[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]



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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]
BILLING CODE 8320-01-P