[Federal Register Volume 78, Number 173 (Friday, September 6, 2013)]
[Rules and Regulations]
[Pages 54763-54766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21674]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 3
RIN 2900-AO32
Disease Associated With Exposure to Certain Herbicide Agents:
Peripheral Neuropathy
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
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SUMMARY: The Department of Veterans Affairs (VA) adopts as a final rule
its proposal to amend its adjudication regulations by clarifying and
expanding the terminology regarding presumptive service connection for
acute and subacute peripheral neuropathy associated with exposure to
certain herbicide agents. This amendment implements a decision by the
Secretary of Veterans Affairs based on findings from the National
Academy of Sciences (NAS) Institute of Medicine report, Veterans and
Agent Orange: Update 2010. It also amends VA's regulation governing
retroactive awards for certain diseases associated with herbicide
exposure as required by court orders in the class action litigation of
Nehmer v. U.S. Department of Veterans Affairs.
DATES: Effective Date: This rule is effective September 6, 2013.
Applicability Date: This final rule shall apply to claims received
by VA on or after September 6, 2013 and to claims pending before VA on
that date. Additionally, VA will apply this rule in readjudicating
certain previously denied claims as required by court orders in Nehmer
v. Department of Veterans Affairs.
FOR FURTHER INFORMATION CONTACT: Dr. Nick Olmos-Lau, Medical Officer,
Regulations Staff (211D), or Nancy Copeland, Consultant, Compensation
Service, Veterans Benefits Administration, Department of Veterans
Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-9700.
(This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: As required by the Agent Orange Act of 1991,
codified in part at 38 U.S.C. 1116, the Department of Veterans Affairs
(VA) asks the National Academy of Sciences (NAS) to evaluate scientific
literature regarding possible associations between the occurrence of a
disease in humans and exposure to an herbicide agent. Congress mandated
that NAS to the extent possible determine (1) Whether there is a
statistical association between exposure to herbicide agents and the
illness, taking into account the strength of the scientific evidence
and the appropriateness of the scientific methodology used to detect
the association; (2) the increased risk of illness among individuals
exposed to herbicide agents during service in the Republic of Vietnam
during the Vietnam era; and (3) whether a plausible biological
mechanism or other evidence of a causal relationship exists between
exposure to the herbicides and the illness. That statute provides that
whenever the Secretary determines, based on sound medical and
scientific evidence, that a positive association (i.e., the credible
evidence for the association is equal to or outweighs the credible
evidence against the association) exists between an illness and
exposure to herbicide agents in an herbicide used in support of U.S.
military operations in the Republic of Vietnam, the Secretary will
publish regulations establishing presumptive service connection for
that illness. On August 10, 2012, VA published a proposed rule in the
Federal Register (77 FR 47795), to amend its adjudication regulations
regarding presumptive service connection for acute and subacute
peripheral neuropathy associated with exposure to certain herbicide
agents. Specifically, based on findings from the September 29, 2010 NAS
report titled, Veterans and Agent Orange: Update 2010 (hereinafter
``Update 2010''), which concluded that early-onset peripheral
neuropathy associated with herbicide exposure is not necessarily a
transient condition, we
[[Page 54764]]
proposed replacing the terms ``acute and subacute'' in 38 CFR
3.307(a)(6)(ii) and 38 CFR 3.309(e) with the term ``early-onset'' and
removing the Note to 38 CFR 3.309(e) requiring that the neuropathy be
``transient.'' This change would remove the requirement that acute and
subacute peripheral neuropathy appear ``within weeks or months'' after
exposure and that the condition resolve within two years of the date of
onset in order for the presumption to apply.
This amendment clarifies that VA will not deny presumptive service
connection for early-onset peripheral neuropathy solely because the
condition persisted for more than two years after the date of the last
herbicide exposure. However, it does not change the requirement that
peripheral neuropathy must have become manifest to a degree of ten
percent or more within one year after the veteran's last in-service
exposure in order to qualify for the presumption of service connection.
In Update 2010, NAS found that evidence did not support an association
between herbicide exposure and delayed-onset peripheral neuropathy,
which NAS defined as having its onset more than one year after
exposure.
We also proposed amending 38 CFR 3.816(b)(2), the regulation
governing retroactive awards for certain diseases associated with
herbicide exposure as required by court orders in the class action
litigation in Nehmer v. U.S. Veterans' Admin. 712 F. Supp. 1404 (N.D.
Cal. 1989) (incorporating Final Stipulation and Order, May 14, 1991)
(Nehmer I), enforced, Nehmer v. U.S. Veterans' Admin., 32 F. Supp. 2d
1175 (N.D. Cal. 1999) (Nehmer II), aff'd sub nom., Nehmer v. Veterans'
Admin. of Gov't of U.S., 284 F.3d 1158 (9th Cir. 2002) (Nehmer III);
Nehmer v. U.S. Dep't of Veterans Affairs, 494 F.3d 846, 850 (9th Cir.
2007) (Nehmer IV).
Currently, the regulation states that the Nehmer court orders apply
to presumptions established before October 1, 2002, and lists the
diseases covered by those presumptions, including ``acute and subacute
peripheral neuropathy.'' The courts invalidated the date restriction
and corresponding listing of presumptive conditions because they were
not inclusive of all the conditions VA has determined to be
presumptively service connected based on herbicide exposure under the
Agent Orange Act of 1991. Rather than revising and maintaining separate
lists of diseases covered, VA is removing the list of conditions in 38
CFR 3.816 and the October 1, 2002, date and inserting language
clarifying that the Nehmer court orders apply to the presumptions
listed in 38 CFR 3.309(e).
We provided a 60-day comment period and interested persons were
invited to submit comments on or before October 9, 2012. We received
111 written comments, including 3 from Veterans Service Organizations
and advocacy groups.
The majority of commenters expressed support for VA's proposed
amendments. However, many felt that the action does not go far enough
and urged VA to eliminate the requirement that peripheral neuropathy
manifest to a degree of at least ten percent disabling within the first
year after the veteran's last in-service exposure to herbicides. VA
appreciates these comments. However, in Update 2010, NAS concluded that
there is inadequate or insufficient evidence to determine whether there
is an association between exposure to herbicides (including Agent
Orange) and delayed-onset chronic neuropathy. NAS reaffirmed the
conclusion in each of its prior reports that there are no data to
suggest that exposure to herbicides can lead to the development of
delayed-onset chronic peripheral neuropathy many years after
termination of exposure in those who did not originally experience
early-onset neuropathy. NAS went on to state that ``[t]he committee
considers a neuropathy to be early onset if abnormalities appear within
a year after external exposure has ended.'' Therefore, we make no
changes based on these comments.
Several commenters advocated that VA expand the list of presumptive
conditions for veterans exposed to Agent Orange. Some asserted that
veterans exposed to Agent Orange during service should be granted
entitlement to service connection for all disabilities they currently
have and one commenter stated that all Vietnam era veterans should be
automatically entitled to 100 percent compensation. A service
organization urged that hypertension be added based on the benefit of
the doubt doctrine. The organization contends that, because some
studies link hypertension to herbicide exposure while others do not,
the evidence is in equipoise and veterans should be given the benefit
of the doubt. Another service organization asserted that VA's proposed
rule fails to provide the most favorable interpretation of the existing
science.
In response, VA notes that the Agent Orange Act of 1991, codified
at 38 U.S.C. 1116, established a deliberate process for determining
when a disease should be added. Specifically, the Secretary must
determine, based on sound medical and scientific evidence, that there
is a ``positive association'' between an illness and exposure to
herbicide agents used in support of U.S. military operations in the
Republic of Vietnam. The Secretary must take into account reports from
NAS and ``all other sound medical and scientific information and
analyses available to the Secretary.'' In evaluating any study, the
Secretary must ``take into consideration whether the results are
statistically significant, are capable of replication, and withstand
peer review.'' The law further provides that a positive association
exists if ``the credible evidence for the association is equal to or
outweighs the credible evidence against the association.'' VA adheres
to this process. Following the issuance of Update 2010, VA issued a
negative notice on August 10, 2012, explaining why no additional
diseases were being added to its list of conditions associated with
exposure to herbicides in Vietnam (77 FR 47924). This notice provided
an explanation of VA's decision to not create presumptions of service
connection for a variety of other diseases, including hypertension.
This rulemaking is limited to clarifying and expanding the terminology
regarding presumptive service connection for acute and subacute
peripheral neuropathy associated with exposure to certain herbicides.
See 77 FR 47795. As such, the addition of diseases other than early-
onset peripheral neuropathy to VA's presumptive list is beyond the
scope of this rulemaking. Therefore, we make no changes based on these
comments.
Three commenters, including one service organization, urged VA to
recognize chronic delayed-onset peripheral neuropathy as due to Agent
Orange exposure when no other cause can be established. As explained
earlier, NAS found that there are no data to suggest that exposure to
herbicides can lead to the development of delayed-onset chronic
peripheral neuropathy many years after termination of exposure in those
who did not originally experience early-onset neuropathy. NAS also
noted that some neuropathies are often labeled as idiopathic or of
unknown or spontaneous origin because, in 30 percent of the cases of
chronic neuropathies, there is no apparent cause. Therefore, we make no
changes based on these comments.
We received many comments from veterans who served in the Republic
of Vietnam regarding their individual claims for veterans benefits and
comments from family members and friends in support of veterans who
served in the Republic of Vietnam. These comments are beyond the scope
[[Page 54765]]
of this rulemaking. Therefore, VA makes no changes based on these
comments.
Some commenters, including one service organization, support the
rule but advocate for more research and point to other entities and
studies as additional resources. The service organization also urged VA
to fund well-designed epidemiologic studies of Vietnam veterans. VA
acknowledges the need for ongoing research and continues to carefully
evaluate ongoing NAS herbicide exposure studies, medical and scientific
research findings, discoveries, and recommendations as they occur. In
addition, VA conducts ongoing research on the health effects of
herbicides and supports epidemiologic studies of Vietnam veterans
through grants to outside scientists. We make no changes based on these
comments.
One commenter disagreed with VA's proposed rule, stating that he is
not a veteran and that he was diagnosed with peripheral neuropathy as
the result of shingles. VA recognizes that peripheral neuropathy is not
unique to veterans or exposure to Agent Orange. However, as explained
above, pursuant to the Agent Orange Act of 1991, whenever the Secretary
determines, based on sound medical and scientific evidence, that there
is a positive association (i.e., the credible evidence for the
association is equal to or outweighs the credible evidence against the
association) between an illness and exposure to herbicide agents, the
Secretary will publish regulations establishing presumptive service
connection for that illness. Thus, VA makes no changes based on this
comment.
One commenter suggested that VA should add a regulatory ``discovery
rule'' to the current requirement that peripheral neuropathy become
manifest to a degree of ten percent or more within one year after the
veteran's last in-service exposure. The commenter clarified that his
proposed ``discovery rule'' would provide for a tolling of the current
one-year manifestation requirement until after the veteran is first
diagnosed with peripheral neuropathy (i.e., the veteran first
``discovers'' that he or she has peripheral neuropathy). The commenter
asserted that adding a ``discovery rule'' to the one-year period would
give relief to veterans with peripheral neuropathy whose symptoms were
not recognized until many years after exposure while also balancing
cost concerns. In response, VA notes that the existing statutory and
regulatory framework governing the administration of VA compensation
benefits does not limit the time period during which veterans may file
claims for benefits. Moreover, whether a condition became manifest to a
degree of ten percent or more within one year of the veteran's last in-
service exposure to herbicides is a factual determination that must be
made on a case-by-case basis, considering all the available evidence.
Additionally, even if a veteran is not able to avail himself of the
presumption of service connection, he may still be able to establish
service connection on a direct basis under 38 U.S.C. 1110 and 38 CFR
3.303(d). To the extent the comment recommends changes to VA's overall
scheme for administering benefits, such changes would require
legislation which is beyond the scope of this rulemaking. Thus, VA
makes no changes based on this comment.
One commenter stated that he had type 2 diabetes and asked why a
time limit is being imposed on the onset of peripheral neuropathy,
given that it may result from type 2 diabetes that arises many years
after the initial diagnosis of that condition. Several other commenters
also stated that they had diabetes and asserted that they should be
able to receive compensation for both diabetes and peripheral
neuropathy. These commenters may be confused as to how the peripheral
neuropathy presumption relates to cases where peripheral neuropathy
arises secondary to service-connected type 2 diabetes. In such cases,
service connection can be awarded under 38 CFR 3.310 if the peripheral
neuropathy is found to be secondary to service-connected type 2
diabetes. As a result, the ``early onset'' time limitation contained in
the amended 38 CFR 3.307(a)(6)(ii), would not apply to these cases.
One organization commented that there is a disparity between the
law and actual practice and stated that the Board of Veterans' Appeals
has considered the latent nature of peripheral neuropathy and found in
favor of disabled veterans on many occasions. Decisions of the Board
are not considered precedential and are binding only with regard to the
specific case addressed in each decision. Moreover, as discussed above,
determinations regarding entitlement to service connection are made on
an individual basis, dependent on the facts of each case. Even if a
veteran is unable to avail himself of the presumption afforded by 38
U.S.C. 1116, he may still be able to establish entitlement on a direct
basis. This is particularly important when there is an approximate
balance of positive and negative evidence in a claimant's particular
case because a claimant is entitled to the benefit of the doubt. (38
U.S.C. 5107(b)) The fact that VA has made favorable determinations
underscores its adherence to this principle when deciding the merits of
each case. VA makes no changes based on this comment.
One organization stated that using the term ``early-onset'' in 38
CFR 3.307(a)(6)(ii) is unnecessary and confusing because the
requirement in that regulation that the disease be manifest to a ten
percent degree within one year of exposure is sufficient to indicate
that the presumption applies only to early-onset peripheral neuropathy.
However, we believe that using the term ``early-onset peripheral
neuropathy'' is necessary and helpful in 38 CFR 3.309(e), which lists
the diseases presumptively associated with herbicide exposure, and we
believe that using consistent terminology in 38 CFR 3.307(a)(6)(ii) and
3.309(e) will minimize confusion rather than creating it. The commenter
also asserted that the changes to 38 CFR 3.816(b)(2) are unrelated to
NAS' findings regarding peripheral neuropathy and that cross-
referencing between 38 CFR 3.816 and 38 CFR 3.309 appears to obfuscate
the diseases that receive a presumptive service connection and may
serve to undermine the Agent Orange Act of 1991. We have considered the
language used and believe it is clear and accurate. As explained in the
proposed rule, we are revising 3.816(b)(2) to comport with the Nehmer
court orders and believe that cross-referencing 38 CFR 3.816 and 38 CFR
3.309 will simplify updating the list of diseases covered. This
revision will clarify that Nehmer court orders apply to all presumptive
conditions covered by Sec. 3.309(e). As such, we make no change based
on these comments.
Based on the rationale set forth in the proposed rule and this
document, we are adopting the proposed rule as a final rule with no
changes.
Administrative Procedure Act
The Secretary finds good cause to dispense with the delayed-
effective-date requirement of 5 U.S.C. 553(d) because 38 U.S.C. 1116
(c)(2) requires that final regulations establishing presumptions of
service connection for diseases associated with exposure to certain
herbicide agents ``shall be effective on the date of issuance.''
Paperwork Reduction Act
This document contains no provisions constituting a new collection
of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).
Regulatory Flexibility Act
The Secretary hereby certifies that this rule will not have a
significant economic impact on a substantial
[[Page 54766]]
number of small entities as they are defined in the Regulatory
Flexibility Act, 5 U.S.C. 601-612. This rule will not affect any small
entities. Only VA beneficiaries could be directly affected. Therefore,
pursuant to 5 U.S.C. 605(b), this rule is exempt from the initial and
final regulatory flexibility analysis requirements of sections 603 and
604.
Executive Order 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,'' which requires review by the Office
of Management and Budget (OMB), 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.''
The economic, interagency, budgetary, legal, and policy
implications of this final rule have been examined and it has been
determined to be a significant regulatory action under Executive Order
12866 because it raises novel legal or policy issues.
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 the
rulemaking and its impact analysis are available on VA's Web site at
http://www1.va.gov/orpm/, by following the link for ``VA Regulations
Published.''
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 year. This rule will have no such effect on State,
local, and tribal governments, or on the private sector.
Catalog of Federal Domestic Assistance Numbers and Titles
The Catalog of Federal Domestic Assistance program number and title
for this rule is 64.109, Veterans Compensation for Service-Connected
Disability.
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. Jose D.
Rojas, Interim Chief of Staff, approved this document on April 22,
2013, for publication.
List of Subjects in 38 CFR Part 3
Administrative practice and procedure, Claims, Disability benefits,
Health care, Pensions, Radioactive materials, Veterans, Vietnam.
Dated: September 3, 2013.
Robert C. McFetridge,
Director of Regulations Policy and Management, Office of the General
Counsel, Department of Veterans Affairs.
For the reasons set out in the preamble, VA amends 38 CFR part 3 as
follows:
PART 3--ADJUDICATION
Subpart A--Pension, Compensation, and Dependency and Indemnity
Compensation
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1. The authority citation for part 3, subpart A continues to read as
follows:
Authority: 38 U.S.C. 501(a), unless otherwise noted.
Sec. 3.307 [Amended]
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2. In Sec. 3.307(a)(6)(ii), remove the term ``acute and subacute
peripheral neuropathy'' and add, in its place, ``early-onset peripheral
neuropathy''.
Sec. 3.309 [Amended]
0
3. Amend Sec. 3.309(e) by:
0
a. Removing the term ``Acute and subacute peripheral neuropathy'' and
adding, in its place, ``Early-onset peripheral neuropathy''.
0
b. Removing Note 2.
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c. Redesignating Note 3 as Note 2.
Sec. 3.816 [Amended]
0
4. Amend Sec. 3.816 by:
0
a. In the introductory text of paragraph (b)(2), removing ``before
October 1, 2002.''
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b. In the introductory text of paragraph (b)(2), removing the period
after ``chloracne'' and the phrase ``Those diseases are:'' and adding,
in their place, ``, as provided in Sec. 3.309(e).''
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c. Removing paragraphs (b)(2)(i) through (ix).
[FR Doc. 2013-21674 Filed 9-5-13; 8:45 am]
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