Discussion

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 December 6, 2018 (83 FR 62741). The NPRM was prompted by reports of cracks caused by corrosion of the edge of the bore of the spot face and corrosion of the lug bore of certain side-strut support fitting lugs. The NPRM proposed to require repetitive detailed inspections of the left and right side-strut support fitting lugs with bushings installed for any corrosion, any crack, or any severed lug; repetitive detailed and HFEC inspections of the left and right side-strut support fitting lugs with bushings removed for any corrosion or any crack; and applicable on-condition actions.

We are issuing this AD to address cracks caused by corrosion, which could result in sudden loss of the side-strut support fitting joint and main landing gear attachment to the airplane, resulting in the collapse of a main landing gear.

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.

Aviation Partners Boeing stated that accomplishing Supplemental Type Certificate (STC) ST01219SE does not affect the actions specified in the proposed AD.

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.

Boeing requested that we eliminate paragraph (h) of the proposed AD and incorporate the information as paragraph (g)(2) of this AD. Boeing pointed out that the title of paragraph (g) of the proposed AD would change to “Required Actions,” and that paragraphs (g)(1) and (g)(2) of this AD would apply to Group 7 and Groups 1 through 6, respectively. Boeing stated that this request is for consistency with previous ADs for Boeing airplanes.

We disagree that elimination of paragraph (h) of the proposed AD and incorporating the information as paragraph (g)(2) of this AD is necessary. Over time we have used both formats, but most recently we have been using the format that was utilized in the NPRM. We do not find that there is a difference in clarity of the required actions. We also find that the requested change does not affect the requirements of this final rule in this case. We have not changed this AD in this regard.

Boeing requested that we clarify the ACO branch that has the authority to approve AMOCs for this group of airplanes. Boeing pointed out that previous final rules for The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes have identified The Manager, Los Angeles ACO Branch, FAA, had the authority to approve AMOCs, even when the service bulletin was submitted for approval through the Seattle ACO Branch. Additionally, Boeing pointed out that previous ADs for The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes identified a Los Angeles ACO Branch specialist in the “Related Information” paragraph of the proposed rule, even when the service bulletin was submitted for approval through the Seattle ACO Branch.

We agree that clarification is necessary. Normally, in NPRMs for The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes, we include the Manager, Los Angeles ACO Branch, as the designated approval authority for AMOCs. We have updated paragraph (j) of this AD to specify The Manager, Los Angeles ACO Branch. The Seattle ACO Branch is responsible during drafting of the NPRM and final rule of an AD for The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. After publication of the final rule, responsibility for the product is transferred to the Los Angeles ACO Branch. Therefore, when we draft the final rule of an AD for The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes, we also specify a specialist from the Los Angeles ACO Branch. We have updated paragraph (k) of this AD to include the responsible specialist from the Los Angeles ACO Branch.

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 Service Bulletin 737-53-1246, Revision 1, dated May 30, 2018. This service information describes procedures for repetitive detailed inspections of the left and right side-strut support fitting lugs at body station (BS) 685 with bushings installed for any corrosion, any crack, or any severed lug; repetitive detailed and HFEC inspections of the left and right side-strut support fitting lugs at BS 685 with bushings removed for any corrosion or any crack; and applicable on-condition actions. On-condition actions include, among other things, inspections, corrosion removal, and a preventative modification. Doing the repetitive detailed and HFEC inspections of the side-strut support fitting lugs at BS 685 with bushings removed terminates the repetitive detailed inspections of the side-strut support fitting lugs at BS 685 with bushings installed. 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 302 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary on-condition actions that would be required. We have no way of determining the number of aircraft that might need these on-condition actions:

We have received no definitive data that would enable us to provide parts cost estimates for the on-condition inspections and repairs 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:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2008-24-14, Amendment 39-15758 (73 FR 73785, December 4, 2008) (“AD 2008-24-14”). AD 2008-24-14 applied to all Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The NPRM published in the Federal Register on October 1, 2018 (83 FR 49317). The NPRM was prompted by reports of cracks on the MLG trunnion fitting during fatigue testing; the introduction of new AWL tasks with revised inspection, modification, and safe-life requirements; and a determination that the trunnion fitting lower flange and both forward and aft bore holes are also subject to fatigue cracking. The NPRM proposed to require revising the maintenance or inspection program, as applicable, to incorporate certain AWLs. The NPRM also proposed to require reworking the trunnion fitting in order to meet new structural safe-life limits. We are issuing this AD to address fatigue cracking of the MLG trunnion fitting. Failure of the MLG trunnion fitting could result in MLG collapse.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2017-27, dated August 2, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model CL-600-2B19 (Regional Jet Series 100 & 440) 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-2018-0801.

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.

Air Line Pilots Association, International stated its support for the NPRM.

Air Wisconsin Airlines requested that we clarify the compliance times for the rework specified in paragraph (l) of the proposed AD. Air Wisconsin Airlines stated that the AWLs do not include requirements to incorporate the service information identified in paragraph (l)(1), (l)(2), and (l)(3) of this AD. Air Wisconsin Airlines added that Bombardier Service Bulletin 601R-57-046, Revision C, dated December 20, 2012, would be required only if Bombardier Service Bulletin 601R-57-048, Revision C, dated June 6, 2013, is done and therefore there is no requirement to do Bombardier Service Bulletin 601R-57-046, Revision C, dated December 20, 2012.

We agree to clarify the compliance times for the rework required by paragraph (l) of this AD. We acknowledge that the compliance times for incorporating the rework are not clear. We note that Bombardier Service Bulletin 601R-57-046, Revision C, dated December 20, 2012, is not contingent on whether Bombardier Service Bulletin 601R-57-048, Revision C, dated June 6, 2013, is done. As specified in certain AWLs, “SB 601R-57-046 shall be incorporated at or before 34,900 flight cycles.”

However, we acknowledge that the AWLs do not specify requirements to incorporate Bombardier Service Bulletin 601R-57-047, Revision B, dated October 2, 2012; and Bombardier Service Bulletin 601R-57-048, Revision C, dated June 6, 2013. Since the AWLs do not specify compliance times for incorporating that service information, operators would need to accomplish the actions specified in that service information within 2,000 flight cycles after the effective date of this AD.

However, we have determined that the actions specified in Bombardier Service Bulletin 601R-57-046, Revision C, dated December 20, 2012; Bombardier Service Bulletin 601R-57-047, Revision B, dated October 2, 2012; and Bombardier Service Bulletin 601R-57-048, Revision C, dated June 6, 2013; must be done within the initial compliance times specified in the service information, or within 2,000 flight cycles after the effective date of this AD, whichever occurs later. We have coordinated with TCCA to clarify the compliance times for incorporating the service information. We have added compliance times to paragraphs (l)(1) through (l)(3) of this AD accordingly.

Air Wisconsin Airlines requested that paragraph (g) of the proposed AD be reworded to indicate that paragraph (f)(1) of AD 2008-24-14 required incorporation of Bombardier Maintenance Requirements Manual (MRM), CSP A-253, Part 2, Appendix B task AWL 57-21-161, because Temporary Revision (TR) 2B-2136 (Global alternative method of compliance (AMOC) with log #14-83) was superseded by TR 2B-2153 and later incorporated into a general revision of Bombardier Maintenance Requirements Manual (MRM), CSPA-253, Part 2, Appendix B.

We disagree, because the requirements specified in paragraph (g) of this AD are a restatement of the actions required by paragraph (f)(1) of AD 2008-24-14 and are still applicable until the new actions required by paragraph (i) of this AD are done. The FAA cannot impose the latest requirements for a paragraph that has the initial compliance date of AD 2008-24-14 since the latest documents were not available at the time that AD 2008-24-14 became effective. Additionally, paragraph (i) of this AD addresses the commenter's concerns regarding the latest documents. For clarity, we have added a statement to paragraph (i) of this AD to specify that accomplishing the revision required by paragraph (i) of this AD terminates the revision required by paragraph (g) of this AD.

Air Wisconsin Airlines observed that the reference to “table 1 or table 2 to paragraphs (g) and (j) of this AD, as applicable” in paragraph (g) was not in AD 2008-24-14 and therefore is a change to that paragraph, because paragraph (j) is a new requirement of the proposed AD. We infer that the commenter would like us to clarify the inclusion of a reference to “paragraph (j)” within paragraph (g) of the proposed AD.

We agree to clarify the paragraph in question. The inclusion of “paragraph (j)” within paragraph (g) of this AD is merely as part of the designation of one of the tables referenced and has no bearing upon the requirements of paragraph (g) of this AD. 1 CFR parts 8 and 21 require orderly codification of regulations. This means that all elements of an AD, including tables and figures, must be properly designated. A table's designation includes the sequential number of the table, the paragraphs to which it applies, and the location of the table within the AD. The Office of the Federal Register (OFR) requires a complete designation when a table is cross-referenced. Both of the tables in question are referenced in paragraphs (g) and (j) of this AD, therefore, the correct reference is to “table 1 to paragraphs (g) and (j)” and “table 2 to paragraphs (g) and (j),” as stated in paragraphs (g) and (j) of this AD. We have not changed this AD with regard to table designations.

Air Wisconsin Airlines requested that we reword the compliance time statement in paragraph (j)(2) of the proposed AD to specify the compliance time instead of referring to the AWL. The commenter stated that rewording would simplify the paragraph.

We acknowledge the commenter's request. However, the information is contained in the AWL and we matched the language in the MCAI by referring to the AWL. Unless the language in the MCAI is not enforceable, we generally do not deviate from the MCAI. We have not changed this AD in this regard.

Bombardier requested that we add paragraph (j)(4) to the proposed AD in order to align with the instructions in paragraph B.3. of the MCAI. Bombardier stated that paragraph (j)(3) of the proposed AD mentions the compliance time for the initial inspection but not for the limitation for AWL 57-21-145 and AWL 57-21-155. Additionally, Air Wisconsin Airlines asked whether our intent in paragraph (j)(3) of the proposed AD was to “speak only to the initial inspections in AWL 57-21-145 and AWL 57-21-155.” We infer Air Wisconsin Airlines is also requesting that we address the missing compliance time statement for the limitation sections of AWL 57-21-145 and AWL 57-21-155.

We agree with the request to include the information in paragraph B.3. of the MCAI in this AD. The compliance time in paragraph B.3. of the MCAI includes the grace period for both the initial inspection and the limitation sections of the AWLs. We have added paragraph (j)(4) of this AD to address the compliance time for the limitation sections of AWL 57-21-145 and AWL 57-21-155.

Air Wisconsin Airlines requested that we consider combining paragraphs (h) and (k) of the proposed AD. The commenter asserted that paragraph (h) of the proposed AD does not restate the requirement of paragraph (f)(2) of AD 2008-24-14.

We do not agree to the request to combine paragraphs (h) and (k) of this AD because the retained and new requirements are addressed separately in this supersedure AD. Paragraph (h) of this AD restates the requirements of paragraph (f)(2) of AD 2008-24-14, with a new exception. Paragraph (h) of this AD applies to the retained action required by paragraph (g) of this AD while paragraph (k) of this AD applies to the new action required by paragraph (i) of this AD. We have not changed this AD in this regard.

Air Wisconsin Airlines requested that we clarify the reference to “the AWLs identified in figure 1 to paragraphs (i) and (o)” in paragraph (o) of the proposed AD. The commenter remarked that no AWLs are specifically listed in paragraph (o) of the proposed AD.

We agree to clarify the figure reference in paragraph (o) of this AD. The AWLs are specifically listed in figure 1, which is designated “figure 1 to paragraphs (i)(1) and (o).” Paragraphs (i)(1) and (o) both reference that figure. As previously mentioned, OFR requires that the designation of any figure in an AD must include all paragraphs in which it is referenced, and the full designation is required in each reference. The correct designation of the figure in question is “figure 1 to paragraphs (i)(1) and (o),” as referenced in paragraphs (i)(1) and (o) of this AD. We have not changed this AD with regard to figure designations.

Air Wisconsin Airlines requested that we revise paragraph (l) of the proposed AD to state that the compliance time for the limitation section is at the applicable time specified in the applicable AWLs.

As stated previously, we have revised paragraph (l) of this AD to specify the compliance times for the rework. We note that the compliance times for the limitation sections are provided in paragraphs (j)(2) and (j)(4) of this AD. If affected parts are removed and replaced with MLG trunnion, part numbers 601R10068-5 and -6, the inspection and limitation sections compliance times of the affected AWLs start from the installation of the new part numbers 601R10068-5 and -6. After the part replacement, the inspections and limitation sections of AWL 57-21-155 and AWL 57-21-161 still apply.

Where the compliance times for the repetitive inspections and life limits specified in the TRs identified in figure 1 to paragraphs (i)(1) and (o) of this AD specify “landings,” those compliance times are based on the landings of the affected part. The compliance times for the initial inspections are specified in paragraphs (j)(1) and (j)(3) of this AD and those compliance times are based on flight cycles or landings of the airplane. We have clarified the compliance times in paragraphs (i) and (j)(3) of this AD.

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.

Bombardier has issued the following service information.

• Bombardier Service Bulletin 601R-57-046, Revision C, dated December 20, 2012, describes the cold working of fastener holes in the MLG trunnion fitting, and related investigative and corrective actions.

• Bombardier Service Bulletin 601R-57-047, Revision B, dated October 2, 2012, describes the installation of forcemate bushings in the MLG trunnion, and related investigative and corrective actions.

• Bombardier Service Bulletin 601R-57-048, Revision C, dated June 6, 2013, describes the cold working of holes on the web of the MLG trunnion, and related investigative and corrective actions.

Bombardier has also issued the following temporary revisions (TRs), which are distinct because they describe different AWL tasks that apply to different Canadair part numbers.

• Bombardier Maintenance Requirements Manual Temporary Revision 2B-2237, dated June 19, 2014. This TR describes AWL task 57-21-145, MLG Mounting Trunnion Fitting Assembly (Pre-SB 601R-57-047).

• Bombardier Maintenance Requirements Manual Temporary Revision 2B-2238, dated June 19, 2014. This TR describes AWL task 57-21-161, MLG Mounting Trunnion Web at WS66 (Pre-SB 601R-57-046 or Pre-SB 601R-57-048).

• Bombardier Maintenance Requirements Manual Temporary Revision 2B-2239, dated June 19, 2014. This TR describes AWL task 57-21-155, MLG Mounting Trunnion Fitting Assembly (Pre-SB 601R-57-046 or Pre-SB 601R-57-048).

• Bombardier Maintenance Requirements Manual Temporary Revision 2B-2241, dated June 19, 2014. This TR describe AWL tasks 57-21-162, MLG Mounting Trunnion Assembly; and 57-21-163, MLG Mounting Trunnion Assembly.

• Bombardier Maintenance Requirements Manual Temporary Revision 2B-2242, dated June 19, 2014. This TR removes certain AWL tasks.

• Bombardier Maintenance Requirements Manual Temporary Revision 2B-2246, dated November 7, 2014. This TR describes AWL tasks 57-21-162, MLG Mounting Trunnion Assembly; and 57-21-163, MLG Mounting Trunnion Assembly.

This AD also requires Bombardier Temporary Revision 2B-2136, dated May 1, 2008, to the Bombardier CL-600-2B19 Maintenance Requirements Manual, Part 2, Appendix B—Airworthiness Limitations, which the Director of the Federal Register approved for incorporation by reference as of December 19, 2008 (73 FR 73785, December 4, 2008).

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

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

We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in 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 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.

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:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class E airspace extending upward from 700 feet above the surface and the Class E airspace extending upward from 1,200 feet above the surface at Schoolcraft County Airport, Manistique, MI, to support IFR operations at this airport.

The FAA published a notice of proposed rulemaking in the Federal Register (84 FR 8834; March 12, 2019) for Docket No. FAA-2019-0105 to amend the Class E airspace extending upward from 700 feet above the surface and the Class E airspace extending upward from 1,200 feet above the surface at Schoolcraft County Airport, Manistique, MI. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. Two comments were received supporting the proposed action. The FAA provides the following response.

Class E airspace extending from 700 feet and 1,200 feet above the surface of an airport is provided for transition to and from the terminal or en route environment within the National Airspace System. The size and design of this airspace is determined by FAA Order 7400.2M, Procedures for Handling Airspace Matters, and is designed to enhance safety and support IFR operations at the associated airports. Airspace design does not “cause” the decommissioning of a navigational aid. The decommissioning of the Schoolcraft VOR was determined by the VOR MON Program, a national program. Airspace redesign is needed due to the decommissioning of the Schoolcraft VOR and the cancellation and revision of instrument flight procedures at the airport. Airspace design takes the current airport requirements and current instrument and visual departures and arrival procedures into consideration to insure the safety of operations at the airport.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C 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 by amending the Class E airspace extending upward from 700 feet above the surface to within a 6.5-mile radius (reduced from a 7-mile radius) of Schoolcraft County Airport, Manistique, MI; amending the Class E airspace extending upward from 1,200 feet above the surface to within a 9-mile radius of Schoolcraft County Airport; removing the extension to the east of the airport, as it is no longer required; removing the city associated with the airport from the airspace legal description to comply with FAA Order 7400.2M, Procedures for Handling Airspace Matters; and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database.

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

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

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

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

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

The FAA published a notice of proposed rulemaking in the Federal Register (84 FR 10455; March 21, 2019) for Docket No. FAA-2019-0134 to amend the Class E airspace extending upward from 700 feet above the surface at Portland Municipal Airport, Portland, TN. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Subsequent to publication, the FAA discovered a typographic error in the geographic coordinates (“Lat. 36°35′35″ N” should be “lat. 36°35′34″ N”) contained in the airspace legal description and in the bearing (“193°” should be “191°”). Those errors are corrected in this action.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C 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 by amending the Class E airspace extending upward from 700 feet above the surface to within a 6.5-mile radius (increased from a 6.3-mile radius) of Portland Municipal Airport, Portland, TN; removing the Bowling Green VORTAC and the associated extension from the airport legal description; adding an extension 2 miles each side of the 191° (corrected from 193°) bearing from the airport extending from the 6.5-mile radius to 10.8 miles south of the airport; and updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database.

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

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

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

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class D airspace and Class E airspace extending upward from 700 feet above the surface at Richard Lloyd Jones Jr. Airport, Tulsa, OK, and the Class E airspace extending upward from 700 feet above the surface at William R. Pogue Municipal Airport, Sand Springs, OK, to support instrument flight rule operations at these airports.

The FAA published a notice of proposed rulemaking in the Federal Register (84 FR 10453; March 21, 2019) for Docket No. FAA-2019-0110 to amend the Class D airspace and Class E airspace extending upward from 700 feet above the surface at Richard Lloyd Jones Jr. Airport, Tulsa, OK, and the Class E airspace extending upward from 700 feet above the surface at William R. Pogue Municipal Airport, Sand Springs, OK. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. Two comments were received. Neither comment addressed the proposed amendments but opposed the decommissioning of the Glenpool VOR. The FAA provides the following response.

The proposed decommissioning of the Glenpool VOR was addressed in airspace case 17-ASW-03NR. The public was given the opportunity to comment on the proposal between February 8, 2017, and April 10, 2017. No objections to the proposal were received. The Service Area Discontinuance Committee reviewed the aeronautical study and recommended the VOR be decommissioned. The Service Area Directors approved the recommendation on June 9, 2017, and the Glenpool VOR was decommissioned on February 28, 2019.

Subsequent to publication, the FAA discovered a typographic error in the geographic coordinates for the Richard Lloyd Jones Jr.: RWY 01L-LOC (“long. 95°59′07″ W” should be “long. 95°59′01″ W”). That error is corrected in this action.

Class D and E airspace designations are published in paragraph 5000 and 6005, respectively, of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C 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 by:

Amending the Class D airspace at Richard Lloyd Jones Jr. Airport, Tulsa, OK, by removing the Glenpool VOR/DME and the associated extension to the south of the airport from the airspace legal description; adding an extension 1 mile each side of the 193° bearing from the Richard Lloyd Jones Jr.: RWY 01L-LOC extending from the 4-mile radius to 4.1 miles south of the airport; updating the location in the header of the airspace legal description to Tulsa, OK (previously Tulsa Richard Lloyd Jones Jr. Airport, OK), to comply with FAA Order 7400.2M, Procedures for Handling Airspace Matters; removing the city associated with the airport from the airspace legal description to comply with FAA Order 7400.2M; updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database; making an editorial change replacing the outdated term “Airport/Facility Directory” with “Chart Supplement”; and correcting a typographical error in the geographic coordinates for the Richard Lloyd Jones Jr.: RWY 01L-LOC;

Amending the Class E airspace extending upward from 700 feet above the surface to within a 6.5-mile radius (increased from a 6.4-mile radius) of Richard Lloyd Jones Jr. Airport; and removing the city associated with the airport from the airspace legal description to comply with FAA Order 7400.2M;

And amending the Class E airspace extending upward from 700 feet above the surface to within a 6.5-mile radius (decreased from a 7.2-mile radius) of the William R. Pogue Municipal Airport, Sand Springs, OK; removing the Glenpool VOR/DME and the associated extension northwest of the William R. Pogue Municipal Airport from the Tulsa, OK, from the airspace legal description; and removing the city associated with the airport from the airspace legal description to comply with FAA Order 7400.2M.

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

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

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

The Postal Service is revising several sections of Mailing Standards of the United States Postal Service, International Mail Manual (IMM), to reflect classification changes to Mailing Services. These changes implement a lower maximum weight limit on FCMI large envelopes (flats), to bring them closer to limits established by the Universal Postal Union (UPU).

On October 10, 2018, the Postal Service filed a notice with the PRC in Docket No. R2019-1 of mailing services price adjustments, effective on January 27, 2019. In addition, on October 17, 2018, the Postal Service published a notice of proposed product and price changes in the Federal Register entitled “International Mailing Services: Proposed Product and Price Changes—CPI” (83 FR 52351). In the proposed rule, the Postal Service stated that on October 10, 2018, it also filed a notice with the PRC in Docket No. MC2019-3, proposing a change in the maximum weight limit for FCMI large envelopes (flats) from the current 64 ounces to under 16 ounces (the actual weight limit is 15.994 ounces, to accommodate Postal Service systems that round to three decimal places and thus round items that weigh 15.995-15.999 ounces up to 16 ounces). This change would more closely align the Postal Service's definition of FCMI large envelopes (flats) with the UPU Convention's weight limit, which allows a maximum weight of 500 grams (17.6 ounces) for flat-shaped letter post items.

Because the proposed change to FCMI large envelopes (flats) upper weight limit that was the subject of Docket No. MC2019-3 was pending at the time the PRC was scheduled to complete its review in Docket No. R2019-1, the PRC issued an interim order on October 19, 2018, in Docket No. R2019-1. That interim order required the Postal Service to revise its filing in the R2019-1 docket so that the Postal Service's proposed changes in the R2019-1 docket would not include the proposed revision to the FCMI large envelopes (flats) maximum weight limit. See PRC Order No. 4859, Interim Order Relating to Outbound Single-Piece First-Class Mail International Flats, Docket No. R2019-1, October 19, 2018. The PRC subsequently favorably reviewed the revised maximum weight limit for FCMI large envelopes (flats) in Order No. 4932, issued December 19, 2018, in Docket No. MC2019-3. On March 11, 2019, the Postal Service announced an implementation date of June 23, 2019, for the revised FCMI large envelopes (flats) maximum weight limit. See Notice of the United States Postal Service of Effective Date of Update to the Maximum Weight Limit for Outbound Single-Piece First-Class Mail International Large Envelopes (Flats) in the Mail Classification Schedule, PRC Docket No. MC2019-3 (March 11, 2019).

As a result, effective June 23, 2019, mailers must mail items weighing 15.994 ounces or more with First-Class Package International Service, Priority Mail Express International service, or Priority Mail International service. If a mailer, counter to the Postal Service's regulations, presents an FCMI large envelope (flat) weighing above the newly established weight limit, the Postal Service will offer the customer the option of mailing at the applicable First-Class Package International Service, Priority Mail Express International service, or Priority Mail International service price if the item meets the requirements for those mail classes.

International Priority Airmail (IPA) service, including IPA M-bags, is a commercial service designed for volume mailings of all FCMI postcards, letters, and large envelopes (flats), and for volume mailings of FCPIS packages (small packets). IPA shipments are typically flown to a foreign destination (exceptions apply to Canada and Mexico) and are then entered into that country's air or surface priority mail system for delivery. To qualify for IPA service, a mailpiece must either meet the FCMI characteristics defined in IMM 141.5 or the FCPIS characteristics as defined in IMM 141.6, except for weight, as follows:

International Surface Air Lift (ISAL) service, including ISAL M-bags, is a commercial service designed for volume mailings of all FCMI postcards, letters, and large envelopes (flats), and for volume mailings of FCPIS packages (small packets). ISAL shipments are typically flown to a foreign destination (exceptions apply to Canada and Mexico) and are then entered into that country's surface nonpriority mail system for delivery. To qualify for ISAL service, a mailpiece must meet either the FCMI characteristics defined in IMM 141.5 or the FCPIS characteristics as defined in IMM 141.6, except for weight, as follows:

Accordingly, for the reasons stated, the Postal Service has adopted the following changes to Mailing Standards of the United States Postal Service, International Mail Manual (IMM®), which is incorporated by reference in the Code of Federal Regulations in accordance with 39 CFR 20.1, along with associated changes to Notice 123, Price List.

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

On March 11, 2019, the EPA proposed to approve Oregon's September 25, 2018, SIP submission as meeting certain infrastructure requirements of the CAA for the 2015 ozone NAAQS (84 FR 8647). We also proposed to approve, and incorporate by reference, an associated Oregon Administrative Rule (OAR) update, submitted on December 11, 2018, as part of the Cleaner Air Oregon program, which identifies the November 2018 edition of the Code of Federal Regulations (CFR) as the CFR version referred to throughout the state's rule. The public comment period for this proposed action ended on April 10, 2019. The EPA did not receive comments on the proposal.

The EPA is approving Oregon's September 25, 2018, SIP submission as meeting specific infrastructure requirements of the Clean Air Act. We find that the Oregon SIP meets the following Clean Air Act section 110(a)(2) infrastructure elements for the 2015 ozone NAAQS: (A), (B), (C), (D)(i)(II), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M). We are also approving, and incorporating by reference at 40 CFR part 52, subpart MM, the OAR 340-200-0035(1) Reference Materials, submitted as part of the Cleaner Air Oregon SIP on December 11, 2018. The EPA is approving these SIP revisions because they are consistent with section 110 of the CAA.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, we are finalizing the incorporation by reference as described in section II. Final Action, above, and the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these materials generally available through https://www.regulations.gov and at the EPA Region 10 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by the EPA into that plan, are fully Federally-enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

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

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 5, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

For the reasons stated in the preamble, 40 CFR part 52 is amended as follows:

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

Section 110 of the CAA requires states to develop air pollution regulations and control strategies to ensure that air quality meets the EPA's National Ambient Air Quality Standards (NAAQS). These ambient standards are established under CAA section 109 and they currently address six criteria pollutants: Carbon monoxide (CO), nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide. Each state is responsible for developing a SIP which provides for the implementation, maintenance, and enforcement of the NAAQS. The SIP must be submitted to EPA for approval and any changes a state makes to the approved SIP also must be submitted to the EPA for approval.

On November 20, 2018, the Texas Commission on Environmental Quality (TCEQ or State) submitted to EPA revisions to the Texas SIP. The submitted revisions address removal of two rules within Title 30 of the Texas Administrative Code (denoted 30 TAC), Chapter 114 (Control of Air Pollution from Motor Vehicles): (1) Subchapter B—Motor Vehicle Anti-Tampering Requirements; and (2) Subchapter C, Division 3, Section 114.86—Low Income Repair Assistance Program (LIRAP) for Participating Early Action Compact (EAC) Counties.

The criteria used to evaluate these SIP revisions are found primarily in CAA section 110. Section 110( l ) of the Act requires that a SIP revision submitted to EPA be adopted after reasonable notice and public hearing and requires that EPA not approve a SIP revision if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable requirement of the CAA.

In the revision submitted on November 20, 2018, the State removes Subchapter B (Motor Vehicle Anti-Tampering Requirements) from the SIP in its entirety. The section 114 requirements would remain in place in the State regulation. The anti-tampering measures restrict removal or modification of motor vehicle emission control equipment. The first anti-tampering rules in the Texas SIP were adopted by the State and submitted to EPA in 1985 (see 54 FR 6286, February 9, 1989). Subsequent revisions to the State's anti-tampering rules were submitted to EPA in 1988, 1989, and 1993, and these revisions were disapproved on February 10, 1998 (63 FR 6651). The State submitted revisions to EPA in 1997 that recodified and renumbered the anti-tampering rules in Chapter 114 to new Subchapter B, which EPA approved into the Texas SIP on July 1, 1998 (63 FR 35839). 1 Between 1994 and 2015, the State submitted four other revisions to the anti-tampering rules that EPA did not act on and those revisions have been withdrawn from our consideration at the State's request. 2

The anti-tampering measures at 30 TAC 114, Subchapter B are not required under the CAA and did not supersede or otherwise modify requirements for pollution control devices on motor vehicles. The CAA addresses tampering prohibition for emission control equipment for motor vehicles and motor vehicle engines at section 203(a)(3) and prohibits tampering with any device or element of design installed on or in a motor vehicle or motor vehicle engine in compliance with motor vehicle emission standards. 42 U.S.C. 7522(a)(3). 3 In addition, the anti-tampering rules in the Texas SIP were not relied upon as a source of emissions reductions in any State Air Quality Plan and thus, did not contribute toward rate of progress, attainment, or maintenance of the NAAQS in Texas (see 54 FR 6286 and 63 FR 35839). Removal of Subchapter B from the Texas SIP does not cause a loss in emissions reductions because more stringent anti-tampering rules are in place and enforceable at the federal level. 42 U.S.C. 7522(a)(3).

Vehicle Inspection and Maintenance (I/M) programs are required by the CAA for certain ozone and CO nonattainment areas, depending upon population and nonattainment classification or design value (see 40 CFR 51, subpart S). TheI/M programs focus on reducing vehicle emissions, including nitrogen oxides and volatile organic compounds (precursors to ozone formation), through automobile inspections, which lead to repair and maintenance of such vehicles. The LIRAP is a voluntary program designed to enhance the Texas I/M program. Texas counties implementing the Texas I/M program are eligible to opt-in to the LIRAP. The LIRAP provides funds to assist eligible vehicle owners with emissions-related repairs, retrofits, or the option to retire the vehicle. 4 Vehicle owners in participating counties whose automobiles have failed a recent emissions test and who meet the low-income criteria may be eligible to receive LIRAP funds. The LIRAP also provides funds for local projects targeted at improving air quality in the counties implementing the LIRAP. The Federal I/M rules do not require States to implement a LIRAP type program. The LIRAP rules are found at 30 TAC 114 Subchapter C, Division 2 and are not part of the Texas SIP. It was not necessary to include this program in the Texas SIP because it is not required by the I/M rules and the State did not rely on reductions from the program in any of its air quality programs.

In 2004, Texas adopted rules in Chapter 114, Subchapter C, Division 3 for an I/M program that applies only in Early Action Compact (EAC) areas. Section 114.86 provides local officials in EAC areas the opportunity to opt into an EAC I/M LIRAP. 5 The EAC I/M program is distinct from the State's SIP-approved I/M program in Chapter 114, Subchapter C, Division 1, applicable to nonattainment areas ( see 70 FR 45542, August 8, 2005). Two Texas counties—Travis and Williamson—adopted the EAC I/M program (70 FR 45542).

There were no emission reduction credits requested or approved, however, for implementation of EAC I/M LIRAP for Travis and Williamson counties ( see 70 FR 48640, August 19, 2005). In addition, the EAC I/M LIRAP is not a CAA requirement and was not relied upon in the SIP to demonstrate reasonable further progress, attainment, or maintenance. The State is simply removing the EAC I/M LIRAP from the SIP to be consistent with the LIRAP rules for nonattainment areas at 30 TAC 114 Subchapter C, Division 2, which, as discussed previously, are not in the Texas SIP.

The EAC I/M LIRAP rules in 30 TAC 114.86 were adopted as a voluntary enhancement to the EAC I/M program. Participation in the LIRAP, however, is at the discretion of each eligible county. Under the rules currently approved in the SIP, Travis and/or Williamson Counties may choose to participate in the EAC I/M LIRAP in any given year at the counties' discretion. Due to this uncertainty, the EAC I/M LIRAP was adopted into the SIP as a voluntary measure and with no quantified or relied upon emissions reductions. As a result, removal of these provisions from the SIP to be consistent with the I/M provisions in nonattainment counties is reasonable and will not contribute to nonattainment or interfere with maintenance.

Pursuant to the CAA, the EPA is approving revisions to the Texas SIP submitted by the TCEQ on November 20, 2018. The revisions remove 30 TAC 114, Subchapter B (the Motor Vehicle Anti-tampering Requirements) in its entirety; and the LIRAP for Participating EAC Counties at 30 TAC 114, Section 114.86 from the SIP. These rules both currently remain in place at the State level.

The EPA is publishing this rule without prior proposal because we view this as a non-controversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the SIP revision if relevant adverse comments are received. This rule will be effective on September 4, 2019 without further notice unless we receive relevant adverse comment by July 8, 2019. If we receive relevant adverse comments, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so now. Please note that if we receive relevant adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the revisions to the Texas regulations as described in the Final Action section above. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 6 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.

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

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 5, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

David Gray was designated the Acting Regional Administrator on May 28, 2019 through the order of succession outlined in Regional Order R6-1110.13, a copy of which is included in the docket for this action.

40 CFR part 52 is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0674 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 August 5, 2019. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0674, 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 July 24, 2018 (83 FR 34968) (FRL-9980-31), 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 7E8616) by Interregional Research Project Number 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.658 be amended by establishing tolerances for residues of the fungicide penthiopyrad, (N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide), in or on Brassica, leafy greens, subgroup 4-16B at 50 parts per million (ppm); Bushberry subgroup 13-07B at 6 ppm; Caneberry subgroup 13-07A at 10 ppm; Celtuce at 30 ppm; Fennel, Florence at 30 ppm; Fruit, stone, group 12-12 at 4.0 ppm; Kohlrabi at 5.0 ppm; Leaf petiole vegetable subgroup 22B at 30 ppm; Leafy greens subgroup 4-16A at 30 ppm; Nut, tree, group 14-12 at 0.06 ppm; Oilseed group 20 at 1.5 ppm; and Vegetable, brassica, head and stem, group 5-16 at 5.0 ppm.

The petitioner also requested that the following established tolerances be removed upon establishment of the petitioned-for tolerances: Brassica, head and stem, subgroup 5A at 5.0 ppm; Brassica, leafy greens, subgroup 5B at 50 ppm; Canola at 1.5 ppm; Cotton, seed at 1.5 ppm; Fruit, stone, group 12 at 4.0 ppm; Nut, tree, group 14 at 0.06 ppm; Pistachio at 0.06 ppm; Sunflower, seed at 1.5 ppm and Vegetable, leafy, except Brassica, group 4 at 30 ppm. That document referenced a summary of the petition prepared by DuPont, 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, EPA has made certain corrections and modifications to petitioned-for tolerances. The reasons for these changes are explained in Unit IV.C.

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

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

The liver and thyroid are target organs for penthiopyrad toxicity. Metabolism studies show higher radioactive residues in the liver, compared to other tissues. Short-term oral exposure resulted in liver alterations (weight increases, enzyme changes, hypertrophy, and/or histopathology) in rats and mice at similar doses, and dogs at higher doses. Of the three species, the liver effects observed in rats were more significant (fatty change, hepatocellular degeneration, and Kupffer cell proliferation) than the liver effects in the other species ( e.g., increased liver weight, hepatocellular hypertrophy).

Short-term exposure also resulted in thyroid changes in mice (hypertrophy) and rats (decreased weight, hypertrophy/proliferation, and hormone changes). Other effects observed were body weight changes and hematological alterations in rats and dogs, along with gallbladder effects (inflammation and edema) in dogs. Short-term dermal exposure did not result in dermal irritation or systemic effects up to the limit dose.

Subchronic rat studies are also available for penthiopyrad metabolites PCA and DM-PCA. Short-term exposure to PCA did not result in treatment-related effects up to the limit dose. Short-term exposure to DM-PCA resulted in decreased body weight gain and food consumption at high doses. However, the effects with DM-PCA were seen at higher doses than the effects observed in subchronic rat studies with the technical grade active ingredient.

Long-term exposure in rats (at lower doses) resulted in liver effects comparable to those seen in subchronic studies, as well as adrenal and thyroid hypertrophy. Higher doses resulted in more progressive liver effects (vacuolation, periportal cell swelling, and necrosis), thyroid tumors (males), and ovarian hypertrophy. No effects were observed in the ovaries in other toxicity studies. In mice, chronic exposure led to liver and thyroid effects and liver tumors (males). Alveolar foamy cell accumulation was also seen in mice, but it was not considered to be an adverse effect. In dogs, effects noted (liver, gallbladder, and adrenal gland) were similar to those seen in subchronic dog studies, with the addition of gallbladder hypertrophy/hyperplasia.

In the developmental toxicity study in rats, comparable toxicity was noted in fetal and maternal animals. Effects observed were decreased body weight gain and food consumption, increased resorptions (resulting in decreased post-implantation survival), decreased litter size, and decreased gravid uterine weight at the limit dose. No effects were noted in a preliminary study in rats up to the limit dose. In the developmental toxicity study in rabbits, decreased fetal body weight was seen in the presence of maternal toxicity. Abortion was noted in one maternal animal, preceded by a period of markedly reduced food consumption and body weight loss, at the highest dose tested. In a preliminary study, decreased fetal body weight was seen at the limit dose. At lower doses, maternal effects including decreased water and food consumption, body weight loss, and abnormal feces were seen. At the limit dose, increased abortions and mortality were noted in maternal animals. In the reproductive toxicity study in rats, body weight changes, liver, adrenal, and thyroid effects were seen in maternal animals in preliminary and definitive studies. Offspring effects included body weight changes, delay in preputial separation, and decreased thymus weights at similar doses. Decreased spleen weights were seen in offspring animals in the preliminary reproduction study. No reproductive toxicity was observed.

In the developmental neurotoxicity study in rats (definitive study), decreased body weight, increased motor activity, and tremors were seen in offspring animals in the absence of maternal toxicity. In the preliminary study, decreased pup weight, deterioration, and mortality were seen in offspring animals in the absence of maternal toxicity. Clinical signs were observed in the acute neurotoxicity study with penthiopyrad. Transient functional alterations (hunched posture, unsteady gait, reduced body temperature, and increased landing footsplay) and decreased motor activity were seen at the estimated time-to-peak-effect (4 hours). In a subchronic neurotoxicity study, decreased body weight gain was seen at the highest dose tested; however, no clinical signs were observed, and there was no evidence of neurotoxicity.

Immunotoxicity studies were conducted in both mice and rats for penthiopyrad. In the immunotoxicity study in mice, decreased plaque forming ability was observed at the limit dose. However, in the immunotoxicity study in rats, no evidence of immunotoxicity was observed up to the highest dose tested. General toxicity noted in the rat study included decreased body weight gain and food consumption, increased liver weight, and decreased spleen weight.

A mutagenicity battery is available for penthiopyrad technical ingredient and the majority of the studies were negative; however, chromosome aberrations were observed at cytotoxic concentrations in an in vitro assay. Mutagenicity studies are also available for several penthiopyrad metabolites (PCA, DM-PCA, PAM, and 753-A-OH). These studies were usually negative; however, the PAM metabolite induced chromosome aberrations (-S9 after 24 hours) and PCA induced a weakly positive mutant frequency (after 24 hours); however, based on the overall analysis of the available data, penthiopyrad is not considered to be mutagenic.

EPA classified penthiopyrad as having “suggestive evidence of carcinogenicity,” based on an increased incidence of treatment-related liver tumors in male mice. Thyroid tumors were observed in male rats but were not considered to be treatment related. In accordance with the EPA's Final Guidelines for Carcinogen Risk Assessment (March 2005), the Agency has determined that the quantification of risk using a non-linear approach based on the chronic reference dose ( i.e., cRfD) which is 7x lower than the dose at which tumors were observed will adequately account for all chronic toxicity, including carcinogenicity, that could result from penthiopyrad exposure.

Specific information on the studies received and the nature of the adverse effects caused by penthiopyrad as well as the no-observed-adverse-effects-level (NOAEL) and the lowest-observed-adverse-effects-level (LOAEL) identified from the toxicity studies can be found at http://www.regulations.gov in document SUBJECT: Penthiopyrad. Human Health Risk Assessment for Proposed New Use on Caneberry Subgroup 13-07A and Bushberry Subgroup 13-07B; and Crop Group/Subgroup Conversions and Expansions at page 39 in docket ID number EPA-HQ-OPP-2017-0674.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (PODs) 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the previously applied penthiopyrad toxicological endpoints for human risk assessment is discussed in Unit III of the final rule published in the Federal Register of March 9, 2012 (77 FR 14291) (FRL-9335-7). That database was recently re-evaluated/updated based on current practices and includes updated dermal endpoints and PODs selected for adults and children. As a result of the database update, one endpoint and POD based on the 28-day oral toxicity study in the dog is used for all populations, and also used to derive the endpoints/PODs for the incidental oral and inhalation routes of exposure. The updated NOAELs, LOAELs, and the PODs are summarized below for the affected exposure/scenarios:

i. Children and adult dermal exposures. Children and adult dermal exposures were previously assessed with separate endpoints/PODs. Dermal exposure is now being evaluated using the same endpoint and POD for all ages, from the 28-day dog study. The revised dermal NOAEL is 80 milligrams per kilogram (mg/kg/day), based on mucosal edema in gall bladder as well as clinical chemistry and increased organ weight/histopathology in the livers of females at the LOAEL of 269 mg/kg/day.

ii. Previous adult dermal assessment. The developmental rabbit study was previously used for the adult dermal assessment with a NOAEL of 75 mg/kg/day based on abortions in one animal at the LOAEL of 225 mg/kg/day. The endpoint is not strong, and the dose spacing is comparable to the selected 28-day dog study.

iii. Previous children's dermal assessment. Previously the developmental neurotoxicity (DNT) was selected for the children's dermal assessment. The respective NOAEL and LOAEL for that study are 100 mg/kg/day and 250 mg/kg/day. Again, due to dose spacing, the study is comparable to the 28-dog study, whose NOAEL is protective of the DNT NOAEL. In addition, the effects seen in the 28-day dog study include gallbladder effects, an organ rats do not have, which is a potentially human-relevant effect.

iv. Inhalation and incidental oral assessments. The 28-day dog study, which previously was used and continues to also be used for the inhalation and incidental oral assessments was also updated. The NOAEL is now 80 mg/kg/day, based on mucosal edema in the gallbladder; as well as clinical chemistry, increased organ weight and histopathology in the liver of females at the LOAEL of 269 mg/kg/day. The updated NOAEL is comparable to or protective of other NOAEL and LOAEL values in the database, including those relating to susceptibility.

v. Residential incidental oral, inhalation, and dermal exposures. The 28-day dog study is now being used to assess residential incidental oral, inhalation, and dermal exposures.

A summary of the toxicological endpoints for penthiopyrad used for dietary and non-occupational human health risk assessment is shown in the Table of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to penthiopyrad, EPA considered exposure under the petitioned-for tolerances as well as all existing penthiopyrad tolerances in 40 CFR 180.658. EPA assessed dietary exposures from penthiopyrad in food as follows:

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

Such effects were identified for penthiopyrad. In estimating acute dietary exposure, EPA used 2003-2008 food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Survey/What We Eat in America (NHANES/WWEIA). The acute dietary (food and drinking water) exposure assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID), Version 3.16. As to residue levels in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level residues for all existing and proposed commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the 2003-2008 food consumption information from the USDA NHANES/WWEIA. The chronic dietary (food and drinking water) exposure assessment was conducted using DEEM-FCID, Version 3.16. As to residue levels in food, EPA assumed 100 PCT and tolerance-level residues for all existing and proposed commodities.

iii. Cancer. EPA classified penthiopyrad as having “suggestive evidence of carcinogenicity,” based on an increased incidence of treatment-related liver tumors in male mice and determined that the quantification of risk using a non-linear approach ( i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity, that could result from penthiopyrad exposure.

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for penthiopyrad. 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 penthiopyrad in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of penthiopyrad. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the First Index Reservoir Screening Tool (FIRST) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of penthiopyrad are based on the use pattern of highest exposure, which is the currently labeled use on turf at 2.9 lbs active ingredient per acre per year. The residues of concern assessed in drinking water included penthiopyrad and its cleavage product PAM. For acute exposures, EDWCs are estimated to be 240 parts per billion (ppb) for surface water and 1,330 ppb for ground water. For chronic exposures for non-cancer assessments, EDWCs are estimated to be 131 ppb for surface water and 978 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 1,330 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 978 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).

Although the proposed new uses do not include any residential use, registered residential uses including turf, lawn, and sod could result in residential exposure and have been reassessed in support of this rulemaking to reflect updates to new dermal, inhalation, and incidental oral PODs. There is the potential for post-application exposure for individuals exposed as a result of being in an environment that has been previously treated with penthiopyrad. The quantitative exposure/risk assessment for residential post-application exposures is based on the following scenarios:

i. Adult dermal post-application exposure resulting from contact with treated turf;

ii. Dermal post-application exposure to youth 11-16 yrs. old resulting from mowing and playing golf on turf;

iii. Dermal post-application exposure to children 6-11 yrs. old resulting from playing golf on turf;

iv. Dermal post-application exposure to children 1 to <2 yrs. old resulting from playing on turf; and

v. Incidental oral post-application exposure to children 1 to <2 yrs. old resulting from playing on turf.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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

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

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

2. Prenatal and postnatal sensitivity. No evidence of increased quantitative or qualitative susceptibility was observed in developmental toxicity studies in rats or rabbits or in a reproduction toxicity study in rats. However, increased quantitative susceptibility was seen in DNT studies in rats. Decreased body weight (250 mg/kg/day), and increased motor activity and tremors were seen in offspring animals at 500 mg/kg/day. Decreased body weight was seen at 300 mg/kg/day, and mortality was noted at 1,000 mg/kg/day in offspring animals. The effects observed in offspring animals in the DNT studies were seen in the absence of maternal toxicity.

EPA concluded that there is a low concern and no residual uncertainties for prenatal and/or postnatal toxicity effects of penthiopyrad, notwithstanding observed increased susceptibility seen in the preliminary and definitive DNT studies, based on the following data:

i. The pup body weight changes noted in the definitive and preliminary DNT studies were also observed in developmental and reproduction studies at similar doses. Additionally, the body weight changes in these studies occurred in the presence of significant maternal toxicity. Although clinical signs (tremors and increased motor activity) were noted in offspring animals in the definitive study, the neurotoxic potential of penthiopyrad has been adequately characterized in the available neurotoxicity studies. Tremors and changes in motor activity were observed at very high doses in the acute neurotoxicity study and were not present in the subchronic neurotoxicity study. In the preliminary DNT study, mortality was observed in the offspring animals at the limit dose. However, this finding is attributed to the poor condition (body weight loss, under activity, pallor) of the offspring animals in this dose group.

ii. A clear NOAEL has been identified for all offspring effects in the DNT studies, and the PODs used in the risk assessments are protective of the observed effects.

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

i. The toxicity database for penthiopyrad is complete.

ii. There is no concern for neurotoxicity after exposure to penthiopyrad. A complete neurotoxicity battery is available for penthiopyrad. The database includes acute neurotoxicity, subchronic neurotoxicity, and DNT studies in rats. As a result, the neurotoxic potential of penthiopyrad is well characterized, and no additional data are needed.

iii. As discussed in Unit IV.D.2., EPA has concluded that there are no residual uncertainties concerning prenatal and postnatal effects, that would warrant retaining the 10X FQPA safety factor.

iv. There are no residual uncertainties identified in the exposure databases. There are no residual uncertainties with regard to dietary and residential exposure. The dietary food exposure assessments were performed based on conservative assumptions that ensure that exposures to penthiopyrad are not underestimated, including tolerance-level residues and 100 PCT estimates for all registered commodities. The use of default assumptions did not result in risk estimates of concern for the proposed new uses. Actual exposures and risk estimates from penthiopyrad will likely be lower. Furthermore, conservative, upper-bound assumptions were used to determine exposure through drinking water and residential sources, such that these exposures have not been underestimated. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by penthiopyrad.

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 to penthiopyrad will occupy 21% of the aPAD for all infants (<1-year-old), the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to penthiopyrad from food and water will utilize 29% of the cPAD for all infants (<1-year-old), the population group receiving the greatest exposure.

3. Short-and Intermediate-term risk. Short- and intermediate-term risk aggregate exposure takes into account short- and intermediate-term risk residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The short- and intermediate-term toxicological endpoints for penthiopyrad are the same for each route of exposure. Therefore, for residential exposure scenarios, only short-term exposures were assessed, and are protective of intermediate-term exposure and risk.

Penthiopyrad is proposed for registration for uses that could result in short-/intermediate-term residential exposures, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short -term residential exposures to penthiopyrad. These assessments include exposure through the dermal route for adults and youth, and from dermal and incidental oral exposure for children (1 to <2 yrs.).

EPA selected the following two residential exposure scenarios which represent the highest exposure and risk scenarios for each population: (1) Adult post-application exposure and (2) children's (1 to <2 yrs.) post-application exposure resulting from contact with treated turf. The level of concern for these assessments is 100. The chronic dietary exposure estimate for adults was the background exposure added to the dermal residential post-application exposure estimates. The adult short-term aggregate risk assessment resulted in estimated MOEs of 440. The chronic dietary exposure estimate for the subgroup children 1 to <2 years old was the background exposure added to the children's dermal and incidental oral residential post-application exposure estimates. The children's short-term aggregate risk assessment resulted in estimated MOEs of 220. These risk estimates are not of concern to EPA.

5. Aggregate cancer risk for U.S. population. EPA classified penthiopyrad as having “suggestive evidence of carcinogenicity” based on liver tumors in male mice. The quantification of risk using a non-linear approach ( i.e., the RfD) adequately accounts for all chronic toxicity, including carcinogenicity, therefore cancer risk is not of concern.

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

Adequate enforcement methodology (a Liquid chromatography-tandem mass spectrometry (LC/MS/MS) method known as Method CEM 3399-001) is available to enforce the tolerance expression.

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

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

The U.S. tolerance definition for penthiopyrad is harmonized with those of Canada and Codex and most relevant established tolerance levels are harmonized with Canadian and Codex MRLs. There are currently no established Canadian or Codex MRLs for the proposed new uses for bushberries or caneberries.

In accordance with its authority in FFDCA section 408(d)(4)(A)(i), EPA is establishing tolerances in this rule that vary slightly from what the petitioner sought. These variations are explained below.

1. The petitioner requested tolerances in Fruit, stone, group 12-12 at 4.0 ppm, Kohlrabi at 5.0 ppm, and Vegetable, brassica, head and stem, group 5-16 at 5.0 ppm; EPA is establishing those tolerances without the additional zero to be consistent with OECD calculation procedures.

2. The petitioner requested a tolerance for “Fennel, Florence”; EPA is establishing a tolerance for the commodity “Fennel, Florence, fresh leaves and stalk” to be consistent with commodity terms the Agency uses in tolerances.

3. EPA is establishing a tolerance for the Nut, tree group 14-12 tolerance at 0.05 ppm instead of 0.06 ppm as requested in order to harmonize with Codex MRL. The established tolerance level is appropriate as the highest average field trial residue was 0.037 ppm while other residues were below LOQ (0.01 ppm).

In this final rule, EPA is reducing the existing tolerances for the commodities in the nut, tree group 14-12 from 0.06 ppm to 0.05 ppm. The Agency is reducing these tolerances to harmonize with Codex MRLs, and available residue data demonstrates that tolerances at 0.05 ppm are sufficient to cover residues on these commodities.

In accordance with the World Trade Organization's (WTO) Sanitary and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the WTO of this revision. In addition, the SPS Agreement requires that members provide a “reasonable interval” between the publication of a regulation subject to the agreement and its entry into force to allow time for producers in exporting member countries to adapt to the new requirement. At this time, EPA is establishing an expiration date for the existing tolerances to allow those tolerances to remain in effect for a period of six months after the effective date of this final rule, in order to address the requirement to provide a reasonable interval. After the six-month period expires, residues of penthiopyrad on commodities included in the nut, tree group 14-12 cannot exceed the newly established tolerances of 0.05 ppm.

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

Therefore, tolerances are established for residues of penthiopyrad, (N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide), in or on Brassica, leafy greens, subgroup 4-16B at 50 ppm; Bushberry subgroup 13-07B at 6 ppm; Caneberry subgroup 13-07A at 10 ppm; Celtuce at 30 ppm; Fennel, Florence, fresh leaves and stalk at 30 ppm; Fruit, stone, group 12-12 at 4 ppm; Kohlrabi at 5 ppm; Leaf petiole vegetable subgroup 22B at 30 ppm; Leafy greens subgroup 4-16A at 30 ppm; Nut, tree, group 14-12 at 0.05 ppm; Oilseed group 20 at 1.5 ppm; and Vegetable, brassica, head and stem, group 5-16 at 5 ppm. In addition, EPA is removing the following tolerances from paragraph (a)(1) because they are superseded by the new tolerances being established in this rulemaking: Brassica, head and stem, subgroup 5A at 5.0 ppm; Brassica, leafy greens, subgroup 5B at 50 ppm; Canola at 1.5 ppm; Cotton, seed at 1.5 ppm; Fruit, stone, group 12 at 4.0 ppm; Sunflower, seed at 1.5 ppm; and Vegetable, leafy, except brassica, group 4 at 30 ppm. Finally, EPA is establishing a six-month expiration date for the established pistachio and tree nut group tolerances.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

On March 2, 2018, Michigan submitted a complete program revision application seeking authorization of changes to its hazardous waste program in accordance with 40 CFR 271.21. EPA now makes a final decision that Michigan's hazardous waste program revisions that are being authorized are equivalent to, consistent with, and no less stringent than the Federal program, and therefore satisfy all the requirements necessary to qualify for final authorization. For a list of State rules being authorized with this final rule, please see the proposed rule published in the October 10, 2018, Federal Register at 83 FR 50869.

See the October 10, 2018, proposed rule for a description of which state rules are different from the federal rules, with one exception. The proposed rule incorrectly stated that Michigan has proposed additions to its Universal Wastes that will add Antifreeze, Aerosol Cans and Paint Wastes that are not already regulated as hazardous waste. This statement should be disregarded.

Codification is the process of placing citations and references to the State's statutes and regulations that comprise the State's authorized hazardous waste program into the Code of Federal Regulations. EPA does this by adding those citations and references to the authorized state rules in 40 CFR part 272. EPA is not codifying the authorization of Michigan's revisions at this time. However, EPA reserves the ability to amend 40 CFR part 272, subpart X for the authorization of Michigan's program changes at a later date.

This final authorization revises Michigan's authorized hazardous waste management program pursuant to Section 3006 of RCRA and imposes no requirements other than those currently imposed by state law. For further information on how this authorization complies with applicable executive orders and statutory provisions, please see the proposed rule published in the October 10, 2018 Federal Register at 83 FR 50869. The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this document 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 in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This final action will be effective on June 6, 2019.

I. Background

On May 19, 2015, in District Hospital Partners v. Burwell, 786 F.3d 46 (D.C. Cir. 2015), the Court of Appeals for the District of Columbia Circuit held that the FY 2004 fixed-loss threshold (FLT) was inadequately explained in the federal fiscal year (FY) 2004 hospital inpatient prospective payment systems (IPPS) final rule. The court of appeals ordered the district court to remand to CMS for further explanation of the handling of data pertaining to 123 hospitals the agency had identified as likely to have engaged in “turbocharging,” that is, manipulating their charges to obtain greater outlier payments. The United States District Court for the District of Columbia then remanded to the Secretary in accordance with the decision of the Court of Appeals. Order, Dist. Hosp. Partners, L.P. v. Burwell, Civil Action No. 11-0116 (ESH) (D.D.C. August 13, 2015).

On September 2, 2015, the District Court issued an order in a separate case, Banner Health v. Burwell, No. 10-1638 (ECF Nos. 149 and 150), 126 F. Supp. 3d 28 (D.D.C. 2015), remanding for additional explanation of the FLT from the FY 2004 final rule consistent with the D.C. Circuit's decision in District Hospital Partners. The court stated that the agency should explain further why it did not exclude data from the 123 hospitals from the outlier charge inflation calculation used to produce estimates of future Medicare payments for FY 2004.

In the January 22, 2016 Federal Register (81 FR 3727), we published an additional explanation in response to these court orders. In the October 14, 2016 Federal Register (81 FR 70980), we published a minor, non-substantive correction to the January 2016 document.

In Banner Health v. Price, 867 F.3d 1323 (D.C. Cir. 2017), the court of appeals reviewed the January 2016 document and found that the agency still had not adequately explained why the agency, in the FY 2004 rulemaking, did not exclude the charge data from the 123 hospitals it had identified as likely turbochargers when calculating the charge inflation factor used to transform historical charges into future charges for purposes of the agency's projections. The court of appeals also found that the agency had not adequately explained why it did not apply a downward adjustment to hospitals' cost-to-charge ratios when determining the FLTs for FYs 2004, 2005, and 2006, an issue not addressed in the Court of Appeals decision in District Hospital Partners. The court in Banner Health ordered the district court to remand to CMS to provide additional explanation on these two points. The district court issued a remand order on April 12, 2018. The district court also entered a similar order with respect to the FY 2004 determination in another case, District Hospital Partners, L.P. v. Azar, 320 F. Supp. 3d 42 (D.D.C. 2018).

We are issuing this document to provide the additional explanation required by these decisions.

The first issue pertains to the use of data pertaining to 123 hospitals whom we described in a March 5, 2003 proposed rule (68 FR 10420), as hospitals likely to have engaged in turbocharging. We chose to calculate the FY 2004 charge inflation adjustment using data that incorporated data pertaining to the 123 hospitals, instead of choosing to omit data pertaining to those hospitals.

As we discussed in our earlier publications, the 123 hospitals were identified through an analysis of Medicare Provider Analysis and Review (MedPAR) file data from FY 1999 to FY 2001. We singled out hospitals whose percentage of outlier payments relative to total diagnosis-related group (DRG) payments increased by at least 5 percentage points over that period, and whose case-mix (the average DRG relative weight value for all of a hospital's Medicare cases) adjusted charges increased at a rate at or above the 95th percentile rate of charge increase for all hospitals over the same period. We note that we conducted this analysis primarily for the purpose of assessing and diagnosing the problem of turbocharging, not for the purpose of making adjustments to our projections for the FY 2004 rulemaking.

We identified the 123 hospitals based on data from the interval from FY 1999 to FY 2001. Our charge inflation calculation for FY 2004 was based on data covering a more recent interval, from FY 2000 to FY 2002. We were attempting to project charge increases over a third period, from FY 2002 to FY 2004.

The hypothesis underlying the suggestion that the 123 hospitals should have been omitted is that charge inflation for those 123 hospitals was likely to begin slowing in FY 2004 in response to the adoption of the June 9, 2003 Outlier final rule (68 FR 34494), while charge inflation for other hospitals would remain in line with historical patterns between FY 2002 and 2004. Consequently, according to this hypothesis, an estimate computed from FY 2000 to 2002 charge data that included the 123 hospitals would likely overstate FY 2004 hospital charges for the entire population of hospitals. But this hypothesis depends on assumptions that, at the time of the FY 2004 rulemaking, we did not find appreciably more credible than the alternative assumptions we ultimately relied upon.

The hypothesis that the 123 hospitals identified in our analysis should have been dropped from the charge inflation computation treats the removal of the 123 hospitals as synonymous with accounting for turbocharging. It presumes that removing the 123 hospitals from the measure of charge inflation would have accounted for the end of turbocharging, without otherwise introducing error or bias, and that, conversely, including the 123 hospitals introduced systematic error. But that assumes both that all of the 123 hospitals were in fact engaged in turbocharging, and that the population of turbocharging hospitals remained for the most part unchanged over all three intervals from FY 1999 through the end of FY 2003—that is, that those 123 hospitals continued to engage in turbocharging after FY 2001, that they did not materially increase their rate of turbocharging during that period, and that no other hospitals started to turbocharge or otherwise increase their rate of charge inflation. We did not feel sufficiently confident that such an assumption would enhance the accuracy of the outlier threshold calculation to incorporate it into our projections for FY 2004.

While our analysis confirmed that turbocharging was a problem, and that rule changes were warranted along the lines of the changes we adopted in June 2003, we did not otherwise have a confident grasp on which hospitals were turbocharging at what times. Our analysis suggested that the 123 hospitals that we identified were likely engaging in turbocharging during the FY 1999 to FY 2001 interval, but it did not tell us whether the population of turbocharging hospitals remained unchanged through the end of FY 2003, with all 123 hospitals continuing to engage in turbocharging and no other hospitals starting to turbocharge.

There was also good reason to question the assumption that the population of turbocharging hospitals and the behavior of turbocharging hospitals did not change between FYs 2001 and 2003. Industry knowledge of turbocharging may have become more widespread late in calendar year (CY) 2002 after publication of an investment analyst report on the subject. As we previously explained in our March 2003 and June 2003 documents (68 FR 10426 and 10427 and 68 FR 34505, respectively), we believed that it was possible that, before the June 2003 final rule took effect, hospitals that had not previously engaged in turbocharging would take advantage of this new knowledge and increase their charges to catch up to the charging practices of their competitors. Likewise, we had reason to believe that turbocharging hospitals, in anticipation of CMS's regulatory action curbing the effects of turbocharging, would accelerate their turbocharging, either so that they could gain as much as they could from the practice before CMS's regulatory changes took effect or because the hospitals now had less reason to keep turbocharging limited to avoid detection. For these reasons, HHS could not necessarily count on the assumption that aggregate charge inflation between FYs 2002 and 2004 would be significantly lower than predicted by the FY 2000 to FY 2002 data.

In sum, in evaluating how to handle the 123 hospitals in estimating charge growth, we were faced with choices among various uncertain assumptions. We understand the intuitive appeal behind the suggestion that we could have imputed the phenomenon of turbocharging strictly and exclusively to those 123 hospitals, and accordingly assumed that dropping those 123 hospitals' charge data from the charge inflation estimate would remove a source of distortion. But that suggestion itself rests on a set of assumptions. Ultimately, we were faced with a choice between those assumptions and the alternative assumption that, by and large, charge inflation between FYs 2000 and 2002 would adequately predict charge inflation between FYs 2002 and 2004 overall. We did not see reason to conclude that those other assumptions were superior.

We note also that there was only a very limited time interval between the finalization of the June 2003 rule and the publication of the FY 2004 final rule on August 1, 2003, so we had very little time to analyze the potential impact of the June 2003 rule, as finally adopted, on our projections. In addition, the June 2003 rule did not take effect upon publication. Instead, some parts of the rule were to take effect August 8, 2003, and the rest were to take effect October 1, 2003. Consequently, at the time of the FY 2004 final rule, we did not yet have any actual data on hospital charging behavior under the June 2003 rule. We did take several measures designed to adapt the FY 2004 estimates in light of the adoption of the final 2003 rule, and those measures resulted in a significantly lower fixed-loss threshold. But the timing of our efforts constrained our ability to explore additional avenues of analysis we might have otherwise explored.

The court rulings also call for additional explanation of a second issue with respect to each of the FY 2004, 2005, and 2006 IPPS rulemakings. Specifically, the court questioned why, in simulating future DRG payments and outlier payments, we did not apply a downward adjustment to hospitals' cost-to-charge ratios to account for the possibility that, after a more recent cost report is tentatively settled during the coming fiscal year, a given hospital's outlier payments will be calculated based on an updated, and possibly lower, cost-to-charge ratio.

We acknowledge that, by the time of the FY 2004 rulemaking, we had reason to believe that the posited phenomenon was real. The cost-to-charge ratio used to compute a hospital's outlier payments was likely to change at some point during the year once a new cost report was tentatively settled. Furthermore, we had reason to believe that, by and large, a given hospital's updated cost-to-charge ratio would likely be lower than its earlier cost-to-charge ratio, because we had long observed that hospital charges generally increased faster than costs. We also acknowledge that the methods we employed did not include an adjustment to account for this specific phenomenon, though they did account for other effects associated with the general phenomenon of charges increasing faster than costs and the general pattern of decline in cost-to-charge ratios. Our reasons for not incorporating such an adjustment relate to the uncertainty and complexity associated with the task of devising and implementing such an adjustment.

The problem of projecting changes in cost-to-charge ratios over time is qualitatively different from the problem of estimating charge inflation over time. Hospital charges—like hospital costs—are a simple scalar quantity, reflecting tangible real-world activity and measured in dollar values greater than zero. Measuring and projecting changes in dollar quantities of this kind is a relatively common problem, both in the administration of the Medicare program in particular and in business- and finance-related fields more generally. Calculating projected future figures by calculating an estimated percentage change from aggregate figures, and then applying that estimated percentage change to a past measurement, is a familiar approach to that problem.

With respect to outlier threshold projections specifically, at the time of the FY 2004 rulemaking in 2003, we had a great deal of experience estimating changes in quantities of this kind using inflation factors computed from changes in aggregate costs or charges for all hospitals. From 1993 to 2001 (the IPPS rules for FYs 1994 to 2002), we had incorporated a measure of cost inflation to account for year-to-year changes in hospital costs. In 2002 (67 FR 50124), we began accounting for inflation based on year-to-year changes in charges instead of costs. This was not a drastic leap, given that charges and costs are similar quantities measured in the same units.

A cost-to-charge ratio is different in kind. A cost-to-charge ratio does not correspond to a tangible real-world dollar quantity; instead, it is a unitless measure that represents the proportional relationship between two quantities (costs and charges). Charges and costs are virtually always positive values, and charges virtually always exceed costs. Consequently, cost-to-charge ratios virtually always fall between 0 and 1 (instead of ranging from 0 on up as costs and charges do). Within that range between 0 and 1, there is considerable variation in cost-to-charge ratios among individual hospitals, among different types of hospitals, and among geographic areas. This variation is evident in the data we typically make available in connection with our annual IPPS rulemaking (including the impact files and Tables 8A and 8B published in the Federal Register ).

As discussed previously, computing an update factor from aggregate figures and applying that estimated percentage change to a dollar figure is a familiar method of projecting future dollar amounts. But it was not evident at the time of the FY 2004 rulemaking that the same approach would translate well to the task of projecting updates to cost-to-charge ratios. If we knew that all hospitals' cost-to-charge ratios were fairly uniform and tended to move in similar ways over time, then we could be fairly confident that applying a uniform update factor based on aggregate changes in costs and aggregate changes in charges would be a satisfactory way to compute projected cost-to-charge ratios. But, as noted previously, we knew there was substantial variation in cost-to-charge ratios across hospitals. We also did not have a solid understanding of whether there was variation across hospitals in how cost-to-charge ratios change over time. Given these factors, at the time of the FY 2004 rulemaking, it was not yet clear to us that it would be appropriate to compute a uniform adjustment factor from aggregate changes in costs and aggregate changes in charges and then apply that same uniform adjustment factor to the cost-to-charge ratios of all hospitals across the board.

At the time of the FY 2004 rulemaking, we also had not yet developed any more complex method that might avoid some of the potential pitfalls of a uniform adjustment factor. A more complex method piling adjustments on top of adjustments could introduce uncertainties of its own, especially when done in the limited time we have to project the annual outlier threshold each year. It is incorrect to assume that adding to the complexity of a simulation method, or increasing the number of factors it purports to take into account, will necessarily improve results.

Even if a clearly sound technique had been available to us for estimating updates to hospitals' historical cost-to-charge ratios, applying such a technique in FY 2004 would have involved an additional complication. As explained in our August 1, 2003 document, (68 FR 45476 through 45477), to account for our change from the use of settled cost reports to the use of tentatively settled cost reports, we elected not to employ actual historical hospital cost-to-charge ratios in estimating FY 2004 payments. Instead, for most hospitals, we used cost and charge data from the most recent cost reporting year to compute estimated cost-to-charge ratios, and we used a different method to calculate estimated cost-to-charge ratios for 50 hospitals identified as likely to have their cost reports reconciled. Thus, even if we had had a method for projecting future cost-to-charge ratios (CCRs) from historical CCRs, we would have had to further modify that method for use with the estimated CCRs we computed for FY 2004.

Perhaps it might have been acceptable to incorporate a cost-to-charge ratio adjustment despite all these uncertainties (and we have done so in more recent years). But at the time of the FY 2004 rulemaking, we did not believe the case for such an adjustment was so compelling as to make such an adjustment essential.

Our decisions are also affected by the limited time we have to devise and implement adjustments to our methods in each year's annual outlier rulemaking. At the time of the FY 2004 rulemaking, we had recently made significant changes to our outlier policies in the June 2003 rule, and we recognized that those changes would have a significant effect on Medicare outlier payments. In making adjustments to our methods, we chose to focus our efforts on those issues we judged most likely to have the most significant relative impact on our projections, while deferring fuller analysis of other issues we judged less likely to have a significant impact, including the effect of updates to CCRs.

We strive to make the best possible estimates, but estimation, by definition, involves approximation, and perfect accuracy is unattainable in our payment projections. Adding additional layers to an estimation technique does not necessarily improve the estimates. And adding complexity to an estimation method can simply create an illusion of accuracy instead of actual improvements in accuracy.

In light of all these complexities, it was not evident to us in the FY 2004 calculation that any particular adjustment to cost-to-charge ratios would improve our projections. Since we believe we acted appropriately and in accordance with statutory requirements, we are not recalculating the FY 2004 threshold.

In our FY 2005 projections, we again chose not to introduce a new adjustment to attempt to account for the updating of cost-to-charge ratios during the year as new tentative cost reports were settled. Most of the factors discussed previously were still present: The fundamental differences in the nature and properties of charges and cost-to-charge ratios; the complexity of simulating the updating of cost-to-charge ratios through either application of a uniform update factor or a more complex adjustment; and our lack of experience with that task.

Also, at the time of the FY 2005 rulemaking, we were still focusing our efforts on the task that we believed had the most significant potential impact on our projections: Monitoring the effects of the June 2003 rule changes and related changes in hospital behavior. We again chose to defer closer examination of the possibility of an adjustment to capture the effect of updates to cost-to-charge ratios.

Also, again, it is important not to overestimate the likely impact of updates to cost-to-charge ratios on the overall robustness of our projections. First, the effect typically comes into play only for part of the year. In our FY 2005 projections, we did not use estimated cost-to-charge ratios as we had done in the FY 2004 rulemaking. Rather, for the FY 2005 final rule, we used CCRs from the March 2004 update of the Provider Specific File, the latest data available (the proposed FY 2005 IPPS rule refers to the same data as the “April 2004” update (69 FR 49277)). CCRs are typically in use for 1 year or more, so, for many hospitals, the CCR in the March 2004 update of the Provider Specific File would be the same CCR used for payment at the beginning of FY 2005, which began in October 2004.

Also, the effect of updates to cost-to-charge ratios is just one of many factors—many of them highly unpredictable—that affect our projections. We note that several commenters on the proposed FY 2005 IPPS rule (69 FR 49276 and 49277) advocated for adjustments to account for CCR updates. Three commenters in particular provided us with analyses that purported to include such adjustments. One of these commenters advocated for a FY 2005 threshold of $26,600, another commenter suggested a threshold of $28,455, and a third advocated for a threshold “no higher than $27,000.” In other words, each of these three commenters purported to incorporate adjustments designed to account for the effect of updated CCRs, among many other factors, yet each arrived at a fixed-loss threshold estimate considerably higher than the $25,800 level we ultimately set.

Because we believe we acted appropriately and in accordance with statutory requirements, we are not recalculating the FY 2005 threshold.

The factors discussed previously were all still present for FY 2006: (1) The fundamental differences in the nature and properties of charges and cost-to-charge ratios; (2) the complexity of simulating the updating of cost-to-charge ratios; and (3) our desire to focus on monitoring the aftermath of the 2003 rule changes.

While we carefully analyzed comments suggesting we make a separate adjustment to the CCRs, we again declined to do so, noting that the CCRs we were using from the March 2005 Provider-Specific File were the most recent available, were the CCRs that in many instances Medicare contractors would be using to make outlier payments in FY 2006, and were approximately 3 percent lower than the CCRs used in the FY 2006 proposed rule (70 FR 47494).

As had been the case in FY 2005, two commenters submitted recommendations based on an analysis that purported to account for updates to CCRs, and those recommendations were in turn endorsed by many other comments. These commenters advocated for a threshold of $24,050, higher than the $23,600 level that we computed. This lent further support to our decision to defer closer study of the effect of updates to cost-to-charge ratios.

Because we believe we acted appropriately and in accordance with statutory requirements, we are not recalculating the FY 2006 threshold.

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

This is a summary of the Commission's Order on Reconsideration, FCC 19-29, adopted on April 10, 2019 and released on April 12, 2019. The complete text of this document is available for public inspection and copying from 8 a.m. to 4:30 p.m. Eastern Time (ET) Monday through Thursday or from 8 a.m. to 11:30 a.m. ET on Fridays in the FCC Reference Information Center, 445 12th Street SW, Room CY-A257, Washington, DC 20554. The complete text is also available on the Commission's website at https://www.fcc.gov/edocs. Alternative formats are available to persons with disabilities by calling the Consumer & Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (tty).

1. In 2013, the Commission released the H Block Report and Order 78 FR 50214 (Aug. 16, 2013), which adopted licensing and technical rules as well as a band plan for the 1915-1920 MHz and 1995-2000 MHz bands (the “H Block”) and procedures for assigning H Block licenses through a system of competitive bidding. The Rural Wireless Association, Inc. (RWA) filed a Petition for Reconsideration later that year asking the Commission to reconsider its decisions to license H Block spectrum using Economic Areas (EAs) and to adopt population-based performance requirements. The Commission disagrees with RWA's contention that the Commission should have: (1) Licensed H Block spectrum using CMAs rather than EAs, and (2) adopted geographic-based, rather than population-based, performance requirements.

2. In this document, the Commission dismisses in part and denies in part RWA's Petition for Reconsideration because the Commission acted well within its discretion, struck a reasonable and well-justified balance among multiple statutory goals. RWA also asked the Commission not to use package bidding, particularly Hierarchical Package Bidding, in the H Block Auction. The Commission dismissed this request as moot because package bidding was rejected in a related proceeding. 28 FCC Rcd 13019. Accordingly, it is ordered pursuant to section 4(i), 4(j), 303(r), and 309(j) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 303(r), and 309(j), as well as § 1.429 of the Commission's rules, 47 CFR 1.429, that the Petition for Reconsideration filed by the Rural Wireless Association, Inc., on September 16, 2013, is dismissed to the extent specified in this Order on Reconsideration and, alternatively and independently, denied as specified in the Order on Reconsideration.

This is a summary of the Commission's Report and Order, document FCC 19-39, adopted on May 9, 2019, released on May 15, 2019, in CG Docket Nos. 10-51 and 03-123. The Commission previously sought comment on these issues in the Further Notice of Proposed Rulemaking ( 2017 VRS Improvements FNPRM ), published at 82 FR 17613, April 12, 2017. A Further Notice of Proposed Rulemaking (FNPRM) contained in document FCC 19-39 is published elsewhere in this issue of the Federal Register . The full text of document FCC 19-39 will be available for public inspection and copying via the Commission's Electronic Comment Filing System (ECFS), and during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street SW, Room CY-A257, Washington, DC 20554. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov, or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice) or (202) 418-0432 (TTY).

The Commission sent a copy of document FCC 19-39 to Congress and the Government Accountability Office pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A).

The Report and Order in document FCC 19-39 contains modified information collection requirements, which are not effective until approval is obtained from OMB. The Commission, as part of its continuing effort to reduce paperwork burdens, will invite the general public to comment on these information collection requirements as required by the Paperwork Reduction Act (PRA) of 1995, Public Law 104-13. The Commission will publish a separate document in the Federal Register announcing approval of the information collection requirements. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, 44 U.S.C. 3506(c)(4), the Commission previously sought comment on how the Commission might “further reduce the information burden for small business concerns with fewer than 25 employees.” 2017 VRS Improvements FNPRM.

Amendments to §§ 64.611, 64.613, and 64.615 of the Commission's rules, which contain modified information collection requirements, shall be effective on the date specified in a document to be published in the Federal Register announcing Office of Management and Budget (OMB) approval of the information collection requirements of such rules pursuant to the Paperwork Reduction Act.

1. VRS is a form of TRS that enables people with hearing or speech disabilities who use sign language to make telephone calls over broadband with a videophone. In addition to enabling communication between ASL users and voice users, the VRS system also enables ASL users to communicate directly with other ASL users via video.

2. In order to facilitate direct video calling between sign language users and customer support call centers, the Commission allows telephone numbers and routing information for qualifying call centers to be entered in the TRS Numbering Directory (Numbering Directory or Directory). Entities designated as “Qualified Direct Video Entities” may be granted access to the Directory in order to support direct communications between registered VRS users and customer support call centers. As the Commission has previously recognized, point-to-point video supports the purposes of section 225 of the Act more directly than VRS does, because the communication it enables is direct, rather than mediated, and far more efficient. Therefore, the Commission's action provides a major opportunity to enhance the ability of sign language users to engage in more effective, efficient, and private communication with customer support—especially because so much of VRS traffic involves calls placed to the customer support call centers of large businesses and government agencies. For the same reason, enabling such communication makes possible major cost savings for the TRS Fund, by reducing the need for third-party CAs to participate in customer support calls.

3. To implement this change, the Commission first clarifies who can be afforded such Directory access. Because the purpose of this rule is to facilitate the use of telephone numbers to reach direct-video-capable customer support centers, the Commission defines a Qualified Direct Video Entity that may be granted Directory access as an individual or entity that is engaged in direct video customer support and that (1) is the end-user customer that has been assigned the telephone number(s) used for direct video customer support calls or (2) is the designee of such an entity.

4. Obtaining Numbering Directory Access. In order to obtain authorization for access to the Directory as a Qualified Direct Video Entity, an interested party must submit an application to the Commission's Consumer and Governmental Affairs Bureau (CGB) that includes: (1) The applicant's name, address, telephone number, and email address; (2) a description of the service to be provided; (3) an acknowledgment that Directory access is conditional on compliance with applicable Commission rules, obligations, and standards; (4) contact information for personnel responsible for such compliance; and (5) certification that the applicant's description of service meets the definition of direct video customer support and that the information provided is accurate and complete. CGB, in consultation with the Commission's Office of the Managing Director, shall approve Directory access if the applicant demonstrates, through its responses to each of the above requests for information and any additional information requested by CGB, that it has a legitimate need for such access and is aware of its regulatory obligations. A Qualified Direct Video Entity may relinquish its Directory access authorization by so notifying the Commission, and such authorization will terminate automatically if one year elapses with no call-routing queries received regarding any of the Entity's numbers. Further, the Commission may terminate such authorization if it determines, after notice to the entity and an opportunity to contest such termination, that the entity is no longer qualified as described in its application, has materially misrepresented information to the Commission, the TRS Numbering Administrator, or the User Database administrator, has failed to provide required information in the format requested, or has violated an applicable Commission rule or order. Following the termination of an authorization, the TRS Numbering administrator shall remove the previously authorized entity's telephone numbers from the TRS Numbering Directory.

5. After receiving Commission approval, a Qualified Direct Video Entity shall enter a telephone number into the Directory by submitting the telephone number, associated call routing information, and registration information in accordance with instructions provided by the TRS Numbering administrator. For each customer support telephone number to be entered into the Directory, unless otherwise instructed by the User Database administrator, a Qualified Direct Video Entity must create an equivalent entry in the Database by providing: The Entity's name; the date that the Entity was approved for Directory access; the name of the end-user customer support call center(s) (if different from the Entity); contact information for the end-user customer support call center(s) that will receive calls placed to the customer support number; and other information reasonably requested by the User Database administrator. Providing such information will enable the User Database administrator and the TRS Numbering administrator to confirm that the Qualified Direct Video Entity has been approved for Directory access and will help ensure that the Directory provides an appropriate response to a VRS provider's per-call validation query regarding the customer support telephone number. A Qualified Direct Video Entity must provide appropriate notification as directed by the User Database administrator and the TRS Numbering Administrator if any of the information provided changes or if a customer support number entered in the Directory is transferred to a different Qualified Direct Video Entity or is no longer being used for a qualified direct video purpose. The User Database administrator shall remove from the User Database each customer support telephone number for a Qualified Direct Video Entity that has had its authorization to access the TRS Numbering Directory terminated.

6. A Qualified Direct Video Entity's Directory access includes (1) adding and deleting customer support telephone numbers and routing information, (2) conducting data queries to obtain routing information for outbound point-to-point video calls originating from such telephone numbers, (3) conducting data queries to enable the transfer of inbound direct video calls to a VRS provider when needed, and (4) performing other necessary administrative functions as determined by the TRS Numbering administrator in consultation with the User Database administrator and the Commission.

7. Qualified Direct Video Entities granted access to the Directory will be held to the same rules and obligations that govern VRS providers' access to the Directory and use of Directory numbers, including complying with the instructions of the TRS Numbering Administrator, and applicable standards pertaining to privacy, security, and reliability. To ensure effective telephone communication, the Commission further require that videophones, software, and transmission protocols used for direct video customer support adhere to the same interoperability standards applicable to VRS providers. Further, Qualified Direct Video Entities may be subject to fees to recover any additional costs incurred by the TRS Numbering Administrator or other TRS administrators. Accordingly, the Commission does not anticipate that any significant regulatory burdens or costs will be imposed on the TRS Fund or VRS providers. Moreover, because participation by video entities is strictly voluntary, the Commission is confident that the benefits of such participation will far exceed the minimal participation costs incurred by those entities choosing to participate.

8. Customer Support Telephone Numbers for VRS and Direct Video Callers. The Commission will let the business or government agency involved in customer support services determine whether to make direct video communication available via a dedicated video number or via the generally advertised customer support number, as long as consumers retain the ability to communicate with customer support centers through VRS.

9. Outset of a Call—Dedicated Direct Video Customer Support Number. If the telephone number entered in the Directory is a dedicated direct video line that is different from the company's generally advertised telephone number, a consumer will be able to choose between dialing the dedicated direct video number or dialing the generally advertised customer support number and communicating through VRS. If operating a dedicated direct video customer support number, businesses or government agencies may also use interactive response systems that allow the host system to interact with the VRS user through the use of ASL and dual-tone multi-frequency signaling (DTMF). Currently, before setting up a relay call, VRS providers must check the Directory to ensure that the call is not being made to a destination telephone number that can accept video calls directly. If the call center uses a dedicated number for direct video calls, only the dedicated number will be listed in the Directory, and VRS users seeking to communicate via direct video must dial that dedicated number. The generally advertised customer support number will not be listed in the Directory; therefore, a VRS user who wishes to initiate a customer support call via VRS can simply dial the general customer support number, instead of the dedicated video number, and a VRS provider will automatically handle the call as a VRS call, in the same manner as when a VRS user dials any voice telephone number.

10. Outset of a Call—Single Unified Customer Support Number. Alternatively, the direct video number entered in the directory may be the same as the generally advertised telephone number used for voice calls to the customer support call center. In this case, VRS users seeking to communicate with customer support via direct video will simply dial the generally advertised number on their videophone, and—because that generally advertised number will be listed in the Directory—the call will be routed directly to the customer support center as a point-to-point video call. The customer support center then will detect the call as a videophone call and connect the caller directly to a representative using sign language, a sign language-enabled Interactive Video Response system, or another appropriate network termination for the sign language user. Sign language users who instead wish to use VRS will be able to bypass the direct video option by first entering their VRS provider's URL (or selecting a menu option on their device's screen to do this) and then directing the VRS CA to place a VRS call to the generally advertised customer support number. Once the CA is on the call, it will be routed as a voice call and detected as such by the customer support center. Any prompts or announcements conveyed to VRS users regarding calls to direct-video-equipped call centers must be neutral and must not be worded so as to “steer” the user toward requesting that a customer support call be handled as a VRS call rather than as a direct video call.

11. The Commission directs the TRS Numbering Administrator to implement a method for identifying single unified customer support numbers ( e.g., by adding an appropriate field to the format for routing query responses). The Commission also directs the TRS Fund administrator to provide a method for reporting VRS calls involving unified customer support numbers and verifying the compensability of such calls. The Commission directs the Disability Rights Office to announce the effective date for the rules governing single unified customer support numbers once these steps have been taken.

12. Converting Direct Video Calls to VRS. Under either of the above alternatives, authorizations for TRS Numbering Directory access are conditional on the customer support center being able to initiate a call transfer that converts a point-to-point video call into a VRS call, in the event that a VRS user communicating with a direct video customer agent needs to be transferred to a hearing person, such as a supervisor or specialist within the customer support center, while the call is in progress. Although the Commission does not mandate how this is to be done, it notes that existing protocols, such as the Session internet Protocol (SIP) transfer procedure, provide a framework for call transfers, whereby the caller's default VRS provider could re-connect the call to a VRS CA, who would then complete the call between the VRS user and the hearing customer support agent via VRS. As there is at least one commonly deployed mechanism for dynamically, seamlessly upgrading a direct video call to a VRS call that is a common part of the SIP standard, the Commission believes there will be little cost to this integration, and that such costs will be exceeded by the benefits of enabling videophone users to easily access VRS providers when CA services are necessary. Further, the VRS provider's obligation to implement such a call transfer on request is consistent with a VRS provider's obligations to route and deliver a user's inbound and outbound calls, ensure interoperability, and provide functionally equivalent service. To expedite this process, the Commission encourages VRS providers and Qualified Direct Video Entities to work cooperatively to implement the necessary technical changes for such call transfers that minimize the burden to VRS users to communicate with the appropriate party on a call. No later than six months after the effective date of the amendments to this section, each VRS provider shall be capable of activating an effective call transfer procedure within 60 days after receiving a request to do so from a Qualified Direct Video Entity. Finally, to the extent that call transfers of this kind are prohibited by the VRS Provider Interoperability Profile technical standard, the Commission exempts such call transfers from such prohibition. The Commission directs the TRS Fund administrator to revise its filing instructions to provide appropriate and timely guidance to VRS providers on the format to be used and the information to be provided when claiming compensation for VRS calls that are involved in such call transfers.

13. Facilitating Call Validation through the TRS Numbering Directory. The Commission's rules require VRS providers to validate the eligibility of the party on the video side of each VRS call by querying the User Registration Database. The Commission amends its rules to allow for implementation of a querying method that makes use of the existing TRS Numbering Directory querying system by requiring VRS providers to direct call validation queries to the appropriate system of records (either the Numbering Directory or the User Database) that is identified in the relevant instructions, which will be issued by the Commission, the TRS Fund administrator, or the TRS Numbering Administrator. The Commission takes this action to provide greater flexibility for administration of the VRS program and enable the operation of TRS data systems in the most effective and efficient way.

14. With the adoption of this rule change, as well as the requirement for registration of enterprise and public videophones, discussed below, the stage is set for activation of the per-call query function. A compliance date for the per-call validation requirement will be set by public notice, which will be issued by CGB no earlier than 90 days after the expiration of the 120-day window for submission of enterprise and public videophone registration data to the Database. This will allow a period of parallel operation once all of the data is submitted to the Database, but before providers are required to rely on the per-call validation queries.

15. Registering Enterprise and Public Videophones in the Database. The Commission amends its rules to require VRS providers to submit registration information to the User Registration Database administrator for public and enterprise videophones. Such registration is necessary to assist the Fund administrator in reviewing compensation requests involving such videophones and auditing how such videophones are used, and thereby to help prevent waste, fraud, and abuse in the VRS program. A VRS provider must submit registration information for any enterprise or public videophone for which it assigns or receives a port of a NANP telephone number ( i.e., for which it is the default VRS provider). As with individual user registrations, once an enterprise or public videophone has been registered in the User Registration Database, the videophone's telephone number will be transmitted to the TRS Numbering Directory to enable per-call validation queries.

16. The Commission does not address at this time the proposal to require default VRS providers to implement log-in procedures for individuals using enterprise and public videophones for VRS calls. Pending Commission action on the log-in proposal, VRS providers will be paid for compensable calls that are completed to and from such videophones in compliance with rules in effect at the time of the call.

17. Definitions. The Commission defines an “enterprise videophone” as a videophone maintained by a business, organization, government agency, or other entity and designated for use by its employees or other individuals in private or restricted areas. Videophones provided by enterprises may be situated in a variety of locations, including private or shared offices, conference rooms, other common rooms, or hospital rooms, and therefore may be intended for use by individuals other than “employees”—while still not fitting the definition of a “public” videophone. The Commission defines a “public videophone” as a videophone maintained by a business, organization, government agency, or other entity, and made available for use by the public in a public space, such as a public area of a business, school, hospital, library, airport, or government building. As adopted, both definitions make clear that the covered devices may be used for point-to-point calls by people who may not know ASL. Because the TRS Fund does not compensate for point-to-point calls, there is no reason to require ASL as opposed to any other form of sign language during such calls.

18. Registration and Certification Requirements. The Commission requires each VRS provider to submit the following registration information for enterprise and public videophones for which it assigns or receives a port of a NANP telephone number: The name of the default VRS provider; the videophone's NANP telephone number; The name and physical address of the organization, business, or agency where the enterprise or public videophone is located; the date that the default VRS provider initiated service to the videophone; the name of the individual associated with the organization, business, or agency who is responsible for the videophone; and confirmation that the provider has obtained a signed certification from that individual stating that such person understands the function of the videophone and that the cost of VRS calls made on the videophone is financed by the federally regulated Interstate TRS Fund.

19. For enterprise videophones, the signed certification must also include a statement from the responsible individual that the organization, business, or agency will make reasonable efforts to ensure that only persons with a hearing or speech disability are permitted to use the phone for VRS. The VRS provider must also state whether the device is assigned to a hearing individual who knows sign language and identify the specific type of location where the videophone is placed within the organization, business, or agency, to enable the administrator to conduct studies of how these phones are used and to identify unusual calling patterns that might signal waste, fraud, or abuse.

20. The Commission does not require VRS providers to submit the tax identification (ID) number of a registering enterprise because other information is available to verify the identity and location of an enterprise. The Commission requires VRS providers to maintain the confidentiality of any registration and certification information they obtain for enterprise and public videophones.

21. Timeframe for Compliance. The Commission will release a public notice announcing a 120-day period within which VRS providers must submit registration information to the Database administrator for all enterprise and public videophones then in service. For VRS calls placed on or before the data submission deadline ( i.e., the last day of this 120-day period) to and from phone numbers identified by TRS providers as associated with enterprise and public videophones, compensation will be paid if such calls are determined to be compensable in accordance with the procedures in place as of the date of the call. For calls placed after the data submission deadline, if registration data for the enterprise or public videophone was submitted to the Database on or before the data submission deadline, and the verification check is not completed as of that deadline, compensation will be paid or withheld in accordance with the guidance provided in the TRS-URD Registration Extension Order, document DA 18-196. If a public or enterprise videophone is activated after the data submission deadline, or if registration information for an existing phone is not submitted until after the deadline, VRS calls to or from the videophone are compensable only if made after the registration data has been submitted and verified.

22. Terminations and Usage Monitoring. In the Report and Order, the Commission requires VRS providers to monitor enterprise and public videophone usage and to report any unusual activity to the TRS Fund administrator. In addition, the Commission requires VRS providers to notify the TRS Fund administrator within one business day after a registered enterprise or public videophone is removed or permanently disconnected from VRS. The collection of this information is necessary to prevent waste, fraud, and abuse, given that enterprise and public videophones are available for use by multiple individuals.

23. In the Report and Order, the Commission prohibits VRS providers from offering or providing non-service related inducements that are intended to entice consumers to sign up for or use a VRS provider's service. Specifically, the Commission adopts a new rule prohibiting VRS providers from offering or providing, to any individual or entity, any form of direct or indirect incentives, financial or otherwise, whether express or implied, for the purpose of encouraging individuals to register for or use a VRS provider's service.

24. The rule amendment addresses sign-up incentives aimed primarily at inducing current VRS users to switch (or refrain from switching) providers, rather than recruiting entirely new users. Such incentives undermine the achievement of statutory objectives, albeit in a more indirect fashion. Competition among providers to offer sign-up inducements tends to increase VRS costs without improving the quality of service, impairing providers' ability and incentive to compete on service quality. Further, to the extent that inducements to choose a particular provider are offered selectively to relatively high volume users (or to consumers perceived as such), they are likely to increase the cost burden on the TRS Fund, by generating a perverse incentive for users to make calls that otherwise would not be made. In the context of a service supported by the TRS Fund, the record does not disclose any benefit from non-service-related incentives that could conceivably offset the harms described above.

25. The inducements the Commission prohibits are not limited to loyalty programs, user appreciation awards, charitable donations and other incentives to increase VRS usage, but also include non-service-related give-aways, such as video game systems, that reward or entice users to register for or use a particular provider's VRS. The prohibition covers inducements to continue using a particular provider as well as inducements to change one's default provider or to dial-around to a particular provider. The Commission does not prohibit de minimis give-aways, such as pens and T-shirts, as such items do not rise to the level of an inducement sufficient to entice a consumer to sign up for or use a particular provider's service. The Commission concludes that this approach builds upon the Commission's earlier financial incentives rulings in ways that account for the particular harms to statutory goals and TRS policies arising from these types of incentives. Where a consumer device is given out to induce users to switch default providers, or stay with their current provider, and is not the type of device ordinarily needed or used to place a VRS call, it should be prohibited. In determining whether a free give-away constitutes a non-service related inducement, the Commission will consider, among other things, the extent to which the equipment is designed, marketed, and used for relay communication. Providers that are uncertain about the permissibility of giving away a particular device may seek guidance from the Commission prior to engaging in such activity.

26. Although this new rule does not cover providing VRS-related items, such as videophones and video monitors, at no or minimal charge, the Commission's existing rule prohibiting VRS provider practices that improperly stimulate VRS usage necessarily encompasses the practice of providing VRS-related equipment at no or minimal charge to select users based on their actual or expected volume of VRS minutes. The Commission reminds VRS providers that, absent a clear justification, e.g., based on the nature of a particular person's disability, or the launching of a limited-duration opt-in product testing program with clear instruction on participation requirements, the provision of equipment at no or minimal charge to select individuals, whether or not service-related, may be deemed evidence that a provider has violated the rule against practices that cause or encourage the making of VRS calls that would not otherwise be made.

27. The Commission amends § 64.604(c) of its rules to correct erroneous cross-references and an incorrect paragraph number. Specifically, the cross-references in the current text of § 64.604(c)(5)(iii)(D) of its rules, citing provisions of paragraph (c)(5)(iii)(C), are corrected to cite the corresponding provisions of paragraph (c)(5)(iii)(D). In addition, § 64.604(c)(12) of its rules, which includes two paragraphs (c)(12)(ii), is corrected to change the numbering of the second paragraph from (c)(12)(ii) to (c)(12)(iii).

28. As required by the Regulatory Flexibility Act of 1980, as amended, the Commission incorporated an Initial Regulatory Flexibility Analysis (IRFA) into 2017 VRS Improvements FNPRM. The Commission sought written public comment on the proposals in the 2017 VRS Improvements FNPRM, including comment on the IRFA. No comments were received in response to the IRFA.

29. With regard to enterprise and public videophones, the Report and Order adopts requirements for VRS providers to: (1) Submit registration information to the User Database administrator for each enterprise or public videophone after notice from the Commission that the Database is ready to accept such information; (2) notify the TRS Fund administrator in the event a registered enterprise or public videophone is removed from service or permanently disconnected from VRS, within one business day of such termination; and (3) monitor videophone usage and report any unusual activity to the TRS Fund administrator.

30. The Report and Order also (1) adopts a requirement for VRS providers, when validating the eligibility of the party on the video side of each VRS call, to query either the User Database or the TRS Numbering Directory, as directed by the Commission, the TRS Fund administrator, or the TRS Numbering Administrator; (2) allows qualified entities to access the TRS Numbering Directory in order to enable direct video calling (direct video) by registered VRS users to customer support call centers; and (3) prohibits VRS providers from offering or providing any form of direct or indirect incentives for the purpose of encouraging consumers to register for or use VRS.

31. No comments were filed in response to the IRFA.

32. The Chief Counsel for Advocacy of the Small Business Administration did not file any comments in response to the proposed rules in this proceeding.

33. The rules adopted in the Report and Order will affect obligations of VRS providers and providers of direct video services. These services can be included within the broad economic category of All Other Telecommunications.

34. The rule prohibiting VRS providers from offering or providing incentives to register for or use VRS does not create direct reporting and recordkeeping requirements, but does impose compliance requirements on VRS providers. Specifically, this rule requires VRS providers to refrain from offering or providing incentives to encourage consumers to register for or use VRS.

35. The rules affecting enterprise and public videophones will require VRS providers to collect and retain identifying information for the videophones for which they are the default VRS provider and to provide that information to the User Database administrator, including the name of the default VRS provider, the name and physical address of the organization, business, or agency where the videophone is located, the date that service to the videophone is initiated, the name of the individual associated with the organization, business, or agency who is responsible for maintaining the videophone, and confirmation that the provider has obtained a signed certification from that individual stating that such person understands the function of the videophones and that the cost of VRS calls is financed by the federally regulated Interstate TRS Fund, and for enterprise phones that the person certifying will make reasonable efforts to ensure that only eligible users make use of the videophones. VRS providers are also required to monitor usage of enterprise and public videophones and report unusual activity to the TRS Fund administrator.

36. The rules require VRS providers, when validating the eligibility of the party on the video side of each VRS call, to query either the User Database or the TRS Numbering Directory, as directed by the Commission, the TRS Fund administrator or the TRS Numbering Administrator, rather than requiring that only the User Database may be queried.

37. Qualified Direct Video Entities seeking access to the TRS Numbering database are required to submit an application that includes: (1) The applicant's name, address, telephone number, and email address; (2) a description of the service to be provided; (3) an acknowledgment that the authorization granted under this paragraph is subject to compliance with applicable Commission rules; (4) contact information for personnel responsible for addressing issues relating to such compliance; and (5) certification that the applicant possesses the financial, managerial, and technical expertise to provide reliable service. To enter a telephone number into the TRS Numbering Directory, Qualified Direct Video Entities will be required to submit the telephone number, associated call routing information, and registration information in accordance with instructions provided by the User Database administrator. The Qualified Direct Video Entity must provide to the User Database administrator the Qualified Direct Video Entity's name; the date that the Qualified Direct Video Entity was approved for numbering access; the name of the end-user customer support center (if different from the Qualified Direct Video Entity); the physical address of the customer support center or centers that will receive calls placed to the direct video number and other information reasonably requested by the User Database administrator.

38. The provision of VRS to enterprise and public videophones is optional for VRS providers. The registration requirements for such videophones apply equally to all VRS providers and users, and are necessary to prevent waste, fraud, and abuse of the TRS Fund by making it possible for the TRS Fund administrator to monitor call data records for unusual call patterns. The registration requirements for enterprise and public videophones are no more burdensome than the registration requirements for individual videophones. To the extent there are differences in operating costs resulting from economies of scale, those costs are reflected in the different rate structures applicable to large and small VRS providers.

39. The rule requiring VRS providers, when validating the eligibility of the party on the video side of each VRS call, to query either the User Database or the TRS Numbering Directory, as directed by the Commission, the TRS Fund administrator, or the TRS Numbering Administrator, rather than requiring that only the User Database may be queried, as the rules are currently written, is not burdensome. This change does not alter the basic requirement to query a database; its only effect is to possibly change the database that providers must query.

40. Permitting Qualified Direct Video Entities to access the TRS Numbering Directory is necessary for the purpose of routing calls to and from such customer support call centers. Granting access will subject Qualified Direct Video Entities to call-routing, application, and registration rules that are similar to and no more burdensome than those currently applicable to VRS providers. The application and registration requirements apply only to those entities that seek to place numbers in the TRS Numbering Directory and are necessary to ensure that such entities are aware of and capable of meeting their regulatory obligations and have a legitimate need to access the TRS Numbering database.

41. Prohibiting VRS providers from offering or providing direct or indirect inducements to register for or use VRS will help ensure that VRS is available to the extent possible and in the most efficient manner while helping to limit waste, fraud, and abuse by preventing VRS providers from encouraging users to make calls that the users might otherwise not make. Adopting this prohibition may benefit small VRS providers by removing competitive costs associated with offering inducements unrelated to providing service and focusing competition on service quality.

42. Pursuant to sections 1, 2, 225, and 251 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 225, 251, document FCC 19-39 is adopted and part 64 of title 47 is amended.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 64 as follows: