Federal Register Vol. 83, No.178,

Effective January 28, 1980, the Authority and the General Counsel published, at 45 FR 3482, January 17, 1980, final rules and regulations to govern the processing of cases by the Authority and the General Counsel under chapter 71 of title 5 of the United States Code. These rules and regulations are required by title VII of the Civil Service Reform Act of 1978 and are set forth in 5 CFR chapter XIV (2018).

After an examination of budgets, caseloads, rental costs, operating costs, and staffing, the Authority is closing its Dallas Regional Office and reassigning its jurisdiction to the Denver and Atlanta Regional Directors, effective September 21, 2018. It is also reassigning jurisdiction for the state of South Dakota from the Denver Regional Director to the Chicago Regional Director. The Authority expects no adverse effect on the quality or efficiency of casehandling as a result of the Dallas Regional Office closure.

This amendment updates paragraphs (d) and (f) of Appendix A to 5 CFR chapter XIV to reflect the new organizational structure by removing the Dallas Regional Office from the list of current addresses, telephone numbers, and fax numbers of the Authority's Regional Offices and by revising the geographical jurisdictions of the Federal Labor Relations Authority. As this rule pertains to agency organization, procedure, or practice, it is exempt from prior notice and public comment pursuant to 5 U.S.C. 553(b)(A). For this same reason, pursuant to 5 U.S.C. 553(d)(3), the Authority finds that good cause exists for not providing a more delayed effective date. This type of action is also exempt from review under Executive Orders 12866 (58 FR 51735, October 4, 1993), 13563 (76 FR 3821, January 21, 2011), and 13771 (82 FR 9339, February 3, 2017).

For additional information regarding case handling procedures following the Dallas Regional Office closure, please go to www.flra.gov.

For the reasons set forth in the preamble and under the authority of 5 U.S.C. 7134, the authority amends 5 CFR chapter XIV as follows:

The Authority voted in January 2018 to close the Boston and Dallas Regional Offices. At that time, the Authority considered arguments echoing those of Member DuBester. We concluded, however, that consolidating the FLRA's Regional Office structure would husband the FLRA's budgetary and operational resources and best serve the labor-management relations community.

In the end, Member DuBester raises nothing new. We have reprinted Chairman Kiko's March 26, 2018 letter to the Senate Subcommittee on Financial Services and General Government, Committee on Appropriations (attachments omitted), explaining why we undertook this Regional Office consolidation. We have also included Chairman Kiko's May 21, 2018 response to the letter from a group of Senators that Member DuBester references, which reiterates the rationale for the consolidation and offers Chairman Kiko's additional personal reflections on the need for reform. In our opinion, these two letters thoroughly refute Member DuBester's dissent.

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, CN-235-300, and C-295 airplanes. The NPRM published in the Federal Register on June 4, 2018 (83 FR 25587). The NPRM was prompted by reports that cracks were found on the door mechanism actuator shaft assemblies of the NLG. The NPRM proposed to require repetitive inspections of the NLG door mechanism actuator shaft assemblies having certain part numbers, and corrective actions if necessary. The NPRM also proposed to provide an optional terminating action for the repetitive inspections for Model CN-235, CN-235-100, CN-235-200, and CN-235-300 airplanes. We are issuing this AD to address such cracking, which could lead to an in-flight NLG door opening and possibly result in detachment of the affected door, and consequent damage to, or reduced control 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 AD 2017-0181, dated September 18, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Defense and Space S.A. Model CN-235, CN-235-100, CN-235-200, CN-235-300, and C-295 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-2018-0493.

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

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

Airbus Defence and Space has issued Alert Operators Transmission (AOT) AOT-CN235-32-0001, Revision 2, dated October 26, 2016; and AOT AOT-C295-32-0001, Revision 2, dated October 26, 2016. This service information describes procedures for inspections for cracking of the door mechanism actuator shaft assemblies of the NLG, and corrective actions. These documents are distinct since they apply to different airplane models.

Airbus Defence and Space has also issued Service Bulletin SB-235-32-0031C, dated September 22, 2016. This service information describes procedures for modification of the NLG door latching mechanism.

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 14 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 inspections. 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 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 a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus SAS Model A350-941 airplanes. The NPRM published in the Federal Register on June 11, 2018 (83 FR 26882). The NPRM was prompted by the discovery of inadequate corrosion protection in certain areas of the horizontal stabilizer and the rear fuselage cone structure. The NPRM proposed to require application of sealant and protective treatment on the affected areas of the horizontal stabilizer and the rear fuselage cone structure and, for certain airplanes, modification of the THS torsion box and re-identification of the elevator.

We are issuing this AD to address reduced structural integrity of the horizontal stabilizer and the rear fuselage cone structure.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0036, dated February 7, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus SAS Model A350-941 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-2018-0506.

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

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

Airbus SAS has issued Service Bulletin A350-53-P029, dated November 17, 2017. This service information describes procedures to apply sealant and protective treatment on the affected areas of the rear fuselage cone structure.

Airbus SAS has issued Service Bulletin A350-55-P003, dated November 6, 2017. This service information describes procedures to apply sealant and protective treatment on the affected areas of the horizontal stabilizer, modify the THS torsion box in zone 330 and 340, and re-identify the elevator in zone 335 and 345.

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 6 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

According to the manufacturer, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all known costs in our cost estimate.

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

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0145R3, dated July 24, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus SAS Model A350-941 and -1041 airplanes. The MCAI states:

You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0765.

Airbus SAS has issued Alert Operators Transmission A27P012-18, Rev 01, dated May 29, 2018, including Appendixes 1 through 6. This service information describes procedures for replacing affected servocontrols with serviceable servocontrols. 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.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

This AD requires accomplishing the actions specified in the service information described previously.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because the unsafe condition could lead to uncommanded flight control actuator movement, or an unresponsive flight control actuator while in active mode, possibly resulting in reduced controllability of the airplane. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0765; Product Identifier 2018-NM-105-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD based on 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 AD.

We estimate that this AD affects 11 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 to the Director of the System Oversight 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 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 a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2016-13-06, Amendment 39-18570 (81 FR 41432, June 27, 2016) (“AD 2016-13-06”). AD 2016-13-06 applied to certain Saab AB, Saab Aeronautics Model 340A (SAAB/SF340A) and SAAB 340B airplanes. The NPRM published in the Federal Register on April 17, 2018 (83 FR 16792). The NPRM was prompted by reports of ruptured horizontal stabilizer de-icing boots. The NPRM proposed to continue to require a revision of the applicable AFM, repetitive inspections of the horizontal stabilizer de-icing boots, and applicable corrective actions. The NPRM also proposed to require replacement of single stitched de-icing boots with improved double stitched boots, and re-identification of the modified horizontal stabilizer leading edge. We are issuing this AD to detect and correct ruptured horizontal stabilizer de-icing boots, which could lead to complete loss of the de-icing function within its associated zone and severe vibrations, possibly resulting in reduced control 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 AD 2017-0144, dated August 9, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Saab AB, Saab Aeronautics Model 340A (SAAB/SF340A) and SAAB 340B 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-2018-0271.

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

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

Saab AB, Saab Aeronautics has issued the following service information.

• Service Bulletin 340-30-094, dated March 27, 2015. This service information describes procedures for repetitive detailed inspections of the de-icing boots installed on the horizontal stabilizers, and repair and replacement of damaged de-icing boots.

• Service Bulletin 340-30-095, dated April 3, 2017. This service information describes procedures for replacement of single stitched de-icing boots with improved double stitched boots, and re-identification of the modified horizontal stabilizer leading edge.

Saab AB, Saab Aeronautics has also issued the following AFMs, which describe performance limitations and general data. These AFMs are distinct since they apply to different airplane models in different configurations.

• AFM 340A 001, Revision 57, dated March 27, 2015.

• AFM 340B 001, Revision 35, dated March 27, 2015.

• AFM 340B 010, Revision 28, dated March 27, 2015.

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 51 airplanes of U.S. registry.

The actions required by AD 2016-13-06, and retained in this AD take about 6 work-hours per product, at an average labor rate of $85 per workhour. Based on these figures, the estimated cost of the actions that are required by AD 2016-13-06 is $510 per product.

In addition, we estimate that any necessary follow-on actions required by AD 2016-13-06, and retained in this AD take about 6 work-hours and require parts costing $9,500, for a cost of $10,010 per product. We have no way of determining the number of aircraft that might need these actions.

We also estimate that it would take about 6 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $13,500 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $714,510, or $14,010 per product.

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 to the Director of the System Oversight 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 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:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. The NPRM published in the Federal Register on February 21, 2018 (83 FR 7425). The NPRM was prompted by reports of cracking in certain flanges, and the adjacent web, of the wing outboard flap track at certain positions, and a determination that new inspections of certain flap track flanges and webs forward of the rear spar attachment are necessary. The NPRM proposed to require an inspection to determine the part number of the wing outboard flap track assembly; repetitive inspections of each affected wing outboard flap track for discrepancies, and applicable on-condition actions; and repetitive overhaul of each wing outboard flap track.

We are issuing this AD to detect and correct cracking of the wing outboard flap tracks. Cracking in the area between the forward and rear spar attachments of the wing outboard flap tracks could lead to the inability of a principal structural element to sustain required flight loads, and result in loss of the outboard trailing edge flap and consequent reduced controllability of the airplane.

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

All Nippon Airways (ANA) and Utair Aviation requested that paragraph (h) of the proposed AD be revised to extend the compliance time from 6 months to 18 months after the effective date of the final rule. The commenters are concerned that there are not enough spare flap track parts available. The commenters indicated that overhaul of the removed flap tracks takes significant time, and if the final rule is released without a sufficient number of spare flap tracks available, there could be a long-term aircraft on ground (AOG) situation if the proposed compliance times are used.

Furthermore, Utair Aviation stated that a review of maintenance records on 38 airplanes for flap tracks at positions 1 and 8 did not find any records of inspections or overhaul, and it would not be able to replace the subject flap tracks within the compliance time specified in the proposed AD. Utair Aviation also noted that it took 60 days, including shipping, to replace the outboard flap tracks for similar requirements specified in AD 2013-09-02, Amendment 39-17443 (78 FR 27010, May 9, 2013).

We do not agree with the commenters' requests. The 6-month compliance time for inspection and overhaul is applicable only to flap tracks that have unknown maintenance records and flap tracks that were last overhauled several years ago. Airplanes with flap tracks that have known maintenance records generally have later compliance times, depending on how long it has been since the flap tracks were overhauled. The NPRM was issued to address findings of stress corrosion cracking in the flap tracks. Stress corrosion cracking is more likely to occur in flap tracks that have been in operation for a longer time. Flap tracks with unknown maintenance records and flap tracks that were last overhauled several years ago are more susceptible to the unsafe condition. The probability of the existence of stress corrosion cracking on flap tracks with unknown maintenance history is higher and warrants the shorter compliance time. We have verified that spare flap tracks are available on the parts surplus market; however, since we do not know how many flap tracks have unknown maintenance records, it is difficult to estimate how many spare flap tracks will be necessary to meet the demand. If there is a critical shortage of parts, operators may contact the FAA and request an adjustment to the compliance time using the procedures specified in paragraph (l) of this AD. We might approve a longer compliance time if additional data are presented that would justify an extension to the compliance time while still maintaining an adequate level of safety.

We urge operators to seek out maintenance records for their flap tracks in order to justify use of the extended compliance times specified in Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017. We cannot justify extending the compliance times for flap tracks without maintenance records to 18 months. We have not changed this AD in regard to this issue.

Utair Aviation stated that it is inadvisable to require operators to do the inspections included in “INSPECTION 1,” as defined in Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017. The commenter noted that “ACTION 1” in Table 1 and Table 2 of paragraph 3, “Compliance,” of Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017, states that operators need to do INSPECTION 1. The commenter suggested that “ACTION 2,” overhaul of each affected flap track, would already include all of the inspections included in INSPECTION 1.

We infer that the commenter is requesting that the proposed requirement to do the inspections included in INSPECTION 1 of the specified service bulletin be removed from the proposed AD. We do not agree with the commenter's request. ACTION 1 and ACTION 2 have different purposes. The inspections included in ACTION 1 are intended to detect specific existing damage on the flap track, including cracks, nicks, corrosion, galling, broken pieces, and stop drills. The intention of ACTION 2, overhaul of each affected flap track, is a visual examination for defects. The intent of this visual examination during overhaul is to identify additional discrepancies, such as excessive wear or degraded surface finish, that might not be noted during INSPECTION 1. It is important to detect these additional discrepancies since they can be early indicators of stress corrosion cracking. Since the inspections to detect specific existing damage on the flap track are not included in the overhaul instructions, it is necessary to require both ACTION 1 and ACTION 2 in this AD. We have not changed this AD in regard to this issue.

ANA requested that an alternative to overhaul of the flap tracks be provided that does not involve removing the flap tracks from the wing. The commenter suggested that an on-wing inspection could be used instead of the overhaul. The commenter is concerned that there is not a sufficient supply of spare flap track parts.

We do not agree with the commenter's request. There is no on-wing inspection method available that can detect the additional discrepancies that overhaul of the flap tracks is designed to address. The concern regarding availability of spare flap track parts was addressed in the response to an earlier comment. We have not changed this AD in regard to this issue.

Boeing requested that the Parts Installation Limitation Paragraph, paragraph (k) in the proposed AD, be revised to allow flap tracks to be installed and inspected at the time of installation. Boeing noted that paragraph (k) states “. . . no person may install a flap track unless the flap track is inspected prior to installation.” Boeing pointed out that there are several inspections that pertain to the track-to-wing joint, which cannot be accomplished until after the flap track is installed.

We agree with the commenter's request for the reasons provided by the commenter. We have revised paragraph (k) of this AD to state “As of the effective date of this AD, no person may install, on any airplane, a wing outboard flap track having a part number listed in paragraph 1.B. of Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017, unless the inspections . . . are accomplished prior to or concurrently with the part's installation on the airplane.”

Aviation Partners Boeing stated that accomplishing the installation of winglets using Supplemental Type Certificate (STC) ST01219SE does not affect compliance with the actions proposed in the NPRM.

We concur with the commenter. We have redesignated paragraph (c) of the proposed AD as paragraph (c)(1) of this AD and added paragraph (c)(2) to this AD to state that installation of STC ST01219SE does not affect the ability to accomplish the actions required by this AD. Therefore, for airplanes on which STC ST01219SE is installed, a “change in product” alternative method of compliance (AMOC) approval request is not necessary to comply with the requirements of 14 CFR 39.17.

The proposed AD included Note 1 to paragraph (h), which stated that guidance for accomplishing the proposed actions could be found in Boeing Alert Service Bulletin 737-57A1338, dated September 25, 2017, which is referred to in Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017. Since the proposed AD was published, Boeing has issued Boeing Information Notice 737-57A1338 IN 01, dated October 16, 2017; Boeing Information Notice 737-57A1338 IN 02, dated March 16, 2018; and Boeing Information Notice 737-57A1338 IN 03, dated March 20, 2018. These information notices provide additional guidance material related to Boeing Alert Service Bulletin 737-57A1338, dated September 25, 2017, including clarification of compliance times for spares (not AD compliance times), inspection figures, and the relationship between flap track part numbers and airplanes groups. We have revised Note 1 to paragraph (h) in this AD to include these information notices.

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

We reviewed Boeing Alert Requirements Bulletin 737-57A1338 RB, dated September 25, 2017. This service information describes procedures for repetitive inspections and repetitive overhaul of the wing outboard flap tracks, and applicable on-condition actions including repair and replacement of the wing outboard flap tracks. 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 160 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

We have received no definitive data that will enable us to provide cost estimates for the actions for Group 1 airplanes, the repetitive overhaul, or the on-condition actions specified in 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:

On May 11, 2018, at 83 FR 21964, the Federal Register published our notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR part 39 by adding an AD that would apply to Airbus Helicopters Model AS-365N2 and AS 365 N3 helicopters with a lower strobe light installed.

The NPRM proposed to require installing a cable mount on the helicopter structure and inspecting the lower strobe light electrical harness and the electrical harness between the cut-off connector and Frame 2000 for torn spiral tape and for any chafing on the harness cables. If the spiral tape is torn, the NPRM proposed to require replacing the spiral tape. If there is any chafing on the cable, the NPRM proposed to require replacing the harness. The proposed requirements were intended to prevent interference between the lower strobe light electrical harness wiring and the helicopter structure, which could result in chafing of an electrical harness adjacent to the inboard fuel tank vapor space, a fuel tank fire, and subsequent loss of control of the helicopter.

The NPRM was prompted by AD No. 2016-0258, dated December 16, 2016, issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for Airbus Helicopters Model AS 365 N2 and AS 365 N3 helicopters with certain serial numbers and configurations. EASA advises of in-production helicopters with lower strobe light wiring harnesses that were interfering with either the helicopter structure or the adjacent fuel tank support. EASA further states that an investigation determined that the electrical harnesses of these lower strobe lights were manufactured with additional length to facilitate removal and installation of the lower strobe light assembly. However, the additional length of wiring in the harness was not properly secured to the helicopter structure. According to EASA, this could result in chafing of the harness on the helicopter structure, creating an ignition source adjacent to the inboard fuel tank vapor space, and result in a fuel tank fire.

To address this unsafe condition, the EASA AD requires installing a cable mount, inspecting the lower strobe light electrical harness for damage, and re-routing the electrical harness.

We gave the public the opportunity to participate in developing this AD, but we did not receive any comments on the NPRM.

These helicopters have been approved by the aviation authority of France and are approved for operation in the United States. Pursuant to our bilateral agreement with France, EASA, its technical representative, has notified us of the unsafe condition described in the EASA AD. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs and that air safety and the public interest require adopting the AD requirements as proposed.

The EASA AD limits the applicability to helicopters with a lower strobe light installed and with certain serial numbers or that are in a configuration based upon a modification, service information, or engineering drawings. This AD applies to all Model AS-365N2 and AS 365 N3 helicopters with a lower strobe light installed.

We reviewed Airbus Helicopters Alert Service Bulletin No. AS365-05.00.73, Revision 1, dated December 12, 2016, which specifies procedures for inspecting the lower strobe light electrical harness for interference and chafing with the helicopter structure and also specifies procedures for installing a cable mount to secure the electrical harness. These procedures correspond to Airbus Helicopters modification (MOD) 365P084778.00.

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 30 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD.

At an average labor rate of $85 per work-hour, installing a cable mount and inspecting the strobe light wiring harnesses requires about 1 work-hour, and required parts cost about $50, for a cost of $135 per helicopter and a total cost of $4,050 to all U.S. operators.

If required, replacing torn spiral tape requires about 1 work-hour, and required parts cost $45, for a cost of $130 per helicopter.

If required, replacing a chafed wiring harness between the cut-off connector and Frame 2000 requires about 3 work-hours, and required parts cost $90, for a cost of $345 per helicopter.

If required, replacing a chafed lower strobe light wiring harness requires about 3 work-hours, and required parts cost $154, for a cost of $409 per helicopter.

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 helicopters identified in this rulemaking action.

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

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

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

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

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

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

We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E en route airspace extending upward from 1,200 feet above the surface to support IFR aircraft under control of the Los Angeles ARTCC, Los Angeles, CA.

The FAA published a notice of proposed rulemaking (NPRM) in the Federal Register (83 FR 24050; May 24, 2018) for Docket No. FAA-2017-1202 to establish Class E en route airspace extending 1,200 feet above the surface for IFR aircraft under control of the Los Angeles ARTCC, Los Angeles, CA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. One comment was received in support of this action.

Subsequent to publication, a typographical error was discovered in one of the coordinates listed in the airspace description. The longitude coordinate of “lat. 32°32′03″ N, long. 117°07′25″ W” is amended to “lat. 32°32′03″ N, long. 117°07′29″ W” to correct the error.

Class E airspace designations are published in paragraph 6006 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

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

The FAA is amending Title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class E en route airspace extending upward from 1,200 feet above the surface to accommodate instrument flight rules (IFR) aircraft under control of the Los Angeles Air Route Traffic Control Center (ARTCC), Los Angeles, CA to ensure controlled airspace exists in those areas where the Federal airway structure is inadequate.

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

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

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace at Waimea-Kohala Airport, Kamuela, HI, in support of IFR operations at the airport.

The FAA published a notice of proposed rulemaking in the Federal Register (83 FR 7433; February 21, 2018) for Docket No. FAA-2017-1145 to amend Class E surface area airspace and Class E airspace extending upward from 700 feet above the surface at Waimea-Kohala Airport, Kamuela, HI. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6002, and 6005, respectively, of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

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

The FAA is amending Title 14 Code of Federal Regulations (14 CFR) part 71 by removing the part-time NOTAM status of Class E surface area airspace and defining its boundaries with reference to the Waimea-Kohala Airport, Kamuela, HI (instead of the Kamuela VOR/DME). Class E airspace extends upward from the surface within the 4.3-mile radius of Waimea-Kohala Airport, and within 2.4 miles north and 1.8 miles south of the 069° bearing from the airport extending from the 4.3-mile radius to 7.3 miles east of the airport (currently 1.8 miles northwest of and 2.6 miles southeast of the Kamuela VOR 063° radial, extending from the 4.3-mile radius to 7.8 miles northeast of the Kamuela VOR/DME).

Class E airspace extending upward from 700 feet above the surface will be modified to within a 4.3-mile radius (from a 6.4-mile radius) of Waimea-Kohala Airport and within 4.1 miles each side of the 069° bearing from the airport extending from the 4.3-mile radius to 12.8 miles east of the airport, and within 1.3 miles each side of the 244° bearing from the airport extending from the 4.3-mile radius to 5.8 miles southwest of the airport (currently 2 miles each side of the Kamuela VOR/DME 068° radial, extending from the 6.4-mile radius 12.6 miles northeast of the Kamuela VOR/DME, and within 2 miles each side of the Kamuela VOR/DME 246° extending from the 6.4-mile radius to 13.4 miles southwest of the Kamuela VOR/DME). This airspace redesign expands the airspace areas slightly northeast and reduces the airspace from southeast clockwise to north to only that area necessary to contain IFR operations at the airport.

Additionally, an editorial change replaces Waimea-Kohala Airport, HI, with Kameula, HI, in the airspace designation of the above classes of airspace to comply with a recent change to FAA Order 7400.2L, Procedures for Handling Airspace Matters.

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

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

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace extending upward from 700 feet above the surface, at Washington Island Airport, Washington Island, WI to support IFR operations at the airport.

On March 23, 2018, the FAA published in the Federal Register (83 FR 12688) Docket No. FAA-2018-0018, a notice of proposed rulemaking (NPRM) to establish Class E airspace extending upward from 700 feet above the surface, at Washington Island Airport, Washington Island, WI. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

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

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface to within a 6.0-mile radius of Washington Island Airport, Washington Island, WI.

Controlled airspace is necessary to accommodate new standard instrument approach procedures developed at Washington Island Airport, and for the safety and management of instrument flight rules (IFR) operations.

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

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

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it clarifies airspace designations by eliminating the redundancy.

The FAA published a notice of proposed rulemaking in the Federal Register (83 FR 8207; February 26, 2018) for Docket No. FAA-2017-1088 to remove Class E airspace extending upward from 1,200 feet above the surface at Crows Landing Airport, Crows Landing, CA, as the airspace already is contained within Class E en route airspace (see 82 FR 27988; June 20, 2017). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

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

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

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 removes Class E airspace extending upward from 1,200 feet above the surface at Crows Landing Airport, Crows Landing, CA. This airspace is wholly contained within the Sacramento en route airspace area and duplication is not necessary.

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

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

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

The FAA published a final rule in the Federal Register for Docket No. FAA-2018-0632 (83 FR 40662, August 16, 2018), amending the Chicago Class B and Chicago Class C airspace area descriptions by changing references to the Chicago O'Hare VOR/DME to “Point of OrigiN” Additionally, the Chicago Class B and Chicago Class C airspace area descriptions were edited to reflect the Chicago Midway International Airport name change. Subsequent to publication, the FAA identified editorial errors in the Chicago Class B description to the geographic coordinates of the Chicago O'Hare International Airport ARP, the geographic coordinates to two points in Area A, and the geographic coordinates to one point in Area F. To accurately reflect the Chicago Class B airspace area on aeronautical charts and digital charting applications, this correction changes the geographic coordinates of the Chicago O'Hare International Airport ARP from “(lat. 41°58′38″ N, long. 87°54′29″ W)” to read “(lat. 41°58′28″ N, long. 87°54′24″ W)”; the geographic coordinates to two points in Area A from “(lat. 41°57′12″ N, long. 88°01′56″ W)” to read “(lat. 41°57′26″ N, long. 88°01′39″ W)” and from “(lat. 42°05′03″ N, long. 87°56′26″ W)” to read “(lat. 42°05′03″ N, long. 87°56′25″ W)”; and the geographic coordinates to one point in Area F from “(lat. 41°50′40″ N, long. 88°25′44″ W)” to read “(lat. 41°50′39″ N, long. 88°25′43″ W)”.

On September 4, 2018, at 83 FR 44821, BIS published a rule amending the Entity List in 15 CFR part 744, supplement 4. An amendatory instruction noted the addition of two entities for Pakistan, but provided the name of one only. Both entities appeared in the amendment's regulatory text and were codified on the rule's effective date. This document clarifies the rule by correcting the amendatory instruction to carry the names of both entities as originally intended.

Therefore, in FR Rule Doc. No. 2018-18766, published September 4, 2018, at 83 FR 44821, the following correction is made:

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

The drawspan will be secured in the closed-to-navigation position from 8 a.m. to 11 a.m. on October 14, 2018, to allow the community to participate in the Making Strides Walk against Breast Cancer event. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised. Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

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

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

On April 6, 2018, the City of Boston notified the Coast Guard that the Massachusetts Department of Transportation's Highways Division will be conducting emergency repairs to the S99 Alford Street Drawbridge at mile 1.4 on the Mystic River between Charlestown and Everett, Massachusetts from May 2018 through the summer of 2019.

In response, on July 17, 2018, the Coast Guard published a Notice of proposed rulemaking (NPRM) titled “Safety Zone, S99 Alford Street Bridge-Emergency Grid Replacement Project, Mystic River, Charlestown and Everett, MA,” (83 FR 33165). There, we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this safety zone. During the comment period that ended on August 16, 2018, we received zero (0) comments.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231.

The COTP Boston has determined that potential hazards exist associated with the emergency replacement of the steel grid deck on all four bascule spans of the S99 Alford Street Bridge. Potential hazards include the use of the waterway underneath the bridge to conduct heavy lift operations, as well as possible falling equipment and materials. This rule is needed to protect personnel, vessels, and the marine environment on navigable waters within 150-yards of the S99 Alford Street Bridge, at mile 1.4 on the Mystic River between Charlestown and Everett, Massachusetts, during these emergency repairs.

As noted above, we received no comments on our NPRM published on July 17, 2018. There are no changes to the regulatory text of this rule from the proposed rule in the NPRM.

The rule establishes a safety zone enforceable 24 hours a day from 12:01 a.m. on October 1, 2018, to 11:59 p.m. on April 30, 2019. The safety zone covers all navigable waters within 150-yards of the S99 Alford Street Bridge, at mile 1.4 on the Mystic River between Charlestown and Everett, Massachusetts. The zone is intended to ensure the safety of vessels, the maritime public, construction workers, and these navigable waters during the repairs on the S99 Alford Street Bridge over the main channel of the Mystic River. No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP Boston or a designated representative.

The Coast Guard will notify the public about this safety zone through the Massachusetts Bay Harbor Safety Committee meetings, Boston's Port Operators Group meetings, and Local Notice to Mariners. Moreover, the Coast Guard will issue a Safety Marine Information Broadcast via marine channel 16 (VHF-FM) fourteen (14) days in advance of the commencement of the safety zone. If the project is completed before April 30, 2019, enforcement of the safety zone will be suspended and notice will be given to the public to the greatest extent possible.

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

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

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. We expect the adverse economic impact of this rule to be minimal since we will provide ample notice of the safety zone effective dates and vessels will be able to enter the safety zone when construction equipment is not occupying the channel. Although this regulation may have some adverse impact on the public, the potential impact will be minimal because boating season for vessels on the Mystic River usually concludes around mid-October and consequently the amount of traffic in this waterway during the effective period for the safety zone is limited.

This safety zone is of similar dimension and a shorter duration to the one established in 2011 (73916 FR/Vol. 77, No. 239) for the original rehabilitation of the bridge.

Notification of the emergency repairs to the Alford Street Drawbridge and the associated safety zone will be made to mariners through the Massachusetts Bay Harbor Safety Committee meetings, Boston's Port Operators Group meetings, and Local Notice to Mariners. Moreover, the Coast Guard will issue a Safety Marine Information Broadcast via marine channel 16 (VHF-FM) fourteen (14) days in advance of the commencement of the safety zone. The rule will allow vessels to seek permission to enter the zone when the channel is not being occupied by construction equipment.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves establishing a temporary safety zone extending 150 yards around a bridge to complete emergency repairs to the S99 Alford Street Bridge during a seven-month period when boating traffic is minimal on the Mystic River. It is categorically excluded from further review under paragraph L60(b) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

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

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

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0416 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 13, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0416, 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 Avenue NW, Washington, DC 20460-0001.

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

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

In the Federal Register of August 12, 2016 (81 FR 53380) (FRL-9949-53), 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 6F8468) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528. The petition requested that 40 CFR part 180 be amended by establishing permanent tolerances in primary crops for residues of the insecticide afidopyropen, [(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-[(cyclopropylcarbonyl)oxy]-1,3,4,4a,5,6,6a,12,12a,12b-decahydro-6,12-dihydroxy-4,6a,12b-trimethyl-11-oxo-9-(3-pyridinyl)-2H,11H-naphtho[2,1-b]pyrano[3,4-e]pyran-4-yl]methyl cyclopropanecarboxylate, its metabolites, and degradates, in or on the following raw agricultural and processed commodities: Almond, hulls at 0.15 parts per million (ppm); Apple, wet pomace at 0.05 ppm; Citrus, oil at 0.3 ppm; Cotton, gin byproducts at 2 ppm; Cotton, undelinted seed at 0.1 ppm; Fruit, citrus, group 10-10 at 0.15 ppm; Fruit, pome, group 11-10 at 0.03 ppm; Fruit, stone, group 12-12 at 0.03 ppm; Nut, tree, group 14-12 at 0.01 ppm; Plum, prune at 0.06 ppm; Soybean, aspirated grain fractions at 0.4 ppm; Soybean, seed at 0.01 ppm; Vegetable, brassica, head and stem, group 5-13 at 0.5 ppm; Vegetable, cucurbit, group 9 at 0.7 ppm; Vegetable, fruiting, group 8-10 at 0.15 ppm; Vegetable, leaf petioles, subgroup 22B at 3 ppm; Vegetable, leafy, subgroup 4-13A at 2 ppm; Vegetable, leafy, subgroup 4-13B at 5 ppm; and Vegetable, tuberous and corm, subgroup 1C at 0.01 ppm. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition and EPA policy, the Agency has revised some of the commodity definitions and tolerance levels from the petition, and concluded that the following tolerances are appropriate for afidopyropen in or on the following commodities: Almond, hulls at 0.15 ppm; Apple, wet pomace at 0.05 ppm; Brassica, head and stem, group 5-16 at 0.50 ppm; Brassica, leafy greens, subgroup 4-16B at 5.0 ppm; Citrus, oil at 0.40 ppm; Cotton, gin byproducts at 2.0 ppm; Cotton, undelinted seed at 0.08 ppm; Fruit, citrus, group 10-10 at 0.15 ppm; Fruit, pome, group 11-10 at 0.02 ppm; Fruit, stone, group 12-12 at 0.03 ppm; Grain, aspirated fractions at 0.15 ppm; Leafy Greens, subgroup 4-16A at 2.0 ppm; Leaf petiole vegetable subgroup 22B at 3.0 ppm; Nut, tree, group 14-12 at 0.01 ppm; Soybean, seed at 0.01 ppm; Tomato, dried at 0.50 ppm; Vegetable, cucurbit, group 9 at 0.70 ppm; Vegetable, fruiting, group 8-10 at 0.20 ppm; and Vegetable, tuberous and corm, subgroup 1C at 0.01 ppm. 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 afidopyropen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with afidopyropen 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.

Afidopyropen is classified as category III for acute oral and acute dermal, and category IV for acute inhalation, primary eye irritation, and dermal irritation. The toxicology database for afidopyropen is complete. The target organs identified following exposure to afidopyropen are the liver, heart, brain, spleen, and reproductive organs of both sexes. The liver is a main target organ in both subchronic and chronic oral toxicity studies in all three-species tested (i.e., mouse, rat, and dog).

There was no evidence of neurotoxicity seen in the subchronic neurotoxicity study in rats up to the highest dose tested. Afidopyropen caused neurotoxic effects in the acute neurotoxicity study; however, only at the limit dose of 2,000 milligrams/kilogram/day (mg/kg/day).

There is evidence of increased susceptibility following pre- and or post-natal exposure to afidopyropen. In a prenatal developmental study in rats, adverse effects in fetuses included an increased incidence of skeletal variations (lumbar ribs), increased ossification of the metatarsi, and an altered sex ratio (increased percentage of male pups); however, maternal effects were not observed up to the highest dose tested. In a second developmental study in rats, adverse fetal effects (increased incidence of skeletal variations and supernumerary ribs) occurred at a lower dose as compared to maternal effects (mortality in one animal). In a developmental study in rabbits, fetal developmental and maternal effects occurred at the same dose level. Effects included a decreased number of live fetuses, increased early resorptions and completely resorbed litters, as well as increased post-implantation loss. Fetuses also exhibited an altered sex ratio (increased percentage of male pups) at this dose level.

Quantitative susceptibility was also observed in two 2-generation rat studies. In the first study, no reproductive or parental effects were observed, while offspring effects were decreased absolute body weight in both sexes and F1 pup and litter deaths. In the second study, offspring effects included decreased absolute body weight and decreased spleen and thymus weights in both sexes. Reproductive effects included effects on ovary and uterus weight, decreased implantation sites, and an altered sex ratio (increased percentage of male pups). In this study, the parental and offspring effects occurred at the same dose level.

Afidopyropen did not display systemic effects in the 28-day dermal study, even at the limit dose of 1,000 mg/kg/day. There were no adverse effects observed in the route-specific dermal toxicity study up to the limit dose; however, there is evidence of increased susceptibility following pre- and/or post-natal exposure to afidopyropen. As a result, an oral point of departure was selected since the dermal toxicity study did not evaluate developmental or reproductive endpoints. A point of departure (POD) for dermal exposures (all durations) was selected from the 2-generation reproduction study in rats, this POD reflects the most sensitive endpoint in the database, and is protective of effects observed following subchronic exposure, including the fetal effects seen in the rat and rabbit developmental studies. This POD is also selected for inhalation exposures (all durations), and incidental oral and chronic dietary exposures. Chronic dietary was set using 2 co-critical studies (chronic dog study and 2-generation rat reproduction study). For acute dietary exposure, the POD is based on maternal and developmental effects (increased early resorptions of litters) observed in the rabbit developmental study and is applicable to females of childbearing age. An acute dietary POD was not identified for the general population because acute effects of concern for this population were not observed in the toxicology database.

In an immunotoxicity study in the rat, there were no adverse effects noted up to the highest dose tested.

Afidopyropen is classified as “Suggestive Evidence of Carcinogenic Potential” based on benign hepatocellular adenomas in male rats and uterine adenocarcinomas and combined adenocarcinomas and adenomas in female rats. There is insufficient evidence to support the petition's description of a uterine tumor mode-of action (MOA) in female rats. There is no concern for mutagenicity. Quantification of human cancer risk is not required. The chronic Reference Dose (RfD) will adequately account for all chronic toxicity, including carcinogenicity, which could result from exposure to afidopyropen.

More detailed information on the studies received and the nature of the adverse effects caused by afidopyropen 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 in the document entitled “Afidopyropen. Human Health Risk Assessment for Section 3 Requests for a New Active Ingredient,” dated April 4, 2018, by going to http://www.regulations.gov. The referenced document is available in the docket established by this action, which is described under ADDRESSES. Locate and double-click on the hyperlink for the referenced document to view the referenced information on pages 16-23 of 112.

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

A summary of the toxicological endpoints for afidopyropen used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to afidopyropen, EPA considered exposure under the petitioned-for tolerances, and assessed dietary exposures from afidopyropen 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. In estimating acute dietary (food and drinking water) exposure, EPA used food consumption information from the Dietary Exposure Evaluation Model-Food Commodity Intake Database (DEEM-FCIDTM, Version 3.16), which incorporates 2003-2008 consumption data from the United States Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). The acute dietary assessment was conducted using recommended tolerance-level residues and 100% crop treated assumptions. Empirical and default processing factors were used. Screening-level estimated drinking water concentrations (EDWCs) were incorporated as point estimates, based on surface water modeling. The acute EDWC (7.1 ppb) was modeled using the Florida cabbage scenario.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used DEEM-FCIDTM, Version 3.16, which incorporates 2003-2008 consumption data from the USDA's NHANES/WWEIA. The chronic dietary assessment was conducted using recommended tolerance-level residues and 100% crop treated assumptions. Empirical and default processing factors were used. Screening-level EDWCs were incorporated as point estimates, based on surface water modeling. The chronic EDWC (3.9 ppb) was modeled using the California lettuce scenario.

iii. Cancer. As explained in unit III.A., quantification of risk using a non-linear approach (i.e., a cPAD) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to afidopyropen.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use any anticipated residue or PCT information in the dietary assessment for afidopyropen. Tolerance-level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for afidopyropen in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of afidopyropen.

Afidopyropen may be transported to surface water and groundwater via runoff, leaching, or spray drift. Afidopyropen is a new chemical; therefore, at this point, no monitoring data are available. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling, taking into account data on the physical and fate characteristics of afidopyropen. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the latest version of the Pesticides in Water Calculator (PWC 1.52) and incorporating the Pesticide Root Zone Model for Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of afidopyropen for acute exposures are estimated to be 7.1 parts per billion (ppb) for surface water, and 3.8 × 10− 4 ppb for ground water. For chronic exposures for non-cancer assessments, the EDWCs are estimated to be 3.9 ppb for surface water and 1.1 × 10− 4 ppb for ground water.

Modeled estimates for drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 7.1 ppb was used to assess the contribution to drinking water. For chronic and cancer dietary risk assessment, the water concentration value of 3.9 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). The proposed use of afidopyropen on ornamentals can be in residential or recreational settings. All afidopyropen product labels require users to wear specific clothing and PPE (i.e., gloves), and are assumed to be marketed for commercial use; therefore, a quantitative residential handler assessment was not conducted.

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 afidopyropen to share a common mechanism of toxicity with any other substances. Afidopyropen and another pesticide, aminocyclopyrachlor, both produce the common toxic metabolite CPCA; however, co-exposure to CPCA from both pesticides are unlikely to occur. Drinking water is the only expected exposure pathway for CPCA for either pesticide. The likelihood of having ground water residues of both afidopyropen and aminocyclopyrachlor at the EDWC predicted in the screening ground water modeling in the same location is miniscule for the following reasons: Ground water modeling assumes application of a chemical at the maximum rate, and the maximum number of applications, every year for up to 100 years, and because lateral flow of chemicals away from the application site is relatively slow, both chemicals would have to be applied in approximately the same location every year at the maximum application rates, at maximum numbers of applications for each, for the exposures to be additive, and this is not a feasible scenario. For the purposes of this tolerance action; therefore, EPA has assumed that afidopyropen does not have a common mechanism of toxicity with other substances or cause a cumulative effect as a result of the common metabolite with aminocyclopyrachlor. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

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. Pre-natal and post-natal sensitivity. There is evidence of increased susceptibility following pre- and or post-natal exposure to afidopyropen. In a prenatal developmental study in rats, adverse effects in fetuses included an increased incidence of lumbar ribs, increased ossification of the metatarsi, and an increased percentage of male pups; however, maternal effects were not observed up to the highest dose tested. In a second developmental study in rats, adverse fetal effects (increased incidence of skeletal variations and supernumerary ribs) occurred at a lower dose as compared to maternal effects (mortality in one animal). In a developmental study in rabbits, fetal developmental and maternal effects (increased early resorptions and completely resorbed litters) were observed.

Quantitative susceptibility was also observed in two 2-generation rat studies. In the first study, no reproductive or parental effects were observed, while offspring effects were decreased absolute body weight in both sexes and F1 pup and litter deaths. In the second study, offspring effects included decreased absolute body weight and decreased spleen and thymus weights in both sexes. Reproductive effects included effects on ovary and uterus weight, decreased implantation sites, and an altered sex ratio (increased percentage of male pups). In this study, the parental and offspring effects occurred at the same dose level.

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 for all exposure scenarios. That decision is based on the following findings:

i. The toxicology database for afidopyropen is considered complete for evaluating and characterizing toxicity, assessing children's susceptibility under FQPA, and selecting endpoints for the exposure pathways of concern.

ii. Acute oral (gavage) and sub-chronic oral (dietary) neurotoxicity studies were conducted in rats. No evidence of specific neurotoxicity was seen in the subchronic neurotoxicity study up to the highest dose tested (369/438 mg/kg/day). Afidopyropen caused neurotoxic effects in the acute study; however, only at the limit dose.

Indications of neurotoxicity in mice and dogs were limited to vacuolation of white matter and/or spinal cord. The Agency has low concern because the nervous tissues in the mouse and dog studies were not perfused in-situ; therefore, the vacuolation that was observed is more likely an artifact of not preparing the tissues properly. The nervous tissue vacuolation seen in the subchronic dog and mice (subchronic and chronic) studies occurred at doses 7.5X-115X higher than the POD for the chronic dietary risk assessment. As a result, the effects are well-characterized with clearly established NOAEL/LOAEL values and the selected PODs are protective for the observed neurotoxic effects.

Based on the weight of the evidence and taking into consideration the PODs selected for risk assessment, a developmental neurotoxicity study is not required at this time. Clear NOAELs have been established for all lifestages, the selected PODs are protective of all pre- and post-natal toxicity observed throughout the database, and no specific neuropathological effects were noted. The adverse neuropathological effects observed in the subchronic mouse and dog and the chronic mouse studies occurred at doses 7.5X-115X higher than the lowest POD, and the rat (species typically used in the DNT) is less sensitive than dogs and mice to afidopyropen's putative neurotoxic effects.

iii. There is evidence of increased susceptibility following pre- and/or post-natal exposure to afidopyropen. In pre-natal developmental studies in rats, adverse fetal effects occurred at lower doses as compared to the maternal generation. In the first 2-generation study, offspring effects were observed while no adverse reproductive or parental effects occurred. In the second 2-generation study, offspring effects occurred at a lower dose as compared to the reproductive and parental effects. Clear NOAELs have been established for the developmental effects in rats and rabbits as well as the offspring effects in the two-generation reproduction studies. The NOAEL used for the chronic dietary risk assessment (8 mg/kg/day), based on effects observed in the 2-generation reproduction study in rats, is protective of all developmental and offspring effects seen in the database.

iv. There are no residual uncertainties identified in the exposure databases. The dietary assessment is based on high-end assumptions such as tolerance-equivalent residue levels of the parent compound in foods, 100% CT, default processing factors, and modeled, high-end estimates of residues in drinking water. All of the exposure estimates are based on high-end assumptions and are not likely to underestimate risk. In addition, the residential exposure assessment was conducted based on the Residential SOPs such that residential exposure and risk will not be underestimated.

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water only to afidopyropen will occupy 3.6% of the aPAD for females, 13-49 years old. Since there was no acute endpoint identified for the general population, an acute dietary exposure assessment was not conducted for the U.S. general population and other population subgroups.

2. 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). In estimating the short-term aggregate risk, EPA has aggregated the total short-term residential exposure and average dietary (food and water) exposure. The selected residential exposure scenarios for aggregation, adults and children (6 to <11 years old) contacting treated ornamentals, represent the worst-case risk estimates and are protective of all other lifestages and exposure scenarios. The short-term aggregate MOEs for adults (2,000) and children (2,500) are above the LOC (100), and are not of concern.

3. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no intermediate-term exposure is anticipated, afidopyropen is not expected to pose an intermediate-term aggregate risk.

4. Chronic risk. Chronic aggregate risk assessments address exposures that are likely to occur continuously for greater than six months. Using the exposure assumptions discussed in this unit for chronic exposure, EPA has concluded that chronic dietary exposure to afidopyropen from food and water only will occupy 2.2% of the cPAD for the U.S. general population, and the population subgroup with the highest estimated risk was for children, 1-2 years old at 4.4% of the cPAD. Residential exposures to afidopyropen are not expected to occur on a chronic basis; therefore, the chronic aggregate risk estimates are equivalent to the chronic dietary risk estimates, and are below EPA's LOC.

5. Aggregate cancer risk for U.S. population. Afidopyropen is classified as having “Suggestive Evidence of Carcinogenic Potential.” The cRfD (cPAD) is considered to be protective of all chronic toxicity, including carcinogenicity, that could result from exposure to afidopyropen.

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

Suitable tolerance enforcement methods for plants and livestock using liquid chromatography- mass spectrometer/mass spectrometer (LC-MS/MS) analyses were submitted for the analysis of afidopyropen. The reported limit of quantitation (LOQ) of each method is 0.01 ppm for afidopyropen.

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. Maximum residue limits (MRLs) for afidopyropen have not been established by Codex.

For this pesticide, the U.S. EPA and Health Canada's Pest Management Regulatory Agency (PMRA) have conducted a joint review of the available data. That review used the Organization for Economic Co-operation and Development (OECD) calculation procedures to determine the appropriate MRLs. Therefore, the EPA tolerance levels are harmonized with MRLs to be established by Health Canada's PMRA.

Several of the tolerances requested by the petitioner are different from those established in this rule. EPA's tolerance levels are expressed to provide sufficient precision for enforcement purposes, and this may include the addition of trailing zeros (such as 0.30 ppm rather than 0.3 ppm). This is to avoid the situation where rounding of an observed violative residue to the level of precision of the tolerance expression would result in a residue considered non-violative (such as 0.34 ppm being rounded to 0.3 ppm). This revision has been made for the following: Brassica, head and stem, group 5-16; Brassica, leafy greens, subgroup 4-16B; Cotton, gin byproducts; Leafy Greens, subgroup 4-16A; Leaf petiole vegetable subgroup 22B; and Vegetable, cucurbit, group 9.

For citrus oil and cotton, undelinted seed, the levels differ because of differences in rounding the values calculated from the residue data. The pome fruit tolerance is different because of differences in the MRL calculation for pear. Two pear field trials were concluded to be replicates for calculation and the petitioner also used an additional residue value which is believed to be a transcription error. A tolerance for the processed food prunes is not needed because residues are not expected to concentrate in prunes. For fruiting vegetables, these differences are attributable to the petitioner having combined both the bell and non-bell pepper data together for calculation. In addition, the petitioner did not request a tolerance for the dried tomato processed commodity, but EPA has concluded that the tolerance for the crop group will not be adequate to cover that commodity. Finally, regarding “Soybean, aspirated grain fractions,” the tolerance level requested by the petitioner was not consistent with data submitted with the petition. EPA reviewed the requested use pattern and supporting data, corrected the proposed commodity definition, and has decided to establish a tolerance for commodity “Grain, aspirated fractions.”

Therefore, tolerances are established for residues of afidopyropen, [(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-[(cyclopropylcarbonyl)oxy]-1,3,4,4a,5,6,6a,12,12a,12b-decahydro-6,12-dihydroxy-4,6a,12b-trimethyl-11-oxo-9-(3-pyridinyl)-2H,11H-naphtho[2,1-b]pyrano[3,4-e]pyran-4-yl]methyl cyclopropanecarboxylate, including its metabolites and degradates, in or on Almond, hulls at 0.15 ppm; Apple, wet pomace at 0.05 ppm; Brassica, head and stem, group 5-16 at 0.50 ppm; Brassica, leafy greens, subgroup 4-16B at 5.0 ppm; Citrus, oil at 0.40 ppm; Cotton, gin byproducts at 2.0 ppm; Cotton, undelinted seed at 0.08 ppm; Fruit, citrus, group 10-10 at 0.15 ppm; Fruit, pome, group 11-10 at 0.02 ppm; Fruit, stone, group 12-12 at 0.03 ppm; Grain, aspirated fractions at 0.15 ppm; Leafy Greens, subgroup 4-16A at 2.0 ppm; Leaf petiole vegetable subgroup 22B at 3.0 ppm; Nut, tree, group 14-12 at 0.01 ppm; Soybean, seed at 0.01 ppm; Tomato, dried at 0.50 ppm; Vegetable, cucurbit, group 9 at 0.70 ppm; Vegetable, fruiting, group 8-10 at 0.20 ppm; and Vegetable, tuberous and corm, subgroup 1C at 0.01 ppm.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2017-0702 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 13, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0702, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of March 6, 2018 (83 FR 9471) (FRL-9973-27), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7F8573) by OmniLytics, Inc., 9100 South 500 West, Sandy, UT 84070. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the bactericide bacteriophage active against Erwinia amylovora in or on apple and pear. That document referenced a summary of the petition prepared by the petitioner OmniLytics, Inc. and available in the docket via http://www.regulations.gov. There were no comments regarding this exemption received in response to the notice of filing.

Based upon review of data and other information supporting the petition, EPA is granting a tolerance exemption that differs slightly from what the petition requested. The reason for this difference is explained in Unit III.C.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption 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. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”

EPA evaluated the available toxicological and exposure data on bacteriophage active against Erwinia amylovora and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Safety Determination for Bacteriophage Active Against Erwinia amylovora.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.

The available data demonstrated that bacteriophage active against Erwinia amylovora are not anticipated to be toxic, pathogenic, or infective via any route of exposure. Furthermore, humans, including infants and children, have been exposed to bacteriophage through food and water, where they are commonly found, with no known adverse effects. Although there may be some exposure to residues of bacteriophage active against Erwinia amylovora that are used on apple and pear in accordance with label directions and good agricultural practices, there is a lack of concern due to the lack of potential for adverse effects. EPA also determined that retention of the Food Quality Protection Act (FQPA) safety factor was not necessary as part of the qualitative assessment conducted for bacteriophage active against Erwinia amylovora.

Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of bacteriophage active against Erwinia amylovora. Therefore, an exemption from the requirement of a tolerance is established for residues of lytic bacteriophage active against Erwinia amylovora that are produced in Erwinia amylovora in or on apple and pear, when used in accordance with label directions and good agricultural practices.

An analytical method is not required because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.

In its petition, the petitioner requested generally that EPA issue an exemption from the requirement of a tolerance for residues of bacteriophage active against Erwinia amylovora in or on apple and pear. The petitioner's supporting materials indicated that the actual pesticide that would be used would be safe because the bacteriophage were lytic and were produced in Erwinia amylovora. EPA believes that only bacteriophage that have these same characteristics as the organism tested would be safe and should be exempt from the requirement of a tolerance. Therefore, EPA is issuing a tolerance exemption that differs slightly from the petition by limiting the exemption to residues of bacteriophage that possess the same characteristics as the bacteriophage that were tested to support this exemption.

This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. 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, 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 exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (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. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 (2 U.S.C. 1501 et seq.).

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

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

Therefore, 40 CFR chapter I is amended as follows:

I. General Information A. Does this Action Apply to Me?

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 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.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2017-0703 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 13, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0703, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of March 21, 2018 (83 FR 12311) (FRL-9974-76), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7F8574) by OmniLytics, Inc., 9100 South 500 West, Sandy, UT 84070. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the bactericide bacteriophage active against Xanthomonas citri subsp. citri in or on citrus fruit, including orange, grapefruit, pummelo, mandarin, lemon, lime, tangerine, tangelo, and kumquat. That document referenced a summary of the petition prepared by the petitioner OmniLytics, Inc. and available in the docket via http://www.regulations.gov. There were no comments regarding this exemption received in response to the notice of filing.

Based upon review of data and other information supporting the petition, EPA is granting a tolerance exemption that differs slightly from what the petition requested. The reason for this difference is explained in Unit III.C.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption 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. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”

EPA evaluated the available toxicological and exposure data on bacteriophage active against Xanthomonas citri subsp. citri and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Safety Determination for Bacteriophage Active Against Xanthomonas citri subsp. citri.” This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.

The available data demonstrated that bacteriophage active against Xanthomonas citri subsp. citri are not anticipated to be toxic, pathogenic, or infective via any route of exposure. Furthermore, humans, including infants and children, have been exposed to bacteriophage through food and water, where they are commonly found, with no known adverse effects. Although there may be some exposure to residues of bacteriophage active against Xanthomonas citri subsp. citri that are used on citrus fruit in accordance with label directions and good agricultural practices, there is a lack of concern due to the lack of potential for adverse effects. EPA also determined that retention of the Food Quality Protection Act (FQPA) safety factor was not necessary as part of the qualitative assessment conducted for bacteriophage active against Xanthomonas citri subsp. citri.

Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of bacteriophage active against Xanthomonas citri subsp. citri. Therefore, an exemption from the requirement of a tolerance is established for residues of lytic bacteriophage active against Xanthomonas citri subsp. citri that are produced in Xanthomonas citri subsp. citri in or on food commodities included in the fruit, citrus groups 10 and 10-10, when used in accordance with label directions and good agricultural practices.

An analytical method is not required because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.

In its petition, the petitioner requested generally that EPA issue an exemption from the requirement of a tolerance for residues of bacteriophage active against Xanthomonas citri subsp. citri in or on citrus fruit, including orange, grapefruit, pummelo, mandarin, lemon, lime, tangerine, tangelo, and kumquat. The petitioner's supporting materials indicated that the actual pesticide that would be used would be safe because the bacteriophage was lytic and were produced in Xanthomonas citri subsp. citri. EPA believes that only bacteriophage that have these same characteristics as the organism tested would be safe and should be exempt from the requirement of a tolerance. Therefore, EPA is issuing a tolerance exemption that differs slightly from the petition by limiting the exemption to residues of the bacteriophage that possess the same characteristics as the bacteriophage that were tested to support this exemption.

This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. 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, 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 exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (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. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 (2 U.S.C. 1501 et seq.).

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2017-0525 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 13, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0525, by one of the following methods:

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

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

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of December 15, 2017 (82 FR 59604) (FRL-9970-50), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7E8567) by Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the microbial pesticide Pepino mosaic virus, strain CH2, isolate 1906 in or on tomato. That document referenced a summary of the petition prepared by the petitioner IR-4 and available in the docket via http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit III.C.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption 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. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”

EPA evaluated the available toxicological and exposure data on Pepino mosaic virus, strain CH2, isolate 1906 and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) Safety Determination for Pepino mosaic virus, strain CH2, isolate 1906” (Safety Determination). This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES.

The available data demonstrated that in regard to humans Pepino mosaic virus, strain CH2, isolate 1906 is not likely to be toxic or pathogenic, is not infective, and is not able to replicate in human cells. Furthermore, humans, including infants and children, continuously consume plant viruses, including Pepino mosaic virus, strain CH2, isolate 1906, due to the ubiquitous nature of these viruses in plants and fruits, and no cases have been documented of any plant virus causing toxicity or diseases in humans or animals. Although there may be some exposure to residues of Pepino mosaic virus, strain CH2, isolate 1906 that are used on tomato in accordance with label directions and good agricultural practices, such exposure is unlikely to cause any adverse effects. EPA also determined in the Safety Determination that retention of the Food Quality Protection Act (FQPA) safety factor was not necessary as part of the qualitative assessment conducted for Pepino mosaic virus, strain CH2, isolate 1906.

Based upon its evaluation in the Safety Determination, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Pepino mosaic virus, strain CH2, isolate 1906. Therefore, an exemption from the requirement of a tolerance is established for residues of Pepino mosaic virus, strain CH2, isolate 1906 in or on tomato when this pesticide chemical is used in accordance with label directions and good agricultural practices.

An analytical method is not required because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.

Three comments were received in response to the notice of filing. EPA reviewed the comments and determined that they are irrelevant to the tolerance exemption in this action.

This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. 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 (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 exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (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. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (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:

In 1980, Congress enacted the Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9601-9675 (“CERCLA” or “the Act”), in response to the dangers of uncontrolled releases or threatened releases of hazardous substances, and releases or substantial threats of releases into the environment of any pollutant or contaminant that may present an imminent or substantial danger to the public health or welfare. CERCLA was amended on October 17, 1986, by the Superfund Amendments and Reauthorization Act (“SARA”), Public Law 99-499, 100 Stat. 1613 et seq.

To implement CERCLA, the EPA promulgated the revised National Oil and Hazardous Substances Pollution Contingency Plan (“NCP”), 40 CFR part 300, on July 16, 1982 (47 FR 31180), pursuant to CERCLA section 105 and Executive Order 12316 (46 FR 42237, August 20, 1981). The NCP sets guidelines and procedures for responding to releases and threatened releases of hazardous substances, or releases or substantial threats of releases into the environment of any pollutant or contaminant that may present an imminent or substantial danger to the public health or welfare. The EPA has revised the NCP on several occasions. The most recent comprehensive revision was on March 8, 1990 (55 FR 8666).

As required under section 105(a)(8)(A) of CERCLA, the NCP also includes “criteria for determining priorities among releases or threatened releases throughout the United States for the purpose of taking remedial action and, to the extent practicable, taking into account the potential urgency of such action, for the purpose of taking removal action.” “Removal” actions are defined broadly and include a wide range of actions taken to study, clean up, prevent or otherwise address releases and threatened releases of hazardous substances, pollutants or contaminants (42 U.S.C. 9601(23)).

The NPL is a list of national priorities among the known or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. The list, which is appendix B of the NCP (40 CFR part 300), was required under section 105(a)(8)(B) of CERCLA, as amended. Section 105(a)(8)(B) defines the NPL as a list of “releases” and the highest priority “facilities” and requires that the NPL be revised at least annually. The NPL is intended primarily to guide the EPA in determining which sites warrant further investigation to assess the nature and extent of public health and environmental risks associated with a release of hazardous substances, pollutants or contaminants. The NPL is of only limited significance, however, as it does not assign liability to any party or to the owner of any specific property. Also, placing a site on the NPL does not mean that any remedial or removal action necessarily need be taken.

For purposes of listing, the NPL includes two sections, one of sites that are generally evaluated and cleaned up by the EPA (the “General Superfund section”) and one of sites that are owned or operated by other federal agencies (the “Federal Facilities section”). With respect to sites in the Federal Facilities section, these sites are generally being addressed by other federal agencies. Under Executive Order 12580 (52 FR 2923, January 29, 1987) and CERCLA section 120, each federal agency is responsible for carrying out most response actions at facilities under its own jurisdiction, custody or control, although the EPA is responsible for preparing a Hazard Ranking System (“HRS”) score and determining whether the facility is placed on the NPL.

There are three mechanisms for placing sites on the NPL for possible remedial action (see 40 CFR 300.425(c) of the NCP): (1) A site may be included on the NPL if it scores sufficiently high on the HRS, which the EPA promulgated as appendix A of the NCP (40 CFR part 300). The HRS serves as a screening tool to evaluate the relative potential of uncontrolled hazardous substances, pollutants or contaminants to pose a threat to human health or the environment. On December 14, 1990 (55 FR 51532), the EPA promulgated revisions to the HRS partly in response to CERCLA section 105(c), added by SARA. On January 9, 2017 (82 FR 2760), a subsurface intrusion component was added to the HRS to enable the EPA to consider human exposure to hazardous substances or pollutants and contaminants that enter regularly occupied structures through subsurface intrusion when evaluating sites for the NPL. The current HRS evaluates four pathways: Ground water, surface water, soil exposure and subsurface intrusion, and air. As a matter of agency policy, those sites that score 28.50 or greater on the HRS are eligible for the NPL. (2) Each state may designate a single site as its top priority to be listed on the NPL, without any HRS score. This provision of CERCLA requires that, to the extent practicable, the NPL include one facility designated by each state as the greatest danger to public health, welfare or the environment among known facilities in the state. This mechanism for listing is set out in the NCP at 40 CFR 300.425(c)(2). (3) The third mechanism for listing, included in the NCP at 40 CFR 300.425(c)(3), allows certain sites to be listed without any HRS score, if all of the following conditions are met:

• The Agency for Toxic Substances and Disease Registry (ATSDR) of the U.S. Public Health Service has issued a health advisory that recommends dissociation of individuals from the release.

• The EPA determines that the release poses a significant threat to public health.

• The EPA anticipates that it will be more cost-effective to use its remedial authority than to use its removal authority to respond to the release.

The EPA promulgated an original NPL of 406 sites on September 8, 1983 (48 FR 40658) and generally has updated it at least annually.

A site may undergo remedial action financed by the Trust Fund established under CERCLA (commonly referred to as the “Superfund”) only after it is placed on the NPL, as provided in the NCP at 40 CFR 300.425(b)(1). (“Remedial actions” are those “consistent with a permanent remedy, taken instead of or in addition to removal actions” (40 CFR 300.5).) However, under 40 CFR 300.425(b)(2), placing a site on the NPL “does not imply that monies will be expended.” The EPA may pursue other appropriate authorities to respond to the releases, including enforcement action under CERCLA and other laws.

The NPL does not describe releases in precise geographical terms; it would be neither feasible nor consistent with the limited purpose of the NPL (to identify releases that are priorities for further evaluation), for it to do so. Indeed, the precise nature and extent of the site are typically not known at the time of listing.

Although a CERCLA “facility” is broadly defined to include any area where a hazardous substance has “come to be located” (CERCLA section 101(9)), the listing process itself is not intended to define or reflect the boundaries of such facilities or releases. Of course, HRS data (if the HRS is used to list a site) upon which the NPL placement was based will, to some extent, describe the release(s) at issue. That is, the NPL site would include all releases evaluated as part of that HRS analysis.

When a site is listed, the approach generally used to describe the relevant release(s) is to delineate a geographical area (usually the area within an installation or plant boundaries) and identify the site by reference to that area. However, the NPL site is not necessarily coextensive with the boundaries of the installation or plant, and the boundaries of the installation or plant are not necessarily the “boundaries” of the site. Rather, the site consists of all contaminated areas within the area used to identify the site, as well as any other location where that contamination has come to be located, or from where that contamination came.

In other words, while geographic terms are often used to designate the site (e.g., the “Jones Co. Plant site”) in terms of the property owned by a particular party, the site, properly understood, is not limited to that property (e.g., it may extend beyond the property due to contaminant migration), and conversely may not occupy the full extent of the property (e.g., where there are uncontaminated parts of the identified property, they may not be, strictly speaking, part of the “site”). The “site” is thus neither equal to, nor confined by, the boundaries of any specific property that may give the site its name, and the name itself should not be read to imply that this site is coextensive with the entire area within the property boundary of the installation or plant. In addition, the site name is merely used to help identify the geographic location of the contamination, and is not meant to constitute any determination of liability at a site. For example, the name “Jones Co. plant site,” does not imply that the Jones Company is responsible for the contamination located on the plant site.

EPA regulations provide that the remedial investigation (“RI”) “is a process undertaken . . . to determine the nature and extent of the problem presented by the release” as more information is developed on site contamination, and which is generally performed in an interactive fashion with the feasibility study (“FS”) (40 CFR 300.5). During the RI/FS process, the release may be found to be larger or smaller than was originally thought, as more is learned about the source(s) and the migration of the contamination. However, the HRS inquiry focuses on an evaluation of the threat posed and therefore the boundaries of the release need not be exactly defined. Moreover, it generally is impossible to discover the full extent of where the contamination “has come to be located” before all necessary studies and remedial work are completed at a site. Indeed, the known boundaries of the contamination can be expected to change over time. Thus, in most cases, it may be impossible to describe the boundaries of a release with absolute certainty.

Further, as noted previously, NPL listing does not assign liability to any party or to the owner of any specific property. Thus, if a party does not believe it is liable for releases on discrete parcels of property, it can submit supporting information to the agency at any time after it receives notice it is a potentially responsible party.

For these reasons, the NPL need not be amended as further research reveals more information about the location of the contamination or release.

The EPA may delete sites from the NPL where no further response is appropriate under Superfund, as explained in the NCP at 40 CFR 300.425(e). This section also provides that the EPA shall consult with states on proposed deletions and shall consider whether any of the following criteria have been met:

(i) Responsible parties or other persons have implemented all appropriate response actions required;

(ii) All appropriate Superfund-financed response has been implemented and no further response action is required; or

(iii) The remedial investigation has shown the release poses no significant threat to public health or the environment, and taking of remedial measures is not appropriate.

In November 1995, the EPA initiated a policy to delete portions of NPL sites where cleanup is complete (60 FR 55465, November 1, 1995). Total site cleanup may take many years, while portions of the site may have been cleaned up and made available for productive use.

The EPA also has developed an NPL construction completion list (“CCL”) to simplify its system of categorizing sites and to better communicate the successful completion of cleanup activities (58 FR 12142, March 2, 1993). Inclusion of a site on the CCL has no legal significance.

Sites qualify for the CCL when: (1) Any necessary physical construction is complete, whether or not final cleanup levels or other requirements have been achieved; (2) the EPA has determined that the response action should be limited to measures that do not involve construction (e.g., institutional controls); or (3) the site qualifies for deletion from the NPL. For more information on the CCL, see the EPA's internet site at https://www.epa.gov/superfund/construction-completions-national-priorities-list-npl-sites-number.

The Sitewide Ready for Anticipated Use measure represents important Superfund accomplishments and the measure reflects the high priority the EPA places on considering anticipated future land use as part of the remedy selection process. See Guidance for Implementing the Sitewide Ready-for-Reuse Measure, May 24, 2006, OSWER 9365.0-36. This measure applies to final and deleted sites where construction is complete, all cleanup goals have been achieved, and all institutional or other controls are in place. The EPA has been successful on many occasions in carrying out remedial actions that ensure protectiveness of human health and the environment for current and future land uses, in a manner that allows contaminated properties to be restored to environmental and economic vitality. For further information, please go to https://www.epa.gov/superfund/about-superfund-cleanup-process#tab-9.

In order to maintain close coordination with states and tribes in the NPL listing decision process, the EPA's policy is to determine the position of the states and tribes regarding sites that the EPA is considering for listing. This consultation process is outlined in two memoranda that can be found at the following website: https://www.epa.gov/superfund/statetribal-correspondence-concerning-npl-site-listing.

The EPA has improved the transparency of the process by which state and tribal input is solicited. The EPA is using the Web and where appropriate more structured state and tribal correspondence that (1) explains the concerns at the site and the EPA's rationale for proceeding; (2) requests an explanation of how the state intends to address the site if placement on the NPL is not favored; and (3) emphasizes the transparent nature of the process by informing states that information on their responses will be publicly available.

A model letter and correspondence between the EPA and states and tribes where applicable, is available on the EPA's website at http://semspub.epa.gov/src/document/HQ/174024.

Yes, documents relating to the evaluation and scoring of the sites in this final rule are contained in dockets located both at the EPA headquarters and in the EPA regional offices.

An electronic version of the public docket is available through https://www.regulations.gov (see table below for docket identification numbers). Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facilities identified in section II.D.

The headquarters docket for this rule contains the HRS score sheets, the documentation record describing the information used to compute the score and a list of documents referenced in the documentation record for each site.

The EPA regional dockets contain all the information in the headquarters docket, plus the actual reference documents containing the data principally relied upon by the EPA in calculating or evaluating the HRS score. These reference documents are available only in the regional dockets.

You may view the documents, by appointment only, after the publication of this rule. The hours of operation for the headquarters docket are from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding federal holidays. Please contact the regional dockets for hours. For addresses for the headquarters and regional dockets, see ADDRESSES section in the beginning portion of this preamble.

You may obtain a current list of NPL sites via the internet at https://www.epa.gov/superfund/national-priorities-list-npl-sites-site-name or by contacting the Superfund docket (see contact information in the beginning portion of this document).

This final rule adds the following five sites to the General Superfund section of the NPL. These sites are being added to the NPL based on HRS score.

General Superfund section:

The EPA reviewed all comments received on the sites in this rule and responded to all relevant comments. The EPA is adding five sites to the NPL in this final rule. Three sites were proposed for NPL addition on January 18, 2018 (83 FR 2576). The sites are: Broadway Street Corridor Groundwater Contamination in Anderson, IN; Rockwell International Wheel & Trim in Grenada, MS; and Southside Chattanooga Lead in Chattanooga, TN. Two sites were proposed for NPL addition on May 17, 2018 (83 FR 22918). Those sites are: Donnelsville Contaminated Aquifer in Donnelsville, OH; and Delfasco Forge in Grand Prairie, TX.

Comments on Rockwell International Wheel & Trim, Southside Chattanooga Lead and Broadway Street Corridor Groundwater Contamination are being addressed in response to comment support documents available in the public docket concurrently with this rule. To view public comments on these sites, as well as EPA's response, please refer to the support documents filed in connection with this rule.

The EPA received no comments on the Delfasco Forge site.

For the Donnelsville Contaminated Aquifer site, the EPA received one comment from community members in support of NPL listing and one comment unrelated to NPL listing.

On January 18, 2018 (83 FR 2576) the EPA proposed to add the “Southside Chattanooga Lead Site” site to the NPL. The EPA is dropping “Site” from the site name and henceforth referring to it as Southside Chattanooga Lead.

EPA placed the West Vermont Drinking Water Contamination site located in Indianapolis, Indiana on the NPL on September 9, 2016 (81 FR 62397). On May 18, 2018, the U.S. Court of Appeals for the District of Columbia Circuit vacated the 2016 rule which placed the site on the NPL (Genuine Parts Co. v. EPA, No. 16-1416 (DC Cir. 2018)). Consequently, EPA has withdrawn the West Vermont Drinking Water Contamination site from the NPL.

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 rule does not contain any information collection requirements that require approval of the OMB.

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 rule listing sites on the NPL does not impose any obligations on any group, including small entities. This rule also does not establish standards or requirements that any small entity must meet, and imposes no direct costs on any small entity. Whether an entity, small or otherwise, is liable for response costs for a release of hazardous substances depends on whether that entity is liable under CERCLA 107(a). Any such liability exists regardless of whether the site is listed on the NPL through this rulemaking.

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 imposes no enforceable duty on any state, local or tribal governments or the private sector. Listing a site on the NPL does not itself impose any costs. Listing does not mean that the EPA necessarily will undertake remedial action. Nor does listing require any action by a private party, state, local or tribal governments or determine liability for response costs. Costs that arise out of site responses result from future site-specific decisions regarding what actions to take, not directly from the act of placing a site on the NPL.

This final rule 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. Listing a site on the NPL does not impose any costs on a tribe or require a tribe to take remedial action. 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 this action itself is procedural in nature (adds sites to a list) and does not, in and of itself, provide protection from environmental health and safety risks. Separate future regulatory actions are required for mitigation of environmental health and safety risks.

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 because it does not affect the level of protection provided to human health or the environment. As discussed in Section I.C. of the preamble to this action, the NPL is a list of national priorities. The NPL is intended primarily to guide the EPA in determining which sites warrant further investigation to assess the nature and extent of public health and environmental risks associated with a release of hazardous substances, pollutants or contaminants. The NPL is of only limited significance as it does not assign liability to any party. Also, placing a site on the NPL does not mean that any remedial or removal action necessarily need be taken.

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

Provisions of the Congressional Review Act (CRA) or section 305 of CERCLA may alter the effective date of this regulation. Under 5 U.S.C. 801(b)(1), a rule shall not take effect, or continue in effect, if Congress enacts (and the President signs) a joint resolution of disapproval, described under section 802. Another statutory provision that may affect this rule is CERCLA section 305, which provides for a legislative veto of regulations promulgated under CERCLA. Although INS v. Chadha, 462 U.S. 919,103 S. Ct. 2764 (1983), and Bd. of Regents of the University of Washington v. EPA, 86 F.3d 1214,1222 (D.C. Cir. 1996), cast the validity of the legislative veto into question, the EPA has transmitted a copy of this regulation to the Secretary of the Senate and the Clerk of the House of Representatives.

If action by Congress under either the CRA or CERCLA section 305 calls the effective date of this regulation into question, the EPA will publish a document of clarification in the Federal Register.

40 CFR part 300 is amended as follows:

Federal civilian employees of an agency as defined in FTR § 301-1.1, if authorized to travel via business-class air accommodations, must use the business-class city-pair fare (coded as “—CB”) where awarded for the route(s) listed on the travel authorization. The Federal traveler must use this fare or have an authorized exception to mandatory use of a contract city-pair fare per the FTR. The information outlined in FTR Bulletin 18-08 will provide clarity and promote consistency across the Government. This bulletin is located at www.gsa.gov/ftr under the “FTR & Related Files” tab.

On April 6, 2018, VA published a proposed rule in the Federal Register (83 FR 14826), which announced VA`s intent to amend regulations for VAAR Case RIN 2900-AQ02 (Parts 831 and 833). In particular, this final rule revises VAAR part 831 to clarify the cost principles under the chapter 31 program and to apply those principles to both fixed-price and cost reimbursement contracts with educational institutions, as well as those with commercial and non-profit organizations. It revises VAAR part 833 to update information for where an interested party may protest to the contracting officer; provides for independent review a level above the contracting officer; and clarifies how interested parties may appeal a contracting officer's decision on a protest. Other revisions include clarification of the types of protests that may be dismissed by VA without consideration of the merits, or may be forwarded to another agency for appropriate action; states that certain challenges of the legal status of a firm as a regular dealer or manufacturer is determined solely by the procuring agency, the Small Business Administration (SBA) if a small business is involved, and the Secretary of Labor; updates two clauses in part 852 related to protests; clarifies a contractor's obligation to continue performance under a dispute; and, revises a definition of a term in VAAR part 871 to comport with the same term used in VAAR part 831.

VA provided a 60-day comment period for the public to respond to the proposed rule. The comment period for the proposed rule ended on June 5, 2018 and VA received no comments. This document adopts as a final rule the proposed rule published in the Federal Register on April 6, 2018, with minor stylistic and grammatical edits. This final rule has Federal Register administrative format changes in the amendatory text which make no substantive text changes at the affected sections.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal Governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal Governments or on the private sector.

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

This final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule will generally be small business neutral. The overall impact of the rule will be of benefit to small businesses owned by Veterans or service-disabled Veterans as the VAAR is being updated to remove extraneous procedural information that applies only to VA's internal operating procedures. VA is merely adding existing and current regulatory requirements to the VAAR and removing any guidance that is applicable only to VA's internal operation processes or procedures. VA estimates no cost impact to individual businesses will result from these rule updates. This rulemaking does not change VA's policy regarding small businesses, does not have an economic impact to individual businesses, and there are no increased or decreased costs to small business entities. On this basis, the final rule will not have an economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. Therefore, under 5 U.S.C. 605(b), this regulatory action is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits of reducing costs, of harmonizing rules, and of promoting flexibility. E.O. 12866, Regulatory Planning and Review, defines “significant regulatory action” to mean any regulatory action that is likely to result in a rule that may: “(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive order.”

VA has examined the economic, interagency, budgetary, legal, and policy implications of this regulatory action, and it has been determined not to be a significant regulatory action under E.O. 12866 because it does not raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.

VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's website at http://www.va.gov/orpm by following the link for VA Regulations Published from FY 2004 Through Fiscal Year to Date. This final rule is not subject to the requirements of E.O. 13771 because this final rule is expected to result in no more than de minimis costs.

The Secretary of Veterans Affairs approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Robert L. Wilkie, Secretary, Department of Veterans Affairs, approved this document on August 24, 2018, for publication.

For the reasons set out in the preamble, VA amends 48 CFR parts 831, 833, 852 and 871 as follows:

Executive Summary

This direct final rule makes changes to the EPAAR, Federal Acquisition Regulation (FAR), 48 CFR parts 1506 and 1552. This rule includes the following content changes: (1) Under EPAAR § 1506.302-5(b)(1), adds clarifying language that the Contracting Officer need not provide any written justification under FAR 8.405-6 or 13.501 for use of other than full and open competition when acquiring expert services under the authority of section 109(e) of the Superfund Amendments and Reauthorization Act of 1986 (SARA); (2) revises EPAAR § 1552.232-70 to add information on circumstances that may require obtaining subcontractor costs, makes minor administrative changes, and incorporates invoice preparation instructions; and (3) revises EPAAR § 1552.235-79 to expand the possible circumstances where the EPA may release the Contractor's CBI.

EPA is publishing this rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. If EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. Any parties interested in commenting must do so at this time.

EPAAR §§ 1552.232-70 and 1552.235-79 apply to contractors who hold a cost-reimbursable contract with EPA. EPAAR § 1506.302-5 applies to EPA contracting personnel providing for and imposing responsibilities when contracting under other than full and open competition.

1. Submitting CBI. Do not submit this information to EPA through www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for Preparing Your Comments. When submitting comments, remember to:

• Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).

• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

• Describe any assumptions and provide any technical information and/or data that you used.

• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

• Provide specific examples to illustrate your concerns, and suggest alternatives.

• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

• Make sure to submit your comments by the comment period deadline identified.

EPAAR § 1552.235-79—Release of Contractor Confidential Business Information, was promulgated in the Federal Register (61 FR 14267, April 1, 1996). A Determination and Findings (D&F) found that changes were required to this EPAAR section because complete cost information was vital to the Government's ability to recover federal funds expended for oil spill responses from the parties responsible for these spills. Consequently, a Class Deviation, signed on March 22, 2001 by Judy S. Davis, Acting Director, Office of Acquisition Management to this EPAAR section, was developed to allow EPA to release cost information from the Emergency and Rapid Response Services (ERRS) and Superfund Technical Assessment and Response Team (START) contracts to federal agencies and other parties involved in oil spill cost recovery efforts. The rule incorporates the Class Deviation for EPAAR § 1552.235-79 into the EPAAR and makes other minor administrative updates.

EPAAR § 1552.232-70, Submission of Invoices, was promulgated in the Federal Register (61 FR 29317, June 10, 1996). The Class Deviation is also dated June 1996 and adds in Invoice Preparation Instructions for SF-1034. The rule incorporates the Class Deviation for EPAAR § 1552.232-70 into the EPAAR and makes other minor administrative updates.

EPAAR § 1506.302-5, Authorized or Required by Statute, was promulgated in the Federal Register (53 FR 31872, Aug. 22, 1988). This current action clarifies the applicability of the requirement for written justification for the use of other than full and open competitive procedures when acquiring expert services under the authority of section 109(e) of Superfund Amendments and Reauthorization Act of 1986 (SARA). The FAR was amended on January 2, 1997, to include FAR 13.501 sole source justification requirements for simplified acquisitions under part 13, and again on June 18, 2004, to include FAR 8.405-6 limited source justification (LSJ) requirements for Federal Supply Service acquisitions under part 8. EPA never amended EPAAR § 1506.302-5 to account for the LSJ and sole source requirements of those FAR sections.

This action is not a “significant regulatory action” under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and therefore, not subject to review under the EO.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. No information is collected under this action.

The Regulatory Flexibility Act generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute; unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impact of this rule on small entities, “small entity” is defined as: (1) A small business that meets the definition of a small business found in the Small Business Act and codified at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; or (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. After considering the economic impacts of this rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This action revises a current EPAAR provision and does not impose requirements involving capital investment, implementing procedures, or record keeping. This rule will not have a significant economic impact on small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, Local, and Tribal governments and the private sector. This rule contains no Federal mandates (under the regulatory provisions of the Title II of the UMRA) for State, Local, and Tribal governments or the private sector. The rule imposes no enforceable duty on any State, Local or Tribal governments or the private sector. Thus, the rule is not subject to the requirements of sections 202 and 205 of the UMRA.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and Local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that 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 rule 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 as specified in Executive Order 13132.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This rule does not have tribal implications as specified in Executive Order 13175.

Executive Order 13045, entitled “Protection of Children from Environmental Health and Safety Risks” (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is determined to be economically significant as defined under Executive Order 12886, and (2) concerns an environmental health or safety risk that may have a proportionate effect on children. This rule is not subject to Executive Order 13045 because it is not an economically significant rule as defined by Executive Order 12866, and because it does not involve decisions on environmental health or safety risks.

This final rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use” (66 FR 28335, May 22, 2001), because it is not a significant regulatory action under Executive Order 12866.

Section 12(d) (15 U.S.C. 272 note) of NTTA, Public Law 104-113, directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This final rulemaking does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards.

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA has determined that this final rulemaking will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. This rulemaking does not involve human health or environmental effects.

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. Section 804 exempts from section 801 the following types of rules (1) rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding this action under section 801 because this 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, 48 CFR parts 1506 and 1552 are amended as set forth below: