[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Rules and Regulations]
[Pages 4173-4185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00499]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 3
RIN 2900-AP66
Diseases Associated With Exposure to Contaminants in the Water
Supply at Camp Lejeune
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
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SUMMARY: The Department of Veterans Affairs (VA) amends its
adjudication regulations regarding presumptive service connection,
adding certain diseases associated with contaminants present in the
base water supply at U.S. Marine Corps Base Camp Lejeune (Camp
Lejeune), North Carolina, from August 1, 1953, to December 31, 1987.
This final rule establishes that veterans, former reservists, and
former National Guard members, who served at Camp Lejeune for no less
than 30 days (consecutive or nonconsecutive) during this period, and
who have been diagnosed with any of eight associated diseases, are
presumed to have incurred or aggravated the disease in service for
purposes of entitlement to VA benefits. In addition, this final rule
establishes a presumption that these individuals were disabled during
the relevant period of service for purposes of establishing active
military service for benefits purposes. Under this presumption,
affected former reservists and National Guard members have veteran
status for purposes of entitlement to some VA benefits. This amendment
implements a decision by the Secretary of Veterans Affairs that service
connection on a presumptive basis is warranted for claimants who served
at Camp Lejeune during the relevant period and for the requisite amount
of time and later develop certain diseases.
DATES: Effective Date: This final rule is effective March 14, 2017.
FOR FURTHER INFORMATION CONTACT: Eric Mandle, Policy Analyst,
Regulations Staff (211D), Compensation Service,
[[Page 4174]]
Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC
20420, (202) 461-9700. (This is not a toll-free telephone number.)
SUPPLEMENTARY INFORMATION:
I. Purpose of the Final Rule
VA amends its adjudication regulations to add certain diseases
associated with contaminants present in the base water supply at U.S.
Marine Corps Base Camp Lejeune, North Carolina, from August 1, 1953, to
December 31, 1987. This final rule establishes that veterans, former
reservists, and former National Guard members, who served at Camp
Lejeune for no less than 30 days (consecutive or nonconsecutive) during
this period and who have been diagnosed with any of eight associated
diseases, are presumed to have incurred or aggravated the disease in
service for purposes of entitlement to VA benefits. In addition, this
final rule establishes a presumption that these individuals were
disabled during the relevant period of service for purposes of
establishing active military service for benefits purposes. Under this
presumption, affected former reservists and National Guard members have
veteran status for purposes of entitlement to some VA benefits.
Section 501(a)(1) of title 38, United States Code, provides that
``[t]he Secretary has authority to prescribe all rules and regulations
which are necessary or appropriate to carry out the laws administered
by [VA] and are consistent with those laws, including . . . regulations
with respect to the nature and extent of proof and evidence and the
method of taking and furnishing them in order to establish the right to
benefits under such laws.'' This broad authority encompasses the
establishment of an evidentiary presumption of service connection and
exposure under specified circumstances, provided there is a rational
basis for the presumptions. In this case, the Secretary has determined
that proof of qualifying service at Camp Lejeune, consistent with
Public Law 112-154, the Honoring America's Veterans and Caring for Camp
Lejeune Families Act of 2012 (Camp Lejeune Act), and the subsequent
development of one of the eight listed diseases is sufficient to
support the presumption that the resulting disease was incurred in the
line of duty during active military, naval, or air service, to include
qualifying reserve or National Guard service, to establish entitlement
to service connection. See 38 U.S.C. 1110 and 1131.
II. Summary of Major Provisions
The major provisions of this final rule include the following: VA
will amend 38 CFR 3.307 to establish presumptions of service connection
associated with exposure to contaminants in the water supply at Camp
Lejeune. This amendment presumes exposure to contaminants in the water
supply at Camp Lejeune for all active duty, reserve, and National Guard
personnel who served for no less than 30 days (consecutive or
nonconsecutive) at Camp Lejeune during the period beginning August 1,
1953, and ending on December 31, 1987. This presumption specifically
allows former reservists and National Guard members to establish
veteran status by presuming that a covered disease was incurred in the
line of duty and was disabling during a period of qualifying service.
VA will also amend 38 CFR 3.309 to prescribe the eight conditions
that are subject to presumptive service connection in relation to
exposure to contaminants in the water supply at Camp Lejeune.
III. Technical Correction
In the proposed rule, VA proposed amending the heading of 38 CFR
3.307 to read ``Presumptive service connection for chronic, tropical or
prisoner-of-war related disease, disease associated with exposure to
certain herbicide agents, or disease associated with the contaminants
in the water supply at Camp Lejeune; wartime and service on or after
January 1, 1947.'' Additionally, VA proposed amending paragraph (a) of
Sec. 3.307 to mirror the title. In reviewing this amendment for the
final rule, however, VA realized that the current and proposed text of
paragraph (a) contain errors. Namely, they refer to a ``chronic,
tropical, prisoner of war related disease'' rather than a ``chronic,
tropical or prisoner of war related disease,'' as referenced in the
heading of Sec. 3.307. Additionally, the heading and proposed text
omitted the words ``exposure to'' before ``contaminants in the water
supply.'' This document corrects these errors by inserting ``or'' in
place of the comma between ``tropical'' and ``prisoner of war'' in
paragraph (a) to clarify that the terms ``chronic,'' ``tropical,'' and
``prisoner of war related'' refer to three separate categories of
disease rather than characteristics of a single disease; and inserting
``exposure to'' in the heading and paragraph (a) in the phrase
pertaining to contaminants in the water supply at Camp Lejeune.
IV. Public Comments
On September 9, 2016, VA published in the Federal Register (81 FR
62419) a notice of a proposed rulemaking to amend 38 CFR 3.307 and
3.309 to establish presumptive service connection for certain diseases
associated with contaminants present in the base water supply at U.S.
Marine Corps Base Camp Lejeune, North Carolina, from August 1, 1953 to
December 31, 1987. VA provided a 30-day public comment period, which
ended on October 11, 2016, and received 290 comments on the proposed
rule, one of which was received after the comment period. Although VA
is not legally required to consider late-filed comments, it has
reviewed, considered, and addressed all comments received in the
interest of maximizing public dialogue to further serve veterans,
claimants, and authorized representatives. VA received comments from
various organizations and individuals, including Disabled American
Veterans (DAV), Veterans of Foreign Wars (VFW), Vietnam Veterans of
America (VVA), National Organization of Veterans' Advocates (NOVA), C-
123 Veterans Association, Fort McClellan Veterans Stakeholders Group,
Reserve Officers Association, Marine Corps Reserve Association, United
Parkinson's Advocacy Council, Legal Counsel for the Elderly, Project on
Government Oversight, a member of Congress, and other interested
persons. VA responds to all commenters as follows.
All of the issues raised by the commenters that concerned at least
one portion of the rule can be grouped together by similar topic, and
VA has organized the discussion of the comments accordingly. VA also
received 85 comments from veterans and surviving spouses regarding
individual claims for veterans' benefits. VA does not respond to these
comments in this document as they are beyond the scope of this
rulemaking.
For the reasons set forth in the proposed rule and below, VA adopts
the proposed rule as final, with changes, as explained below.
A. 30-Day Exposure Requirement
VA received 18 comments, including organizational comments from
DAV, VVA, NOVA, Project on Government Oversight, and Legal Counsel for
the Elderly, regarding its proposal that a veteran, or former reservist
or National Guard member must serve no less than 30 days (consecutive
or nonconsecutive) at Camp Lejeune during the period beginning August
1, 1953, and ending
[[Page 4175]]
on December 31, 1987, to receive a presumption of service connection
for the eight listed diseases based on exposure to contaminants in the
water supply. Two commenters suggested changing the exposure
requirement to one week and two weeks, respectively; neither commenter
offered a rationale for these time limits. Several commenters suggested
eliminating the exposure requirement completely, noting that the 30-day
requirement was inconsistent with other toxic exposure presumptions and
that it was not supported with scientific evidence. One commenter
stated that the 30-day requirement would essentially exclude National
Guard members from eligibility. One commenter stated that a 30-day
exposure requirement would exclude veterans serving in the Naval
Amphibious Force who docked at Camp Lejeune.
1. Comparison to Prior Exposure Regulations
VA received several comments, including from DAV, NOVA, VVA, Legal
Counsel for the Elderly, and Project on Government Oversight, stating
that a 30-day exposure period is inconsistent with VA's requirements
for presumptive service connection based on toxic and other exposures.
For example, VA has previously established regulations governing
presumptive service connection for diseases associated with exposure to
certain herbicide agents and certain disabilities occurring in Persian
Gulf veterans. See 38 CFR 3.307, 3.309, and 3.317. These regulations do
not include a minimum exposure requirement; a veteran must show that he
or she served in an identified location or under enumerated
circumstances to receive a presumption of service connection.
While the commenters are correct in that VA does not require a
minimum level or duration of exposure for some previously-established
presumptions, VA notes that these regulations serve to provide
presumptive service connection based on the specified and particular
exposures, conditions, and nature of military service in accordance
with the scientific and other evidence supporting them. They do not set
a binding precedent for future rulemakings that address unrelated
circumstances. For example, while presumptive service connection for
certain disabilities occurring in Persian Gulf veterans does not
require a minimum exposure during military service, 38 CFR 3.317
requires that the qualifying chronic disability must manifest to a
degree of 10 percent or more no later than December 31, 2021. This
regulation, though, does not require conditions associated with
exposure to contaminants in the water supply at Camp Lejeune to
manifest by a certain date. Similarly, 38 CFR 3.311 specifies that
disabilities presumed to be associated with exposure to ionizing
radiation must manifest within certain time periods after exposure to
radiation (the time period varies depending on the condition in
question). Nothing in this regulation requires a condition associated
with exposure to contaminants in the water supply at Camp Lejeune to
manifest within a certain period of time following service.
In addition to being based on different scientific, medical, and
military evidence, the prior toxic exposure regulations often stem from
a specific, separate statutory authority or requirement. These statutes
prescribe the method by which the Secretary may create a regulatory
presumption, to include the evidentiary basis for establishing a
presumption, periods in which a disability must manifest, covered
disabilities, how the Secretary shall determine that a condition is
associated with a given toxic exposure, and other requirements specific
to the toxic exposure under review. For example, the statutory
authority to award presumptive service connection for certain
disabilities associated with herbicide exposure in the Republic of
Vietnam prescribes the dates during which the veteran must have served
within the Republic of Vietnam. See 38 U.S.C. 1116. Similarly, 38
U.S.C. 1117 prescribes the requirements for eligibility for benefits
associated with service in the Persian Gulf War. Notably, this statute
also grants the Secretary the authority to determine the period of time
following service during which a qualifying disability must manifest.
See 38 U.S.C. 1117(b).
In the case of this regulation, Congress did not enact a specific
statute authorizing the Secretary to establish compensation for
disabilities presumptively related to exposure to contaminants in the
water supply at Camp Lejeune. While creating this presumption via
regulation fits within the authority conferred by section 501, the
Secretary's rulemaking actions must have a rational basis. The
Secretary has determined that, in the absence of evidence establishing
an appropriate period of time for an exposure requirement, the soundest
course is to maintain consistency with the Camp Lejeune Act, which
establishes eligibility for VA health care for Camp Lejeune veterans
who meet applicable criteria, including a 30-day service requirement.
See 38 U.S.C. 1710(e)(1)(F), 38 CFR 17.400. This will help to avoid
public confusion and inconsistent results, for example where some Camp
Lejeune veterans would be eligible for a presumption for purposes of
disability compensation, but not the statutory presumption for health
care benefits.
2. Modality of Exposure to Contaminants
Comments from DAV and Legal Counsel for the Elderly stated that
failure to consider periods of service shorter than 30 days ignores the
likelihood of regular and repeated exposure to contaminants through
multiple modalities. The commenters noted that the National Research
Council (NRC) explored three major routes of exposure to contaminants:
Inhalation, skin contact, and ingestion. The NRC's 2009 study noted
that doses of contaminants from showering could provide inhalation and
dermal exposures that are equivalent to ingesting two liters of water,
as water temperature impacted the volatility of the contaminants.
Accordingly, commenters argued that when taking into account multiple
modalities of exposure, the exposure to contaminants could be much
greater in a shorter time period than compared to 30 days of drinking
the water. This comment was echoed by several individual commenters.
As noted in the proposed rule, the Technical Working Group's (TWG)
assessment relied on a hazard evaluation model, focusing on the
strength of the evidence that a chemical is capable of causing a given
health condition. The TWG did not take into account estimated levels of
contamination in the water during the period of contamination at Camp
Lejeune or the estimated length or intensity of exposure. This is in
part because contaimination levels and exposures were not well
documented. For example, the 2009 NRC committee was ``not aware of any
historical information that documents individual water-use patterns and
behaviors of residents of base housing.'' Committee on Contaminated
Drinking Water at Camp Lejeune; National Research Council, Contaminated
Water Supplies at Camp Lejeune, Assessing Potential Health Effects 61
(National Academies Press, 2009). Accordingly, the TWG did not
characterize the risk associated with potential alternative levels of
exposure (to include various modalities of exposure) of those who
served or resided at Camp Lejeune during the period of contamination.
It is also relevant to note that the scientific evidence was not
analyzed by
[[Page 4176]]
VA for sufficiency to support an expert opinion in a legal proceeding
regarding causation in any individual case. Therefore, VA intimates no
conclusion regarding any individual veteran's development of a disease
and its relationship to exposure to contaminated water at Camp Lejeune
for any purpose beyond entitlement to disability benefits administered
by VA.
In the notice of proposed rulemaking, VA acknowledged that the
available scientific evidence does not provide data on levels of
exposure associated with each condition and proposed to rely upon the
30-day service requirement contained in the provisions of the Camp
Lejeune Act. In the absence of scientific evidence which supports
establishment of an alternative service or exposure requirement, VA's
determination favors consistency and parity with its own health care
regulation and the statute stands. Congress understood the Camp Lejeune
Act to mean that ``veterans deserve the presumptions of the service
connection in the bill to ensure that they receive the benefits to
which they are due,'' and did not specify that a different service
requirement should exist for purposes of disability compensation. 158
Cong. Rec. H5430 (July 31, 2012) (statement by Rep. Dingell). Creation
of a separate standard for the purposes of disability compensation
would create inconsistency in the administration of benefits for Camp
Lejeune veterans where the statute includes a clear service requirement
for health care eligibility; inclusion of the 30-day requirement
ensures consistency and parity in this regard with both the Camp
Lejeune Act and VA's own regulations implementing the health care
provisions of the act. For example, including a service requirement
less than that in the Camp Lejeune Act could lead to the situation
wherein a veteran is determined to be ineligible for VA health care on
the grounds that he or she did not have the necessary 30 days of
service at Camp Lejeune, but is then granted service connection on a
presumptive basis based on the same service at Camp Lejuene upon filing
a claim for compensation. A veteran in this situation could, via
operation of this presumption, become eligible for VA health care based
on their service connection rating, even though he or she would not
have been eligible under the 30-day service requirement of the Camp
Lejeune Act. This confusing result could raise a question as to whether
VA had indirectly contravened a portion of the Camp Lejeune Act by
virtue of a liberalizing evidentiary presumption meant for compensation
claims.
One commenter expressed concern with the 30-day requirement because
the individual had documentation stating that his or her length of stay
at Camp Lejeune was four weeks (which would be 28 days if read
strictly). The individual noted that Department of Defense
documentation sometimes references weeks of training, rather than days
of training and expressed concern with personal and administrative
burden associated with documenting presence on base for a day or two
before and/or after training. As stated above, VA is adopting a 30-day
requirement to ensure consistency with the Camp Lejeune Act. In
adjudicating individual claims, VA is required to assist claimants in
obtaining evidence and to resolve reasonable doubt in claimants' favor.
Thus, while VA acknowledges and thanks the commenters for their
input, VA is unable to make any changes based upon these comments at
this time. However, VA will continue to review relevant information as
it becomes available and will consider future amendments to the 30-day
requirement as appropriate.
3. Decide Claims Through Tort Law
Another commenter felt that the statutory 30-day requirement lacked
a medical basis and felt that veterans' claims should be handled
through tort law rather than the disability claim process. VA notes
that the 30-day requirement for health care benefits was established by
Congress. Furthermore, the presumptions set forth in this rulemaking
are for the purposes of administering VA disability compensation
benefits only; VA expresses no view regarding the potential correlation
between any given level or duration of exposure and the increased risk
of disease and/or disability for any purpose beyond this rulemaking.
Accordingly, VA takes no action based on this comment.
4. Eliminate 30-Day Requirement for Health Care
Another commenter stated that VA should not require 30 days of
service at Camp Lejeune to establish entitlement to health care
benefits. The service requirement to establish entitlement to health
care is mandated by the Camp Lejeune Act. The Camp Lejeune Act is a
statute, the provisions of which were enacted by Congress. VA lacks the
legal authority to alter, amend, or otherwise change the provisions of
a statute and therefore takes no action based on this comment. We
discuss the difference in scope between the Camp Lejeune Act and this
final rule in greater detail in section D.1, below.
5. Conduct Additional Studies on Exposure Requirements
A comment from VFW stated that VA should conduct additional studies
to cover the impact of exposure on individuals who served less than 30
days, with the ultimate goal of reducing the 30-day exposure
requirement. VA thanks VFW for its suggestion regarding conducting
additional studies. However, this rulemaking pertains solely to
establishing presumptions of service connection associated with
exposure to contaminants in the water supply at Camp Lejeune;
conducting scientific and/or medical studies is beyond the scope of
this rulemaking. As such, VA makes no change to the final rule based on
this comment.
6. Miscellaneous Alternative Exposure Requirement Comments
VA received several comments offering additional alternative
minimum exposure requirements, with suggestions including a single day
at Camp Lejeune and an increase to 90 days. While these comments
offered alternative exposure criteria, they did not provide a rationale
for the suggested alternative that was rooted in scientific, medical,
or other rational basis.
As discussed above, the notice of proposed rulemaking acknowledged
that the current science does not support a specific minimum exposure
level for any of the conditions, as the available scientific and
medical evidence focused on hazard models when studying the long-term
health effects of the contaminants. Lacking such a scientific basis, VA
relied upon the only source available in deciding to establish a 30-day
exposure requirement: The Camp Lejeune Act. As VA acknowledged in the
notice of proposed rulemaking, the Camp Lejeune Act does not provide a
legal requirement for prescribing a 30-day service requirement for the
purposes of disability compensation. However, the Camp Lejeune Act and
VA's prior implementation of its provisions require 30 days of service
at Camp Lejeune for a veteran to establish entitlement to health care.
See 38 CFR 17.400. In light of the Camp Lejeune Act, VA's
implementation of its provisions through 38 CFR 17.400, and the lack of
an alternative exposure requirement supported by scientific, medical,
or other rational evidence, VA determined that inclusion of the 30-day
requirement in this rulemaking ensures consistency
[[Page 4177]]
and parity with both its health care regulations and the statute.
Without a rational basis to explain and support an alternative
exposure requirement, VA's rulemaking would not comply with the
statutory requirements of 38 U.S.C. 501 and therefore takes no action
based on these comments. VA will continue to review relevant
information as it becomes available and will consider future changes to
the regulation as appropriate.
VA notes that nothing in the provisions of this rule prevents
veterans without the requisite 30 days (consecutive or nonconsecutive)
of service at Camp Lejeune from establishing service connection for any
disease or disability on a direct basis. Direct service connection for
any disease alleged to have been caused by the contaminants in the
water supply at Camp Lejeune requires evidence of a current disease or
disability, evidence of exposure to contaminated water at Camp Lejeune,
and a medical nexus between the two, supported by a sufficient medical
explanation.
B. Definition of Service at Camp Lejeune
VA received seven comments concerning the definition of service at
Camp Lejeune for the purposes of establishing entitlement to disability
benefits on a presumptive basis, as contained in proposed Sec.
3.307(f)(7)(iii). These comments suggested that the rule make reference
to specific locations within the borders of Camp Lejeune, some of which
may be considered satellite camps/locations. One commenter noted that
veterans may have lived in one of the specified satellite camps/
locations while assigned to Camp Lejeune, or vice versa. Another
commenter stated that listing specific satellite locations included
within the definition of Camp Lejeune would avoid confusion for
eligible veterans and minimize the risk of improper denials by claims
processors who may not be aware of the satellite camps/locations. One
commenter stated that the proposed rule did not include Marine Corps
Air Station New River. Legal Counsel for the Elderly stated the
presumption should extend to those who served in circumstances
``likely'' to have resulted in exposure to contaminants in the water
supply at Camp Lejeune. This comment gave examples of those who served
in training exercises or ships outside of Camp Lejeune but ``likely''
used water drawn from Camp Lejeune. An additional comment referenced
Navy Amphibious Forces that docked at Camp Lejeune and most likely took
on board fresh water from the Camp.
VA makes no change based on these comments. As stated in the
proposed rule, VA broadly defined service at Camp Lejeune as any
service within the borders of the entirety of the United States Marine
Corps Base Camp Lejeune and Marine Corps Air Station New River, North
Carolina, during the period beginning on August 1, 1953, and ending on
December 31, 1987, as established by military orders or other official
service department records. This definition is consistent with the Camp
Lejeune Act and VA's prior implementation of the act, promulgated at 38
CFR 17.400. To ensure accurate and consistent application of the
definition of service at Camp Lejeune, VA will administratively provide
claims processors with all necessary factual and background information
to process claims in accordance with this regulation.
Marine Corps Air Station (MCAS) New River, while located within the
borders of the entirety of Camp Lejeune, falls under a separate command
from Camp Lejeune itself. VA identified MCAS New River as a separate
location as military orders or other official service department
records may specifically denote service at or assignment to MCAS New
River; failure to specify this location may result in improper denials
of claims or create confusion for otherwise eligible veterans. VA notes
that service at MCAS Cherry Point, which is geographically separate
from Camp Lejeune (approximately 55 miles away), has a separate water
source, and is under a separate command structure, does not meet the
definition of service at Camp Lejeune for purposes of this rulemaking.
VA notes that the definition of service at Camp Lejeune relies on
military orders or other official service department records to
establish that an individual had service at Camp Lejeune for the
purposes of entitlement to presumptive service connection based on
exposure to contaminants in the water supply. As discussed in the
proposed rule, the 2007 United States General Accounting Office (GAO)
study found that the contaminated water supply systems served housing,
administrative, and recreational facilities, as well as the base
hospital at Camp Lejeune. See U.S. General Accounting Office, Defense
Health Care: Activities Related to Past Drinking Water Contamination at
Marine Corps Base Camp Lejeune (2007). Neither the GAO nor any other
available study indicated that individuals who served aboard amphibious
vessels were exposed to contaminants found in the water supply at Camp
Lejeune. Without evidence in official service department records
documenting official orders or assignment to serve, either in an
individual capacity or as part of a larger unit, at Camp Lejeune, a
claimant does not meet the evidentiary standard for presumptive service
connection. As such, without military orders or other official service
department records reflecting service at Camp Lejeune, veterans, former
reservists or National Guard members who served aboard vessels that
docked at Camp Lejeune during the period of contamination are not
eligible for presumptive service connection under the provisions of
this rule.
As stated in the proposed rule, veterans without the requisite 30
days (consecutive or nonconsecutive) of service at Camp Lejeune,
including those who allege exposure aboard amphibious vessels without
military orders or other official service department records reflecting
assignment to serve at Camp Lejeune, may still establish service
connection for any disease or disability on a direct basis. Direct
service connection for any disease alleged to have been caused by the
contaminants in the water supply at Camp Lejeune requires evidence of a
current disease or disability, evidence of exposure to contaminated
water at Camp Lejeune, and a medical nexus between the two, supported
by a sufficient medical explanation.
C. Benefits for Former Reservists and National Guard Members
VA received five comments regarding benefits for former reservists
and National Guard members. One commenter stated that VA should define
what benefits are available to reservists under the rule, noting that
the rule states reservists would be entitled to ``some'' benefits under
the rulemaking. Similarly, another commenter stated that VA does not
consider reservists and former National Guard members ``veterans''
unless they have a service-connected disability. Another commenter
noted that reserve and National Guard status does not meet the
requirements of 38 CFR 3.6, and urged VA to amend other regulations to
eliminate any conflict for applying presumptions of disability to
reserve and National Guard members. Finally, one commenter stated that
the rule does not include reservists and asked for VA to amend the
rulemaking to include reservists.
As stated in the proposed rule, basic eligibility for VA benefits
requires that an individual be a ``veteran'' as that term is defined in
38 U.S.C. 101(2). Reserve duty during a period of active
[[Page 4178]]
duty for training or inactive duty for training generally does not
qualify an individual as a ``veteran,'' because it does not constitute
``active military, naval, or air service,'' unless the person is
disabled or dies during that period of service as prescribed by 38
U.S.C. 101(24)(B) and (C). However, under this rule, former reservists
and National Guard members meeting the service criteria for presumptive
service connection based on exposure to contaminants at Camp Lejeune
have veteran status for the purpose of entitlement to service
connection for the enumerated disabilities; there is no limitation of
benefits to former reservists and National Guard members under this
rule. VA makes no change based upon these comments.
Another commenter stated that VA's inclusion of former reservists
and National Guard members in the rulemaking stretches Congressional
intent with regards to the definition of ``veteran.'' The commenter
also suggested that Congress should provide guidance on the definition
of a veteran, and that VA is underestimating the financial impact of
this rule. As explained in the proposed rule, although 38 U.S.C.
101(24) requires a period of active duty for training or inactive duty
training ``during which the individual was disabled or died'' for this
period to constitute active military, naval, or air service, this
statute was enacted at a time when the latent effects of exposures to
certain harmful chemicals were unrecognized. Further, the legislative
history behind this statute does not specifically explain Congress'
intent in requiring that the individual ``was disabled or died'' during
the period of service in question. As section 101(24) serves a
generally beneficial purpose to recognize certain reserve and National
Guard service which results in disability or death as affording veteran
status for the purposes of VA disability benefits, and in light of
increased medical understanding of the possible latent effects of toxic
exposure, VA feels it is reasonable to include former reservists and
National Guard members with qualifying service under this rule.
Accordingly, VA makes no change based upon this comment.
D. Comments Pertaining to Presumptive Disabilities
VA received several comments regarding the disabilities included in
the proposed rulemaking. These comments fell into two basic categories:
One group related to the general differences between the disabilities
in the proposed rule and the health care provisions in the Camp Lejeune
Act, while the other comments focused on individual disabilities.
1. Presumptive Disabilities Differ From the Camp Lejeune Act
VA received 42 comments, including from VVA, NOVA, and Legal
Counsel for the Elderly, regarding the disabilities in our proposed
rulemaking and the disabilities listed in the Camp Lejeune Act. The
commenters noted that VA's proposed rulemaking contained fewer and
different conditions than the Camp Lejeune Act, with several commenters
urging VA to adopt the list of disabilities in the Camp Lejeune Act in
its entirety, without change. One commenter stated that veterans who
develop a condition listed in the health care provisions of the Camp
Lejeune Act but not listed as a presumptive disability would be denied
compensation benefits for conditions for which health care is being
provided. For the reasons enumerated below, VA makes no change based on
these comments.
As explained in the proposed rule, the Camp Lejeune Act provides
medical care, but not compensation benefits, to veterans who served on
active duty at Camp Lejeune for the 15 identified conditions
``notwithstanding that there is insufficient medical evidence to
conclude that such illnesses or conditions are attributable to such
service.'' VA's more recent review of scientific evidence was
undertaken to determine the appropriateness of establishing
presumptions of service connection for claimants who served at Camp
Lejeune. As noted in the proposed rulemaking, this review included the
analysis of several hazard evaluations on the chemicals of interest
conducted by multiple bodies of scientific experts and was not an
evaluation of the specific risks of exposure to contaminated water at
Camp Lejeune. VA's review resulted in the recognition that liver cancer
and Parkinson's disease, two diseases that were not included in the
Camp Lejeune Act, are conditions for which there is strong evidence of
a causal relationship and evidence that the condition may be caused by
exposure to the contaminants. However, at this time, VA concludes that
there is insufficient evidence to establish presumptions of service
connection for the following diagnosed chronic disabilities in the Camp
Lejeune Act: Esophageal cancer, lung cancer, breast cancer,
neurobehavioral effects, and scleroderma. As noted in the notice of
proposed rulemaking, none of the evidence reviewed concluded that there
is a positive association between these conditions and the volatile
organic compounds of interest. The exclusion of scleroderma is
addressed separately in the next section.
Additionally, the health care provisions of the Camp Lejeune Act
provide medical coverage for health effects that are not themselves
diagnosed diseases or clearly associated with a specific diagnosed
disease. To establish that disability arising years after service is
associated with harmful exposure in service, the evidence generally
must show that the disability results from a disease associated with
the in-service exposure. Accordingly, in Sec. 3.307, VA has
established presumptions of service connection for specific diseases,
as distinguished from general health effects that may result from
specific diseases but are not themselves diseases. The available
scientific evidence did not identify a specific or general diagnosis of
disease associated with renal toxicity or hepatic steatosis, conditions
which are included in the provisions of the Camp Lejeune Act.
Finally, the Camp Lejeune Act included health care for female
infertility and miscarriage. However, as noted in the proposed rule,
the NRC's 2009 report indicated that the occurrence of female
infertility and miscarriage were limited to exposure concurrent with
those health effects. As such, the inclusion of these conditions in the
Camp Lejeune Act does not provide a basis at this time for presuming
current health effects of this type to be associated with past
exposure. Additionally, as stated in the proposed rule, these two
conditions are not in and of themselves disabilities for which VA can
provide disability compensation.
Accordingly, as noted by one commenter, an outcome of VA's review
of the available scientific evidence, to include additional evidence
that did not exist at the time the Camp Lejeune Act was passed, may
result in situations where an individual receives VHA health care for a
covered condition without an associated copayment under the Camp
Lejeune Act, but is not eligible for presumptive service connection for
disability compensation for that condition under this rulemaking. While
these individuals may not be eligible for presumptive service
connection under this rulemaking, they may be eligible for direct
service connection for any disease alleged to have been caused by the
contaminants in the water supply at Camp Lejeune, including a disease
or disability covered under the Camp Lejeune Act. As noted earlier in
section B, direct service connection requires
[[Page 4179]]
evidence of a current disease or disability, evidence of exposure to
contaminated water at Camp Lejeune, and a medical nexus between the
two, supported by a sufficient medical explanation. Conversely, it is
similarly possible that a condition not exempted from copayment under
the Camp Lejeune Act, such as liver cancer or Parkinson's disease,
could be granted presumptive service connection pursuant to this final
rule. We note that a grant of service connection for such a condition
would exempt treatment associated with that condition from copayment
requirements, as VA copayments do not apply to treatment of service
connected disabilities. A grant of presumptive service connection could
also create an alternative basis for enrollment in the VA health care
system. See 38 CFR 17.36.
VA will continue to review relevant information as it becomes
available and will consider future additions to the list of covered
conditions as appropriate.
In addition to suggesting that VA should provide disability
compensation for the conditions in the Camp Lejeune Act, one commenter
suggested that, alternatively, VA should change the provisions of the
Camp Lejeune Act to match the eight disabilities covered in the
proposed rule. The Camp Lejeune Act is a statute, the provisions of
which were enacted by Congress. VA lacks the legal authority to alter,
amend, or otherwise change the provisions of a statute and therefore
takes no action based on this comment.
2. Exclusion of Scleroderma as a Presumptive Disability
Eight commenters, including the Project on Government Oversight,
Legal Counsel for the Elderly, and a member of Congress, specifically
questioned VA's exclusion of scleroderma as a presumptive disability.
These commenters noted that scleroderma was included in the health care
provisions of the Camp Lejeune Act and suggested that VA specifically
include this condition as a presumptive disability. Additionally, the
comment from a member of Congress stated that there was modest causal
evidence from the Agency for Toxic Substances and Disease Registry
(ATSDR) and the economic impact of including scleroderma would be
minimal, as the number of Camp Lejeune veterans suffering from this
condition is small.
As explained in the proposed rule, due to the lack of new
scientific/medical evidence (outside of the available evidence
considered by the TWG) linking any of the contaminants found in the
water supply with the development of scleroderma specifically, VA
cannot create a presumption of service connection for Camp Lejeune
veterans at this time. Though the available evidence has established a
role for trichloroethylene (TCE) in the development of autoimmune
diseases, the studies that specifically report on scleroderma include
factors that introduce significant uncertainty into their results, to
include small sample sizes and an unexplained gender effect. Although
the science does not at this time support the addition of scleroderma
to the list of covered diseases, VA will continue to monitor and review
future studies as they become available and will consider future
additions to the list of covered diseases as appropriate.
3. Inclusion of Neurobehavioral Effects and Parkinsonism
VA received eight comments regarding the issue of neurobehavioral
effects and parkinsonism, including an organizational comment from the
United Parkinson's Advocacy Council. Three commenters stated the
presumptive disabilities should include neurobehavioral effects, with
one commenter specifying inclusion of specific types of neurobehavioral
effects. Another commenter suggested that VA include ``Parkinson-like''
symptoms as a presumptive disability under the general diagnosis of
neurobehavioral effects. The third commenter asked if parkinsonism was
included under the definition of Parkinson's disease. Another commenter
stated that there is no way to definitively diagnose Parkinson's
disease. The United Parkinson's Advocacy Council stated VA should
include ``atypical parkinsonism'' in the rulemaking.
Parkinson's disease was included in the list of presumptive
disabilities due to a recommendation made by the Institute of Medicine
(IOM) in their 2015 report ``Review of VA Clinical Guidance for the
Health Conditions Identified by the Camp Lejeune Legislation.'' The IOM
noted that Parkinson's disease is a specific neurobehavioral effect
that may be experienced by individuals exposed to the contaminants in
the water supply at Camp Lejeune.
Parkinson's disease is medically distinguishable and separately
diagnosable from a variety of parkinsonian syndromes, including drug-
induced parkinsonism and neurodegenerative diseases, such as multiple
systems atrophy, which have parkinsonian features combined with other
abnormalities. Most notably, the pathologic findings in cases of
parkinsonism show different patterns of brain injury than those noted
in patients with Parkinson's disease. See Institute of Medicine of the
National Academies, Veterans and Agent Orange: Update 2012, The
National Academies Press (Washington, DC, 2014). The studies that have
established a relationship between the contaminants in the water supply
at Camp Lejeune and Parkinson's disease reported specifically on
Parkinson's disease, not parkinsonism or other parkinsonian syndromes.
At this time, the available evidence does not establish that
parkinsonism and other manifestations of small fiber nerve damage are
associated with exposure to the contaminants in the water supply at
Camp Lejeune. Therefore, VA makes no change based on these comments.
4. Adult Leukemia
VA received 12 comments, including from the Project on Government
Oversight and VFW, and one from a member of Congress, addressing the
condition of adult leukemia. The commenters stated that VA should
clarify the disabilities included in adult leukemia by changing the
term to ``leukemia,'' ``adult leukemias,'' or by listing all sub-types
of leukemia included in the definition of adult leukemia. A comment
from a member of Congress specifically cited an ATSDR report, which
noted all leukemia sub-types are associated with exposure to
contaminants in the water supply at Camp Lejeune. The same member of
Congress also stated the use of ``adult leukemia'' was unnecessary
because all who qualify for this benefit are adults, as the rulemaking
does not apply to dependents. Another commenter stated that VA should
replace the term ``adult leukemia'' with ``chronic or acute forms of
lymphocytic and myeloid leukemia'' to clarify what conditions are
covered. VA disagrees and makes no change based on these comments.
The term ``adult leukemia'' clarifies that the types of leukemia
covered under this rulemaking must have their onset in adulthood. This
distinction between adult and non-adult leukemias is necessary, as the
disability compensation provided by this rulemaking applies only to
disabilities arising in veterans, reservists, or National Guard members
as a result of their exposure to contaminants in the water supply at
Camp Lejeune while serving under official military orders or other
official assignment. As such, the presumptions of this rulemaking do
not apply to veterans, reservists or National Guard members who develop
leukemia
[[Page 4180]]
prior to qualifying service at Camp Lejeune.
The use of the term ``adult leukemia'' was not intended to restrict
the types of leukemia covered by this rulemaking. No sub-type of
leukemia was identified in the rulemaking in order to be inclusive to
all types of leukemia, including the sub-types identified by
commenters. VA notes that inclusion of specific sub-types included
within this definition will lead to an incomplete list, potentially
confusing veterans, reservists and National Guard members who have a
qualifying disability, as well as claims processors.
5. Miscellaneous Disabilities
VA received 53 comments, including organizational comments from the
Fort McClellan Veterans Stakeholders Group, which requested inclusion
of miscellaneous conditions and disabilities, both specified and
unspecified, that were not the subject of the proposed rulemaking, nor
were they included in the provisions of the Camp Lejeune Act. These
conditions include: Hodgkin's disease, diabetes mellitus, depression,
sleep apnea, throat cancer, fibroid sarcoma, prostate cancer, colon
cancer, brain cancer, mesothelioma, soft tissue sarcoma, gynecomastia,
prolactemia, Crohn's disease, amyloidosis, hidradenitis suppurativa,
immune system toxicity, gastrointestinal cancers, other unspecified
immune system effects, unspecified neurologic disorders, unspecified
skin conditions, unspecified endocrine disorders, unspecified cellular
mutation, cancerous and non-cancerous urinary tract conditions,
unspecified kidney effects, unspecified liver effects, unspecified
endocrine effects, unspecified cardiovascular disorders, and
unspecified cancers. Additionally some commenters stated that VA should
include additional disabilities without specifying those additions. Two
commenters stated that VA should consider all diseases and disabilities
as associated with exposure to contaminants in the water supply at Camp
Lejeune, noting that VA should bear the burden of proof as to why any
disability is unrelated to exposure to contaminants at Camp Lejeune.
Another commenter suggested inclusion of conditions not identified by
scientific evidence. Finally, one commenter cited a decision by the
Board of Veterans' Appeals (BVA) as sufficient evidence to support
adding prostate cancer to the list of presumptive disabilities. The
same commenter also stated VA should consider adding hepatitis C,
noting a correlation between it and prostate cancer.
As stated in the proposed rule, VA undertook a deliberative
scientific process to determine whether available scientific evidence
was sufficient to support a presumption of service connection for any
health condition as a result of exposure to the chemicals found in the
drinking water at Camp Lejeune. This process involved an evaluation of
comprehensive hazard studies conducted by several internationally
respected expert bodies. VA also notes that BVA decisions are made on
the facts, circumstances, and evidence of individual claims on a case-
by-case basis; these cases do not set precedent. At this time, there is
insufficient medical and scientific evidence to establish a presumption
of service connection for any disability beyond the eight conditions
included in the rulemaking; therefore, VA makes no change in response
to these comments at this time.
VA relies heavily on studies of exposed populations in order to
establish such an association, and will continue to monitor future
studies, especially those conducted on the Camp Lejeune population, as
they become available. VA will consider additions to the list of
presumptive disabilities as appropriate, should future studies provide
sufficient evidence for such a change.
As previously discussed, it is also relevant to note that the
scientific evidence was not analyzed by VA for sufficiency to support
an expert opinion in a legal proceeding regarding causation in any
individual case. Therefore, VA intimates no conclusion regarding any
individual veteran's development of a disease and its relationship to
exposure to contaminated water at Camp Lejeune.
6. Kidney Cancer
One commenter asked why VA is not recognizing kidney cancer as a
presumptive disability. As noted in the proposed rule under amended
Sec. 3.309(f), kidney cancer is one of the listed conditions VA
recognizes as presumptively associated with exposure to contaminants in
the water at Camp Lejeune. VA makes no change based upon this comment.
E. Effective Date
VA received 27 comments, including from the C-123 Veterans
Association, VFW, and NOVA, concerning the effective date of the
regulation. Comments included suggestions that this rule should be
effective the date a claim was initially filed, even if prior to the
effective date of the final rule, or on the date of onset or diagnosis
of a covered illness. Other commenters stated the rule should be
effective retroactively to the date an eligible veteran first served at
Camp Lejeune. Some commenters stated that the rule excludes previously
denied claims, and therefore VA should apply the provisions of the
Nehmer v. U.S. Department of Veterans Affairs (Nehmer) court order to
determine a retroactive effective date for awards. See Nehmer v. U.S.
Department of Veterans Affairs, No. CV-86-6161 TEH (N.D. Cal.). One
commenter suggested that the rule should be effective the date the
proposed rule was published, as it should have been published as an
interim final rule. Finally, one commenter asked if a ``pending'' claim
includes the one-year period following notice of a denial as well as
appeals before the BVA.
As stated in the proposed rule, this rule will apply to claims
received by VA on or after the effective date of the final rule and to
claims pending before VA on that date. Under 38 CFR 3.160(c), a claim
that has not been finally adjudicated (which includes claims where a
final and binding decision has been issued but the appeal period has
not expired) is still considered a pending claim. The rule does not
apply retroactively to claims that are finally adjudicated. VA must
adhere to the provisions of its change of law regulation, 38 CFR 3.114,
which states that where pension, compensation, dependency and indemnity
compensation is awarded or increased pursuant to a liberalizing law, or
a liberalizing VA issue approved by the Secretary or by the Secretary's
direction, the effective date of such award or increase shall be fixed
in accordance with the facts found, but shall not be earlier than the
effective date of the act or administrative issue. See also 38 U.S.C.
5110(g).
This final regulation is based on the Secretary's broad authority
under 38 U.S.C. 501(a) to ``prescribe all rules and regulations which
are necessary or appropriate to carry out the laws administered by the
Department and are consistent with those laws, including-- . . .
regulations with respect to the nature and extent of proof and evidence
. . . in order to establish the right to benefits under such laws.''
This rulemaking authority does not explicitly afford the Secretary
authority to assign retroactive effect to the regulations created
thereunder, and retroactivity is heavily disfavored in the law. As
explained in the proposed rule, a claimant whose claim was previously
and finally denied may file a new claim to obtain a new determination
of
[[Page 4181]]
entitlement under the final regulation. Finally, VA notes that the
effective date provisions of the Nehmer court order apply only to
claims based on exposure to herbicides in the Republic of Vietnam
during the Vietnam era and are therefore inapplicable to this final
rule.
The Administrative Procedures Act (APA) provides guidance as to
when a rulemaking may be published as an interim final rule. Under the
APA, a rulemaking may be published as an interim final rule if it is
determined that notice and public comment ``are impracticable,
unnecessary, or contrary to the public interest.'' 5 U.S.C.
553(b)(3)(B). As this rulemaking involves significant economic costs,
the opportunity for prior review and comment was necessary and in
accordance with the public interest. VA has acted expeditiously to
consider these public comments and prepare a final rulemaking.
Therefore, VA makes no changes based on these comments.
F. Date Range for Contamination
One commenter stated the date range for exposure should be extended
without specifying exact dates. The commenter stated that contamination
likely still existed even after the water supply met unspecified
Environmental Protection Agency (EPA) standards. Similarly, VVA stated
the contamination period should be extended until December 31, 2000,
the last day of the year that the Navy removed contaminated soil and
other items from the sites surrounding Camp Lejeune. Another commenter
stated the background information in the proposed rule regarding
contamination was incorrect; this commenter stated that contamination
ended in 1987 and the initial contamination warnings were in 1980.
Another commenter stated VA should expand the date range to include
those who served from January 1, 1947, through July 31, 1953, without
further elaboration.
As stated in the proposed rule, the Camp Lejeune Act specified a
period of contamination from August 1, 1953, through December 31, 1987.
This date range is likely based on some of the earliest assessments of
the Camp Lejeune water supply noted in the NRC report. This period also
represents the ATSDR's best estimate of the period of contamination at
Camp Lejeune. In the absence of additional scientific evidence to
support an expansion of the contamination period, VA makes no change
based upon these comments at this time.
G. Additional Contaminants
VA received two comments regarding consideration of additional
contaminants. One commenter stated that VA should include information
about unspecified lead contamination during the 1990s. The commenter
also requested inclusion of information contained in an unspecified
1997 study. Another commenter stated that VA's assessment of
contaminants is incomplete, as it does not consider toxic compounds
outside those noted in the rulemaking.
As stated in the proposed rule, VA is only addressing the
contamination of the water supplies by the four chemicals of interest
(i.e., TCE, perchloroethylene (PCE), benzene, and vinyl chloride) that
occurred between August 1, 1953, and December 31, 1987, as a result of
on-base industrial activities and an off-base dry cleaning facility.
Exposure events unrelated to the specified date range and sources of
contamination are unrelated to the subject and scope of this
rulemaking; therefore VA makes no change in response to this comment.
H. Additional Scientific or Medical Evidence
Two commenters stated that VA should reference additional, uncited
studies, stating the rulemaking should consider the effects of exposure
to solvent mixtures. One commenter stated VA should reference an
unspecified study of the individuals who were actually exposed to
contaminants in the water supply at Camp Lejeune. Another commenter,
the Fort McClellan Veterans Stakeholders Group, without further
elaboration, stated that VA uses the wrong method to evaluate toxic
exposures. VA also received a comment stating that unspecified evidence
exists to possibly support the addition of more disabilities. One
commenter stated that the NRC did not perform a study, it merely
reviewed available literature, and the 2009 NRC is flawed and outdated.
This same commenter also stated that the description of the
collaboration between ATSDR, VA's Camp Lejeune Science Liaison Team,
and VA's Technical Workgroup (TWG) was incorrect. The commenter stated
that the community was not directly involved in this collaboration.
Another commenter stated it was unclear which ATSDR studies were
considered in the rulemaking. Other commenters stated generally that
inclusion or performance of additional studies could result in a larger
list of presumptive disabilities. Finally, one commenter stated that a
source with the Center for Disease Control stated it is impossible to
determine the minimum level of exposure to a contaminant needed to
result in negative health effects.
VA currently has no information at its disposal to define the
specific hazardous exposure levels or combinations of exposure that any
one individual received, which would determine exactly who in the
veteran population might be at an increased risk of experiencing
adverse health effects related to their service at Camp Lejeune. As
explained in the proposed rule, the VA review consisted of a hazard
evaluation for the four chemicals of interest: TCE, PCE, benzene and
vinyl chloride, and focused on the effects of these individual
contaminants without regard to specific exposure levels. Additionally,
as explained in the rulemaking, VA reviewed evidence from several
internationally recognized scientific authorities, including groups
other than the NRC. Regarding the description of the process employed
by ATSDR, VA notes that ATSDR is an external entity and, as such, is
not subject to VA's control. VA also notes that the notice of proposed
rulemaking contains a full list of scientific studies and reviews cited
in the rulemaking in section E, ``Weight-of-Evidence Analyses
Considered by the TWG.''
VA's rule is as inclusive as possible in covering the illnesses of
veterans, former reservists and National Guard members exposed to
contaminants in the water supply at Camp Lejeune based on the available
scientific evidence, in the absence of specific exposure information.
VA makes no change based on these comments.
I. Expedite Rulemaking
VA received 17 comments, including an organizational comment from
VFW, urging VA to expedite the rulemaking, to include publication of a
final rule under which benefits may be granted. VA must adhere to the
requirements of the APA, which includes a period for public comment and
review of the rulemaking. VA appreciates these comments and has taken
the necessary steps to ensure this rule is finalized while conforming
to the legal requirements of notice and comment rulemaking.
J. Benefits for Veterans Born at Camp Lejeune Without Service at Camp
Lejeune
One commenter asked if the rule provides compensation for veterans
who were born at Camp Lejeune but do not have qualifying active duty,
reserve, or National Guard service at Camp Lejeune. VA is only
authorized to pay disability compensation for disability
[[Page 4182]]
resulting from injury suffered or disease contracted in line of duty
``in the active military, naval, or air service''. 38 U.S.C. 1110,
1131. Thus, VA has no authority to pay compensation for disability
arising from events prior to service entry. VA makes no change based
upon this comment.
K. Standard of Evidence for Claims
One commenter stated that the proposed rulemaking would still
require eligible veterans, former reservists and National Guard members
to present a medical opinion in support of their claim for a
presumptive disability. As stated in the proposed rulemaking, if a
veteran, former reservist or National Guard member meets the stated
requirements for service at Camp Lejeune, then the subsequent
development of any of the eight listed disabilities is presumed to be
related to the exposure to contaminants, in the absence of clear and
convincing evidence to the contrary. These presumptions do not require
any further evidence to support a claim, including a medical opinion.
Therefore, VA makes no change based on this comment.
Another commenter stated that the proposed rule makes no reference
for individual genetic predisposition to increased vulnerability to a
specific toxin. The commenter stated this places an unrealistic burden
of proof on an individual to prove that he or she suffers a disability
due to exposure to toxins. VA has no information at its disposal to
define the specific hazardous exposure any individual received, which
could assist in determining who in the veteran population was or would
be at an increased risk of suffering adverse health effects related to
their service at Camp Lejeune. Furthermore, once the basic eligibility
requirements of this rule are met (qualifying service and diagnosis of
a listed disability), no further information, to include evidence of a
genetic vulnerability to a specific toxin, is necessary. Therefore, VA
makes no change based on this comment.
Two commenters asked if a medical opinion that served as the basis
of a previous denial could serve as affirmative evidence to rebut the
presumption created by this rule. The circumstances of individual
claims are beyond the scope of this rulemaking and VA makes no change
based upon this comment. However, VA notes that 38 CFR 3.307(d), which
pertains to rebuttal of presumptive service connection, specifically
requires consideration of all evidence of record when determining the
issue of presumptive service connection. As noted above, a claimant
whose claim was previously and finally denied may file a new claim to
obtain a new determination of entitlement under the final regulation.
All claims are adjudicated individually based upon the entire
evidentiary record and in accordance with all applicable regulations.
Legal Counsel for the Elderly stated that VA should allow for a
veteran's lay testimony to establish the occurrence of exposure to
contaminants in the water supply at Camp Lejeune. VA will consider all
evidence of record when deciding claims, including lay testimony.
However, VA notes that current regulations provide very specific
circumstances as to when a veteran's lay testimony is sufficient to
establish an occurrence for the purposes of entitlement to disability
benefits. For example, a veteran's lay testimony may be sufficient to
establish the occurrence of an injury or event that occurred during
combat, if that testimony is consistent with the circumstances,
conditions, or hardships of that veteran's service, even where no
official record of such incurrence exists. The purpose of this lay
statement exception is to acknowledge certain circumstances where
official records likely will not exist to establish a fact; in this
example, it is highly unlikely that medical records will exist to
document the occurrence of an injury at the time it occurred during
combat. In the present rulemaking, establishing service at Camp Lejeune
requires documentation of 30 days of service at Camp Lejeune by
military orders or other official service department records. These
documents are regularly and routinely issued by the military as a part
of its normal duties in documenting personnel assignments and location
and are a part of every servicemember's personnel file. As the evidence
required to establish service at Camp Lejeune, and therefore satisfy
the condition necessary to presume exposure to contaminants in the
water supply, is readily available, VA makes no change based upon this
comment.
Similarly, one commenter stated VA should provide a ``benefit of
the doubt'' to anyone who served at Camp Lejeune in the 1980s. As
stated in the rule, this presumption of service connection applies to
any veteran, to include former reserve and National Guard members, who
served at Camp Lejeune during the relevant time period. This
presumption reduces the evidentiary burden required to establish
entitlement to disability compensation for certain claims, as further
explained in the notice of proposed rulemaking. VA makes no change
based upon this comment.
L. Benefits for Family Members or Civilians
VA received 11 comments, including an organizational comment from
the United Parkinson's Advocacy Council, stating that family members or
civilians who were exposed to contaminants in the water supply at Camp
Lejeune should receive disability compensation. VA notes that this
rulemaking provides disability compensation for qualifying veterans,
former reservists or National Guard members; benefits for family
members or civilians are beyond the scope of the rulemaking and
therefore VA will not respond to this comment. Additionally, VA notes
that there is currently no statutory authority to provide benefits to
the classes of people identified by the commenters.
M. General Support for the Rulemaking
VA received 56 comments, including from the C-123 Veterans
Association, DAV, VFW, VVA, Project on Government Oversight, Reserve
Officers Association, Marine Corps Reserve Association, United
Parkinson's Advocacy Council, and Legal Counsel for the Elderly,
expressing support for the rulemaking in general. Many of these
comments, which were received from individuals as well as organizations
in the veteran community, stated appreciation for VA's actions in
establishing a presumption of exposure and service connection for
veterans, reservists, and National Guard members exposed to
contaminants in the water supply at Camp Lejeune. VA appreciates the
time and effort expended by these commenters in reviewing the proposed
rule and in submitting comments, as well as their support for this
rulemaking.
N. Negative Comments
VA received five comments indicating opposition to the rulemaking.
These comments expressed disagreement with the rulemaking process in
general, and presumptive service connection in particular. VA's
decision to create a presumption of exposure to contaminants in the
water supply at Camp Lejeune and presumptive service connection for the
listed disabilities was issued after the Secretary considered the
available scientific evidence and recommendations, as explained in the
notice of proposed rulemaking. This evidence demonstrated at least an
association between the contaminants in the water supply at Camp
Lejeune and the eight listed disabilities. This evidence is supported
by published reports from multiple internationally-recognized
authorities, and the
[[Page 4183]]
Secretary has determined this evidence provides a rational basis to
issue regulations for presumptions of exposure and service connection.
Accordingly, VA makes no change based on these comments.
O. Character of Discharge and Eligibility for Benefits
One commenter stated that individuals with an other than honorable
discharge are excluded from eligibility under this rulemaking. This
rulemaking amends 38 CFR 3.307 and 3.309; it does not affect the
provisions of 38 CFR 3.12, which pertains to the character of discharge
requirements for benefits eligibility. Therefore, this comment is
outside the scope of the rulemaking and VA makes no change based on it.
P. Statements About Personal Claims
As stated previously, many commenters made general statements about
their own experiences with one or more of the presumptive disabilities,
non-presumptive disabilities, their personal disability claims, or
their personal health care claims. Comments regarding situations
involving the possible outcome of individual claims, or the medical or
claims history presented by individual veterans are beyond the scope of
this rulemaking. Claimants should contact their VA regional office for
assistance with their individual claims.
Q. Other Comments Unrelated to or Outside the Scope of This Rulemaking
VA received 30 comments dealing with issues not directly related to
the new presumption of exposure or the new presumptively service-
connected diseases. Such comments covered a wide range of topics;
examples of such comments appear below.
One commenter stated that VA needs to update the VA Schedule for
Rating Disabilities, noting that the criteria used to evaluate the
diseases covered under this rulemaking are subjective. Another
commenter stated that VA should evaluate individuals who were
previously denied as 100 percent disabled. One commenter stated that VA
should provide a zero-percent evaluation for any veteran, reservist, or
former National Guard member who served at Camp Lejeune during the
qualifying period. Two commenters stated that VA should provide health
care in addition to disability compensation for veterans, reservists,
and former National Guard members contemplated under this rulemaking.
Two commenters stated that the rule does not include a mechanism for
notifying eligible veterans who may be unaware of their exposure to
contaminants in the water supply at Camp Lejeune. Similarly, VFW stated
VA should provide notification to claimants who were previously denied
benefits. VFW also stated that VA should update the Catalog of Federal
Domestic Assistance titles in the rulemaking to indicate the
eligibility to additional benefits available to reservists and National
Guard members as a result of the rulemaking. Another commenter urged VA
to change the health care priority group level for reservists and
National Guard members. Another comment stated that the same standards
of evidence used to prosecute a corporation that harms an individual
with toxic chemicals should be re-introduced in this rulemaking. Two
commenters, including the Fort McClellan Veterans Stakeholders Group
and the Project on Government Oversight, stated VA should pay benefits
to veterans who served at Fort McClellan. Another commenter asked what
effect this rulemaking has on the Camp Lejeune Act or House Resolution
3954--The Camp Lejeune Reservist Parity Act of 2015. One commenter
stated the government uses members of the armed forces as guinea pigs
for vaccines that have not been approved by the Food and Drug
Administration. VA received one comment that stated this policy change
does not protect the rights of veterans. Another commenter stated that
the contamination is a violation of the 5th Amendment rights of those
who were exposed and stated the base should be evacuated. Six
commenters, including the Reserve Officers Association, requested that
VA create or add their information to unspecified lists/registries.
Another commenter stated that Parkinson's disease should have been
specifically listed as a neurobehavioral effect. One commenter stated
that VA should use available scientific evidence to ``dismantle'' the
provisions of other exposure presumptions, such as benefits related to
radiation exposure. The same commenter stated that the presumption of
soundness does not apply to National Guard or reserve members who did
not undergo physical examination during active duty. Finally, this
commenter stated that VA should consider National Guard and reserve
members as exposed to herbicides while serving in Canada. Another
commenter asked if VA would provide compensation to private insurers
for treatment of a covered disability. Without elaborating further, one
commenter stated the proposal is too limited in scope and took too long
to enact; a similar comment was received stating that the rule does not
provide ``sufficient redress.'' Another commenter stated VA should
cover the cost of in-vitro fertilization or adoption for veterans
experiencing female infertility. One commenter, the Reserve Officers
Association, urged Congress to enact additional legislation. A comment
from VFW suggested VA study the combined effects of exposure to
herbicides and contaminants in the water supply at Camp Lejeune.
Another commenter stated that there is nothing in writing that pertains
to the individuals who were stationed at Camp Lejeune. VA received a
comment stating that VA should provide former Marines with the Purple
Heart. One individual stated that qualifying individuals should receive
a blanket settlement from the government.
VA does not respond to these comments because they are either
unrelated to this rulemaking or beyond its scope.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, and other advantages; distributive impacts;
and equity). Executive Order 13563 (Improving Regulation and Regulatory
Review) emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Executive Order 12866 (Regulatory Planning and Review) defines a
``significant regulatory action,'' requiring review by the Office of
Management and Budget (OMB), unless OMB waives such review, as ``any
regulatory action that is likely to result in a rule that may: (1) Have
an annual effect on the economy of $100 million or more or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or communities; (2)
Create a serious inconsistency or otherwise interfere with an action
taken or planned by another agency; (3) Materially alter the budgetary
impact of entitlements, grants, user fees, or loan programs or the
rights and obligations of recipients thereof; or (4) Raise novel legal
or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in this Executive Order.''
[[Page 4184]]
The economic, interagency, budgetary, legal, and policy
implications of this regulatory action have been examined, and it has
been determined to be a significant regulatory action under Executive
Order 12866 because it is likely to result in a rule that may have an
annual effect on the economy of $100 million or more and may raise
novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in this Executive
Order. VA's impact analysis can be found as a supporting document at
http://www.regulations.gov, usually within 48 hours after the
rulemaking document is published. Additionally, a copy of this
rulemaking and its impact analysis are available on VA's Web site at
http://www.va.gov/orpm/, by following the link for ``VA Regulations
Published from FY 2004 Through Fiscal Year to Date.''
Regulatory Flexibility Act
The Secretary hereby certifies that these regulatory amendments
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). These amendments will directly affect only individuals
and will not directly affect small entities. Therefore, pursuant to 5
U.S.C. 605(b), these amendments are exempt from the regulatory
flexibility analysis requirements of sections 603 and 604.
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 such effect on
State, local, and tribal governments, or on the private sector.
Paperwork Reduction Act
This final rule contains no provisions constituting a collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).
Congressional Review Act
Generally, under the Administrative Procedure Act, the required
publication of a substantive rule shall be made not less than 30 days
before its effective date. 5 U.S.C. 553(d). However, this regulatory
action is a major rule under the Congressional Review Act, 5 U.S.C.
801-808, because it may result in an annual effect on the economy of
$100 million or more. Therefore, in accordance with 5 U.S.C. 801(a)(1),
VA will submit to the Comptroller General and to Congress a copy of
this regulatory action and VA's Regulatory Impact Analysis. Provided
Congress does not adopt a joint resolution of disapproval, this rule
will become effective the later of the date occurring 60 days after the
date on which Congress receives the report, or the date the rule is
published in the Federal Register. 5 U.S.C. 801(a)(3)(A).
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance numbers and titles for
the programs affected by this document are 64.109, Veterans
Compensation for Service-Connected Disability; 64.110, Veterans
Dependency and Indemnity Compensation for Service-Connected Death.
Signing Authority
The Secretary of Veterans Affairs, or designee, approved this
document and authorized the undersigned to sign and submit the document
to the Office of the Federal Register for publication electronically as
an official document of the Department of Veterans Affairs. Gina S.
Farrisee, Deputy Chief of Staff, Department of Veterans Affairs,
approved this document on November 16, 2016, for publication.
Dated: January 9, 2017.
Michael Shores,
Acting Director, Regulation Policy & Management, Office of the
Secretary, Department of Veterans Affairs.
List of Subjects in 38 CFR Part 3
Administrative practice and procedure, Claims, Disability benefits,
Veterans.
For the reasons stated in the preamble, the Department of Veterans
Affairs amends 38 CFR part 3 as follows:
PART 3--ADJUDICATION
Subpart A--Pension, Compensation, and Dependency and Indemnity
Compensation
0
1. The authority citation for part 3, subpart A, continues to read as
follows:
Authority: 38 U.S.C. 501(a), unless otherwise noted.
0
2. Amend Sec. 3.307 by revising the section heading and paragraphs (a)
introductory text and (a)(1), and adding paragraph (a)(7) to read as
follows:
Sec. 3.307 Presumptive service connection for chronic, tropical, or
prisoner-of-war related disease, disease associated with exposure to
certain herbicide agents, or disease associated with exposure to
contaminants in the water supply at Camp Lejeune; wartime and service
on or after January 1, 1947.
(a) General. A chronic, tropical, or prisoner of war related
disease, a disease associated with exposure to certain herbicide
agents, or a disease associated with exposure to contaminants in the
water supply at Camp Lejeune listed in Sec. 3.309 will be considered
to have been incurred in or aggravated by service under the
circumstances outlined in this section even though there is no evidence
of such disease during the period of service. No condition other than
one listed in Sec. 3.309(a) will be considered chronic.
(1) Service. The veteran must have served 90 days or more during a
war period or after December 31, 1946. The requirement of 90 days'
service means active, continuous service within or extending into or
beyond a war period, or which began before and extended beyond December
31, 1946, or began after that date. Any period of service is sufficient
for the purpose of establishing the presumptive service connection of a
specified disease under the conditions listed in Sec. 3.309(c) and
(e). Any period of service is sufficient for the purpose of
establishing the presumptive service connection of a specified disease
under the conditions listed in Sec. 3.309(f), as long as the period of
service also satisfies the requirements to establish a presumption of
exposure to contaminants in the water supply at Camp Lejeune under
paragraph (a)(7)(iii) of this section.
* * * * *
(7) Diseases associated with exposure to contaminants in the water
supply at Camp Lejeune. (i) For the purposes of this section,
contaminants in the water supply means the volatile organic compounds
trichloroethylene (TCE), perchloroethylene (PCE), benzene and vinyl
chloride, that were in the on-base water-supply systems located at
United States Marine Corps Base Camp Lejeune, during the period
beginning on August 1, 1953, and ending on December 31, 1987.
(ii) The diseases listed in Sec. 3.309(f) shall have become
manifest to a degree of 10 percent or more at any time after service.
(iii) A veteran, or former reservist or member of the National
Guard, who had no less than 30 days (consecutive or nonconsecutive) of
service at Camp Lejeune during the period beginning on
[[Page 4185]]
August 1, 1953, and ending on December 31, 1987, shall be presumed to
have been exposed during such service to the contaminants in the water
supply, unless there is affirmative evidence to establish that the
individual was not exposed to contaminants in the water supply during
that service. The last date on which such a veteran, or former
reservist or member of the National Guard, shall be presumed to have
been exposed to contaminants in the water supply shall be the last date
on which he or she served at Camp Lejeune during the period beginning
on August 1, 1953, and ending on December 31, 1987. For purposes of
this section, service at Camp Lejeune means any service within the
borders of the entirety of the United States Marine Corps Base Camp
Lejeune and Marine Corps Air Station New River, North Carolina, during
the period beginning on August 1, 1953, and ending on December 31,
1987, as established by military orders or other official service
department records.
(iv) Exposure described in paragraph (a)(7)(iii) of this section is
an injury under 38 U.S.C. 101(24)(B) and (C). If an individual
described in paragraph (a)(7)(iii) of this section develops a disease
listed in Sec. 3.309(f), VA will presume that the individual concerned
became disabled during that service for purposes of establishing that
the individual served in the active military, naval, or air service.
* * * * *
0
3. Add Sec. 3.309(f) to read as follows:
Sec. 3.309 Disease subject to presumptive service connection.
* * * * *
(f) Disease associated with exposure to contaminants in the water
supply at Camp Lejeune. If a veteran, or former reservist or member of
the National Guard, was exposed to contaminants in the water supply at
Camp Lejeune during military service and the exposure meets the
requirements of Sec. 3.307(a)(7), the following diseases shall be
service-connected even though there is no record of such disease during
service, subject to the rebuttable presumption provisions of Sec.
3.307(d).
(1) Kidney cancer.
(2) Liver cancer.
(3) Non-Hodgkin's lymphoma.
(4) Adult leukemia.
(5) Multiple myeloma.
(6) Parkinson's disease.
(7) Aplastic anemia and other myelodysplastic syndromes.
(8) Bladder cancer.
[FR Doc. 2017-00499 Filed 1-12-17; 8:45 am]
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