied California's request for these extensions of the attainment date.7 Consequently, on November 23, 2016, the EPA determined that the San Joaquin Valley had failed to attain the 1997 annual and 24-hour PM2.5 NAAQS by the December 31, 2015 Serious Area attainment date.8 This determination triggered a requirement for California to submit, by December 31, 2016, a revised PM2.5 attainment plan that satisfies the requirements of CAA section 189(d).9

The section 189(d) plan must, among other things, demonstrate expeditious attainment of the 1997 PM2.5 NAAQS within the time period provided under CAA section 179(d) and provide for annual reductions in emissions of direct PM2.5 or a PM2.5 plan precursor pollutant within the area of not less than five percent per year from the most recent emissions inventory for the area until attainment.10 The section 189(d) plan must also include, among other things:

1. A comprehensive, accurate, current inventory of actual emissions from all sources of PM2.5 and PM2.5 precursors in the area (CAA section 172(c)(3));

2. plan provisions that require reasonable further progress (RFP) (CAA 172(c)(2));

3. quantitative milestones which are to be achieved every 3 years until the area is redesignated attainment and which demonstrate RFP toward attainment by the applicable date (CAA section 189(c)); and

4. contingency measures to be implemented if the area fails to meet RFP or to attain by the applicable attainment date (CAA section 172(c)(9)).

On October 17, 2006, the EPA revised the 24-hour PM2.5 NAAQS by lowering it from 65 µg/m3 to 35 µg/m3.11 Effective December 14, 2009, the EPA designated the San Joaquin Valley as nonattainment for the 2006 24-hour PM2.5 NAAQS. The EPA initially classified the San Joaquin Valley area as a Moderate Area effective July 2, 2014, and reclassified the area as a Serious Area for the 2006 PM2.5 NAAQS effective February 19, 2016.12

Upon the area's reclassification as a Serious Area for the 2006 PM2.5 NAAQS, California was required to submit additional SIP revisions by August 21, 2017, to satisfy the statutory requirements that apply to Serious PM2.5 nonattainment areas, including the requirements of subpart 4 of part D, title I of the Act.13

The Serious Area plan must include, among other things:

1. A comprehensive, accurate, current inventory of actual emissions from all sources of PM2.5 and PM2.5 precursors in the area (CAA section 172(c)(3));

2. provisions for the implementation of BACM, including best available control technology (BACT), for sources of direct PM2.5 and all PM2.5 plan precursors no later than 4 years after the area is reclassified (CAA section 189(b)(1)(B));

4. plan provisions that require RFP (CAA 172(c)(2));

5. quantitative milestones which are to be achieved every 3 years until the area is redesignated attainment and which demonstrate RFP toward attainment by the applicable date (CAA section 189(c));

6. provisions to assure that control requirements applicable to major stationary sources of PM2.5 also apply to major stationary sources of PM2.5 precursors, except where the state demonstrates to the EPA's satisfaction that such sources do not contribute significantly to PM2.5 levels that exceed the standard in the area (CAA section 189(e));

7. contingency measures to be implemented if the area fails to meet RFP or to attain by the applicable attainment date (CAA section 172(c)(9)); and

8. a revision to the nonattainment NSR program to lower the applicable “major stationary source” thresholds from 100 tpy to 70 tpy (CAA section 189(b)(3)).

3. 2012 PM2.5 NAAQS

On December 14, 2012, the EPA revised the primary annual PM2.5 standard by lowering it from 15.0 to 12.0 µg/m3.15 Effective April 15, 2015, the EPA designated and classified the San Joaquin Valley as a Moderate nonattainment area for the 2012 annual PM2.5 NAAQS.16 This designation and classification triggered a requirement for California to submit a Moderate Area plan addressing attainment of the 2012 annual PM2.5 NAAQS in the San Joaquin Valley no later than 18 months after the designation, i.e., by October 15, 2016.17

The Moderate Area plan must include, among other things:

1. A comprehensive, accurate, current inventory of actual emissions from all sources of PM2.5 and PM2.5 precursors in the area (CAA section 172(c)(3));

2. provisions for the implementation of RACM, including reasonably available control technology (RACT), for sources of direct PM2.5 and all PM2.5 plan precursors no later than 4 years after designation (CAA section 189(a)(1)(C));

3. a demonstration (including air quality modeling) that the plan provides for attainment as expeditiously as practicable but no later than December 31, 2021, or a demonstration that attainment by that date is impracticable (CAA section 189(a)(1)(B));

4. plan provisions that require RFP (CAA 172(c)(2));

5. quantitative milestones which are to be achieved every 3 years until the area is redesignated attainment and which demonstrate RFP toward attainment by the applicable date (CAA section 189(c));

6. provisions to assure that control requirements applicable to major stationary sources of PM2.5 also apply to major stationary sources of PM2.5 precursors, except where the state demonstrates to the EPA's satisfaction that such sources do not contribute significantly to PM2.5 levels that exceed the standard in the area (CAA section 189(e));

7. contingency measures to be implemented if the area fails to meet RFP or to attain by the applicable attainment date (CAA section 172(c)(9)); and

8. Any revisions to the nonattainment NSR program necessary to implement the requirements of CAA section 189(a)(1)(A) for the 2012 PM2.5 NAAQS.

Section 110(k)(1)(A) of the CAA requires that the EPA promulgate minimum criteria that any plan submission must meet before the EPA is required to act on such submission. The EPA has promulgated these criteria at 40 CFR part 51, appendix V. We refer to these requirements as the “completeness criteria.” Section 2.1 of the completeness criteria requires that each plan submission include, among other things: (1) Evidence that the State has adopted the plan in the State code or body of regulations, including the date of adoption or final issuance as well as the effective date of the plan, if different from the adoption/issuance date, and (2) evidence that the State followed all of the procedural requirements of the State's laws and constitution in conducting and completing the adoption/issuance of the plan. Section 2.2 of the completeness criteria requires that each plan submission contain certain technical support, including (1) a demonstration that the SIP will protect RFP if approved, and (2) modeling to support the proposed revision. The completeness criteria also identify other administrative materials and technical support documentation that must be included in each plan submission.18

Section 110(k)(2) of the CAA requires the EPA to act on a SIP submission only after the State has submitted a SIP submission (or part thereof) that meets the completeness criteria, either by EPA determination or by operation of law under CAA section 110(k)(1)(B).

On November 16, 2018, California submitted to the EPA a draft of the “2018 Plan for the 1997, 2006, and 2012 PM2.5 Standards” (“2018 PM2.5 Plan”), a comprehensive plan for attainment of the PM2.5 NAAQS in the San Joaquin Valley. This submission includes substantial portions of a section 189(d) plan addressing attainment of the 1997 PM2.5 NAAQS, a Serious Area plan addressing attainment of the 2006 PM2.5 NAAQS, and a Moderate Area plan addressing attainment of the 2012 PM2.5 NAAQS in the San Joaquin Valley. The San Joaquin Valley Air Pollution Control District adopted the 2018 PM2.5 Plan on November 15, 2018.

As a threshold matter, however, the California Air Resources Board (CARB) noted in its letter transmitting the SIP submission to the EPA that CARB had not yet presented the 2018 PM2.5 Plan to its Board or adopted it for submission to the EPA as a revision to the California SIP. CARB stated that it was providing the submission to the EPA now so that EPA staff can begin its review while CARB completes the final step in plan development when it considers approval of the 2018 PM2.5 Plan at its hearing scheduled for January 24-25, 2019.19

Accordingly, the EPA cannot at this time find that California has submitted the required complete PM2.5 SIP revisions for the San Joaquin Valley nonattainment area. CARB's November 16, 2018 SIP submission does not include evidence that the State has adopted the plan in the State code or body of regulations or evidence that the State followed all of the procedural requirements of the State's laws and constitution in conducting and completing the adoption/issuance of the plan, as required by 40 CFR part 51, appendix V, section 2.1. Based on these deficiencies alone, the SIP submission fails to meet the EPA's minimum completeness criteria. In addition, until we receive the formal SIP submission, we cannot determine whether the plan that CARB ultimately adopts will contain all of the necessary components of the required PM2.5 attainment plans for the San Joaquin Valley and the associated technical support required for each submission under 40 CFR part 51, appendix V, section 2.2.

We note, however, that CARB's submission represents a significant step in the State's and District's multi-year effort to address the Act's attainment planning requirements for the PM2.5 NAAQS in the San Joaquin Valley, and we commit to continue working closely with both agencies as they implement and enforce the requirements of these plans going forward.

Under section 110(k)(1)(C) of the Act, where the EPA determines that a SIP submission (or part thereof) does not meet the EPA's minimum completeness criteria established in 40 CFR part 51, appendix V, the state shall be treated as not having made the submission (or part thereof). Sections 179(a) and 110(c) of the CAA establish specific consequences for failure to submit complete SIP submissions or SIP elements required under part D of title I of the Act, including the eventual imposition of mandatory sanctions in the affected area.

In accordance with the EPA's sanctions sequencing rule in 40 CFR 52.31, the offset sanction identified in CAA section 179(b)(2) would apply in the San Joaquin Valley area 18 months after the effective date of these findings, if the EPA has not affirmatively determined by that date that the State has submitted a complete SIP addressing the deficiency that is the basis for these findings. If, within 6 months after the offset sanction applies, the EPA still has not affirmatively determined that the State has submitted a complete SIP addressing the deficiency that is the basis for the findings, the highway funding sanction identified in CAA section 179(b)(1) would also apply in the San Joaquin Valley. Under 40 CFR 52.31(d)(5), neither sanction would apply if the EPA determines within 18 months after the effective date of these findings that the State has submitted a complete SIP submission addressing the deficiency that is the basis for these findings.

Additionally, a finding of failure to submit a complete SIP submission triggers an obligation under CAA section 110(c) for the EPA to promulgate a FIP no later than 2 years after the finding, unless the state has submitted, and the EPA has approved, the required SIP submittal. Thus, the EPA would be required to promulgate a PM2.5 FIP for the San Joaquin Valley, in relevant part, if California does not submit and the EPA does not approve all of the necessary SIP submissions within 2 years after the effective date of these findings.

The EPA is finding that California has failed to submit complete SIP revisions for implementation of the 1997, 2006, and 2012 PM2.5 NAAQS in the San Joaquin Valley as required under subparts 1 and 4 of part D, title I of the CAA and the PM2.5 SIP Requirements Rule. The consequences of these findings are discussed above in section II of this notice.

This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget (OMB) for review.

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

This action does not impose an information collection burden under the provisions of the PRA. This final rule does not establish any new information collection requirement apart from what is already required by law. This rule relates to the requirements in the CAA for states to submit SIPs under sections 172, 188 and 189 which address the statutory requirements that apply to areas designated as nonattainment for the PM2.5 NAAQS.

I certify that this rule will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. The rule is a finding that California has not submitted the necessary SIP revisions.

This action does not contain any unfunded mandate as described in UMRA 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

This action does not have federalism implications. 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.

This action does not have tribal implications as specified in Executive Order 13175. This rule finds that California has failed to submit SIP revisions that satisfy certain nonattainment area planning requirements under sections 172, 188 and 189 of the CAA for the 1997, 2006, and 2012 PM2.5 NAAQS for the San Joaquin Valley nonattainment area. No tribe is subject to the requirement to submit an implementation plan under section 172 or under subpart 4 of part D of Title I of the CAA. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it is a finding that California has failed to submit certain SIP revisions that satisfy the nonattainment area planning requirements under sections 172, 188 and 189 of the CAA for the 1997, 2006, and 2012 PM2.5 NAAQS for the San Joaquin Valley nonattainment area and does not directly or disproportionately affect children.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income, or indigenous populations. In finding that California has failed to submit SIP revisions that satisfy certain nonattainment area planning requirements under sections 172, 188 and 189 of the CAA for the1997, 2006, and 2012 PM2.5 NAAQS for the San Joaquin Valley nonattainment area, this action does not directly affect the level of protection provided to human health or the environment.

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 4, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

To access the OCSPP test guidelines referenced in this document electronically, please go to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select “Test Methods and Guidelines.”

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-2017-0372 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 February 4, 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-2017-0372, 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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.

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 October 23, 2017 (82 FR 49020) (FRL-9967-37), 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 7E8581) by IR-4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.425 be amended by establishing tolerances for residues of the herbicide clomazone, 2-[(2-chlorophenyl)methyl]-4,4-dimethyl-3-isoxazolidinone, in or on Bean, dry at 0.05 parts per million (ppm); Bean, succulent at 0.05 ppm; Broccoli, Chinese at 0.10 ppm; Cilantro, dried leaves at 0.3 ppm; Cilantro, fresh leaves at 0.05 ppm; Coriander, seed at 0.05 ppm; Cottonseed subgroup 20C at 0.05 ppm; Dill, dried leaves at 0.4 ppm; Dill, fresh leaves at 0.08 ppm; Dill, oil at 0.06 ppm; Dill, seed at 0.05 ppm; Kohlrabi at 0.10 ppm; Rapeseed subgroup 20A at 0.05 ppm; Stalk and stem vegetable subgroup 22A, except kohlrabi at 0.05 ppm; Vegetable, brassica, head and stem, group 5-16 at 0.10 ppm; and Vegetable, cucurbit, group 9 at 0.1 ppm.

The petitioner also proposed to remove the following established tolerances Asparagus at 0.05 ppm; Bean, snap, succulent at 0.05 ppm; Brassica, head and stem, subgroup 5A at 0.10 ppm; Cotton, undelinted seed at 0.05 ppm; Cucumber at 0.1 ppm; Pea, southern, dry seed at 0.05 ppm; Pea, southern, succulent seed at 0.05 ppm; Pumpkin at 0.1 ppm; Squash, summer at 0.1 ppm; Squash, winter at 0.1 ppm; Sweet potato, roots at 0.05 ppm; Vegetable, cucurbit, group 9 at 0.05 ppm. That document referenced a summary of the petition prepared by FMC Corporation, the registrant, which is available in the docket, http://www.regulations.gov. EPA received one comment the notice of filing. EPA's response to this comment is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA is establishing tolerances that vary from the levels requested. The reasons for these changes are 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 clomazone including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with clomazone 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 target of clomazone is the liver, with hepatocellular cytomegaly and increased liver weight noted in the sub-chronic rat study. There were no effects up to the limit dose in the chronic dog study. The 28-day dermal toxicity study in rats showed no effects up to the limit dose. There was no quantitative or qualitative evidence of susceptibility in the developmental toxicity study in rabbits or in the 2-generation reproduction toxicity study in rats. In the developmental toxicity study in rabbits, no developmental effects were seen at the highest dose tested where maternal effects, including mortality, abortions, decreased body weight gain and decreased defecation or no feces, occurred. In the 2-generation reproduction study, decreased body weight was seen at the same dose in both parents and offspring. Qualitative susceptibility was observed in the developmental toxicity study in rats. Developmental effects, including delayed ossification in the form of either partial ossification or the absence of the manubrium sternebrae 3-4, xiphoid, caudal vertebrae and metacarpals, occurred at the same dose as maternal effects, which included chromorhinorrhea and abdominogenital staining. The concern is low since there are clear NOAELs and LOAELs in this study and the study was used for risk assessment, and, therefore, is protective of the developmental effects. Using a weight of evidence approach, the Agency concluded that the acute and sub-chronic neurotoxicity studies, mouse carcinogenicity study, inhalation study, and immunotoxicity study are not required at this time. There are no dermal absorption studies available for clomazone. An acceptable dermal toxicity study is available to assess hazard through the dermal route therefore, a dermal absorption study is not required at this time.

In the rat and mouse carcinogenicity studies, there was no evidence of carcinogenicity. The mouse carcinogenicity study was classified as unacceptable/guideline since no systemic toxicity was observed at the highest dose tested, however, the study was considered adequate to assess the carcinogenicity in mice. The Agency has determined that an additional mouse carcinogenicity study is not needed. This finding is based upon the following conclusions: (1) The rat is more sensitive than the mouse for the chronic assessment; (2) the consistent effect in rats (decreased body weight and increased liver weight) has been used as the point of departure for the chronic assessment; (3) a new mouse study would only use doses well above the current POD for the chronic assessment; and (4) even if a new mouse study identified positive carcinogenicity effects, that finding would not result in the adoption of a quantitative linear assessment of cancer risk due to the negative carcinogenicity finding in the rat study and the lack of a positive finding for genotoxicity. Clomazone is classified as “Not Likely to be Carcinogenic to Humans”. Quantification of cancer risk is not required.

Clomazone has low acute toxicity (Category III and IV) via the oral, dermal and inhalation routes. It is non-irritating to the eyes and mildly irritating to the skin. It is not a dermal sensitizer. Clomazone is absorbed, metabolized (16 metabolites identified) and rapidly excreted in urine and feces in rats following oral administration. Most of the administered dose (48-85%) is eliminated within 24 hours, mostly in urine. The quantities of metabolites varied with dose regimen, sex and route of administration, but were the same qualitatively in urine and feces. The total recovery after 48 hours was 91-100%.

Specific information on the studies received and the nature of the adverse effects caused by clomazone 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 Clomazone: Human Health Risk Assessment for Proposed (1) New Uses on Cilantro, Dill, and Rapeseed Subgroup 20A; (2) Tolerance Revisions of Cucurbit Vegetable Group 9; (3) Tolerance Expansions of Representative Commodities to (i) Cottonseed Subgroup 20C, (ii) Stalk and Stem Vegetable Subgroup 22A, except Kohlrabi, (iii) Dry Bean, and (iv) Succulent Bean; and (4) Tolerance Conversions from Crop Subgroup 5A (Head and Stem Brassica) to Crop Group 5-16 (Brassica, Head and Stem Vegetable), Chinese Broccoli and Kohlrabi at page 35 in docket ID number EPA-HQ-OPP-2017-0372.

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

A summary of the toxicological endpoints for clomazone used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of November 10, 2016 (Vol. 81 FR 78914) (FRL-9953-88).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to clomazone, EPA considered exposure under the petitioned-for tolerances as well as all existing clomazone tolerances in 40 CFR 180.425. EPA assessed dietary exposures from clomazone in food as follows:

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

Such effects were identified for clomazone. In estimating acute dietary exposure, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16, which incorporates 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA incorporated tolerance level residues, assumed 100% crop treated, and used DEEM default processing factors.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the DEEM-FCID Version 3.16, which incorporates 2003-2008 food consumption data from USDA's NHANES/WWEIA. As to residue levels in food, EPA incorporated tolerance level residues, assumed 100% crop treated, and used DEEM default processing factors.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that clomazone 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 clomazone. Tolerance level residues and/or 100% CT were assumed for all food commodities.

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

Based on the Food Quality Protection Act (FQPA) Index Reservoir Screening Tool (FIRST), Tier 1 Rice Model and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of clomazone and its degradate, FMC 65317 (N-[(2-chlorophenyl)methyl]-3-hydroxy-2,2-dimenthylpropanamide), for acute exposures are estimated to be 550 parts per billion (ppb) for surface water and 85.7 ppb for ground water.

The EDWCs of clomazone plus FMC 65317 for chronic exposures for non-cancer assessments are estimated to be 550 ppb for surface water and 77.4 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 550 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 550 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Clomazone is not registered for any specific use patterns that would result in residential exposure. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found clomazone to share a common mechanism of toxicity with any other substances, and clomazone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that clomazone does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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

2. Prenatal and postnatal sensitivity. There was no evidence of increased quantitative or qualitative susceptibility in the prenatal developmental toxicity study in rabbits or in the reproductive toxicity study in rats with clomazone. In the developmental toxicity study in rats, delayed ossification occurred at doses that produced maternal effects (chromorhinorrhea and abdominogenital staining). Although qualitative susceptibility was observed in the developmental toxicity study in rats, the concern is low since there are clear NOAELs and LOAELs and the PODs selected for risk assessment are protective of the qualitative susceptibility.

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

i. The toxicity database for clomazone is complete.

ii. There is no indication that clomazone 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 clomazone results in increased quantitative susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

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

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure analysis, the risk estimate for acute dietary exposure from food and water to clomazone is at 3.0% of the aPAD for females 13-49 years old, the only population group for which an acute dietary endpoint was selected. The acute dietary risk for females 13-49 years old is not of concern (<100% of aPAD).

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure analysis, EPA has concluded that the risk estimates for chronic exposure to clomazone from food and water are not of concern (<100% of cPAD) with a risk estimate at 3.6% of the cPAD for all infants less than 1 year of age, the population group receiving the greatest exposure.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Currently, there are no registered or proposed residential uses for clomazone, therefore, a short-term aggregate risk is the same as the chronic risk, which does not exceed the Agency's level of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Currently, there are no registered or proposed residential uses for clomazone, therefore, an intermediate-term aggregate risk is the same as the chronic risk, which does not exceed the Agency's level of concern..

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

Adequate enforcement methodology, gas chromatography (GC) using a nitrogen phosphorus detector (NPD) or mass spectrometer (MS), is available. A confirmatory procedure (GC/MS-SIM: Gas Chromatography/Mass Spectroscopy-Selected Ion Monitoring) is also available (Method I, PAM [Pesticide Analytical Manual] II) to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

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

The Codex has not established any MRLs for clomazone.

One comment was received on the Notice of Filing expressing concern about the effects of wind turbines on bats. The comment did not raise any issue related to the Agency's safety determination for clomazone tolerances. The receipt of this comment is acknowledged; however, this comment is not relevant to this action.

For dill oil, the Agency is establishing a tolerance at 0.07 ppm rather than 0.06 ppm due to rounding based on the available data. Although the petitioner requested a tolerance for vegetable, cucurbit, group 9 at 0.1 ppm, the Agency is maintaining the established tolerance of 0.05 ppm for cucurbit vegetable group 9 and setting an expiration date for the existing tolerances on the individual commodities of cucumber, summer squash, winter squash and pumpkin at 0.1 ppm. Available residue data demonstrates that the 0.05 ppm tolerance value is sufficient to cover residues on the commodities in this group so there is no need to maintain the separate higher tolerances. Moreover, setting these tolerances at 0.05 ppm would harmonize tolerance values with Canada. In addition, the Agency is adding significant figures to the tolerances requested for cilantro, dried leaves and dill, dried leaves to conform to Agency practice.

The petitioner requested tolerances on “bean, dry” and “bean, succulent”. Although those terms are defined in 40 CFR 180.1(g), the Agency is establishing individual tolerances for each of the dry and succulent forms of the beans contained in that definition to more accurately reflect the commodities as distributed in interstate commerce: asparagus bean, chickpea, kidney bean, mung bean, navy bean, pinto bean, grain lupin, sweet lupin, white lupin, and white sweet lupin come in the dry bean form only; snap bean and wax bean come in succulent form only; and broad bean, lima bean, and southern pea come in both the dry and succulent forms. Tolerances for snap bean (succulent) and southern pea (dry and succulent) are already established and are being maintained.

In this Final Rule, EPA is reducing the existing tolerances for the commodities of cucumber, pumpkin, and summer and winter squash from 0.1 ppm to 0.05 ppm as part of vegetable, cucurbit, group 9. The Agency is reducing these tolerances to harmonize with Canadian tolerances on cucurbit vegetables and available residue data demonstrates that tolerances at 0.05 ppm are sufficient to cover residues on these commodities.

In accordance with the World Trade Organization's (WTO) Sanitary and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the WTO of this revision in order to satisfy its obligation. In addition, the SPS Agreement requires that Members provide a “reasonable interval” between the publication of a regulation subject to the Agreement and its entry into force to allow time for producers in exporting Member countries to adapt to the new requirement. At this time, EPA is establishing an expiration date for the existing tolerances to allow those tolerances to remain in effect for a period of six months after the effective date of this final rule, in order to address this requirement. After the six-month period expires, residues of clomazone on cucumber, pumpkin, and summer and winter squash cannot exceed the vegetable, cucurbit, group 9 tolerance of 0.05 ppm.

This reduction in tolerance levels is not discriminatory; the same food safety standard contained in the FFDCA applies equally to domestically produced and imported foods. The new tolerance levels are supported by available residue data.

Therefore, tolerances are established for residues of clomazone, 2-[(2-chlorophenyl)methyl]-4,4-dimethyl-3-isoxazolidinone, in or on Bean, asparagus, dry seed at 0.05 parts per million (ppm); Bean, broad, dry seed at 0.05 ppm; Bean, broad, succulent seed at 0.05 ppm; Bean, kidney, dry seed at 0.05 ppm; Bean, lima, dry seed at 0.05 ppm; Bean, lima, succulent seed at 0.05 ppm; Bean, mung, dry seed at 0.05 ppm; Bean, navy, dry seed at 0.05 ppm; Bean, pinto, dry seed at 0.05 ppm; Bean, wax, succulent seed at 0.05 ppm; Broccoli, Chinese at 0.10 ppm; Chickpea, dry seed at 0.05 ppm; Cilantro, dried leaves at 0.30 ppm; Cilantro, fresh leaves at 0.05 ppm; Coriander, seed at 0.05 ppm; Cottonseed subgroup 20C at 0.05 ppm; Dill, dried leaves at 0.40 ppm; Dill, fresh leaves at 0.08 ppm; Dill, oil at 0.07 ppm; Dill, seed at 0.05 ppm; Grain, lupin, dry seed at 0.05 ppm; Kohlrabi at 0.10 ppm; Rapeseed subgroup 20A at 0.05 ppm; Stalk and stem vegetable subgroup 22A, except kohlrabi at 0.05 ppm; Sweet, lupin, dry seed at 0.05 ppm; Vegetable, Brassica, head and stem, group 5-16 at 0.10 ppm; White lupin, dry seed at 0.05 ppm; and White sweet lupin, dry seed at 0.05 ppm. Upon the establishment of the tolerances referenced above, the following tolerances for residues of the herbicide clomazone, 2-[(2-chlorophenyl)methyl]-4,4-dimethyl-3-isoxazolidinone in or on the raw agricultural commodities should be removed: Asparagus at 0.05 parts per million (ppm); Brassica, head and stem, subgroup 5A at 0.10 ppm; Cotton, undelinted seed at 0.05 ppm; and Sweet potato, roots at 0.05 ppm. In addition, EPA is imposing an expiration date on the tolerances for Cucumber at 0.1 ppm; Pumpkin at 0.1 ppm; Squash, summer at 0.1 ppm; and Squash, winter at 0.1 ppm, so that they will expire six months after the publication of this rule.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp and select “Test Guidelines for Pesticides and Toxic Substances.”

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2018-0717 in the subject line on the first page of your submission. All requests must be in writing, and must be received by the Hearing Clerk on or before February 4, 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-2018-0717, by one of the following methods:

• Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.

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

EPA previously published final rules in the Federal Register for each chemical/commodity combination listed, establishing time-limited tolerances under FFDCA section 408, 21 U.S.C. 346a.

EPA established the tolerances because FFDCA section 408(l)(6) requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established on EPA's own initiative and without providing notice or time for public comment.

EPA received requests to extend the uses of these chemicals for this year's growing season. After having reviewed these submissions, EPA concurs that emergency conditions exist. EPA assessed the potential risks presented by residues for each chemical in the listed commodities. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18.

The data and other relevant material have been evaluated and discussed in the final rules originally published to support these uses. Based on those data and information considered, the Agency reaffirms that extension of these time-limited tolerances will continue to meet the requirements of FFDCA section 408(l)(6). Therefore, the time-limited tolerances are extended until the dates listed. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations (CFR). Although these tolerances will expire and are revoked on the date listed, under FFDCA section 408(l)(5), residues of the pesticides not in excess of the amounts specified in the tolerances remaining in or on the named commodities after that date will not be unlawful, provided the residues are present as a result of an application or use of the pesticides at a time and in a manner that was lawful under FIFRA, the tolerances were in place at the time of the application, and the residues do not exceed the levels that were authorized by the tolerances. EPA will act to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Tolerances for the uses of the following pesticide chemicals on specific commodities are being extended:

Bifenthrin. EPA has authorized under FIFRA section 18 the use of bifenthrin on apple, peach, and nectarine for control of the brown marmorated stinkbug in multiple states. This regulation extends existing time-limited tolerances for residues of the insecticide bifenthrin, including its metabolites and degradates, in or on apple, peach, and nectarine at 0.5 part per million (ppm) for an additional three-year period. These tolerances will expire and are revoked on December 31, 2021. Time-limited tolerances originally published in the Federal Register of September 14, 2012 (77 FR 56782) (FRL-9361-6).

Dinotefuran. EPA has authorized under FIFRA section 18 the use of dinotefuran on pome fruit and stone fruit for control of the brown marmorated stinkbug in multiple states. This regulation extends existing time-limited tolerances for residues of the insecticide dinotefuran, including its metabolites and degradates in or on fruit, pome, group 11 and fruit, stone, group 12 at 2.0 ppm for an additional three-year period. These tolerances will expire and are revoked on December 31, 2021. Time-limited tolerances originally published in the Federal Register of November 9, 2012 (77 FR 67282) (FRL-9366-3); and were revised in the Federal Register of January 22, 2014 (79 FR 3508) (FRL-9402-8).

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 MRLs for bifenthrin in/on apple, peach, or nectarine; nor dinotefuran in/on pome fruit or stone fruit.

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

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances 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:

Background

The final rule is implemented under the Tuna Conventions Act (16 U.S.C. 951 et seq.). This final rule applies to U.S. purse seine vessels fishing for tropical tunas in the IATTC Convention Area. The IATTC Convention Area is defined as waters of the EPO bounded by the west coast of the Americas and by 50° N latitude, 150° W longitude, and 50° S latitude.

Resolution C-18-05 imposes new restrictions on FAD design standards. NMFS implemented FAD construction standards adopted by the IATTC in a final rule published on April 11, 2018, in the Federal Register (83 FR 15503) which implemented Resolution C-17-02 (Conservation Measures for Tropical Tunas in the Eastern Pacific Ocean During 2018-2020 and Amendment to Resolution C-17-01). These regulations are set to become effective January 1, 2019.

Although Resolution C-17-02 included broadly worded restrictions on the use of entangling material on FADs, NMFS opted to establish standards that were more specific than the Resolution in the April 2018 final rule. NMFS did this to aid with compliance and enforcement and to further the intent of the Resolution that member nations require owners and operators of their vessels ensure FADs designed and deployed reduce entanglements of sharks, sea turtles, and other species.

Under the April 2018 final rule, U.S. vessel owners, operators, or crew must ensure any netting used in the subsurface structure of the FAD is tightly tied into bundles (“sausages”). In addition, if the FAD design includes a covered raft (e.g., flat raft or rolls of material) and if mesh netting is used for the cover, the mesh netting must be tightly wrapped around the entire raft such that no loose netting hangs below.

This final rule implements provisions in Resolution C-18-05 that specifies materials and designs that must be used to reduce entanglement on FADs; those specifications are only partially consistent with the April 2018 final rule. In accordance with Resolution C-18-05, this final rule gives fishermen an additional option for netting that hangs beneath a FAD, i.e., netting with small mesh (stretched mesh size less than 7 centimeters) in a panel that is weighted on the lower end with at least enough weight to keep the netting taut in the water column. In addition, also in accordance with Resolution C-18-05, this final rule also requires that if mesh netting is used as part of the raft (e.g., flat raft or rolls of material) then the mesh netting must be small mesh and must be tightly wrapped such that no netting hangs below the FAD when deployed. This final rule also includes a definition for mesh as the distance between the inside of one knot to the inside of the opposing knot when the mesh is stretched, regardless of twine size.

These requirements are intended to prohibit FAD designs that are most dangerous for bycatch species, such as sharks. As stated in the preamble of the April 2018 final rule, NMFS recognizes that any netting used in a FAD may become loose over time. However, to achieve the intent of Resolution C-18-05, the netting must remain secure and tight whenever deployed. Therefore, NMFS reminds the fleet that in order to keep FADs in compliance with these regulations, the purse seine operators must remain vigilant in maintaining and securing all mesh net used in FADs.

Futhermore, NMFS recognizes that the IATTC may continue to conduct more work to define non-entangling FADs and to develop more specific guidance on materials and designs for FADs. The United States intends to continue working with the IATTC FAD Working Group and the IATTC on methods to reduce entanglements in FADs. These regulations are likely to be amended again in the next few years as the IATTC refines FAD design requirements.

Although Resolution C-17-02 does not specifically define an “Active FAD,” paragraph 10 of Resolution C-17-02 states that for the purposes of this resolution, a FAD is considered active when it: (a) Is deployed at sea; and (b) starts transmitting its location and is being tracked by the vessel, its owner, or operator. The April 2018 Final rule codified a definition of “Active FAD” at 50 CFR 300.21 as a FAD that is equipped with gear capable of tracking location, such as radio or satellite buoys. A FAD with this equipment attached shall be considered an Active FAD unless/until the equipment is removed and the vessel owner or operator notifies the IATTC or HMS Branch that the FAD is no longer active (i.e., deactivated). After publication of that rule, information became available to NMFS from both industry and the IATTC FAD Working Group meetings that revealed U.S. vessels and vessels from other countries often stop tracking the location of FADs, while the FAD is deployed on the high seas, but typically do not remove the tracking equipment from FADs. Sometimes vessel owners or operators sell the information or the right to access the existing tracking equipment to other vessel owners or operators; the new owners/operators then assume ownership and start tracking the FAD. The owner of the FAD also, at times, stop tracking the location of a FAD for a period of time and then “reactivate” and begin to track the location of the FAD again at a later time.

In re-evaluating the meaning of “Active FAD” in Resolution C-17-02, NMFS interprets paragraph 10(b) to mean that an Active FAD is a FAD that is being “tracked” by a vessel owner or operator. Therefore, in this rule, NMFS revises the definition of Active FAD to clarify that a FAD that a FAD is considered Active when its location is being tracked by the vessel owner or operator using tracking equipment, such as radio or satellite buoys. A FAD shall be considered an Active FAD unless/until (i) the vessel is no longer tracking it, and (ii) the vessel owner or operator notifies the IATTC that the FAD is no longer active (i.e., deactivated). In addition, NMFS is revising the prohibition at § 300.24 (kk) and FAD restrictions at § 300.28 (b) to clarify that “when deploying a FAD” the tracking equipment must be turned on. This revision is necessary to clarify that FADs already deployed at sea may be reactivated if they were previously deactivated.

After consultation with the Departments of State and Homeland Security, the NMFS Assistant Administrator has determined that this final rule is consistent with the Tuna Conventions Act of 1950, as amended, and other applicable laws, subject to further consideration after public comment.

This rule has been determined to be not significant for purposes of Executive Order 12866.

This rule does not require new collection-of-information requirements subject to the Paperwork Reduction Act (PRA). The existing information collection approval requirements under Office of Management and Business (OMB) Control No. 0648-0148 (West Coast Region Pacific Tuna Fisheries Logbook and Fish Aggregating Device Form) covers the collections of information as amended by this rule. Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number. All currently approved NOAA collections of information may be viewed at: http://www.cio.noaa.gov/services_programs/prasubs.html.

The Assistant Administrator for Fisheries has determined that the need to comply by January 2019 with the international obligations of the United States under a binding resolution adopted by the IATTC under the Antigua Convention constitutes good cause, under 5 U.S.C. 553(b)(B), to waive the requirement for providing advance notice and comment.

Good cause exists because the IATTC adopted Resolution C-18-05 at the end of August, effective January 2019, rather than adopting the resolution in June or early July, which is the typical timing of the IATTC annual meeting. If the effectiveness of this rule were delayed pending publication of a proposed rule, consideration of additional public comments, and a 30-day delay in effectiveness, the U.S. would likely miss the January 2019 deadline and be out of compliance with a binding resolution. Additionally, the purse seine industry would be delayed in being allowed the option of using small mesh hanging in a panel beneath FADs, which we understand industry prefers to the current requirement that it be tied in a bundle.

Further rationale for finding good cause to waive advance notice and comment is that the proposed rule published on November 14, 2017, in the Federal Register (82 FR 52700) to implement Resolution C-17-02 (Conservation Measures for Tropical Tunas in the Eastern Pacific Ocean During 2018-2020 and Amendment to Resolution C-17-01), gave the public notice that the FAD design requirements were likely to be further refined. The revised requirements in Resolution C-18-05 are within the scope of the alternatives for FAD design discussed in that proposed rule. NMFS had initially proposed more stringent FAD construction requirements than those that were promulgated in the final rule. The changes between the proposed and final rule were made in consideration of a comment from the American Tunaboat Association (ATA) that proposed FAD design regulation went beyond the requirements in Resolution C-17-02 and would disadvantage the U.S. fleet.

The revisions to the Active FAD definition and regulations related to activating a FAD before deploying in the water will relieve restrictions, as explained in the preamble of this rule.

The owners and operators of the sixteen U.S. large purse seine vessels registered to fish in the EPO that would be impacted by the rule are already familiar with the measures adopted by the IATTC. In addition to sending professional representatives and lobbyists, many owners and operators personally attended the 2017 and 2018 IATTC meetings when Resolution C-17-02 and C-18-05 were adopted and were closely involved in briefings and discussions with U.S. State Department and NOAA leadership and staff. This action is necessary for the United States to satisfy its international obligations as a member of the IATTC.

As soon as the rule is published, NMFS will send a notice of this rule to owners of vessels that are affected by this rule. The Regulatory Flexibility Act (RFA), 5 U.S.C. 605(b), requires a Regulatory Flexibility Analysis only for rules promulgated through notice and comment rulemaking under Section 553(b) of the Administrative Procedure Act or any other law. Because there is good cause to waive notice and comment for this final rule, an RFA Analysis was not prepared for this rule.

For the reasons set out in the preamble, 50 CFR part 300, subpart C, is amended as follows:

The snapper-grouper fishery of the South Atlantic includes red snapper and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

The commercial ACL for red snapper in the South Atlantic is 124,815 lb (56,615 kg), round weight. Under 50 CFR 622.193(y)(1), NMFS is required to close the commercial sector for red snapper when landings reach, or are projected to reach, the commercial ACL by filing a notification to that effect with the Office of the Federal Register.

NMFS previously projected that the commercial ACL for South Atlantic red snapper for the 2018 fishing year would be reached by November 7, 2018. Accordingly, NMFS published a temporary rule in the Federal Register to implement accountability measures (AMs) to close the commercial sector for red snapper in the South Atlantic EEZ effective November 7, 2018 (83 FR 55292; November 5, 2018).

However, recent landings data for red snapper indicate that the commercial ACL has not been yet been reached. Consequently, and in accordance with 50 CFR 622.8(c), NMFS temporarily re-opens the commercial sector for red snapper effective at 12:01 a.m. on December 5, 2018. The commercial sector will remain open for 10 calendar days and will close at 12:01 a.m. on December 15, 2018. Re-opening the commercial sector for 10 days allows an additional opportunity to commercially harvest the red snapper ACL while minimizing the risk of exceeding the commercial ACL. For the 2019 fishing year, NMFS will announce the commercial season opening date in the Federal Register.

The Regional Administrator, NMFS Southeast Region, has determined this temporary rule is necessary for the conservation and management of red snapper and the South Atlantic snapper-grouper fishery and is consistent with the Magnuson-Stevens Act and other applicable laws.

This action is taken under 50 CFR 622.8(c) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA), finds that the need to immediately implement this action to temporarily re-open the commercial sector for red snapper constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule implementing the commercial ACL and AMs for red snapper has already been subject to notice and comment, and all that remains is to notify the public of the re-opening. Such procedures are contrary to the public interest because of the need to immediately implement this action to allow commercial fishers to further harvest the commercial ACL of red snapper from the South Atlantic EEZ, while minimizing the risk of exceeding the commercial ACL. Prior notice and opportunity for public comment would require time and would delay the re-opening of the commercial sector.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).