[Federal Register Volume 73, Number 213 (Monday, November 3, 2008)]
[Proposed Rules]
[Pages 65280-65282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26175]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 73, No. 213 / Monday, November 3, 2008 /
Proposed Rules
[[Page 65280]]
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 3
RIN 2900-AN01
Presumptive Service Connection for Disease Associated With
Exposure to Certain Herbicide Agents: AL Amyloidosis
AGENCY: Department of Veterans Affairs.
ACTION: Proposed rule.
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SUMMARY: The Department of Veterans Affairs (VA) is proposing to amend
its adjudication regulations concerning presumptive service connection
for a certain disease based on the most recent National Academy of
Sciences (NAS) Institute of Medicine committee report, ``Veterans and
Agent Orange: Update 2006 (Update 2006).'' This proposed amendment is
necessary to implement a decision of the Secretary of Veterans Affairs
that there is a positive association between exposure to herbicides
used in the Republic of Vietnam during the Vietnam era and the
subsequent development of AL amyloidosis. The intended effect of this
proposed amendment is to establish presumptive service connection for
AL amyloidosis based on herbicide exposure.
DATES: Comments must be received by VA on or before January 2, 2009.
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 Avenue,
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-AN01--Disease Associated With
Exposure to Certain Herbicide Agents: AL Amyloidosis.'' 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
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: Rhonda F. Ford, Chief, Regulations
Staff (211D), Compensation and Pension Service, Veterans Benefits
Administration, Department of Veterans Affairs, 810 Vermont Avenue,
NW., Washington, DC 20420, (202) 461-9739. (This is not a toll-free
number.)
SUPPLEMENTARY INFORMATION: Section 3 of the Agent Orange Act of 1991,
Public Law 102-4, 105 Stat. 11, directed the Secretary to seek to enter
into an agreement with NAS to review and summarize the scientific
evidence concerning the association between exposure to herbicides used
in support of military operations in the Republic of Vietnam during the
Vietnam era and each disease suspected to be associated with such
exposure. Congress mandated that NAS determine, to the extent possible:
(1) Whether there is a statistical association between the suspect
diseases and herbicide exposure, taking into account the strength of
the scientific evidence and the appropriateness of the methods used to
detect the association; (2) the increased risk of disease among
individuals exposed to herbicides during service in the Republic of
Vietnam during the Vietnam era; and (3) whether there is a plausible
biological mechanism or other evidence of a causal relationship between
herbicide exposure and the suspect disease. Section 3 of Public Law
102-4 also required that NAS submit reports on its activities every 2
years (as measured from the date of the first report) for a 10-year
period. The Veterans Education and Benefits Expansion Act of 2001
(Benefits Expansion Act), Public Law 107-103, Sec. 201(d), extended
through October 1, 2014, the period for submission of NAS reports.
Section 1116(b) of title 38, United States Code, as enacted by the
Agent Orange Act of 1991, Public Law 102-4, 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 exposure of humans to an herbicide agent
(i.e., a chemical in an herbicide used in support of the United States
and allied military operations in the Republic of Vietnam during the
Vietnam era) and a disease, the Secretary will publish regulations
establishing presumptive service connection for that disease. If the
Secretary determines that a presumption of service connection is not
warranted, he is to publish a notice of that determination, including
an explanation of the scientific basis for that determination. The
Secretary's determination must be based on consideration of the NAS
reports and all other sound medical and scientific information and
analysis available to the Secretary.
Although 38 U.S.C. 1116(b) does not define ``credible,'' it does
instruct the Secretary to ``take into consideration whether the results
[of any study] are statistically significant, are capable of
replication, and withstand peer review.'' Simply comparing the number
of studies which report a positive relative risk to the number of
studies which report a negative relative risk for a particular
condition is not a valid method for determining whether the weight of
evidence overall supports a finding that there is or is not a positive
association between herbicide exposure and the subsequent development
of the particular condition. Because of differences in statistical
significance, confidence levels, control for confounding factors, bias,
and other pertinent characteristics, some studies are clearly more
credible than others, and the Secretary has given the more credible
studies more weight in evaluating the overall weight of the evidence
concerning specific diseases.
Section 2 of the Agent Orange Act of 1991, Public Law 102-4,
provided that the congressional mandate that the Secretary establish
presumptions of service connection under 38 U.S.C. 1116(b) would expire
10 years after the first day of the fiscal year in which the NAS
transmitted its first report to VA. The first NAS report was
transmitted to VA in July 1993, during the fiscal year that began on
October 1, 1992. Accordingly, under the Agent Orange Act of 1991,
Public Law 102-4, the mandate for VA to issue regulatory
[[Page 65281]]
presumptions as specified in section 1116(b) expired on September 30,
2002. In December 2001, however, Congress enacted the Benefits
Expansion Act, section 201(d) of which extended the mandate under
section 1116(b) through September 30, 2015. Pursuant to the Benefits
Expansion Act, Public Law 107-103, VA must issue new regulations
between October 1, 2002, and September 30, 2015, establishing
additional presumptions of service connection for diseases that are
found to be associated with exposure to an herbicide agent.
I. History of Agent Orange Presumptions
Pursuant to 38 U.S.C. 1116 and prior NAS reports received between
July 1993 and March 2005, VA regulations contain presumptions of
service connection for eleven categories of disease based on exposure
to an herbicide agent. Those diseases are listed in 38 CFR 3.309(e) as
follows: Chloracne or other acneform disease consistent with chloracne,
Type 2 diabetes (also known as Type II diabetes mellitus or adult-onset
diabetes), Hodgkin's disease, Chronic lymphocytic leukemia, Multiple
myeloma, Non-Hodgkin's lymphoma, Acute and subacute peripheral
neuropathy, Porphyria cutanea tarda, Prostate cancer, Respiratory
cancers (cancer of the lung, bronchus, larynx, or trachea), and Soft-
tissue sarcoma (other than osteosarcoma, chondrosarcoma, Kaposi's
sarcoma, or mesothelioma).
If a veteran who was exposed to an herbicide agent in service
subsequently develops one of the presumptive diseases, VA will presume
the disease was caused by the exposure to an herbicide agent in service
for purposes of establishing entitlement to service-connected benefits.
To qualify for this presumption, chloracne, porphyria cutanea tarda,
and acute and subacute peripheral neuropathy must become manifest to a
degree of disability of 10 percent or more within 1 year after the date
of last exposure. The other conditions are presumed service connected
if they are manifest to a degree of disability of 10 percent or more at
any time after exposure. 38 U.S.C. 1116(a)(2). VA presumes that any
veteran who served in the Republic of Vietnam during the period
beginning on January 9, 1962, and ending on May 7, 1975, was exposed to
an herbicide agent during such service. 38 U.S.C. 1116(f).
II. Prior Actions Concerning AL Amyloidosis
VA identified AL amyloidosis as a concern after the publication of
Veterans and Agent Orange: Update 1998. AL amyloidosis was considered
by the NAS in its reports: Veterans and Agent Orange: Update 2000,
Veterans and Agent Orange: Update 2002, and Veterans and Agent Orange:
Update 2004. In these reports, NAS concluded that there was inadequate
or insufficient evidence to determine whether there was an association
between exposure to the compounds of interest and AL amyloidosis. After
reviewing each of those reports, the Secretary determined that the
credible evidence against an association between exposure to an
herbicide agent and the occurrence of AL amyloidosis in exposed persons
outweighed the credible evidence for such an association, and that a
positive association therefore did not exist. 72 FR 32395, 32405 (June
12, 2007); 68 FR 27630, 27640 (May 20, 2003); 67 FR 42600, 42607-08
(June 24, 2002).
III. Latest NAS Review of AL Amyloidosis
In Update 2006, VA specifically requested a focused review of the
evidence related to whether the occurrence of acute myeloid leukemia,
tonsil cancer, AL amyloidosis, and lupus may be associated with
exposure to the components of herbicides used by the military in
Vietnam and requested explicit indication of the appropriate category
of association for all forms of cancer. NAS issued its report,
``Veterans and Agent Orange: Update 2006'' on July 27, 2007. In
pertinent part in that report, NAS concluded that ``there is limited or
suggestive evidence of an association between exposures to the
compounds of interest and AL amyloidosis.'' The term ``limited or
suggestive evidence of an association,'' as explained in the NAS
report, means that the evidence suggests an association between
exposure to herbicides and the outcome considered, but the evidence is
limited because chance, bias, and confounding could not be ruled out
with confidence. For example, a well-conducted study showing a positive
association combined with less compelling results from studies of
populations with similar exposures could constitute such evidence.
In Update 2006, NAS re-categorized the section on AL amyloidosis
from its position in the previous reports, where it was grouped with a
variety of non-neoplastic health conditions, and placed it closer to
related conditions, such as multiple myeloma and some types of B-cell
lymphoma. The conditions share several biological features, most
notably clonal hyperproliferation of B-cell-derived plasma cells and
production of abnormal amounts of immunoglobulins. NAS found that
because AL amyloidosis is a rare condition, there is little
epidemiologic literature. One study indicates that AL amyloidosis and
non-Hodgkin's lymphoma are closely related. Another study reviewed the
relationship between AL amyloidosis and other plasma cell disorders. It
describes AL amyloidosis as a clonal plasma cell disorder characterized
by low tumor burden but profound multisystemic disease. The observation
of common chromosomal abnormalities in AL amyloidosis and multiple
myeloma and of ``progression'' from AL amyloidosis to multiple myeloma
support the biologic plausibility of linking AL amyloidosis with
multiple myeloma. It is known that AL amyloidosis is associated with B-
cell diseases and roughly 15-20 percent of the time it occurs with
multiple myeloma. Other diagnoses associated with AL amyloidosis
include B-cell lymphomas (which are types of non-Hodgkin's lymphoma),
monoclonal gammopathies, agammaglobulinemia, and monoclonal gammopathy
of undetermined significance. Thus, AL amyloidosis can result from such
medical conditions as multiple myeloma and B-cell lymphomas for which
there is evidence of association with exposure to the compounds of
interest. The NAS committee's conclusion that there is limited or
suggestive evidence of an association between herbicide exposure and AL
amyloidosis is predicated primarily on the evidence of a
pathophsyiological association between AL amyloidosis and these other
diseases, which have previously been found to be associated with
herbicide exposure.
IV. The Secretary's Determination on AL Amyloidosis
After considering all of the evidence, the Secretary has determined
that there is a positive association between exposure to herbicide
agents and the occurrence of AL amyloidosis.
The biological and pathophysiological features of AL amyloidosis
link it to multiple myeloma and some lymphomas that are associated with
herbicide exposure in pervious NAS reports. Establishing presumptive
service connection for AL amyloidosis is consistent with existing VA
recognition of multiple myeloma and some lymphomas as presumptively
service connected based on exposure to an herbicide agent. Although
there is relatively little direct epidemiological evidence concerning
the relation of AL amyloidosis to herbicide exposure, the Secretary
notes that NAS considered the evidence linking AL amyloidosis to
[[Page 65282]]
multiple myelomas and lymphomas to be significant, if indirect,
evidence of an association. Therefore, the Secretary concludes that the
credible evidence for an association between exposure to an herbicide
agent and the occurrence of AL amyloidosis in humans outweighs the
credible evidence against such an association. Accordingly, the
Secretary has determined that a presumption of service connection for
AL amyloidosis is warranted pursuant to 38 U.S.C. 1116(b).
This proposed rule does not reflect determinations concerning any
disease other than AL amyloidosis. The Secretary's determinations
concerning other diseases discussed in the Update 2006 report will be
addressed in future documents published in the Federal Register.
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 Order 12866
Executive Order 12866 directs agencies to assess all 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,
and other advantages; distributive impacts; and equity). The Executive
Order classifies a ``significant regulatory action,'' requiring 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 the 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 the Executive
Order because it is likely to result in a rule that may raise novel
legal or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order.
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.
Catalog of Federal Domestic Assistance Numbers and Titles
The Catalog of Federal Domestic Assistance program numbers and
titles for this proposed rule are 64.109, Veterans Compensation for
Service-Connected Disability, and 64.110, Veterans Dependency and
Indemnity Compensation for Service-Connected Death.
List of Subjects in 38 CFR Part 3
Administrative practice and procedure, Claims, Disability benefits,
Health care, Veterans, Vietnam.
Approved: September 30, 2008.
Gordon H. Mansfield,
Deputy Secretary 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.
Sec. 3.309 [Amended]
2. In Sec. 3.309(e) the listing of diseases is amended by adding
``AL amyloidosis'' immediately preceding ``Chloracne or other acneform
disease consistent with chloracne.''
[FR Doc. E8-26175 Filed 10-31-08; 8:45 am]
BILLING CODE 8320-01-P