VA
To Grant Benefits To More Vietnam Veterans (CLL)
January 23, 2003........NEW UPDATE....SEE 2006 INFO....BELOW...
WASHINGTON – Based upon a recently released review of
scientific studies, Secretary of Veterans Affairs Anthony J. Principi has
decided to extend benefits to Vietnam veterans with chronic lymphocytic
leukemia (CLL).
“Compelling evidence has emerged within the
scientific community that exposure to herbicides such as Agent Orange is
associated with CLL,” Principi said. “I’m exercising my legal authority to ensure
the full range of VA benefits is available to Vietnam veterans with CLL.”
The ruling means that veterans with CLL who served in
Vietnam during the Vietnam War don’t have to prove that illness is related to
their military service to qualify for Department of Veterans Affairs disability
compensation. Additionally, for more than 20 years, VA has offered
special access to medical care to Vietnam veterans with any health problems
that may have resulted from Agent Orange exposure, and this decision will ensure
higher-priority access to care in the future.
The decision to provide compensation was based upon a
recent report by the Institute of Medicine (IOM) that found among scientific
studies “sufficient evidence of an association" between exposure to herbicides
during the Vietnam War and CLL.
The IOM review, conducted at VA's request, was the
latest in a series spanning the period since 1993 when the independent,
non-governmental agency first published a report for VA that examined thousands
of relevant scientific studies on the health effects of various substances to
which American servicemembers may have been exposed in Vietnam.
“On the modern battlefield, not all injuries are
caused by shrapnel and bullets,” Principi said. “This latest IOM
study and my decision to act upon it are the latest examples of VA’s continuing
efforts to care for the needs of our combat veterans.”
VA requested the IOM panel of experts to focus on CLL
in their report because of veterans' concerns that CLL shares some similarities
with non-Hodgkin's lymphoma, which the IOM had previously connected to Agent
Orange exposure.
Principi ordered the development of regulations to
enable VA to begin paying compensation benefits once a final rule takes
effect. Publication of that regulation is expected in the near
future. VA will publish further details, when available, on its Web
site at http://www.vba.va.gov/bln/21/benefits/herbicide/.
In the meantime, veterans with questions about
health-care, compensation and survivor benefits may call a toll-free help line
at 1-800-749-8387 for information. VA also encourages Vietnam
veterans who have not done so to request a subscription to Agent Orange Review,
VA's free newsletter that will keep them abreast of developments on this issue
and other policies and scientific findings in the future.
Newsletter subscription information is available from
the help line number above. Back issues and additional information
about Agent Orange are available at another VA Web site at http://www.va.gov/agentorange/.
October 28,
2003 UPDATE
SUBJ: Final Rule
Concerning Chronic Lymphocytic Leukemia (CLL)
1. Final regulatory amendment to 38 CFR § 3.309 was
published in the Federal Register, pages 59540-59542,
on October 16, 2003. This final amendment establishes
presumptive service connection for the development of Chronic Lymphocytic
Leukemia (CLL) due to herbicide exposure.
2. This regulatory
amendment is effective October 16, 2003.
3. Attached is an
explanation and additional information regarding the change to
§3.309 along with the text of the regulatory amendment.
4. This letter is
rescinded effective October 28, 2004.
Sincerely,
Ronald J. Henke, Director
Compensation and Pension Service
Attachments
Regulatory Amendment
3-03-3
Regulations
affected: 38 CFR §3.309.
Effective Date of Regulation: October 16, 2003.
Date
Secretary Approved Regulation: August 27, 2003.
Federal
Register Citation: 68 FR 59540 (October 16, 2003).
The purpose of the following comment on the changes included in this amendment
of VA regulations is to inform all concerned why this change is being made.
This comment is not regulatory.
Section 3 of the Agent Orange Act of 1991, Pub. L. 102-4, 105 Stat. 11, directed
the Secretary to seek to enter into an agreement with the National Academy of
Sciences (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 Pub. L. 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.
Section 1116(b) of title 38, United States Code, as enacted by the Agent Orange
Act of 1991, Pub. L. 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
Secretary's authority to 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, VA's
authority to issue regulatory presumptions as specified in section 1116(b)
expired on September 30, 2002. In December 2001, however, Congress enacted the
Veterans Education and Benefits Expansion Act of 2001 (Benefits Expansion Act),
Public Law 107-103. Section 201(d) of that Act extended VA's authority under
section 1116(b) through September 30, 2015. Pursuant to the Benefits Expansion
Act, Public Law 107-103, VA may 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
April 2001, VA regulations contain presumptions of service connection for ten
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, 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 and porphyria cutanea tarda must become manifest to a
degree of disability of 10 percent or more within one year after the date of
last exposure. The other conditions are presumed service connected if they are
manifest to a degree of disability of ten 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 Leukemia
In each of its four previous biennial reports under the Agent Orange Act of
1991, the NAS concluded that there was "inadequate/insufficient"
evidence to determine whether an association exists between exposure to an
herbicide agent and the subsequent occurrence of leukemia in exposed persons.
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 leukemia in exposed persons outweighed the credible
evidence for such an association, and that a positive association therefore did
not exist. 67 FR 42600, 42604 (June 24, 2002); 64 FR 59232, 59238 (Nov. 2,
1999); 61 FR 41442, 41445 (Aug. 8, 1996); 59 FR 341, 344 (Jan. 4, 1994).
III. Latest NAS Review of Chronic Lymphocytic Leukemia
After receiving and reviewing the last prior NAS report in 2001, the Secretary
asked that NAS' next report separately review the scientific evidence
concerning the association between herbicide exposure and one particular form
of leukemia, known as chronic lymphocytic leukemia (CLL). NAS issued its
report, "Veterans and Agent Orange: Update 2002," on January 23,
2003. In that report, NAS concluded that "there is sufficient evidence of
an association between exposure to at least one of the chemicals of interest
(2,4-D, 2,4,5-T or its contaminant TCDD, picloram, or cacodylic acid) and
CLL." The term "sufficient evidence of an association," as
explained in the NAS report, means that a positive association has been
observed between herbicides and the outcome in studies in which chance, bias,
and confounding could be ruled out with reasonable confidence.
NAS discussed several studies that reported findings regarding the incidence of
CLL as distinguished from other types of leukemia. One study of site-specific
cancer incidence among 7,016 males and females in a rural farming community
found a standard incidence ratio of 1.8, with a 95% confidence interval (CI) of
0.8-3.2 for CLL. (Waterhouse D et al. 1996. Cancer incidence in the rural
community of Tecumseh, Michigan: a pattern of increased lymphopoietic
neoplasms. Cancer 77(4): 763-770). A population-based case-control study in an
agricultural area of Italy noted an increased risk of CLL among farmers (Odds
Ratio (OR) = 1.6, CI = 0.5-5.2) and animal breeders (OR = 3.1 CI = 1.1-8.3),
although no information was provided on herbicide exposure in the study
population. (Amadori D et al. 1995. Chronic lymphocytic leukaemias and
non-Hodgkin's lymphomas by histological type in farming-animal breeding
workers: a population case-control study based on job titles. Occupational and
Environmental Medicine 52(6): 374-379). A study of cancer risk in Danish male
gardeners reportedly exposed to pesticides and herbicides showed a significant
increase in CLL (relative risk = 2.8, CI = 1.0-6.0), although no specific data
on herbicide exposure were given. (Hansen ES et al. 1992. A cohort study on
cancer incidence among Danish gardeners. American Journal of Industrial
Medicine 21(5): 651-660). One study showed a significant increase in mortality
due to CLL among farmers in Nebraska from 1957-1974 (OR = 1.7), although no
data regarding herbicide exposure were given. (Blair A, White DW. 1985.
Leukemia cell types and agricultural practices in Nebraska. Archives of
Environmental Health 40(4): 211-214).
Two epidemiologic studies reported specifically on herbicide exposure and CLL.
In a study of 1,675 white Iowa males who died of leukemia, CLL was
significantly increased in farmers (OR = 1.9, CI=1.2-3.1). (Burmeister LF et
al. 1982. Leukemia and farm practices in Iowa. American Journal of Epidemiology
115(5): 720-728). Further analysis showed a strong relationship of CLL deaths
in counties with acres treated with erbicides. In a population-based
case-control interview study of 578 white men with leukemia and 1,245 controls,
CLL mortality was higher in farmers than nonfarmers. (Brown LM et al. Pesticide
exposures and other agricultural risk factors for leukemia among men in Iowa
and Minnesota. Cancer Research 50(20): 6585-6591). When risk was calculated for
CLL subtype, odds ratios were significantly increased for use of any herbicide
(OR = 1.4). The risk of CLL in farmers who ever handled 2,4-D was 1.3. The risk
of CLL in men who first handled 2,4,5-T at least 20 years before interview was
significantly increased (OR = 3.3, CI = 1.2-8.9).
NAS also noted that a recent follow-up study of residents of Seveso, Italy
found no increased risk of lymphocytic leukemia. (Bertazzi PA et al. 2001.
Health effects of dioxin exposure: a 20-year mortality study. American Journal
of Epidemiology 153(11): 1031-1044). NAS stated that the epidemiologic
studies indicate that farming occupation is associated with significant risk of
CLL, especially when there is exposure to the herbicides 2,4-D and 2,4,5-T. NAS
further noted that CLL shares more traits with non-Hodgkin's lymphoma (NHL)
than with other types of leukemia and could have a common etiology, and that
many studies support the hypothesis that herbicide exposure can contribute to
the risk of NHL. NAS also concluded, as in its prior reports, that a connection
between exposure to TCDD, a contaminant of 2,4,5-T, and human health effects is
considered biologically plausible.
IV. The Secretary's Determination on Chronic Lymphocytic Leukemia
After considering all of the evidence, the Secretary has determined that there
is a positive association between the exposure of humans to an herbicide agent
and the occurrence of CLL in humans. The studies cited by NAS consistently show
an increased risk of CLL among agricultural workers and two of the studies show
a significantly increased risk among farmers who were exposed to herbicides.
Some of the findings noted by NAS are statistically significant, and the
consistency of the findings overall supports the view that an association
exists. Under these circumstances, the Secretary concludes that the credible
evidence for an association between exposure to an herbicide agent and the
occurrence of CLL in humans outweighs the credible evidence against such an
association. Accordingly, the Secretary has determined that a presumption of
service connection for CLL is warranted pursuant to 38 U.S.C. 1116(b).
This rule does not reflect determinations concerning any disease other than
CLL. The Secretary's determinations concerning other diseases discussed in the
current NAS report will be addressed in future documents published in the
Federal Register.
For the reasons set forth in the preamble, 38 CFR part 3 is amended 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. 3.309, paragraph (e) the listing of diseases is amended by
adding "Chronic lymphocytic leukemia" between "Hodgkin's disease"
and "Multiple myeloma" to read as follows:
Sec.
3.309 Diseases subject to presumptive service connection.
Chronic
lymphocytic leukemia
VA AGENT ORANGE CLAIMS
UPDATE 2006:
The American Legion and the National Veterans Legal Services
Program (NVLSP) have been working closely together over the last 15 years to
make sure that the VA pays all of the benefits that
1.) CLL Claims: Chronic lymphocytic leukemia
(CLL) is the latest disease the VA added to the list of diseases presumptively
service connected due to Agent Orange. The VA issued the regulation
adding CLL on 16 OCT 03. CLL is a malignancy (cancer) of the white
blood that results from an acquired injury to the DNA of a single cell, a
lymphocyte, in the bone marrow. This injury is not present at birth.
As a result of the Nehmer lawsuit [Nehmer v. U.S. Veterans
Administration, 32 F. Supp. 2d 1175 (N.D. Cal. 1999)] the VA is normally
required to pay benefits for an Agent Orange-related disease retroactive to the
date the VA received the first claim the veteran or survivor filed based on the
disease with the exception of claims that were finally denied before 25 SEP
85. VA took the position that when it was service connected CLL the
Nehmer rules did not apply to CLL claims. As a result, the VA
assigned an effective date no earlier than 16 OCT 03 whenever the VA granted a
disability or DIC claim based on CLL even if the first CLL claim was filed
before 16 OCT 03.
The Nehmer lawsuit is a class
action brought by National Veterans Legal Services Program (NVLSP) on behalf of
2.) Blue Water Disability/DIC claims: From 1991
to 2002, the VA took the position that Navy veterans who were awarded the
Vietnam Service Medal as a result of service in the waters offshore Vietnam
(blue water vets) were entitled to the same presumption of exposure to Agent
Orange as veterans who set foot on land in Vietnam. As a result,
many Navy veterans who served offshore and their survivors were granted
disability or DIC benefits based on an Agent Orange-related disease. However,
in FEB 02 the VA amended VA Manual M21-1 to limit the presumption of exposure
to Agent Orange to only those veterans who actually set foot on the land mass
of
NVLSP has appealed to the Court of
Appeals for Veterans Claims many of the BVA decisions denying benefits to blue
water veterans. NVLSP has argued in these cases that the VA's change
of position in 2002 violates the Agent Orange Act of 1991. On 10 JAN
06, a panel of the Court heard argument in one of NVLSP's
appeals and a decision on the legality of the VA's set-foot-on-land requirement
is expected some time this year. In any case in which you are
representing yourself or another blue water Navy veteran/survivor on a claim
based on an Agent Orange-related disease, you should keep the claim alive by
filing a timely Notice of Disagreement (NOD) after the VA denial,
and a timely substantive appeal after the Statement of the Case
(SOC). If the BVA denies the claim, contact NVLSP
attorney Rick Spataro so that a timely appeal can be filed with the
[Source: NVLSP Staff Attorney msg
16 Feb 06]
