82_FR_4182 82 FR 4173 - Diseases Associated With Exposure to Contaminants in the Water Supply at Camp Lejeune

82 FR 4173 - Diseases Associated With Exposure to Contaminants in the Water Supply at Camp Lejeune

DEPARTMENT OF VETERANS AFFAIRS

Federal Register Volume 82, Issue 9 (January 13, 2017)

Page Range4173-4185
FR Document2017-00499

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.

Federal Register, Volume 82 Issue 9 (Friday, January 13, 2017)
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Rules and Regulations]
[Pages 4173-4185]
From the Federal Register Online  [www.thefederalregister.org]
[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]
BILLING CODE 8320-01-P



                                                                      Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations                                                4173

                                                  Thus, increasing the current civil                      Unfunded Mandates Reform Act of 1995                   § 401.101   Criminal penalty.
                                                  penalty amount would not result in an                                                                             (a) A person, as described in
                                                                                                            The Unfunded Mandates Reform Act
                                                  annual effect on the economy of $100                                                                           § 401.101(b) who violates a regulation is
                                                                                                          of 1995, Public Law 104–4, requires
                                                  million or more.                                                                                               liable to a civil penalty of not more than
                                                                                                          agencies to prepare a written assessment
                                                                                                          of the cost, benefits and other effects of             $90,063.
                                                  Regulatory Flexibility Act
                                                                                                          proposed or final rules that include a                 *      *     *     *    *
                                                    We have also considered the impacts                   Federal mandate likely to result in the                  Issued on December 30, 2016.
                                                  of this notice under the Regulatory                     expenditure by State, local, or tribal                 Carrie Lavigne,
                                                  Flexibility Act. I certify that this rule               governments, in the aggregate, or by the               Chief Counsel.
                                                  will not have a significant economic                    private sector, of more than $100                      [FR Doc. 2016–32050 Filed 1–12–17; 8:45 am]
                                                  impact on a substantial number of small                 million annually. Because this rule will
                                                                                                                                                                 BILLING CODE 4910–61–P
                                                  entities. The following provides the                    not have a $100 million effect, no
                                                  factual basis for this certification under              Unfunded Mandates assessment will be
                                                  5 U.S.C. 605(b). The St. Lawrence                       prepared.
                                                  Seaway Regulations and Rules primarily                                                                         DEPARTMENT OF VETERANS
                                                                                                          Executive Order 12778 (Civil Justice                   AFFAIRS
                                                  relate to the activities of commercial
                                                                                                          Reform)
                                                  users of the Seaway, the vast majority of                                                                      38 CFR Part 3
                                                  whom are foreign vessel operators.                         This rule does not have a retroactive
                                                  Therefore, any resulting costs will be                  or preemptive effect. Judicial review of               RIN 2900–AP66
                                                  borne mostly by foreign vessels.                        a rule based on this proposal may be
                                                                                                          obtained pursuant to 5 U.S.C. 702. That                Diseases Associated With Exposure to
                                                  Executive Order 13132 (Federalism)                      section does not require that a petition               Contaminants in the Water Supply at
                                                                                                          for reconsideration be filed prior to                  Camp Lejeune
                                                     Executive Order 13132 requires
                                                  SLSDC to develop an accountable                         seeking judicial review.                               AGENCY:    Department of Veterans Affairs.
                                                  process to ensure ‘‘meaningful and                      Paperwork Reduction Act                                ACTION:   Final rule.
                                                  timely input by State and local officials
                                                  in the development of regulatory                          In accordance with the Paperwork                     SUMMARY:   The Department of Veterans
                                                  policies that have federalism                           Reduction Act of 1980, we state that                   Affairs (VA) amends its adjudication
                                                                                                          there are no requirements for                          regulations regarding presumptive
                                                  implications.’’ ‘‘Policies that have
                                                                                                          information collection associated with                 service connection, adding certain
                                                  federalism implications’’ is defined in
                                                                                                          this rulemaking action.                                diseases associated with contaminants
                                                  the Executive Order to include
                                                  regulations that have ‘‘substantial direct              Privacy Act                                            present in the base water supply at U.S.
                                                  effects on the States, on the relationship                                                                     Marine Corps Base Camp Lejeune
                                                                                                            Please note that anyone is able to                   (Camp Lejeune), North Carolina, from
                                                  between the national government and
                                                                                                          search the electronic form of all                      August 1, 1953, to December 31, 1987.
                                                  the States, or on the distribution of
                                                                                                          comments received into any of our                      This final rule establishes that veterans,
                                                  power and responsibilities among the                    dockets by the name of the individual
                                                  various levels of government.’’ Under                                                                          former reservists, and former National
                                                                                                          submitting the comment (or signing the                 Guard members, who served at Camp
                                                  Executive Order 13132, the agency may                   comment, if submitted on behalf of an
                                                  not issue a regulation with Federalism                                                                         Lejeune for no less than 30 days
                                                                                                          association, business, labor union, etc.).             (consecutive or nonconsecutive) during
                                                  implications, that imposes substantial                  You may review DOT’s complete                          this period, and who have been
                                                  direct compliance costs, and that is not                Privacy Act Statement in the Federal                   diagnosed with any of eight associated
                                                  required by statute, unless the Federal                 Register published on April 11, 2000                   diseases, are presumed to have incurred
                                                  government provides the funds                           (Volume 65, Number 70; Pages 19477–                    or aggravated the disease in service for
                                                  necessary to pay the direct compliance                  78), or you may visit http://dms.dot.gov.              purposes of entitlement to VA benefits.
                                                  costs incurred by State and local                                                                              In addition, this final rule establishes a
                                                  governments, the agency consults with                   List of Subjects in 33 CFR Part 401
                                                                                                                                                                 presumption that these individuals were
                                                  State and local governments, or the                       Hazardous materials transportation,                  disabled during the relevant period of
                                                  agency consults with State and local                    Navigation (water), Penalties, Radio,                  service for purposes of establishing
                                                  officials early in the process of                       Reporting and recordkeeping                            active military service for benefits
                                                  developing the proposed regulation.                     requirements, Vessels, Waterways.                      purposes. Under this presumption,
                                                     This rule will not have substantial                    Accordingly, the Saint Lawrence                      affected former reservists and National
                                                  direct effects on the States, on the                    Seaway Development Corporation is                      Guard members have veteran status for
                                                  relationship between the national                       amending 33 CFR part 401 as follows:                   purposes of entitlement to some VA
                                                  government and the States, or on the                                                                           benefits. This amendment implements a
                                                  distribution of power and                               PART 401—SEAWAY REGULATIONS                            decision by the Secretary of Veterans
                                                  responsibilities among the various                      AND RULES                                              Affairs that service connection on a
                                                  levels of government, as specified in                                                                          presumptive basis is warranted for
                                                  Executive Order 13132.                                  Subpart A—Regulations                                  claimants who served at Camp Lejeune
                                                                                                                                                                 during the relevant period and for the
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                     The reason is that this rule will                    ■ 1. The authority citation for subpart A
                                                  generally apply to commercial users of                                                                         requisite amount of time and later
                                                                                                          of part 401 is amended to read as                      develop certain diseases.
                                                  the Seaway, the vast majority of whom                   follows:
                                                  are foreign vessel operators. Therefore,                                                                       DATES: Effective Date: This final rule is
                                                  any resulting costs will be borne mostly                  Authority: 33 U.S.C. 981–990, 1231 and               effective March 14, 2017.
                                                                                                          1232, 49 CFR 1.52, unless otherwise noted.
                                                  by foreign vessels. Thus, the                                                                                  FOR FURTHER INFORMATION CONTACT: Eric
                                                  requirements of Section 6 of the                        ■ 2. In § 401.102, paragraph (a) is                    Mandle, Policy Analyst, Regulations
                                                  Executive Order do not apply.                           revised to read as follows:                            Staff (211D), Compensation Service,


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                                                  4174                Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations

                                                  Department of Veterans Affairs, 810                     II. Summary of Major Provisions                        IV. Public Comments
                                                  Vermont Avenue NW., Washington, DC                                                                                On September 9, 2016, VA published
                                                  20420, (202) 461–9700. (This is not a                     The major provisions of this final rule
                                                                                                          include the following: VA will amend                   in the Federal Register (81 FR 62419) a
                                                  toll-free telephone number.)                                                                                   notice of a proposed rulemaking to
                                                                                                          38 CFR 3.307 to establish presumptions
                                                  SUPPLEMENTARY INFORMATION:                              of service connection associated with                  amend 38 CFR 3.307 and 3.309 to
                                                                                                          exposure to contaminants in the water                  establish presumptive service
                                                  I. Purpose of the Final Rule                                                                                   connection for certain diseases
                                                                                                          supply at Camp Lejeune. This
                                                                                                                                                                 associated with contaminants present in
                                                     VA amends its adjudication                           amendment presumes exposure to
                                                                                                                                                                 the base water supply at U.S. Marine
                                                  regulations to add certain diseases                     contaminants in the water supply at
                                                                                                                                                                 Corps Base Camp Lejeune, North
                                                  associated with contaminants present in                 Camp Lejeune for all active duty,
                                                                                                                                                                 Carolina, from August 1, 1953 to
                                                  the base water supply at U.S. Marine                    reserve, and National Guard personnel
                                                                                                                                                                 December 31, 1987. VA provided a 30-
                                                  Corps Base Camp Lejeune, North                          who served for no less than 30 days                    day public comment period, which
                                                  Carolina, from August 1, 1953, to                       (consecutive or nonconsecutive) at                     ended on October 11, 2016, and
                                                  December 31, 1987. This final rule                      Camp Lejeune during the period                         received 290 comments on the proposed
                                                  establishes that veterans, former                       beginning August 1, 1953, and ending                   rule, one of which was received after the
                                                  reservists, and former National Guard                   on December 31, 1987. This                             comment period. Although VA is not
                                                  members, who served at Camp Lejeune                     presumption specifically allows former                 legally required to consider late-filed
                                                  for no less than 30 days (consecutive or                reservists and National Guard members                  comments, it has reviewed, considered,
                                                  nonconsecutive) during this period and                  to establish veteran status by presuming               and addressed all comments received in
                                                  who have been diagnosed with any of                     that a covered disease was incurred in                 the interest of maximizing public
                                                  eight associated diseases, are presumed                 the line of duty and was disabling                     dialogue to further serve veterans,
                                                  to have incurred or aggravated the                      during a period of qualifying service.                 claimants, and authorized
                                                  disease in service for purposes of
                                                                                                            VA will also amend 38 CFR 3.309 to                   representatives. VA received comments
                                                  entitlement to VA benefits. In addition,
                                                                                                          prescribe the eight conditions that are                from various organizations and
                                                  this final rule establishes a presumption
                                                                                                          subject to presumptive service                         individuals, including Disabled
                                                  that these individuals were disabled
                                                                                                          connection in relation to exposure to                  American Veterans (DAV), Veterans of
                                                  during the relevant period of service for
                                                                                                          contaminants in the water supply at                    Foreign Wars (VFW), Vietnam Veterans
                                                  purposes of establishing active military
                                                                                                          Camp Lejeune.                                          of America (VVA), National
                                                  service for benefits purposes. Under this
                                                                                                                                                                 Organization of Veterans’ Advocates
                                                  presumption, affected former reservists                 III. Technical Correction                              (NOVA), C–123 Veterans Association,
                                                  and National Guard members have
                                                                                                                                                                 Fort McClellan Veterans Stakeholders
                                                  veteran status for purposes of                             In the proposed rule, VA proposed
                                                                                                                                                                 Group, Reserve Officers Association,
                                                  entitlement to some VA benefits.                        amending the heading of 38 CFR 3.307
                                                                                                                                                                 Marine Corps Reserve Association,
                                                     Section 501(a)(1) of title 38, United                to read ‘‘Presumptive service connection
                                                                                                                                                                 United Parkinson’s Advocacy Council,
                                                  States Code, provides that ‘‘[t]he                      for chronic, tropical or prisoner-of-war
                                                                                                                                                                 Legal Counsel for the Elderly, Project on
                                                  Secretary has authority to prescribe all                related disease, disease associated with
                                                                                                                                                                 Government Oversight, a member of
                                                  rules and regulations which are                         exposure to certain herbicide agents, or
                                                                                                                                                                 Congress, and other interested persons.
                                                  necessary or appropriate to carry out the               disease associated with the                            VA responds to all commenters as
                                                  laws administered by [VA] and are                       contaminants in the water supply at                    follows.
                                                  consistent with those laws, including                   Camp Lejeune; wartime and service on                      All of the issues raised by the
                                                  . . . regulations with respect to the                   or after January 1, 1947.’’ Additionally,              commenters that concerned at least one
                                                  nature and extent of proof and evidence                 VA proposed amending paragraph (a) of                  portion of the rule can be grouped
                                                  and the method of taking and furnishing                 § 3.307 to mirror the title. In reviewing              together by similar topic, and VA has
                                                  them in order to establish the right to                 this amendment for the final rule,                     organized the discussion of the
                                                  benefits under such laws.’’ This broad                  however, VA realized that the current                  comments accordingly. VA also
                                                  authority encompasses the                               and proposed text of paragraph (a)                     received 85 comments from veterans
                                                  establishment of an evidentiary                         contain errors. Namely, they refer to a                and surviving spouses regarding
                                                  presumption of service connection and                   ‘‘chronic, tropical, prisoner of war                   individual claims for veterans’ benefits.
                                                  exposure under specified                                related disease’’ rather than a ‘‘chronic,             VA does not respond to these comments
                                                  circumstances, provided there is a                      tropical or prisoner of war related                    in this document as they are beyond the
                                                  rational basis for the presumptions. In                 disease,’’ as referenced in the heading of             scope of this rulemaking.
                                                  this case, the Secretary has determined                 § 3.307. Additionally, the heading and                    For the reasons set forth in the
                                                  that proof of qualifying service at Camp                proposed text omitted the words                        proposed rule and below, VA adopts the
                                                  Lejeune, consistent with Public Law                     ‘‘exposure to’’ before ‘‘contaminants in               proposed rule as final, with changes, as
                                                  112–154, the Honoring America’s                         the water supply.’’ This document                      explained below.
                                                  Veterans and Caring for Camp Lejeune                    corrects these errors by inserting ‘‘or’’ in
                                                  Families Act of 2012 (Camp Lejeune                      place of the comma between ‘‘tropical’’                A. 30-Day Exposure Requirement
                                                  Act), and the subsequent development                    and ‘‘prisoner of war’’ in paragraph (a)                  VA received 18 comments, including
                                                  of one of the eight listed diseases is                  to clarify that the terms ‘‘chronic,’’                 organizational comments from DAV,
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  sufficient to support the presumption                   ‘‘tropical,’’ and ‘‘prisoner of war                    VVA, NOVA, Project on Government
                                                  that the resulting disease was incurred                 related’’ refer to three separate                      Oversight, and Legal Counsel for the
                                                  in the line of duty during active                       categories of disease rather than                      Elderly, regarding its proposal that a
                                                  military, naval, or air service, to include             characteristics of a single disease; and               veteran, or former reservist or National
                                                  qualifying reserve or National Guard                    inserting ‘‘exposure to’’ in the heading               Guard member must serve no less than
                                                  service, to establish entitlement to                    and paragraph (a) in the phrase                        30 days (consecutive or nonconsecutive)
                                                  service connection. See 38 U.S.C. 1110                  pertaining to contaminants in the water                at Camp Lejeune during the period
                                                  and 1131.                                               supply at Camp Lejeune.                                beginning August 1, 1953, and ending


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                                                                      Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations                                          4175

                                                  on December 31, 1987, to receive a                      require conditions associated with                     help to avoid public confusion and
                                                  presumption of service connection for                   exposure to contaminants in the water                  inconsistent results, for example where
                                                  the eight listed diseases based on                      supply at Camp Lejeune to manifest by                  some Camp Lejeune veterans would be
                                                  exposure to contaminants in the water                   a certain date. Similarly, 38 CFR 3.311                eligible for a presumption for purposes
                                                  supply. Two commenters suggested                        specifies that disabilities presumed to                of disability compensation, but not the
                                                  changing the exposure requirement to                    be associated with exposure to ionizing                statutory presumption for health care
                                                  one week and two weeks, respectively;                   radiation must manifest within certain                 benefits.
                                                  neither commenter offered a rationale                   time periods after exposure to radiation
                                                                                                                                                                 2. Modality of Exposure to
                                                  for these time limits. Several                          (the time period varies depending on
                                                                                                                                                                 Contaminants
                                                  commenters suggested eliminating the                    the condition in question). Nothing in
                                                  exposure requirement completely,                        this regulation requires a condition                      Comments from DAV and Legal
                                                  noting that the 30-day requirement was                  associated with exposure to                            Counsel for the Elderly stated that
                                                  inconsistent with other toxic exposure                  contaminants in the water supply at                    failure to consider periods of service
                                                  presumptions and that it was not                        Camp Lejeune to manifest within a                      shorter than 30 days ignores the
                                                  supported with scientific evidence. One                 certain period of time following service.              likelihood of regular and repeated
                                                  commenter stated that the 30-day                           In addition to being based on different             exposure to contaminants through
                                                  requirement would essentially exclude                   scientific, medical, and military                      multiple modalities. The commenters
                                                  National Guard members from                             evidence, the prior toxic exposure                     noted that the National Research
                                                  eligibility. One commenter stated that a                regulations often stem from a specific,                Council (NRC) explored three major
                                                  30-day exposure requirement would                       separate statutory authority or                        routes of exposure to contaminants:
                                                  exclude veterans serving in the Naval                   requirement. These statutes prescribe                  Inhalation, skin contact, and ingestion.
                                                  Amphibious Force who docked at Camp                     the method by which the Secretary may                  The NRC’s 2009 study noted that doses
                                                  Lejeune.                                                create a regulatory presumption, to                    of contaminants from showering could
                                                                                                          include the evidentiary basis for                      provide inhalation and dermal
                                                  1. Comparison to Prior Exposure                         establishing a presumption, periods in                 exposures that are equivalent to
                                                  Regulations                                             which a disability must manifest,                      ingesting two liters of water, as water
                                                     VA received several comments,                        covered disabilities, how the Secretary                temperature impacted the volatility of
                                                  including from DAV, NOVA, VVA,                          shall determine that a condition is                    the contaminants. Accordingly,
                                                  Legal Counsel for the Elderly, and                      associated with a given toxic exposure,                commenters argued that when taking
                                                  Project on Government Oversight,                        and other requirements specific to the                 into account multiple modalities of
                                                  stating that a 30-day exposure period is                toxic exposure under review. For                       exposure, the exposure to contaminants
                                                  inconsistent with VA’s requirements for                 example, the statutory authority to                    could be much greater in a shorter time
                                                  presumptive service connection based                    award presumptive service connection                   period than compared to 30 days of
                                                  on toxic and other exposures. For                       for certain disabilities associated with               drinking the water. This comment was
                                                  example, VA has previously established                  herbicide exposure in the Republic of                  echoed by several individual
                                                  regulations governing presumptive                       Vietnam prescribes the dates during                    commenters.
                                                  service connection for diseases                         which the veteran must have served                        As noted in the proposed rule, the
                                                  associated with exposure to certain                     within the Republic of Vietnam. See 38                 Technical Working Group’s (TWG)
                                                  herbicide agents and certain disabilities               U.S.C. 1116. Similarly, 38 U.S.C. 1117                 assessment relied on a hazard
                                                  occurring in Persian Gulf veterans. See                 prescribes the requirements for                        evaluation model, focusing on the
                                                  38 CFR 3.307, 3.309, and 3.317. These                   eligibility for benefits associated with               strength of the evidence that a chemical
                                                  regulations do not include a minimum                    service in the Persian Gulf War.                       is capable of causing a given health
                                                  exposure requirement; a veteran must                    Notably, this statute also grants the                  condition. The TWG did not take into
                                                  show that he or she served in an                        Secretary the authority to determine the               account estimated levels of
                                                  identified location or under enumerated                 period of time following service during                contamination in the water during the
                                                  circumstances to receive a presumption                  which a qualifying disability must                     period of contamination at Camp
                                                  of service connection.                                  manifest. See 38 U.S.C. 1117(b).                       Lejeune or the estimated length or
                                                     While the commenters are correct in                     In the case of this regulation, Congress            intensity of exposure. This is in part
                                                  that VA does not require a minimum                      did not enact a specific statute                       because contaimination levels and
                                                  level or duration of exposure for some                  authorizing the Secretary to establish                 exposures were not well documented.
                                                  previously-established presumptions,                    compensation for disabilities                          For example, the 2009 NRC committee
                                                  VA notes that these regulations serve to                presumptively related to exposure to                   was ‘‘not aware of any historical
                                                  provide presumptive service connection                  contaminants in the water supply at                    information that documents individual
                                                  based on the specified and particular                   Camp Lejeune. While creating this                      water-use patterns and behaviors of
                                                  exposures, conditions, and nature of                    presumption via regulation fits within                 residents of base housing.’’ Committee
                                                  military service in accordance with the                 the authority conferred by section 501,                on Contaminated Drinking Water at
                                                  scientific and other evidence supporting                the Secretary’s rulemaking actions must                Camp Lejeune; National Research
                                                  them. They do not set a binding                         have a rational basis. The Secretary has               Council, Contaminated Water Supplies
                                                  precedent for future rulemakings that                   determined that, in the absence of                     at Camp Lejeune, Assessing Potential
                                                  address unrelated circumstances. For                    evidence establishing an appropriate                   Health Effects 61 (National Academies
                                                  example, while presumptive service                      period of time for an exposure                         Press, 2009). Accordingly, the TWG did
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                                                  connection for certain disabilities                     requirement, the soundest course is to                 not characterize the risk associated with
                                                  occurring in Persian Gulf veterans does                 maintain consistency with the Camp                     potential alternative levels of exposure
                                                  not require a minimum exposure during                   Lejeune Act, which establishes                         (to include various modalities of
                                                  military service, 38 CFR 3.317 requires                 eligibility for VA health care for Camp                exposure) of those who served or
                                                  that the qualifying chronic disability                  Lejeune veterans who meet applicable                   resided at Camp Lejeune during the
                                                  must manifest to a degree of 10 percent                 criteria, including a 30-day service                   period of contamination.
                                                  or more no later than December 31,                      requirement. See 38 U.S.C.                                It is also relevant to note that the
                                                  2021. This regulation, though, does not                 1710(e)(1)(F), 38 CFR 17.400. This will                scientific evidence was not analyzed by


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                                                  4176                Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations

                                                  VA for sufficiency to support an expert                 presumption meant for compensation                     scope between the Camp Lejeune Act
                                                  opinion in a legal proceeding regarding                 claims.                                                and this final rule in greater detail in
                                                  causation in any individual case.                         One commenter expressed concern                      section D.1, below.
                                                  Therefore, VA intimates no conclusion                   with the 30-day requirement because
                                                                                                          the individual had documentation                       5. Conduct Additional Studies on
                                                  regarding any individual veteran’s
                                                                                                          stating that his or her length of stay at              Exposure Requirements
                                                  development of a disease and its
                                                  relationship to exposure to                             Camp Lejeune was four weeks (which                       A comment from VFW stated that VA
                                                  contaminated water at Camp Lejeune for                  would be 28 days if read strictly). The                should conduct additional studies to
                                                  any purpose beyond entitlement to                       individual noted that Department of                    cover the impact of exposure on
                                                  disability benefits administered by VA.                 Defense documentation sometimes                        individuals who served less than 30
                                                     In the notice of proposed rulemaking,                references weeks of training, rather than              days, with the ultimate goal of reducing
                                                  VA acknowledged that the available                      days of training and expressed concern                 the 30-day exposure requirement. VA
                                                  scientific evidence does not provide                    with personal and administrative                       thanks VFW for its suggestion regarding
                                                  data on levels of exposure associated                   burden associated with documenting                     conducting additional studies. However,
                                                  with each condition and proposed to                     presence on base for a day or two before               this rulemaking pertains solely to
                                                  rely upon the 30-day service                            and/or after training. As stated above,                establishing presumptions of service
                                                  requirement contained in the provisions                 VA is adopting a 30-day requirement to                 connection associated with exposure to
                                                  of the Camp Lejeune Act. In the absence                 ensure consistency with the Camp                       contaminants in the water supply at
                                                                                                          Lejeune Act. In adjudicating individual                Camp Lejeune; conducting scientific
                                                  of scientific evidence which supports
                                                                                                          claims, VA is required to assist                       and/or medical studies is beyond the
                                                  establishment of an alternative service
                                                                                                          claimants in obtaining evidence and to                 scope of this rulemaking. As such, VA
                                                  or exposure requirement, VA’s
                                                                                                          resolve reasonable doubt in claimants’                 makes no change to the final rule based
                                                  determination favors consistency and
                                                                                                          favor.                                                 on this comment.
                                                  parity with its own health care                           Thus, while VA acknowledges and
                                                  regulation and the statute stands.                      thanks the commenters for their input,                 6. Miscellaneous Alternative Exposure
                                                  Congress understood the Camp Lejeune                    VA is unable to make any changes based                 Requirement Comments
                                                  Act to mean that ‘‘veterans deserve the                 upon these comments at this time.
                                                  presumptions of the service connection                                                                            VA received several comments
                                                                                                          However, VA will continue to review
                                                  in the bill to ensure that they receive the                                                                    offering additional alternative minimum
                                                                                                          relevant information as it becomes
                                                  benefits to which they are due,’’ and did                                                                      exposure requirements, with
                                                                                                          available and will consider future
                                                  not specify that a different service                                                                           suggestions including a single day at
                                                                                                          amendments to the 30-day requirement
                                                  requirement should exist for purposes of                                                                       Camp Lejeune and an increase to 90
                                                                                                          as appropriate.
                                                  disability compensation. 158 Cong. Rec.                                                                        days. While these comments offered
                                                  H5430 (July 31, 2012) (statement by                     3. Decide Claims Through Tort Law                      alternative exposure criteria, they did
                                                  Rep. Dingell). Creation of a separate                      Another commenter felt that the                     not provide a rationale for the suggested
                                                  standard for the purposes of disability                 statutory 30-day requirement lacked a                  alternative that was rooted in scientific,
                                                  compensation would create                               medical basis and felt that veterans’                  medical, or other rational basis.
                                                  inconsistency in the administration of                  claims should be handled through tort                     As discussed above, the notice of
                                                  benefits for Camp Lejeune veterans                      law rather than the disability claim                   proposed rulemaking acknowledged
                                                  where the statute includes a clear                      process. VA notes that the 30-day                      that the current science does not
                                                  service requirement for health care                     requirement for health care benefits was               support a specific minimum exposure
                                                  eligibility; inclusion of the 30-day                    established by Congress. Furthermore,                  level for any of the conditions, as the
                                                  requirement ensures consistency and                     the presumptions set forth in this                     available scientific and medical
                                                  parity in this regard with both the Camp                rulemaking are for the purposes of                     evidence focused on hazard models
                                                  Lejeune Act and VA’s own regulations                    administering VA disability                            when studying the long-term health
                                                  implementing the health care provisions                 compensation benefits only; VA                         effects of the contaminants. Lacking
                                                  of the act. For example, including a                    expresses no view regarding the                        such a scientific basis, VA relied upon
                                                  service requirement less than that in the               potential correlation between any given                the only source available in deciding to
                                                  Camp Lejeune Act could lead to the                      level or duration of exposure and the                  establish a 30-day exposure
                                                  situation wherein a veteran is                          increased risk of disease and/or                       requirement: The Camp Lejeune Act. As
                                                  determined to be ineligible for VA                      disability for any purpose beyond this                 VA acknowledged in the notice of
                                                  health care on the grounds that he or                   rulemaking. Accordingly, VA takes no                   proposed rulemaking, the Camp Lejeune
                                                  she did not have the necessary 30 days                  action based on this comment.                          Act does not provide a legal
                                                  of service at Camp Lejeune, but is then                                                                        requirement for prescribing a 30-day
                                                  granted service connection on a                         4. Eliminate 30-Day Requirement for                    service requirement for the purposes of
                                                  presumptive basis based on the same                     Health Care                                            disability compensation. However, the
                                                  service at Camp Lejuene upon filing a                      Another commenter stated that VA                    Camp Lejeune Act and VA’s prior
                                                  claim for compensation. A veteran in                    should not require 30 days of service at               implementation of its provisions require
                                                  this situation could, via operation of                  Camp Lejeune to establish entitlement                  30 days of service at Camp Lejeune for
                                                  this presumption, become eligible for                   to health care benefits. The service                   a veteran to establish entitlement to
                                                  VA health care based on their service                   requirement to establish entitlement to                health care. See 38 CFR 17.400. In light
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                                                  connection rating, even though he or                    health care is mandated by the Camp                    of the Camp Lejeune Act, VA’s
                                                  she would not have been eligible under                  Lejeune Act. The Camp Lejeune Act is                   implementation of its provisions
                                                  the 30-day service requirement of the                   a statute, the provisions of which were                through 38 CFR 17.400, and the lack of
                                                  Camp Lejeune Act. This confusing                        enacted by Congress. VA lacks the legal                an alternative exposure requirement
                                                  result could raise a question as to                     authority to alter, amend, or otherwise                supported by scientific, medical, or
                                                  whether VA had indirectly contravened                   change the provisions of a statute and                 other rational evidence, VA determined
                                                  a portion of the Camp Lejeune Act by                    therefore takes no action based on this                that inclusion of the 30-day requirement
                                                  virtue of a liberalizing evidentiary                    comment. We discuss the difference in                  in this rulemaking ensures consistency


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                                                                      Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations                                           4177

                                                  and parity with both its health care                       VA makes no change based on these                   evidence in official service department
                                                  regulations and the statute.                            comments. As stated in the proposed                    records documenting official orders or
                                                    Without a rational basis to explain                   rule, VA broadly defined service at                    assignment to serve, either in an
                                                  and support an alternative exposure                     Camp Lejeune as any service within the                 individual capacity or as part of a larger
                                                  requirement, VA’s rulemaking would                      borders of the entirety of the United                  unit, at Camp Lejeune, a claimant does
                                                  not comply with the statutory                           States Marine Corps Base Camp Lejeune                  not meet the evidentiary standard for
                                                  requirements of 38 U.S.C. 501 and                       and Marine Corps Air Station New                       presumptive service connection. As
                                                  therefore takes no action based on these                River, North Carolina, during the period               such, without military orders or other
                                                  comments. VA will continue to review                    beginning on August 1, 1953, and                       official service department records
                                                  relevant information as it becomes                      ending on December 31, 1987, as                        reflecting service at Camp Lejeune,
                                                  available and will consider future                      established by military orders or other                veterans, former reservists or National
                                                  changes to the regulation as appropriate.               official service department records. This              Guard members who served aboard
                                                    VA notes that nothing in the                          definition is consistent with the Camp                 vessels that docked at Camp Lejeune
                                                  provisions of this rule prevents veterans               Lejeune Act and VA’s prior                             during the period of contamination are
                                                  without the requisite 30 days                           implementation of the act, promulgated                 not eligible for presumptive service
                                                  (consecutive or nonconsecutive) of                      at 38 CFR 17.400. To ensure accurate                   connection under the provisions of this
                                                  service at Camp Lejeune from                            and consistent application of the                      rule.
                                                  establishing service connection for any                 definition of service at Camp Lejeune,                   As stated in the proposed rule,
                                                                                                          VA will administratively provide claims                veterans without the requisite 30 days
                                                  disease or disability on a direct basis.
                                                                                                          processors with all necessary factual                  (consecutive or nonconsecutive) of
                                                  Direct service connection for any
                                                                                                          and background information to process                  service at Camp Lejeune, including
                                                  disease alleged to have been caused by
                                                                                                          claims in accordance with this                         those who allege exposure aboard
                                                  the contaminants in the water supply at
                                                                                                          regulation.                                            amphibious vessels without military
                                                  Camp Lejeune requires evidence of a
                                                                                                             Marine Corps Air Station (MCAS)                     orders or other official service
                                                  current disease or disability, evidence of
                                                                                                          New River, while located within the                    department records reflecting
                                                  exposure to contaminated water at
                                                                                                          borders of the entirety of Camp Lejeune,               assignment to serve at Camp Lejeune,
                                                  Camp Lejeune, and a medical nexus
                                                                                                          falls under a separate command from                    may still establish service connection
                                                  between the two, supported by a
                                                                                                          Camp Lejeune itself. VA identified                     for any disease or disability on a direct
                                                  sufficient medical explanation.                         MCAS New River as a separate location                  basis. Direct service connection for any
                                                  B. Definition of Service at Camp Lejeune                as military orders or other official                   disease alleged to have been caused by
                                                                                                          service department records may                         the contaminants in the water supply at
                                                    VA received seven comments                            specifically denote service at or                      Camp Lejeune requires evidence of a
                                                  concerning the definition of service at                 assignment to MCAS New River; failure                  current disease or disability, evidence of
                                                  Camp Lejeune for the purposes of                        to specify this location may result in                 exposure to contaminated water at
                                                  establishing entitlement to disability                  improper denials of claims or create                   Camp Lejeune, and a medical nexus
                                                  benefits on a presumptive basis, as                     confusion for otherwise eligible                       between the two, supported by a
                                                  contained in proposed § 3.307(f)(7)(iii).               veterans. VA notes that service at MCAS                sufficient medical explanation.
                                                  These comments suggested that the rule                  Cherry Point, which is geographically
                                                  make reference to specific locations                                                                           C. Benefits for Former Reservists and
                                                                                                          separate from Camp Lejeune
                                                  within the borders of Camp Lejeune,                                                                            National Guard Members
                                                                                                          (approximately 55 miles away), has a
                                                  some of which may be considered                         separate water source, and is under a                     VA received five comments regarding
                                                  satellite camps/locations. One                          separate command structure, does not                   benefits for former reservists and
                                                  commenter noted that veterans may                       meet the definition of service at Camp                 National Guard members. One
                                                  have lived in one of the specified                      Lejeune for purposes of this rulemaking.               commenter stated that VA should define
                                                  satellite camps/locations while assigned                   VA notes that the definition of service             what benefits are available to reservists
                                                  to Camp Lejeune, or vice versa. Another                 at Camp Lejeune relies on military                     under the rule, noting that the rule
                                                  commenter stated that listing specific                  orders or other official service                       states reservists would be entitled to
                                                  satellite locations included within the                 department records to establish that an                ‘‘some’’ benefits under the rulemaking.
                                                  definition of Camp Lejeune would avoid                  individual had service at Camp Lejeune                 Similarly, another commenter stated
                                                  confusion for eligible veterans and                     for the purposes of entitlement to                     that VA does not consider reservists and
                                                  minimize the risk of improper denials                   presumptive service connection based                   former National Guard members
                                                  by claims processors who may not be                     on exposure to contaminants in the                     ‘‘veterans’’ unless they have a service-
                                                  aware of the satellite camps/locations.                 water supply. As discussed in the                      connected disability. Another
                                                  One commenter stated that the proposed                  proposed rule, the 2007 United States                  commenter noted that reserve and
                                                  rule did not include Marine Corps Air                   General Accounting Office (GAO) study                  National Guard status does not meet the
                                                  Station New River. Legal Counsel for the                found that the contaminated water                      requirements of 38 CFR 3.6, and urged
                                                  Elderly stated the presumption should                   supply systems served housing,                         VA to amend other regulations to
                                                  extend to those who served in                           administrative, and recreational                       eliminate any conflict for applying
                                                  circumstances ‘‘likely’’ to have resulted               facilities, as well as the base hospital at            presumptions of disability to reserve
                                                  in exposure to contaminants in the                      Camp Lejeune. See U.S. General                         and National Guard members. Finally,
                                                  water supply at Camp Lejeune. This                      Accounting Office, Defense Health Care:                one commenter stated that the rule does
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                                                  comment gave examples of those who                      Activities Related to Past Drinking                    not include reservists and asked for VA
                                                  served in training exercises or ships                   Water Contamination at Marine Corps                    to amend the rulemaking to include
                                                  outside of Camp Lejeune but ‘‘likely’’                  Base Camp Lejeune (2007). Neither the                  reservists.
                                                  used water drawn from Camp Lejeune.                     GAO nor any other available study                         As stated in the proposed rule, basic
                                                  An additional comment referenced                        indicated that individuals who served                  eligibility for VA benefits requires that
                                                  Navy Amphibious Forces that docked at                   aboard amphibious vessels were                         an individual be a ‘‘veteran’’ as that
                                                  Camp Lejeune and most likely took on                    exposed to contaminants found in the                   term is defined in 38 U.S.C. 101(2).
                                                  board fresh water from the Camp.                        water supply at Camp Lejeune. Without                  Reserve duty during a period of active


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                                                  4178                Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations

                                                  duty for training or inactive duty for                  while the other comments focused on                    compounds of interest. The exclusion of
                                                  training generally does not qualify an                  individual disabilities.                               scleroderma is addressed separately in
                                                  individual as a ‘‘veteran,’’ because it                                                                        the next section.
                                                                                                          1. Presumptive Disabilities Differ From                   Additionally, the health care
                                                  does not constitute ‘‘active military,
                                                                                                          the Camp Lejeune Act                                   provisions of the Camp Lejeune Act
                                                  naval, or air service,’’ unless the person
                                                  is disabled or dies during that period of                  VA received 42 comments, including                  provide medical coverage for health
                                                  service as prescribed by 38 U.S.C.                      from VVA, NOVA, and Legal Counsel                      effects that are not themselves
                                                  101(24)(B) and (C). However, under this                 for the Elderly, regarding the disabilities            diagnosed diseases or clearly associated
                                                  rule, former reservists and National                    in our proposed rulemaking and the                     with a specific diagnosed disease. To
                                                  Guard members meeting the service                       disabilities listed in the Camp Lejeune                establish that disability arising years
                                                  criteria for presumptive service                        Act. The commenters noted that VA’s                    after service is associated with harmful
                                                  connection based on exposure to                         proposed rulemaking contained fewer                    exposure in service, the evidence
                                                  contaminants at Camp Lejeune have                       and different conditions than the Camp                 generally must show that the disability
                                                  veteran status for the purpose of                       Lejeune Act, with several commenters                   results from a disease associated with
                                                  entitlement to service connection for the               urging VA to adopt the list of                         the in-service exposure. Accordingly, in
                                                  enumerated disabilities; there is no                    disabilities in the Camp Lejeune Act in                § 3.307, VA has established
                                                  limitation of benefits to former                        its entirety, without change. One                      presumptions of service connection for
                                                  reservists and National Guard members                   commenter stated that veterans who                     specific diseases, as distinguished from
                                                  under this rule. VA makes no change                     develop a condition listed in the health               general health effects that may result
                                                  based upon these comments.                              care provisions of the Camp Lejeune Act                from specific diseases but are not
                                                     Another commenter stated that VA’s                   but not listed as a presumptive                        themselves diseases. The available
                                                  inclusion of former reservists and                      disability would be denied                             scientific evidence did not identify a
                                                  National Guard members in the                           compensation benefits for conditions for               specific or general diagnosis of disease
                                                  rulemaking stretches Congressional                      which health care is being provided. For               associated with renal toxicity or hepatic
                                                  intent with regards to the definition of                the reasons enumerated below, VA                       steatosis, conditions which are included
                                                  ‘‘veteran.’’ The commenter also                         makes no change based on these                         in the provisions of the Camp Lejeune
                                                  suggested that Congress should provide                  comments.                                              Act.
                                                  guidance on the definition of a veteran,                   As explained in the proposed rule, the                 Finally, the Camp Lejeune Act
                                                  and that VA is underestimating the                      Camp Lejeune Act provides medical                      included health care for female
                                                  financial impact of this rule. As                       care, but not compensation benefits, to                infertility and miscarriage. However, as
                                                  explained in the proposed rule,                         veterans who served on active duty at                  noted in the proposed rule, the NRC’s
                                                  although 38 U.S.C. 101(24) requires a                   Camp Lejeune for the 15 identified                     2009 report indicated that the
                                                  period of active duty for training or                   conditions ‘‘notwithstanding that there                occurrence of female infertility and
                                                  inactive duty training ‘‘during which                   is insufficient medical evidence to                    miscarriage were limited to exposure
                                                  the individual was disabled or died’’ for               conclude that such illnesses or                        concurrent with those health effects. As
                                                  this period to constitute active military,              conditions are attributable to such                    such, the inclusion of these conditions
                                                  naval, or air service, this statute was                 service.’’ VA’s more recent review of                  in the Camp Lejeune Act does not
                                                  enacted at a time when the latent effects               scientific evidence was undertaken to                  provide a basis at this time for
                                                  of exposures to certain harmful                         determine the appropriateness of                       presuming current health effects of this
                                                  chemicals were unrecognized. Further,                   establishing presumptions of service                   type to be associated with past
                                                  the legislative history behind this                     connection for claimants who served at                 exposure. Additionally, as stated in the
                                                  statute does not specifically explain                   Camp Lejeune. As noted in the                          proposed rule, these two conditions are
                                                  Congress’ intent in requiring that the                  proposed rulemaking, this review                       not in and of themselves disabilities for
                                                  individual ‘‘was disabled or died’’                     included the analysis of several hazard                which VA can provide disability
                                                  during the period of service in question.               evaluations on the chemicals of interest               compensation.
                                                  As section 101(24) serves a generally                   conducted by multiple bodies of                           Accordingly, as noted by one
                                                  beneficial purpose to recognize certain                 scientific experts and was not an                      commenter, an outcome of VA’s review
                                                  reserve and National Guard service                      evaluation of the specific risks of                    of the available scientific evidence, to
                                                  which results in disability or death as                 exposure to contaminated water at                      include additional evidence that did not
                                                  affording veteran status for the purposes               Camp Lejeune. VA’s review resulted in                  exist at the time the Camp Lejeune Act
                                                  of VA disability benefits, and in light of              the recognition that liver cancer and                  was passed, may result in situations
                                                  increased medical understanding of the                  Parkinson’s disease, two diseases that                 where an individual receives VHA
                                                  possible latent effects of toxic exposure,              were not included in the Camp Lejeune                  health care for a covered condition
                                                  VA feels it is reasonable to include                    Act, are conditions for which there is                 without an associated copayment under
                                                  former reservists and National Guard                    strong evidence of a causal relationship               the Camp Lejeune Act, but is not
                                                  members with qualifying service under                   and evidence that the condition may be                 eligible for presumptive service
                                                  this rule. Accordingly, VA makes no                     caused by exposure to the contaminants.                connection for disability compensation
                                                  change based upon this comment.                         However, at this time, VA concludes                    for that condition under this
                                                                                                          that there is insufficient evidence to                 rulemaking. While these individuals
                                                  D. Comments Pertaining to Presumptive                   establish presumptions of service                      may not be eligible for presumptive
                                                  Disabilities                                            connection for the following diagnosed                 service connection under this
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                                                    VA received several comments                          chronic disabilities in the Camp Lejeune               rulemaking, they may be eligible for
                                                  regarding the disabilities included in                  Act: Esophageal cancer, lung cancer,                   direct service connection for any disease
                                                  the proposed rulemaking. These                          breast cancer, neurobehavioral effects,                alleged to have been caused by the
                                                  comments fell into two basic categories:                and scleroderma. As noted in the notice                contaminants in the water supply at
                                                  One group related to the general                        of proposed rulemaking, none of the                    Camp Lejeune, including a disease or
                                                  differences between the disabilities in                 evidence reviewed concluded that there                 disability covered under the Camp
                                                  the proposed rule and the health care                   is a positive association between these                Lejeune Act. As noted earlier in section
                                                  provisions in the Camp Lejeune Act,                     conditions and the volatile organic                    B, direct service connection requires


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                                                                      Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations                                           4179

                                                  evidence of a current disease or                        development of scleroderma                             pathologic findings in cases of
                                                  disability, evidence of exposure to                     specifically, VA cannot create a                       parkinsonism show different patterns of
                                                  contaminated water at Camp Lejeune,                     presumption of service connection for                  brain injury than those noted in patients
                                                  and a medical nexus between the two,                    Camp Lejeune veterans at this time.                    with Parkinson’s disease. See Institute
                                                  supported by a sufficient medical                       Though the available evidence has                      of Medicine of the National Academies,
                                                  explanation. Conversely, it is similarly                established a role for trichloroethylene               Veterans and Agent Orange: Update
                                                  possible that a condition not exempted                  (TCE) in the development of                            2012, The National Academies Press
                                                  from copayment under the Camp                           autoimmune diseases, the studies that                  (Washington, DC, 2014). The studies
                                                  Lejeune Act, such as liver cancer or                    specifically report on scleroderma                     that have established a relationship
                                                  Parkinson’s disease, could be granted                   include factors that introduce                         between the contaminants in the water
                                                  presumptive service connection                          significant uncertainty into their results,            supply at Camp Lejeune and
                                                  pursuant to this final rule. We note that               to include small sample sizes and an                   Parkinson’s disease reported specifically
                                                  a grant of service connection for such a                unexplained gender effect. Although the                on Parkinson’s disease, not
                                                  condition would exempt treatment                        science does not at this time support the              parkinsonism or other parkinsonian
                                                  associated with that condition from                     addition of scleroderma to the list of                 syndromes. At this time, the available
                                                  copayment requirements, as VA                           covered diseases, VA will continue to                  evidence does not establish that
                                                  copayments do not apply to treatment of                 monitor and review future studies as                   parkinsonism and other manifestations
                                                  service connected disabilities. A grant of              they become available and will consider                of small fiber nerve damage are
                                                  presumptive service connection could                    future additions to the list of covered                associated with exposure to the
                                                  also create an alternative basis for                    diseases as appropriate.                               contaminants in the water supply at
                                                  enrollment in the VA health care                                                                               Camp Lejeune. Therefore, VA makes no
                                                                                                          3. Inclusion of Neurobehavioral Effects
                                                  system. See 38 CFR 17.36.                                                                                      change based on these comments.
                                                     VA will continue to review relevant                  and Parkinsonism
                                                  information as it becomes available and                    VA received eight comments                          4. Adult Leukemia
                                                  will consider future additions to the list              regarding the issue of neurobehavioral                    VA received 12 comments, including
                                                  of covered conditions as appropriate.                   effects and parkinsonism, including an                 from the Project on Government
                                                     In addition to suggesting that VA                    organizational comment from the                        Oversight and VFW, and one from a
                                                  should provide disability compensation                  United Parkinson’s Advocacy Council.                   member of Congress, addressing the
                                                  for the conditions in the Camp Lejeune                  Three commenters stated the                            condition of adult leukemia. The
                                                  Act, one commenter suggested that,                      presumptive disabilities should include                commenters stated that VA should
                                                  alternatively, VA should change the                     neurobehavioral effects, with one                      clarify the disabilities included in adult
                                                  provisions of the Camp Lejeune Act to                   commenter specifying inclusion of                      leukemia by changing the term to
                                                  match the eight disabilities covered in                 specific types of neurobehavioral                      ‘‘leukemia,’’ ‘‘adult leukemias,’’ or by
                                                  the proposed rule. The Camp Lejeune                     effects. Another commenter suggested                   listing all sub-types of leukemia
                                                  Act is a statute, the provisions of which               that VA include ‘‘Parkinson-like’’                     included in the definition of adult
                                                  were enacted by Congress. VA lacks the                  symptoms as a presumptive disability                   leukemia. A comment from a member of
                                                  legal authority to alter, amend, or                     under the general diagnosis of                         Congress specifically cited an ATSDR
                                                  otherwise change the provisions of a                    neurobehavioral effects. The third                     report, which noted all leukemia sub-
                                                  statute and therefore takes no action                   commenter asked if parkinsonism was                    types are associated with exposure to
                                                  based on this comment.                                  included under the definition of                       contaminants in the water supply at
                                                                                                          Parkinson’s disease. Another                           Camp Lejeune. The same member of
                                                  2. Exclusion of Scleroderma as a
                                                                                                          commenter stated that there is no way                  Congress also stated the use of ‘‘adult
                                                  Presumptive Disability                                  to definitively diagnose Parkinson’s                   leukemia’’ was unnecessary because all
                                                     Eight commenters, including the                      disease. The United Parkinson’s                        who qualify for this benefit are adults,
                                                  Project on Government Oversight, Legal                  Advocacy Council stated VA should                      as the rulemaking does not apply to
                                                  Counsel for the Elderly, and a member                   include ‘‘atypical parkinsonism’’ in the               dependents. Another commenter stated
                                                  of Congress, specifically questioned                    rulemaking.                                            that VA should replace the term ‘‘adult
                                                  VA’s exclusion of scleroderma as a                         Parkinson’s disease was included in                 leukemia’’ with ‘‘chronic or acute forms
                                                  presumptive disability. These                           the list of presumptive disabilities due               of lymphocytic and myeloid leukemia’’
                                                  commenters noted that scleroderma was                   to a recommendation made by the                        to clarify what conditions are covered.
                                                  included in the health care provisions of               Institute of Medicine (IOM) in their                   VA disagrees and makes no change
                                                  the Camp Lejeune Act and suggested                      2015 report ‘‘Review of VA Clinical                    based on these comments.
                                                  that VA specifically include this                       Guidance for the Health Conditions                        The term ‘‘adult leukemia’’ clarifies
                                                  condition as a presumptive disability.                  Identified by the Camp Lejeune                         that the types of leukemia covered
                                                  Additionally, the comment from a                        Legislation.’’ The IOM noted that                      under this rulemaking must have their
                                                  member of Congress stated that there                    Parkinson’s disease is a specific                      onset in adulthood. This distinction
                                                  was modest causal evidence from the                     neurobehavioral effect that may be                     between adult and non-adult leukemias
                                                  Agency for Toxic Substances and                         experienced by individuals exposed to                  is necessary, as the disability
                                                  Disease Registry (ATSDR) and the                        the contaminants in the water supply at                compensation provided by this
                                                  economic impact of including                            Camp Lejeune.                                          rulemaking applies only to disabilities
                                                  scleroderma would be minimal, as the                       Parkinson’s disease is medically                    arising in veterans, reservists, or
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                                                  number of Camp Lejeune veterans                         distinguishable and separately                         National Guard members as a result of
                                                  suffering from this condition is small.                 diagnosable from a variety of                          their exposure to contaminants in the
                                                     As explained in the proposed rule,                   parkinsonian syndromes, including                      water supply at Camp Lejeune while
                                                  due to the lack of new scientific/                      drug-induced parkinsonism and                          serving under official military orders or
                                                  medical evidence (outside of the                        neurodegenerative diseases, such as                    other official assignment. As such, the
                                                  available evidence considered by the                    multiple systems atrophy, which have                   presumptions of this rulemaking do not
                                                  TWG) linking any of the contaminants                    parkinsonian features combined with                    apply to veterans, reservists or National
                                                  found in the water supply with the                      other abnormalities. Most notably, the                 Guard members who develop leukemia


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                                                  4180                Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations

                                                  prior to qualifying service at Camp                        As stated in the proposed rule, VA                  covered illness. Other commenters
                                                  Lejeune.                                                undertook a deliberative scientific                    stated the rule should be effective
                                                     The use of the term ‘‘adult leukemia’’               process to determine whether available                 retroactively to the date an eligible
                                                  was not intended to restrict the types of               scientific evidence was sufficient to                  veteran first served at Camp Lejeune.
                                                  leukemia covered by this rulemaking.                    support a presumption of service                       Some commenters stated that the rule
                                                  No sub-type of leukemia was identified                  connection for any health condition as                 excludes previously denied claims, and
                                                  in the rulemaking in order to be                        a result of exposure to the chemicals                  therefore VA should apply the
                                                  inclusive to all types of leukemia,                     found in the drinking water at Camp                    provisions of the Nehmer v. U.S.
                                                  including the sub-types identified by                   Lejeune. This process involved an                      Department of Veterans Affairs
                                                  commenters. VA notes that inclusion of                  evaluation of comprehensive hazard                     (Nehmer) court order to determine a
                                                  specific sub-types included within this                 studies conducted by several                           retroactive effective date for awards. See
                                                  definition will lead to an incomplete                   internationally respected expert bodies.               Nehmer v. U.S. Department of Veterans
                                                  list, potentially confusing veterans,                   VA also notes that BVA decisions are                   Affairs, No. CV–86–6161 TEH (N.D.
                                                  reservists and National Guard members                   made on the facts, circumstances, and                  Cal.). One commenter suggested that the
                                                  who have a qualifying disability, as well               evidence of individual claims on a case-               rule should be effective the date the
                                                  as claims processors.                                   by-case basis; these cases do not set                  proposed rule was published, as it
                                                  5. Miscellaneous Disabilities                           precedent. At this time, there is                      should have been published as an
                                                                                                          insufficient medical and scientific                    interim final rule. Finally, one
                                                     VA received 53 comments, including                   evidence to establish a presumption of                 commenter asked if a ‘‘pending’’ claim
                                                  organizational comments from the Fort                   service connection for any disability                  includes the one-year period following
                                                  McClellan Veterans Stakeholders Group,                  beyond the eight conditions included in                notice of a denial as well as appeals
                                                  which requested inclusion of                            the rulemaking; therefore, VA makes no                 before the BVA.
                                                  miscellaneous conditions and                            change in response to these comments                      As stated in the proposed rule, this
                                                  disabilities, both specified and                        at this time.                                          rule will apply to claims received by VA
                                                  unspecified, that were not the subject of                  VA relies heavily on studies of                     on or after the effective date of the final
                                                  the proposed rulemaking, nor were they                  exposed populations in order to                        rule and to claims pending before VA on
                                                  included in the provisions of the Camp                  establish such an association, and will                that date. Under 38 CFR 3.160(c), a
                                                  Lejeune Act. These conditions include:                  continue to monitor future studies,                    claim that has not been finally
                                                  Hodgkin’s disease, diabetes mellitus,                   especially those conducted on the Camp                 adjudicated (which includes claims
                                                  depression, sleep apnea, throat cancer,                 Lejeune population, as they become                     where a final and binding decision has
                                                  fibroid sarcoma, prostate cancer, colon                 available. VA will consider additions to               been issued but the appeal period has
                                                  cancer, brain cancer, mesothelioma, soft                the list of presumptive disabilities as                not expired) is still considered a
                                                  tissue sarcoma, gynecomastia,                           appropriate, should future studies                     pending claim. The rule does not apply
                                                  prolactemia, Crohn’s disease,                           provide sufficient evidence for such a                 retroactively to claims that are finally
                                                  amyloidosis, hidradenitis suppurativa,                  change.                                                adjudicated. VA must adhere to the
                                                  immune system toxicity, gastrointestinal                   As previously discussed, it is also                 provisions of its change of law
                                                  cancers, other unspecified immune                       relevant to note that the scientific                   regulation, 38 CFR 3.114, which states
                                                  system effects, unspecified neurologic                  evidence was not analyzed by VA for                    that where pension, compensation,
                                                  disorders, unspecified skin conditions,                 sufficiency to support an expert opinion               dependency and indemnity
                                                  unspecified endocrine disorders,                        in a legal proceeding regarding                        compensation is awarded or increased
                                                  unspecified cellular mutation,                          causation in any individual case.                      pursuant to a liberalizing law, or a
                                                  cancerous and non-cancerous urinary                     Therefore, VA intimates no conclusion                  liberalizing VA issue approved by the
                                                  tract conditions, unspecified kidney                    regarding any individual veteran’s                     Secretary or by the Secretary’s direction,
                                                  effects, unspecified liver effects,                     development of a disease and its                       the effective date of such award or
                                                  unspecified endocrine effects,                          relationship to exposure to                            increase shall be fixed in accordance
                                                  unspecified cardiovascular disorders,                   contaminated water at Camp Lejeune.                    with the facts found, but shall not be
                                                  and unspecified cancers. Additionally                                                                          earlier than the effective date of the act
                                                  some commenters stated that VA should                   6. Kidney Cancer                                       or administrative issue. See also 38
                                                  include additional disabilities without                    One commenter asked why VA is not                   U.S.C. 5110(g).
                                                  specifying those additions. Two                         recognizing kidney cancer as a                            This final regulation is based on the
                                                  commenters stated that VA should                        presumptive disability. As noted in the                Secretary’s broad authority under 38
                                                  consider all diseases and disabilities as               proposed rule under amended § 3.309(f),                U.S.C. 501(a) to ‘‘prescribe all rules and
                                                  associated with exposure to                             kidney cancer is one of the listed                     regulations which are necessary or
                                                  contaminants in the water supply at                     conditions VA recognizes as                            appropriate to carry out the laws
                                                  Camp Lejeune, noting that VA should                     presumptively associated with exposure                 administered by the Department and are
                                                  bear the burden of proof as to why any                  to contaminants in the water at Camp                   consistent with those laws, including—
                                                  disability is unrelated to exposure to                  Lejeune. VA makes no change based                      . . . regulations with respect to the
                                                  contaminants at Camp Lejeune. Another                   upon this comment.                                     nature and extent of proof and evidence
                                                  commenter suggested inclusion of                                                                               . . . in order to establish the right to
                                                  conditions not identified by scientific                 E. Effective Date                                      benefits under such laws.’’ This
                                                  evidence. Finally, one commenter cited                     VA received 27 comments, including                  rulemaking authority does not explicitly
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                                                  a decision by the Board of Veterans’                    from the C–123 Veterans Association,                   afford the Secretary authority to assign
                                                  Appeals (BVA) as sufficient evidence to                 VFW, and NOVA, concerning the                          retroactive effect to the regulations
                                                  support adding prostate cancer to the                   effective date of the regulation.                      created thereunder, and retroactivity is
                                                  list of presumptive disabilities. The                   Comments included suggestions that                     heavily disfavored in the law. As
                                                  same commenter also stated VA should                    this rule should be effective the date a               explained in the proposed rule, a
                                                  consider adding hepatitis C, noting a                   claim was initially filed, even if prior to            claimant whose claim was previously
                                                  correlation between it and prostate                     the effective date of the final rule, or on            and finally denied may file a new claim
                                                  cancer.                                                 the date of onset or diagnosis of a                    to obtain a new determination of


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                                                                      Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations                                           4181

                                                  entitlement under the final regulation.                 G. Additional Contaminants                             determine the minimum level of
                                                  Finally, VA notes that the effective date                 VA received two comments regarding                   exposure to a contaminant needed to
                                                  provisions of the Nehmer court order                    consideration of additional                            result in negative health effects.
                                                  apply only to claims based on exposure                                                                           VA currently has no information at its
                                                                                                          contaminants. One commenter stated
                                                  to herbicides in the Republic of Vietnam                                                                       disposal to define the specific
                                                                                                          that VA should include information
                                                  during the Vietnam era and are therefore                                                                       hazardous exposure levels or
                                                                                                          about unspecified lead contamination
                                                  inapplicable to this final rule.                                                                               combinations of exposure that any one
                                                                                                          during the 1990s. The commenter also
                                                                                                                                                                 individual received, which would
                                                     The Administrative Procedures Act                    requested inclusion of information
                                                                                                                                                                 determine exactly who in the veteran
                                                  (APA) provides guidance as to when a                    contained in an unspecified 1997 study.
                                                                                                                                                                 population might be at an increased risk
                                                  rulemaking may be published as an                       Another commenter stated that VA’s
                                                                                                                                                                 of experiencing adverse health effects
                                                  interim final rule. Under the APA, a                    assessment of contaminants is
                                                                                                                                                                 related to their service at Camp Lejeune.
                                                  rulemaking may be published as an                       incomplete, as it does not consider toxic              As explained in the proposed rule, the
                                                  interim final rule if it is determined that             compounds outside those noted in the                   VA review consisted of a hazard
                                                  notice and public comment ‘‘are                         rulemaking.                                            evaluation for the four chemicals of
                                                  impracticable, unnecessary, or contrary                   As stated in the proposed rule, VA is                interest: TCE, PCE, benzene and vinyl
                                                  to the public interest.’’ 5 U.S.C.                      only addressing the contamination of                   chloride, and focused on the effects of
                                                  553(b)(3)(B). As this rulemaking                        the water supplies by the four chemicals               these individual contaminants without
                                                  involves significant economic costs, the                of interest (i.e., TCE, perchloroethylene              regard to specific exposure levels.
                                                  opportunity for prior review and                        (PCE), benzene, and vinyl chloride) that               Additionally, as explained in the
                                                  comment was necessary and in                            occurred between August 1, 1953, and                   rulemaking, VA reviewed evidence from
                                                  accordance with the public interest. VA                 December 31, 1987, as a result of on-                  several internationally recognized
                                                                                                          base industrial activities and an off-base             scientific authorities, including groups
                                                  has acted expeditiously to consider
                                                                                                          dry cleaning facility. Exposure events                 other than the NRC. Regarding the
                                                  these public comments and prepare a
                                                                                                          unrelated to the specified date range                  description of the process employed by
                                                  final rulemaking. Therefore, VA makes
                                                                                                          and sources of contamination are                       ATSDR, VA notes that ATSDR is an
                                                  no changes based on these comments.
                                                                                                          unrelated to the subject and scope of                  external entity and, as such, is not
                                                  F. Date Range for Contamination                         this rulemaking; therefore VA makes no                 subject to VA’s control. VA also notes
                                                                                                          change in response to this comment.                    that the notice of proposed rulemaking
                                                     One commenter stated the date range
                                                                                                          H. Additional Scientific or Medical                    contains a full list of scientific studies
                                                  for exposure should be extended
                                                                                                          Evidence                                               and reviews cited in the rulemaking in
                                                  without specifying exact dates. The
                                                                                                                                                                 section E, ‘‘Weight-of-Evidence
                                                  commenter stated that contamination                       Two commenters stated that VA
                                                                                                                                                                 Analyses Considered by the TWG.’’
                                                  likely still existed even after the water               should reference additional, uncited                     VA’s rule is as inclusive as possible
                                                  supply met unspecified Environmental                    studies, stating the rulemaking should                 in covering the illnesses of veterans,
                                                  Protection Agency (EPA) standards.                      consider the effects of exposure to                    former reservists and National Guard
                                                  Similarly, VVA stated the                               solvent mixtures. One commenter stated                 members exposed to contaminants in
                                                  contamination period should be                          VA should reference an unspecified                     the water supply at Camp Lejeune based
                                                  extended until December 31, 2000, the                   study of the individuals who were                      on the available scientific evidence, in
                                                  last day of the year that the Navy                      actually exposed to contaminants in the                the absence of specific exposure
                                                  removed contaminated soil and other                     water supply at Camp Lejeune. Another                  information. VA makes no change based
                                                  items from the sites surrounding Camp                   commenter, the Fort McClellan Veterans                 on these comments.
                                                  Lejeune. Another commenter stated the                   Stakeholders Group, without further
                                                  background information in the proposed                  elaboration, stated that VA uses the                   I. Expedite Rulemaking
                                                  rule regarding contamination was                        wrong method to evaluate toxic                            VA received 17 comments, including
                                                  incorrect; this commenter stated that                   exposures. VA also received a comment                  an organizational comment from VFW,
                                                  contamination ended in 1987 and the                     stating that unspecified evidence exists               urging VA to expedite the rulemaking,
                                                  initial contamination warnings were in                  to possibly support the addition of more               to include publication of a final rule
                                                  1980. Another commenter stated VA                       disabilities. One commenter stated that                under which benefits may be granted.
                                                  should expand the date range to include                 the NRC did not perform a study, it                    VA must adhere to the requirements of
                                                  those who served from January 1, 1947,                  merely reviewed available literature,                  the APA, which includes a period for
                                                  through July 31, 1953, without further                  and the 2009 NRC is flawed and                         public comment and review of the
                                                  elaboration.                                            outdated. This same commenter also                     rulemaking. VA appreciates these
                                                                                                          stated that the description of the                     comments and has taken the necessary
                                                     As stated in the proposed rule, the                  collaboration between ATSDR, VA’s                      steps to ensure this rule is finalized
                                                  Camp Lejeune Act specified a period of                  Camp Lejeune Science Liaison Team,                     while conforming to the legal
                                                  contamination from August 1, 1953,                      and VA’s Technical Workgroup (TWG)                     requirements of notice and comment
                                                  through December 31, 1987. This date                    was incorrect. The commenter stated                    rulemaking.
                                                  range is likely based on some of the                    that the community was not directly
                                                  earliest assessments of the Camp                        involved in this collaboration. Another                J. Benefits for Veterans Born at Camp
                                                  Lejeune water supply noted in the NRC                   commenter stated it was unclear which                  Lejeune Without Service at Camp
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                                                  report. This period also represents the                 ATSDR studies were considered in the                   Lejeune
                                                  ATSDR’s best estimate of the period of                  rulemaking. Other commenters stated                       One commenter asked if the rule
                                                  contamination at Camp Lejeune. In the                   generally that inclusion or performance                provides compensation for veterans who
                                                  absence of additional scientific evidence               of additional studies could result in a                were born at Camp Lejeune but do not
                                                  to support an expansion of the                          larger list of presumptive disabilities.               have qualifying active duty, reserve, or
                                                  contamination period, VA makes no                       Finally, one commenter stated that a                   National Guard service at Camp
                                                  change based upon these comments at                     source with the Center for Disease                     Lejeune. VA is only authorized to pay
                                                  this time.                                              Control stated it is impossible to                     disability compensation for disability


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                                                  4182                Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations

                                                  resulting from injury suffered or disease               whose claim was previously and finally                 L. Benefits for Family Members or
                                                  contracted in line of duty ‘‘in the active              denied may file a new claim to obtain                  Civilians
                                                  military, naval, or air service’’. 38 U.S.C.            a new determination of entitlement                       VA received 11 comments, including
                                                  1110, 1131. Thus, VA has no authority                   under the final regulation. All claims                 an organizational comment from the
                                                  to pay compensation for disability                      are adjudicated individually based upon                United Parkinson’s Advocacy Council,
                                                  arising from events prior to service                    the entire evidentiary record and in                   stating that family members or civilians
                                                  entry. VA makes no change based upon                    accordance with all applicable
                                                                                                                                                                 who were exposed to contaminants in
                                                  this comment.                                           regulations.
                                                                                                                                                                 the water supply at Camp Lejeune
                                                                                                             Legal Counsel for the Elderly stated
                                                  K. Standard of Evidence for Claims                      that VA should allow for a veteran’s lay               should receive disability compensation.
                                                     One commenter stated that the                        testimony to establish the occurrence of               VA notes that this rulemaking provides
                                                  proposed rulemaking would still require                 exposure to contaminants in the water                  disability compensation for qualifying
                                                  eligible veterans, former reservists and                supply at Camp Lejeune. VA will                        veterans, former reservists or National
                                                  National Guard members to present a                     consider all evidence of record when                   Guard members; benefits for family
                                                  medical opinion in support of their                     deciding claims, including lay                         members or civilians are beyond the
                                                  claim for a presumptive disability. As                  testimony. However, VA notes that                      scope of the rulemaking and therefore
                                                  stated in the proposed rulemaking, if a                 current regulations provide very specific              VA will not respond to this comment.
                                                  veteran, former reservist or National                   circumstances as to when a veteran’s lay               Additionally, VA notes that there is
                                                  Guard member meets the stated                           testimony is sufficient to establish an                currently no statutory authority to
                                                  requirements for service at Camp                        occurrence for the purposes of                         provide benefits to the classes of people
                                                  Lejeune, then the subsequent                            entitlement to disability benefits. For                identified by the commenters.
                                                  development of any of the eight listed                  example, a veteran’s lay testimony may                 M. General Support for the Rulemaking
                                                  disabilities is presumed to be related to               be sufficient to establish the occurrence
                                                  the exposure to contaminants, in the                    of an injury or event that occurred                       VA received 56 comments, including
                                                  absence of clear and convincing                         during combat, if that testimony is                    from the C–123 Veterans Association,
                                                  evidence to the contrary. These                         consistent with the circumstances,                     DAV, VFW, VVA, Project on
                                                  presumptions do not require any further                 conditions, or hardships of that                       Government Oversight, Reserve Officers
                                                  evidence to support a claim, including                  veteran’s service, even where no official              Association, Marine Corps Reserve
                                                  a medical opinion. Therefore, VA makes                  record of such incurrence exists. The                  Association, United Parkinson’s
                                                  no change based on this comment.                        purpose of this lay statement exception                Advocacy Council, and Legal Counsel
                                                     Another commenter stated that the                    is to acknowledge certain circumstances                for the Elderly, expressing support for
                                                  proposed rule makes no reference for                    where official records likely will not                 the rulemaking in general. Many of
                                                  individual genetic predisposition to                    exist to establish a fact; in this example,            these comments, which were received
                                                  increased vulnerability to a specific                   it is highly unlikely that medical                     from individuals as well as
                                                  toxin. The commenter stated this places                 records will exist to document the                     organizations in the veteran community,
                                                  an unrealistic burden of proof on an                    occurrence of an injury at the time it                 stated appreciation for VA’s actions in
                                                  individual to prove that he or she                      occurred during combat. In the present                 establishing a presumption of exposure
                                                  suffers a disability due to exposure to                 rulemaking, establishing service at                    and service connection for veterans,
                                                  toxins. VA has no information at its                    Camp Lejeune requires documentation                    reservists, and National Guard members
                                                  disposal to define the specific                         of 30 days of service at Camp Lejeune                  exposed to contaminants in the water
                                                  hazardous exposure any individual                       by military orders or other official                   supply at Camp Lejeune. VA appreciates
                                                  received, which could assist in                         service department records. These                      the time and effort expended by these
                                                  determining who in the veteran                          documents are regularly and routinely                  commenters in reviewing the proposed
                                                  population was or would be at an                        issued by the military as a part of its                rule and in submitting comments, as
                                                  increased risk of suffering adverse                     normal duties in documenting                           well as their support for this
                                                  health effects related to their service at              personnel assignments and location and                 rulemaking.
                                                  Camp Lejeune. Furthermore, once the                     are a part of every servicemember’s                    N. Negative Comments
                                                  basic eligibility requirements of this rule             personnel file. As the evidence required
                                                  are met (qualifying service and                         to establish service at Camp Lejeune,                     VA received five comments indicating
                                                  diagnosis of a listed disability), no                   and therefore satisfy the condition                    opposition to the rulemaking. These
                                                  further information, to include evidence                necessary to presume exposure to                       comments expressed disagreement with
                                                  of a genetic vulnerability to a specific                contaminants in the water supply, is                   the rulemaking process in general, and
                                                  toxin, is necessary. Therefore, VA makes                readily available, VA makes no change                  presumptive service connection in
                                                  no change based on this comment.                        based upon this comment.                               particular. VA’s decision to create a
                                                     Two commenters asked if a medical                       Similarly, one commenter stated VA                  presumption of exposure to
                                                  opinion that served as the basis of a                   should provide a ‘‘benefit of the doubt’’              contaminants in the water supply at
                                                  previous denial could serve as                          to anyone who served at Camp Lejeune                   Camp Lejeune and presumptive service
                                                  affirmative evidence to rebut the                       in the 1980s. As stated in the rule, this              connection for the listed disabilities was
                                                  presumption created by this rule. The                   presumption of service connection                      issued after the Secretary considered the
                                                  circumstances of individual claims are                  applies to any veteran, to include former              available scientific evidence and
                                                  beyond the scope of this rulemaking and                 reserve and National Guard members,                    recommendations, as explained in the
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                                                  VA makes no change based upon this                      who served at Camp Lejeune during the                  notice of proposed rulemaking. This
                                                  comment. However, VA notes that 38                      relevant time period. This presumption                 evidence demonstrated at least an
                                                  CFR 3.307(d), which pertains to rebuttal                reduces the evidentiary burden required                association between the contaminants in
                                                  of presumptive service connection,                      to establish entitlement to disability                 the water supply at Camp Lejeune and
                                                  specifically requires consideration of all              compensation for certain claims, as                    the eight listed disabilities. This
                                                  evidence of record when determining                     further explained in the notice of                     evidence is supported by published
                                                  the issue of presumptive service                        proposed rulemaking. VA makes no                       reports from multiple internationally-
                                                  connection. As noted above, a claimant                  change based upon this comment.                        recognized authorities, and the


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                                                                      Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations                                           4183

                                                  Secretary has determined this evidence                  notifying eligible veterans who may be                 to enact; a similar comment was
                                                  provides a rational basis to issue                      unaware of their exposure to                           received stating that the rule does not
                                                  regulations for presumptions of                         contaminants in the water supply at                    provide ‘‘sufficient redress.’’ Another
                                                  exposure and service connection.                        Camp Lejeune. Similarly, VFW stated                    commenter stated VA should cover the
                                                  Accordingly, VA makes no change                         VA should provide notification to                      cost of in-vitro fertilization or adoption
                                                  based on these comments.                                claimants who were previously denied                   for veterans experiencing female
                                                                                                          benefits. VFW also stated that VA                      infertility. One commenter, the Reserve
                                                  O. Character of Discharge and Eligibility
                                                                                                          should update the Catalog of Federal                   Officers Association, urged Congress to
                                                  for Benefits
                                                                                                          Domestic Assistance titles in the                      enact additional legislation. A comment
                                                     One commenter stated that                            rulemaking to indicate the eligibility to              from VFW suggested VA study the
                                                  individuals with an other than                          additional benefits available to                       combined effects of exposure to
                                                  honorable discharge are excluded from                   reservists and National Guard members                  herbicides and contaminants in the
                                                  eligibility under this rulemaking. This                 as a result of the rulemaking. Another                 water supply at Camp Lejeune. Another
                                                  rulemaking amends 38 CFR 3.307 and                      commenter urged VA to change the                       commenter stated that there is nothing
                                                  3.309; it does not affect the provisions                health care priority group level for                   in writing that pertains to the
                                                  of 38 CFR 3.12, which pertains to the                                                                          individuals who were stationed at Camp
                                                                                                          reservists and National Guard members.
                                                  character of discharge requirements for                                                                        Lejeune. VA received a comment stating
                                                                                                          Another comment stated that the same
                                                  benefits eligibility. Therefore, this                                                                          that VA should provide former Marines
                                                                                                          standards of evidence used to prosecute
                                                  comment is outside the scope of the                                                                            with the Purple Heart. One individual
                                                                                                          a corporation that harms an individual
                                                  rulemaking and VA makes no change                                                                              stated that qualifying individuals
                                                                                                          with toxic chemicals should be re-
                                                  based on it.                                                                                                   should receive a blanket settlement from
                                                                                                          introduced in this rulemaking. Two
                                                  P. Statements About Personal Claims                     commenters, including the Fort                         the government.
                                                                                                                                                                    VA does not respond to these
                                                    As stated previously, many                            McClellan Veterans Stakeholders Group
                                                                                                                                                                 comments because they are either
                                                  commenters made general statements                      and the Project on Government
                                                                                                                                                                 unrelated to this rulemaking or beyond
                                                  about their own experiences with one or                 Oversight, stated VA should pay
                                                                                                                                                                 its scope.
                                                  more of the presumptive disabilities,                   benefits to veterans who served at Fort
                                                  non-presumptive disabilities, their                     McClellan. Another commenter asked                     Executive Orders 12866 and 13563
                                                  personal disability claims, or their                    what effect this rulemaking has on the                    Executive Orders 12866 and 13563
                                                  personal health care claims. Comments                   Camp Lejeune Act or House Resolution                   direct agencies to assess the costs and
                                                  regarding situations involving the                      3954—The Camp Lejeune Reservist                        benefits of available regulatory
                                                  possible outcome of individual claims,                  Parity Act of 2015. One commenter                      alternatives and, when regulation is
                                                  or the medical or claims history                        stated the government uses members of                  necessary, to select regulatory
                                                  presented by individual veterans are                    the armed forces as guinea pigs for                    approaches that maximize net benefits
                                                  beyond the scope of this rulemaking.                    vaccines that have not been approved by                (including potential economic,
                                                  Claimants should contact their VA                       the Food and Drug Administration. VA                   environmental, public health and safety
                                                  regional office for assistance with their               received one comment that stated this                  effects, and other advantages;
                                                  individual claims.                                      policy change does not protect the rights              distributive impacts; and equity).
                                                                                                          of veterans. Another commenter stated                  Executive Order 13563 (Improving
                                                  Q. Other Comments Unrelated to or                       that the contamination is a violation of               Regulation and Regulatory Review)
                                                  Outside the Scope of This Rulemaking                    the 5th Amendment rights of those who                  emphasizes the importance of
                                                    VA received 30 comments dealing                       were exposed and stated the base                       quantifying both costs and benefits,
                                                  with issues not directly related to the                 should be evacuated. Six commenters,                   reducing costs, harmonizing rules, and
                                                  new presumption of exposure or the                      including the Reserve Officers                         promoting flexibility. Executive Order
                                                  new presumptively service-connected                     Association, requested that VA create or               12866 (Regulatory Planning and
                                                  diseases. Such comments covered a                       add their information to unspecified                   Review) defines a ‘‘significant
                                                  wide range of topics; examples of such                  lists/registries. Another commenter                    regulatory action,’’ requiring review by
                                                  comments appear below.                                  stated that Parkinson’s disease should                 the Office of Management and Budget
                                                    One commenter stated that VA needs                    have been specifically listed as a                     (OMB), unless OMB waives such
                                                  to update the VA Schedule for Rating                    neurobehavioral effect. One commenter                  review, as ‘‘any regulatory action that is
                                                  Disabilities, noting that the criteria used             stated that VA should use available                    likely to result in a rule that may: (1)
                                                  to evaluate the diseases covered under                  scientific evidence to ‘‘dismantle’’ the               Have an annual effect on the economy
                                                  this rulemaking are subjective. Another                 provisions of other exposure                           of $100 million or more or adversely
                                                  commenter stated that VA should                         presumptions, such as benefits related                 affect in a material way the economy, a
                                                  evaluate individuals who were                           to radiation exposure. The same                        sector of the economy, productivity,
                                                  previously denied as 100 percent                        commenter stated that the presumption                  competition, jobs, the environment,
                                                  disabled. One commenter stated that VA                  of soundness does not apply to National                public health or safety, or State, local,
                                                  should provide a zero-percent                           Guard or reserve members who did not                   or tribal governments or communities;
                                                  evaluation for any veteran, reservist, or               undergo physical examination during                    (2) Create a serious inconsistency or
                                                  former National Guard member who                        active duty. Finally, this commenter                   otherwise interfere with an action taken
                                                  served at Camp Lejeune during the                       stated that VA should consider National                or planned by another agency; (3)
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                                                  qualifying period. Two commenters                       Guard and reserve members as exposed                   Materially alter the budgetary impact of
                                                  stated that VA should provide health                    to herbicides while serving in Canada.                 entitlements, grants, user fees, or loan
                                                  care in addition to disability                          Another commenter asked if VA would                    programs or the rights and obligations of
                                                  compensation for veterans, reservists,                  provide compensation to private                        recipients thereof; or (4) Raise novel
                                                  and former National Guard members                       insurers for treatment of a covered                    legal or policy issues arising out of legal
                                                  contemplated under this rulemaking.                     disability. Without elaborating further,               mandates, the President’s priorities, or
                                                  Two commenters stated that the rule                     one commenter stated the proposal is                   the principles set forth in this Executive
                                                  does not include a mechanism for                        too limited in scope and took too long                 Order.’’


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                                                  4184                Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations

                                                     The economic, interagency,                           annual effect on the economy of $100                   § 3.307 Presumptive service connection
                                                  budgetary, legal, and policy                            million or more. Therefore, in                         for chronic, tropical, or prisoner-of-war
                                                  implications of this regulatory action                  accordance with 5 U.S.C. 801(a)(1), VA                 related disease, disease associated with
                                                  have been examined, and it has been                                                                            exposure to certain herbicide agents, or
                                                                                                          will submit to the Comptroller General
                                                                                                                                                                 disease associated with exposure to
                                                  determined to be a significant regulatory               and to Congress a copy of this regulatory              contaminants in the water supply at Camp
                                                  action under Executive Order 12866                      action and VA’s Regulatory Impact                      Lejeune; wartime and service on or after
                                                  because it is likely to result in a rule that           Analysis. Provided Congress does not                   January 1, 1947.
                                                  may have an annual effect on the                        adopt a joint resolution of disapproval,                  (a) General. A chronic, tropical, or
                                                  economy of $100 million or more and                     this rule will become effective the later              prisoner of war related disease, a
                                                  may raise novel legal or policy issues                  of the date occurring 60 days after the                disease associated with exposure to
                                                  arising out of legal mandates, the                      date on which Congress receives the                    certain herbicide agents, or a disease
                                                  President’s priorities, or the principles               report, or the date the rule is published              associated with exposure to
                                                  set forth in this Executive Order. VA’s                 in the Federal Register. 5 U.S.C.                      contaminants in the water supply at
                                                  impact analysis can be found as a                       801(a)(3)(A).                                          Camp Lejeune listed in § 3.309 will be
                                                  supporting document at http://                                                                                 considered to have been incurred in or
                                                  www.regulations.gov, usually within 48                  Catalog of Federal Domestic Assistance
                                                                                                                                                                 aggravated by service under the
                                                  hours after the rulemaking document is                    The Catalog of Federal Domestic                      circumstances outlined in this section
                                                  published. Additionally, a copy of this                 Assistance numbers and titles for the                  even though there is no evidence of
                                                  rulemaking and its impact analysis are                  programs affected by this document are                 such disease during the period of
                                                  available on VA’s Web site at http://                                                                          service. No condition other than one
                                                                                                          64.109, Veterans Compensation for
                                                  www.va.gov/orpm/, by following the                                                                             listed in § 3.309(a) will be considered
                                                                                                          Service-Connected Disability; 64.110,
                                                  link for ‘‘VA Regulations Published                                                                            chronic.
                                                                                                          Veterans Dependency and Indemnity
                                                  from FY 2004 Through Fiscal Year to                                                                               (1) Service. The veteran must have
                                                                                                          Compensation for Service-Connected
                                                  Date.’’                                                                                                        served 90 days or more during a war
                                                                                                          Death.
                                                  Regulatory Flexibility Act                                                                                     period or after December 31, 1946. The
                                                                                                          Signing Authority                                      requirement of 90 days’ service means
                                                     The Secretary hereby certifies that                                                                         active, continuous service within or
                                                  these regulatory amendments will not                      The Secretary of Veterans Affairs, or                extending into or beyond a war period,
                                                  have a significant economic impact on                   designee, approved this document and                   or which began before and extended
                                                  a substantial number of small entities as               authorized the undersigned to sign and                 beyond December 31, 1946, or began
                                                  they are defined in the Regulatory                      submit the document to the Office of the               after that date. Any period of service is
                                                  Flexibility Act (5 U.S.C. 601–612).                     Federal Register for publication                       sufficient for the purpose of establishing
                                                  These amendments will directly affect                   electronically as an official document of              the presumptive service connection of a
                                                  only individuals and will not directly                  the Department of Veterans Affairs. Gina               specified disease under the conditions
                                                  affect small entities. Therefore, pursuant              S. Farrisee, Deputy Chief of Staff,                    listed in § 3.309(c) and (e). Any period
                                                  to 5 U.S.C. 605(b), these amendments                    Department of Veterans Affairs,                        of service is sufficient for the purpose of
                                                  are exempt from the regulatory                          approved this document on November                     establishing the presumptive service
                                                  flexibility analysis requirements of                    16, 2016, for publication.                             connection of a specified disease under
                                                  sections 603 and 604.                                                                                          the conditions listed in § 3.309(f), as
                                                                                                            Dated: January 9, 2017.
                                                  Unfunded Mandates                                       Michael Shores,                                        long as the period of service also
                                                     The Unfunded Mandates Reform Act                     Acting Director, Regulation Policy &                   satisfies the requirements to establish a
                                                  of 1995 requires, at 2 U.S.C. 1532, that                Management, Office of the Secretary,                   presumption of exposure to
                                                  agencies prepare an assessment of                       Department of Veterans Affairs.                        contaminants in the water supply at
                                                  anticipated costs and benefits before                                                                          Camp Lejeune under paragraph
                                                                                                          List of Subjects in 38 CFR Part 3                      (a)(7)(iii) of this section.
                                                  issuing any rule that may result in the
                                                  expenditure by State, local, and tribal                   Administrative practice and                          *       *     *     *     *
                                                  governments, in the aggregate, or by the                procedure, Claims, Disability benefits,                   (7) Diseases associated with exposure
                                                  private sector, of $100 million or more                 Veterans.                                              to contaminants in the water supply at
                                                  (adjusted annually for inflation) in any                                                                       Camp Lejeune. (i) For the purposes of
                                                  one year. This final rule will have no                    For the reasons stated in the                        this section, contaminants in the water
                                                  such effect on State, local, and tribal                 preamble, the Department of Veterans                   supply means the volatile organic
                                                  governments, or on the private sector.                  Affairs amends 38 CFR part 3 as follows:               compounds trichloroethylene (TCE),
                                                                                                                                                                 perchloroethylene (PCE), benzene and
                                                  Paperwork Reduction Act                                 PART 3—ADJUDICATION                                    vinyl chloride, that were in the on-base
                                                    This final rule contains no provisions                                                                       water-supply systems located at United
                                                  constituting a collection of information                Subpart A—Pension, Compensation,                       States Marine Corps Base Camp
                                                  under the Paperwork Reduction Act of                    and Dependency and Indemnity                           Lejeune, during the period beginning on
                                                  1995 (44 U.S.C. 3501–3521).                             Compensation                                           August 1, 1953, and ending on
                                                                                                                                                                 December 31, 1987.
                                                  Congressional Review Act                                ■ 1. The authority citation for part 3,                   (ii) The diseases listed in § 3.309(f)
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                                                    Generally, under the Administrative                   subpart A, continues to read as follows:               shall have become manifest to a degree
                                                  Procedure Act, the required publication                   Authority: 38 U.S.C. 501(a), unless                  of 10 percent or more at any time after
                                                  of a substantive rule shall be made not                 otherwise noted.                                       service.
                                                  less than 30 days before its effective                                                                            (iii) A veteran, or former reservist or
                                                  date. 5 U.S.C. 553(d). However, this                    ■ 2. Amend § 3.307 by revising the                     member of the National Guard, who had
                                                  regulatory action is a major rule under                 section heading and paragraphs (a)                     no less than 30 days (consecutive or
                                                  the Congressional Review Act, 5 U.S.C.                  introductory text and (a)(1), and adding               nonconsecutive) of service at Camp
                                                  801–808, because it may result in an                    paragraph (a)(7) to read as follows:                   Lejeune during the period beginning on


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                                                                      Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations                                            4185

                                                  August 1, 1953, and ending on                           FEDERAL COMMUNICATIONS                                 amendments to the rules, thus fulfilling
                                                  December 31, 1987, shall be presumed                    COMMISSION                                             the requirements of section 3(a) of the
                                                  to have been exposed during such                                                                               FOIA Improvement Act.
                                                  service to the contaminants in the water                47 CFR Parts 0 and 1                                      3. The amendments made by this
                                                  supply, unless there is affirmative                                                                            Order can generally be grouped into two
                                                                                                          [FCC 16–171]
                                                  evidence to establish that the individual                                                                      categories. First are rule amendments
                                                  was not exposed to contaminants in the                  Freedom of Information Act                             that are required by or flow directly
                                                  water supply during that service. The                   Improvement Act Implementation                         from changes made by the FOIA
                                                  last date on which such a veteran, or                   Order                                                  Improvement Act. These include
                                                  former reservist or member of the                                                                              regulatory changes specifically
                                                  National Guard, shall be presumed to                    AGENCY:  Federal Communications                        mandated by the FOIA Improvement
                                                  have been exposed to contaminants in                    Commission.                                            Act, as well as changes that are
                                                  the water supply shall be the last date                 ACTION: Final rule.                                    informed by the FOIA Improvement
                                                  on which he or she served at Camp                                                                              Act. Second are rule amendments
                                                  Lejeune during the period beginning on                  SUMMARY:    In this document, the Federal              designed to conform the rules to
                                                  August 1, 1953, and ending on                           Communications Commission amends                       existing Commission FOIA practice,
                                                  December 31, 1987. For purposes of this                 its rules to update various sections                   streamline FOIA procedures, and
                                                  section, service at Camp Lejeune means                  implementing the Freedom of                            provide for clerical corrections. A
                                                  any service within the borders of the                   Information Act (FOIA) to reflect                      number of years have passed since the
                                                  entirety of the United States Marine                    changes in the law made by the FOIA                    Commission’s FOIA regulations were
                                                  Corps Base Camp Lejeune and Marine                      Improvement Act of 2016, to making                     last updated, and new technology,
                                                  Corps Air Station New River, North                      conforming edits to reflect existing                   practices, and procedures have arisen
                                                  Carolina, during the period beginning                   Commission FOIA practice, to                           since that time. We update the
                                                  on August 1, 1953, and ending on                        streamline the Commission’s FOIA                       regulations to reflect the current state of
                                                  December 31, 1987, as established by                    procedures, and to provide for clerical                the Commission’s FOIA process.
                                                  military orders or other official service               corrections.                                              4. The Commission’s FOIA
                                                  department records.                                     DATES: Effective February 13, 2017.                    implementing rules are presently found
                                                     (iv) Exposure described in paragraph                 FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                 at 47 CFR 0.441–0.470. The amended
                                                  (a)(7)(iii) of this section is an injury                Ryan Yates, 202–418–0886 or TTY: 202–                  rules are set forth in the Appendix to
                                                  under 38 U.S.C. 101(24)(B) and (C). If an                                                                      this Order and are described in more
                                                                                                          418–0484; Ryan.Yates@fcc.gov.
                                                                                                                                                                 detail below.
                                                  individual described in paragraph                       SUPPLEMENTARY INFORMATION:                                5. The following rule changes are
                                                  (a)(7)(iii) of this section develops a                     1. This is a synopsis of the Federal                either required by the text of the FOIA
                                                  disease listed in § 3.309(f), VA will                   Communication Commission’s Order,                      Improvement Act or are made in
                                                  presume that the individual concerned                   FCC 16–171, released on December 15,                   response to issues raised in the FOIA
                                                  became disabled during that service for                 2016, amending Parts 0 and 1 of the                    Improvement Act.
                                                  purposes of establishing that the                       Commission’s rules to update sections                     6. Section 0.251—Authority
                                                  individual served in the active military,               implementing the FOIA. The complete                    Delegated. Section 0.251 describes the
                                                  naval, or air service.                                  text of the document is available on the               authorities delegated to the General
                                                  *      *      *     *     *                             Commission’s Web site at http://                       Counsel by the Commission. We add to
                                                  ■ 3. Add § 3.309(f) to read as follows:                 www.fcc.gov or at https://apps.fcc.gov/                the rule by delegating to the General
                                                                                                          edocs_public/attachmatch/FCC-16-                       Counsel the authority to act as the Chief
                                                  § 3.309 Disease subject to presumptive                  171A1.pdf. It is also available for                    FOIA Officer. The position of Chief
                                                  service connection.                                     inspection and copying during normal                   FOIA Officer was created by the Open
                                                  *     *     *     *    *                                business hours in the FCC Reference                    Government Act of 2007 and expanded
                                                    (f) Disease associated with exposure                  Information Center, Portals II, 445 12th               upon by the FOIA Improvement Act.
                                                  to contaminants in the water supply at                  Street SW., Room CY–A257,                                 7. Section 0.441—General. Section
                                                  Camp Lejeune. If a veteran, or former                   Washington, DC 20554.                                  0.441 sets forth general information
                                                  reservist or member of the National                        2. By this Order, we amend Part 0 of                related to the Commission’s FOIA
                                                  Guard, was exposed to contaminants in                   the Commission’s rules to update                       practice. We make two changes to this
                                                  the water supply at Camp Lejeune                        various sections implementing the                      section that are required by the FOIA
                                                  during military service and the exposure                Freedom of Information Act (FOIA). On                  Improvement Act. First, we include a
                                                  meets the requirements of § 3.307(a)(7),                June 30, 2016, the President signed into               notice that FOIA requesters may seek
                                                  the following diseases shall be service-                law the FOIA Improvement Act of 2016                   the assistance of the FOIA Public
                                                  connected even though there is no                       (FOIA Improvement Act). The law went                   Liaison or the Office of Government
                                                  record of such disease during service,                  into effect July 1, 2016, and requires,                Information Services to assist in
                                                  subject to the rebuttable presumption                   inter alia, that agencies review their                 resolving disputes, along with the
                                                  provisions of § 3.307(d).                               FOIA regulations and promulgate new                    procedure for engaging such assistance.
                                                    (1) Kidney cancer.                                    rules in accordance with the substantive               These changes are specifically required
                                                    (2) Liver cancer.                                     provisions of the law. These provisions                by the FOIA Improvement Act. Second,
                                                    (3) Non-Hodgkin’s lymphoma.                           included providing 90 days for                         in light of the FOIA Improvement Act’s
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                                                    (4) Adult leukemia.                                   requesters to file appeals of FOIA                     emphasis on the duties of the Chief
                                                    (5) Multiple myeloma.                                 requests, ensuring that requesters are                 FOIA Officer, including new
                                                    (6) Parkinson’s disease.                              informed of avenues for FOIA dispute                   responsibilities to offer training to
                                                    (7) Aplastic anemia and other                         resolution, and providing for public                   agency staff and to serve as the liaison
                                                  myelodysplastic syndromes.                              posting of materials that are requested                with the National Archives and Records
                                                    (8) Bladder cancer.                                   multiple times. The Commission has                     Administration’s Office of Government
                                                  [FR Doc. 2017–00499 Filed 1–12–17; 8:45 am]             completed review of its FOIA                           Information Services and the
                                                  BILLING CODE 8320–01–P                                  regulations and in this Order adopts                   Department of Justice’s Office of


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Document Created: 2017-01-13 02:44:38
Document Modified: 2017-01-13 02:44:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesEffective Date: This final rule is effective March 14, 2017.
ContactEric Mandle, Policy Analyst, Regulations Staff (211D), Compensation Service, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-9700. (This is not a toll-free telephone number.)
FR Citation82 FR 4173 
RIN Number2900-AP66
CFR AssociatedAdministrative Practice and Procedure; Claims; Disability Benefits and Veterans

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