[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Proposed Rules]
[Pages 47795-47797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19634]
[[Page 47795]]
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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: Proposed rule.
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SUMMARY: The Department of Veterans Affairs (VA) proposes to amend its
adjudication regulation concerning presumptive service connection for
acute and sub-acute peripheral neuropathy associated with exposure to
certain herbicide agents.
This proposed amendment is necessary to implement a decision by the
Secretary of Veterans Affairs to clarify and expand the terminology
regarding presumption of service connection for peripheral neuropathy
associated with exposure to certain herbicide agents.
DATES: Comments must be received by VA on or before October 9, 2012.
ADDRESSES: Written comments may be submitted through http://www.regulations.gov; by mail or hand-delivery to Director, Regulations
Management (02REG), Department of Veterans Affairs, 810 Vermont Ave.
NW., Room 1068, Washington, DC 20420; or by fax to (202) 273-9026.
(This is not a toll free number). Comments should indicate that they
are submitted in response to ``RIN 2900-AO32--Disease Associated With
Exposure to Certain Herbicide Agents: Peripheral Neuropathy.'' Copies
of comments received will be available for public inspection in the
Office of Regulation Policy and Management, Room 1063B, between the
hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except
holidays). Please call (202) 461-4902 for an appointment. (This is not
a toll free number.) In addition, during the comment period, comments
may be viewed online through the Federal Docket Management System at
http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Nick Olmos-Lau, Medical Officer,
Regulations Staff (211D), Compensation Service, Veterans Benefits
Administration, Department of Veterans Affairs, 810 Vermont Avenue NW.,
Washington, DC 20420, (202) 461-9695. (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 September 29, 2011, NAS publicly released the report titled,
Veterans and Agent Orange: Update 2010, which describes the law
mandating the NAS review and highlights of the ninth biennial update.
In Update 2010, NAS conducted a comprehensive search of all medical and
scientific studies on health effects of herbicides used in the Vietnam
War, including more than 6,600 potentially relevant studies, of which
1,300 were carefully reviewed, and about 65 ultimately contributed new
information. Relevant animal studies, as with previous biennial ``Agent
Orange Updates,'' were also reviewed to determine biological
plausibility and possible mechanisms of action.
Compared to previous reports, a notable change is the NAS decision
to revise and clarify the description of the types of peripheral
neuropathy that may be associated with exposure to an herbicide agent
to include all early-onset peripheral neuropathies, regardless of
whether they are transient or persistent in nature. In 1996, NAS found
that there was ``limited/suggestive evidence'' of an association
between herbicide exposure and the occurrence of ``acute and subacute
transient peripheral neuropathy.'' In subsequent updates, NAS continued
to find ``limited or suggestive evidence'' of an association between
herbicide exposure and that condition, but in 2004, NAS revised its
description of the condition to ``early onset transient peripheral
neuropathy.'' This terminology reflected NAS's judgment that peripheral
neuropathy associated with herbicide exposure would have its onset
proximate in time to herbicide exposure and would be of a transient
nature that would resolve over time. Pursuant to the 1996 NAS Report,
VA established a regulatory presumption of service connection for
``acute and subacute peripheral neuropathy,'' which is defined as
``transient peripheral neuropathy that appears within weeks or months
of exposure to an herbicide agent and resolves within two years of the
date of onset.''
In Update 2010, NAS concluded that there is ``limited or suggestive
evidence of an association'' between exposure to the chemicals of
interest and ``early-onset peripheral neuropathy that may be
persistent.'' This description reflects NAS' decision to remove the
term ``transient'' from the description of the peripheral neuropathies
associated with herbicide exposure. In Update 2010, NAS reexamined
several studies reviewed in prior NAS reports concerning early-onset
peripheral neuropathy in individuals exposed to herbicides and found
that, in several of the studies, some exposed individuals continued to
exhibit neurological symptoms several years after exposure. NAS
explained that, for the purpose of identifying peripheral neuropathies
related to herbicide exposure, the diagnosis of the condition is
contingent upon the proximity of the disease onset to the exposure,
rather than upon the adverse outcome having a transitory nature. NAS
stated that, in cases of an immediate response of peripheral neuropathy
following a toxic exposure, stabilization or improvement is the rule
after exposure ends, but that the recovery may not be complete and the
degree of recovery can depend on the severity of the initial impairment
and the particular exposure. NAS further noted that there may be
persistent subclinical effects that are not immediately apparent but
that may be detected by detailed examination and testing. Accordingly,
NAS concluded that early-onset peripheral neuropathy associated with
herbicide exposure is not necessarily a transient condition. However,
NAS reaffirmed the conclusion in each of its prior reports that no data
suggests that exposure to the chemicals of interest can lead to the
development of delayed-onset chronic
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neuropathy many years after termination of exposure in those who did
not originally experience early-onset neuropathy.
As stated above, VA's current regulation presumes service
connection for ``acute and subacute peripheral neuropathy'' which the
regulation defines as ``transient peripheral neuropathy that appears
within weeks or months of exposure to an herbicide agent and resolves
within two years of the date of onset.'' After careful review of NAS'
conclusions, VA proposes to replace the terms ``acute and subacute'' in
38 CFR 3.309(e) with the term ``early-onset'' and remove the Note to
the regulation requiring that the neuropathy be ``transient.''
Accordingly, VA proposes to remove the current requirement that acute
and subacute peripheral neuropathy appear ``within weeks or months''
after exposure and remove the requirement that the condition resolve
within two years of the date of onset in order for the presumption to
apply.
For purposes of consistency, VA further proposes to replace the
terms ``acute and subacute'' with ``early-onset'' in 38 CFR
3.307(a)(6)(ii) requiring peripheral neuropathy to become manifest to a
degree of 10 percent or more within one year after the last date of
herbicide exposure in order to be subject to presumptive service
connection under 38 CFR 3.309(e).
This amendment would clarify that presumptive service connection
for early-onset peripheral neuropathy will not be denied solely because
the peripheral neuropathy persisted for more than two years after the
date of last herbicide exposure. However, this amendment would not
change the current requirement that peripheral neuropathy must have
become manifest to a degree of 10 percent or more within one year after
the date of last exposure in order to qualify for the presumption of
service connection. In Update 2010, the NAS found that evidence did not
indicate an association between herbicide exposure and delayed-onset
peripheral neuropathy, which NAS defined as peripheral neuropathy
having its onset more than one year after exposure.
The one-year presumption period in 38 CFR 3.307(a)(6)(ii) is
measured from the date of last herbicide exposure in service. In many
cases, such as those based on service in the Republic of Vietnam during
the Vietnam era, this would require evidence that peripheral neuropathy
was manifest to a degree of ten percent or more during a period several
years or decades in the past. Under 38 U.S.C. 1110, VA may pay
disability compensation for disability resulting from a service-
connected disease or injury. In adjudicating individual claims for
benefits, it may therefore be necessary to determine whether evidence
shows that current disability exists as a result of the service-
connected peripheral neuropathy that was manifest within the
presumption period. VA will develop and decide these issues on a case-
by-case basis in accordance with established law.
Additionally, we propose to revise 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 the case of Nehmer v. U.S. Department of Veterans
Affairs. Currently Sec. 3.816(b)(2) 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.'' Rather than revising this list, we
propose to remove the list of conditions and the October 1, 2002, date
and insert language clarifying that the Nehmer court orders apply to
the presumptions listed in Sec. 3.309(e). This change is necessary
because the district court and the U.S. Court of Appeals for the Ninth
Circuit in Nehmer found the date restriction and the corresponding
listing of presumptive conditions based on herbicide exposure found at
Sec. 3.816(b)(2) to be invalid as it is not inclusive of all
conditions the Secretary has determined to be presumptively service
connected based on herbicide exposure under the Agent Orange Act of
1991. Therefore, VA proposes to remove paragraphs (b)(2)(i)-(ix) and
the phrase ``before October 1, 2002'' and to add a reference to Sec.
3.309(e) that reflects the inclusive listing in the introduction to
paragraph (b)(2).
Paperwork Reduction Act
This document contains no provisions constituting a collection of
information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).
Regulatory Flexibility Act
The Secretary hereby certifies that this proposed rule 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. This proposed rule would not affect any small entities.
Only VA beneficiaries could be directly affected. Therefore, pursuant
to 5 U.S.C. 605(b), this proposed rule is exempt from the initial and
final regulatory flexibility analysis requirements of sections 603 and
604.
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,'' 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 proposed 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.
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 proposed rule would have no such effect on
State, local, and tribal governments, or on the private sector.
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Catalog of Federal Domestic Assistance Numbers and Titles
The Catalog of Federal Domestic Assistance program numbers and
titles for this rule are 64.109, Veterans Compensation for Service-
Connected Disability; and 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. John R.
Gingrich, Chief of Staff, Department of Veterans Affairs, approved this
document on April 5, 2012, 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: August 7, 2012.
Robert C. McFetridge,
Director, Regulation Policy and Management, Office of the General
Counsel, Department of Veterans Affairs.
For the reasons set out in the preamble, VA proposes to amend 38
CFR part 3 as follows:
PART 3--ADJUDICATION
Subpart A-Pension, Compensation, and Dependency and Indemnity
Compensation
1. The authority citation for part 3, subpart A continues to read
as follows:
Authority: 38 U.S.C. 501(a), unless otherwise noted.
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''.
3. Amend Sec. 3.309(e) by:
a. Removing the term ``Acute and subacute peripheral neuropathy''
and adding, in its place, ``Early-onset peripheral neuropathy''.
b. Removing Note 2.
c. Redesignating Note 3 as Note 2.
4. Amend Sec. 3.816(b)(2) by:
a. In the introductory text, removing ``before October 1, 2002.''
b. In the introductory text, removing the period after
``chloracne'' and all that follows through the end of the introductory
text and adding, in its place, ``, as provided in Sec. 3.309(e).''
c. Removing paragraphs (i) through (ix).
[FR Doc. 2012-19634 Filed 8-9-12; 8:45 am]
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