Disease Associated With Exposure to Certain Herbicide Agents: Peripheral Neuropathy, 54763-54766 [2013-21674]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[Federal Register Volume 78, Number 173 (Friday, September 6, 2013)]
[Rules and Regulations]
[Pages 54763-54766]
From the Federal Register Online via the Government Printing 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 
https://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 
https://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

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.


Sec.  3.307  [Amended]

0
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.
0
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.''
0
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).''
0
c. Removing paragraphs (b)(2)(i) through (ix).

[FR Doc. 2013-21674 Filed 9-5-13; 8:45 am]
BILLING CODE 8320-01-P