The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-0094; Project Identifier AD-2021-01251-E” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Mehdi Lamnyi, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA was notified by the engine manufacturer of the detection of melt-related freckles in the billet, which may reduce the life of certain compressor rotor stages 6-10 spools, HPT rotor mid seals, HPT rotor stage 2 disks, LPT stage 2 disks, and LPT stage 3 disks (life-limited parts (LLPs)). The manufacturer's investigation determined that, as a result of such freckles forming in the billet, these LLPs may have undetected subsurface anomalies that developed during the manufacturing process, resulting in reduced material properties and a lower fatigue life capability. Reduced material properties may cause premature LLP fracture, which could result in uncontained debris release. As a result of its investigation, the manufacturer determined the need to reduce the life limits of these LLPs. To reflect these reduced life limits, the manufacturer revised the CFM ALS, Chapter 05 of LEAP-1B ESM. Additionally, the manufacturer published service information that specifies procedures for the removal and replacement of these LLPs before reaching their new life limits. The FAA is proposing to require operators to update the ALS of the applicable CFM LEAP-1B ESM, with the reduced life limits for these LLPs.

This condition, if not addressed, could result in uncontained debris release, damage to the engine, and damage to the airplane.

The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

The FAA reviewed CFM High Pressure Compressor Rotor Life Limits LEAP-1B-05-11-02-01A-0B1B-C, Issue 009-00, dated July 26, 2021 (CFM LEAP-1B-05-11-02-01A-0B1B-C); CFM High Pressure Turbine Rotor Life Limits LEAP-1B-05-11-03-01A-0B1B-C, Issue 006-00, dated July 26, 2021 (CFM LEAP-1B-05-11-03-01A-0B1B-C); and CFM Low Pressure Turbine Rotor Life Limits LEAP-1B-05-11-04-01A-0B1B-C, Issue 006-00, dated June 1, 2021 (LEAP-1B-05-11-04-01A-0B1B-C). CFM LEAP-1B-05-11-02-01A-0B1B-C provides new high pressure compressor rotor life limits. CFM LEAP-1B-05-11-03-01A-0B1B-C provides new HPT rotor life limits. CFM LEAP-1B-05-11-04-01A-0B1B-C provides new LPT rotor life limits. 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 ADDRESSES .

The FAA reviewed CFM Service Bulletin LEAP-1B-72-00-0342-01A-930A-D, Issue 002-00, dated July 26, 2021 (LEAP-1B-72-00-0342-01A-930A-D). LEAP-1B-72-00-0342-01A-930A-D specifies procedures for removing and replacing the LLPs, and provides new life limits for certain serial numbers of the LLPs.

This proposed AD would require revising the ALS of the CFM LEAP-1B ESM, as applicable to each affected engine model, and the operator's existing approved CAMP to incorporate reduced life limits for certain LLPs.

The FAA estimates that this AD, if adopted as proposed, would affect 378 engines installed on airplanes of U.S. registry.

The FAA estimates the following costs to comply with this proposed 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.

The FAA is 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.

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

For the reasons discussed above, I certify this proposed regulation:

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

(2) Would not affect intrastate aviation in Alaska, and

(3) Would 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 proposes to amend 14 CFR part 39 as follows:

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-0010; Project Identifier AD-2021-00850-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Greg Rutar, Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3529; email: greg.rutar@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA has received a report indicating that during a C-check, corrosion was found in the vertical fin tension bolt hole located in the aluminum crown frames at Section 48. Upon further investigation, it was found that the corrosion was caused by insufficient sealant application during the vertical fin tension bolt installation. This condition, if not addressed, could result in undetected corrosion. Undetected corrosion in this location could lead to the structure falling below residual strength requirements and the loss of the vertical fin, which could result in loss of control of the airplane.

The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

The FAA reviewed Boeing Alert Requirements Bulletin B787-81205-SB550010-00 RB, Issue 001, dated May 24, 2021. This service information specifies, depending on airplane configuration, procedures for a detailed inspection of the vertical fin tension bolt holes (16 locations) in the aluminum crown frames, composite deck, and root fittings for corrosion and finish degradation; a review of the existing maintenance or inspection program, as applicable, related to the vertical fin tension bolt installation procedure to determine if the sealant application is correct; a review of the maintenance records to determine if a vertical fin tension bolt has been replaced and to determine the sealant application procedure that was used; and applicable on-condition actions. On-condition actions include applying sealant and installing new vertical fin tension bolts and barrel nuts; revising the existing maintenance or inspection program, as applicable, to include the minimum requirement for the correct vertical fin tension bolt sealant application procedure; a detailed inspection for corrosion and finish degradation of only the affected vertical fin tension bolt holes in the aluminum crown frame, composite deck, and root fittings; 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 ADDRESSES .

This proposed AD would require accomplishing the actions specified in the service information already described. For information on the procedures and compliance times, see this service information at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-0010.

The FAA estimates that this AD, if adopted as proposed, would affect 116 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:

The FAA estimates the following costs to do any necessary detailed inspection of the affected holes that would be required based on the results of the proposed actions. The agency has no way of determining the number of aircraft that might need these on-condition actions:

The FAA has determined that revising the existing maintenance or inspection program, if required, takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the FAA estimates the average total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).

The FAA has received no definitive data on which to base the cost estimates for the repair specified in this proposed AD.

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators.

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.

The FAA is 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.

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

For the reasons discussed above, I certify this proposed regulation:

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

(2) Would not affect intrastate aviation in Alaska, and

(3) Would 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 proposes to amend 14 CFR part 39 as follows:

The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2022-0100; Project Identifier MCAI-2021-01128-R” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Andrea Jimenez, Aerospace Engineer, COS Program Management Section, Operational Safety Branch, Compliance & Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-7330; email andrea.jimenez@faa.gov. Any commentary that the FAA receives that is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0231, dated October 15, 2021 (EASA AD 2021-0231), to correct an unsafe condition for all serial-numbered Airbus Helicopters Deutschland GmbH (AHD) Model MBB-BK 117 C-2 helicopters.

This proposed AD was prompted by a report of restricted collective lever movement caused by entanglement of the emergency flashlight strap with the cargo hook emergency release lever, causing the emergency flashlight to leave its seat. The FAA is proposing this AD to address entanglement of the emergency flashlight strap with the cargo hook emergency release lever. The unsafe condition, if not addressed, could result reduced control of the helicopter, resulting in damage to the helicopter and injury to occupants. See EASA AD 2021-0231 for additional background information.

EASA AD 2021-0231 requires replacing each affected emergency flashlight with a serviceable part. EASA AD 2021-0231 also specifies that an affected part can be modified and re-identified into a serviceable part. EASA AD 2021-0231 also prohibits the installation of an affected part.

This material 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.

The FAA also reviewed Airbus Helicopters Alert Service Bulletin ASB MBB-BK117 C‐2-25A‐021, Revision 0, dated August 25, 2021. This service information specifies procedures for removing the strap from the emergency flashlight and then writing a new part number on the emergency flashlight.

These helicopters have been approved by EASA and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the European Union, EASA has notified the FAA about the unsafe condition described in its AD. The FAA is proposing this AD after evaluating all known relevant information and determining that the unsafe condition described previously is likely to exist or develop on other helicopters of the same type design.

This proposed AD would require accomplishing the actions specified in EASA AD 2021-0231, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this proposed AD and except as discussed under “Differences Between this Proposed AD and the EASA AD.”

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2021-0231 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2021-0231 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2021-0231 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2021-0231. Service information referenced in EASA AD 2021-0231 for compliance will be available at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-0100 after the FAA final rule is published.

EASA AD 2021-0231 requires compliance within 12 months after the effective date of the EASA AD, whereas this proposed AD would require compliance within 3 months after the effective date of this AD.

The FAA estimates that this AD, if adopted as proposed, would affect 117 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this proposed AD.

Replacing an emergency flashlight would take about 1 work-hour and parts would cost about $219 for an estimated cost of $304 per flashlight and up to $35,568 for the U.S. fleet. Alternatively, modifying an emergency flashlight would take about 1 work-hour for an estimated cost of $85 per flashlight.

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.

The FAA is 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.

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

For the reasons discussed above, I certify this proposed regulation:

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

(2) Would not affect intrastate aviation in Alaska, and

(3) Would 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 proposes to amend 14 CFR part 39 as follows:

On January 7, 2022, the Commission published a notice of proposed rulemaking (NPR) in the Federal Register , proposing to issue a Safety Standard for Operating Cords on Custom Window Coverings under the Consumer Product Safety Act (CPSA; 15 U.S.C. 2051-2089), and seeking written comments. 87 FR 1014. The NPR seeks to address an unreasonable risk of strangulation to children 8 years old and younger associated with custom window coverings that have accessible operating cords that are longer than 8 inches. The NPR would require that operating cords on custom window coverings meet the same requirements as operating cords on stock window coverings, as set forth in the applicable voluntary standard, ANSI/WCMA A100.1—2018, American National Standard for Safety of Corded Window Covering Products. Thus, the proposed rule proposes that operating cords on custom window coverings must be cordless, inaccessible, or 8 inches or shorter in length in any use position. If finalized, operating cords on custom window coverings would require testing and certification to the rule under section 14 of the CPSA. Moreover, operating cords on custom window coverings that meet the definition of a “children's product” would require third party testing by a CPSC-accredited third party conformity assessment body. Accordingly, the proposed rule also proposes to amend the Commission's regulation at 16 CFR part 1112 to add “Safety Standard for Operating Cords on Custom Window Coverings” to the list of rules that require third party testing. The NPR is available at: https://www.federalregister.gov/d/2021-27896, and CPSC staff's briefing package for the NPR is available at: https://www.cpsc.gov/s3fs-public/NPRs-Add-Window-Covering-Cords-to-Substantial-Product-Hazard-List-Establish-Safety-Standard-for-Operating-Cords-on-Custom-Window-Coverings-updated-10-29-2021.pdf?VersionId=HIM05bK3WDLRZrlNGogQLknhFvhtx3PD.

The Administrative Procedure Act (5 U.S.C. 551-562) and section 9 of the CPSA require the Commission to provide interested parties with an opportunity to submit “written data, views, or arguments” regarding a proposed rule. 5 U.S.C. 553(c); 15 U.S.C. 2058(d)(2). The NPR invited such written comments. Section 9 of the CPSA also requires the Commission to provide interested parties “an opportunity for oral presentation of data, views, or arguments.” 15 U.S.C. 2058(d)(2). The Commission must keep a transcript of such oral presentations. Id. To satisfy this requirement, the Commission is providing a forum for oral presentations concerning the proposed Safety Standard for Operating Cords on Custom Window Coverings. 1

To request the opportunity to make an oral presentation, see the information under the DATES and ADDRESSES sections of this notice. Participants should limit their presentations to approximately 10 minutes, excluding time for questioning by the Commissioners or CPSC staff. To avoid duplicate presentations, groups should designate a spokesperson, and the Commission reserves the right to limit presentation times or impose further restrictions, as necessary.

On January 10, 2022, the Commission published an NPR in the Federal Register , proposing to issue a safety standard for magnets under the Consumer Product Safety Act (CPSA; 15 U.S.C. 2051-2089), and seeking written comments. 87 FR 1260. The proposed rule seeks to address the risk of injury or death associated with magnet ingestions, by requiring loose or separable magnets in subject magnet products to be either too large to swallow, or weak enough to reduce the risk of internal interaction injuries when swallowed. The proposed rule would apply to “subject magnet products,” which are consumer products that are designed, marketed, or intended to be used for entertainment, jewelry (including children's jewelry), mental stimulation, stress relief, or a combination of these purposes, and that contain one or more loose or separable magnets. The NPR proposed a rule to require each loose or separable magnet in a subject magnet product that fits entirely within CPSC's small parts cylinder (described in 16 CFR 1501.4) to have a flux index of less than 50 kG 2 mm 2 . Toys that are subject to CPSC's mandatory toy standard in 16 CFR part 1250 are exempt from the proposed rule. The NPR is available at: https://www.govinfo.gov/content/pkg/FR-2022-01-10/pdf/2021-27826.pdf, and CPSC staff's briefing package for the NPR is available at: https://www.cpsc.gov/s3fs-public/Proposed-Rule-Safety-Standard-for-Magnets.pdf?VersionId=2Xizl5izY1OvQRVazWpkqdJHXg5vzRY.

The Administrative Procedure Act (5 U.S.C. 551-562) and section 9 of the CPSA require the Commission to provide interested parties with an opportunity to submit “written data, views, or arguments” regarding a proposed rule. 5 U.S.C. 553(c); 15 U.S.C. 2058(d)(2). The NPR invited such written comments. In addition, section 9 of the CPSA requires the Commission to provide interested parties “an opportunity for oral presentation of data, views, or arguments” 15 U.S.C. 2058(d)(2). The Commission must keep a transcript of such oral presentations. Id. In accordance with this requirement, the Commission is providing a forum for oral presentations concerning the proposed standard for magnets.

To request the opportunity to make an oral presentation, see the information under the DATES and ADDRESSES sections of this notice. Participants should limit their presentations to approximately 10 minutes, excluding time for questioning by the Commissioners or CPSC staff. To avoid duplicate presentations, groups should designate a spokesperson, and the Commission reserves the right to limit presentation times or impose further restrictions, as necessary.

We are proposing to amend or add the following rules and forms:

On January 12, 2022, the United States Capitol Police notified the Coast Guard that the Democratic National Caucus (DNC) is being held in the vicinity of Penns Landing located in Philadelphia, PA from 11 a.m. on March 9, 2022 through 11:59 p.m. on March 11, 2022. The DNC is being held adjacent to the Delaware River and this security zone is needed to provide protection and security of the VIPs attending the Democratic National Caucus in the vicinity of this waterway. The presence of these persons creates unique safety and security concerns. The Captain of the Port Delaware Bay (COTP) has determined that attendance of VIPs at the Democratic National Caucus March 9, 2022, through March 11, 2022, presents a potential target for terrorist acts, sabatoge, or other subversive acts, accidents, or other causes of a similar nature.

The purpose of this rulemaking is to protect these persons, the public, and the surrounding waterway, because the Democratic National Caucus is being held at Penns landing which is a highly populated area, adjacent to the Delaware River. The Coast Guard is proposing this rulemaking under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231).

The COTP is proposing to establish a security zone from March 9, 2022, through March 11, 2022, on certain waters of the Delaware River in Philadelphia, PA. Specifically, the security zone would cover all waters within the Delaware River contiguous to the Pennsylvania shoreline and extending out into the Delaware River approximately 250 yards, within an area bounded by a line connecting the following points: Beginning at the Pennsylvania shoreline at latitude 39°56.87′ N, longitude 075°8.36′ W, thence east to latitude 39°56.85′ N, longitude 075°8.20′ W, thence south to latitude 39°56.45′ N, longitude 075°8.25′ W, thence west to the Pennsylvania shoreline at latitude 39°56.47′ N, longitude 075°8.41′ W, thence north following the shoreline to the originating point.

This zone will be enforced intermittently during the effective dates. Enforcement of this zone will be broadcast via Broadcast Notice to Mariners on VHF-FM marine channel 16 as well as actual notice via on scene Coast Guard Personnel.

No vessel or person will be permitted to enter or transit these security zones without obtaining permission from the COTP or a designated representative and must proceed as directed by on scene enforcement vessels. Any vessel permitted to transit the zone will be required to continue through the zone without pause or delay as directed by on scene enforcement vessels.

The regulatory text we are proposing appears at the end of this document.

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

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the duration, size, location and time of year of the zone. During this time of year, this Security Zone is primarily used by Commercial Traffic. That traffic will be permitted to transit through the zone without pause or delay upon receiving approval of on-scene enforcement vessels. This zone will only be enforced for limited durations when deemed necessary by the COTP to augment the protection of the VIPs attending the Democratic Natioanl Caucus.

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

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

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

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

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

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

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

We have analyzed this proposed rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a security zone which will be intermittently enforced over the course of 3 days. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A preliminary Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

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

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

Submitting comments. We encourage you to submit comments through the Federal Decision Making Portal at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2022-0040 in the search box and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER INFORMATION CONTACT section of this proposed rule for alternate instructions.

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For the reasons discussed in the preamble, the Coast Guard is proposing to amend 33 CFR part 165 as follows:

As part of its ongoing revision of the Schedule for Rating Disabilities (VASRD, or the Rating Schedule), VA is proposing changes to the portions of the VASRD that address the audiology system, which VA last addressed in 1999 (see 64 FR 25202), as well as the respiratory system, which VA last addressed in 2006 (see 71 FR 52457). The proposed rule reflects advances in medical knowledge, recommendations from VA experts in audiology and respiratory conditions, and comments from experts and the public gathered during an October 2011 forum in New York City.

VA proposes to incorporate more current respiratory and auditory terminology and apply current standards of assessing and evaluating impairment. Where changes to the scientific and/or medical nature of a given condition have been proposed, VA has cited the published, publicly-available sources for these changes. The proposed changes are not a reflection of any particular expert's comments or recommendations but were based on published, peer-reviewed materials. Materials from the public forum are available for public inspection at the Office of Regulation Policy and Management (see the ADDRESSES section of this rulemaking), and other deliberative materials are cited herein.

VA also intends to reorganize the Rating Schedule so its classifications of injuries and diseases more closely resemble those used in health care. This reorganization involves moving several diagnostic codes (DCs) from “The Respiratory System” to a new body system designated as “Ear, Nose, Throat, and Auditory Disabilities.”

VA proposes to revise § 4.96 to clarify, simplify, and eliminate redundancies in the special provisions regarding respiratory conditions. Paragraph (a) currently precludes simultaneous ratings for specific coexisting respiratory conditions. VA proposes to amend paragraph (a) by simply stating that VA may not combine, under 38 CFR 4.25, Combined Ratings Table, coexisting respiratory conditions unless otherwise directed. Under this proposed rule, the only respiratory disability that VA may combine with other respiratory disabilities is DC 6847, sleep apnea. The proposed rule notes which DCs may be combined with DC 6847.

VA does not propose any change to current paragraph (b), which discusses veterans who received, or were entitled to receive, compensation for tuberculosis as of August 19, 1968.

VA proposes to remove paragraph (c), which deals with special monthly compensation (SMC) for complete organic aphonia. Complete organic aphonia, currently evaluated under DC 6519, is among those disabilities that VA is proposing to move to the new body system, “Ear, Nose, Throat, and Auditory Disabilities,” as DC 6230, with a footnote discussing SMC. Therefore, the respiratory system no longer requires this paragraph.

As a result of this deletion, VA intends to redesignate current paragraph (d) as paragraph (c). The current paragraph (d) provides information on the use of pulmonary function tests (PFTs) to evaluate the severity of certain respiratory conditions. As discussed in detail below, VA proposes to evaluate a number of respiratory conditions using a General Rating Formula for Respiratory Conditions (General Rating Formula), which reference various PFTs. As such, VA proposes to amend the subheading for revised § 4.96(c) to expand the list of all DCs that VA will rate using the General Rating Formula.

Within revised paragraph (c), VA proposes to amend subparagraph (1). Currently, § 4.96(d)(1)(ii) states that PFTs are not necessary when an individual is diagnosed with pulmonary hypertension, cor pulmonale, or right ventricular hypertrophy. A new DC addressing the requirements for “pulmonary hypertension” (discussed below) is being proposed herein. Furthermore, the proposed General Rating Formula for Respiratory Conditions includes METS as an evaluation criteria, which are the same evaluation criteria used in the General Rating Formula for Diseases of the Heart. This means cor pulmonale and right ventricular hypertrophy can both be evaluated within the respiratory system under its General Rating Formula. Therefore, the current subparagraph (d)(1)(ii) will no longer be necessary. With the absence of that subparagraph, VA proposes to redesignate current subparagraphs (d)(1)(iii) and (d)(1)(iv) as subparagraphs (c)(1)(ii) and (c)(1)(iii), respectively.

Current subparagraph (d)(2) discusses the use of diffusion capacity of the lung for carbon monoxide by the single breath method (DLCO (SB)). The new General Rating Formula and proposed pulmonary hypertension code have sufficient alternative criteria to evaluate respiratory disabilities when the DLCO (SB) is not available. VA may still consider using DLCO (SB) to evaluate respiratory disabilities, but VA will not require it and the examiner need not state why the test would not be useful or valid in a particular case. Accordingly, VA proposes to delete current subparagraph (d)(2).

VA proposes to remove current subparagraphs (d)(4) and (d)(5). These paragraphs discuss the need for post-bronchodilator studies during examinations, except in certain circumstances, and the need to utilize post-bronchodilator results as a more accurate value in evaluating respiratory disabilities. VA proposes to remove these subparagraphs because whether pre- or post-bronchodilator studies accurately reflect an individual's medical condition is a medical determination and therefore is more appropriately decided by a medical practitioner and/or examiner; this information should be considered as part of the medical record, to include treatment notes and/or examination. Therefore, there is no need to instruct rating personnel on the use of post-bronchodilator studies.

VA also proposes to remove current subparagraph (d)(7) because it is inaccurate. Obstructive respiratory disease may be present, ratable, and compensable even though both Forced Expiratory Volume in one second (FEV-1) and Forced Vital Capacity (FVC) are greater than 100 percent. See Matthew J. Hegewald and Robert O. Crapo, “Pulmonary Function Testing,” Murray and Nadel's Textbook of Respiratory Medicine 527-28 (5th ed. 2010).

As a result of the above deletions, VA intends to redesignate current subparagraph (d)(3) as (c)(2), and redesignate current subparagraph (d)(6) as (c)(3), with no substantive changes.

Finally, VA proposes to add a new paragraph (d), Respiratory conditions and comorbid cardiovascular conditions. A MET is defined as the amount of oxygen consumed by a person at rest. This measurement is used to calculate the energy cost of a specific activity in multiples of the amount of oxygen consumed by a person at rest. Oxygen consumption is possible through the integrated operation of two distinct body systems, the cardiovascular and respiratory systems. The respiratory system captures and collects oxygen, while the cardiovascular system delivers the oxygen to muscles (including the heart itself) performing the work associated with a specific activity. See M. Jette. “Metabolic Equivalents (METS) in Exercise Testing, Exercise Prescription, and Evaluation of Functional Capacity,” 13(8) Clin. Cardiol. 555-65 (1990).

Typically, when disability affects either the cardiovascular or respiratory systems, it is easy to apportion disability using METs to the affected system. However, when both the cardiovascular and respiratory systems are involved, it is difficult to apportion the contribution to the observed disability by each system. To avoid the potential rating complications posed by situations where coexistent cardiovascular and respiratory disabilities can be evaluated using METs, VA will instruct raters to evaluate only one body system using METs and evaluate the other body system using criteria other than METs, absent instructions otherwise in individual DCs. (The evaluation levels for METs will be the same in both cardiovascular and respiratory systems—that is, the METs yielding a 60 percent evaluation level in the cardiovascular system will yield the same evaluation in the respiratory system.) The General Rating Formula for Respiratory Conditions in § 4.97 lists several types of test results that can be used to evaluate a respiratory condition. When METs are used to evaluate a respiratory disability under § 4.97, they will not be used to evaluate a comorbid cardiovascular disability under § 4.104, and vice versa. Raters will use METs in the evaluation of the disability that would provide the veteran with the most advantageous combined rating.

This proposed rule addresses VA's outdated organization of the DCs within the current respiratory schedule. This rule also updates diagnostic naming conventions and evaluation criteria according to modern medical practice.

VA proposes to remove the heading “Diseases of the Nose and Throat.” As discussed in more detail below, VA is relocating DCs 6502 through 6524, currently located under this heading, to 38 CFR 4.87, as they share similarities in features, impairment assessment, and severity levels. Such similarities are more closely related to the disability criteria that VA will propose for the ear, nose, and throat schedule.

VA also proposes adding the General Rating Formula to the beginning of the respiratory system. The proposed formula incorporates much of the criteria currently used by several DCs for respiratory conditions, notably DCs 6600, 6603, 6604, 6825 through 6833, and 6840 through 6845. VA designed the proposed General Rating Formula to more succinctly organize the Rating Schedule by referring applicable DCs to a single formula, rather than repeating the same formula after each DC to which it applies. The introduction of the General Rating Formula for Respiratory Conditions revises the criteria for multiple DCs.

VA derived the model for the General Rating Formula from the table entitled “Pulmonary Dysfunction” in Guides to the Evaluation of Permanent Impairment 88 (Robert D. Rondinelli et al. eds., 6th ed. 2008). The table defines four different levels of impairment severity based on FVC, FEV-1, DLCO (SB), Maximum Oxygen Consumption (VO2 Max), and METs. VA proposes to modify these levels to rate respiratory conditions. The General Rating Formula VA proposes will utilize common PFT findings, such as FEV-1, FVC, the ratio of FEV-1 to FVC (FEV-1/FVC), and DLCO (SB), and continue to utilize most of the levels found throughout current § 4.97, as they differ only slightly from the levels found in the “Pulmonary Dysfunction” table and are generally more advantageous to veterans.

One change from current § 4.97, however, is to require less of a reduction in FEV-1 to qualify for 100 percent disability rating (an FEV-1 of less than 45 percent of predicted value, rather than the current 40 percent), which is advantageous to veterans. Another is to no longer provide a 100 percent rating for outpatient oxygen therapy: The need for oxygen is not a sufficiently accurate measure of the severity of a disability to allow for a consistent evaluation without regard to other more objective measures.

VA also proposes to adjust the values for maximum oxygen consumption, which has a fixed relationship to METs (every 3.5 ml of oxygen consumed is equal to 1 MET). This modification will ensure equity with values already used in other body systems using METs to evaluate disability (in particular, the cardiovascular system). Finally, VA proposes to continue utilizing FEV-1/FVC as a PFT that can be used for rating purposes despite its absence from the “Pulmonary Dysfunction” table.

Note (1) to the proposed General Rating Formula will instruct rating personnel to base the impairment assessment on the criteria that reflects the greatest impairment and, therefore, the greatest evaluation. Note (2) will address combined ratings, consistent with proposed § 4.96(a).

Finally, VA will add Note (3) to the proposed General Rating Formula, which will address comorbid respiratory and cardiovascular disabilities in accord with proposed § 4.96(d). As noted above, raters may use METs to evaluate the respiratory disability under § 4.97 or the cardiovascular disability under § 4.104, but not both.

It should be noted that the General Rating Formula does not reference cor pulmonale and right ventricular hypertrophy. Under current § 4.97, some evaluation criteria reference cor pulmonale and right ventricular hypertrophy without an associated respiratory system disability. One of VA's goals with this revision is to ensure that all evaluation criteria within § 4.97 contain at least one element of respiratory disability. Thus, under the proposed rule, any cardiovascular disabilities incorporated within § 4.97 will be associated with at least one respiratory disability as part of any and all evaluation criteria.

In addition to incorporating the General Rating Formula, VA proposes a number of organizational changes to the respiratory system. Specifically, VA proposes removing the current headings and subheadings and reorganizing the VASRD Respiratory System under two broad headings. The first heading will be “Intrinsic Lung Diseases.” VA proposes to add seven subheadings under Intrinsic Lung Diseases: “Airway Disorders (Trachea, Bronchi),” “Tuberculous Lung Diseases,” “Vascular Lung Diseases,” “Lung Neoplasms,” “Bacterial Lung Diseases,” “Parenchymal Lung Disease (Including Interstitium and Alveolar Spaces),” and “Mycotic Lung Diseases.” The second heading that VA proposes is “Other Respiratory Conditions.” VA will include these remaining respiratory diagnoses in accordance with modern medical practice. See Peter D. Wagner et al., “Ventilation, Blood Flow and Gas Exchange,” Murray and Nadel's Textbook of Respiratory Medicine 53-88 (5th ed. 2010).

To help the reader understand VA's proposed changes to the individual DCs within the Respiratory System, VA has organized the following discussion by the seven subheadings under Intrinsic Lung Diseases in the order of their appearance. VA will then discuss changes within the proposed Other Respiratory Conditions.

Current DCs 6600 through 6604 shall appear in their current order under this proposed rule after the subheading Airway Disorders (Trachea, Bronchi). VA proposes to modify the rating criteria for DCs 6600, 6601, 6603, and 6604 to refer to the General Rating Formula, which assesses severity using current medical understanding. As discussed above, VA is proposing a General Rating Formula to simplify evaluations and expand the criteria upon which to evaluate respiratory conditions, to include FEV-1 and METs. Regarding DC 6602, bronchial asthma, VA proposes to maintain most of the current evaluation criteria but reorganize how the VASRD presents the various criteria for improved usefulness. This reorganization is similar to the proposed General Rating Formula: Each evaluation requires meeting at least one of its criteria.

VA proposes removing the heading “Diseases of the Lung and Pleura-Tuberculosis” and replacing it with “Tuberculous Lung Diseases.” VA proposes to retain the current subheadings, “Ratings for Pulmonary Tuberculosis Entitled on August 19, 1968,” “Ratings for Pulmonary Tuberculosis Initially Evaluated After August 19, 1968,” and their corresponding DCs. These changes organize the DCs along current medical practice.

VA will not substantively alter the criteria for evaluating tuberculosis for individuals entitled on August 19, 1968, though it will delete a statutory reference that no longer exists. It also will not substantively change the current rating instructions for chronic, active pulmonary tuberculosis (DC 6730). However, VA proposes to amend the evaluation criteria for DC 6731, Chronic, inactive primary pulmonary tuberculosis. The current criteria evaluate residuals “as interstitial lung disease, restrictive lung disease, or, when obstructive lung disease is the major residual, as chronic bronchitis (DC 6600).” The amended rule would refer specifically to the General Rating Formula and provide notes consistent with the language of current DC 6731. VA proposes this change because the General Rating Formula provides sufficient rating criteria for assessing residual lung function of this disorder. VA proposes no substantive change to DC 6732.

VA proposes to replace the current heading, “Nontuberculous diseases,” with the subheading “Vascular Lung Diseases.” This arrangement will form the third subheading under “Intrinsic Lung Diseases.” VA also proposes that DC 6817, presently “Pulmonary vascular disease,” be renamed as “Pulmonary thromboembolic disease.” The new name reflects current medical terminology for the same condition. See Timothy A. Morris and Peter F. Fedullo, “Pulmonary Thromboembolism,” Murray and Nadel's Textbook of Respiratory Medicine 1186 (5th ed. 2010).

VA proposes the following changes to the criteria of DC 6817: (1) Removing “primary pulmonary hypertension” from the 100 percent evaluation criteria, because it will be rated under new DC 6849, (2) removing references to cor pulmonale, which can be adequately evaluated under the proposed General Rating Formula, (3) recharacterizing the current note as Note (1), (4) adding a note (Note (2)) prohibiting separate evaluations for pulmonary thromboembolic disease with right ventricular hypertrophy and selected comorbid cardiovascular conditions in order to avoid pyramiding, and (5) adding a note (Note (3)) outlining when a rating under DC 6817 can be combined with other ratings under § 4.97.

Additionally, VA proposes adding a new DC 6849 for “Pulmonary hypertension.” Currently, VA rates pulmonary hypertension analogously to other respiratory conditions. However, this common condition has its own features and treatments, so evaluations analogous to other respiratory DCs may be inadequate or inappropriate. As indicated previously, medicine assesses impairment by changes in right ventricular diameter, B-natriuretic levels, and mean pulmonary artery pressure. The rating criterion VA proposes for DC 6849 applies such measurements to this unique respiratory condition. VA proposes four levels of disability, similar to the levels of the proposed General Rating Formula. Where rating criteria METs levels conflict with other METs levels found within the cardiovascular system, the conflicting METs levels will conform to those found within the cardiovascular system. See Rondinelli, supra at 71-73.

Three notes would accompany DC 6849. The first would state that acute pulmonary hypertension is not a disability for ratings purposes. VA compensates disabilities that impair earning capacity, not temporary conditions that generally do not impact earning capacity. See 38 U.S.C. 1155; Davis v. Principi, 276 F.3d 1341, 1345-47 (Fed. Cir. 2002); see also Moore v. Shinseki, 555 F.3d 1369, 1373 (Fed. Cir. 2009). The second note would prohibit separate evaluations for pulmonary hypertension and selected coexisting cardiovascular conditions; instead, one rating would be assigned either under DC 6849 or under the appropriate cardiovascular DC (38 CFR 4.104), whichever represents the predominant disability. Compensating the same disability under two different body systems would represent pyramiding, which is impermissible under 38 CFR 4.14. The third note would outline when a rating under DC 6849 can be combined with other ratings under § 4.97.

VA next proposes to reorganize DCs 6819, “Neoplasms, malignant, any specified part of respiratory system exclusive of skin growths,” and 6820, “Neoplasms, benign, any specified part of respiratory system,” under the proposed subheading “Lung Neoplasms.” DCs 6819 and 6820 are currently listed under “Nontuberculous Diseases.”

VA also proposes to modify the note for DC 6819, which currently instructs rating personnel to evaluate residuals six months after the cessation of all forms of active treatment. VA intends to refer rating personnel to the General Rating Formula because this evaluation tool provides the most appropriate criteria for assessing residual impairment from a malignant lung neoplasm. Potential residuals include, but are not limited to, removal (resection) of a lung (in part or in whole) or persistent pleural effusions.

Similarly, VA proposes that DC 6820, benign neoplasms of the respiratory system, be rated under the General Rating Formula. Currently, DC 6820 directs rating personnel to “Evaluate using an appropriate respiratory analogy.” The General Rating Formula provides a broad range of alternative criteria with which to assess most respiratory conditions.

VA proposes renaming the heading “Bacterial Infections of the Lung” to the subheading “Bacterial Lung Diseases.” DCs 6822 through 6824 will continue to appear under Bacterial Lung Diseases. VA does not propose any substantive criteria changes for the rating formula for these DCs.

VA proposes to remove the current subheading, “Interstitial Lung Disease,” to add instead, “Parenchymal Lung Disease (Including Interstitium and Alveolar Spaces).” VA also proposes to relocate DC 6846 (Sarcoidosis) from the current “Restrictive Lung Disease” subheading to the newly proposed “Parenchymal Lung Disease (Including Interstitium and Alveolar Spaces)” subheading, as sarcoidosis is medically-categorized as a parenchymal lung disease. This new subheading reflects modern medical terminology for the associated DCs. In addition, VA proposes to rate these conditions under the General Rating Formula. This change will incorporate current medical standards for assessing impairment. By applying the General Rating Formula, VA proposes to expand the types of PFT results, to include FEV-1/FVC, and METs, to evaluate these conditions.

In addition, VA proposes to include a note for DCs 6825 through 6833 and DC 6846. This note instructs rating personnel to add an additional 10 percent to any rating during certain kinds of treatment, specifically, oral prednisone greater than 20 milligrams (mg) daily, or daily second-line immunosuppressive medication ( e.g., non-steroidal agents; such immunomodulatory drugs as azathioprine or cyclophosphamide; anti-fibrotic agents such as colchicine; penicillamine; or biologic agents such as etanercept). VA proposes to add this additional 10 percent rating because the treatments themselves may result in adverse effects involving the blood-forming organs or the gastrointestinal system. See M. Selman et al., “Idiopathic Interstitial Pneumonias,” Murray and Nadel's Textbook of Respiratory Medicine 1380-81 (5th ed. 2010).

VA also proposes to rename DC 6825, “Diffuse interstitial fibrosis (interstitial pneumonitis, fibrosing alveolitis), to ”Diffuse interstitial fibrosis (interstitial pneumonitis, fibrosing alveolitis, idiopathic fibrosis).” The proposed name reflects current medical terminology. See id. at 1370.

VA also proposes to rename “Mycotic Lung Disease” to “Mycotic Lung Diseases” and organize DCs 6834 through 6839 under this subheading. No substantive criteria changes are proposed for these diseases.

The final organizational change VA proposes for the respiratory system is assembling all remaining respiratory disabilities under the heading “Other Respiratory Conditions.” VA will arrange DCs 6840 through 6847 under this heading.

In addition to moving these DCs under the new heading, VA proposes to rename DCs 6841 and 6842. Specifically, VA intends to rename DC 6841, currently “Spinal cord injury with respiratory insufficiency,” as “Respiratory insufficiency due to spinal cord injury.” As for DC 6842, “Kyphoscoliosis, pectus excavatum, pectus carinatum,” VA proposes to rename it as “Pulmonary disease secondary to kyphoscoliosis, pectus excavatum, or pectus carinatum.” Renaming these DCs clarifies that the primary disability is related to the respiratory system.

VA proposes that DCs 6840 through 6846 be rated under the General Rating Formula. This proposed change modifies the current criteria by, most notably, adding FVC and METs as additional measures. This proposed change favors veterans because it allows additional, alternative criteria to assess disability that do not currently exist in these DCs. As previously discussed, VA proposes to change these criteria to reflect current medical standards for assessing the severity of impairment.

VA also proposes to modernize the rating criteria for DC 6847, “Sleep Apnea Syndromes (Obstructive, Central, Mixed)” and retitle that DC as “Sleep Apnea Syndromes (Obstructive, Central, or Mixed)”. The discipline of sleep medicine has greatly evolved since VA published the existing criteria. The American Academy of Sleep Medicine (AASM), founded since then, conducted in-depth, peer-reviewed research in conjunction with its partners to develop scientifically-refined criteria regarding the definition, measurement, and treatment of sleep apnea. Sleep apnea may be defined as complaints of unintentional sleep episodes and/or awakenings and/or snoring associated with an apnea-hypopnea index (AHI) equal to or greater than 5 per hour or, alternatively, an asymptomatic patient with an AHI greater than 15 per hour. See Richard B. Berry, Fundamentals of Sleep Medicine 238 (2012). Additional findings supporting a diagnosis of sleep apnea include oxygen desaturation greater than 4 percent and/or a reduction in airflow below 70 percent. Such measurements can evaluate the effectiveness of treatment intervention or lifestyle modifications such as weight loss.

VA proposes to extensively revise the rating criteria for sleep apnea to primarily provide compensation that is more compatible with earning impairment than the current criteria. The current criteria evaluate based upon treatment rather than actual impairment. VA currently assigns higher ratings to individuals when their physicians prescribe more intensive therapies, such as continuous airway pressure (CPAP) machines, without regard to whether individuals first tried more conservative therapies, such as weight loss or oral appliances, or what actual impairment continues following use of CPAP machines. As discussed below, VA's proposed criteria will focus on the result rather than the type of treatment. Hence, individuals whose treatments are equally effective will receive equal disability ratings, regardless of the treatments. Individuals for whom treatment similarly fails (or is only partially effective) will also receive similar ratings. These proposed changes for sleep apnea comply with 38 U.S.C. 1155 that the VASRD ratings reflect average losses in earning capacity.

Specifically, VA proposes to assign a 0 percent evaluation when sleep apnea syndrome is asymptomatic, with or without treatment. VA would assign a 10 percent evaluation when treatment yields “incomplete relief.” VA would assign ratings above 10 percent ( e.g., 50 and 100 percent) only when treatment is either ineffective or the veteran is unable to use the prescribed treatment due to comorbid conditions. VA would assign a 100 percent evaluation only if there is also end-organ damage. VA proposes to include an informational note that defines and gives examples of qualifying comorbid conditions, i.e., conditions that, in the opinion of a qualified medical provider, directly impede or prevent the use of, or implementation of, a recognized form of treatment intervention normally shown to be effective.

VA proposes to add a new DC 6848 for “Lung transplantation.” Lung transplantation involves a unique treatment that is not addressed in the current Rating Schedule. This procedure for a service connected pulmonary condition results in significant disability that is not adequately captured by the current rating schedule. For one, recovery with pulmonary function testing performance usually takes about 12 months. Yet outcome studies reveal significant variation in return to work time. This can be explained when you look at the two main populations receiving lung transplants. There is a population who receive the lung transplant due to hereditary/genetic conditions that would preclude military service all together (such as cystic fibrosis), and another population who receive a lung transplant due to acquired conditions (such as chronic obstructive pulmonary disease). VA believes the population with lung transplantation due to acquired conditions is a better characterization of the population of veterans who might receive this procedure and thus would be eligible for compensation. On this basis, VA intends to assign a 100 percent evaluation for lung transplantation surgery, and for one year following discharge from the hospital for such surgery. Thereafter, consistent with other respiratory conditions, VA will base the evaluation on residuals according to the proposed General Rating Formula, but with a minimum evaluation of 30 percent. See Lisa Cicutto et al., “Factors Affecting Attainment of Paid Employment After Lung Transplantation,” 23 J. Heart Lung Transplant 481-86 (2004); see also Dmitry Tumin et al., “Attained Functional Status Moderates Functional Outcomes of Return to Work After Lung Transplantation,” 194 Lung 437-45 (2016).

Otolaryngology is the field of medicine concerned with diseases of, and injury to, the ears, nose, and throat. Currently, the VASRD spreads these diseases and conditions among several systems. This disbursement of diseases and conditions amongst several body systems does not represent the current scientific and medical understanding of the specific anatomy, etiology, and disabling effect of diseases and conditions of the ears, nose, and throat. Reorganization of these diseases and conditions to reflect current medical and scientific practice improves rating efficiency and effectiveness by allowing for easy identification of the medical source for each rating and reducing the need to rely on analogous codes when evaluating certain disabilities.

The system titled “Impairment of Auditory Acuity,” found at 38 CFR 4.85-4.87, already includes conditions of hearing and the ear, including the symptom of tinnitus (ringing in the ear), hearing loss, vestibular disorders (dizziness), neoplasms (tumors), and infections. For the reasons discussed above, VA proposes to rename the body system “Ear, Nose, Throat, and Auditory Disabilities” and relocate 16 DCs from § 4.97, the Respiratory System, to § 4.87. Under § 4.87, VA will redesignate DCs 6502 through 6524 as DCs 6220 through 6235, respectively. VA discusses in more detail below any changes to the sections and/or DCs under this new arrangement ( e.g., §§ 4.85 through 4.87).

VA considered expanding the current definition of hearing loss, located at 38 CFR 3.385, to include the concept of acoustic “notches” (see below). However, VA concluded that the current definition of hearing loss is sufficient and fair for evaluating levels of disability.

Noise exposure is often associated with a pattern of hearing loss across frequencies referred to as “noise notches” or a “notch.” According to a 2006 Institute of Medicine (IOM) study, a noise notch typically shows hearing that is normal or nearly normal at lower frequencies (less than 2000 Hertz (Hz)), with worse hearing thresholds typically occurring at frequencies in the 3000-6000 Hz region, with better hearing thresholds at 8000 Hz. IOM, Noise and Military Service: Implications for Hearing Loss and Tinnitus 38 (The National Academies Press, 2006). A notched pattern in the 3000-6000 Hz frequency region, together with supporting evidence from a detailed case history, can lead to the diagnosis of noise-induced hearing loss. However, this characteristic pattern in the high frequencies is not limited to noise-induced hearing loss. The high-frequency hearing loss pattern from aging is indistinguishable from the cumulative effects of noise-induced hearing loss. See Linda M. Luxon, “The clinical diagnosis of noise induced hearing loss,” Biological Effects of Noise 83-113 (Deepak Prasher and Linda Luxon eds. 1998); Victor Osei-Lah and L.H. Yeoh, “High-frequency audiometric notch: an outpatient clinic survey,” 49(2) Int'l J. of Audiology 95-98 (2010).

More recent publications examined noise notches in the veteran population to again define the presence or absence of a noise notch more objectively than by simply relying on the visual pattern of high frequency hearing loss. See, e.g., Richard H. Wilson and Rachel McArdle, “Characteristics of the Audiometric 4,000 Hz Notch (744,553 veterans) and 3,000, 4,000 and 6,000 Hz Notches (539,932 veterans),” 50 J. of Rehabilitative Research and Development 111-32 (2013); Ross Coles et al., “Guidelines on the diagnosis of noise-induced hearing loss for medicolegal purposes,” 25(4) Clin. Otolaryngology 264-73 (2000). However, the observed pattern of hearing loss in these studies neither rebutted nor confirmed noise injuries. In the Wilson and McArdle study, nothing indicated that notched audiograms were characteristic of audiograms in veterans of any age. Similarly, Coles et al. noted that the presence of notches was not indicative of noise exposure because such configurations were found in people with no significant noise exposure and not in persons with known exposure. Given the results of these studies, VA concludes that including notches in a definition of hearing loss disability would not rationally justify compensation benefits to veterans. Therefore, VA proposes no substantive changes to the current definition in § 3.385.

Although VA will not alter its definition of hearing loss for compensation purposes, it proposes several updates of the current terminology found in 38 CFR 3.385, 4.85-4.86. VA also proposes a note to § 4.85 adding a 10 percent evaluation for noncompensable hearing loss with tinnitus present, where tinnitus is related to the diagnosis of hearing loss.

VA proposes a number of nonsubstantive changes for readability and to update terminology according to current medicine. VA proposes to replace the terms “speech recognition” and “speech discrimination” with “word recognition” in § 3.385 and throughout § 4.85. Although used interchangeably, the term most frequently used today is “word recognition.”

VA also proposes to replace the term “hearing impairment” or “impaired hearing” with “hearing loss” throughout Part 3 and Part 4, as “hearing loss” is more commonly used today.

In addition, VA proposes to change the spelling of “puretone” throughout §§ 4.85 and 4.86, to include tables VI and VIA. According to Dorland's Illustrated Medical Dictionary 179 (32d ed. 2012), two words form the correct spelling, i.e., “pure tone” or, as a compound adjective before the noun, “pure-tone threshold.”

During the October 2011 audiology forum, VA received a recommendation to clarify the units that it uses to measures hearing loss. Therefore, VA also proposes to add to 4.85, paragraph (a), “Hearing levels are measured in decibels and expressed as dB HL.”

Finally, VA proposes to replace the term “rating veterans service representative” in § 4.86 with “rating activity.” This terminology update recognizes that not all claims are adjudicated by a rating veterans service representative (RVSR); some decisions are rendered by a decision review officer (DRO) or another individual with the proper authority to adjudicate a claim for benefits. This terminology update does not otherwise change the application of the provisions in § 4.86.

Currently, VA evaluates hearing loss using pure-tone thresholds, but no regulation specifies the type of measurement. Audiology pure-tone threshold uses either air or bone conduction testing. See Joe Walter Kutz Jr. et al., “Audiology Pure-Tone Testing,” Medscape Reference, http://emedicine.medscape.com/article/1822962-overview#showall (last visited July 24, 2018). VA proposes to clarify that pure-tone thresholds refer to air conduction thresholds throughout §§ 3.385, 4.85, and 4.86, to include tables VI and VIA. VA chose this particular technique because it measures the usual mode of hearing. On the other hand, bone conduction testing is simply a diagnostic tool and one of a battery of tests by which audiologists determine the etiology and severity of hearing loss. To reflect this change, VA proposes to replace the term “puretone threshold” with “pure-tone air conduction threshold” wherever it appears in §§ 4.85 and 4.86. Similarly, VA also proposes to replace the references to “auditory” thresholds in § 3.385 with “pure-tone auditory air conduction” thresholds.

Current § 4.85(c) provides that “Table VIA will be used when the examiner certifies that use of the speech discrimination test is not appropriate because of language difficulties, inconsistent speech discrimination scores, etc., or when indicated under the provisions of § 4.86.” VA proposes to clarify the term “language difficulties” with the addition of the phrase “ e.g., English non-fluency.” Several VA audiology experts with whom the Veterans Benefits Administration consulted noted that the most common language difficulty in service members is that their first language is not English, thus invalidating the speech discrimination scores. Additionally, an increased number of service members have cognitive difficulties resulting from traumatic brain injuries. These injuries result in decreased speech discrimination scores. See, e.g., Henry L. Lew et al., “Audiology dysfunction in Traumatic Brain Injury,” 44(7) J. of Rehabilitation Research & Development 921-28 (2007). Therefore, VA also proposes to add “cognitive difficulties” to the list of reasons why word recognition testing may be inappropriate.

VA proposes to revise the evaluation criteria for this DC in order to provide (1) a 10 percent rating for tinnitus associated with service-connected, noncompensable hearing loss, and (2) two notes pertaining to tinnitus. Tinnitus is defined as the perception of sound in the absence of an external source. In many cases, the patient cannot identify the onset or cause of the tinnitus. J.L. Stouffer and Richard S. Tyler, “Characterization of tinnitus by tinnitus patients,” 55(3) J. of Speech and Hearing Disorders, 439-53 (Aug. 1990). However, current medicine reflects that tinnitus likely results from abnormal neural activity at some point or points in the auditory pathway, which is incorrectly interpreted by the brain as an actual sound. Id. As a result, it is a symptom associated with an underlying condition, such as hearing loss, Meniere's disease, traumatic brain injury and cerebral atherosclerosis, not an independent disease. Id.

Recognition of tinnitus for evaluation purposes dates back to at least 1925, when raters were instructed to “add 15 [percent] to loss of hearing as a combined rating.” “The Schedule for Rating of Disability Ratings,” U.S. Veterans' Bureau, Table II, p.59 (1925 ed.). Accordingly, tinnitus was rated in conjunction with hearing loss, rather than a disease in and of itself. In a final rule published in 1976, VA's rating criteria recognized tinnitus for evaluation purposes when “[p]ersistent as a symptom of head injury, concussion, or acoustic trauma.” 41 FR 11291, 11298 (Mar. 18, 1976). In a final rule published in 1999, in part motivated by an effort to standardize tinnitus evaluations beyond these three specific injuries, the regulation was changed to award a single 10 percent evaluation without mention of the underlying condition resulting in tinnitus. 64 FR 25202, 25206 (May 11, 1999). While not intended by VA, this rulemaking created the impression that tinnitus is an independent condition, rather than a symptom associated with an underlying condition. VA's intent with the presently proposed revision is to accurately restore the medically-supported relationship between tinnitus and an underlying pathology, consistent with current medical practice.

VA proposes to evaluate tinnitus only as part of its underlying pathology and to delete DC 6260 entirely. In other words, tinnitus will be compensated through application of DCs 6100, 6204, 6205, 8045, 8046, or 9305, depending on its service-connected cause. For tinnitus associated with service-connected hearing loss in particular, the presence of tinnitus generally does not impact earning capacity beyond what is already contemplated at the compensable levels of hearing loss, though VA recognizes that the presence of tinnitus combined with noncompensable hearing loss could have more than a 0% impact on earning capacity. Thus, DC 6100 will provide a 10% evaluation for tinnitus associated with hearing loss only when hearing loss is noncompensable (only when hearing loss, on its own, does not warrant a 10% evaluation or higher). If hearing loss is compensable (warranting a 10% evaluation or greater), an additional 10% evaluation for tinnitus associated with the hearing loss shall not be assigned.

To that end, VA will add two notes under DC 6100. The first note will list examples of which disabilities contemplate tinnitus as a symptom of a given underlying pathology. The second note will provide that tinnitus is only compensated as part of an underlying service-connected condition. VA notes that this proposal will have no impact on veterans currently in receipt of service connection for tinnitus under DC 6260; these evaluations are governed under the provisions of 38 CFR 3.951(a).

In Doucette v. Shulkin, 28 Vet. App. 366, 373 (2017), the U.S. Court of Appeals for Veterans Claims noted the potential value if VA “provide[d] additional guidance on what symptoms the rating criteria [for hearing loss] contemplate.” Doucette involved a veteran who argued for extraschedular consideration under 38 CFR 3.321(b)(1) because his hearing loss resulted in difficulty distinguishing sounds in a crowded environment, locating the source of sounds, understanding conventional speech, hearing the television, and using the telephone. Id. at 371. The court held that such functional effects of decreased hearing and difficulty understanding speech in an everyday environment were contemplated by the schedular rating criteria, id. at 369, 371-72, though a dissenting judge argued that the “criteria are inadequate to contemplate a veteran's functional effects and entire disability picture.” Id. at 374 (Schoelen, J., dissenting).

In response to the court's statement concerning additional guidance, we clarify here that DC 6100 contemplates all natural or expected effects of decreased hearing. It is expected and natural that a veteran with hearing loss like Mr. Doucette will, for example, experience difficulties distinguishing sounds or using the telephone. The schedule was designed to determine a veteran's level of hearing loss disability through objective testing and match it to a disability rating that compensates for the average impairment in earning capacity associated with that level of disability. 38 U.S.C. 1155; 38 CFR 4.1, 4.10, 4.85. To the extent a particular veteran's hearing loss may seem more impactful than the rating provided, that is characteristic of a schedule that compensates for “the average impairments of earning capacity”—it is not an indication that the schedule is inadequate. 38 U.S.C. 1155.

When a symptom of a hearing loss disability properly rated under this code is unusual or exceptional for that disability, and not contemplated by the code, there are alternative methods to ensure that a veteran is adequately compensated. First, if the symptom of the hearing loss disability implicates a disability addressed elsewhere in the schedule, an evaluation may be appropriate under the listed diagnostic code which accounts for the disability. If the symptom implicates a disability that is not listed in the schedule, an evaluation may be appropriate by analogy using a closely related disease or injury, giving due consideration to the functions affected, anatomical localization, and symptomatology. 38 CFR 4.20. In such a case, because another diagnostic code in the schedule addresses a disability analogous to the disability implicated by the symptom, the schedule is not inadequate to rate the veteran's disability. Finally, if the unusual or exceptional symptom of the hearing loss disability does not implicate any other provision or code in the schedule (either directly or through analogy), the schedule may not contemplate the hearing loss disability presented; and 38 CFR 3.321(b)(1) may be considered.

As noted above, VA proposes to relocate a number of conditions from § 4.97 to § 4.87. It also intends to update several of the relocated codes, as well as DCs already included in § 4.87, to ensure that the medical descriptions reflect the most current knowledge, practice, and standards of care, and that the criteria determining the levels of compensation provide fair and accurate benchmarks for veterans. As VA intends to relocate a number of conditions affecting the nose, throat and larynx (voice box) to § 4.87, VA proposes to retitle this section from “Schedule of ratings—ear” to “Schedule of ratings—ear, nose, and throat.”

VA proposes to revise the note under this DC from “Evaluate hearing loss, and complications such as labyrinthitis, tinnitus, facial nerve paralysis, or bone loss of skull, separately.” to “Evaluate hearing loss and complications such as labyrinthitis, facial nerve paralysis, or bone loss of skull, separately.” This revision is necessary as tinnitus associated with hearing loss is now contemplated under DC 6100.

VA currently evaluates otosclerosis under DC 6202. To ensure greater consistency in decision making, VA proposes to rename this code to include residuals of stapedectomy and stapedotomy. Surgeons perform these procedures involving the middle ear to prevent further deterioration of hearing caused by otosclerosis by improving the movement of sound to the inner ear. The primary residual of stapedectomy and stapedotomy is continued hearing loss, albeit without further deterioration of hearing, so VA may evaluate these conditions similarly to otosclerosis by the degree of the hearing loss. See S. George Lesinski, “Causes of Conductive Hearing Loss After Stapedectomy or Stapedotomy: A Prospective Study of 279 Consecutive Surgical Revisions,” 23(3) Otology & Neurotology 281-88 (May 2002).

Peripheral vestibular disorders (DC 6204) may originate in one or both ears and may cause varying degrees of disability. B. Gurr and N. Moffat, “Psychological consequences of vertigo and the effectiveness of vestibular rehabilitation for brain injury patients,” 15 Brain Injury 387 (2001); Hannelore K. Neuhauser et al., “Burden of dizziness and vertigo in the community,” 168 Archives of Internal Medicine 2118 (2008). DC 6204 currently evaluates such disorders using only dizziness and staggering ( i.e., alteration of gait). VA therefore proposes to amend DC 6204 to better reflect the full scope of these disorders and their effect on a veteran's ability to work and engage in other activities that impact earning capacity.

Specifically, VA proposes to provide increasingly higher ratings depending on the impact of a veteran's vestibular disorder on activities of self-care. VA may evaluate self-care activities for the purposes of this DC using assessments by qualified health care providers that address the capacity to bathe, dress, eat, manage hygiene, and/or move the body from place to place. VA will also evaluate the ability to work, to include whether the veteran requires significant modification and/or accommodation to accomplish tasks. Additionally, VA intends to expand the current disability evaluation levels from two (10 and 30 percent) to three (10, 30, and 100 percent); the 100 percent evaluation will include veterans whose vestibular disorders severely impact their life and result in the substantial inability to work.

The proposed criteria provide a 10 percent evaluation for a documented vestibular disorder with symptoms during the last six months that require brief and temporary modification of activity but do not prevent continuation of normal activities such as self-care and/or work. VA proposes a 30 percent evaluation for symptoms that occur with sufficient frequency to require routine limitation in activities, which the individual can overcome with effort and some modification and/or accommodation. VA proposes a 100 percent evaluation for symptoms that result in an inability to independently perform self-care and/or work activities, even with modification of activity or accommodation. Finally, VA proposes two notes for this DC—one defining self-care activities and another continuing this DC's current requirement of objective findings supporting the diagnosis.

Originating in the inner ear, the specific causes of Meniere's syndrome (DC 6205) remain unclear. However, the effects, which may include vertigo, tinnitus, hearing loss, and unstable gait, may impact a veteran's earning capacity. The current rating criteria for DC 6205 provide for 30, 60, and 100 percent evaluations depending upon the presence of hearing loss and the frequency of attacks of vertigo and cerebellar gait. Alternatively, rating personnel must separately evaluate vertigo (as a peripheral vestibular disorder) and hearing loss if a higher combined rating for Meniere's syndrome results.

VA does not intend to significantly alter the current rating criteria for DC 6205. However, it does propose to change evaluative criteria so they are consistent and clear. VA proposes to alter the frequency for the 100 percent evaluation from “more than once weekly” to “five or more times a month” to be consistent with the monthly timeframes provided in the 30 and 60 percent levels. VA also proposes to eliminate the current reference to “attacks of vertigo and cerebellar gait.” Individuals with Meniere's syndrome experience attacks of dizziness (or vertigo) that appear suddenly but may or may not result in gait disturbance. See “Meniere's disease,” National Institute on Deafness and Other Communication Disorders, https://www.nidcd.nih.gov/health/balance/pages/meniere.aspx (last visited July 24, 2018). Occasionally, however, an individual's vertigo is so extreme and frequent that it results in disequilibrium or gait instability. Id. Therefore, VA proposes to include vertigo in all evaluation levels, with the only reference to gait being the 100 percent evaluation. VA proposes a 100 percent evaluation for hearing loss with either persistent disequilibrium and gait instability, or with vertigo occurring five or more times a month. Finally, VA proposes to reorganize the criteria within each evaluation for improved clarity and usability. Specifically, VA notes that each evaluation currently includes hearing loss. The crucial point is the frequency of vertigo or, for a 100-percent evaluation, the presence of persistent disequilibrium. VA proposes to reorganize the criteria to emphasize this.

VA intends to amend the current note to DC 6205 and redesignate it as Note (3). For reasons explained in this preamble's discussion of tinnitus, proposed Note (3) will no longer include any reference to a separate evaluation for tinnitus.

To ensure consistent evaluations, VA proposes to include a new Note (1), which will indicate that the Meniere's diagnosis must be made by a otolaryngologist or neurologist. Id. The requirement for a specialist evaluation is based on the complexity of the diagnostic work up. This work up is best performed by those whose focus is on this area of medical care, as opposed to a provider without focused expertise, to ensure the proper diagnostic assessment is made. In addition, VA proposes a new Note (2) to direct rating personnel to calculate the average vertigo frequency using a six-month period. This period ensures that the assigned evaluation represents the average level of impairment, taking into account occasional flare-ups that may not represent a true increase in the overall severity of the disease.

As previously noted under revisions to § 4.85, VA proposes to remove DC 6260.

As previously noted, VA proposes to move 16 conditions from § 4.97 (the Respiratory System) to § 4.87 (the proposed ENT System). VA will redesignate these DCs, currently designated 6502 through 6524, as DCs 6220 through 6240, respectively. VA proposes to change the evaluation criteria for a number of these relocated DCs. However, VA proposes no substantive changes to the following codes: DC 6502, Septum, nasal, deviation of (proposed DC 6220); DC 6515, Laryngitis, tuberculous, active or inactive (proposed DC 6227); DC 6516, Laryngitis, chronic (proposed DC 6228); DC 6518, Laryngectomy, total (proposed DC 6229); DC 6519, Aphonia, complete organic (proposed DC 6230); and DC 6521, Pharynx, injuries to (proposed DC 6232). VA will update accordingly any references to these DCs within other codes.

In relocating DC 6504, loss of part of the nose or nasal scars, to § 4.87, VA proposes to redesignate it as DC 6221. The current criteria for DC 6504 assign 10 or 30 percent evaluations based on the exposure of nasal passages, loss of ala (the wings of the nose), or other obvious disfigurement. This focus on loss of particular nasal parts, rather than on the overall quantifiable loss of nasal tissue and/or structure, may result in inconsistent evaluations for similarly disabling conditions. As such, VA proposes to assign evaluations based on defined loss of the nose ( i.e., more or less than half). Additionally, because the use of nasal prosthetics often has a positive impact on an individual's psychosocial functioning, VA proposes to incorporate the mitigating value of any nasal prosthetics used. VA intends to provide for higher ratings when the loss is not amenable to the use of prosthesis. See Satyabodh S. Guttal et al., “Interim Prosthetic Rehabilitation of a Patient Following Partial Rhinectomy: A Clinical Report,” 4(4) European J. of Dentistry 482, 482-83 (Oct. 2010).

Under the proposed criteria, VA would assign a 0 percent evaluation for any loss or disfigurement of the nose for which a qualified medical provider does not require or recommend a prosthesis. VA would assign a 10 percent evaluation for any loss of the nose for which a qualified medical provider requires or recommends a prosthesis and the patient is capable of using it. VA proposes a 20 percent evaluation for a loss that a prosthesis cannot treat (as documented by a qualified provider) and that loss involves less than 50 percent of the nose. Finally, VA proposes a 30 percent evaluation for a loss that a prosthesis cannot treat (as documented by a qualified provider) and that loss involves at least 50 percent or more of the nose. VA intends to retain the current note directing rating personnel to alternatively evaluate any loss or scar under DC 7800, disfiguring scars of the head, face, or neck.

Current DCs 6510 through 6514 all refer to various types of chronic sinusitis evaluated using the General Rating Formula for Sinusitis, located under DC 6514. VA proposes to redesignate these codes as DCs 6222 through 6226, respectively, under § 4.87; additionally, VA proposes to rename each code to reflect current medical terminology. VA proposes to rename the redesignated DC 6222 as “Rhinosinusitis, pansinusitis.” VA proposes to rename the redesignated DC 6223 as “Rhinosinusitis, ethmoid.” VA proposes to rename the redesignated DC 6224 as “Rhinosinusitis, frontal.” VA proposes to rename the redesignated DC 6225 as “Rhinosinusitis, maxillary.” VA proposes to rename the redesignated DC 6226 as “Rhinosinusitis, sphenoid.” VA also proposes to reflect current medical terminology by renaming the General Rating Formula for Sinusitis as General Rating Formula for Chronic Rhinosinusitis and Recurrent Acute Rhinosinusitis. VA will place this renamed rating formula immediately before the redesignated DC 6222.

To modernize the rating schedule in regard to chronic sinusitis, VA will first introduce current medical terminology and definitions. Rhinosinusitis is defined as symptomatic inflammation of the paranasal sinuses and nasal cavity. Modern medicine understands three different clinical presentations of inflamed nasal passages and sinuses (rhinosinusitis): Acute, recurrent acute, and chronic. Richard M. Rosenfeld et al., “Clinical practice guideline: Adult sinusitis,” 137(3 Supp.) Otolaryngology-Head and Neck Surgery S19, Table 10 (2007).

Acute rhinosinusitis (ARS) is defined as up to four weeks of purulent drainage (anterior, posterior, or both) accompanied by nasal obstruction, facial fullness, or both. Acute rhinosinusitis can occur as viral rhinosinusitis (or VRS, defined as rhinosinusitis caused by a virus and typically lasting less than 10 days). Acute rhinosinusitis can also occur as acute bacterial rhinosinusitis (or ABRS, defined as a bacterial infection that causes symptoms of rhinosinusitis for at least 10 days after the onset of an upper respiratory infection or causes recurrence of symptoms within seven days after initial improvement). If rhinosinusitis symptoms last at least four but less than 12 weeks, it is defined as subacute rhinosinusitis (SAR). Id.

Recurrent acute rhinosinusitis (RARS) is defined as four or more episodes of ABRS without signs or symptoms of rhinosinusitis between episodes. Id.

Finally, chronic rhinosinusitis, or CRS, is defined as 12 weeks or more of at least two of the following—mucopurulent drainage (anterior, posterior, or both); nasal obstruction (congestion); facial pain-pressure-fullness; or decreased sense of smell—in combination with inflammation as documented by at least one of the following: Purulent mucus (not clear) in the middle meatus or ethmoid region; polyps in the nasal cavity or the middle meatus; or radiographic imaging showing inflammation of the paranasal sinuses. Id.

VA compensates disabilities that impair earning capacity, not temporary conditions that generally do not impact earning capacity. See 38 U.S.C. 1155; Davis, 276 F.3d at 1345-47; see also Moore, 555 F.3d at 1373. In that regard, CRS and RARS are distinguishable from ARS and SAR. To assist the public and rating activity in better understanding what disabilities are compensated under this General Rating Formula, VA proposes to include a note identifying which conditions are eligible for compensation and another note specifying which conditions are explicitly excluded from compensation.

The present rating criteria evaluate chronic sinusitis predominantly on the frequency of “incapacitating episodes,” which includes prolonged antibiotic treatment, as well as the need for “bed rest” and “treatment by a physician.” Current standards of medical care, however, no longer describe incapacitating episodes or bed rest as treatment. VA therefore proposes to retain those elements of the existing criteria—namely, frequency/duration of antibiotic treatment—that still relate to current medical practice and eliminate reference to incapacitating episodes. VA also proposes to retain the 50 percent criteria that require unresponsiveness to surgery to reflect the severity of disability that accompanies that rating level.

In light of the above, VA's proposed General Rating Formula for Chronic Rhinosinusitis (CRS) and Recurrent Acute Rhinosinusitis (RARS) will retain the same rating levels as the current General Rating Formula for Sinusitis ( i.e., 0, 10, 30, and 50 percent). The criteria begin with a 50 percent evaluation granted for CRS/RARS which requires 12 weeks or more of treatment with antibiotics and unresponsiveness to surgical intervention with endoscopy or other surgical procedure designed to treat CRS/RARS. A 30 percent evaluation will be granted for CRS/RARS that requires 12 weeks or more of treatment with antibiotics during the preceding 12-month period. A 10 percent evaluation will be granted for CRS/RARS which requires antibiotic treatment for at least four weeks but less than 12 weeks during the preceding 12-month period. Finally, a 0 percent evaluation will be granted when there has been less than four weeks treatment with antibiotics during the preceding 12-month period. Rosenfeld, supra, at S1-31; see also Thomas A. Tami, “Granulomatous Diseases and Chronic Rhinosinusitis,” 38 Otolaryngol. Clin. N. Am. 1267-78 (2005).

Finally, DC 6514 currently contains a note that defines an “incapacitating episode” for purposes of assigning evaluations. The proposed criteria above render this note no longer necessary, so VA proposes to delete it.

VA proposes to redesignate stenosis of the larynx, currently evaluated under DC 6520, as DC 6231. It also proposes to amend the rating criteria for this DC, which will result in evaluations based upon the measured degree of stenosis, rather than the current utilization of PFTs. While stenosis of the trachea may affect PFTs, many other diseases may also impact them. Advances in diagnostic devices, including fiber optics, have improved visualization of the larynx and its associated structures and allowed more accurate assessment of anatomy. L. Sulica, “Hoarseness,” 137 Archives of Otolaryngology-Head and Neck Surgery 616 (2011). Hence, VA proposes to update its evaluative criteria.

Specifically, VA proposes to evaluate partial obstruction of the larynx with less than 25 percent narrowing of the airways as 30 percent disabling. VA proposes a 50 percent evaluation for partial obstruction of the larynx, with 25 percent to less than 50 percent narrowing of airways. Partial obstruction of the larynx, with 50 percent or more narrowing of airways, will warrant a 70 percent evaluation. Finally, VA proposes to assign a 100 percent evaluation for obstruction of the larynx, requiring permanent tracheostomy. VA will retain the current note allowing for an alternative evaluation as aphonia. VA notes that research indicates airway cross-sectional area reduced by 50 percent or more impairs breathing. See Sylvia Verbanck et al., “Detecting upper airway obstruction in patients with tracheal stenosis,” 109 J. of Applied Physiology 47 (July 2010). As such, obstruction less than 50 percent reflects no more than moderate disability ( i.e., warranting a 30 or 50 percent evaluation).

The current DC 6522 is “Allergic or vasomotor rhinitis” and VA will rename it “Rhinitis, allergic or nonallergic (vasomotor).” VA proposes to redesignate this DC as 6240 under § 4.87. VA also proposes to modify the rating criteria to reflect current medical understanding and practice. First, VA proposes to modify the criteria for a 10 percent rating to require continuous therapy (almost always self-administered) to control symptoms. VA also proposes a 30 percent rating for the presence of polyps, preserving the prior rating criteria. VA will add a note that directs personnel to rate under proposed DC 6233 (rhinosinusitis, allergic and nonallergic (vasomotor) related) using the General Rating Formula for Rhinosinusitis instead of proposed DC 6240 (Rhinitis, allergic or nonallergic (vasomotor)) if either chronic or recurrent acute form of rhinosinusitis is present. See Rosenfeld, supra at S1-31.

Currently, DC 6523 (bacterial rhinitis) addresses chronic residuals related to bacterial infection of the sinuses. VA proposes to redesignate DC 6523 as 6234 under § 4.87. Additionally, VA proposes to rename this DC, “Rhinosinusitis, infection related,” for clarity to ensure that readers understand that it includes rhinosinusitis caused by bacterial or fungal agents.

VA proposes that infection-related rhinosinusitis be evaluated under the proposed General Rating Formula for CRS and RARS to, again, reflect current medical understanding.

Current DC 6524 (granulomatous rhinitis) provides for a 100 percent evaluation for Wegener's granulomatosis or lethal midline granuloma; VA assigns a 20 percent evaluation for other types of granulomatous infection. These evaluations are outdated for a number of reasons. Modern medical science has identified lethal midline granuloma (also referred to as lymphomatoid granulomatosis or polymorphic reticulosis) as a peripheral T-cell lymphoma. Wegener's (now referred to as granulomatous disease with polyangiitis, or GPA), Churg-Strauss disease (now referred to as eosinophilic granulomatous disease with polyangiitis, or EGPA), and sarcoidosis are all autoimmune conditions that can affect the sinuses and nasal passages. They typically require systemic immunosuppressive treatment for extended periods (one to two years, or more) and may recur, requiring resumption of immunosuppressive treatment. As a result, VA proposes several revisions to incorporate current medical understanding of these conditions.

First, VA proposes to redesignate this code as DC 6235 under § 4.87. Second, VA proposes to rename this code “Rhinosinusitis, autoimmune, granulomatous or other causes,” to update terminology. Third, VA proposes to ensure consistent application by adding a note that directs rating personnel to evaluate lethal midline granuloma under proposed DC 6238, as such condition is best characterized as a malignant neoplasm. Fourth, VA proposes to transfer the 100 percent evaluation from the current DC 6524 to the new DC 6235, as well as modify its criteria by linking it to the current use of systemic immunosuppressive therapy. Fifth, VA proposes to direct personnel to use the proposed General Rating Formula for CRS and RARS for any evaluation less than 100 percent under proposed DC 6235. This instruction helps ensure appropriate, uniform ratings for any chronic residuals that do not rise to the level of malignancy.

In addition to amending current DCs under § 4.87 and relocating those from § 4.97, VA proposes to add several new conditions to better evaluate veterans using a more complete ear, nose and throat schedule.

The first new DC VA proposes to add to § 4.87 is Rhinosinusitis, allergic and nonallergic (vasomotor) related (DC 6233). This DC enables rating personnel to capture CRS or RARS as a consequence of DC 6240 (Rhinitis, allergic or nonallergic (vasomotor)). DC 6240 will instruct rating personnel to select DC 6233 (rhinosinusitis, allergic or nonallergic (vasomotor) related) if either CRS or RARS is present.

A new condition frequently present in veterans that VA proposes to add to § 4.87 is vocal cord paralysis (DC 6236). Its primary symptom is hoarseness, so VA proposes to direct rating personnel to evaluate this condition analogous to chronic laryngitis (DC 6228) or aphonia (DC 6230). See Seth R. Schwartz et al., “Clinical practice guideline: Hoarseness (dysphonia),” 141(Supp. 3) Otolaryngology-Head and Neck Surgery S1 (2009).

Benign and malignant neoplasms of the nasopharynx occur with such sufficient frequency among veterans that VA proposes to add discrete codes (DCs 6237 and 6238, respectively) for these conditions. VA proposes to rate benign neoplasms according to impairment of function by utilizing the most appropriate evaluation criteria because the disability due to these neoplasms varies. The addition of DC 6237 does not represent a substantive change in the evaluation of benign neoplasms, but it allows for better tracking and data analysis of this condition by providing a specific DC.

VA proposes to evaluate malignant neoplasms similarly to other malignancies in the VASRD. Specifically, VA will assign an evaluation of 100 percent for six months beyond the cessation of any surgery, radiation treatment, antineoplastic chemotherapy, or other therapeutic procedures. Then, VA will determine the appropriate disability rating by ordering a mandatory VA examination. VA will apply the provisions of § 3.105(e) of this chapter to any change in evaluation based upon that or any subsequent examination. Rating personnel will evaluate residual impairment of function barring subsequent local recurrence or metastasis.

VA proposes to add a new DC for diseases of the salivary glands, other than neoplasms (DC 6239). These conditions generally result in xerostomia (dry mouth), a condition that may lead to secondary effects of dental disease, nutritional deficit, pain, formation of salivary duct stones, and/or changes in taste. See James J. Sciubba and David Goldenberg., “Oral complications of radiotherapy,” 7 Lancet Oncology 175 (2006); S.B. Jensen et al., “A systematic review of salivary gland hypofunction and xerostomia induced by cancer therapies: management strategies and economic impact,” 18 Support Care Cancer 1061 (2010).

VA proposes to assign a 0 percent evaluation for xerostomia (dry mouth) not accompanied by secondary conditions such as difficulty in mastication of food or painless swelling of the salivary glands. VA would assign a 10 percent evaluation for xerostomia with altered sensation of taste and difficulty with lubrication and mastication of food but without associated weight loss or increase in dental caries. VA would also award a 10 percent evaluation if there was chronic inflammation of a salivary gland with pain and swelling on eating; or one or more salivary calculi, or gland stricture. Finally, VA proposes a maximum 20 percent evaluation for xerostomia with altered sensation of taste and difficulty with lubrication and mastication of food that results in either weight loss or an increase in dental caries. Diseases of the salivary glands may also result in neurological residuals and facial disfigurement due to swelling, so VA intends to include a note directing rating personnel to evaluate such residuals under the appropriate code(s).

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. The Office of Information and Regulatory Affairs has determined that this rule is an economically significant regulatory action under Executive Order 12866. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

The Secretary hereby certifies that this proposed 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). The certification is based on the fact that no small entities or businesses assign evaluations for disability claims. Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.

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 is likely to 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 given year. This proposed rule would have no such effect on State, local, and tribal governments, or on the private sector.

Although this proposed rule contains provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521), no new or proposed revised collections of information are associated with this proposed rule. Specifically, the information collection requirements associated with this proposed rule are related to the filing of disability benefits claims (VA Form 21-526EZ) as well as Disability Benefits Questionnaires (DBQs) (Groups 3 and 4) which enable claimants to gather the necessary information from his or her treating physician as to the current symptoms and severity of a disability. The information collection requirements are approved by OMB and have been assigned OMB control numbers 2900-0747, 2900-0778, and 2900-0781.

The Assistance Listing numbers and titles for this rule are 64.104, Pension for Non-Service-Connected Disability for Veterans; 64.109, Veterans Compensation for Service-Connected Disability; and 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death.

Denis McDonough, Secretary of Veterans Affairs, approved this document on July 6, 2021, 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.

For the reasons set forth in the preamble, VA proposes to amend 38 CFR parts 3 and 4 as set forth below:

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The revisions and additions read as follows:

As part of its ongoing revision of the VASRD, VA proposes changes to the rating schedule for mental disorders, including the General Rating Formula for Mental Disorders codified at 38 CFR 4.130. The proposed changes would update evaluation criteria based on the DSM-5, medical advances since the last substantive revision of the rating schedule for mental disorders in 1996, and current understanding of functional impairment associated with, or resulting from, mental disorders. These changes also reflect comments received from subject matter experts in the Veterans Benefits Administration (VBA), Veterans Health Administration (VHA), Board of Veterans' Appeals (BVA), Department of Defense (DoD), and Veterans Service Organizations (VSOs). Overall, VA did not rely on one particular input for these proposed changes, but the multitude of published, publicly available, and peer-reviewed, scientific and medical sources cited below.

In 2006, the Veterans' Disability Benefits Commission (VDBC) asked the Institute of Medicine (IOM) (now named the National Academy of Medicine) to study and recommend improvements for the VASRD. The IOM recommended updating the medical content of the rating schedule, by placing greater emphasis on a disabled veteran's ability to function in the work setting, rather than focusing on symptoms alone. Institute of Medicine, “A 21st Century System for Evaluating Veterans for Disability Benefits” 113-14 (Michael McGeary et al. eds., 2007).

In March 2015, VA published a final rule (RIN 2900-AO96) that updated the nomenclature for mental disorders and removed outdated references to the fourth editions of DSM (DSM-IV and DSM-IV-TR), replacing them with references to the latest fifth edition (DSM-5). While this rule updated the nomenclature to conform to the DSM-5, VA did not update the rating criteria used to evaluate mental disorders.

VA now proposes, however, to update the rating criteria for mental disorders in accord with IOM's recommendation and the latest medical science. VA's updates are based on the framework associated with the International Classification of Functioning, Disability, and Health (ICF) and its companion assessment instrument, the World Health Organization (WHO) Disability Assessment Schedule 2.0 (WHODAS 2.0), as well as the International Classification of Diseases (ICD), and concepts and methodology from the DSM-5.

The WHODAS 2.0 is a validated instrument that assesses health and disability across all diseases, including mental, neurological, and addictive disorders. O. Garin et al., “Validation of the `World Health Organization Disability Assessment Schedule, WHODAS-2' in patients with chronic diseases,” 8 Health and Quality of Life Outcomes 51 (2010). It assesses the ability to perform tasks in six functional domains by measuring the impact of a disability across various life functions and assigning a score for each domain. “WHO Disability Assessment Schedule 2.0 (WHODAS 2.0),” World Health Organization, https://www.who.int/classifications/icf/whodasii/en/ (last visited Nov. 19, 2019) (hereinafter “WHODAS 2.0”).

The ICD is a standard tool for the diagnosis of disabilities for the purposes of epidemiology, health management, and clinical practice. By employing a standardized numerical labeling system, the ICD allows disease to be classified, monitored, and analyzed for statistical purposes. “Classifications,” World Health Organization, https://www.who.int/classifications/en/ (last visited Nov. 19, 2019).

Finally, the DSM-5 is a standardized classification of mental disorders for mental health professionals in the United States. The DSM-5 contains every mental health disorder recognized by the American Psychiatric Association and provides detailed diagnostic criteria. As a standard for mental health, the DSM-5 is also used to collect data regarding public health matters involving psychiatric disorders. See generally American Psychiatric Association (APA), “Diagnostic and Statistical Manual of Mental Disorders” (American Psychiatric Publishing, 5th ed. 2013) (hereinafter “DSM-5”).

Previous versions of the DSM relied upon a categorical diagnostic classification scheme requiring a clinician to determine whether a disorder was absent or present with a multiaxial system, each axis of which gave a different type of information about the diagnosis. Axis V, in particular, was comprised of the Global Assessment of Functioning (GAF) scale, which was used by clinicians to assess an individual's overall level of functioning on a hypothetical continuum of mental health illness.

The DSM-5 eliminates the multiaxial approach and instead provides for a “dimensional approach, which allows a clinician more latitude to assess the severity of a condition.” APA, “DSM-5's Integrated Approach to Diagnosis and Classifications,” https://www.psychiatry.org/File%20Library/Psychiatrists/Practice/DSM/APA_DSM-5-Integrated-Approach.pdf. According to the APA, a growing body of scientific evidence supports multi-faceted or multi-dimensional concepts in assessing functional impairment due to mental disorders. DSM-5 at 733-737. Clinicians who assess the consequences of mental disorders should consider a combination of all domains of functioning, and a comprehensive approach incorporates variations of features within the individual, rather than relying on a simple combination of presented symptoms. Id.

This dimensional approach incorporates differential severity of individual symptoms both within and outside of a disorder's diagnostic criteria as measured by intensity, duration, or number of symptoms, along with other features such as type and severity of disabilities. DSM-5 at 733. In sum, the dimensional approach is consistent with current diagnostic practice and comprehensively examines the functional consequences of a mental disability. Id.; see Lonnie R. Bristow, Preface to “A 21st Century System for Evaluating Veterans for Disability Benefits” xii (some of the signature injuries incurred in Operations Enduring Freedom/Iraqi Freedom, such as posttraumatic stress disorder (PTSD), must be evaluated in terms of their functional consequences). Accordingly, the DSM-5 now advocates for assessments like the WHODAS 2.0, which “has proven useful as a standardized measure of disability for mental disorders.” DSM-5 at 21. The WHODAS 2.0 corresponds to concepts contained in the WHO's ICF. T. Bedirhan Üstün et al., “Developing the World Health Organization Disability Assessment Schedule 2.0,” Bull. World Health Organ. 815 (2010) (hereinafter “Developing WHODAS 2.0”). The WHODAS 2.0 does not depend on symptom levels. Rather, the WHODAS 2.0 is a 36-item or 12-item measure that assesses an individual's performance over the past 30 days in activities in the following six domains (areas of functioning): (1) Understanding and communication; (2) getting around; (3) self-care; (4) getting along with people; (5) life activities; and (6) participation in society. World Health Organization, “Measuring Health and Disability Manual for WHO Disability Assessment Schedule WHODAS 2.0” 4-5 (T.B. Üstün et al. eds., 2010) (hereinafter “Manual”). The WHODAS 2.0 asks how much difficulty the individual has had performing certain activities within each domain using the following scale: No difficulty (1), mild difficulty (2), moderate difficulty (3), severe difficulty (4), and extreme difficulty or cannot do (5). Id. at 38, 41.

The WHODAS 2.0 is similar to the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), which is the “gold standard in PTSD assessment.” See Frank W. Weathers et al., “The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)” (2013), cited at https://www.ptsd.va.gov/professional/assessment/adult-int/caps.asp (last visited Nov. 19, 2019) (hereinafter “Weathers 2013”); Frank W. Weathers et al., “ The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and Initial Psychometric Evaluation in Military Veterans,” Psychol. Assess. 30(3) (2018), available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5805662/ (last visited Nov. 19, 2019). The CAPS-5 is a 30-item structured interview administered by clinicians and clinical researchers that is used to render a diagnosis of PTSD and assess the severity of the 20 PTSD symptoms in the DSM-5 based on symptom frequency and intensity using a scale similar to the WHODAS 2.0, i.e., absent (0), mild (1), moderate (2), severe (3), and extreme (4). See Weathers 2013, supra. The scores for frequency and intensity are combined to form a single severity score for each symptom, and a total severity score is calculated by combining all the individual severity scores for the 20 PTSD symptoms. Id.

There is evidence that a standardized assessment for disability related to mental disorders, such as the WHODAS 2.0 and CAPS-5, leads to a more reliable and valid disability examination process. IOM, “Psychological Testing in the Service of Disability Determination” 66 (2015), https://www.nap.edu/read/21704. The WHODAS 2.0 “has good psychometric qualities, including good reliability and item-response characteristics” and shows concurrent validity when compared with other measures of disability or health status or with clinician ratings. Developing WHODAS 2.0, supra. A VA study compared clinical interviews with standardized assessments that incorporated the CAPS-5 for PTSD diagnosis and the WHODAS 2.0 for functional impairment and found that administering a standardized disability assessment resulted in more complete assessment of functional impairment and diagnostic coverage of PTSD. Ted Speroff et al., “ Compensation and Pension Examination for PTSD,” VA Office of Health Services Research & Development Service Forum 7 (May 2012). VA therefore proposes a General Rating Formula for Mental Disorders, h is explained below, that would provide a standardized assessment of disability similar to the WHODAS 2.0 and CAPS-5. It would also create a common language between clinicians and adjudicators, which VA believes will lead to more efficient and accurate adjudication of claims for mental disorders.

Another important purpose for updated rating criteria is the fact that, since September 11, 2001, the United States has deployed more than 2.5 million American service members to Iraq, Afghanistan, and other dangerous regions around the world. These deployments have exposed service members to a variety of stressors, including sustained risk of, and exposure to, injury and death, as well as an array of family pressures. U.S. Department of Defense, “DoD, VA, Other Agencies Team to Study PTSD, TBI,” American Forces Press Service (Aug. 14, 2013) https://archive.defense.gov/News/NewsArticle.aspx?ID=120620 (last visited Nov. 19, 2019). Multiple deployments involve prolonged exposure to combat-related stressors. The psychological toll of these deployments must be taken seriously. RAND Corporation, Preface to “Invisible Wounds of War: Psychological and Cognitive Injuries, Their Consequences, and Services to Assist Recovery” iii (T. Tanielian & L.H. Jaycox eds., 2008). Recent reports have referred to PTSD and traumatic brain injury (TBI) as the signature wounds of the conflicts in Afghanistan and Iraq. Id. With increasing incidence of suicide and suicide attempts among returning veterans, concern about depression and other mental health disorders is also on the rise.

Indeed, individuals with mental disorders such as depression, anxiety and adjustment disorders frequently experience recurrent absences from work. I. Arends et al., “Prevention of Recurrent Sickness Absence in Workers with Common Mental Disorders: Results of a Cluster-Randomized Controlled Trial,” 71 Occupational Envtl Med. 21 (2014). As compared to physical disorders, mental disorders cause less engagement in life activities, including work. M.A. Buist-Bouwman et al., “Comparing Functioning Associated with Mental and Physical disorders,” 113 Acta Psychiatr. Scand. 499 (2006). One comprehensive study based on a WHO questionnaire estimated that employees with bipolar disorder lost the equivalent of about 28 work days annually from sick time and other absences. “Mental health problems in the workplace,” Harvard Mental Health Letter (Feb. 2010), https://www.health.harvard.edu/newsletter_article/mental-health-problems-in-the-workplace; see also N.L. Kleinman et al., “Lost Time, Absence Costs, and Reduced Productivity Output for Employees With Bipolar Disorder,” 47 J. Occupational & Envtl. Med. 1117, 1121 (Nov. 2005). Moreover, compared to the general population, the risk of recurrent sickness absence is higher for employees with mental disorders, and such recurrent absences are often more serious and long-lasting. See 71 Occupational Envtl Med. at 21.

As the understanding of mental disorders has advanced, so has the ability to recognize and quantify the components that form both the diagnosis as well as its attendant disability. Therefore, VA proposes to update the section of the rating schedule that addresses mental disorders to provide clear, consistent, and accurate evaluation criteria. Updating the General Rating Formula for Mental Disorders will also improve the timeliness and accuracy of adjudications by providing uniform objective criteria based on modern medical science.

Finally, the proposed changes are necessary to address potential inadequacies in the current mental health criteria of the VASRD. In August 2007, the Center for Naval Analyses (CNA) prepared an earnings loss study in response to a request from the VDBC to assess compensation levels under the VASRD. Eric Christensen et al., “Final Report for the Veterans' Disability Benefits Commission: Compensation, Survey Results, and Selected Topics” (CNA 2007). The study found that those veterans with primary mental disabilities do not receive adequate compensation to offset any earnings losses. Id. at 193. On the basis of its findings, CNA recommended that VA review and adjust evaluations for mental disorders to provide adequate compensation for earnings losses. Id.

Another study, completed by Economic Systems, Inc. (EconSys), in September 2008, focused on the adequacy of VA benefits to compensate for loss of earnings and functional impairment. EconSys, “A Study of Compensation Payments for Service-Connected Disabilities” (2008). Like CNA, EconSys found that veterans with mental disorders generally were undercompensated by the VASRD. Id. at 33. EconSys also recommended a re-evaluation of the criteria for mental disorders, noting that VA should update the VASRD to reflect modern medical science. Id at 35.

Given the foregoing, VA proposes to adopt new evaluation criteria that more accurately capture the occupational impairment caused by mental disabilities and provide more adequate compensation for the earnings losses experienced by veterans with service-connected mental disorders. A more detailed discussion of the specific evaluation criteria VA proposes and how VA will apply it follows.

The current rating schedule for mental disorders provides two separate rating formulas, the General Rating Formula for Mental Disorders and the Rating Formula for Eating Disorders. The General Rating Formula for Mental Disorders bases evaluations on a list of signs and symptoms that characteristically produce a particular level of disability. 61 FR 52695, 52700 (Oct. 8, 1996). VA believes that an updated formula considering the severity, frequency and duration of symptoms would provide the most accurate and consistent method for evaluating functional impairment.

The current Rating Formula for Eating Disorders bases evaluations on the extent of weight loss, incapacitating episodes, and required periods of hospitalization, in accordance with the now-outdated DSM-IV. 60 FR 54825, 54829 (Oct. 26, 1995). VA believes that an updated formula can better evaluate how symptoms or episodes attributable to eating disorders actually translate into functional and occupational impairment.

As noted above, the understanding of disability resulting from mental disorders has evolved with the science. The IOM report recognized that some of the signature injuries ( e.g., PTSD) incurred in Operations Enduring Freedom/Iraqi Freedom are not visible or subject to a laboratory test. See also Bristow, supra. Instead, they must be evaluated in terms of their functional consequences. Id. In that regard, properly evaluating mental disability requires the ability to recognize and quantify the components that form the diagnosis as well as resulting impairment. While symptoms determine the diagnosis, they do not necessarily translate directly to functional impairment. Thus, we believe that, in order to accurately measure functional impairment, VA must consider the frequency and severity of the symptoms and how they impact functioning and performance across a variety of domains: That, is aspects of human behavior and functioning.

To ensure evaluations are accurate and consistent with modern medicine, VA is proposing a new, comprehensive general rating formula for all mental disorders, to include eating disorders. The proposed evaluation criteria will measure a veteran's essential ability to participate in the work environment and the impact of the mental disorder on earning capacity via a comprehensive assessment of occupational and social functioning. Diagnoses must still be established according to the DSM-5. 38 CFR 4.125(a). However, once an examiner has diagnosed a specific mental disorder, the proposed rating criteria will enable VA to assign an evaluation by analyzing the frequency, intensity, and overall severity of occupational and social impairment due to the diagnosed mental disorder and in accordance with the updated clinical standards of the DSM-5.

The proposed evaluation criteria, as further discussed below, encapsulate the dimensional approach of the WHODAS 2.0, ICD, DSM-5, and CAPS-5.

Congress requires VA to base its rating schedule, “as far as practicable, upon the average impairments of earning capacity” in “civil occupations” that a veteran will experience due to the disability in question. 38 U.S.C. 1155. VA recognizes that a veteran's earning capacity after disability is highly dependent upon both occupational and social functioning. Studies have shown that the objective evaluation of functional performance, rather than subjective criteria, is a strong predictor of impairment in earning capacity in individuals with a diagnosed mental disorder. A. Galvao et al., “Predicting Improvement in Work Status of Patients With Chronic Mental Illness After Vocational and Integrative Rehabilitation Measurements,” 44 Rehabilitation 208, 208-14 (2005). VA has therefore determined that a multidimensional approach to evaluating mental disorders will provide the most efficient and satisfactory method for measuring the impact of mental health disabilities on a veteran's earning capacity.

VA would continue to require that a diagnosis of a mental disorder be established in accordance with the DSM-5 as required by 38 CFR 4.125(a). However, for purposes of rating the extent of disability attributable to a mental disorder, VA proposes a rating formula using five domains of functioning to evaluate the extent of disability, similar to the approach of the WHODAS 2.0.

As explained above, the WHODAS 2.0 assesses an individual's ability to perform life activities based upon six domains (areas of functioning): (1) Understanding and communicating, (2) ability to move and get around, (3) caring for oneself, (4) getting along with people, (5) carrying out life activities, and (6) participating in society. However, “getting along with people” and “participation in society” can essentially be categorized as one domain of “interpersonal interactions and relationships” for VA's purpose of evaluating a veteran's earning capacity. 38 U.S.C. 1155. Therefore, the proposed General Rating Formula for Mental Disorders would evaluate the extent of a veteran's disability based upon all evidence of record relevant to the following five domains: (1) Cognition ( i.e., understanding and communicating), (2) interpersonal interactions and relationships ( i.e., interacting with people and participating in society), (3) task completion and life activities, (4) navigating environments ( i.e., getting around), and (5) self-care.

The domain of “Cognition” would assess a veteran's mental processing involved in gaining knowledge and comprehension. These processes include, but are not limited to, memory, concentration, attention, goal setting, speed of processing information, planning, organizing, prioritizing, problem solving, judgment, decision making, or flexibility in adapting when appropriate.

The domain of “Interpersonal Interactions and Relationships” would assess a veteran's ability to effectively interact with other people in both social and occupational settings and participate in society. This domain includes both informal (social, associational, etc.) and formal (coworkers, supervisors, etc.) relationships.

The domain of “Task Completion and Life Activities” would assess a veteran's ability to manage task-related demands. This domain includes, but is not limited to, the following types of activities: Vocational, educational, domestic chores, social, or caregiving.

The domain of “Navigating Environments” would assess a veteran's physical and mental ability to go from place to place. This domain includes, but is not limited to, the following: leaving the home, being in confined or crowded spaces, independently moving in surroundings, navigating new environments, driving, or using public transportation.

The domain of “Self-Care” would assess a veteran's ability to take care of himself or herself. This domain would include, but would not be limited to, the following types of activities: Hygiene, dressing appropriately, or nourishment.

In order to accurately measure occupational and social impairment due to a mental disorder, VA proposes to measure a veteran's functioning within each of the five domains discussed above based upon the level of difficulty the veteran experiences in performing tasks associated with the domain (intensity) and the percentage of time that these difficulties occur (frequency). See Jon D. Elhai et al., “Posttraumatic Stress Disorder's Frequency and Intensity Ratings Are Associated With Factor Structure Differences in Military Veterans,” 22 Psychol. Assess. 723 (2010); A.J. Rush, Jr., et al., “Handbook of Psychiatric Measures” 103-05 (American Psychiatric Publishing, 2d ed. 2008). This approach would be outlined in 38 CFR 4.126(a), which will state that, when evaluating a mental disorder, an adjudicator must consider the intensity and frequency of psychiatric symptoms that bear on the five domains discussed above. Section 4.126(a) would also state that VA will assess the intensity and frequency of symptoms in each domain and will assign an evaluation based on the combined levels of functioning in these domains as explained in the General Rating Formula For Mental Disorders. VA would delete paragraph (b) of current section 4.126, which provides that VA will consider social impairment but will not assign an evaluation “solely on the basis of social impairment,” as obsolete, because that principle would be more clearly addressed in one of the domains for assessment, providing for consideration of “interpersonal interactions and relationships.” Paragraphs (c) and (d) would be redesignated as paragraphs (b) and (c), respectively.

As to the proposed General Rating Formula, there will be 100, 70, 50, 30, and 10 percent evaluations based on the severity of impairment in all five domains. To measure the severity in an individual domain, VA will first evaluate the intensity of impairment in that domain. Intensity refers to the difficulties in functioning, i.e., interference with completing tasks. The levels of intensity for each domain will be none, mild, moderate, severe, or total, generally defined as follows:

As a technical note, the “task completion and life activities” domain uses slightly different criteria to define these levels, and several of the domains consider the effect of accommodations or assistance in their assessment.

When evaluating intensity under the proposed criteria, examiners and VA adjudicators should be cognizant of the fact that some symptoms may overlap between domains. VA will provide training or additional guidance to help avoid the artificial inflation of the severity of a condition through the double-counting of symptoms. Cf. 38 CFR 4.14. Moreover, consistent with 38 U.S.C. 1155 (VASRD shall compensate for impairments in earning capacity), examiners and VA adjudicators generally should assess impairments with a view toward their effect on earning capacity. Finally, examiners and VA adjudicators generally should assess impairments due to the service-connected disability, not other causes. See ICF Checklist (Version 2.1a, Clinician Form) (“The level of capacity should be judged relative to that normally expected of the person, or the person's capacity before they acquired their health condition.”), https://www.who.int/classifications/icf/icfchecklist.pdf?ua=1; see also Manual at 39 (WHODAS 2.0 responses should address difficulties with activities due to health conditions, rather than to other causes). Again, training and additional guidance will be provided to VA personnel for further edification on appropriately applying the revised general rating formula.

After determining the intensity for each domain, VA would address frequency. Frequency refers to the percentage of time, in the past month, that impairment occurs. Consistent with the WHO's ICF Checklist rates and the CAPS-5, VA proposes to differentiate between impairment occurring less than 25 percent of the time over the past month, and 25 percent of the time or more over the past month. The CAPS-5 distinguishes in its ratings between a frequency of “some of the time” (20 to 30 percent) and more frequent occurrences. Weathers 2013, supra. The WHO's ICF checklist, upon which the WHODAS 2.0 is based, similarly distinguishes between impairments that are present less than 25 percent of the time and those occurring more than 25 percent of the time in the past month. See ICF Checklist, pt. 2; see also Manual at 39 (“Recall abilities are most accurate for the period of one month.”). Like other validated measures, VA recognizes that impairments that occur 25 percent or more of the time present a greater impact on social and occupational functioning than those that occur less frequently.

Consideration of both the intensity and frequency would yield the level of impairment of functioning in each domain, and each level would correlate to a numerical value, ranging from 0 to 4, which would be defined as follows:

Once an adjudicator determines the level of impairment of functioning for each domain caused by a mental disorder, VA would assign an evaluation of 10, 30, 50, 70, or 100 percent for the disorder based upon the numerical value for each domain and the number of domains affected. VA would assign the following ratings based upon the following criteria:

As reflected in this formula, veterans who have more severe impairment in more domains will receive higher ratings. Veterans with less severe impairment in less domains will receive lower ratings. But, notably, a numerical value of 4 in just one domain will warrant a 100 percent rating; and a numerical value of 3 in just one domain will warrant a 70 percent rating. This criterion should generally lead to more generous compensation for veterans than the current rating formula, which requires “total occupational and social impairment” for a 100 percent rating and “deficiencies in most areas” for a 70 percent rating. Moreover, VA proposes to eliminate the current rating formula's provision for a noncompensable rating, and to provide a minimum rating of 10 percent for all mental disorders. This is because a disorder that meets the DSM-5 requirements for being a mental disorder must include elements indicative of both harm and dysfunction. Michael B. First et al., “Diagnostic Criteria as Dysfunction Indicators: Bridging the Chasm Between the Definition of Mental Disorder and Diagnostic Criteria for Specific Disorders,” 58 Canadian J. of Psychiatry 663, 665 (Dec. 2013). Thus, a DSM-5 disorder will rarely produce zero dysfunction. Id. Because the DSM-5 requirements represent thresholds of minimal clinical confidence that a dysfunction is present, VA will assign at least a 10 percent rating for such disorders. Id. at 668.

As previously noted, current § 4.130 includes two separate rating formulae for mental disorders—the General Rating Formula for Mental Disorders and the Rating Formula For Eating Disorders. VA created a separate Formula for Eating Disorders “because their more disabling aspects are manifested primarily by physical findings rather than by psychological symptoms.” 60 FR at 54829. The current Rating Formula for Eating Disorders bases evaluations on the extent of weight loss, incapacitating episodes, and required periods of hospitalization. Id. However, in the DSM-5 at 339, the only eating disorder for which weight is a diagnostic criterion is anorexia nervosa, and body mass index (BMI) (weight in kilograms divided by height in meters squared (kg/m 2 )) is used to specify the current severity of the disorder. Weight and BMI are not diagnostic criteria in the DSM-5 for other eating disorders, such as bulimia nervosa and binge-eating disorder, nor are they specifiers for the severity of other eating disorders. DSM-5 at 329-54.

As explained above, assessments like the WHODAS 2.0 can be used to assess an individual's ability to perform life activities based upon six areas of functioning as a result of any disorder, including eating disorders. Liza H. Gold, “DSM-5 and the Assessment of Functioning: The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0),” 42 J. Am Acad. Psychiatry L. 173, 174-75 (2014). The test-retest reliability, internal consistency, and concurrent validity of the WHODAS 2.0 in comparison to other instruments for measuring disability has been established in various patient populations and in general population samples. Manual at 19-25. Based upon the diagnostic criteria and severity specifiers for most eating disorders in the DSM-5 and the universal applicability of the WHODAS 2.0, VA no longer sees a need for a separate rating formula for eating disorders, and VA proposes to instead evaluate the extent of disability caused by eating disorders based upon the effect of an individual's disorder on the five domains of functioning under the General Rating Formula for Mental Disorders discussed above. VA seeks comment on this approach.

To derive the appropriate level to assign to each domain ( e.g., 0 through 4), VA conducted a proof-of-concept study with 100 veterans with service-connected mental disorders. Commonly known as feasibility studies, proof-of-concept studies are designed to examine new methods or treatments. The results of such studies improve the program or evaluation procedure before using it on a larger scale. L. Thabane et al., “A tutorial on pilot studies: the what, why, and how,” BMC Medical Research Methodology 10:1, https://www.biomedcentral.com/content/pdf/1471-2288-10-1.pdf (last visited Nov. 19, 2019).

VA identified four specific aims of the proof-of-concept study to examine the feasibility of the proposed rating criteria for mental disorders. The first objective was to examine the distribution of evaluations under the current and proposed rating criteria for mental disorders. The second objective was to examine the extent to which the revised Mental Disorders Disability Benefits Questionnaire (DBQ) would adequately collect information needed to rate disabilities based upon the proposed rating criteria. The third objective was to examine the extent to which adjudicators were easily able to extract rating data from the revised DBQ and apply the new evaluation criteria. The fourth objective was to examine the extent to which Compensation and Pension (C&P) examiners found the revised DBQ adequate and easy to use.

Regarding the first objective, the proof-of-concept study found that the proposed General Rating Formula for Mental Disorders would increase the average disability evaluation. Compared to the current rating formula, fewer veterans would be rated at or below 50 percent disability and more would be rated above 50 percent under the proposed criteria. The two formulae seemed to yield similar results at 70 percent disabling, and the number of veterans who would receive 100 percent disability was greater under the proposed criteria than under the current criteria.

Regarding the second objective, adjudicators reported that the revised Mental Disorders DBQ provided all the information they needed to evaluate based on the proposed criteria. Regarding the third objective, adjudicators reported that they were easily able to extract rating data from the revised DBQ and apply new evaluation criteria. Finally, C&P examiners reported that the revised DBQ was adequate and easy to use in a clinical setting.

Importantly, one major theme in the feedback regarding mental disorders has been the need for a common language in the VASRD—a language familiar to both clinicians and adjudicators. According to the proof-of-concept study results, VA achieved this objective with the proposed General Rating Formula for Mental Disorders.

VA proposes to add three notes at the end of the General Rating Formula for Mental Disorders to promote greater consistency and accuracy in applying the criteria.

The first note would provide that only one evaluation will be assigned for co-existing service-connected mental disorders. According to 38 U.S.C. 1155, the VA rating schedule shall compensate veterans for “impairments of earning capacity,” not specific diagnoses. And according to 38 CFR 4.14, evaluations of the same disability or manifestation under different diagnoses is to be avoided. Most mental disorders are “composed of multiple emotional, cognitive, and behavioral dimensions, many of which are shared across disorders.” Lee Ann Clark et al., “Three Approaches to Understanding and Classifying Mental Disorder: ICD-11, DSM-5, and the National Institute of Mental Health's Research Domain Criteria (RDoC),” 18 Psychol. Sci. in the Pub. Int. 72, 112 (2017). In addition, co-existing mental disorders, that is, comorbidity, “is the rule rather than the exception.” Id. Therefore, consistent with 38 U.S.C. 1155 and the rule against pyramiding, 38 CFR 4.14, Note (1) will instruct adjudicators not to assign individual disability ratings to more than one mental disorder given the likelihood of comorbid mental disorders and the prevalence of overlapping symptoms among such disorders.