Diseases Associated With Exposure to Contaminants in the Water Supply at Camp Lejeune, 4173-4185 [2017-00499]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[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 
https://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 
https://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]
BILLING CODE 8320-01-P