[Federal Register Volume 88, Number 212 (Friday, November 3, 2023)]
[Rules and Regulations]
[Pages 75498-75500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24195]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AR44


Presumptive Service Connection for Rare Respiratory Cancers Due 
to Exposure to Fine Particulate Matter

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This rulemaking adopts as final, without changes, an interim 
final rule amending the Department of Veterans Affairs (VA) 
adjudication regulations to establish presumptive service connection 
for nine rare respiratory cancers in association with presumed exposure 
to fine particulate matter. These presumptions apply to Veterans with a 
qualifying period of service, i.e., who served on active military, 
naval, or air service in the Southwest Asia theater of operations 
during the Persian Gulf War (hereinafter Gulf War), from August 2, 
1990, onward, as well as in Afghanistan, Syria, Djibouti, or 
Uzbekistan, on or after September 19, 2001, during the Gulf War. This 
rulemaking implements a decision by the Secretary of Veterans Affairs 
that determined there is sufficient evidence to support these cancers 
as presumptive based on exposure to fine particulate matter during 
service in the Southwest Asia theater of operations, Afghanistan, 
Syria, Djibouti, or Uzbekistan during certain periods and the 
subsequent development of the following rare respiratory cancers: 
squamous cell carcinoma (SCC) of the larynx, SCC of the trachea, 
adenocarcinoma of the trachea, salivary gland-type tumors of the 
trachea, adenosquamous carcinoma of the lung, large cell carcinoma of 
the lung, salivary gland-type tumors of the lung, sarcomatoid carcinoma 
of the lung, and typical and atypical carcinoid of the lung. The 
intended effect of this rulemaking is to ease the evidentiary burden of 
this population of Veterans who file claims with VA for these nine rare 
respiratory cancers.

DATES: 
    Effective date: This rule is effective November 3, 2023.
    Applicability date: The provisions of this final rule shall apply 
to all applications for service connection for squamous cell carcinoma 
(SCC) of the larynx, SCC of the trachea, adenocarcinoma of the trachea, 
salivary gland-type tumors of the trachea, adenosquamous carcinoma of 
the lung, large cell carcinoma of the lung, salivary gland-type tumors 
of the lung, sarcomatoid carcinoma of the lung, and typical and 
atypical carcinoid of the lung based on service in the Southwest Asia 
theater of operations during the Gulf War, from August 2, 1990, onward, 
as well as Afghanistan, Syria, Djibouti, or Uzbekistan, on or after 
September 19, 2001, during the Gulf War, received by VA on or after 
April 26, 2022, or that were pending before VA, the United States Court 
of Appeals for Veterans Claims, or the United States Court of Appeals 
for the Federal Circuit on April 26, 2022.

FOR FURTHER INFORMATION CONTACT: Bryant Coleman, Regulations Analyst; 
Robert Parks, Chief, Regulations Staff (211), Compensation Service 
(21C), 810 Vermont Avenue NW, Washington, DC, (202) 461-9700. (This is 
not a toll-free telephone number.)

SUPPLEMENTARY INFORMATION: On April 26, 2022, VA published an interim 
final rule at 87 FR 24421, to amend its adjudication regulations to 
establish presumptive service connection for nine rare respiratory 
cancers in association with presumed exposure to fine particulate 
matter. These presumptions apply to Veterans with a qualifying period 
of service, i.e., who served on active military, naval, or air service 
in the Southwest Asia theater of operations during the Gulf War, from 
August 2, 1990, onward, as well as in Afghanistan, Syria, Djibouti, or 
Uzbekistan, on or after September 19, 2001, during the Gulf War. The 
60-day comment period ended on June 27, 2022.
    VA received nine comments from interested individuals and 
organizations. The comments are discussed below under the appropriate 
headings. VA made no changes based on comments received. However, we 
note that changes made to Sec.  3.320 in the final rule for RIN 2900-
AR25 are carried forward here and continue to remain in effect. Based 
on the rationale set forth in the interim final rule and in this final 
rule, VA adopts the provisions of the interim final rule as a final 
rule without change.

Confusion Regarding Qualifying Service Dates

    VA received three comments that expressed confusion regarding 
whether service in the Southwest Asia theater of operations during the 
first Gulf War is included under the definition of the phrase 
qualifying period of service. VA agrees with these comments that the 
rulemaking could have caused some confusion, and acknowledges that 
additional clarity is needed. So, to clarify, as currently written, the 
rule applies to those who served in Desert Shield or Desert Storm as 
part of the Persian Gulf War from August 2,1990 to February 28, 1991. 
We note that the definition of qualifying period of service contained 
in paragraph (a)(5)(i) refers to Sec.  3.2(i), which defines ``Persian 
Gulf War'' as: ``August 2, 1990, through date to be prescribed by 
Presidential proclamation or law.'' However, VA makes no changes based 
on these comments because this issue was addressed in the final rule 
for RIN 2900-AR25, which changes have been carried forward here and 
continue to remain in effect.

General Comments

    One commenter expressed general support for the rulemaking. VA 
thanks the commenter for their view. VA makes no changes based on this 
comment.
    VA received two comments that addressed time frames and locations 
that qualify for the presumption of exposure contained in Sec.  3.320. 
In particular, one commenter stated that he was on an aircraft carrier 
in the theater of Southwest Asia in July of 1987. He went on to state 
that ``[a]ll Military Service-members should qualify for all exposures 
during active duty in this theater of operations.'' Another commenter 
asked ``is this related to burn pits? If so, why are you just making 
this available to only veterans who served for that time period?'' The 
commenter went on to state that they served in Beirut, Lebanon in 1982-
1983 and were exposed to burning human waste during that time. While VA 
sympathizes with these commenters, VA's rulemaking establishes 
presumptive service connection for nine rare respiratory cancers in 
association with presumed exposure to fine particulate matter; it does 
not address the locations or periods of service that qualify for the 
presumption of exposure to fine particulate matter. Thus, these 
comments are outside the scope of the present rulemaking.
    Additionally, we note that the Secretary has made the decision to 
limit these presumptive conditions to a timeframe and locations during 
which VA has evidence of relevant levels of fine particulate matter in 
the air. When VA created the presumption of exposure to fine 
particulate matter in 38 CFR 3.320, it was based on scientific and 
medical studies that focused on the

[[Page 75499]]

respiratory effects of fine particulate matter for Veterans who served 
in the Southwest Asia theater of operations, Afghanistan, Syria, 
Djibouti, and Uzbekistan during the Gulf War. Veterans began reporting 
a variety of respiratory health issues during and after the initial 
Gulf War conflict, and as a result, Congress mandated that VA study the 
health outcomes of veterans deployed to the Southwest Asia theater of 
operations. VA then requested the National Academies of Sciences, 
Engineering, and Medicine (NASEM) to study the evidence regarding 
respiratory health outcomes in veterans of the Southwest Asia 
conflicts. The results of that study formed the basis for this 
rulemaking. As service prior to the Gulf War was not considered in 
these studies, it cannot be included as part of the qualifying 
timeframe under 38 CFR 3.320.
    While this rulemaking is based on current medical and scientific 
evidence related to the respiratory health effects of fine particulate 
matter on Veterans who served during the Gulf War, VA will continue to 
review new scientific evidence as it develops relating to other 
exposures and to all health effects resulting from exposure to fine 
particulate matter. This rulemaking does not limit the future 
establishment of presumptive service connection for conditions related 
to respiratory or other body systems, or the establishment of 
presumptions of exposure for service in other locations or during other 
time frames. Additionally, VA encourages all Veterans who believe that 
they are entitled to VA compensation to file a claim with their local 
VA regional office. VA makes no change to the final rule based on the 
comment.
    One commenter reported that they had filed 3 intent letters and had 
not received a response. The commenter went on to report that they had 
been turned down for compensation in the past. VA's rulemaking 
establishes presumptive service connection for nine rare respiratory 
cancers in association with presumed exposure to fine particulate 
matter. This comment, which relates to an individual case, is outside 
the scope of the present rulemaking. However, VA encourages all 
Veterans who believe that they are entitled to VA compensation to file 
a claim with their local VA regional office. VA makes no change to the 
final rule based on the comment.
    One commenter stated that her husband served in the US Army and 
while serving he died of squamous cell carcinoma of the larynx. While 
VA sympathizes with this commenter, VA's rulemaking establishes 
presumptive service connection for nine rare respiratory cancers in 
association with presumed exposure to fine particulate matter. This 
comment refers to a specific case, which is outside the scope of the 
present rulemaking. However, VA encourages all Veterans and dependents 
who believe that they are entitled to VA compensation to file a claim 
with their local VA regional office. VA makes no change to the final 
rule based on the comment.
    Another commenter objected to the rulemaking because it did not 
cover all diseases and disabilities caused by open air burn pits or the 
chemical contamination in Gulf War I. Additionally, the commenter 
stated that the ``interim final rule does not clearly define the 
provisions attaching to Gulf War I. Including coverage dates would 
eliminate any possible confusion.'' As noted above, while this 
rulemaking is based on current medical and scientific evidence related 
to the respiratory health effects of fine particulate matter on 
Veterans who served during the Gulf War, VA will continue to review new 
scientific evidence as it develops relating to other exposures and to 
all health effects resulting from exposure to fine particulate matter. 
This rulemaking does not limit the future establishment of presumptive 
service connection for conditions related to respiratory or other body 
systems, or the establishment of presumptions of exposure for service 
in other locations or during other time frames. Also, the potential 
confusion regarding service during the first Gulf War was addressed in 
the final rule for RIN 2900-AR25, which changes have been carried 
forward here and continue to remain in effect. VA makes no change to 
the final rule based on the comment.
    Further, we again note that changes made to Sec.  3.320 in the 
final rule for RIN 2900-AR25 are carried forward here and continue to 
remain in effect. Additionally, provisions of the Sergeant First Class 
Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act 
of 2022, Public Law 117-168, relevant to this regulation will be the 
subject of separate and future rulemaking.

Administrative Procedure Act

    This document affirms the amendment made by the interim final rule 
that is already in effect. The Secretary concluded that, pursuant to 5 
U.S.C. 553(b)(B) and (d)(3), there was good cause to publish this rule 
without prior opportunity for public comment and good cause to publish 
this rule with an immediate effective date. Delay in the implementation 
of this rule would have been impracticable, unnecessary, and contrary 
to public interest, particularly to Veterans.

Executive Orders 12866, 13563, and 14094

    Executive Order 12866 (Regulatory Planning and Review) directs 
agencies to assess the costs and benefits of available regulatory 
alternatives and, when regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety effects, and other advantages; 
distributive impacts; and equity). Executive Order 13563 (Improving 
Regulation and Regulatory Review) emphasizes the importance of 
quantifying both costs and benefits, reducing costs, harmonizing rules, 
and promoting flexibility. Executive Order 14094 (Executive Order on 
Modernizing Regulatory Review) supplements and reaffirms the 
principles, structures, and definitions governing contemporary 
regulatory review established in Executive Order 12866 of September 30, 
1993 (Regulatory Planning and Review), and Executive Order 13563 of 
January 18, 2011 (Improving Regulation and Regulatory Review). The 
Office of Information and Regulatory Affairs has determined that this 
rulemaking is not a significant regulatory action under Executive Order 
12866, as amended by Executive Order 14094. The Regulatory Impact 
Analysis associated with this rulemaking can be found as a supporting 
document at www.regulations.gov.

Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-
612). The certification is based on the fact that no small entities or 
businesses determine service connection or the rating criteria, or 
assign evaluations for disability claims. Therefore, pursuant to 5 
U.S.C. 605(b), the initial and final regulatory flexibility analysis 
requirements of sections 603 and 604 do not apply.

Unfunded Mandates

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

[[Page 75500]]

such effect on State, local, and tribal governments, or on the private 
sector.

Paperwork Reduction Act (PRA)

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

Assistance Listing

    The Assistance Listing numbers and titles for this rule are 64.101, 
Burial Expenses Allowance for Veterans; 64.102, Compensation for 
Service-Connected Deaths for Veterans' Dependents; 64.105, Pension to 
Veterans, Surviving Spouses, and Children; 64.109, Veterans 
Compensation for Service-Connected Disability; and 64.110, Veterans 
Dependency and Indemnity Compensation for Service-Connected Death.

Congressional Review Act

    Pursuant to Subtitle E of the Small Business Regulatory Enforcement 
Fairness Act of 1996 (known as the Congressional Review Act) (5 U.S.C. 
801 et seq.), the Office of Information and Regulatory Affairs 
designated this rule as not a major rule, as defined by 5 U.S.C. 
804(2).

List of Subjects in 38 CFR Part 3

    Administrative practice and procedure, Claims, Disability benefits, 
Health care, Pensions, and Veterans.

Signing Authority

    Denis McDonough, Secretary of Veterans Affairs, signed and approved 
this document on August 24, 2023, 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.

Jeffrey M. Martin,
Assistant Director, Office of Regulation Policy & Management, Office of 
General Counsel, Department of Veterans Affairs.

PART 3--ADJUDICATION

0
The interim final rule amending 38 CFR part 3 which was published at 87 
FR 24421 on April 26, 2022, is adopted as final without change.

[FR Doc. 2023-24195 Filed 11-2-23; 8:45 am]
BILLING CODE 8320-01-P