Federal Register Vol. 83, No.108,

On May 24, 2018, the President signed the Economic Growth Act,1 which among other things, amended the definition section of the MBL provisions of the FCU Act.2 Prior to the Economic Growth Act, the FCU Act defined an MBL, in relevant part, as any loan, line of credit, or letter of credit, the proceeds of which will be used for a commercial, corporate or other business investment property or venture, or agricultural purpose but does not include an extension of credit that is fully secured by a lien on a 1-to 4- family dwelling that is the primary residence of a member. 3

The Economic Growth Act removed from that definition the words “that is the primary residence of a member.” As a result, the definition of an MBL now excludes all extensions of credit that are fully secured by a lien on a 1- to 4- family dwelling regardless of the borrower's occupancy status. Because these kinds of loans are no longer considered MBLs, they do not count towards the aggregate MBL cap imposed on each federally insured credit union by the FCU Act.

This statutory amendment became effective upon enactment of the Economic Growth Act. The Board is issuing this final rule to conform the NCUA's MBL rule to the revised FCU Act.

This final rule also revises the NCUA's Prompt Corrective Action rule, part 702,4 by amending outdated citations to the NCUA's MBL rule. These changes are technical in nature and will not have any substantive effect.

The Board is issuing this rule as final, without having first provided notice and an opportunity for public comment because the NCUA for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest pursuant to the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(3)(B). This rule implements a mandated statutory change that provides the NCUA with no choice and no discretion. The Board finds these reasons are good cause to dispense with the APA's notice and comment requirements.

In accordance with the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.) (PRA), the NCUA may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The information collection requirements associated with part 723 are currently approved by OMB and assigned OMB control number 3133-0101. This rule will not impose any new paperwork burdens or amend existing paperwork burdens, as defined by the PRA.

The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) provides generally for congressional review of agency rules. A reporting requirement is triggered in instances where the NCUA issues a final rule as defined by Section 551 of the APA. The NCUA believe this final rule is “major” within the meaning of the relevant sections of SBREFA. The NCUA has submitted the rule to the Office of Management and Budget for its determination in that regard.

Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. The NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order to adhere to fundamental federalism principles. The final rule does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. The NCUA has therefore determined that this final rule does not constitute a policy that has federalism implications for purposes of the executive order.

The NCUA has determined that this rule will not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, 1999, Public Law 105-277, 112 Stat. 2681 (1998).

For the reasons discussed above, the NCUA amends 12 CFR parts 702 and 723 as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2014-02-01, Amendment 39-17729 (79 FR 7382, February 7, 2014) (“AD 2014-02-01”). AD 2014-02-01 applied to certain Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702), Model CL-600-2D15 (Regional Jet Series 705), and Model CL-600-2D24 (Regional Jet Series 900) airplanes. The NPRM published in the Federal Register on January 16, 2018 (83 FR 2090). The NPRM was prompted by reports that when installing RTL return spring part number BA-670-93468-1, the RTL limiter arm assembly lug(s) can become deformed when the RTL return spring attachment bolt is torqued; and the determination that additional airplanes are affected by the unsafe condition. The NPRM proposed to require an inspection of the RTL return springs for signs of chafing; an inspection of the casing of the primary actuator for signs of chafing or missing paint; replacement of the RTL return springs; and an inspection of the lugs of the RTL limiter arm assembly for cracks, and modification or replacement, as applicable; and applicable corrective actions. The NPRM also proposed to add airplanes to the applicability. We are issuing this AD to prevent deformed RTL limiter arm assembly lug(s), which can lead to failure of the RTL limiter arm assembly lug(s). In combination with failure of the RTL, failure of the RTL limiter arm assembly lug(s) could result in reduced controllability of the airplane.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2017-19, dated June 6, 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-600-2C10 (Regional Jet Series 700, 701, & 702), Model CL-600-2D15 (Regional Jet Series 705), and Model CL-600-2D24 (Regional Jet Series 900) airplanes. The MCAI states:

Required actions include: A detailed visual inspection of the RTL return springs for signs of chafing; a detailed visual inspection of the casing of the primary actuator for signs of chafing or missing paint; replacement of the RTL return springs; an eddy current inspection of the lugs of the RTL limiter arm assembly for cracks, and modification or replacement of the RTL limiter arm assembly, as applicable; and applicable corrective actions. Corrective actions include: replacement of the RTL return springs, repair of the primer and topcoat of the primary actuator, and replacement of the primary actuator. 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-2017-1246.

We gave the public the opportunity to participate in developing this AD. We considered the comment received. The Air Line Pilots Association, International supported the NPRM.

We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:

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

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

Bombardier has issued Bombardier Service Bulletin 670BA-27-070, Revision B, dated March 31, 2017. This service information describes procedures for an inspection of the RTL return springs for signs of chafing; an inspection of the casing of the primary actuator for signs of chafing or missing paint; replacement of the RTL return springs; and an inspection of the lugs of the RTL limiter arm assembly for cracks, and modification or replacement, as applicable; and applicable corrective actions. 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 544 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

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

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

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

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

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 767-300 and -300F series airplanes. The NPRM published in the Federal Register on June 5, 2015 (80 FR 32066). The NPRM was prompted by reports of fatigue cracking on airplanes with Aviation Partners Boeing winglets installed. The NPRM proposed to require a HFEC inspection for cracking of the lower outboard wing skin, and repair or modification if necessary. The NPRM also proposed to require one of three follow-on actions: Repeating the HFEC inspections, modifying certain internal stringers and oversizing and plugging the existing fastener holes of the lower wing, or modifying the external doubler/tripler and doing repetitive post-modification inspections.

We issued an SNPRM to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 767-300 and -300F series airplanes. The SNPRM published in the Federal Register on November 27, 2017 (82 FR 55958). The SNPRM proposed adding new HFEC inspections for cracking of an expanded area of the lower outboard wing skin for certain airplanes.

We are issuing this AD to address fatigue cracking in the lower outboard wing skin, which could result in failure and subsequent separation of the wing and winglet and consequent reduced controllability of the airplane.

We gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the SNPRM and the FAA's response to each comment. One commenter, Matt Leritz, supported the content of the SNRPM.

Aviation Partners Boeing (APB) and United Airlines (UAL) asked that we correct the compliance time in paragraphs (h)(2)(ii) and (h)(3)(ii) of the proposed AD (in the SNPRM). The commenters stated that those paragraphs would require the initial post-repair HFEC inspection of the lower wing skin at stringer L-6.5 at the applicable time specified in paragraph 1.E., “Compliance,” of Aviation Partners Boeing Service Bulletin AP767-57-014, Revision 1, dated April 12, 2017. The commenters added that the compliance time for the Part 3 HFEC inspection specified in paragraph 1.E. does not begin after doing the Part 2 repair, but instead begins after the initial issue of the service bulletin (after the effective date of the AD). UAL stated that, as written, this would require doing post-repair inspections on airplanes above the total flight-hour and flight-cycle threshold within 18 months after the effective date of the AD, regardless of if or when the repair was actually done. APB confirmed that the calendar-based compliance time in the referenced service information, for airplanes in Group 1, Configurations 2 and 3, and Groups 2 and 3, should be the same as for airplanes in Group 1, Configuration 1, on which the Part 2 repair has been done. The commenters asked that the compliance time for the Part 3 HFEC inspection be corrected to the following: “Within 6,000 flight cycles after doing the Part 2 repair, or within 18,000 flight hours since doing the Part 2 repair, whichever occurs first.”

We agree with the commenters' request for the reasons provided. We have added paragraph (j)(3) of this AD to include this compliance-time exception.

Boeing asked that we remove the terminating action sentence at the end of paragraph (g)(2) of the proposed AD (in the SNPRM). Paragraph (g)(2) of the proposed AD (in the SNPRM) applies to Group 3 airplanes with external doublers, and if a crack is found it requires a repair using a method approved by the FAA. That paragraph also specifies that “[a]n approved repair terminates the repetitive inspections required by paragraph (g)(2) of this AD.” Boeing stated that any repair for cracks found will require follow-on repetitive inspections, which would be approved as part of the AMOC repair approval process.

We agree that the repairs for Group 3 airplanes will have an approved follow-on inspection program, but the repairs may apply to the cracked areas only. We do not agree with removing the terminating action provision because other areas may require the repetitive inspections specified in paragraph (g)(2) of this AD, for which approved terminating action would be appropriate. We have revised that sentence as follows: “An approved repair terminates the repetitive inspections required by paragraph (g)(2) of this AD for the repaired area only.”

American Airlines (AAL), APB, UAL, and Delta Airlines (Delta) asked that we add a grace period for the proposed post-repair (modification) inspections.

AAL stated that Table 4 of paragraph 1.E., “Compliance,” of Aviation Partners Boeing Service Bulletin AP767-57-010, Revision 11, dated April 3, 2017, includes numerous inspections that are due within a specified number of flight hours or flight cycles after previous repair or modification of the airplane. AAL added that since it has completed many repairs and modifications using previous revisions of the referenced service information, there will be airplanes out of compliance with the AD requirements on the effective date because there is no grace period based on the AD due date.

APB and Delta stated that paragraph (g) of the proposed AD (in the SNPRM) specifies compliance times specified in paragraph 1.E., “Compliance,” of Aviation Partners Boeing Service Bulletin AP767-57-010, Revision 11, dated April 3, 2017, for initial post-repair inspections. APB added that the referenced service information added a flight-hour threshold of 90,000 total flight cycles to the existing flight-cycle threshold of 30,000 total flight cycles for the initial compliance time. APB noted that the grace period published in the referenced service information for airplanes on which the flight-hour or flight-cycle threshold has been reached is set to 18 months after accomplishment of the repair. APB stated that this creates a drop-dead inspection situation for airplanes on which either the flight-hour or flight-cycle threshold has been reached, and on which the Part 8 or Part 11 repair was accomplished over 18 months ago. Delta stated that the compliance table on pages (i) and (ii) of Aviation Partners Boeing Service Bulletin AP767-57-010, Revision 11, dated April 3, 2017, should be added to paragraph 1.E., “Compliance” and included in the AD.

UAL stated that paragraph (g) of the proposed AD (in the SNPRM) would require the repetitive post-repair inspections specified in Parts 9 and 13 of Aviation Partners Boeing Service Bulletin AP767-57-010, Revision 11, dated April 3, 2017, in airplane total times or within 18 months after accomplishment of Part 8 and 11 repairs, respectively. UAL is concerned that older airplanes on which the repair was done more than 18 months ago could be out of compliance on the effective date of the AD. UAL noted that the 18-month grace period covers the initial inspection, but does not cover post-repair inspections. UAL suggested that we provide similar relief for airplanes on which the threshold has been exceeded.

We do not agree with the commenters' requests to add a grace period. The current revisions of the referenced service information provide a compliance time of 18 months for the initial inspection for all airplanes. The compliance times for certain conditional inspections are in terms of airplane threshold or time since accomplishment of the specified repair or modification. Those previously installed repairs or modifications may have been done using a version of Aviation Partners Boeing Service Bulletin AP767-57-010 before Revision 11 or alternative method, and may involve deviations, additional repair activity, and previous repairs. Under the provisions of paragraph (k) of this AD, we will consider requests for approval of AMOCs to extend the compliance time if sufficient data are submitted to substantiate that it would provide an acceptable level of safety. We have determined that each situation must be handled separately in the AMOC evaluation. We have not changed this AD in this regard.

Delta asked that a compliance table be added to Aviation Partners Boeing Service Bulletin AP767-57-014, Revision 1, dated April 12, 2017, for airplanes on which the actions specified in Aviation Partners Boeing Service Bulletin AP767-57-010 have been previously accomplished. Delta noted that page i of Aviation Partners Boeing Service Bulletin AP767-57-014, Revision 1, dated April 12, 2017, provides a compliance information table only for Group 3 airplanes; there are no tables for Groups 1 and 2 airplanes.

We do not agree with the commenter's request. The compliance information table on page i of Aviation Partners Boeing Service Bulletin AP767-57-014, Revision 1, dated April 12, 2017, provides only a description of additional work, if any, necessary based on work accomplished using the previous revision. These tables are reference information only, and do not reflect all the actions required by the AD. The necessary compliance tables are provided in paragraph 1.E., “Compliance” of Aviation Partners Boeing Service Bulletin AP767-57-014, Revision 1, dated April 12, 2017. Therefore, we have not changed this AD in this regard.

UAL asked that we include a clarification in the proposed AD (in the SNPRM) that Group 4 airplanes are not affected. UAL stated that Group 4 airplanes are identified in the effectivity table in paragraph 1.A. of Aviation Partners Boeing Service Bulletin AP767-57-010, Revision 11, dated April 3, 2017. UAL noted that an equivalent change to the service information was incorporated during winglet installation with no additional work being necessary. UAL asked that we add paragraph (g)(3) to the AD to clarify that Group 4 airplanes are not affected by the requirements in the AD.

We agree with the commenter for the reasons provided. Aviation Partners Boeing Service Bulletin AP767-57-010, Revision 11, dated April 3, 2017, specifies that an equivalent change has been incorporated in APB winglet retrofit kits for Group 4 airplanes, and that no more work is necessary on those airplanes. We have included a clarification in paragraph (g)(3) of this AD that specifies that Group 4 airplanes are not affected by the actions required by paragraph (g) of this AD.

FedEx asked that we remove the airplane having line number 1027 from the applicability in the proposed AD (in the SNPRM), or allow Aviation Partners Boeing Service Bulletin AP767-57-012, dated September 2015, as an AMOC. FedEx stated that it will be modifying that airplane by removing the winglets and installing Boeing wing tips in accordance with Aviation Partners Boeing Service Bulletin AP767-57-012, dated September 2015. FedEx anticipated that the modification will be completed prior to the effective date of the AD. FedEx added that the unsafe condition will be addressed when the winglets are removed.

We do not agree with the commenter's request. There are many factors that led to the cracking of the lower wing skin, and the additional loading of the winglet is only one of those factors. Other contributory factors are design details with the added internal wing structure, which resulted in shortening the fatigue life of the blended winglet installation. We have not changed this AD in this regard.

UAL asked that provisions be added to paragraph (g) of the proposed AD (in the SNPRM) to allow an alternative open-hole HFEC inspection procedure to inspect for cracking at the five inboard fastener locations. UAL stated that an open-hole HFEC inspection with the fasteners removed, in accordance with nondestructive test (NDT) Part 6, Chapter 51-00-16, using the same notch sensitivity provides an equivalent crack detection method. UAL added that APB has concurred with the inspection. UAL concluded that it has been performing the optional preventive modification, which trims out the skin containing the five fastener holes, and allows for the open-hole HFEC to be performed easily because the fasteners in the doubler are removed.

We do not agree with the commenter's request. Although UAL developed an inspection method that works better for its situation, the HFEC inspection specified in the referenced service information is required by this AD to address all situations. However, under the provisions of paragraph (k) of this AD, we will consider requests for approval of AMOCs if sufficient data are submitted to substantiate that the open-hole HFEC inspection procedure provides an acceptable level of safety. We have not changed this AD in this regard.

All Nippon Airways (ANA), AAL, APB, and Delta asked that we clarify credit in paragraph (i) of the proposed AD (in the SNPRM), for previously accomplished repairs approved by a Boeing ODA prior to June 15, 2017.

ANA stated that during discussions with the FAA, it was informed that repair deviations approved by Boeing ODAs prior to the FAA approval of the APB revised fatigue analysis issued on June 15, 2017, and the release of Aviation Partners Boeing Service Bulletins AP767-57-010, Revision 11, AP767-57-013, Revision 1, and AP767-57-014, Revision 1, do not qualify for AMOC credit to the AD after it is released. ANA added that the proposed AD (in the SNPRM) would provide AMOC credit for repair deviations approved by Boeing ODAs with 8100-9 forms dated after June 15, 2017, because the Boeing ODAs would be using the APB revised fatigue analysis.

AAL stated that paragraph (i) of the proposed AD (in the SNPRM) specifies that repairs accomplished before June 15, 2017, and before the AD effective date approved by a Boeing ODA can be considered approved repairs in accordance with paragraphs (g) and (h) of the proposed AD (in the SNPRM). AAL added that Boeing has indicated through Multi-Operator Message MOM-MOM-17-0480-01B that repairs approved prior to June 15, 2017, can be re-evaluated and approved on a new 8100-9 form. AAL noted that the language in paragraph (i) should be clarified to indicate that repairs accomplished prior to June 15, 2017, are also acceptable, as long as they have an 8100-9 approval from a Boeing ODA dated after June 15, 2017.

APB requested that we clarify paragraph (i) of the proposed AD (in the SNPRM) to state that accomplishment of previous revisions of Aviation Partners Boeing Service Bulletins AP767-57-010 should be acceptable for credit for previously accomplished repairs and modifications of the lower outboard wing skin. APB stated that after the effective date of the AD, operators that did not seek relief for previously completed actions would need to request approval of AMOCs.

Delta stated that paragraph (i) of the proposed AD (in the SNPRM) provides repair approval for repairs of the lower outboard wing skin done after June 15, 2017, and before the effective date of the AD, that are approved by the Boeing ODA authorized by the Manager, Seattle ACO Branch, are approved for the applicable repairs required by paragraphs (g) and (h) of the AD. Delta added that prior to issuance of the referenced service information, both inspection and repair instructions for stringers L-9.5 and L-6.5 were contained in Revisions 1, 2, 4, 6, 7, 8, and 9 of Aviation Partners Boeing Service Bulletin AP767-57-010. Delta added that it has performed many inspections and repairs for stringers L-9.5 and L-6.5 with those revisions. Delta suggested that credit be provided for repairs approved by a Boeing 8100-9 or previously accomplished using Revisions 1, 2, 4, 6, 7, 8, and 9 of Aviation Partners Boeing Service Bulletin AP767-57-010. Delta added that AMOCs will have to be obtained for each approved 8100-9 if no credit is provided.

We agree to clarify the language in paragraph (i) of this AD to include certain language provided by the commenters' for the reasons provided. We have clarified the language in paragraph (i) of this AD by adding that the ODA repairs approved after June 15, 2017, and before the effective date of this AD, will have post-installation inspection requirements in lieu of the post-inspection instructions specified in Aviation Partners Boeing Service Bulletin AP767-57-010, Revision 11, dated April 3, 2017; and Aviation Partners Boeing Service Bulletin AP767-57-014, Revision 1, dated April 12, 2017.

APB and UAL asked that we correct an error specified in Part 13 of Aviation Partners Boeing Service Bulletin AP767-57-010, Revision 11, dated April 3, 2017.

APB and UAL stated that paragraphs (g)(1)(i)(D)(2), (g)(1)(ii)(B)(2), and (g)(1)(iii)(B)(2) of the proposed AD (in the SNPRM) would require the post-repair HFEC inspection in accordance with Part 13 of the referenced service information. UAL stated that Part 13, Step 1.d., specifies repeating the Part 9 HFEC inspection; however, it should specify repeating the Part 13 HFEC inspection because Part 9 applies to airplanes without the stringer replacement. UAL noted that the paragraphs in the proposed AD (in the SNPRM) correctly specify repeating the Part 13 HFEC inspection. UAL added that the steps in the referenced service information are listed as RC (required for compliance), and must be done to comply with the AD.

We agree that the error exists in the service information. We have added an exception in paragraph (j)(4) of this AD that specifies repeating the Part 13 HFEC inspection instead of the Part 9 inspection.

AAL, UAL, and United Parcel Service (UPS) asked that we provide credit for doing the modification required by paragraph (i) of the proposed AD (in the SNPRM) using previous revisions of the referenced service information. UAL and UPS noted that paragraph (i) of the proposed AD (in the NPRM), which provided credit for previous actions using previous revisions of the referenced service information, was deleted in the SNPRM.

We do not agree with the commenters' requests. No credit is given for previously installed repairs or modifications due to each situation being unique; therefore, a re-evaluation will have to be done and may involve additional work for certain airplanes. Under the provisions of paragraph (k) of this AD, we will consider requests for approval of AMOCs if sufficient data are submitted to substantiate that work done using previous revisions of the service information provides an acceptable level of safety. We have not changed this AD in this regard.

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 SNPRM for addressing the unsafe condition; and

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

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 APB Service Bulletin AP767-57-010, Revision 11, dated April 3, 2017. The service information describes procedures for an HFEC inspection for cracking of the external surface of the lower outboard wing skin at stringer L-9.5, and on-condition actions that include repetitive HFEC inspections, modification by oversizing and plugging the existing fastener holes of the wing skin, repair (modification) of the stringer with new stringer, and repair (modification) of the stringer with external doubler/tripler; repetitive post-repair inspections for cracking, and repair.

We also reviewed APB Service Bulletin AP767-57-014, Revision 1, dated April 12, 2017. The service information describes procedures for an HFEC inspection for cracking of the lower outboard wing skin at stringer L-6.5 and on-condition actions that include repetitive HFEC inspections, repair (modification) of the stringer with new stringer, repetitive post-repair HFEC inspections for cracking, and repair.

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 140 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 based on the results of the inspection. 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 cost estimates for on-condition repairs for the post-repair inspections 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:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 767-200 and -300 series airplanes. The NPRM was published in the Federal Register on December 6, 2017 (82 FR 57552). The NPRM was prompted by a report of a crack on the transition radius of the station (STA) 883.5 frame inner chord and an additional crack indication at a fastener hole in the frame inner chord common to a material review board (MRB) filler that extended above the frame-to-stub-beam joint. The NPRM proposed to require a detailed inspection for any MRB filler installed in the area from the frame web to the stub-beam fitting at certain stations to determine if the filler extends above the frame-to-stub-beam joint, and applicable on-condition actions.

We are issuing this AD to detect and correct cracking of the frame inner chord, which could result in the inability of one or more overwing stub frames between STA 808 and STA 933, each a principal structural element, to sustain limit loads; this condition could adversely affect the structural integrity of the airplane.

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

Aviation Partners Boeing stated that accomplishing the Supplemental Type Certificate (STC) ST01920SE does not affect the actions specified in the NPRM.

We concur with the commenter. We have redesignated paragraph (c) of the proposed AD as paragraph (c)(1) of this AD and added paragraph (c)(2) to this AD to state that installation of STC ST01920SE does not affect the ability to accomplish the actions required by this AD. Therefore, for airplanes on which STC ST01920SE 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.

Paragraph (h)(1) of the proposed AD allowed operators to substitute “the effective date of this AD” for “the original issue date of Requirements Bulletin 767-53A0278 RB.” United Airlines noted that this wording is different from that of recent NPRMs, where the AD effective date is the sole compliance date. United added that the proposed wording suggested that the operator can choose to use either the AD effective date or the original issue date of the RB when determining the compliance timeline. United requested that we clarify the intent of the provision of paragraph (h)(1) of the proposed AD.

We agree with the commenter. We have revised paragraph (h)(1) of this AD to specify use of the effective date of this AD in determining the compliance time.

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

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

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

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

We reviewed Boeing Alert Requirements Bulletin 767-53A0278 RB, dated June 30, 2017. This service information describes procedures for a detailed inspection for any MRB filler installed in the area from the frame web to the stub-beam fitting on the left and right side at STA 859.5, 883.5, and 903.5 to determine if the filler extends above the frame-to-stub-beam joint, and applicable on-condition actions. The applicable on-condition actions include repetitive surface high frequency eddy current inspections and repair for cracking in the frame inner chord around the end fastener common to each affected MRB filler. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD affects 51 airplanes of U.S. registry. 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 cost estimates for the on-condition 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:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 787-8 airplanes. The NPRM was published in the Federal Register on August 25, 2017 (82 FR 40511). The NPRM was prompted by a report of possible degraded bond-line performance of co-bonded upper wing stringer-to-skin joints. The NPRM proposed to require repetitive inspections of certain upper wing stringers for any disbond, and corrective actions if necessary; and a terminating preventive modification of installing DBA fasteners. The NPRM also proposed to require revising the inspection or maintenance program to incorporate an airworthiness limitation.

The degraded stringer bond-line does not meet the residual strength requirements if an adjacent stringer becomes disbonded due to induced damage at a critical location. We are issuing this AD to prevent upper wing stringer-to-skin joint disbonding, which can reduce the structural integrity of the airplane.

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

One commenter, Ken Mayes, and United Airlines (UAL) expressed support for the NPRM.

UAL, Japan Airlines (JAL), All Nippon Airways (ANA), and Boeing requested that we specify a later revision of the service information. Boeing pointed out that Issue 002 of Boeing Alert Service Bulletin B787-81205-SB570030-00 is expected to be released in the first half of 2018. JAL pointed out that Boeing has released Information Notice B787-81205-SB570030-00 IN-01, dated April 5, 2017, to include a certain special tool. JAL mentioned communications with Boeing regarding “location 2” fasteners that are for the dry bay installation and part of the basic design features. JAL also mentioned that Boeing communicated that certain specifications for ultraviolet protections were not the latest revisions in Boeing Alert Service Bulletin B787-81205-SB570030-00, Issue 001, dated March 17, 2017. JAL specifically mentioned its preference to avoid deviations based on these issues. UAL specified that seven airplanes from the UAL fleet are affected by the NPRM. ANA pointed out that Issue 002 of Boeing Alert Service Bulletin B787-81205-SB570030-00 is expected to include alternative non-destructive test (NDT) procedures, alternative cleaning procedures, additional removal and installation specifications, and alternative special tools. ANA also pointed out that certain details regarding the new copper foils are incorrect in Issue 001 of the service information and that Issue 002 will correct those inaccuracies.

We do not consider that delaying this action until release of the planned service bulletin is warranted. Issue 002 of Boeing Alert Service Bulletin B787-81205-SB570030-00 is not yet approved, and we cannot specify future revisions of service information in this AD. Boeing Alert Service Bulletin B787-81205-SB570030-00, Issue 001, dated March 17, 2017, is the currently available revision, and it provides adequate information to address the identified unsafe condition. We have not reviewed the proposed Issue 002 of Boeing Alert Service Bulletin B787-81205-SB570030-00. However, the proposed Issue 002 of Boeing Alert Service Bulletin B787-81205-SB570030-00, is expected to provide more options, clarifications, and corrections, which may be helpful, but are not necessary to accomplish the requirements of this AD. These revisions are not expected to affect an operator's ability to comply with this AD. Therefore, we do not plan to wait for the release of Issue 002 of Boeing Alert Service Bulletin B787-81205-SB570030-00 before issuing this AD. However, we will consider requests for approval of an alternative method of compliance (AMOC) to allow the use of Issue 002 of Boeing Alert Service Bulletin B787-81205-SB570030-00 after it has been published, under the provisions of paragraph (l) of this AD. We have not changed this final rule regarding this issue.

Boeing requested that we clarify the information leading to the AD action in the SUMMARY of the NPRM and paragraph (e) of the proposed AD. The commenter pointed out that Boeing notified the FAA of possible degraded bond-line performance, but that there have been no reports of stringer disbonds found in the fleet.

We agree for the reasons provided. We have revised the SUMMARY section of this final rule and paragraph (e) of this AD to specify that this AD was prompted by a report of possible degraded bond-line performance of co-bonded upper wing stringer-to-skin joints.

Boeing requested that we clarify the cause of the possible degraded bond-line performance. The commenter pointed out that a specific type of Boeing Material Specification (BMS) 8-308 peel ply, and exposure to cure times that exceeded 4 hours at a temperature of 355 Fahrenheit degrees (±10 Fahrenheit degrees), are contributing factors. The commenter also pointed out that other types of BMS 8-308 peel ply are not affected by the unsafe condition. The commenter also mentioned that the temperature specified (345 Fahrenheit degrees (±10 Fahrenheit degrees)) in Boeing Alert Service Bulletin 787-81205-SB570030-00, Issue 001, dated March 17, 2017, in the description of the incident was incorrect.

We agree that clarification is necessary, in that, the BMS 8-308 specification includes multiple different types of peel ply material, and not all BMS 8-308 material types are affected by this AD. In fact, the replacement peel ply material specified in the service information was also selected from the BMS 8-308 specification. However, we do not agree to specify the temperature in this AD, because that information is not restated in the final rule. We have not changed this final rule regarding this issue.

Boeing requested that we revise the Discussion section of the NPRM to clarify the condition that could cause the unsafe condition. The commenter pointed out that the upper wing stringer-to-skin joint may not sustain limit load if a stringer has a one-bay disbond and is adjacent to a critical stringer with a degraded bond-line, which could adversely affect the structural integrity of the airplane. The commenter also pointed out that the degraded bond-lines are good for ultimate load and long-term durability when not assuming an adjacent stringer disbond. The commenter stated that the only way to show less than limit load capability is to assume that the degraded bond-line is adjacent to a one-bay disbond.

We agree that clarification is necessary, in that, the unsafe condition is a residual strength requirement that assumes an already damaged structure. We have revised the Discussion section of this final rule to reflect this condition.

Boeing requested that we revise the NPRM to specify that the unsafe condition is based on additional assumed conditions. The commenter stated that the NPRM would not prevent anything, as the structure is good for ultimate static and fatigue, but would ensure that no “assumed” disbonds could be adjacent to a degraded bond-line.

We disagree with the request to revise paragraph (e) of this AD. This AD mandates inspections and provides a terminating action for airplanes with a known manufacturing non-conformance, which, under certain conditions, could reduce the structural capability of the airframe to less than limit load. We have not changed this final rule regarding this issue.

Boeing requested that we revise the “FAA's Determination” section of the NPRM to specify that while the unsafe condition could exist, it cannot develop. The commenter pointed out that the unsafe condition is a function of fabrication and not durability issues.

We disagree to make the requested wording change. The “FAA's Determination” section of the NPRM is not restated in the final rule. We have not changed this final rule regarding this issue.

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

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

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

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

We reviewed Boeing Alert Service Bulletin B787-81205-SB570030-00, Issue 001, dated March 17, 2017. The service information describes procedures for inspection of certain upper wing stringers for any disbond and corrective actions; and for a preventive modification which consists of, depending on airplane configuration, applying copper foil to the upper wing at certain stringer and rib bay locations, installing DBA fasteners on the upper flanges of the upper wing stringers at the stringer and rib bay locations, applying cap seals to the DBA fasteners, and applying edge sealant to the stringers at the DBA fastener installation locations.

We have also reviewed Airworthiness Limitation (AWL) 57-AWL-13, “Inspection Requirements for In-Tank Fasteners and Edge Seal near Disbond Arrestment (DBA) Fastener Installations in Lightning Zone 2,” of Boeing 787 Special Compliance Items/Airworthiness Limitations, D011Z009-03-04, dated February 2017. This service information describes tasks for inspecting in-tank fasteners and edge seals near DBA fastener installations of lightning zone 2.

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

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

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

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

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

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

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

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

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

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

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

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

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2018-0008, dated January 10, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A350-941 airplanes. The MCAI states:

You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0490.

Airbus has issued Service Bulletin A350-57-P011, dated May 17, 2017. This service information describes procedures for a detailed inspection of the four retaining pins installed in the MLGSS trunnion block, left- and right-hand sides, and related investigative and corrective actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

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

Since none of the affected aircraft are currently on the U.S. Register, notice and opportunity for public comment before issuing this AD are unnecessary.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2018-0490; Product Identifier 2018-NM-018-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD based on those comments.

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

Currently, there are no affected U.S.-registered airplanes. If an affected airplane is imported and placed on the U.S. Register in the future, we provide the following cost estimates to comply with this AD:

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

We have received no definitive data that would enable us to provide cost estimates for the on-condition repairs 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 known costs in our cost estimate.

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

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes 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 Class E airspace extending upward from 700 feet above the surface at Halliburton Field, Duncan, OK, to support instrument flight rules operations at this airport.

The FAA published a notice of proposed rulemaking in the Federal Register (83 FR 10644; March 12, 2018) for Docket No. FAA-2018-0100 to amend the Class E airspace extending upward from 700 feet above the surface at Halliburton Field, Duncan, OK. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

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

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

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies the Class E airspace extending upward from 700 feet above the surface to within a 6.6-mile radius (decreased from a 6.7-mile radius) at Halliburton Field, Duncan, OK, and removes the extension to the north of the airport associated with the Halliburton Field Localizer. This action also adds an extension within 4 miles each side of the 359° bearing from the airport from the 6.6-mile radius to 11.6 miles north of the airport.

The geographic coordinates of the airport are also being updated to coincide with the FAA's aeronautical database, and the name of the city associated with the airport in the airspace legal description is being removed to comply with a change to FAA Order 7400.2L, Procedures for Handling Airspace Matters.

This action is necessary due to an airspace review caused by the decommissioning of the Duncan VOR as part of the VOR MON Program and cancellation of the associated instrument procedures.

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 Class D airspace, establishes Class E airspace designated as a surface area, and amends Class E airspace extending upward from 700 feet above the surface at the University of Oklahoma Westheimer Airport, Norman, OK, to support IFR operations at this airport.

The FAA published a notice of proposed rulemaking in the Federal Register (82 FR 44981; September 27, 2017) for Docket No. FAA-2017-0825 to amend Class D airspace, establish Class E airspace designated as a surface area, and amend Class E airspace extending upward from 700 feet above the surface at the University of Oklahoma Westheimer Airport, Norman, OK, to support IFR operations at the airport. 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 regulatory text for Class E airspace designated as a surface area. The Notice to Airmen information incorrectly references Class D airspace instead of Class E airspace.

Additionally, the names of the cities associated with the airports listed in the airspace descriptions have been removed to comply with a recent change to FAA Order 7400.2L, Procedures for Handling Airspace Matters.

Except for the edits noted above, this rule is the same as published in the NPRM.

Class D and E airspace designations are published in paragraph 5000, 6002, and 6005, respectively, of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.

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

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71:

Amends Class D airspace to within a 4.2-mile radius (reduced from 4.5-miles) of University of Oklahoma Westheimer Airport (formerly University of Oklahoma Westheimer Airpark), Norman, OK, and updates the name of the airport to coincide with the FAA's aeronautical database;

Establishes Class E airspace designated as a surface area within a 4.2-mile radius of University of Oklahoma Westheimer Airport, and corrects the reference to the NOTAM information to Class E airspace vice Class D airspace; and

Amends Class E airspace extending upward from 700 feet above the surface at University of Oklahoma, Westheimer Airport, Norman, OK, contained within the Oklahoma City, OK, airspace description, to within a 6.7-mile radius (reduced from 8.9-miles), removing the University of Oklahoma Westheimer Airport ILS Localizer from the airspace description, and realigning the southwest extension to 2-miles (increased from 1.8-miles) either side of the 213° bearing from the airport (previously referenced from the University of Oklahoma Westheimer Airport ILS Localizer) from the 6.7-mile radius to 7.8-miles southwest of the airport.

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 Class E airspace extending upward from 700 feet above the surface at Bishop International Airport, Flint, MI, and establishes separate Class E airspace extending upward from 700 feet above the surface at Owosso Community Airport, Owosso, MI, to support instrument flight rules (IFR) operations at these airports.

The FAA published a notice of proposed rulemaking in the Federal Register for Docket No. FAA-2018-0020 (83 FR 8638; February 28, 2018) to amend Class E airspace extending upward from 700 feet above the surface at Bishop International Airport, Flint, MI, and establish separate Class E airspace extending upward from 700 feet above the surface at Owosso Community Airport, Owosso, MI. 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 typographical error in the geographic coordinates for Bishop International Airport in the Class E airspace extending upward from 700 feet above the surface airspace description. That error has been corrected in this action.

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

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

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71:

Modifies the Class E airspace designated as a surface area at Bishop International Airport, Flint, MI, by updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database, and replaces the outdated term “Airport/Facility Directory” with the term “Chart Supplement” in the airspace legal description;

Modifies the Class E airspace area extending upward from 700 feet above the surface to within a 6.9-mile radius (decreased from a 10.5-mile radius) at Bishop International Airport; removes the extension to the north referencing the Flint ILS localizer; adds an extension 2.4 miles each side of the 016° radial of the Flint VORTAC extending from the 6.9-mile radius to 7.9 miles north of the airport; adds an extension 2.4 miles each side of the 179° radial of the Flint VORTAC extending from the 6.9-mile radius to 7.9 miles south of the airport; removes the Owosso Community Airport, Owosso, MI, from the airspace description (a separate Class E airspace area extending upward from 700 feet above the surface is being created for Owosso Community Airport as it no longer adjoins the Flint, MI, Class E airspace area extending upward from 700 feet above the surface with this amendment); removes Athelone Williams Memorial Airport, Davison, MI, from the airspace description; removes the PETLI LOM from the airspace description; removes Genesys Regional Medical Center, Grand Blanc, MI, from the airspace description; updates the geographic coordinates for Bishop International Airport and Prices Airport, Linden, MI, to coincide with the FAA's aeronautical database; and removes exclusionary language contained in the legal description to comply with FAA Order 7400.2L; and

Establishes Class E airspace area extending upward from 700 feet above the surface to within a 6.4-mile radius of Owosso Community Airport, Owosso, MI.

Airspace reconfiguration is necessary due to the closure of the Athelone Williams Memorial Airport and the cancellation of the instrument procedures at the Genesys Regional Medical Center, as they no longer require a Class E airspace area extending upward from 700 feet above the surface. This action enhances safety and the management of IFR operations at these airports.

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 establishes Class D airspace at Clinton-Sherman Airport, Burns Flat, OK; removes Class D airspace at Clinton-Sherman Airport, Clinton-Sherman Airport, OK; and amends Class E airspace extending upward from 700 feet above the surface at Clinton-Sherman Airport, Burns Flat, OK; Clinton Municipal Airport, Clinton, OK; and Elk City Regional Business Airport, Elk City, OK, to support the management of instrument flight rule (IFR) operations at these airports.

The FAA published a notice of proposed rulemaking in the Federal Register (82 FR 40078; August 24, 2017) for Docket No. FAA-2017-0618 to establish Class D airspace at Clinton-Sherman Airport, Burns Flat, OK; remove Class D airspace at Clinton-Sherman Airport, Clinton-Sherman Airport, OK; and amend Class E airspace extending upward from 700 feet above the surface at Clinton-Sherman Airport, Burns Flat, OK; Clinton Municipal Airport, Clinton, OK; and Elk City Regional Business Airport, Elk City, OK. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class D and E airspace designations are published in paragraphs 5000 and 6005, respectively, of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.

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

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71:

Establishes Class D airspace within a 4.7-mile radius of Clinton-Sherman Airport, Burns Flat, OK, to replace the airspace designation of Clinton-Sherman Airport, Clinton-Sherman Airport, OK, and bring the airspace legal descriptions in line with the requirements of FAA Order 7400.2L, Procedures for Handling Airspace Matters;

Removes Class D airspace at Clinton-Sherman Airport, Clinton-Sherman Airport, OK; and

Modifies Class E airspace extending upward from 700 feet above the surface as follows:

Within a 7.2-mile radius (reduced from an 8.2-mile radius) of Clinton-Sherman Airport, Burns Flat, OK, and removes the Burns Flat VORTAC and extensions to the south and north of the airport from the airspace legal description;

Correcting the airspace header to Clinton, OK, (formerly Clinton Municipal Airport, OK) to comply with FAA Order 7400.2L, removes the extension south of Clinton Regional Airport (formerly Clinton Municipal Airport), adds an extension 2 miles each side of the 359° bearing from the airport from the 6.5-mile radius to 7 miles north of the airport, and updates the name of the airport to coincide with the FAA's aeronautical database; and

Within a 6.5-mile radius (increased from a 6.4-mile radius) of Elk City Regional Business Airport (formerly Elk City Municipal Airport), Elk City, OK, removes the extension to the northeast of the airport, removes the Elk City RBN from the airspace legal description, and updates the name and geographic coordinates of the airport to coincide with the FAA's aeronautical database.

Airspace reconfiguration is necessary due to the decommissioning of the Sayre VORTAC as part of the VOR MON Program, and to bring the airspace and airspace descriptions into compliance with FAA Order 7400.2L. Controlled airspace is necessary for the safety and management of standard instrument approach procedures for IFR operations at these airports.

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:

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

This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing regulations, 21 CFR part 807, subpart E, require persons who intend to market a new device to submit and obtain clearance of a premarket notification (510(k)) containing information that allows FDA to determine whether the new device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a legally marketed device that does not require premarket approval.

On December 13, 2016, the 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was signed into law. Section 3054 of the Cures Act amended section 510(m) of the FD&C Act. As amended, section 510(m)(2) provides that, 1 calendar day after the date of publication of the final list under section 510(1)(B), FDA may exempt a class II device from the requirement to submit a report under section 510(k) of the FD&C Act, upon its own initiative or a petition of an interested person, if FDA determines that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of the device. This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and provide a 60-calendar-day comment period. Within 120 days of publication of such notice, FDA shall publish an order in the Federal Register that sets forth its final determination regarding the exemption of the device that was the subject of the notice.

There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998, Federal Register notice (63 FR 3142) and subsequently in the guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (“Class II 510(k) Exemption Guidance”). That guidance can be obtained through the internet at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf or by sending an email request to [email protected] to receive a copy of the document. Please use the document number 159 to identify the guidance you are requesting.

Accordingly, FDA generally considers the following factors to determine whether premarket notification is necessary for class II devices: (1) The device does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device; (2) characteristics of the device necessary for its safe and effective performance are well established; (3) changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means such as routine testing, before causing harm, or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not be likely to result in a change in the device's classification. FDA may also consider that, even when exempting devices, these devices would still be subject to the limitations on exemptions.

In the Federal Register of November 7, 2017 (82 FR 51633), FDA published a notice (“November 2017 notice”) announcing its intent to exempt, upon its own initiative, certain class II devices listed in table 1 from 510(k) requirements, subject to certain limitations, and provided opportunity for interested persons to submit comments by January 8, 2018. After reviewing comments received, FDA is now providing its final determination on exempting the certain class II devices listed in table 1 from 510(k) requirements, subject to certain limitations as identified in this order. FDA is also amending the codified language for the classification regulations for the certain class II devices listed in table 1 to reflect this final determination. Persons with pending 510(k) submissions for devices that are now exempt from 510(k), subject to the limitations, should withdraw their submissions.

In response to the November 2017 notice announcing FDA's intent to exempt those device types from 510(k) requirements, FDA received a submission from one commenter—a professional organization—opposing an exemption from 510(k) for the genetic health risk assessment test device type.

To make it easier to identify comments and our responses, the word “Comment” appears in parentheses before the comment's description, and the word “Response” in parentheses precedes the response. Specific issues raised by the comment and the Agency's response follows.

(Comment) The commenter recommended FDA not exempt one-time FDA reviewed genetic health risk assessment system devices from the 510(k) requirement because there would be insufficient oversight to ensure the analytical and clinical validity of these tests, consumers would be misled regarding which tests FDA has affirmed are scientifically valid, and concerns that, if one-time FDA reviewed genetic health risk assessment system devices were exempted, consumers would not be assured of being adequately informed about test quality. The commenter believed it is not possible to assess the analytical and clinical validity of all genetic health risks a company might offer by conducting a one-time review of its `assessment system', as proposed by FDA. Such oversight, it is argued, will only allow FDA to assess the analytical and clinical validity, and `mitigate the risks of false negatives and positives', for tests initially proposed by the company during this one-time review. The commenter believed that it does not appear that there will be assessment of the analytical or clinical validity of subsequent tests offered, nor any assessment of the risks to the consumer of an incorrect result. This commenter believed that FDA's proposal to exempt one-time FDA reviewed genetic health risk assessment system devices will not prevent scientifically invalid tests from being marketed to the public and lacks a comprehensive assessment. Further, the commenter argued that, after undergoing the one-time FDA review for genetic health risk assessment tests, companies would be able to market subsequent tests to the public as part of the same system and declare that the tests meet FDA's standards. Such tests would not be held to any specific standards of analytical or clinical validity. The public would likely assume (and purveyors would likely advertise) that FDA had reviewed and approved such tests as valid even though they had not been reviewed by the Agency. The commenter also argued that there is a vast range of quality (i.e., scientific merit) of direct-to-consumer (DTC) genetic health risk assessment tests on the market. The commenter argued that the market's current mixing of entertainment tests, which make claims unsubstantiated by the scientific literature, with those tests which have a clinical utility, are clinically valid, and can be supported by current scientific literature, is particularly confusing for the average consumer.

(Response) We agree that the concerns raised above are important. These concerns were considered during our review and development of the initial classification regulation for genetic health risk assessment system devices and in our consideration of whether to exempt one-time FDA reviewed genetic health risk assessment system devices from the 510(k) requirement. We believe these concerns have been addressed and accounted for in our determination that the 510(k) requirement is not necessary to provide a reasonable assurance of safety and effectiveness for these devices. We outline our rationale below.

Consumer understanding of genetic risk is clearly an important issue that was considered extensively by FDA in the context of genetic health risk assessment system devices. This issue was balanced with the increasing desire from the public to learn more about one's own genetic makeup and how it affects genetic risk for health conditions. To ensure that the tests and test reports are presented to the lay consumer in a manner that is understandable, we employed several requirements. Consumer understanding of the tests and associated test reports is assured by user comprehension study requirements, specific labeling requirements for these over-the-counter (OTC) tests, and general requirements for devices. The special labeling requirements for these devices under § 866.5950(b) (21 CFR 866.5950(b)) include providing information on the manufacturer's website about frequently asked questions, available professional guidelines, and how to obtain access to a genetic counselor.

A user comprehension study is required under § 866.5950(b)(3)(iii)(M). The required user comprehension study must assess comprehension of the test process and results by potential users of the test with pre- and post-test user comprehension studies. This study must be conducted on a statistically sufficient sample size of non-trained individuals who represent the demographics of the United States as well as a diverse range of age and educational levels. The study must include directly evaluating a representative sample of the material being presented to the user during use of the test. The test that is given to the participants must be informed by a physician and/or genetic counselor that identifies the appropriate general and variant-specific concepts contained within the material being tested in the user comprehension study to ensure that all relevant concepts are incorporated in the study as well as having included the definition of the target condition being tested and related symptoms, explain the intended use and limitations of the test, explain the relevant ethnicities in regard to the variant tested, explain genetic health risks and relevance to the user's ethnicity, and assess participants' ability to understand the following comprehension concepts: The test's limitations, purpose, appropriate action, test results, and other factors that may have an impact on the test results. The outcome of this study has to meet rigorous standards, including meeting predefined primary endpoint criteria, including a minimum of a 90 percent or greater overall comprehension rate (i.e., selection of the correct answer) for each comprehension concept. In addition, the testing must follow a format where users have limited time to complete the studies (such as an onsite survey format and a one-time visit with a cap on the maximum amount of time that a participant has to complete the tests). From our experience with user comprehension studies, the Agency believes that meeting or exceeding these user comprehension study requirements ensures that the materials presented to the user are adequate for OTC use. The information the test provider must provide on its website includes a summary table of comprehension rates regarding comprehension concepts (e.g., purpose of test, test results, test limitations, ethnicity relevance for the test results, etc.) for each study report.

The manufacturer's website must have a frequently asked questions section in the summary and technical information sections under § 866.5950(b)(3)(ii)(C)(3) and (b)(3)(iii)(L)(3). For the frequently asked questions sections, information must be included that is specific for each variant/disease pair that is reported and scientifically valid and supported by corresponding publications. Further information must be included that explains the health condition/disease being tested, the purpose of the test, the information the test will and will not provide, the relevance of race and ethnicity on the test results, information about the population to which the variants in the test is most applicable, the meaning of the result(s), other risks factors that contribute to disease, appropriate followup procedures, how the results of the test may affect the user's family, including children, and links to resources that provide additional information.

Likely the test labeling information provided by the test manufacturer will not be the sole source of information that the consumer is seeking or even requires. For this reason, there are requirements under § 866.5950(b)(3)(ii)(C)(2) and (b)(3)(iii)(L)(2) that the manufacturer of the test provide a pre-purchase page in the summary and technical information sections that includes information regarding professional guidelines for testing specific genes and variants. Similar information must be provided in the frequently asked questions section found in the summary and technical information sections on the manufacturer's website, under § 866.5950(b)(3)(ii)(C)(3) and (b)(3)(iii)(L)(3). These frequently asked questions sections must include a statement about the current professional guidelines for testing these specific gene(s) and variant(s) and, if guidelines do not exist for certain genes or variants being tested for, then this information must be provided as well. Further, to facilitate more personalized support, under § 866.5950(b)(1)(i)(E), test manufacturers are required to provide information in the § 809.10 (21 CFR 809.10) compliant labeling and any pre-purchase page and test report generated regarding how a user obtains access to a genetic counselor, board-certified clinical molecular geneticist, or equivalent healthcare professional regarding the results of a user's test.

The tests that fall under the genetic health risk assessment system regulation are identified in the regulation in § 866.5950(a) as a qualitative in vitro molecular diagnostic system used for detecting variants in genomic deoxyribonucleic acid (DNA) isolated from human specimens that will provide information to users about their genetic risk of developing a disease to inform lifestyle choices and/or conversations with a healthcare professional. This assessment system is for OTC use. This device does not determine the person's overall risk of developing a disease.

The limitations that are most important for lay users to know about the intended use of these tests that fall under this device type are conveyed via the limiting statements required, under § 866.5950(b)(1)(i), to be provided on the § 809.10 compliant labeling and any pre-purchase page and test report generated. One of these limiting statements must explain that this test is not intended to diagnose a disease, tell you anything about your current state of health, or be used to make medical decisions, including whether or not you should take a medication or how much of a medication you should take. The limitations that are most important for healthcare professionals to know about the intended use of tests that fall under this device type are, under § 866.5950(b)(1)(ii), required to be provided in the § 809.10 labeling and any test report generated. These limitations include that the test is intended to provide users with their genetic information to inform lifestyle decisions and conversations with their doctor or other healthcare professional and that any diagnostic or treatment decisions should be based on testing and/or other information that a healthcare professional determines to be appropriate for a patient.

FDA believes the analytical validation requirements are sufficiently detailed in the special controls under § 866.5950(b)(3)(iii)(J) that test providers will have no difficulty in appropriately following these requirements. A high accuracy requirement is necessary for tests that are provided under this regulation and accuracy point estimates for all variants is required to be 99 percent or higher under § 866.5950(b)(3)(iii)(J)(1)(vii) or else they cannot be claimed or reported. Once FDA has reviewed one test that demonstrates this level of accuracy, then the test provider has demonstrated an ability to meet the accuracy requirements for additional similar tests offered.

FDA agrees that there are four important express limitations to the types of tests that can be offered under this classification regulation even when these special controls are met. Tests cannot be offered under this classification regulation that are indicated for prenatal testing; predisposition for cancer where the result of the test may lead to prophylactic screening, confirmatory procedures, or treatments that may incur morbidity or mortality to the patient; assessing the presence of genetic variants that impact the metabolism, exposure, response, risk of adverse events, dosing, or mechanisms of prescription or OTC medications; or assessing the presence of deterministic autosomal dominant variants.

It is a prohibited act for devices to have labeling that is false or misleading in any particular manner, and thus FDA would deem such device to be misbranded under section 502(a) of the FD&C Act (21 U.S.C. 352(a)). This prohibition would include prohibiting the manufacturer of a genetic health risk assessment test device from falsely or misleadingly representing a test as having been part of an original FDA cleared device when it was added subsequently to FDA clearance. This prohibition would also include falsely or misleadingly representing the analytical or clinical validity of one of its tests. In addition, under section 502(c) of the FD&C Act, it is a prohibited act and thus FDA would deem a device to be misbranded if any information required on the labeling of a device by FDA by or under the FD&C Act is not placed prominently thereon with such conspicuousness and in such terms, as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. Thus, a genetic health risk assessment test device for which a manufacturer later modified the formerly compliant labeling to make the labeling such that the labeling was not likely to be read and understood by the ordinary individual under customary conditions of purchase and use would be a misbranded device.

In summary, all tests that are marketed under this classification regulation must meet the general controls and the special controls that are specified in the regulation. Ability of a manufacturer to meet these special controls is demonstrated during the one-time review. Even after the one-time review, the general controls and special controls must continue to be met, including for all tests added or modified after the one-time review of a manufacturer's device.

FDA has determined that 510(k) is not necessary to assure the safety and effectiveness of the class II devices listed in table 1. This determination is based, in part, on the Agency's knowledge of the device, including past experience and relevant reports or studies on device performance (as appropriate), the applicability of general and special controls, and the Agency's ability to limit an exemption.

FDA's exemption from 510(k) for class II devices listed in table 1 applies only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type, or, in the case of in vitro diagnostic devices, for which a misdiagnosis, as a result of using the device, would not be associated with high morbidity or mortality. A manufacturer of a listed device is still required to submit a 510(k) to FDA before introducing a device or delivering it for introduction into commercial distribution when the device meets any of the conditions described in §§ 862.9 to 892.9 (21 CFR 862.9 to 21 CFR 892.9).

In addition to the general limitations, FDA may also partially limit an exemption from 510(k) requirements to specific devices within a listed device type when initial Agency assessment determines that the factors laid out in the Class II 510(k) Exemption Guidance do not weigh in favor of exemption for all devices in a particular group. In such situations where a partial exemption limitation has been identified, FDA has determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices. In table 1, for example, FDA is listing the exemption of the genetic health risk assessment system, but limits the exemption to such devices that have received a first-time FDA marketing authorization (e.g., 510(k) clearance) for the genetic health risk assessment system (a “one-time FDA reviewed genetic health risk assessment system”). FDA has determined that a one-time FDA review (e.g., premarket notification) of a genetic health risk assessment system is necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined that a one-time FDA review of a genetic health risk assessment system is necessary to mitigate the risk of false negatives and false positives by ensuring that certain information be submitted to FDA to allow the Agency to assess the safety and effectiveness of the devices as well as to ensure the devices perform to acceptable standards.

Exemption from the requirement of 510(k) does not exempt a device from other applicable regulatory controls under the FD&C Act, including the applicable general and special controls. This exemption from 510(k), subject to the limitations described above, is immediately in effect for the device types identified in table 1. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulations.

FDA is identifying the following list of class II devices that will no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in §§ 862.9 to 892.9 and any partial exemption limitations identified in table 1:

FDA is revising the name of product code PUP to further clarify the device type that this product code is intended to represent. The device type was previously “Endoscope Maintenance System.” To more accurately reflect the devices which fall within this device type (product code PUP), the device type has been renamed “Endoscope Disinfectant Basin.” Specifically, these devices are described as “Wall-mounted tube(s) for holding disinfectant solution and endoscope insertion tubes and accessories.” This description has not changed since publication of the November 2017 notice.

The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order refers to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 862, 866, 876, 880, and 884 are amended as follows:

In an effort to reduce homelessness in the veteran population, Congress has required VA to expand its benefits for homeless veterans by establishing a new grant program to provide funds to organizations within communities that will provide case management services to improve the retention of housing by veterans who were previously homeless and are transitioning to permanent housing and to veterans who are at risk of becoming homeless. See Public Law 114-315, sec. 712 (Dec. 16, 2016) (codified at 38 U.S.C. 2013). This interim final rule adds this new case management program to VA's Homeless Providers Grant and Per Diem Program regulations by adding a new subpart G to 38 CFR part 61 to accurately reflect these changes in law. The new case management program will mirror existing homeless grant per diem programs as much as possible for ease of administrating and running the new grant program.

Paragraph (a) of § 61.90 states that non-profit organizations and State, local, and tribal governments are eligible to apply for a grant to provide case management services. (For purposes of this program, the term “tribal government” means an entity described in paragraph (2) of the definition of public entity in 38 CFR 61.1.) To ensure that grant funding is used to provide case management services to as many veterans as possible, this same paragraph provides that case management services grant funds under this program “may not be used for veterans who are receiving case management services from permanent supportive housing programs (e.g. Housing and Urban Development-VA Supportive Housing) or rapid re-housing/homeless prevention programs (e.g. Supportive Services for Veterans Families (SSVF)).” Paragraph (b) identifies examples of case management services that grantees can provide using these grant funds. Such services include, but are not limited to, “Making home visits by the case manager to monitor housing stability; Providing or coordinating educational activities related to meal planning, tenant responsibilities, the use of public transportation, community resources, financial management, and the development of natural supports; Making referrals to needed services, such as mental health, substance use disorder, medical, and employment services; and Participating in case conferencing with other service providers who are working with the veteran.” Paragraph (c) sets a 6-month time limit for veterans to receive case management services. However, VA may approve a request to extend services beyond the 6-month period if an organization submits a request to VA in writing and VA approves it before the 6-month time limit expires. Because in most circumstances case management services are provided to veterans after they have been in receipt of benefits under the Grant and Per Diem Program, VA believes that 6 months would, in most cases, be sufficient time for a veteran to have the necessary tools in place to retain permanent housing.

For ease of administration and internal consistency between grant programs benefiting homeless veterans, VA will, to the extent applicable and appropriate, adopt standards for the new case management services grant program from its existing capital grants program. VA has successfully used the application package requirements and rating criteria for the capital grants program found in in §§ 61.12 and 61.13 for other grant programs. See §§ 61.32 and 61.41, We, therefore, adopt these requirements and rating criteria as relevant and slightly modified to meet the needs of the case management services grant program, expecting their use will render equally successful results here. Specifically, an applicant must submit an application package for case management services grants, which must:

• Be on the correct application form.

• Be completed in all parts, including all information requested in the Notice of Fund Availability (NOFA).

• Include a signed Application for Federal Assistance (SF 424) that contains the Employer Identification Number or Taxpayer Identification Number (EIN/TIN) that corresponds to the applicant's Internal Revenue Service (IRS) 501(c)(3) or (19) determination letter. Applicants that apply under a group EIN/TIN must be identified by the parent EIN/TIN as a member or sub-unit of the parent EIN/TIN and provide supporting documentation.

• Be received before the deadline specified by the NOFA.

In addition, the applicant must be an eligible entity at the time of application; the activities for which funding is requested must be eligible for funding under this subpart; the applicant must submit an application and agree to comply with the requirements of this subpart and demonstrate the capacity to do so; the applicant must not have any outstanding obligation to VA that is in arrears, or have an overdue or unsatisfactory response to an audit; and, the applicant must not have been notified by VA as being in default. If the applicant does not meet any one of these requirements, the application will be rejected without further consideration.

As to the rating criteria, the criteria in § 61.13 have been adopted and modified for purposes of this more narrow program, as listed in full in the regulatory text. So, an applicant under this program must receive at least 750 points out of a possible 1000 in order to be considered eligible to receive a grant for case management services. Generally speaking, VA will grant points as follows: Up to 400 points for project planning; up to 200 points for the applicant's ability to develop and operate a project; up to 150 points for the demonstration of a substantial unmet need for supportive services for formerly homeless veterans; up to 50 points based on the review panel's confidence that the applicant has effectively demonstrated that the grant can be completed as described in the application; and up to 200 points for demonstrating the applicant has coordinated with Federal, state, local, private and other entities serving homeless persons or persons at risk for homelessness in the planning and operation of the case management services project.

Section 61.94 describes the selection process for grants available under this subpart and sets out the priorities among applicants as established in the law. Public Law 114-315 mandates that VA give extra priority to organizations that voluntarily stop receiving amounts provided by the Secretary under sections 2012 and 2061 of title 38 and converts a facility that the organization used to provide transitional housing services into a facility that the organization uses to provide permanent housing that meets housing quality standards established under section 8(o)(8)(B) of the United States Housing Act of 1937 (42 U.S.C. 1437f(o)(8)(B)). This extra priority is provided for in paragraph (a)(1) of § 61.94. We would add that in order to obtain this extra priority, organizations must provide documentation showing that the permanent housing meets these housing quality standards. VA will thus award case management services grants first to applicants whose applications that meet the criteria of § 61.94(a)(1). The Public Law also states that VA shall give priority to organizations that demonstrate a capability to provide case management services . . . particularly organizations that are successfully providing or have successfully provided transitional housing services using amounts provided by the Secretary under sections 2012 and 2061 of title 38. We are stating this priority in paragraph (a)(2). So, once all applications described in the “extra priority” paragraph are awarded a grant, VA will award grants to those who qualify for priority under paragraph (a)(2). Paragraph (a)(3) provides that VA may also consider applications from other organizations without a Grant and Per Diem grant that seek to provide time limited case management services “to formerly homeless veterans who have exited VA transitional housing or other VA homeless residential treatment services to permanent housing.” In order to permit VA to rank applications for these grants within each priority, paragraph (b) will state that within each of the three priorities in paragraph (a), an application with more points using the rating criteria in § 61.92(b) will be given a higher priority for a grant award. Ranking applications within each priority would be needed if VA only has enough funds to award grants to some but not all applicants in one of the above priorities.

Section 61.96 describes the award and funding process for grants available under this subpart and identifies permissible uses for the grant funds. Paragraph (a) states that funding for grants for case management services will be offered from the Grant and Per Diem Program budget and will be annually limited by VA's funding availability and commitments to existing programs. VA's aim is to alert potential applicants that yearly funding for the program may vary, which will be stated in the NOFA. Because the available funding for the grants for case management services is limited, paragraph (b) identifies the limited authorized uses of grant funds for costs associated with administrating these grants. Specifically, case management services grant funds may be used for the following administrative purposes: Providing funding for case management staff; providing transportation for the case manager; providing cell phones and computers to facilitate home visits and other case management activities associated with the grant; and, providing office furniture for the use of the case management staff. For all grants awarded under this section, VA will incorporate into the grant agreements the agreement and funding actions described in § 61.61, which currently apply to the Grant and Per Diem Program. This will help align operations for this new grant program with current Grant and Per Diem Program practices. Paragraph (c) therefore states that VA will execute an agreement and make payments to the grantee in accordance with the award and funding actions applicable to the Grant and Per Diem Program as described in § 61.61.

Section 61.98 provides that VA will oversee grants to make certain that grantees operate their programs in accordance with the requirements of §§ 61.90 through 61.98. VA's oversight responsibilities include reviewing and responding to requests from grantees for extensions to the otherwise applicable maximum 6-month time limit. Further, this section states that grantees must also comply with the requirements of 38 CFR 61.65, 61.67(d), 61.67(e), and 61.80(c), (g), (h), (i), (n), (o), (p), and (q). Section 61.80 sets forth requirements for supportive housing and service centers for which assistance is provided under part 61. The assistance provided with case management services grants will not be for the construction, acquisition, renovation, or operation of supportive housing or service centers. We will thus not require grantees under this program to comply with those requirements in § 61.80 pertaining to housing and service centers. For example, VA will not require the housing in which the veterans who obtain services under this program reside to comply with the Life Safety code and state and local housing codes, licensing requirements, fire and safety requirements, or any other State of local requirements as would be otherwise imposed under § 61.80(a). We will also not require that supportive housing in which veterans who receive assistance under this program reside comply with the structural, space, and operational requirements in § 61.80(b) through (f), (m), and (r). We will not require compliance under this program with the requirements for service centers in § 61.80(k) and (l). Finally, we have addressed the requirements in § 61.80(j) by providing that VA may disapprove use of services provided by the grantee if VA determines that such services are of unacceptable quality in which case grant funds may not be used to pay for such services. VA lacks the authority to manage private or public entities and can only select grantees and oversee compliance with the terms of grant agreements consistent with §§ 61.90 through 61.98. VA similarly inspects and provides oversight to other Grant and Per Diem programs as a means to verify that grant funds and services are properly delivered by the grantee. As all transitional housing grants have some form of case management, we will apply the oversight requirements of 38 CFR part 61, subpart F, (in addition to those specifically listed above in § 61.80) as applicable, to grantees in the case management services program.

In accordance with U.S.C. 553(b)(B) and (d)(3), the Secretary of Veterans Affairs has concluded that there is good cause to publish this rule without prior opportunity for public comment and to publish this rule with an immediate effective date. This final rule implements the mandates of section 712 of Public Law 114-315. Section 712 mandates that VA have regulations in place to implement this section no later than one year after the date of the enactment of the Public Law, which was December 16, 2017. One of VA's top priorities is the elimination of homelessness among the veteran population. This rule will, in support of this goal, provide veterans with case management services that will assist them in obtaining and maintaining permanent housing. This rule incorporates statutory requirements and complements the already existing Grant and Per Diem Program. The additional time associated with a public comment period would disadvantage and cause hardship to veterans who are in immediate or near-future need of the case management services available under this program (to avoid lapsing to a state of homelessness) and therefore would be contrary to the public interest. The Secretary finds that it is impracticable and contrary to the public interest to delay this rule for the purpose of soliciting advance public comment or to have a delayed effective date. For the above reason, the Secretary issues this rule as an interim final rule with an immediate effective date. VA will consider and address comments that are received within 60 days of the date this interim final rule is published in the Federal Register.

Title 38 of the Code of Federal Regulations, as revised by this interim final rule, represents VA's implementation of its legal authority on this subject. Other than future amendments to this regulation or governing statutes, no contrary guidance or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rule if possible or, if not possible, such guidance is superseded by this rule.

This interim final rule includes a provision constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) that requires approval by the Office of Management and Budget (OMB). Accordingly, under 44 U.S.C. 3507(d), VA has submitted a copy of this rulemaking to OMB for review.

OMB assigns control numbers to collections of information it approves. VA may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Section 61.92 contains a collection of information under the Paperwork Reduction Act of 1995. If OMB does not approve the collection of information as requested, VA will immediately remove the provision containing a collection of information or take such other action as is directed by OMB.

Comments on the collection of information contained in this interim final rule should be submitted to the Office of Management and Budget, Attention: Desk Officer for the Department of Veterans Affairs, Office of Information and Regulatory Affairs, Washington, DC 20503, with copies sent by mail or hand delivery to the Director, Regulations Management (00REG), Department of Veterans Affairs, 810 Vermont Avenue NW, Room 1068, Washington, DC 20420; fax to (202) 273-9026; or through www.Regulations.gov. Comments should indicate that they are submitted in response to “RIN 2900-AQ15 Case Management Services Grant Program.”

OMB is required to make a decision concerning the collections of information contained in this interim final rule between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment to OMB is best assured of having its full effect if the comment is received within 30 days of publication. This does not affect the 60-day deadline for the public to comment on the interim final rule.

VA considers comments by the public on proposed collections of information in—

• Evaluating whether the proposed collections of information are necessary for the proper performance of the functions of VA, including whether the information will have practical utility;

• Evaluating the accuracy of VA's estimate of the burden of the proposed collections of information, including the validity of the methodology and assumptions used;

• Enhancing the quality, usefulness, and clarity of the information to be collected; and

• Minimizing the burden of the collections of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

The collections of information contained in regulatory section 38 CFR 61.92 are described immediately following this paragraph, under their respective titles.

Title: Case Management Services Grant Program.

Summary of collection of information: Paragraph (a) requires that the applicant must meet the application requirements in this paragraph (a) or the application will be rejected and not considered further. Such documentation must be submitted to VA by the deadline established in the Notice of Fund Availability.

Description of the need for information and use of information: The information is needed to establish eligibility for a case management services grant.

Description of likely respondents: Non-profit organizations, State and local governments, or Tribal Indian governments who seek to receive a case management services grant.

Estimated number of respondents per month/year: 100.

Estimated frequency of responses per month/year: 1 time per year.

Estimated average burden per response: 35 minutes.

Estimated total annual reporting and recordkeeping burden: 58 hours.

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule will only impact those entities that choose to participate and apply for a grant. Small entity applicants will not be affected to a greater extent than large entity applicants. Small entities must elect to participate, and it is considered a benefit to those who choose to apply. To the extent this final rule will have any impact on small entities, it will not have an impact on a substantial number of small entities. VA estimates that possibly up to 150 organizations will submit grant applications under this program and so be affected by this rule. The Secretary therefore certifies that the adoption of this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” requiring review by OMB, unless OMB waives such review, as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's website at http://www.va.gov/orpm/, by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year to Date.” This rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.

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

The Catalog of Federal Domestic Assistance program number and title for this interim final rule are as follows: 64.024 VA Homeless Providers Grant and Per Diem Program.

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Jacquelyn Hayes-Byrd, Acting Chief of Staff, Department of Veterans Affairs, approved this document on May 31, 2018, for publication.

For the reasons set forth in the preamble, we are amending 38 CFR part 61 as follows:

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

The background for this action is discussed in detail in our March 22, 2018 proposal (83 FR 12522). In that document we proposed to approve the December 1, 2015 i-SIP submittal from Texas Commission on Environmental Quality (TCEQ) pertaining to the implementation, maintenance and enforcement of the 2012 PM2.5 NAAQS in Texas and three of the four of the interstate transport requirements.

We received two comments in support of our proposal, one from the TCEQ and one that was anonymously submitted. We also received seventeen comments that are not relevant to the action we proposed. All comments can be found in the docket for this action.

Comment: TCEQ commented that while they are in support of our proposed approval that Texas meets its infrastructure and transport obligation for the 2012 PM2.5 NAAQS, they believe that Texas is meeting all four sub-element requirements of Section 110(a)(2)(D)(i). TCEQ noted that EPA did not provide an explanation as to why no action was taken on the interference with visibility provision for CAA Section 110(a)(2)(D)(i)(II).

Response: We acknowledge TCEQ's support of our proposed action. We note that we did not propose to take any action on the portion of the SIP submittal that was submitted to address the interference with visibility provision found in CAA Section 110(a)(2)(D)(i)(II), therefore the comment related to this provision is outside the scope of this action. EPA believes the visibility transport provision is closely related to the Act's Regional Haze requirements and therefore, intends to address this provision separately in a future action.

We are finalizing this rule as proposed, therefore approving the portions of the December 1, 2015 2012 PM2.5 NAAQS i-SIP submittal pertaining to implementation, maintenance and enforcement including transport except for sub-element four pertaining to interference with visibility protection in other states.

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:

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 6, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On June 22, 2010, EPA promulgated a new 1-hour primary SO2 NAAQS of 75 parts per billion (ppb), which is met at an ambient air quality monitoring site when the 3-year average of the annual 99th percentile of daily maximum 1-hour concentrations does not exceed 75 ppb, as determined in accordance with appendix T of 40 CFR part 50. See 75 FR 35520, codified at 40 CFR 50.17(a) and (b). On August 5, 2013, EPA designated a first set of 29 areas of the country as nonattainment for the 2010 SO2 NAAQS, including the Central New Hampshire Nonattainment Area within the State of New Hampshire. See 78 FR 47191, codified at 40 CFR part 81, subpart C. These “round one” area designations were effective October 4, 2013. Section 191(a) of the CAA directs states to submit SIPs for areas designated as nonattainment for the SO2 NAAQS to EPA within 18 months of the effective date of the designation, i.e., by no later than April 4, 2015 in this case. These SIPs are required to demonstrate that their respective areas will attain the NAAQS as expeditiously as practicable, but no later than 5 years from the effective date of designation, which is October 4, 2018, in accordance with CAA sections 191-192.

Section 192(a) requires that such plans shall provide for NAAQS attainment as expeditiously as practicable, but no later than 5 years from the effective date of the nonattainment designation. Section 172(c) of part D of the CAA lists the required components of a nonattainment plan submittal. The base year emissions inventory (section 172(c)(3)) is required to show a “comprehensive, accurate, current inventory” of all relevant pollutants in the nonattainment area. The nonattainment plan must identify and quantify any expected emissions from the construction of new sources to account for emissions in the area that might affect reasonable further progress (RFP) toward attainment, or that might interfere with attainment and maintenance of the NAAQS, and it must provide for a nonattainment new source review (NNSR) program (section 172(c)(5)). The attainment demonstration must include a modeling analysis showing that the enforceable emissions limitations and other control measures taken by the state will provide for RFP and expeditious attainment of the NAAQS (section 172(c)(2), (4), (6), and (7)). The nonattainment plan must include an analysis and provide for implementation of the RACM considered, including RACT (section 172(c)(1)). Finally, the nonattainment plan must provide for contingency measures (section 172(c)(9)) to be implemented either in the case that RFP toward attainment is not made, or in the case that the area fails to attain the NAAQS by the attainment date.

On April 23, 2014, EPA issued a guidance document entitled, “Guidance for 1-Hour SO2 Nonattainment Area SIP Submissions.” This guidance provides recommendations for the development of SO2 nonattainment SIPs to satisfy CAA requirements (see, e.g., sections 172, 191, and 192). An attainment demonstration must also meet the requirements of 40 CFR part 51, subparts F and G, and 40 CFR part 51, appendix W (the Guideline on Air Quality Models; “the Guideline”), and include inventory data, modeling results, and emissions reduction analyses on which the state has based its projected attainment. The guidance also discusses criteria EPA expects to use in assessing whether emission limits with longer averaging times of up to 30 days ensure attainment of the SO2 NAAQS.

For a number of areas, including the Central New Hampshire Nonattainment Area, EPA published a document on March 18, 2016, that pertinent states had failed to submit the required SO2 nonattainment plan by the submittal deadline. See 81 FR 14736. This finding initiated a deadline under CAA section 179(a) for the potential imposition of new source review and highway funding sanctions, and for EPA to promulgate a federal implementation plan (FIP) under section 110(c) of the CAA. In response to the requirement for SO2 nonattainment plan submittals, New Hampshire submitted a nonattainment plan for the Central New Hampshire Nonattainment Area on January 31, 2017. Pursuant to New Hampshire's January 31, 2017 submittal and EPA's subsequent completeness determination letter dated March 20, 2017, these sanctions under section 179(a) will not be imposed as a result of New Hampshire's having missed the April 4, 2015 submission deadline. Furthermore, with this current action issuing final approval of New Hampshire's SIP submittal, EPA's FIP obligation no longer applies, and no FIP will be imposed as a result of New Hampshire's missing the deadline.

On November 29, 2017, EPA received a letter from New Hampshire correcting a misstatement in its January 2017 submittal to EPA. The State had earlier intended to modify its January 2017 submittal to EPA in response to a public comment on its draft nonattainment area plan, but inadvertently neglected to make the correction. Specifically, the State enclosed in its January 2017 submittal to EPA all comments and responses to comments relating to its draft nonattainment area plan, and among those was a set of comments submitted by Sierra Club to the State on January 5, 2017. Among other comments, Sierra Club asserted that the draft nonattainment area plan “incorrectly suggests that an attainment demonstration can be made based on monitor readings alone,” counter to EPA's April 2014 guidance, and stated that the plan should be revised to remove this inconsistency. In its response to that comment, New Hampshire indicated that it would remove the language per Sierra Club's comment, but inadvertently included the erroneous language nonetheless in its January 2017 submittal to EPA. New Hampshire's November 29, 2017 correction modifies the State's original submittal to exclude the erroneous language identified by Sierra Club, consistent with the State's response to comments. Hereafter, references to the State's January 31, 2017 SIP submittal are intended to include the November 29, 2017 correction.

On September 28, 2017 (82 FR 45242), EPA proposed to approve New Hampshire's January 31, 2017 nonattainment plan submittal and SO2 attainment demonstration. The State's submittal and attainment demonstration included all the specific attainment elements mentioned above, including new SO2 emission limits found to be comparably stringent to the 1-hour form of the primary SO2 NAAQS and associated control technology efficiency requirements for the electric generating source Merrimack Station, currently owned and operated by GSP Merrimack LLC and formerly by Public Service of New Hampshire (PSNH) d/b/a Eversource Energy, impacting the Central New Hampshire Nonattainment Area. Merrimack Station's new SO2 emission limits were developed in accordance with EPA's April 2014 guidance. Comments on EPA's proposed rulemaking were due on or before October 30, 2017. EPA received a single set of comments on the proposed approval of New Hampshire's nonattainment area plan for the Central New Hampshire Nonattainment Area. The comments are available in the docket for this final rulemaking action. EPA's summary of the comments and EPA's responses are provided below. For a comprehensive discussion of New Hampshire's SIP submittal and EPA's analysis and rationale for approval of the State's submittal and attainment demonstration for this area, please refer to EPA's September 28, 2017 notice of proposed rulemaking.

The remainder of this preamble summarizes EPA's final approval of New Hampshire's SIP submittal and attainment demonstration for the Central New Hampshire Nonattainment Area and contains EPA's response to public comments.

The single set of comments addressing the proposed approval of the SIP revision for the Central New Hampshire Nonattainment Area was received from Sierra Club on October 30, 2017. The Sierra Club's October 30, 2017 comments explicitly incorporated a July 15, 2016 comment letter with supporting attachments submitted to New Hampshire by Sierra Club on behalf of both Sierra Club and Conservation Law Foundation (CLF) regarding the State's proposed permit for Merrimack Station. Because the October 30, 2017 Sierra Club comments on EPA's proposal are nearly identical to the prior July 15, 2016 comments, except where the October 30, 2017 comments provide updated information, EPA's responses to the October 30, 2017 Sierra Club comments also serve to respond to issues raised in the July 15, 2016 comments to the State, except where EPA identifies discussion as specifically applying only to comments from July 15, 2016. In the following discussion, EPA will refer to the Sierra Club or Sierra Club/CLF as “the Commenter.” To review the complete set of comments received, refer to the docket for this rulemaking as identified above. A summary of the comments received and EPA's responses are provided below.

Comment 1: The commenter asserted that the proposed 7-day average limit on emissions from Merrimack Station is insufficient to protect the 1-hour NAAQS. The commenter indicated that short-term exposure to SO2 for as little as five minutes has significant health impacts and causes decrement in lung function, aggravation of asthma, chest tightness, and respiratory and cardiovascular morbidity. The commenter stated that such short-term exposure is especially risky for children with asthma. To support these statements regarding health effects, the commenter cited several EPA documents related to the final SO2 NAAQS and air quality trends. The commenter stated that EPA changed the NAAQS from 140 ppb averaged over 24 hours to 75 ppb averaged over one hour in order to address these health impacts. The commenter stated that as a result of the form of the standard, which is evaluated through reference to the fourth-highest daily maximum hourly-average concentrations in each year, emission limits with an averaging period longer than one hour are highly unlikely to be able to protect the 1-hour NAAQS. The commenter indicated that the form of the NAAQS means that ambient air quality can be evaluated as unsafe with as few as four hours of elevated emissions over the course of a year. The commenter stated that even if the 7-day limit is complied with, possible short-term emission “spikes” that may coincide with startup, shutdown, or control system malfunction events, for example, could nevertheless cause ambient 1-hour SO2 concentrations sufficient to violate the NAAQS. In support of this point, the commenter provided language making similar points excerpted from two EPA letters that had been included in the attachments to the commenter's July 15, 2016 comments to New Hampshire, specifically an August 12, 2010 comment letter from EPA Region 7 to Kansas regarding the Sunflower Holcomb Station Expansion Project, and a February 1, 2012 comment letter from EPA Region 5 to Michigan regarding a draft construction permit for the Detroit Edison Monroe Power Plant. The commenter concluded that the 7-day limit proposed for inclusion in the State's SIP has an averaging period that is 168 times longer than that of the 1-hour NAAQS and should be revised to adequately protect the NAAQS. The commenter added that hourly emissions limits are not unreasonable, and cited several examples of permits that impose such limits. Therefore, the commenter concluded that a 1-hour emissions limit should be imposed.

Response 1: EPA appreciates the commenter's concerns about the appropriateness of approving nonattainment plans with emission limitations that apply over a longer time period than the 1-hour form of the 2010 SO2 NAAQS. We discussed similar issues in EPA's April 2014 guidance. In this case, EPA has concluded that the approach employed by New Hampshire to develop the emission limitations for Merrimack Station and included in the State's SIP submittal is consistent with recommendations discussed in EPA's April 2014 guidance and adequately protects against violation of the 1-hour SO2 NAAQS. EPA's rationale for this conclusion is explained in further detail below.

The health effects information provided by the commenter is not in dispute in this rulemaking. This rulemaking instead addresses whether New Hampshire's plan is adequate to meet the previously established NAAQS.

As mentioned above, CAA section 172(c) directs states with areas designated as nonattainment to demonstrate that the submitted nonattainment plan provides for attainment of the NAAQS. EPA's rules at 40 CFR part 51, subpart G further delineate the control strategy requirements that SIPs must meet, and EPA has long required that all control strategies in nonattainment plans reflect four fundamental principles of quantification, enforceability, replicability, and accountability. See “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990; Proposed Rule,” 57 FR 13498 (April 16, 1992) (General Preamble), at 13567-68. Additional guidance is provided in EPA's April 2014 guidance. For SO2, there are generally two components needed to support an attainment demonstration submitted under section 172(c): (1) Emission limitations and other control measures that assure implementation of permanent, enforceable, and necessary emission controls; and (2) a modeling analysis that meets the requirements of 40 CFR part 51, appendix W and demonstrates that these emission limitations and control measures provide for timely attainment of the primary SO2 NAAQS as expeditiously as practicable, but by no later than the applicable attainment date for the affected area. In all cases, the emission limitations and control measures must be accompanied by appropriate methods and conditions to determine compliance with the respective emission limitations and control measures. Furthermore, in all cases, the emission limitations and control measures must be: Quantifiable (i.e., a specific amount of emission reduction can be ascribed to the measures), fully enforceable (specifying clear, unambiguous, and measurable requirements for which compliance can be practicably determined), replicable (the procedures for determining compliance are sufficiently specific and non-subjective such that two independent entities applying the procedures would obtain the same result), and accountable (source specific limitations must be permanent and must reflect the assumptions used in the SIP demonstrations).

In our April 2014 guidance, EPA notes that past Agency guidance has recommended that averaging times in SO2 SIP emissions limitations should not exceed the averaging time of the applicable NAAQS that the limit is intended to help attain (e.g., addressing emissions averaged over one or three hours). EPA's April 2014 guidance also discusses the possibility of utilizing emission limitations with longer averaging times of up to 30 days, so long as the state meets various suggested criteria to show that the longer-term limits are comparably stringent to the 1-hour critical emission value that is needed to meet the NAAQS. See EPA's April 2014 guidance, pp. 22 to 39. The guidance recommends that—should states elect to use longer averaging times—the longer-term average limit should be set at an adjusted level to reflect a stringency comparable to the 1-hour average critical emission value shown to provide for attainment through a modeling analysis that the plan otherwise would have set as an emission limit.

At the outset, EPA notes that the specific examples of earlier EPA statements cited by the commenter (i.e., those contained in Exhibits 1, 2, 3, and 4 to Appendix A of the comment submission) all pre-date the release of EPA's April 2014 guidance. As such these examples only reflect the Agency's development of its policy for implementing the 2010 SO2 NAAQS as of the dates of their own issuance. At the time of their issuance, EPA had not yet addressed the specific question of whether it might be possible to devise an emission limit with an averaging period longer than 1-hour, with appropriate adjustments that would make it comparably stringent to an emission limit shown to attain 1-hour emission level, that could adequately ensure attainment of the SO2 NAAQS. None of the pre-2014 EPA documents cited by the commenter address this question; consequently, it is not reasonable to read any of them as rejecting that possibility. However, EPA's April 2014 guidance specifically addressed this issue as it pertains to requirements for SIPs for SO2 nonattainment areas under the 2010 NAAQS, especially with regard to the use of appropriately set comparably stringent limitations based on averaging times as long as 30 days (see p. 2). EPA developed this guidance pursuant to a lengthy stakeholder outreach process regarding implementation strategies for the 2010 NAAQS, which had not yet concluded (or in some cases even begun) when the documents cited by the commenter were issued. As such, EPA's April 2014 guidance was the first instance in which the Agency provided recommended guidance for that component of this action. Consequently, EPA does not view those prior EPA statements as conflicting with the Agency's guidance addressing this specific question of how to devise a longer-term limit that is comparably stringent to a 1-hour critical emission value that has been modeled to attain the NAAQS. Moreover, EPA notes that the commenter has not raised specific objections to the general policy and technical rationale EPA provided in its proposed approval or in EPA's April 2014 guidance for why such longer-term averaging-based limits may in specific cases be adequate to ensure NAAQS attainment, which we again summarize below.

EPA's April 2014 guidance provides an extensive discussion of EPA's rationale for positing that an appropriately-set, comparably stringent limitation based on an averaging time as long as 30 days can, based on a situation's specific facts, be found to provide for attainment of the 2010 primary SO2 NAAQS, provided it is shown to be comparably stringent to a 1-hour critical emission value that is demonstrated through modeling to attain the NAAQS. Essentially, to achieve such comparable stringency, rather than simply convert an attaining 1-hour emission rate to a longer term limit at the same level, it is expected that an adjustment would be needed to lower the emission rate as the averaging time is increased. It is first necessary to identify a modeled 1-hour emission value that attains the NAAQS before deriving a comparably stringent longer-term emission limit, i.e., an emission limit that has been appropriately adjusted downward. In evaluating this option, EPA considered in the April 2014 guidance the nature of the standard, conducted detailed analyses of the impact of the use of 30-day average limits on the prospects for attaining the standard, and carefully reviewed how best to achieve an appropriate balance among the various factors that warrant consideration in judging whether a state's nonattainment plan provides for attainment. Id. at pp. 22 to 39. See also id. at appendices B, C, and D.

As specified in 40 CFR 50.17(b), the 1-hour primary SO2 NAAQS is met at an ambient air quality monitoring site when the 3-year average of the annual 99th percentile of daily maximum 1-hour concentrations is less than or equal to 75 ppb. In a year with 365 days of valid monitoring data, the 99th percentile would be the fourth highest daily maximum 1-hour value. The 2010 SO2 NAAQS, including this form of determining compliance with the standard, was upheld by the U.S. Court of Appeals for the District of Columbia Circuit in Nat'l Envt'l Dev. Ass'n's Clean Air Project v. EPA, 686 F.3d 803 (D.C. Cir. 2012). Because the standard has this form, a single exceedance of the numerical limit of 75 ppb does not constitute a violation of the standard. Instead, at issue is whether a source operating in compliance with a properly set longer-term average could cause exceedances, and if so the resulting frequency and magnitude of such exceedances. In particular, what matters is whether EPA can have reasonable confidence that a properly set longer-term average limit will provide that the 3-year average of annual fourth highest daily maximum values will be at or below 75 ppb. A synopsis of EPA's review of how to judge whether such plans “provide for attainment,” based on modeling of projected allowable emissions and in light of the form for determining attainment of the NAAQS at monitoring sites, follows.

For SO2 nonattainment plans based on 1-hour emission limits, the standard approach is to conduct modeling using fixed emission rates. The maximum emission rate that would be modeled to result in attainment (i.e., in an “average year” 1 shows fewer than four days with maximum hourly levels exceeding 75 ppb) is labeled the “critical emission value.” The modeling process for identifying this critical emission value inherently considers the numerous variables that affect ambient concentrations of SO2, such as meteorological data, background concentrations, and terrain. In the standard approach, the state would then provide for attainment by setting a continuously applicable 1-hour emission limitation at this critical emission value.

EPA recognizes that some sources may have highly variable emissions, for example due to variations in fuel sulfur content and operating rate, that can make it extremely difficult, even with a well-designed control strategy, to ensure in practice that emissions for any given hour do not exceed the critical emission value. EPA also acknowledges the concern that longer-term emission limits can allow short periods with emissions above the critical emission value, which, if coincident with meteorological conditions conducive to high SO2 concentrations, could create the possibility of a NAAQS exceedance occurring on a day when an exceedance would not have occurred if emissions were continuously controlled at the level corresponding to the 1-hour critical emission value. However, for several reasons, EPA finds that the approach recommended in its April 2014 guidance document suitably addresses this concern, and that in this case, New Hampshire has devised a longer-term limit that is comparably stringent to the 1-hour critical emission value that suitably provides for meeting the NAAQS.

First, from a practical perspective, EPA expects the actual emission profile of a source subject to an appropriately set longer-term average limit to be similar to the emission profile of a source subject to an analogous 1-hour average limit. EPA expects this similarity because it has recommended that the longer-term average limit be set at a level that is comparably stringent to the otherwise applicable 1-hour limit (reflecting a downward adjustment from the critical emission value) and that takes the source's emissions profile into account. As a general matter, EPA would expect that any emission limit with an averaging time longer than 1 hour would need to reflect a downward adjustment to compensate for the loss of stringency inherent in applying a longer term average limit. This expectation is based on the idea that a limit based on the 30-day average of emissions, for example, at a particular level is likely to be a less stringent limit than a 1-hour limit at the same level, since the control level needed to meet a 1-hour limit every hour is likely to be greater than the control level needed to achieve the same limit on a 30-day average basis. EPA's approach for downward adjustment is to account for the expected variability in emissions over the time period up to 30 days to achieve comparable stringency to the emissions and expected air quality impacts for a 1-hour period. As a result, EPA expects either form of emission limit to yield comparable air quality.

Second, from a more theoretical perspective, EPA has compared the likely air quality with a source having maximum allowable emissions under an appropriately set longer-term limit, as compared to the likely air quality with the source having maximum allowable emissions under the comparable 1-hour limit. In this comparison, in the 1-hour average limit scenario, the source is presumed at all times to emit at the critical emission value, and in the longer-term average limit scenario, the source is presumed occasionally to emit more than the critical emission value but on average, and presumably at most times, to emit well below the critical emission value. In an “average year,” compliance with the 1-hour limit is expected to result in three exceedance days (i.e., three days with maximum hourly values above 75 ppb) and a fourth day with a maximum hourly value at 75 ppb. By comparison, with the source complying with a longer-term limit, it is possible that additional exceedances would occur that would not occur in the 1-hour limit scenario (if emissions exceed the critical emission value at times when meteorology is conducive to poor air quality). However, this comparison must also factor in the likelihood that exceedances that would be expected in the 1-hour limit scenario would not occur in the longer-term limit scenario. This result arises because the longer-term limit requires lower emissions most of the time (because the limit is set below the critical emission value), so a source complying with an appropriately set longer-term limit is likely to have lower emissions at critical times than would be the case if the source were emitting as allowed with a 1-hour limit.

As a hypothetical example to illustrate these points, suppose a source that always emits 1,000 pounds of SO2 per hour, which results in air quality exactly at the level of the NAAQS (i.e., results in a design value of 75 ppb). Suppose further that in an “average year,” these emissions cause the five highest maximum daily average 1-hour concentrations to be 100 ppb, 90 ppb, 80 ppb, 75 ppb, and 70 ppb. Then suppose that the source becomes subject to a 30-day average emission limit of 700 pounds per hour, i.e., at a level adjusted downward from 1,000 pounds per hour by 30%. It is theoretically possible for a source meeting this limit to have emissions that occasionally exceed 1,000 pounds per hour, but with a typical emissions profile emissions would much more commonly be between 600 and 800 pounds per hour. In this simplified example, assume a zero background concentration, which allows one to assume a linear relationship between emissions and air quality. (A nonzero background concentration would make the mathematics more difficult but would give similar results.) Air quality will depend on how much emissions occur on which critical hours, but suppose that emissions at the relevant times on these five days are 800 pounds per hour, 1,100 pounds per hour, 500 pounds per hour, 900 pounds per hour, and 1,200 pounds per hour, respectively. (This is a conservative example because the average of these emissions, 900 pounds per hour, is well over the 30-day average emission limit of 700 pounds per hour.) These emissions would result in daily maximum 1-hour concentrations of 80 ppb, 99 ppb, 40 ppb, 67.5 ppb, and 84 ppb. In this example, the fifth day would have an exceedance that would not otherwise have occurred, but the third and fourth days would not have exceedances that otherwise would have occurred. In this example, the fourth highest maximum daily concentration under the 30-day average would be 67.5 ppb.

This simplified example illustrates the findings of a more complicated statistical analysis that EPA conducted using a range of scenarios using actual plant data. As described in appendix B of EPA's April 2014 guidance, EPA found that the requirement for lower average emissions is highly likely to yield better air quality than is required with a comparably stringent 1-hour limit. Based on analyses described in appendix B, EPA expects that an emission profile with maximum allowable emissions under an appropriately set comparably stringent 30-day average limit is likely to have the net effect of having a lower number of exceedances and better air quality than an emission profile with maximum allowable emissions under a 1-hour emission limit at the critical emission value. This result provides a compelling rationale for allowing the use of a longer averaging period, in appropriate circumstances where the facts indicate that this result can be expected to occur.

The question then becomes whether this approach—which is likely to produce a lower number of overall exceedances even though it may produce some unexpected exceedances above the 1-hour critical emission value—meets the requirement in sections 110(a) and 172(c) for state implementation plans to “provide for attainment” of the NAAQS. For SO2, as for other pollutants, it is generally impossible to design a nonattainment plan in the present that will guarantee that attainment will occur in the future. A variety of factors can cause a well-designed nonattainment plan to fail and unexpectedly not result in attainment, for example if meteorology occurs that is more conducive to poor air quality than was anticipated in the plan. Therefore, in determining whether a plan meets the requirement to provide for attainment, EPA's task is commonly to judge not whether the plan provides absolute certainty that attainment will in fact occur, but rather whether the plan provides an adequate level of confidence of prospective NAAQS attainment. From this perspective, in evaluating use of a longer-term limit up to 30-days, EPA must weigh the likely net effect on air quality. Such an evaluation must consider the risk that occasions with meteorology conducive to high concentrations will have elevated emissions leading to exceedances that would not otherwise have occurred, and must also weigh the likelihood that the requirement for lower emissions on average will result in days not having exceedances that would have been expected with emissions at the critical emission value. Additional policy considerations, such as in this case the desirability of accommodating real world emissions variability without significant risk of violations, are also appropriate factors for EPA to weigh in judging whether a plan provides a reasonable degree of confidence that the plan will lead to attainment. Based on these considerations, especially given the high likelihood that a continuously enforceable limit, averaged over as long as 30 days, determined in accordance with EPA's April 2014 guidance, will result in attainment, EPA posits as a general matter that such limits, if appropriately determined, can reasonably be considered to provide for attainment of the 2010 SO2 NAAQS. Furthermore, as discussed below, EPA concludes that in this case, New Hampshire has demonstrated that its longer-term limit was appropriately determined and provides for NAAQS attainment.

As stated by the commenter, the limit included in the State's SIP submittal is for a period of 7 days, or 168 hours. As stated above, EPA posits that limits based on periods of as long as 30 days (720 hours), determined in accordance with our April 2014 guidance, can, in many cases, be reasonably considered to provide for attainment of the 2010 SO2 NAAQS. In EPA's April 2014 guidance, EPA supplied an analysis of the impact of emissions variability on air quality and explained that it may be possible in some specific cases to develop control strategies that account for variability in 1-hour emissions rates through emissions limits with averaging times as long as 30 days and still provide for attainment of the 2010 SO2 NAAQS. Since seven days (168 hours) are well within the period of 30 days (720 hours), EPA has concluded that a limit for Merrimack Station based on a period of 7 days and determined in accordance with EPA's April 2014 guidance can be reasonably considered to provide for attainment.

EPA's April 2014 guidance offers specific recommendations for determining an appropriate longer-term average limit. The recommended method starts with determination of the 1-hour emission limit that would provide for attainment (i.e., the 1-hour critical emission value), and applies an adjustment factor to determine the (lower) level of the longer term average emission limit that would be estimated to have a stringency comparable to the otherwise necessary 1-hour emission limit. This method uses a database of continuous emission data reflecting the type of control that the source will be using to comply with the SIP emission limits, which (if compliance requires new controls) may require use of a different emission database, e.g., from a different but comparable facility using similar emissions control equipment. The recommended method involves using these data to compute a complete set of emission averages, computed according to the averaging time and averaging procedures of the prospective emission limitation. In this recommended method, the ratio of the 99th percentile among these longer-term averages to the 99th percentile of the 1-hour values represents an adjustment factor that may be multiplied by the candidate 1-hour emission limit (i.e., the critical emission value) to determine a longer-term average emission limit that may be considered comparably stringent.2 The guidance also addresses a variety of related topics, such as the potential utility of setting supplemental emission limits, such as mass-based limits, to reduce the likelihood and/or magnitude of elevated emission levels that might occur under the longer-term emission rate limit.

Preferred air quality models for use in regulatory applications are described in appendix A of the Guideline (40 CFR part 51, appendix W).3 In 2005, EPA promulgated AERMOD as the Agency's preferred near-field dispersion modeling for a wide range of regulatory applications addressing stationary sources (for example in estimating SO2 concentrations) in all types of terrain based on extensive developmental and performance evaluation. Supplemental guidance on modeling for purposes of demonstrating attainment of the SO2 standard is provided in appendix A to EPA's April 2014 guidance. Appendix A provides extensive guidance on the modeling domain, the source inputs, assorted types of meteorological data, and background concentrations. Consistency with the recommendations in this guidance is generally necessary for the attainment demonstration to offer adequately reliable assurance that the plan provides for attainment.

As stated previously, attainment demonstrations for the 2010 1-hour primary SO2 NAAQS must demonstrate future attainment and maintenance of the NAAQS in the entire area designated as nonattainment (i.e., not just at the violating monitor) by using air quality dispersion modeling (see appendix W to 40 CFR part 51) to show that the mix of sources and enforceable control measures and emission rates in an identified area will not lead to a violation of the SO2 NAAQS. For a short-term (i.e., 1-hour) standard, EPA asserts that dispersion modeling, using allowable emissions and addressing stationary sources in the affected area (and in some cases those sources located outside the nonattainment area which may affect attainment in the area) is technically appropriate, efficient, and effective in demonstrating attainment in nonattainment areas because it takes into consideration combinations of meteorological and emission source operating conditions that may contribute to peak ground-level concentrations of SO2.

Regarding the commenter's position that only hourly SO2 emissions limits are reasonable, citing the examples supplied in the commenter's submission, EPA agrees that 1-hour limits can be reasonable and protective so long as they are adequately supported by an attainment demonstration establishing those limits as meeting the NAAQS. In this action, EPA is not changing its position regarding the sufficiency in meeting the NAAQS with 1-hour emissions limitations to which other facilities, as cited by the commenter, are subject. The fact that New Hampshire could reasonably have chosen to establish 1-hour limits does not mean that EPA should disapprove limits with comparable stringency using longer averaging times. In this instance, the State's emission limit for Merrimack Station utilizes a 7-day average, and New Hampshire has shown it to be comparably stringent to a 1-hour limit at the critical emission level, which the State demonstrated to suitably provide for attainment of the NAAQS.

Based on EPA's review of the State's submittal, EPA finds that the 7-day average limit of 0.39 pounds (lb) per million British thermal units (MMBtu) established for Merrimack Station provides for a suitable alternative to establishing a 1-hour average emission limit for this source. New Hampshire used a suitable data profile in an appropriate manner and has thereby applied an appropriate adjustment, yielding emission limits that have comparable stringency to the 1-hour average limit that the State determined would otherwise have been necessary to provide for attainment. While the longer-term averaging limit allows occasions in which emissions may be higher than the level that would be allowed with the 1-hour limit, the State's limits compensate by requiring average emissions to be adequately lower than the level that would otherwise have been required by a 1-hour average limit. The September 28, 2017 notice of proposed rulemaking provided a detailed description of EPA's rationale for the proposed finding that the 7-day average limit for Merrimack Station is adequate to provide for attainment, and the commenter has not raised any concerns about this approach that we have not already addressed.

Comment 2: The commenter states that the 7-day average approach would mask significant hours in which emissions are above safe levels. The commenter then presents information regarding historic hourly emissions from Merrimack Station after the flue gas desulfurization (FGD) scrubber system was installed. Specifically, using data from EPA's Air Markets Program Data (AMPD), the commenter identified over 224 individual hours on 62 separate days in the period between January 1, 2012, through September 30, 2017, during which emissions were above the 1-hour critical emission rate of 0.54 lb/MMBtu,4 i.e., the maximum hourly emission rate determined to be protective of the NAAQS. The commenter indicated that during the same period, there do not appear to have been any 7-day periods in which average emissions exceeded the 0.39 lb/MMBtu limit in the SIP revision. The commenter asserts that this disparity, i.e., the fact that emissions during over 224 hours on 62 separate days exceeded the 1-hour critical emission rate of 0.54 lb/MMBtu while the 7-day limit was not exceeded during the time period from January 2012 through September 2017, indicates that the downwardly adjusted 0.39 lb/MMBtu 7-day limit is inadequate to protect the NAAQS.

Response 2: The commenter implies that occasions of emissions above the 1-hour critical emission rate, notwithstanding compliance with a 7-day limit, create an unacceptable risk of additional exceedances that would result in violation of the standard. EPA does not agree with this notion, and the commenter has not supplied evidence to support it. Furthermore, in making this claim, the commenter is relying on an emissions dataset that, for the reasons enumerated below, is not appropriate for assessing the prospective likelihood of Merrimack Station emitting more than the critical emission value, which may result in unsafe air quality. First, the dataset includes emissions from periods during which Merrimack Station was not subject to State permit conditions on the operation of its FGD scrubber system, and is therefore not representative of current and expected future emissions. Second, the dataset includes some emission values that are unrealistically high because they are calculated or substitute data used for purposes of determining compliance with EPA's Acid Rain Program rather than measured data used for determining emissions for compliance with the 7-day limit. Third, emission data for Merrimack Station show that the facility has rarely emitted above the critical emission rate of 0.54 lb/MMBtu since September 1, 2016, when the State's permit TP-0189 became applicable and enforceable. Fourth, the State's rate-based emission limit is designed to ensure consistent control at all load levels during operation, so an exceedance of the critical emission rate (in lb/MMBtu) does not necessarily mean that emissions are higher than the critical emission value (in lb/hour). Fifth and finally, if actual measured emissions from Merrimack Station had occurred at the levels indicated by the commenter, the facility would have violated the current 7-day emission limit, had it been in place at the time, and therefore these data are not evidence that compliance with the 7-day limit would result in a higher risk of NAAQS violations. Each of these points is discussed in greater detail below.

By reviewing the AMPD emissions data using EPA's Field Audit Checklist Tool (FACT) 5 for the period between January 1, 2012, and March 31, 2018, EPA found 227 hours with emissions above 0.54 lb/MMBtu, a number that is consistent with the “over 224 hours” identified by the commenter. In the following discussion, EPA identifies the number of hours of those 227 hours that are not appropriate to use in the analysis of the adequacy of the 7-day emission limit. EPA has included a spreadsheet in the docket of this action which contains the relevant data used in EPA's analysis.

(1) The FGD at Merrimack Station first became operational on September 28, 2011. Under the conditions established in the State's permit TP-0008, Merrimack Station was not permitted to operate MK2, one of its two utility boilers, unless the FGD was in operation. Merrimack Station's other utility boiler, MK1, was permitted to bypass the FGD system for no more than 840 hours per consecutive 12-month period. Both of these permit conditions became applicable and enforceable as of July 1, 2013. (This emission bypass provision is no longer permitted under the September 1, 2016 TP-0189 permit.) Prior to July 1, 2013, the facility was not subject to enforceable permit conditions requiring operation of the FGD. During 2012, Merrimack Station bypassed the FGD for emissions from MK1 on several occasions, the last of which occurred on November 7, 2012. As such, EPA does not view emissions occurring at Merrimack Station prior to July 1, 2013 as being representative of current or expected future emissions because prior to this date the relevant, enforceable permit provisions that required operation of the emission control system at Merrimack Station, as contained in permit number TP-0008, were not effective. Of the 227 hours with emissions above 0.54 lb/MMBtu, there were 188 hours that occurred prior to July 1, 2013, leaving 39 hours for further analysis.

(2) Merrimack Station is subject to emission monitoring and reporting requirements under the Acid Rain Program (40 CFR part 75). Under the Acid Rain Program, Merrimack Station must hold sufficient emission allowances to account for its SO2 emissions. For hours in which direct, quality-assured measurements from the continuous monitoring systems (CEMS) are not available, EPA's Acid Rain Program regulations require that high emission values are calculated or substituted for the emissions that are not monitored in order to ensure that the source holds sufficient allowances to account conservatively for its emissions. See 40 CFR part 75 subpart D. As described in New Hampshire's response to comments for its nonattainment area plan, the CEMS at Merrimack Station was certified on November 21, 2011 using only the low range of a dual range analyzer to measure from 0 to 300 parts per million (ppm) SO2 of in-stack exhaust gas. When the low range was exceeded, i.e., in-stack exhaust gas exceeded 300 ppm SO2, a calculated value of 200% of the maximum potential or uncontrolled concentration was reported to ensure that under reporting did not occur for purposes of the Acid Rain Program. As part of a periodic reassessment of the appropriate analyzer ranges, Merrimack Station retained a low range configuration and adjusted it to measure from 0 to 150 ppm on January 28, 2013. See section 2.1.1.5 of appendix A to 40 CFR part 75. On February 4, 2015, Merrimack Station began calibrating and quality-assuring the high range of the dual range analyzer from 150 to 2,600 ppm, while the lower range continued to be quality assured to measure between 0 and 150 ppm. In accordance with Acid Rain Program requirements, Merrimack Station was required to report calculated emissions at 200% of the maximum potential or uncontrolled concentration during the period from November 21, 2013 to February 4, 2015 when concentrations exceeded the lower range, i.e., in-stack exhaust gas exceeded 300 ppm. See section 2.1.1.4(f) of Appendix A to 40 CFR part 75. These hours are marked as SO2 Method Of Determination Code (MODC) 19 in the FACT database and were reported as such in the hourly electronic emissions records. Additional CEMS outage hours that used substitute data calculated as the average of the hour before and after, reported as SO2 MODC 06, are not measured emissions data but rather are substitute data hours. EPA concludes from the CEMS data that data points flagged as calculated or substitute data with SO2 MODC 06 or 19 are not appropriate for use in assessing NAAQS compliance in this case because these values do not represent actual measured emissions during those hours.

Data points flagged as SO2 MODC 06 or 19 account for 32 hours of the remaining 39 emissions data points over 0.54 lb/MMBtu, leaving seven hours for further analysis.

(3) The emission profile for Merrimack Station, since the issuance of the September 2016 permit containing the 7-day average SO2 emissions limit, shows that exceedances of the critical emission rate, i.e., 0.54 lb/MMBtu, are infrequent. In the period from September 1, 2016, when the State's permit TP-0189 became applicable and enforceable, to March 31, 2018, Merrimack Station has emitted at a level higher than the 0.54 lb/MMBtu on three hours out of 3,109 operating hours with measured emissions data, or less than 0.1%. In addition to the SO2 emission limit, the September 1, 2016 permit TP-0189 included a more stringent limit for the SO2 removal efficiency of the scrubber than was included in the TP-0008 permit. In addition, TP-0189 prohibits the use of the emergency stack to bypass emissions controls except as necessary to prevent severe damage to equipment or potential injury to facility personnel. The infrequency of emissions above 0.54 lb/MMBtu since September 1, 2016 indicates that the multiple SO2 emission control provisions contained in TP-0189, as described above, have been successful in consistently reducing emissions from Merrimack Station. Based on this evidence, EPA expects that future instances of emissions from Merrimack Station above 0.54 lb/MMBtu will continue to be extremely rare.

(4) While emissions exceeded 0.54 lb/MMBtu during each of the seven hours since July 1, 2013 (of which only three hours exceeded 0.54 lb/MMBtu since September 1, 2016, as described above), for six of these hours the total mass-based emission rate, measured in lb/hour, did not exceed the critical emission value of 2,544 lb/hour. Of those six hours, the highest emission level was 1,386.6 pounds of SO2, well below the critical emission value, and the other emission values range from 1.1 to 843.5 pounds SO2. Based on the State's attainment modeling demonstration, these lower emission values would not be expected to result in exceedances of the NAAQS. That is, New Hampshire's modeling indicates that Merrimack Station could emit constantly at the mass-based emission value for each of those six hours and the area would attain the standard.

Only one hour had emissions above the critical emission value of 2,544 lb/hour. Specifically, Merrimack emitted 2,578.6 pounds of SO2 on December 1, 2015 during the 7 a.m. hour.

EPA does not regard the single hour on December 1, 2015 at 7 a.m., during which Merrimack Station had emissions over the critical emission value, by itself as representing a serious risk for causing a violation of the NAAQS. EPA has previously acknowledged that there could possibly be hourly emission levels above the critical emission value from a source complying with a longer-term average emission limit, e.g., a 7-day limit. As stated in the proposal, an hour where emissions are above the critical emission value does not necessarily mean that a NAAQS exceedance is occurring in that hour. Similarly, an individual hour where emissions are above the level of the comparably stringent 7-day limit (0.39 lb/MMBtu in this instance) does not mean that an exceedance of the NAAQS is occurring in that hour, especially if the level of emissions is below the critical emission value. This notion also does not take into account the possible exceedances that would be expected with emissions always at the critical emission value that would otherwise be avoided because emissions are generally required to be lower (in this case, on average 27% lower). Based on this reasoning, EPA concludes that the risk of an exceedance for the one hour with emissions above the critical emission value of 2,544 lb/hour during 4.75 years of emissions from Merrimack Station (from July 1, 2013 to March 31, 2018) does not suggest that a violation of the NAAQS is likely to have occurred.

(5) Notwithstanding the explanations above regarding the appropriateness of omitting certain data points from considering NAAQS compliance, such emissions data, if they had actually been representative of real emissions, would have caused a violation of the permit conditions for Merrimack Station, if the 7-day permit limit had been in place at the time. EPA has evaluated the Merrimack Station emissions data for the period January 1, 2012 through March 31, 2017 in accordance with the 7-day average emission rate limit, both with and without the omission of data points flagged as calculated or substitute data.

This evaluation found 27 periods during which the associated 7-day emission average would have violated the terms of the permit conditions, had those terms been in place at the time and assuming that all data points flagged as calculated or substitute data are actual emissions. Of the 27 7-day periods, 26 occurred in 2012, while the facility was still permitted to bypass the FGD system, a practice that is not permitted under the conditions of the September 2016 permit TP-0189. Even by omitting data points flagged as calculated or substitute data, none of the 7-day emission averages associated with these 26 7-day periods in 2012 would have met the 7-day emission limit, had it been in place at the time.

The one remaining 7-day period ended on December 11, 2014, and the associated 7-day emission average of 0.419 lb/MMBtu would have exceeded the emission limit of 0.39 lb/MMBtu, if data points flagged as calculated or substitute data were treated as actual emissions. By omitting the calculated or substitute data from this time period, the 7-day emission average ending on December 11, 2014 would have been 0.20 lb/MMBtu, which would comply with the 7-day limit of 0.39 lb/MMBtu, had it been in place at the time.

This finding contradicts the commenter's assertion that the “over 224” individual hours with emissions purportedly higher than the critical emission rate would not have resulted in an exceedance of the 7-day average limit. On the contrary, even if the emissions with reported emissions above the critical emission value did represent actual emissions, which EPA argues in the previous sections is incorrect, Merrimack Station would have been out of compliance with the 7-day limit permit had it been in effect at the time.

Therefore, based on the reasoning supplied in the sections above, EPA disagrees with the commenter that emissions data from Merrimack Station demonstrate the inadequacy of the 7-day emission limit imposed by the State. Rather, the data most representative of Merrimack Station's current and expected future emissions indicate that the facility, when complying with the applicable permit restrictions, is extremely unlikely to cause a violation of the SO2 NAAQS. The emissions data presented by the commenter are not representative of Merrimack Station's current and expected future emissions, and are therefore not appropriate for use in assessing NAAQS compliance in this case.

EPA offers the following additional discussion to further respond directly regarding the sufficiency of an appropriately-calculated, longer-term average limit, up to 30-days, with comparable stringency to a 1-hour critical emission value, to provide for attainment of the 1-hour NAAQS. EPA has conducted analyses to evaluate the extent to which longer-term average limits that have been adjusted to have comparable stringency to 1-hour limits at the critical emission value provide for attainment. In brief, while a longer-term average limit as approved in this action will allow occasions when emissions exceed the critical emission value, the use of a lower limit (i.e., as adjusted downward) compensates by requiring most values to be lower than they are required to be with a 1-hour limit at the critical emission value. EPA expects that the net result for this action will be that the comparably stringent limit will provide a sufficient constraint on the frequency and magnitude of occurrences of elevated emissions such that this control strategy based on the comparably stringent limit will reasonably provide for attainment.

As stated in appendix B of EPA's April 2014 guidance, the Agency acknowledges that even with an adjustment to provide comparable stringency, a source complying with a longer term average emission limit could possibly have hourly emissions which occasionally exceed the critical emission value. It is important to recognize that an hour where emissions are above the critical value does not necessarily mean that a NAAQS exceedance is occurring in that hour. EPA's April 2014 guidance states that “if periods of hourly emissions above the critical emission value are a rare occurrence at a source, these periods would be unlikely to have a significant impact on air quality, insofar as they would be very unlikely to occur repeatedly at the times when the meteorology is conducive for high ambient concentrations of SO2” (p. 24).

Exceedances of the SO2 NAAQS occur when emissions from relevant sources are sufficiently high on occasions when the meteorology is conducive for those emissions to cause elevated SO2 concentrations. An illustrative example would be a case in which a single source has a dominant impact on area concentrations, and the source only causes an exceedance at a particular location with light southwest winds with limited dispersion. In this example, the likelihood of an exceedance at that location will be a function of the likelihood of elevated emissions occurring during times of light southwest winds with limited dispersion. Stated more generally, the likelihood of an exceedance is a function of the likelihood of emissions being high when the meteorology is conducive for the source to cause an exceedance. By extension, the likelihood of a violation is a function of the likelihood of emissions being high on a sufficient number of times with meteorology conducive to having exceedances to have the average of the 99th percentile daily maximum values exceed the NAAQS. Viewed another way, the occasions when the meteorology is conducive for the source to cause an exceedance at a particular location are likely to be infrequent, and high concentrations are contingent on both emissions being sufficiently high and the meteorology being sufficiently conducive. The NAAQS itself is based on relatively rare occurrences, being based on the 99th percentile of daily maximum concentrations. Nevertheless, the point here is that the occurrence of high emissions will not cause an exceedance if it does not occur when meteorology is conducive to having an exceedance. Furthermore, a source with rare occurrences of high emissions and with much more frequent occurrences of moderate emissions is more likely to have moderate emissions on those occasions with meteorology conducive for exceedances, and the design value for the source may be more prone to reflect the moderate emissions than the high emissions.

Thus, for a source complying with a limit using an averaging period of up to 30 days reflecting the downward adjustment generally recommended in EPA's April 2014 guidance, at issue is the likelihood that the source would have sufficiently high emissions on a sufficient fraction of the potential exceedance days to cause an SO2 NAAQS violation. Although results will differ according to individual circumstances, EPA has presented illustrative analyses (see appendix B of EPA's April 2014 guidance) that indicate that suitably adjusted longer-term average limits can generally be expected to provide adequate confidence that the attainment plan will provide for attainment.

Therefore, based on the reasoning presented above, EPA disagrees with the commenter about the over 224 hours with emissions purported to be higher than the critical emission rate, and concludes that the longer-term limit for Merrimack Station is not expected to lead to a greater risk of a future violation of the NAAQS.

Comment 3: The commenter stated that New Hampshire's approach to develop a longer-term averaging period using an “adjustment ratio” is problematic.6 Specifically, the commenter posits that the period of time selected by the State (i.e., July 4, 2013 through March 30, 2015) is not representative of current or expected future operations at Merrimack Station. The commenter stated that the State did not disclose the nature of data corrections provided by the Merrimack Station's owner at the time PSNH in documentation accompanying the proposed permit for the facility. The commenter indicated that the nondisclosure regarding the nature of the corrections raises concerns about the accuracy of the State's analysis. For future operations, the commenter points to New Hampshire's projection of Merrimack Station's annual emissions for 2018 of 1,907 tons SO2, which is nearly double the annual emissions total of 1,044 tons SO2 for the facility in 2014. The commenter asserts that the time period selected for developing the adjustment factor is arbitrary and not representative of expected future operations, and that therefore the State should have selected a different time period. The commenter identified “significant spikes” in hourly emissions in the months before or after the time period selected by the State that are not included in the State's emissions database. The commenter suggested that these emission “spikes” are inappropriately excluded, and as a result the State's results are likely to be skewed. The commenter provides several alternative adjustment factors based on different time periods that include periods with emission “spikes,” including an adjustment factor for each year from 2012 through 2015; the period of July 4, 2013 through March 30, 2015, used by the State in its analysis; and the 25-month period from March 1, 2013 through March 30, 2015. The alternative adjustment factors for these periods vary from 0.34 to 0.90, which would result in associated 7-day limits of between 0.19 to 0.48 lb/MMBtu. The commenter states that selecting the wrong time period for analysis can result in a more than doubling of the resulting emission rate. The commenter concludes that the methodology New Hampshire used for developing a 7-day emission rate is inadequate because the adjustment factor depends greatly on which temporal series of emissions data is examined.

Response 3: EPA analyzed the commenter's assertion regarding variability in adjustment factors based on the time period selected. An adjustment factor is a value multiplied by the 1-hour critical emission value (i.e., the maximum 1-hour emission value established to be protective of the NAAQS) to determine a downwardly adjusted longer-term average limit for an emission unit at a level that EPA would expect to be comparably stringent to a 1-hour limit set at the critical emission value.

As stated in EPA's April 2014 guidance, we expect that establishing an appropriate longer-term average limit will involve assessing a downward adjustment in the level of the limit that would provide for comparable stringency. This assessment should generally be conducted using data obtained by CEMS, in order to have sufficient data to obtain a robust and reliable assessment of the anticipated relationship between longer-term average emissions and 1-hour emission values. This is necessary to have a suitable assessment of the warranted degree of adjustment of the longer-term average limit in order to provide comparable stringency to the 1-hour emission rate that is determined to provide for attainment. EPA generally expects that datasets reflecting hourly data for at least 3 to 5 years of stable operation (i.e., without changes that significantly alter emissions variability) would be needed to conduct a suitably reliable analysis.

For Merrimack Station, at the time that New Hampshire had conducted its analysis, only approximately 21 months of emissions data were available that were consistent with anticipated current and future operations. Specifically, the emissions units at Merrimack Station became subject to certain enforceable conditions contained in permit number TP-0008 beginning on July 1, 2013. Thus, emissions from Merrimack Station prior to July 1, 2013 are not expected to have an emissions profile consistent with the current and anticipated future emissions profile for those units. March 2015 was selected by the State as the end point of the emissions dataset because it was the last month in which data were available through AMPD at the time it conducted the analysis. During the period assessed by the State, the combined emissions from Merrimack Station's units MK1 and MK2 were always controlled by FGD and the dataset includes emissions representative of current and expected future typical operations, including startup and shutdown events. Because the dataset includes only data from Merrimack Station while using the control technology, it is appropriate for use in developing adjustment factors for emission limits at this facility. EPA has concluded that New Hampshire used data from an appropriate time period.

Prior to deriving the adjustment factor, the State removed several data points from the AMPD dataset based on information provided by the facility. A justification for removal of these data points was included in the State's response to comments document to permit TP-0189 (included in New Hampshire's Finding of Fact document), which was also included in the State's SIP submittal. Specifically, New Hampshire justified the removal of several data points because of quality assurance issues. The State indicated in its response to comments document that substitute data was included within the AMPD dataset for hours with emissions at levels the CEMS had not been appropriately maintained and quality assured to measure. The State indicated and EPA agrees that these substitute emission data are not representative of actual emissions. According to the State's SIP submittal, the SO2 dual span analyzer in the CEMS was adjusted as of February 4, 2015, to better characterize both lower- and higher-end emissions. In its response to comments, the State provided an hour-by-hour listing of the omitted data points, and a detailed discussion of the reasoning for these omissions. The State's Findings of Fact document is included in the docket for this action. As such, EPA notes that New Hampshire sufficiently provided its rationale and approach for removing certain data points from the AMPD dataset in the State's response to comments document. Therefore, EPA concludes that the State has appropriately disclosed the nature of the data corrections in the State's SIP submittal, and that the public has had adequate notice and opportunity to comment on the State's justification for data removal in the current rulemaking process. EPA has placed the raw data that New Hampshire used in the docket for this action, but EPA asserts that the information provided by the State and by EPA in its proposal was adequate to clarify EPA's rationale for concurring with the State's analysis of the data.

Regarding the omission of calculated or substitute data, the calculated or substitute data points are not reliable indicators of emissions during those hours and are not appropriate for inclusion in the calculation of the adjustment factor. Based on this reasoning, EPA considers the State's omission of these values in the calculation of the adjustment factor to be appropriate.

The adjustment factor was calculated as the ratio of the 99th percentile of mass emissions for the 7-day average period to the 99th percentile of 1-hour mass emissions. For the rolling 7-day averaging period, the adjustment factor was 0.73. That is, using EPA's recommended approach for determining comparably stringent limits, the 7-day mass emission rate limit would need to be 0.73 times (or 27% lower than) the critical emission value to have stringency comparable to a 1-hour limit at the critical emission value. The State multiplied its adjustment factor of 0.73 to the critical emission rate of 0.54 lb/MMBtu to derive a comparably stringent emission rate of 0.39 lb/MMBtu. EPA has confirmed that the State appropriately implemented the recommended methodology for developing an adjustment factor based on the State's supplied dataset. EPA notes that this emission database does include hours representative of startup and shutdown conditions, as well as hours with elevated emissions or “spikes.”

There were five individual alternative adjustment factors for Merrimack Station presented by the commenter as evidence that EPA's methodology (including adjustment factors) is not appropriate for developing emissions limitations based on averaging times for periods up to 30 days. Four of the five alternative adjustment factors presented by the commenter are based upon only one year of emissions data for each of the annual periods of 2012 through 2015. One of the periods presented includes emissions over a period of 25 months, specifically for the period from March 2013 through March 2015 resulting in an alternative adjustment factor of 0.47, compared to the State's adjustment factor of 0.73 based on the 21-month time period of July 2013 through March 2015. None of the alternative adjustment factors provided by the commenter were calculated in accordance with the recommendations contained in EPA's April 2014 guidance. Specifically, EPA stated in its April 2014 guidance “that data sets reflecting hourly data for at least 3 to 5 years of stable operation (i.e., without changes that significantly alter emissions variability) would be needed to obtain a suitably reliable analysis” (p. 30). Furthermore, the alternative adjustment factors for March 2013 through March 2015 and the annual periods for 2012 and 2013 as presented by the commenter include periods of time (i.e., those prior to July 1, 2013 when FGD use was not an enforceable State permit condition) during which operations are not representative of current and expected future operations at Merrimack Station, as discussed in greater detail in our response to Comment 2 of the notice. The remaining alternative adjustment factors that do not contain periods of time prior to July 1, 2013, i.e., the annual periods for 2014 and 2015, are 0.90 and 0.70, respectively, which are reasonably consistent with the State's finding based on a larger dataset. However, the commenter's results illustrate a point that EPA considered in formulating its guidance, which is that using insufficient data, e.g., using only one year's data, is prone to yield results that vary unduly by data period and may not be a sufficiently robust basis for determining a reliable adjustment factor. The variability of these annual values demonstrates the insufficiency of the annual time period for use in development of such an adjustment factor, but does not demonstrate the insufficiency of the method contained within EPA's April 2014 guidance had it been appropriately applied, nor does it demonstrate that New Hampshire's adjustment factor is inappropriate.

EPA recognizes that the State used 21 months in its emissions variability analysis instead of the 3 to 5 years recommended for use in EPA's April 2014 guidance. As such, EPA has evaluated whether the period used by the State results in an appropriate adjustment factor. Specifically, EPA compared the State's adjustment factor to EPA's average 30-day adjustment factor for comparable sources. Merrimack Station's FGD system employs a wet scrubber, and so EPA compared New Hampshire's adjustment factor to the average adjustment factors listed in appendix D of the April 2014 guidance for sources with wet scrubbers (derived from a database of 210 sources). For this set of sources, EPA calculated an average adjustment factor for 30-day average limits of 0.71 and an average adjustment factor for 24-hour limits of 0.89. The comparison of New Hampshire's adjustment factor of 0.73 for a 7-day limit for Merrimack Station suggests that the 21 months of data at Merrimack Station have variability that is quite similar to that of other similar facilities in the United States. Based on this comparison, EPA concludes that the State's adjustment factor is reasonable and will result in an appropriate downward adjustment from the critical emission value.

Based on the State's SIP submittal, New Hampshire's future projection of SO2 emissions at Merrimack Station to 2018 indicates an increase of nearly 85% compared to 2014 emissions for the facility. Specifically, Tables 5-1B and 5-2B of the State's SIP submittal indicate that Merrimack Station's SO2 emissions were 1,044 tons in 2014 and are projected to be 1,927 tons in 2018. The emission projection for 2018 includes the caveat from the State that it relies on an assumed control efficiency for the FGD of 90%, which is less efficient than the updated control efficiency of 94% for the FGD included in the State's SIP submittal. Nevertheless, this projected increase in annual emissions does not, however, indicate a different emissions profile. That is, based on available information, EPA does not expect an increase in the variability of hourly emissions due to an increase in annual emissions. In fact, the attainment demonstration included in New Hampshire's SIP submittal indicates that annual SO2 emissions at the critical emission value, equivalent to annual emissions of 11,144 tons, is anticipated to be protective of the 2010 SO2 NAAQS. The State's comparably stringent 7-day average limit of 0.39 lb/MMBtu equates to total annual SO2 emissions of 8,047 tons. Both values are above the State's 2018 projected emissions of 1,927 tons. Because New Hampshire's attainment demonstration shows that the critical emission value is protective of the NAAQS, and the State's 7-day limit is comparably stringent to the 1-hour critical emission value, EPA concludes that the State's projected 85% increase in annual SO2 emissions from 2014 to 2018 would not result in a violation of the NAAQS.

Therefore, based on the reasoning presented above, EPA has concluded that the commenter has not demonstrated that the State developed its adjustment factor for Merrimack Station inappropriately, or that the State's 7-day limit for Merrimack Station derived using the adjustment factor is inadequate.

Comment 4: The commenter indicates that the polar receptor grid used by the State in its modeling analysis is inadequate because of the small overall number of receptors and lack of coverage over large areas of land. The commenter states that the polar grid ensures that the model will underpredict concentrations due to these “blind spots,” areas where there are no receptors and which the model will overlook when the wind is blowing in their direction across the sources. Because the model is ultimately the basis for the development of the emissions limit for Merrimack Station, the commenter posits that the polar receptor grid with contiguous radial coverage gaps is improper.

Response 4: EPA agrees with the commenter that simple polar grids alone may not be appropriate for use without refinement in refined modeling analyses, though inclusion of a polar receptor grid does not in and of itself disqualify an attainment demonstration.

Receptors are points that represent physical locations at which the air dispersion models will predict ambient pollutant concentrations. Groups of Cartesian or polar receptors usually are defined as a receptor grid network or grid. The primary purpose of this network or grid is to locate the maximum impact of concern per pollutant and averaging period. Deciding which type to use is largely a function of the type of modeling being performed (screening or refined), the size and number of emission sources, or the site location (including topography), and should be selected to provide the best “coverage” for the facility being modeled. Two types of receptors are generally employed: (1) A Cartesian receptor grid, which consists of receptors identified by their x (east-west) and y (north-south) coordinates; and (2) a polar receptor grid that consists of receptors identified by their distance and direction (angle) from a user defined origin (e.g., main boiler stack). Discrete receptors are used to identify specific locations of interest (e.g., school, community building). A modeling receptor grid may consist of any combination of discrete, polar, or Cartesian receptors, but must provide sufficient detail and resolution to identify the maximum impact.

On October 30, 2015, the State submitted preliminary modeling to EPA for the attainment demonstration for the Central New Hampshire Nonattainment Area. EPA responded on January 6, 2016, to the State's preliminary modeling submittal. In EPA's response, the Agency indicated that section 4.2.1.2(b) of the Guideline 7 describes the process for performing screening modeling in areas with complex terrain. As stated in our letter, in areas with complex terrain, “even relatively small changes in a receptor's location may substantially affect the predicted concentration.” The Guideline recommended a dense array of receptors in those situations, and suggests two modeling runs: the first with “a moderate number of receptors carefully located over the area of interest,” and a second with “a more dense array of receptors in areas showing potential for high concentrations, as indicated by the results of the first model run.” This process is also consistent with section 7.2.2 (Critical Receptor Sites) of the Guideline, which states that “selection of receptor sites should be a case-by-case determination taking into consideration the topography, the climatology, monitor sites, and the results of the initial screening procedure.” In our letter to New Hampshire, EPA noted that the preliminary modeling results (i.e., those presented to the Agency on October 30, 2015) showed maximum concentrations resulting from Merrimack Station's SO2 emissions in areas of complex terrain between 9 to 13 kilometers from Merrimack Station. EPA stated that the polar receptor grid at those distances from the source were insufficiently dense to properly characterize the extent of the impacts at locations with complex terrain. For example, at 13 kilometers from the source, the lateral distance between receptors is greater than 2 kilometers. EPA also indicated that other locations with similar terrain characteristics in the same general distance (i.e., 9-13 kilometers) from Merrimack Station did not have adequate receptor coverage. To address this issue, EPA suggested in its January 6, 2016 letter, that New Hampshire perform refined modeling consistent with its existing protocol, but with a denser array of receptors in the areas shown in the preliminary modeling to have the potential for high concentrations. Specifically, areas of complex terrain at distances within 15 kilometers of Merrimack Station, and particularly such areas to the northeast, were suggested by EPA to be modeled with high resolution receptor grids. EPA listed these areas and provided a map of these areas to the State. EPA indicated that these terrain features have the potential to be highly impacted by Merrimack Station because of their geographic characteristics and locations, but were not well characterized by the preliminary modeling due to the sparseness of the polar grid at distances beyond around 5 kilometers.

In response to EPA's January 2016, letter, the State included additional receptors in these areas for its refined modeling conducted in February 2016. Specifically, New Hampshire included 2,308 additional receptors in dense Cartesian arrays with 100-meter spatial resolution over the areas of expected maximum predicted concentrations based on preliminary modeling, including over the areas suggested by EPA within 5-15 kilometers from Merrimack Station. After reviewing the receptor grid included by the State in its refined modeling, EPA concludes that areas of complex terrain within 15 kilometers have adequate coverage to identify potential impacts in those areas. This conclusion is consistent with the statement in section 4 (Models for Carbon Monoxide, Lead, Sulfur Dioxide, Nitrogen Dioxide and Primary Particulate Matter) of the Guideline (specifically section 4.2(a)) that “[i]n most cases, maximum source impacts of inert pollutants will occur within the first 10 to 20 km from the source.” Furthermore, EPA's review of both the preliminary and refined modeling indicate that these areas of complex terrain are likely to include the highest impact area. Therefore, EPA finds that the modeling domain and receptor network are sufficient to identify maximum impacts from Merrimack Station, and are therefore adequate for characterizing the nonattainment area.

Comment 5: The commenter pointed out an error in Table 3-1 of the State's draft SIP submittal. Specifically, the commenter indicated that Table 3-1 incorrectly showed areas that are undesignated in New Hampshire as being designated Unclassifiable. The commenter indicated that those areas should instead be identified as undesignated.

Response 5: EPA agrees with the commenter that all areas in New Hampshire other than the Central New Hampshire Nonattainment Area were undesignated as of the date of New Hampshire's submittal (i.e., January 31, 2017). In its response to this identical comment on its proposed SIP submittal, the State indicated that Table 3-1 had been corrected. EPA has verified that the State did indeed correct the table. EPA notes that revised recommendations from New Hampshire other than those listed in Table 3-1 were received by EPA in December 2016, specifically for attainment at the New Hampshire Seacoast area and attainment/unclassifiable for all other previously undesignated areas. Furthermore, on January 9, 2018, EPA published a document of a final rule that designated all areas in New Hampshire other than the Central New Hampshire Nonattainment Area as attainment/unclassifiable (see 83 FR 1098, 1143, to be codified at 40 CFR 81.330). These inconsistencies in Table 3-1 with subsequent occurrences have to do with the timing of the SIP submittal along with the December 2016 update to the State's recommendations and EPA's January 9, 2018 final designations. These inconsistencies do not affect EPA's view of whether New Hampshire has satisfied applicable nonattainment planning requirements.

Comment 6: The commenter states that the State's SIP submittal incorrectly indicates that an attainment demonstration can be made based on monitor readings alone. This idea is contrary to other statements in the State's SIP submittal, and also to EPA's April 2014 guidance, which states that monitor data alone is insufficient for an attainment demonstration, and that modeling analyses are also required. The commenter asserts that the statement should be removed from the State's SIP submittal.

Response 6: The State indicated in its response to an identical comment on its draft SIP submittal that it planned to remove the phrase “and thus may be able to demonstrate attainment for the SO2 NAAQS” from Section 3.1.1 on page 9 of its SIP submittal. In doing so, the State would be satisfying the request made by the commenter. However, the erroneous phrase still appeared in the State's January 31, 2017 SIP submittal to EPA. EPA agrees with the commenter that the phrase is incorrect and ought not to be in the plan. EPA communicated with the State to confirm that it had intended to remove the phrase as indicated by the State's response to comments on its draft SIP submittal, and to suggest a clarification. On November 29, 2017, New Hampshire sent EPA a letter indicating that the language had been erroneously included in its January 31, 2017 submittal, and providing a corrected page 9 of the State's SIP submittal. EPA considers this amended version (i.e., the January 31, 2017, submittal as amended by the November 29, 2017, correction on page 9) to be consistent with the State's record, as included in its response to comments.

Comment 7: The commenter identifies an error in Table 5-1B of the State's draft SIP submittal. Specifically, the commenter indicates that the table erroneously states that the total estimated emissions for the Central New Hampshire Nonattainment Area for 2014 was 22,947 tons of SO2. The commenter further states that the proper total for 2014 emissions should be 1,480 tons of SO2. The commenter indicates that the figure is assumed to be an error that should be corrected.

Response 7: EPA agrees with the commenter that the total 2014 emissions within the Central New Hampshire Nonattainment Area should be 1,480 tons SO2. The commenter had supplied an identical comment on New Hampshire's draft SIP submittal, and the State's response to comment document included in its final SIP submittal stated that the error would be corrected. As indicated by the State in its response to comments, Table 5-1B shows the corrected value. As such, EPA considers this comment to have been already addressed by the State.

Comment 8: In the incorporated comments dated July 15, 2016, the commenter states that New Hampshire is long overdue for finalizing a plan to ensure attainment and maintenance of the SO2 NAAQS. The commenter goes on to state that the (then) proposed permit is apparently only a step towards developing such a SIP. The commenter concludes by urging the State to swiftly address the issues identified in its comments on the proposed permit for Merrimack Station.

Response 8: There are two plausible interpretations of this comment. The first interpretation is procedural. Interpreted in this fashion, the commenter would be requesting that the permitting authority expedite the permitting for Merrimack Station, which would be a critical component of the anticipated attainment plan for the area around Merrimack Station. Interpreted this first way, the comment is addressed through the current action, which is the final step in the procedure for approving an attainment plan for the area. A second interpretation implies technical insufficiency. Interpreted in this fashion, the commenter would be indicating that the proposed permit, when finalized, would be just one of multiple required actions necessary to ensure attainment in the nonattainment area. Interpreted this second way, the comment rests on the previous arguments provided by the commenter suggesting that the State's proposed plan does not ensure attainment of the NAAQS. On these grounds, EPA disagrees with the commenter that the proposed nonattainment area plan may be insufficient to ensure attainment. EPA has provided ample discussion and evidence, in both the current response to comments and the September 28, 2017 proposal, for why the State's nonattainment plan and SO2 attainment demonstration are sufficient.

EPA has determined that New Hampshire's SO2 nonattainment plan meets the applicable requirements of sections 110, 172, 191, and 192 of the CAA. EPA is approving New Hampshire's January 31, 2017 SIP submission, as amended by the State on November 29, 2017, for attaining the 2010 primary 1-hour SO2 NAAQS for the Central New Hampshire Nonattainment Area and for meeting other nonattainment area planning requirements. This SO2 nonattainment plan includes New Hampshire's attainment demonstration for the SO2 nonattainment area. The nonattainment area plan also addresses requirements for RFP, RACT/RACM, enforceable emission limits and control measures, base-year and projection-year emission inventories, and contingency measures.

In New Hampshire's SIP submittal to EPA, New Hampshire included the applicable monitoring, testing, recordkeeping, and reporting requirements contained in Merrimack Station's permit, TP-0189, to demonstrate how compliance with Merrimack Station's SO2 emission limit will be achieved and determined. EPA is approving into the New Hampshire SIP the provisions of Merrimack Station's permit, TP-0189, that constitute the SO2 operating and emission limits and their associated monitoring, testing, recordkeeping, and reporting requirements. EPA is approving these provisions into the State's SIP through incorporation by reference, as described in section IV., below.

EPA is not removing the portion of the New Hampshire SIP entitled “EPA-approved State Source specific requirements” as it pertains to Merrimack Station's July 2011 permit, TP-0008, because EPA did not receive a request from the State to do so. See 40 CFR 52.1520(d). However, EPA considers those provisions to be superseded by the conditions of TP-0189, which are more stringent, and which are being incorporated into the SIP in this final action. Specifically, two of the provisions, items 6 and 8 from Table 4, relate to SO2 emissions limits that have been superseded by Merrimack Station's September 2016 permit, TP-0189. Item 10 from Table 4 has also been superseded by Merrimack Station's September 2016 permit, TP-0189, in that the existing SIP provision allowed operation of one of Merrimack Station's two boilers, MK1, for up to 840 hours in any consecutive 12-month period through the emergency bypass stack, i.e., not through the FGD system. Each of the corresponding provisions of Merrimack Station's September 2016 permit, TP-0189, are more stringent than those existing SIP provisions. The limits EPA is approving into New Hampshire's SIP in this action do not exempt any hours from being subject to the limit.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of certain federally enforceable provisions of Merrimack Station's permit, TP-0189, effective on September 1, 2016, described in the amendments to 40 CFR part 52 set forth below. Specifically, the following provisions of that permit are incorporated by reference: Items 1, 2, and 3 in Table 4 (“Operating and Emission Limits”); items 1 and 2 in Table 5 (“Monitoring and Testing Requirements”); items 1 and 2 in Table 6 (“Recordkeeping Requirements”); and items 1 and 2 in Table 7 (“Reporting Requirements”). EPA has made, and will continue to make, relevant documents, including the portions of TP-0189 being incorporated by reference, generally available through www.regulations.gov.

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

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

• 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 Clean Air Act; and

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 6, 2018. 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).)

Part 52 of cha pter I, title 40 of the Code of Federal Regulations is amended as follows:

On April 13, 2018, EPA published a direct final rule approving the updated delegation of authority for implementation and enforcement of NSPS and NESHAPs for all sources (both part 70 and non-part 70 sources) to the NMED. The direct final rule was published without prior proposal because EPA anticipated no relevant adverse comments. EPA stated in the direct final rule that if relevant adverse comments were received by May 14, 2018, EPA would publish a timely withdrawal in the Federal Register. EPA received an adverse comment on May 14, 2018. Accordingly, EPA is withdrawing the direct final rule. In a separate subsequent final action EPA will address the comment received. The withdrawal is being taken pursuant to sections 111 and112 of the CAA.

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2017-0666 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 6, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0666, 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 February 27, 2018 (83 FR 8408) (FRL-9972-17), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11023) by BASF Corporation, 100 Park Avenue, Florham Park, NJ 07932. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of poly(oxy-1,2-ethanediyl), α-(1-oxoalkyl)-ω-methoxy-, where the alkyl chain contains a minimum of 6 and a maximum of 18 carbons and the oxyethylene content is 3-13 moles (CAS Reg. Nos. 53100-65-5, 194289-64-0, 34398-00-0, 9006-27-3, 32761-35-6, 53467-81-5, 518299-31-5, 34397-99-4) when used as an inert ingredient (stabilizer and solubilizing agent) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest at a concentration not to exceed 25% by weight in the formulation. That document referenced a summary of the petition prepared by BASF Corporation, the petitioner, which is available in the docket, http://www.regulations.gov. No comments were received in response to the notice of filing that are relevant to establishment of this exemption.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for 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. . . .”

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), 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 ethoxylated fatty acid methyl esters including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with ethoxylated fatty acid methyl esters 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. A series of acute toxicology studies have been conducted with representative EFAMEs. The acute toxicity study test substance was C6-10 ethoxylated fatty acid methyl ester (degree of ethoxylation is 10.6 EO). The studies show that the EFAMEs are practically non-toxic when ingested or inhaled via acute exposure. Skin and eye irritation studies indicate that the EFAMEs are slight skin and eye irritants. The skin sensitization potential of the EFAMEs could not be determined based on the ambiguous result in the Buehler assay.

The genotoxicity studies conducted with representative EFAMEs including bacterial reverse mutation (Ames) test, mouse micronucleus assay and an in vitro mouse lymphoma assay were negative.

Repeat dose data are not available for the EFAMEs; however, several repeat dose studies have been conducted with fatty acid methyl/alkyl esters and alcohol ethoxylates and these studies can be bridged to the EFAMEs based upon the structural similarities between EFAMEs and alcohol ethoxylates which are both nonionic surfactants in which the surfactant properties of each generally result in similar toxicological effects, at comparable dose levels) and the structural similarities of EFAMEs with fatty acid methyl/alkyl esters (both having terminal methoxy or alkoxy groups bound to a fatty acid or fatty acid derivative). The NOAEL of 50 mg/kg/day from a chronic rat oral feeding study is the lowest NOAEL observed and is equal to the lowest NOAEL seen in the subchronic feeding studies. The lowest LOAEL in the subchronic studies, as well as the LOAEL in the chronic rat oral feeding study was established at 250 mg/kg/day based on reduced food consumption and body weight gain. In a dermal toxicity study no signs of tumors were observed and the dermal NOAEL was reported to be 300 mg/kg/day. Most of the 90-day studies reported NOAELs ranging from 50-200 mg/kg/day.

The NOAELs for reproductive performance of males and females, as well as offspring toxicity are considered to range from >250 mg/kg/day to 1,000 mg/kg/day. None of the studies reported adverse reproductive, developmental, neurotoxic, or immunotoxic effects at dose levels below the range of >250 mg/kg/day to 1,000 mg/kg/day.

Specific information on the studies received and the nature of the adverse effects caused by ethoxylated fatty acid methyl esters as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document Ethoxylated Fatty Acid Methyl Esters (CAS Reg. Nos. 53100-65-5, 194289-64-0, 34398-00-0, 9006-27-3, 32761-35-6, 53467-81-5, 518299-31-5, 34397-99-4); “Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient” in docket ID number EPA-HQ-OPP-2017-0666.

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

An effect attributed to a single dose was not identified in the toxicology database. The point of departure for chronic dietary exposures as well as dermal and inhalation exposures is based on a NOAEL of 50 mg/kg/day from a chronic oral feeding study in rats with the EFAMEs surrogate chemical, alcohol ethoxylate. In this study, the LOAEL was 250 mg/kg/day based upon reduced food consumption and body weight gain and elevated organ-to-body weight ratios. This represents the lowest NOAEL in the most sensitive species in the toxicity database. The standard uncertainty factors were applied to account for interspecies (10X) and intraspecies (10X) variations. The FQPA safety factor was reduced to 1X to account for completeness of the toxicity and exposure database and lack of increased prenatal or postnatal sensitivity as well as a lack of concern for neurotoxicity. A dermal absorption factor of 100% was used and a default value of 100% absorption was used for the inhalation absorption factor. The resultant chronic population adjusted dose (cPAD) is 0.5 mg/kg/day and acceptable MOEs for residential exposures are ≥100.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to ethoxylated fatty acid methyl esters, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from ethoxylated fatty acid methyl esters in food as follows.

Dietary exposure (food and drinking water) to ethoxylated fatty acid methyl esters can occur following ingestion of foods with residues from treated crops. Because no adverse effects attributable to a single exposure of ethoxylated fatty acid methyl esters are seen in the toxicity databases, an acute dietary risk assessment is not necessary. For the chronic dietary risk assessment, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCIDTM, Version 3.16, and food consumption information from the U.S. Department of Agriculture's (USDA's) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, no residue data were submitted for ethoxylated fatty acid methyl esters. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high use insecticides, herbicides, and fungicides. One hundred percent crop treated was assumed, default processing factors, and tolerance-level residues for all foods and use limitations of not more than 25% in pesticide formulations. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for ethoxylated fatty acid methyl esters, a conservative drinking water concentration value of 100 ppb based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). Ethoxylated fatty acid methyl esters may be used as inert ingredients in products that are registered for specific uses that may result in residential exposure, such as pesticides used in and around the home. The Agency conducted a conservative assessment of potential residential exposure by assessing ethoxylated fatty acid methyl esters in pesticide formulations (outdoor scenarios) and in disinfectant-type uses (indoor scenarios). The Agency's assessment of adult residential exposure combines high-end dermal and inhalation handler exposure from liquids/trigger sprayer/home garden and indoor hard surface, wiping with a high-end post application dermal exposure from contact with treated lawns. The Agency's assessment of children's residential exposure includes total post-application exposures associated with total exposures associated with contact with treated lawns and surfaces (dermal and hand-to-mouth exposures).

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 ethoxylated fatty acid methyl esters to share a common mechanism of toxicity with any other substances, and ethoxylated fatty acid methyl esters does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that ethoxylated fatty acid methyl esters 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://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. The toxicity database for ethoxylated fatty acid methyl esters contains subchronic and developmental toxicity studies conducted with surrogate chemicals. The NOAELs for reproductive performance of males and females, as well as offspring toxicity are considered to range from >250 mg/kg/day to 1,000 mg/kg/day. None of the studies reported effects on the reproductive system or effects indicative of neurotoxicity.

The established cRfD will be protective of the observed adverse effect, decreased body weight gain and food consumption, which was observed at dose levels much lower than potential adverse effects to infants or children. In addition, the Agency used conservative exposure estimates, with 100 percent crop treated, tolerance-level residues, conservative drinking water modeling numbers, and a conservative assessment of potential residential exposure for infants and children. Based on the adequacy of the toxicity database, the conservative nature of the exposure assessment, and the lack of concern for prenatal and postnatal sensitivity as well as neurotoxicity, the Agency has concluded that there is reliable data to determine that infants and children will be safe if the FQPA SF of 10X is reduced to 1X.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate safety factors (SFs). EPA calculates the aPAD and cPAD by dividing the POD (i.e. toxicological endpoint) by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short, intermediate, and long term aggregate risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

Although there are no known current residential uses associated with EFAMEs, a residential exposure assessment was conducted. The level of concern for residential uses (i.e. non-occupational, non-dietary exposure) associated with the EFAMEs is low. The level of MOEs for combined residential exposure is above 100.

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

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to EFAMEs from food and water will utilize 70% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Generally, a dietary risk estimate that is less than 100% of the cPAD does not exceed the Agency's risk concerns.

3. Short- intermediate- and long-term risk. Short- intermediate- and long-term aggregate exposure takes into account short-, intermediate- and long- term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-, intermediate- and water with sort-, intermediate- and long-term residential exposures to EFAMEs. Using the exposure assumptions describe in this unit for short-term exposures, EPA has concluded the combined respective short-, intermediate- and long- term food water, and residential exposures resulted in aggregate margin of exposures (MOE) of 335 for adults and 122 for children. Because EPA's level of concern for EFAMEs is a MOE of 100 or below, these MOEs are not of concern.

4. Aggregate cancer risk for U.S. population. Based on the discussion in Unit IV. A., EFAMEs is not expected to pose a cancer risk.

5. 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 ethoxylated fatty acid methyl esters residues.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. EPA is establishing limitations on the amount of EFAMEs that may be used in pesticide formulations applied to growing crops. These limitations will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for use on growing crops or raw agricultural commodities after harvest for sale or distribution that exceeds 25% by weight of EFAMEs.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for poly(oxy-1,2-ethanediyl), α-(1-oxoalkyl)-ω-methoxy-, where the alkyl chain contains a minimum of 6 and a maximum of 18 carbons and the oxyethylene content is 3-13 moles (CAS Reg. No. 53100-65-5, 194289-64-0, 4398-00-0, 9006-27-3, 32761-35-6, 53467-81-5, 518299-31-5, and 34397-99-4) when used as an inert ingredient (stabilizer and solubilizing agent) in pesticide formulations applied to growing crops or raw agricultural commodities after harvest at a concentration not to exceed 25% by weight in the formulation.

This action establishes an exemption from the requirement of a tolerance 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); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2010-0234 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 6, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0234, by one of the following methods:

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

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

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

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

In the Federal Register of December 26, 2017 (82 FR 60940) (FRL-9969-97), EPA, pursuant to FFDCA section 408(e), 21 U.S.C. 346a(e), proposed revisions to existing tolerances for the insecticide alpha-cypermethrin to reduce the allowable levels of the pesticide in or on fruit, citrus, group 10-10 from 10 parts per million (ppm) to 0.35 ppm and in or on hog, fat from 1.0 ppm to 0.10 ppm. EPA proposed this action in order to correct a typographical error that occurred in the final rule establishing these tolerances on February 1, 2013 (78 FR 7266) (FRL-9376-1). In support of the 2013 final rule, EPA reviewed residue field trial data and determined that the appropriate tolerance levels for fruit, citrus, group 10-10 and hog, fat were 0.35ppm and 0.10 ppm, respectively. Unfortunately, the instruction to the Federal Register contained incorrect tolerance values for these commodities, resulting in incorrect tolerance levels being finalized in that rule. The proposal would correct that error.

In the proposal, EPA discussed the Agency's assessment of risk and proposed determination of safety for aggregate exposures to alpha-cypermethrin. In summary, the Agency concluded that the proposed tolerances for fruit, citrus, group 10-10 and hog, fat would be safe.

Two comments were received on the proposal. One simply read “Good” and the other was related to the impact of wind-power facilities on bat populations and is therefore not relevant to this action.

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 alpha-cypermethrin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with alpha-cypermethrin can be found in the proposed rule published December 26, 2017, and EPA is incorporating its findings in that preamble into this final rule. For the reasons stated in the proposal, EPA concludes that there is a reasonable certainty that no harm will result to the general population, including infants and children, from aggregate exposure to alpha-cypermethrin.

As noted in the proposal, 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).

There is a Codex MRL established for citrus fruits at 0.3 ppm but not one for hog fat. Because the U.S. use patterns differ from those upon which the Codex MRLs are based, EPA is not harmonizing the U.S. tolerance for citrus fruit.

In this Final Rule, EPA is reducing the existing tolerances for commodities in crop group 10-10 from 10 ppm to 0.35 ppm and on hog, fat from 1.0 ppm to 0.1 ppm. The Agency is reducing these tolerances to correct the tolerance levels that EPA intended to establish in a previous rulemaking based on available residue data.

In accordance with the World Trade Organization's (WTO) Sanitary and Phytosanitary Measures (SPS) Agreement, EPA notified the WTO of its proposed tolerance revision on January 10, 2018. See http://spsims.wto.org/en/Notifications/Search, U.S. Notification (G/SPS/N/USA/2976). EPA also intends to submit another notification to the WTO in order to satisfy its obligation to promptly publish this rule in such a manner as to enable interested WTO members to become acquainted with this rule. In addition, the SPS Agreement requires that Members provide a “reasonable interval” between the publication of a regulation subject to the Agreement and its entry into force to allow time for producers in exporting Member countries to adapt to the new requirement. At this time, EPA is establishing an expiration date for the existing tolerances to allow those tolerances to remain in effect for a period of six months after the effective date of this final rule, in order to address this requirement.

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 alpha-cypermethrin, alpha-cypermethrin, in or on fruit, citrus group 10-10 and hog fat at 0.35 and 0.10 ppm.

This action amends existing tolerances under FFDCA section 408(e) in an action taken on the Agency's own initiative. 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 due to its lack of significance, 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), nor is it subject to 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.), or 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.). 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); or OMB review or any Agency action under Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). 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 Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether establishment of tolerances, exemptions from tolerances, raising of tolerance levels, expansion of exemptions, or revocations might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. These analyses for tolerance establishments and modifications, and for tolerance revocations were published in the Federal Register of May 4, 1981 (46 FR 24950) and December 17, 1997 (62 FR 66020) (FRL-5753-1), respectively, and were provided to the Chief Counsel for Advocacy of the Small Business Administration. In a memorandum dated May 25, 2001, EPA determined that eight conditions must all be satisfied in order for an import tolerance or tolerance exemption revocation to adversely affect a significant number of small entity importers, and that there is a negligible joint probability of all eight conditions holding simultaneously with respect to any particular revocation. Furthermore, for alpha-cypermethrin, the Agency knows of no extraordinary circumstances that exist as to the present rule that would change EPA's previous analysis. Taking into account this analysis, and available information concerning the pesticides listed in this rule, EPA hereby certifies that this rule will not have a significant negative economic impact on a substantial number of small entities. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This action directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this action does not have any “tribal implications” as described in Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This action will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.

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:

HHS published a notice of proposed rulemaking (NPRM) on June 17, 2015, to implement civil monetary penalties (CMPs) for manufacturers that knowingly and intentionally charge a covered entity more than the ceiling price for a covered outpatient drug; to provide clarity regarding the requirement that manufacturers calculate the 340B ceiling price on a quarterly basis; and to establish the requirement that a manufacturer charge $0.01 (penny pricing) for each unit of a drug when the ceiling price calculation equals zero (80 FR 34583, June 17, 2015). After review of the comments, HHS reopened the comment period (81 FR 22960, April 19, 2016) to invite additional comments on the following areas of the NPRM: 340B ceiling price calculations that result in a ceiling price that equals zero (penny pricing); the methodology that manufacturers use when estimating the ceiling price for a new covered outpatient drug; and the definition of the “knowing and intentional” standard to be applied when assessing a CMP for manufacturers that overcharge a covered entity.

On January 5, 2017, HHS published a final rule in the Federal Register (82 FR 1210, January 5, 2017); comments from both the original comment period established in the NPRM and the reopened comment period announced in the April 19, 2016, notice were considered in the development of the final rule. The provisions of that final rule were to be effective March 6, 2017; however, HHS issued a subsequent final rule (82 FR 12508, March 6, 2017) delaying the effective date to March 21, 2017, in accordance with a January 20, 2017, memorandum from the Assistant to the President and Chief of Staff, titled “Regulatory Freeze Pending Review.” 1

To provide affected parties sufficient time to make needed changes to facilitate compliance, and because questions were raised, HHS issued an interim final rule (82 FR 14332, March 20, 2017) to delay the effective date of the final rule to May 22, 2017. HHS solicited additional comments on whether that date should be further extended to October 1, 2017. After careful consideration of the comments received, HHS delayed the effective date of the January 5, 2017, final rule to October 1, 2017 (82 FR 22893, May 19, 2017). HHS later solicited comments on delaying the effective date to July 1, 2018 (82 FR 39553, August 21, 2017) and subsequently delayed the January 5, 2017, final rule to July 1, 2018 (82 FR 45511, September 29, 2017).

HHS issued a proposed rule and solicited additional comments to further delay the effective date to July 1, 2019, and received a number of comments both supporting and opposing the delay (83 FR 20008, May 7, 2018). After consideration of the comments received, HHS has decided to delay the effective date of the January 5, 2017, final rule to July 1, 2019. As HHS changed the effective date of the final rule to July 1, 2019, enforcement will be delayed to July 1, 2019. HHS continues to believe that the delay of the effective date will provide regulated entities with needed time to implement the requirements of the rule, as well as allowing a more deliberate process of considering alternative and supplemental regulatory provisions, and to allow for sufficient time for any additional rulemaking. HHS intends to engage in additional or alternative rulemaking on these issues, and believes it would be counterproductive to effectuate the final rule prior to issuance of additional or alternative rulemaking on these issues. HHS is developing new comprehensive policies to address the rising costs of prescription drugs. These policies will address drug pricing in government programs, such as Medicare Parts B & D, Medicaid, and the 340B Program. Due to the development of these comprehensive policies, we are delaying the effective date of the January 5, 2017, final rule to July 1, 2019.

HHS does not believe this delay will adversely affect any of the stakeholders in a meaningful way.

Section 553(d) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq.) requires that Federal agencies provide at least 30 days after publication of a final rule in the Federal Register before making it effective, unless good cause can be found not to do so or for rules that grant or recognize an exemption or relieve a restriction. HHS finds good cause for making this final rule effective less than 30 days after publication in the Federal Register given that failure to do so would result in the final rule published on January 5, 2017, going into effect on July 1, 2018, several weeks before the final rule delaying the effective date until July 1, 2019, would go into effect. To preclude this uncertainty in the marketplace and to ease the burdens of stakeholders, HHS believes that a clear effective date is an important goal and one that becomes particularly important when it is paired with potential civil monetary penalties. The additional time provided to the public before the rule takes effect will assist stakeholders to prepare for compliance with these new program requirements.

In the proposed rule, HHS solicited comments regarding the impact of delaying the effective date of the final rule, published January 5, 2017, to July 1, 2019, while a more deliberate rulemaking process is undertaken. HHS received 29 comments containing a number of issues from covered entities, manufacturers, and groups representing these stakeholders. In this final rule, we will only respond to comments related to whether HHS should delay the January 5, 2017, final rule to July 1, 2019. We did not consider and do not address comments that raised issues beyond the narrow scope of the proposed rule, including comments related to broader policy matters. However, HHS is considering further rulemaking on issues covered in the January 5, 2017, final rule. We have summarized the relevant comments received and provided our responses below.

Comment: Commenters disagree with HHS that delaying implementation of the rule has no adverse effect given that other more significant remedies are available to entities who believe that they have been overcharged by manufacturers. Commenters request that HHS explain what these “significant remedies” are, as they believe that remedies do not exist. Commenters state they cannot audit manufacturers or sue companies in court. In addition, manufacturers can decide not to participate in the 340B program's current voluntary dispute resolution process, and a proposal to make the process mandatory has been withdrawn. Currently, covered entities cannot check if they are being charged the right price. Any further postponement would prevent Congress' intent that HHS has meaningful oversight and enforcement authority.

Response: HRSA's website describes how it carefully reviews pricing discrepancies brought to its attention. In cases in which the 340B Program's ceiling price appears to have been violated, covered entities are provided the details necessary to settle any discrepancy with the manufacturer directly. It is in the manufacturer's best interest to ensure that they are appropriately reporting AMP and URA to CMS, as well as providing the 340B Program ceiling price to 340B Program covered entities. Inaccuracies in any of this pricing information will negatively impact other drug pricing programs, such as Medicaid or Veterans Affairs programs. Further, misreporting pricing data to CMS could lead to State and Federal False Claims Act liability, which has the potential to carry triple damages and other significant monetary penalties.

Comment: Some commenters stated that HHS alleges in the proposed rule that the delay will not adversely affect stakeholders, which ignores the extent of overcharges as documented in OIG reports. HHS also stated that “a small number of manufacturers have informed HHS over the last several years that they charge more than $0.01 for a drug with a ceiling price below $0.01” and that it “believes” a majority of manufacturers follow the “long-standing HHS policy” on penny pricing. HHS's statement that it merely “believes” most manufacturers are following the policy demonstrates that HHS has not attempted to investigate the extent of noncompliance. The penny pricing policy serves as a disincentive for manufacturers to raise drug prices much quicker than the rate of inflation and the rule should be implemented immediately in order to meet the Administration's goal of lowering drug prices. Until penny pricing is codified in a regulation, there is less incentive for manufacturers to comply and the final rule should be effective immediately.

Response: HHS has consistently stated that “A small number of manufacturers have informed HRSA over the last several years that they charge more than $0.01 for a drug with a ceiling price below $0.01. However, this is a long-standing HRSA policy and HRSA believes the majority of manufacturers currently follow the practice of charging a $0.01. Therefore, this portion of the regulation will not result in a significant impact.” (e.g., 80 FR 34586, June 17, 2015; 82 FR 1227, January 5, 2017). The commenter does not provide evidence that a majority of manufacturers are not following the practice of charging $0.01 for a drug with a ceiling price below $0.01. HRSA's website describes how it carefully reviews pricing discrepancies brought to its attention. Through these and other mechanisms, HRSA monitors the program for noncompliance and maintains its belief that a majority of manufacturers follow the long-standing practice of charging $0.01 for a drug with a ceiling price below $0.01.

Comment: Many commenters oppose delaying the effective date to July 1, 2019. Commenters express concern that until the January 5, 2017, final rule is implemented, covered entities remain unprotected from overcharges that can further exacerbate the negative effects of high-cost drugs. They contend that all accountability in the Program is placed on covered entities, and manufacturers are not being held accountable. They contend that the January 5, 2017, final regulation would have provided covered entities with access to a secure database to confirm ceiling prices. These commenters explain that without access to ceiling price information, covered entities have to rely on HRSA to confirm any instances in which the covered entity suspects that it was overcharged by a manufacturer, thereby hampering any meaningful enforcement against manufacturers. They conclude that continued delay of the final rule inhibits the ability of covered entities to verify whether or not manufacturers' calculations of ceiling prices are correct. The commenters request that HHS should implement the January 5, 2017, rule immediately.

Response: HHS does not agree that that we should enforce the final rule immediately. We are delaying the effective date of the January 5, 2017, final rule to July 1, 2019, because the delay will allow HHS to consider additional rulemaking. The final rule does not represent the only method for HHS to address manufacturer overcharges. In addition to the final rule, HHS performs audits of manufacturers, investigates all allegations of overcharging, and participates in settlements that have returned millions of dollars to covered entities. HHS believes that it would be disruptive to require stakeholders to make potentially costly changes to pricing systems and business procedures to comply with a rule that is under further consideration and for which substantive questions have been raised.

While stakeholders had the opportunity to provide comments on the final rule, the 340B Program is a complex program that is affected by changes in other areas of health care. HHS has determined that this complexity and changing environment warrants further review of the final rule and delaying the final rule affords HHS the opportunity to consider alternative and supplemental regulatory provisions and to allow for sufficient time for any additional rulemaking.

Comment: The commenters also disagreed that “a more deliberative process is needed” as HHS has already spent 8 years considering and responding to multiple delays and stakeholders were given various opportunities to comment. HHS has not complied with the statutory deadline to promulgate the regulation and any further delay is unreasonable and violates the Administrative Procedure Act. Rather than implement the CMP Rule, HHS would reward those manufacturers that are flouting ceiling price requirements. Comments assert that the final rule would give HHS an effective penalty to impose on manufacturers that overcharge covered entities and to deter other manufacturers from doing so. In addition, commenters contend that HHS does not have authority to replace Congress' judgment with its own and ignore the requirements of the law. They urge HHS to immediately implement the January 5, 2017, final rule.

Response: HHS believes it would be counterproductive to effectuate the final rule prior to consideration of additional or alternative rulemaking as HHS is in the process of developing new comprehensive policies to address the rising costs of prescription drugs not limited to the 340B Program. As such, HHS is delaying the effective date of the January 5, 2017, final rule until July 1, 2019. In addition, HHS believes this delay will not adversely impact covered entities and will instead save the healthcare sector compliance costs, as discussed in the January 5, 2017, final rule. Therefore, the rule is being delayed to July 1, 2019.

Comment: Some commenters supported HHS's proposed delay of the effective date of the final rule until not only July 1, 2019, but until HHS fulfills its commitment to engage in additional rulemaking that cures the substantive legal and practical concerns with the final rule. These commenters recommend that HRSA tie the further delay of the effective date of the final rule to the completion of such rulemaking, as opposed to a certain date.

Response: HHS decided to delay the effective date to July 1, 2019, to provide affected parties sufficient time to make needed changes to facilitate compliance and because HHS continues to examine important substantive issues arising from the January 5, 2017, final rule. After reviewing the comments received from stakeholders regarding objections on the timing of the effective date and challenges associated with complying with the final rule, HHS has determined that delaying the effective date to July 1, 2019, is necessary to consider some of the issues raised. HHS believes that delaying the effective date to July 1, 2019, provides sufficient time to address these issues in junction with HHS's stated intention to consider undertaking additional or alternative rulemaking on these issues.

Comment: Some commenters stated that the January 5, 2017, final rule contains several policies that are inconsistent with the 340B statute and imposes unnecessary costs and needless administrative burdens on manufacturers. They believe that manufacturers should not be required to make updates to their systems, policies, and business practices to comply with the January 5, 2017, final rule if further changes or additional rulemaking will be forthcoming. These commenters urge HHS to delay the effective date to July 1, 2019, and use the additional time to reconsider the policies included in the final rule.

Responses: HHS intends to engage in further rulemaking and believes that this delay will provide HHS with time to consider the public comments received. Requiring manufacturers to make targeted and potentially costly changes to pricing systems and business procedures to comply with a rule that is under further consideration would be disruptive. Therefore, HHS is delaying the January 5, 2017, final rule to July 1, 2019.

Comment: Several commenters explained that a delay in the effective date of the final rule is also necessary to align with the Administration's priorities of analyzing final, but not yet effective regulations, and removing or minimizing unwarranted economic and regulatory burdens related to the Affordable Care Act, the law that added the provisions of the 340B statute that are the subject of the final rule.

Response: HHS agrees with the commenters. Executive Order 13765 instructs agencies to use discretion to delay the implementation of certain provisions of the Patient Protection and Affordable Care Act. As previously mentioned, HHS based the January 5, 2017, final rule on changes made to the 340B Program by the Patient Protection and Affordable Care Act. As such, HHS is complying with Executive Order 13765 to delay implementation on provisions of the law that “. . . impose a fiscal burden on any State or a cost, fee, tax, penalty, or regulatory burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications.” The policies finalized in the January 5, 2017, final rule will require targeted and potentially costly changes to pricing systems and business procedures for manufacturers affected by the rule. Thus, HHS is delaying the effective date to July 1, 2019.

Comment: Some commenters recommend that HHS delay the effective date of the final rule until HHS concurrently addresses 340B covered entity compliance obligations and penalties under the 340B statute, which is necessary to strengthen the integrity of the 340B Program.

Response: HHS plans to issue separate policy documents related to drug pricing in government programs, including the 340B Program, and disagrees with the commenters advising HHS to address these issues concurrently.

Comment: Many commenters supported further delaying the effective date to July 1, 2019, at a minimum, and urged HHS to take the opportunity to refocus the 340B Program on its mission, and issue new reforms and new ceiling price and CMP rule as expeditiously as possible.

Response: HHS agrees with the commenters and will delay the effective date of the January 5, 2017, final rule to July 1, 2019.

HHS examined the effects of this final rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 8, 2011), the Regulatory Flexibility Act (Pub. L. 96-354, September 19, 1980), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act, and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866, emphasizing the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year), and a “significant” regulatory action is subject to review by the Office of Management and Budget (OMB).

This final rule will not have economic impacts of $100 million or more in any 1 year, and, therefore, has not been designated an “economically significant” rule under section 3(f)(1) of Executive Order 12866. The 340B Program as a whole creates significant savings for entities purchasing drugs through the program; however, this final rule would not have an economically significant impact on the Program.

When the 2017 Rule was finalized, it was described as not economically significant. Therefore, delay of the effective date of the 2017 Rule is also not likely to have an economically significant impact.

Specifically, the RIA for the 2017 Rule stated that, “[. . .] manufacturers are required to ensure they do not overcharge covered entities, and a civil monetary penalty could result from overcharging if it met the standards in this final rule. HHS envisions using these penalties in rare situations. Since the Program's inception, issues related to overcharges have been resolved between a manufacturer and a covered entity and any issues have generally been due to technical errors in the calculation. For the penalties to be used as defined in the statute and in this [2017] rule, the manufacturer overcharge would have to be the result of a knowing and intentional act. Based on anecdotal information received from covered entities, HHS anticipates that this would occur very rarely if at all.” Since the civil penalties envisioned in the 2017 Rule were expected to be rare, delay of these civil penalties is unlikely to have an economically significant impact.

Additionally, the 2017 Rule codified the practice of manufacturers charging $0.01 for drugs with a ceiling price below $0.01, which the 2017 Rule RIA described as “[. . .] a long-standing HRSA policy, and HRSA believes the majority of manufacturers currently follow the practice of charging $0.01.” Delay of this rule will delay the codification of this practice, but since it is already a longstanding policy and widespread practice, the impact of delay is not likely to be economically significant.

Executive Order 13771, titled “Reducing Regulation and Controlling Regulatory Costs,” was issued on January 30, 2017. This rule is not subject to the requirements of E.O. 13771 because this rule results in no more than de minimis costs.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) and the Small Business Regulatory Enforcement and Fairness Act of 1996, which amended the RFA, require HHS to analyze options for regulatory relief of small businesses. If a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of the rule on small entities and analyze regulatory options that could lessen the impact of the rule. HHS will use an RFA threshold of at least a 3 percent impact on at least 5 percent of small entities.

For purposes of the RFA, HHS considers all health care providers to be small entities either by meeting the Small Business Administration (SBA) size standard for a small business, or by being a nonprofit organization that is not dominant in its market. The current SBA size standard for health care providers ranges from annual receipts of $7 million to $35.5 million. As of January 1, 2018, over 12,800 covered entities participate in the 340B Program, which represent safety-net health care providers across the country.

In addition, the rule would affect drug manufacturers (North American Industry Classification System code 325412: Pharmaceutical Preparation Manufacturing). The small business size standard for drug manufacturers is 750 employees. Approximately 600 drug manufacturers participate in the 340B Program. While it is possible to estimate the impact of the rule on the industry as a whole, the data necessary to project changes for specific or groups of manufacturers is not available, as HRSA does not collect the information necessary to assess the size of an individual manufacturer that participates in the 340B Program. HHS has determined, and the Secretary certifies that this final rule will not have a significant impact on the operations of a substantial number of small manufacturers; therefore, we are not preparing an analysis of impact for this RFA. HHS estimates that the economic impact on small entities and small manufacturers will be minimal.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year.” In 2017, that threshold is approximately $148 million. HHS does not expect this rule to exceed the threshold.

HHS has reviewed this final rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have “federalism implications.” This final rule would not “have substantial direct effects on the States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that OMB approve all collections of information by a federal agency from the public before they can be implemented. This final rule is projected to have no impact on current reporting and recordkeeping burden for manufacturers under the 340B Program. This final rule would result in no new reporting burdens.

Sections 1832, 1834, and 1861 of the Social Security Act (the Act) establish that the provision of durable medical equipment, prosthetic, orthotics, and supplies (DMEPOS) is a covered benefit under Part B of the Medicare program.

Section 1834(a)(15) of the Act authorizes the Secretary to develop and periodically update a list of DMEPOS items that the Secretary determines, on the basis of prior payment experience, are frequently subject to unnecessary utilization and to develop a prior authorization process for these items.

In the December 30, 2015 final rule (80 FR 81674) titled “Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies,” we implemented section 1834(a)(15) of the Act by establishing an initial Master List (called the Master List of Items Frequently Subject to Unnecessary Utilization) of certain DMEPOS that the Secretary determined, on the basis of prior payment experience, are frequently subject to unnecessary utilization and by establishing a prior authorization process for these items. In the same final rule, we also stated that we would inform the public of those DMEPOS items on the Required Prior Authorization List in the Federal Register with 60-day notice before implementation. The Required Prior Authorization List specified in § 414.234(c)(1) is selected from the Master List of Items Frequently Subject to Unnecessary Utilization (as described in § 414.234(b)(1)), and items on the Required Prior Authorization List require prior authorization as a condition of payment.

In addition to the prior authorization process for certain DMEPOS items that we established under section 1834(a)(15) of the Act, on September 1, 2012, we implemented the Medicare Prior Authorization for Power Mobility Devices (PMDs) Demonstration that would operate for a period of 3 years (September 1, 2012 through August 31, 2015). This demonstration was established under section 402(a)(1)(J) of the Social Security Amendments of 1967 (42 U.S.C. 1395b-1(a)(1)(J)), which authorizes the Secretary to conduct demonstrations designed to develop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of care or services provided under the Medicare program. The demonstration was initially implemented in California, Florida, Illinois, Michigan, New York, North Carolina, and Texas. These states were selected for the demonstration based upon their history of having high levels of improper payments and incidents of fraud related to PMDs. On October 1, 2014, we expanded the demonstration to 12 additional states (Pennsylvania, Ohio, Louisiana, Missouri, Washington, New Jersey, Maryland, Indiana, Kentucky, Georgia, Tennessee, and Arizona) that have high expenditures and improper payments for PMDs based on 2012 billing data. On July 15, 2015, we announced we were extending the demonstration for 3 years, through August 31, 2018.

The purpose of this document is to inform the public that we are updating the Required Prior Authorization List of DMEPOS items that require prior authorization as a condition of payment to include all of the power mobility devices that are part of the PMD demonstration, which are also included on the Master List of Items Frequently Subject to Unnecessary Utilization. To assist stakeholders in preparing for implementation of the prior authorization program, CMS is providing 90 days' notice.

The following 31 DMEPOS items are being added to the Required Prior Authorization List:

These codes will be subject to the requirements of the prior authorization program for certain DMEPOS items as outlined in § 414.234. We believe continued prior authorization of these codes will help further our program integrity goals of reducing fraud, waste, and abuse, while protecting access to care. We will implement a prior authorization program for these codes nationwide, for dates of service beginning September 1, 2018. This approach will allow continuity for those suppliers in the 19 states familiar with prior authorization of PMDs under the demonstration, and allows sufficient time for education and outreach to suppliers in the remaining states. HCPCS codes K0856 and K0861, which we placed on the Required Prior Authorization List in a December 21, 2016 notice (81 FR 93636), will continue to be subject to the requirements of prior authorization as well.

Although the PMD demonstration's prior authorization process is similar to the process used for those items on the Required Prior Authorization List, some differences do exist. In particular, items on the Required Prior Authorization List require prior authorization as a condition of payment. As such, lack of a provisionally affirmed prior authorization request will result in a claim denial. Under the PMD demonstration, requesting prior authorization is optional, and claims submitted for payment without an associated prior authorization decision are subject to prepayment review and assessed a 25-percent reduction in Medicare payment if found payable. Additionally, under the PMD demonstration, physicians/treating practitioners may submit prior authorization requests and are eligible to bill HCPCS code G9156 for an incentive payment. This process is not available for items on the Required Prior Authorization List.

Prior to furnishing the item to the beneficiary and prior to submitting the claim for processing, a requester must submit a prior authorization request that includes evidence that the item complies with all applicable Medicare coverage, coding, and payment rules. Consistent with § 414.234(d), such evidence must include the order, relevant information from the beneficiary's medical record, and relevant supplier-produced documentation. After receipt of all applicable required Medicare documentation, CMS or one of its review contractors will conduct a medical review and communicate a decision that provisionally affirms or non-affirms the request.

We will issue specific prior authorization guidance in subregulatory communications, including final timelines, which are customized for the DMEPOS items subject to prior authorization, for communicating a provisionally affirmed or non-affirmed decision to the requester. In the December 30, 2015 final rule, to allow us to safeguard beneficiary access to care, we stated that this approach to final timelines provides the flexibility to develop a process that involves fewer days, as may be appropriate. If at any time we become aware that the prior authorization process is creating barriers to care, we can suspend the program.

The updated Required Prior Authorization list is available in the download section of the following CMS website: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/DMEPOS/Prior-Authorization-Process-for-Certain-Durable-Medical-Equipment-Prosthetic-Orthotics-Supplies-Items.html. We will post additional educational resources to the website.

This notice announces the addition of DMEPOS items on the Required Prior Authorization List and does not impose any new information collection burden under the Paperwork Reduction Act of 1995. However, there is an information collection burden associated with this program that is currently approved under OMB control number 0938-1293 which expires February 28, 2019.

This is a summary of the Commission's Order on Reconsideration, MB Docket No. 13-249, FCC 18-64, adopted on May 21, 2018, and released on May 22, 2018. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Center, Federal Communications Commission, 445 12th Street SW, Washington, DC 20554. This document will also be available via ECFS at https://www.fcc.gov/ecfs/. Documents will be available electronically in ASCII, Microsoft Word, and/or Adobe Acrobat. Copies of the materials can be obtained from the FCC's Reference Information Center at (202) 418-0270. Alternative formats are available for people with disabilities (Braille, large print, electronic files, audio format), by sending an email to [email protected] or calling the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY). This document is not subject to the Congressional Review Act. The Commission is, therefore, not required to submit a copy of this Order on Reconsideration to the General Accounting Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the Petition for Reconsideration was denied and the Petition for Emergency Stay and Motion for Extension of Time were dismissed as moot.

The Commission rejected Prometheus's contentions that the Commission's decision not to adopt a proposed distance limit for siting cross-service FM translator stations (translators re-broadcasting AM station signals) was not a logical outgrowth of the proposed rule and was arbitrary and capricious. It found that the decision not to adopt the proposed 40-mile limit was reasonably foreseeable, especially given that commenters had proposed omitting the 40-mile limit and that Prometheus had access to those comments. The Commission further found that its actions were not arbitrary and capricious, finding that Prometheus's contentions do not raise legitimate concerns and are at best speculative. Prometheus did not provide evidence that omission of a distance limit encourages translators to “box in” incumbent low-power FM (LPFM) stations, restricting their ability to change sites. Additionally, the Commission rejected Prometheus's argument that its final rule violated the Local Community Radio Act of 2010 (LCRA), in part because the LCRA does not mandate that the Commission prefer LPFM stations over FM translators. To the extent the LCRA obliges the Commission to consider local community needs, the Commission has stated that FM translators and LPFM stations both serve community needs in different ways, and that giving AM stations more flexibility in siting fill-in cross-service translators, without a set distance limit, was in the public interest, as it allows an AM station to improve its program service to listeners in the local communities within its primary service contour. The Commission finally rejected Prometheus's argument that the Commission falsely equated the LPFM service with local commercial AM broadcasters, because the amended rule benefits both commercial and noncommercial AM stations.