U.S. Marine Corps Base Camp Lejeune, located in eastern North Carolina, covers 156,000 acres and stretches along 11 miles of beach. It has maintained combat-ready marine units for expedited deployment since 1941. About 170,000 active-duty personnel, family members, retirees, and civilian employees live on base or in the surrounding community. The supporting infrastructure on base includes businesses, schools, recreational facilities, and municipal services such as a base landfill and water treatment system (U.S. Marine Corps, undated). In 2007, an estimated 54,000 people lived and worked on base, with families living on base for an average of 2 years (GAO, 2007).
Between 1957 and 1987 the groundwater at Camp Lejeune was contaminated with industrial chemicals, primarily chlorinated solvents such as trichloroethylene (TCE) and perchloroethylene (PCE, also called tetrachloroethylene). Many of these chemicals were later found to cause cancer and other health problems, although not all of them were recognized as toxicants at the time of contamination. The 30-year period of contamination, the lack of records documenting residence at Camp Lejeune during that time, and the transient nature of military assignments and deployments, make it almost impossible to know who or how many people were exposed. However, it is estimated that between 500,000 and 1,000,000 people may have been exposed (Walters, 2014).
A BRIEF HISTORY OF CAMP LEJEUNE WATER CONTAMINATION
In the 1980s, Camp Lejeune obtained its drinking water from as many as eight water systems fed by more than 100 wells that pumped water from a freshwater aquifer approximately 180 feet below ground. Drinking water was made from treated groundwater supplied by a rotating combination of multiple wells so that not all wells were providing water to a system at any given time. It was in the 1980s that volatile organic compounds—including chlorinated solvents such as PCE and TCE and their degradation products, aromatic solvents such as benzene, and other organic compounds such as vinyl chloride—were detected at Camp Lejeune in two separate water systems—Hadnot Point and Tarawa Terrace—that served base housing areas. Tarawa Terrace was contaminated primarily with PCE and its degradation products; Hadnot Point’s major contaminants were TCE and its degradation product trans-1,2-dichloroethylene (DCE). At that time no action was taken because there was little knowledge about the toxicity of TCE and PCE, there were no drinking water regulations with enforceable limits for these chemicals, and there was uncertainty about the validity of the water tests due to variations in results. Nevertheless, base officials removed 10 contaminated wells from service. The sources of contamination for the Hadnot Point water system were found to be hazardous waste and other materials, and an off-base dry cleaner was the likely source
of contamination for the Tarawa Terrace water system. In 1989, the U.S. Environmental Protection Agency (EPA) placed both Camp Lejeune and the off-base dry cleaner (the source of PCE) on the National Priorities List (also known as Superfund sites). Since that time, several long-term actions to clean up the sources of contamination and to monitor and protect the base’s drinking water have been implemented including the removal of contaminated soils and gasoline storage tanks, and the treatment of contaminated groundwater and soils (GAO, 2007).
AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY RESPONSE TO CONTAMINATION
Concerns about possible adverse health effects associated with exposure to such solvents as TCE and PCE, and to various solvent mixtures led to a variety of activities, including health studies, claims against the federal government, and federal inquiries. From 1991 to 1997, the Agency for Toxic Substances and Disease Registry (ATSDR), which is part of the Centers for Disease Control and Prevention, conducted a public health assessment at Camp Lejeune that included a reconstruction of the estimated contaminant levels in the drinking water systems. In 2006, ATSDR estimated that well contamination from the off-base dry cleaner began as early as 1957. More recent ATSDR assessments indicate that it was most likely around August 1953 that the TCE contamination at Hadnot Point first exceeded the maximum contaminant levels (MCLs)1 of 5μg/L for TCE, PCE, and benzene but that exceedances may have occurred as early as late 1948. PCE concentrations were found to have exceeded the MCL of 5μg/L for most of 1975–1985 with similar findings for the other contaminants (ATSDR, 2013) (see Table 1-1).
The exposure information compiled by ATSDR since the 1980s has been used in several epidemiologic studies of health effects on Camp Lejeune residents who were potentially exposed to contaminated water. These studies have examined a number of endpoints, including birth defects, adverse birth outcomes, cancer, and mortality (ATSDR, 2014).
In the birth defects investigation of 12,493 children born during 1968–1985 to mothers with residential exposure to contaminated drinking water at Camp Lejeune during pregnancy, ATSDR assessed exposure during the first trimester and looked for correlations between those exposures and childhood hematopoietic cancers, neural tube defects, and oral clefts. The telephone survey of parents, conducted between September 1999 and January 2002 (76% response rate), indicated that the number of children with birth defects was small (Ruckart et al., 2013). This study is discussed in more detail in Chapter 3.
For its first mortality study, ATSDR compared deaths among 154,932 marine and Navy personnel who began active duty between 1975 and 1985 and who served at Camp Lejeune with a similar group of 154,969 who served at Camp Pendleton, California, but not at Camp Lejeune, during this time. As of 2008, about 6% (8,964 at Camp Lejeune and 9,365 at Camp Pendleton) of both cohorts had died. When compared with general U.S. mortality rates, most of the standardized mortality ratios (SMRs) for the military cohort were below 1.0 indicating an expected healthy veteran effect (Bove et al., 2014a). A second mortality study compared 4,647 civilian employees who worked on base during that time period with 4,690 civilian employees at Camp Pendleton. As of 2008, about 14% (654) of the civilian cohort at Camp Lejeune had died (Bove et al., 2014b). The authors concluded that long-term follow up is necessary for a more complete assessment. Detailed results of both studies are discussed, where appropriate, in the following chapters.
Although the two studies used similar methodologies, there were several differences between the civilian and military Camp Lejeune cohorts. The proportion of women was much greater among the civilians (57.2% vs 5.2%); the median age of the civilians was about 10 years greater than that of the military cohort (58 vs 49 years old at the end of the follow up in 2008); the median months employed or served was less in the civilians (29 vs 36 months); and the class of employment also differed, with 69.7% of the civilians performing white-collar jobs while only 3.6% of the military cohort were officers. While some outcomes have already shown potentially higher
1 MCLs represent the highest level of contaminant allowed in drinking water as set by EPA. It is reasonable to expect small amounts of these contaminants in drinking water and they do not necessarily pose a health risk. EPA MCLs represent determinations of acceptable risk based on scientific literature and scientific opinion for both cancer and non-cancer effects. MCLs are set as close as feasible to the maximum contaminant level goal for that contaminant using the best available treatment technology (e.g., analytical detection limits) and taking cost into consideration. A maximum contaminant level goal is the level of a contaminant in drinking water below which there is no known or expected risk to health. MCLs are enforceable standards.
TABLE 1-1 Maximum Contaminant Levels and Maximum Estimated Levels of Contaminants Found in Camp Lejeune Drinking Water
|Contaminant||Maximum estimated level in finished water (μg/L)||Maximum contaminant level (μg/L)|
|Tarawa Terrace||Hadnot Point|
|Trans 1,2-dichloroethylene (1,2-tDCE)||(<100)||435||100|
NOTE: Maximum contaminant levels were all set by EPA in 1989 or later—several years after the exposure occurred at Camp Lejeune.
SOURCE: Hadnot Point and Holcomb Boulevard estimates from ATSDR (2013); maximum estimates for Tarawa Terrace from ATSDR (2007).
incidences in Camp Lejeune military personnel and civilians, it is important to note that members of these cohorts were not old enough at the time of follow up to have developed many of the outcomes of interest, let alone to have died from them. Nonetheless, these studies are informative because they provide the best information available on the populations of interest.
ATSDR is currently conducting two additional studies of Camp Lejeune residents (F. Bove, ATSDR, personal communication, July 24, 2014), has recently published a third study, and has proposed a fourth one. The first is a health survey (also referred to as a morbidity study) of Camp Lejeune military personnel, their dependents, and civilians that is designed to study how contaminated water may have affected subjects’ health. The target population for the survey includes about 300,000 people who lived or worked at Camp Lejeune or Camp Pendleton (comparison group) before 1986. The 26-page survey began in 2011 and includes questions about more than 20 types of cancers and other diseases, as well as opportunities for open-ended responses (ATSDR, 2012). Self-reported diseases of interest are confirmed by medical records and cancer registries. Results are expected to be published in 2015.
A second ongoing study compares cases of male breast cancer to other cancer cases not known to be related to solvent exposure using the Veterans Affairs Central Cancer Registry. This case-control study of all marines seeks to determine if cases were more likely than controls to have been exposed to contaminated water while residing at Camp Lejeune. Publication of this study is anticipated in 2015.
A recently published study (Ruckert et al., 2014) looks into the effects of contaminated water at Camp Lejeune on pregnant women, with a specific focus on adverse birth outcomes (a re-analysis of data first published by ATSDR in 1998). The new analysis includes updated information about exposure based on modeling done as recently as 2013.
ATSDR is also proposing a study to assess cancer incidence among military personnel and civilians who resided at Camp Lejeune. ATSDR’s proposal builds on the cohort identified in the mortality study described earlier (Bove et al., 2014a) by linking to state cancer registries and the Veterans Affairs Central Cancer Registry. As of July 2014, the methods and protocol were under development. Final results are not likely to be published for several years.
NATIONAL RESEARCH COUNCIL REPORT
In 2009 the National Research Council (NRC) released Contaminated Water Supplies at Camp Lejeune: Assessing Potential Health Effects in response to a request from Congress to independently assess potential health outcomes associated with past exposure to contaminated water at Camp Lejeune. The committee focused its attention on the toxicologic and epidemiologic literature regarding the effects of TCE, PCE, and solvent mixtures
Categories of Association
Sufficient evidence of a causal relationship: Evidence is sufficient to conclude that a causal relationship exists between exposure to combustion products and a health outcome in humans. The evidence fulfills the criteria for sufficient evidence of a causal association and satisfies several of the criteria used to assess causality: strength of association, dose–response relationship, consistency of association, temporal relationship, specificity of association, and biologic plausibility.
Sufficient evidence of an association: Evidence is sufficient to conclude that there is a positive association. That is, a positive association has been observed between exposure to combustion products and a health outcome in human studies in which bias and confounding could be ruled out with reasonable confidence.
Limited/suggestive evidence of an association: Evidence is suggestive of an association between exposure to combustion products and a health outcome in humans, but this is limited because chance, bias, and confounding could not be ruled out with confidence.
Inadequate/insufficient evidence to determine whether an association does or does not exist: The available studies are of insufficient quality, consistency, or statistical power to permit a conclusion regarding the presence or absence of an association between exposure to combustion products and a health outcome in humans.
Limited/suggestive evidence of no association: There are several adequate studies, covering the full range of levels of exposure that humans are known to encounter, that are mutually consistent in not showing a positive association between exposure to combustion products and a health outcome. A conclusion of no association is inevitably limited to the conditions, levels of exposure, and length of observation covered by the available studies. In addition, the possibility of a very small increase in risk at the levels of exposure studied can never be excluded.
SOURCE: IOM, 2000.
on Camp Lejeune residents, and similarly exposed populations. Health effects for which there was convergent toxicologic and epidemiologic information were of the most interest.
That committee assessed the associations between solvents and health outcomes that were found in the literature and also relied on information about such associations presented in an earlier Institute of Medicine (IOM) report, Gulf War and Health, Volume 2: Insecticides and Solvents (IOM, 2003). The IOM report reviewed the toxicologic and epidemiologic literature to assess the strength and nature of the association between exposure to solvents (primarily in occupational settings) and adverse health effects that might be seen in veterans who had served in the 1990–1991 Gulf War and had been exposed to solvents during deployment. Both the IOM and the NRC committees used five categories to represent the statistical association and strength of the evidence (see Box 1-1 for a description of each category of association).
Based on the evidence, the NRC committee identified the following health outcomes as having limited/suggestive evidence of an association with exposure to TCE, PCE, or solvent mixtures.
- Cancers of the breast, bladder, kidney, esophagus, and lung were associated with TCE or PCE exposure in the epidemiologic literature with the strongest support from toxicologic studies for kidney cancer associated with TCE exposure.
- Multiple myeloma, adult leukemia, and myelodysplastic syndromes were associated with chronic exposure to solvents in the epidemiologic literature.
- Hepatic damage and renal tubular-cell damage were seen in rodents exposed to high levels of TCE and PCE. Hepatic steatosis (fatty liver) and acute renal tubular necrosis were seen in epidemiologic studies of solvent exposures. Damage was associated with exposure to high levels of solvents, but not with chronic low-level exposures.
- Reproductive effects were less clear. Epidemiologic data suggested an association between female infertility and concurrent, but not previous, solvent exposure and between miscarriage and PCE exposure during pregnancy.
- Nervous system effects were seen in epidemiologic studies of inhaled solvents. Neurobehavioral effects were evident during exposure, but there was no evidence of such effects after exposure ceased. In toxicologic studies, nervous system effects were associated with high levels of TCE (e.g., central nervous system depression, attention deficits, alterations in visual evoked potentials), with high levels of PCE (e.g., anesthetic effects), and with low levels of PCE (e.g., changes in behavior and neurochemical markers).
- Immune effects, manifested as chronic glomerulonephritis and scleroderma, were associated with solvent exposure in epidemiologic studies (specifically, scleroderma and TCE exposure), while toxicologic studies of TCE and PCE showed a variety of immune effects (skin sensitization, asthma, immunosuppression, and autoimmune disease for TCE; and allergic sensitization and immunosuppression for PCE).
No health outcomes related to exposure at Camp Lejeune were found to have sufficient evidence to support an association or causal relationship, nor did the NRC committee identify any outcomes with sufficient evidence of no association. Most of the health outcomes were categorized as having inadequate or insufficient evidence of an association. The committee noted that there were other outcomes for which there was insufficient evidence for the committee to make inferences about associations between the outcome and TCE, PCE, or other solvents, and it further noted that other health effects could not be ruled out simply because they had not been included on the list.
The NRC committee also found that while evidence suggested that the levels of exposure to TCE, PCE, and other solvents at Camp Lejeune were unlikely to have caused such health effects, the possibility that health effects were caused by water contamination could not be ruled out. The committee concluded that because of methodologic limitations additional research is unlikely to yield definitive results concerning whether and how residents were adversely affected by the water contamination.
The NRC’s resulting list of 14 health outcomes (see Box 1-2) associated with TCE, PCE, or solvent mixtures with limited/suggestive evidence of an association was used by Congress and the U.S. Department of Veterans Affairs (VA) to inform further policy decisions.
Health Conditions Associated with Camp Lejeune Drinking Water in NRC (2009)*
|Esophageal cancer||Myelodysplastic syndromes|
|Lung cancer||Renal toxicity|
|Breast cancer||Hepatic steatosis|
|Bladder cancer||Female infertility with concurrent exposure|
|Kidney cancer||Miscarriage with exposure during pregnancy|
|Multiple myeloma||Neurobehavioral effects|
* Associations were judged by the NRC committee to have “limited/suggestive evidence of an association.”
SOURCE: NRC, 2009.
HONORING AMERICA’S VETERANS AND CARING FOR CAMP LEJEUNE VETERANS ACT OF 2012
In response to the needs of veterans and families exposed to contaminated water at Camp Lejeune, Congress passed the Honoring America’s Veterans and Caring for Camp Lejeune Families Act of 2012, also known as the Janey Ensminger Act (P.L. 112-154). Section 102 provides health benefits to veterans and family members and designates VA as the last payer for services related to 14 eligible conditions listed in Box 1-2,2 and it also adds non-Hodgkin’s lymphoma3 to the list of eligible conditions.
To be eligible for health benefits through VA’s Camp Lejeune Program for Exposure to Chemically Contaminated Water, a veteran must have served on active duty at Camp Lejeune for 30 days or longer between January 1, 1957, and December 31, 1987. Eligibility criteria for the Camp Lejeune Family Member Program are similar, stipulating that family members must have resided at Camp Lejeune for 30 days or longer during the same time frame. (Note: The committee refers to both of these programs as the Camp Lejeune program in this report and does not distinguish between them.) Eligibility is “notwithstanding that there is insufficient medical evidence to conclude that such illnesses or conditions are attributable to such service” for veterans or to residence at Camp Lejeune for family members. Inclusion is extended to children of pregnant women who resided at Camp Lejeune (P.L. 112-154). However, reservists who trained at Camp Lejeune on active duty are not eligible (Walters, 2014).
Health benefits for the 15 conditions include hospital care, medical services, and reimbursement of copayments for VA services. For family members receiving care outside of the VA system, VA will reimburse for hospital care or medical services as the last payer, that is, after all claims and coverage for payment, including other health insurance plans, have been resolved (Walters, 2014; P.L. 112-154). The act also stipulates that “hospital care and medical services may not be furnished…for an illness or condition of a family member that is found, in accordance with guidelines issued by the Under Secretary for Health, to have resulted from a cause other than the residence [at Camp Lejeune].”
DEPARTMENT OF VETERANS AFFAIRS CAMP LEJEUNE PROGRAM
In August 2012, VA took a series of steps to implement the Janey Ensminger Act. Since inception, eligible veterans have been enrolled in VA services as Priority 6, that is, veterans who are 0% service connected for a health problem.4 VA experts from the Veterans Health Administration (VHA), the Veterans Benefits Administration, the VA Office of General Council, and the VA Office of Congressional and Legislative Affairs formed a task force to help implement the act (Walters, 2014).
Because VA does not regularly provide medical benefits to family members or reimbursement for their care outside VA, specific efforts were made to reach and communicate with these beneficiaries about the Camp Lejeune program. Infrastructure and educational changes included new information technology systems to track requests from eligible veterans and family members, and education for VHA medical staff and social workers about the program. Collaboration with the U.S. Department of Defense was also necessary to develop a system to determine administrative eligibility and to verify active-duty status or residence at Camp Lejeune for 30 days or longer between 1957 and 1987 (Walters, 2014). VA has drafted internal regulations and guidance for its clinicians regarding the Camp Lejeune program (Walters, 2014).
2 This list of 15 is based on the NRC’s 2009 report with a few changes. Adult leukemia became leukemia, exposure qualifications were removed for female infertility and miscarriage, and non-Hodgkin’s lymphoma was added.
3 Non-Hodgkin’s lymphoma was found in the NRC report to have inadequate/insufficient evidence concerning whether an association exists; however, it was later identified by both EPA and the International Agency for Research on Cancer (IARC) as a health effect associated with TCE exposure (EPA, 2011; IARC, 2014).
4 More information on criteria for VA priority groups may be found at http://www.va.gov/healthbenefits/resources/priority_groups.asp (accessed July 9, 2014).
The Guidance for VHA Staff: Honoring America’s Veterans and Caring for Camp Lejeune Families Act of 2012, Section 102, Covered Clinical Conditions (hereafter called “the guidance”; see Appendix B for the full text of the guidance) covers both clinical and procedural decisions that lead to determinations about an individual’s eligibility for health benefits and about the coverage of specific medical services under the program. This guidance is not equivalent to VA’s Clinical Practice Guidelines, which detail diagnostic procedures and treatment options for a variety of health outcomes. The guidance is restricted to the 15 conditions that are listed in the act.
The guidance takes the clinician though three decision points to determine an individual’s eligibility for the program and benefits for a particular service. These are framed as three questions:
- Does the applicant have a medical illness or condition specified in the law?
- Is there another cause for the medical illness or condition?
- Which treatments/bills are associated with the medical illness or condition?
Responding to all three questions requires clinical information and judgment. To assist clinicians, VA also developed a set of algorithms for several of the conditions to guide decisions of eligibility based on clinical information. The most recent draft guidance and algorithms (as of June 1, 2014) are provided in Appendix B.
The guidance is the result of instructions laid out by the legislation, VA policy decisions, and medical and scientific input. For example, while the guidance closely follows the conclusions reached in the NRC’s report, VA made a policy decision to accept cancer and scleroderma diagnoses in eligible veterans regardless of other potential causes. VA also made the decision to provide health benefits for most medical costs (not just those directly related to a cancer diagnosis) during treatment for cancer because many cancer treatments affect the entire body.
To ensure that the clinical guidance for the 15 covered medical conditions listed in P.L. 112-154 is “scientifically sound,” VA asked the IOM to convene an ad hoc committee to review Guidance for VHA Staff and to make recommendations for its improvement. In addition, the committee was asked to address the following questions:
- Based on the latest scientific literature and the committee’s review, describe the medical conditions that result from “renal toxicity” due to solvent exposures.
- Based on the latest scientific literature and the committee’s review, characterize the “neurobehavioral effects” as mandated for coverage in the law.
To address its task, the IOM convened a committee of 12 experts with experience in clinical medicine, occupational and environmental health, epidemiology, toxicology, neurology, and nephrology.
The committee held two open meetings. At the first, VA presented the charge to the committee and discussed its preparation of guidance. At the second session, further discussions were held with VA to clarify the scope and use of the guidance document.
The committee followed the path of the 2009 NRC committee and concentrated on the adverse effects associated with the primary solvents found in the drinking water at Camp Lejeune—TCE and PCE. It also considered studies of mixed solvents where appropriate. The committee noted that, in general, studies of mixed solvents did not allow for adverse effects to be attributed to an individual chemical in a mixture of many and that those mixtures often contained well-characterized toxic substances such as toluene, which was not a contaminant of concern at Camp Lejeune. Although contaminants other than TCE and PCE—such as benzene, toluene, and vinyl chloride—were present in the drinking water at Camp Lejeune, they were generally found at very low concentrations and not in all samples.
For the renal and neurobehavioral endpoints, the committee conducted literature searches in TOXLINE for epidemiologic and toxicologic studies on TCE, PCE, benzene, vinyl chloride, and mixed solvents published in 2008 or later (U.S. National Library of Medicine, 2014). Searches for epidemiologic studies on the various endpoints were also conducted in PubMed and in Google Scholar. Additional targeted searches were conducted to address committee needs and identified gaps. Searches were conducted for authoritative reviews, including EPA Toxicological Reviews, ATSDR Toxicological Profiles, and IARC Monographs published in 2008 or later. The searches identified literature published though the summer of 2014.
The committee reviewed the available literature to identify possible renal and neurobehavioral endpoints; no endpoints were ruled out a priori. The committee adopted a rule that in order to be considered a possible effect, a renal or neurobehavioral effect must be reported with statistical significance5 in at least one relatively well-designed study, or otherwise have enough weight of evidence to be considered a possible effect. For the other outcomes listed in the legislation, the committee reviewed recent literature and previous assessments as well as additional information about each clinical entity to determine whether or not the guidance and algorithms were scientifically sound and to see what, if any, changes might improve them.
The committee was aware of several issues while reviewing the literature and making its findings and recommendations. In cases where the weight of the evidence was sparse but showed a positive association or was equivocal and expert judgment was used in making the finding, the committee gave the benefit of the doubt to the veteran and family members.
Because the only exposure of concern in this report is whether the veteran or family member resided at Camp Lejeune for at least 30 days during the period of contamination covered by the act, the committee considered all the epidemiologic and toxicologic literature on renal and neurobehavioral effects regardless of issues such as dose–response; timing (e.g., in utero, early childhood), route, and duration of exposure; and whether the primary exposure was to TCE, PCE, or another Camp Lejeune drinking water contaminant. As noted in the NRC report (2009), given the numerous limitations in the data and methodologic shortcomings, “only crude estimates of contaminants in the water supply can be obtained,” and only qualitative estimates of dose were applicable. The committee also recognized that many factors can affect the etiology and presentation of a health condition. This is of particular concern as many of the health conditions in the VA clinical guidance require that the clinician determine whether the health condition was caused by something other than the patient’s residence at Camp Lejeune during the time of contamination. VA has made a policy decision that clinicians do not have to consider exclusionary factors for any of the cancers or for scleroderma. Because these are policy decisions and not necessarily based on scientific evidence, the committee did not comment on the validity of these decisions.
Furthermore, the committee recognized that in addition to the possible exclusionary conditions presented in the guidance and algorithms, there are many other risk factors that may influence the development and presentation of a health condition, including life style, occupational exposures, genetics, other health conditions, and the duration and extent of a person’s exposure to the Camp Lejeune contaminants. Although such factors can directly and indirectly affect the etiology of a health condition, it was not possible for the committee to comment on all possible risk factors that may affect the population of concern, nor are they discussed in the guidance. The committee also recognized that given the number of factors that may contribute to the etiology of a condition, it may be impractical to determine the likelihood of a condition resulting from exposure to Camp Lejeune drinking water alone and exclude other well-defined contributory factors such as diabetes and chronic kidney disease, particularly in a clinical setting. The committee notes that for the most part, the effects of synergistic, additive, inhibitory, and other interactions between the contaminants found at Camp Lejeune and other risk factors and the health outcomes listed in the legislation are unknown.
5 Statistical significance may be represented by a confidence interval or a p-value. If the 95% confidence interval for a risk estimate (such as a risk ratio [RR] or odds ratio [OR]) includes 1.0, the association is not considered to be statistically significant; however, if the interval does not include 1.0, the association is said to be statistically significant with an alpha error (likelihood that the association is due to chance) of 5% (that is, p < 0.05). The confidence interval is considered to be the range in which there is a 0.95 probability (95% chance) that the true value falls.
ORGANIZATION OF THE REPORT
This report addresses the committee’s three primary tasks. Chapter 2 provides a review of the literature and the VA guidance with regard to the characterization of the renal toxicity endpoints and the clinical outcomes that may be associated with exposure to the water contaminants at Camp Lejeune. Chapter 3 provides a similar analysis for neurobehavioral effects that may result from exposure to TCE, PCE, and other solvents found at Camp Lejeune. Clinical considerations as presented in the VA guidance for the other 13 conditions listed in the Camp Lejeune legislation are reviewed in Chapter 4. Although these three chapters assess the scientific soundness of the VA clinical guidance, the committee also sought to provide VA with recommendations for improving the accuracy and usability of the guidance. Chapter 5 presents the committee’s discussion of VA’s approach to decision making in the guidance and future considerations for using and updating the guidance. Finally, the report contains three appendices: Appendix A provides short biographical sketches of the committee members; Appendix B is the draft Guidance for VHA Staff: Honoring America’s Veterans and Caring for Camp Lejeune Families Act of 2012, Section 102, Covered Clinical Conditions and the accompanying algorithms that the committee reviewed for this report; and Appendix C contains the relevant sections of the Honoring America’s Veterans and Caring for Camp Lejeune Families Act of 2012.
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