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.
Ronald J. Henke, Director
Compensation and Pension Service
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:
A--Pension, Compensation, and Dependency and Indemnity
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
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]