VA Review of NAS Report on the Agent Orange Act. 1991. Purpose. The purpose of this report is to provide the Agent Orange Task Force recommendations for a comprehensive course of action for the Department in response to the 764-page Agent Orange report, entitled "Veterans and Agent Orange--Health Effects of Herbicides Used iN Vietnam," released on July 27, 1993. Background. Public law 102-4, the Agent Orange Act of 1991, directs VA to provide for the National Academy of Sciences to review and evaluate the available scientific evidence regarding associations between diseases and exposure to dioxin and other chemical compounds in herbicides. (See Appendix A.) The law indicates that for each disease reviewed, the Academy should determine (to the extent that available scientific data permit meaningful determinations) (A) whether a statistical association with herbicide exposure exists, taking into account the strength of the scientific evidence and the appropriateness of the statistical and epidemiological methods used to detect the association; (B) the increased risk of the disease among those exposed to herbicides during service in Vietnam during the Vietnam era; and (C) whether there exists a plausible biological mechanism or other evidence of a casual relationship between herbicide exposure and the disease. The Academy was required to include in its report to VA a full discussion of the scientific evidence and reasoning that led to its conclusion. NAS was also required to make any recommendations it has for additional scientific studies to resolve areas of continuing scientific uncertainty relating to herbicide exposure. In making this determination, under the law, the Academy was required to consider the scientific information currently available, the value and relevance of the information that could result from additional studies, and the cost and feasibility of carrying out such additional studies. In addition, NAS was required to make recommendations regarding whether sections 6 through 9 of the law should be implemented. Section 6 would require VA to compile and analyze clinical data obtained by VA during examinations and treatment of veterans for disabilities related to exposure to certain herbicides or to service in Vietnam. Section 7 would require VA to establish and maintain a system for the collection and storage of voluntarily contributed samples of blood and tissue of veterans who performed active military, naval, or air service in Vietnam during the Vietnam era. Section B would provide for the conduct of studies of the feasibility of conducting additional scientific research on (1) health hazards resulting from exposure to dioxin; (2) health hazards resulting from exposure to other toxic agents in herbicides used in support of United States and allied military operations in Vietnam during the Vietnam era; and (3) health hazards resulting from active military, naval, or air service in Vietnam during the Vietnam era. Section 9 would require VA to obtain, upon the veteran's request, a sufficient amount of blood serum to ascertain the level of 2,3,7,8- tetrachlorodibenzo p-dioxin (TCDD) which may be present in the veteran's body.. In making its recommendations with respect to each of these sections, the Academy was required to consider the scientific information that is currently available, and the value and relevance of the information that could result from implementing that section. In February 1992, the Institute of Medicine (ICM) of the National Academy of the Sciences signed an agreement with VA to perform the functions described in the In Vietnam Veterans of Exposure to Herbicides." This 16- member group represented a wide range of expertise. They served voluntarily, without compensation. Committee members were selected by NAS because they are leading authorities in their scientific fields, are well-respected by their colleagues and peers, have no conflicts of interest with regard to the matters under consideration, and indeed, have taken no public positions regarding the potential health effects of herbicides in Vietnam veterans or related aspects of herbicide or dipxom exposure. To gather information for the report, the Committee held three public meetings to allow veterans and other interested individuals to voice their concerns and opinions. In addition, members of the Committee and the staff sought and received information from a broad array of individual and organizations, including veterans' groups, congressional committees, federal agencies, scientific experts, and the public. The Committee studied both the toxicological and the epidemiologic data on herbicides exposures. After reviewing thousands of studies, the Committee focused on approximately 230 epidemiologic investigations for detailed review and analysis. Most of these studies did not involve Vietnam veterans. Rather, they were studies of people who were exposed to herbicides as a result of their jobs or as a result of contact in the environment. These types of exposures often were at high levels and for long periods of time. Getting a clear picture of the health risks for Vietnam veterans is not so straightforward because the levels of exposures often were extremely wide ranging. Indeed, while most veterans probably had lower levels, some may have experienced levels as high as that of occupational or agricultural exposures. What is uncertain is how many veterans may have been exposed to those higher levels and who those individuals are. The Committee assigned each of the health outcomes considered into one of four categories based on the epidemiologic evidence reviewed. The distinctions between categories are based on "statistical association," not on causality, as is common in scientific review. The four categories are (1) sufficient evidence of an association, (2) limited/suggestive evidence of an association, (3) inadequate/insufficient evidence to determine whether an association exists, and (4) limited/suggestive evidence of no association. The Committee defined the categories as follows: 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 herbicides and the outcome in studies in which chance, bias, and confounding could be ruled out with reasonable confidence. For example, if two small studies that are free from bias and confounding show an association that is consistent in magnitude and direction, there may be sufficient evidence of an association. Limited/suggestive evidence of an association - Evidence is suggestive of an association between herbicides and the outcome, but is limited because chance, bias, and confounding could not be ruled out with confidence. For example, one high-quality study shows a positive association, but the results of other studies are inconsistent. Inadequate/insufficient evidence to determine whether an association exists - The available studies are of insufficient quality, consistency, or statistical power to permit a conclusion regarding the presence or absence of an association. For example, studies fail to control for confounding, have inadequate exposure assessment, or fail to address latency. Limited/suggestive evidence of no association - Several adequate studies, covering the full range of levels of exposure that human beings are known to encounter, are mutually consistent in not showing a positive association between exposure to herbicides and the outcome at any level of exposure. Under Public Law 102-4, whenever VA determines, on the basis of sound medical and scientific evidence, that a positive association exists between the exposure of humans to an herbicide agent and the occurrence of a disease in humans, VA shall prescribe regulations providing that a presumption of service connection is warranted for that disease. In making the determination, VA must consider reports received from the NAS and all other available, sound medical and scientific information. In evaluating any study for the purpose of making such determinations, VA must take into consideration whether the results are statistically significant, are capable of replication, and withstand peer review. NAS finds. NAS concluded that most health outcomes considered should be in the third grouping (inadequate/insufficient evidence to determine. . .). (See Appendix B) Only five health outcomes were included in the first category: soft tissue sarcoma, non-Hodgkin's lymphoma, Hodgkin's disease, chloracne, and porphyria cutanea tarda (in genetically susceptible individuals). Respiratory cancers (lung, larynx, trachea), prostate cancer, and multiple myeloma were the only outcomes included in the second category. The fourth category (limited/suggestive evidence of no association) included skin cancers, gastrointestinal tumors (stomach cancer, pancreatic cancer, colon cancer, rectal cancer), bladder cancer, and brain tumors. NAS made the following recommendations regarding epidemiologic studies of Vietnam veterans. Recommendation 1. The committee endorses continued follow-up of the Air Force Ranch Hand cohort and its comparison group, and recommends that members of the Army Chemical Corps and an appropriate comparison group be followed in a similar study. An independent, nongovernmental scientific panel should be established to review and approve a new, expanded research protocol for both study populations, and to commission and direct a common analysis of the results. Recommendation 2. The Department of Defense and the Department of Veterans Affairs should identify Vietnam service in the computerized index of their records. Recommendation 3. Biomarkers for herbicide exposure should be developed further. Recommendation 4. A nongovernmental organization with appropriate experience in historical exposure reconstruction should be commissioned to develop and test models of herbicide exposure for use in studies of Vietnam veterans. Recommendation 5. The exposure reconstruction models developed according to Recommendation 4 should be evaluated by an independent, nongovernmental scientific panel established for this purpose. Recommendation 6. If the scientific panel proposed in Recommendation 5 determines that a valid exposure reconstruction model is feasible, the Department of Veterans Affairs and other government agencies should facilitate additional epidemiologic studies of veterans. In addition to these six research recommendations, NAS offered broad comments regarding the programs mandated in Section 6-9 of Public law 102-4 (described above). With regard to Section 6, the NAS Committee observed that VA is currently compiling and analyzing clinical data through the Agent Orange Registry program. With regard to Section 7 (collection and storage of blood and tissue samples voluntarily contributed by Vietnam veterans), the Committee noted that systems of this sort have scientific value, but only to the extent that they are components of specific, well-defined studies. In the absence of a clear study design to guide such activities, and without resolution of important design, quality control, and ethical issues regarding tissue banks. The Committee did not recommend the establishment at this time of the clinical data and tissue archiving systems described in Section 6 and 7. The research recommendations fully address the questions raised by Section 8 regarding the feasibility of conducting additional research on health hazards resulting from exposure to dioxin and herbicides used in Vietnam. Implementation of Section 9 (serum testing of Vietnam veterans who apply for medical care or file a disability compensation claim( was not recommended by the NAS. The Committee noted that the purpose of this mandate was unclear. If research purpose are contemplated, the discussion regarding tissue archiving systems would apply. If the serum testing was intended to provide information on individual exposures to aid in individual compensation adjudications, NAS noted that for a variety of reasons, described in the report, individual TCDD serum levels in Vietnam veterans are usually not meaningful. The Committee also recommended that priority be given to additional research on reproductive efforts that would clarify the possible effects of herbicides. In particular, the Committee argued that a reanalysis of the Ranch Hand reproductive data could shed additional light on this subject. VA Response. VA response to the NAS report has been prompt, decisive, and well received in the veteran community. The Department was initially briefed on the NAS findings on Thursday, July 22. On Monday, July 26, the Chief of staff appointed this internal, high-level panel to carefully analyze the report from a medical/scientific perspective and to solicit comments from representatives of veterans service organizations and other interested parties. (See Appendix C and Appendix D.) The following day in conjunction with the public release of the report, VA issued a news release indicating that VA would recognize as service-connected all the conditions identified in the first category of the NAS report. (See Appendix E.) You testified on the report that day before the Senate Committee of Veterans' Affairs (and one week later before its House counterpart). (See Appendix F.) The Task Force established by the Chief of Staff held several meetings to review and develop a proactive response to the report. Two meetings (August 5 and August 24) were held with veterans service organization to invite their oral and written comments. (see Appendix G, Appendix H, and Appeal I.) Task Force Deliberations. The panel reviewed the report as a whole and concluded: a. The NAS had done a thorough review and evaluation of the available scientific and medical information regarding health effects of the exposure to Agent Orange and other herbicides used during the Vietnam conflict. There were no obvious gaps in the information sources cited. b. The Committee members they assembled represented the necessary expertise to review and evaluate the scientific and medical information and appeared to be without obvious bias related to the health effects of Agent Orange and other herbicides in that they had taken no public positions on any alleged effects and had no known conflicts of interest. c. The approach taken by the NAS Committee was reasonable and scientifically sound and the organization of the report was understandable. d. The NAS Committee carried out their charge to determine if there was a statistical association between certain disease and herbicide exposure, taking into account the strength of the association and the methods used to determine the association. e. The NAS report is both a valuable contribution to the medical and scientific literature and a valuable resource to VA in carrying out the Congressional mandate to prescribe regulations for a presumption of service-connection, when VA determines that the credible evidence for the association is equal to or outweighs the credible evidence against the association. The VA panel discussed the definition of "credible evidence" as it related to the determination of positive association. The law does not define credible but does instruct the Secretary to "take into consideration whether the results are statistically significant, are capable of replication, and withstand peer review." The panel concluded that credible was not an absolute term, but that there were variations of credibility, i.e., some studies were clearly more credible than others and should be given more weight in evaluating the overall credibility of the evidence for any given disease. For this reason, going to any given table of selected epidemiologic studies in the NAS report and adding up those with a positive relative risk compared to those with a negative relative risk was not judged to be scientifically valid nor conclusive for positive association. Judgment must be exercised and part of the value of the NAS findings was the usually clear elucidation of what factors influenced their judgment. Therefore, in the relatively brief time allotted to you to make the determination, the VA panel decided to look at the logic and judgment for the categorization of individual diseases and to express that in this report for you ultimate decision. The panel believes that the organization of the NAS's summary of findings into four categories is reasonable and uses that schema for their deliberations and recommendations: Category I - Health Outcomes with Sufficient Evidence of an Association NAS established that five diseases met the criteria for sufficient evidence of an association. The panel has reviewed these diseases and concludes that they also meet the standard for a positive finding under the statute, i.e., the credible evidence for an association is equal to or outweighs the credible evidence against an association. Three of these five diseases are already covered by a VA regulation establishing the presumption of service- connection. The five disease are: Soft tissue sarcoma Non-Hodgkin's lymphoma Hodgkin's disease Chloracne Porphyria cutanea tarda In examining these diseases individually, the VA panel concludes the following: SOFT TISSUE ARCOMA (STS) - Soft tissue sarcomas are tumors arising from the soft somatic tissue that occur within and between organs. These tissues arise from the primitive mesenchyme of the embryonal mesodermal layer. They have diverse characteristics and individual types of soft tissue sarcomas are relatively rare. The NAS Committee chose to relate their findings to the entire class of tumors. In their judgment the Swedish studies were given great weight and the VA panel found no basis for disagreement with this. VA accepts this association based on the number, consistency, and apparent quality of the studies cited in the NAS report. The Task Force concludes that the credible evidence for an association between herbicides and STS outweighs the evidence of no association. CHLORACNE - Chloracne, which may mimic juvenile acne, is a persistent skin condition that has been related to exposure to chlorinated aromatic compounds and has been consistently reported to be associated with Agent Orange and/or dioxin (TCDD). While the condition generally clears, some forms persist up to 30 years. Numerous occupational and environmental exposure studies document the connection of exposure to TCDD and chloracne. The Task Force concludes that the credible evidence of an association between herbicides and chloracne outweighs the evidence of no association. PORPHYRIA CUTANEA TARDA (PCT) - PCT is an uncommon disorder of porphyrin metabolism, manifested by thinning and blistering of exposed skin, hyperpigmentation and excessive hair growth. There are two forms of the disease: hereditary and acquired. In the hereditary form, which requires no precipitating exposure, there are also neuropsychiatric and abdominal manifestations. The acquired form, or induced porphyria, is associated with excessive iron or alcohol intake and exposure to hexachlorobenzene. Epidemiologic studies are few because clinic PCT is rare. However, PCT and increased uroporphyrin excretion have been noted to occur soon after heavy TCDD exposure then improve over time often enough for the NAS to conclude that there is sufficient evidence of an association. The Task Force concludes that the credible evidence for an association between TCDD and porphyria cutanea tarda outweighs the evidence of no association. NON-HODGKIN's LYMPHOMA (NHL) - NHL includes a variety of clinical entities an histologic and prognostic groups. VA has previously accepted the association between service in Vietnam and the development of NHL. The NAS review considered a number of epidemiological studies (including studies involving occupational, environmental, and Vietnam exposures) and concluded that there was sufficient evidence for a positive association between exposure to the major herbicides used in Vietnam and development of NH> The Task Force accepts this association based on the number, consistency, and apparent quality of the studies cited in the NAS report. The Task Force concludes that the credible evidence for an association between herbicides and NHL outweighs the evidence of no association. HODGKIN'S DISEASE (HD) - HD is a form of lymphoma with characteristic histopathologic findings, especially the presence of Reed-Sternberg cells. It also has a number of clinical features that typically differ from other lymphomas. While there were fewer studies for HD than for NHL, the NAS review noted that the pattern of results was consistent with the findings for NHL and concluded that there was sufficient evidence for a positive association between exposure to the major herbicides used in Vietnam and the development of HD. The Task Force accepts this association based on the study findings as well as the difficulty which may occur in trying to distinguish between HD and NHL pathologically, the occasional development of both diseases in the same patient, and the biologic relationship of the two diseases in terms of tissue of origin. The Task Force concludes that the credible evidence for an association between herbicides and HD outweighs the evidence of no association. Category II - Health Outcomes with Suggestive Evidence of an Association NAS established that three conditions met their criteria for suggestive evidence of an association. They are: Respiratory cancers (lung, larynx, trachea) Prostate cancer Multiple myeloma The Task Force has reviewed these diseases and concludes that multiple myeloma and respiratory cancers meet the criteria for credible evidence for an association which is equal to or outweighs the credible evidence against an association. Multiple myeloma is closely related clinically to the two lymphomas in Category I. The Task Force pointed out that term lymphoma connotes a malignant proliferation of cells originating in lymphoid tissue. These disorders are subdivided into two major groups, Hodgkin's disease and non- Hodgkin's lymphoma (NHL). Multiple myeloma is not usually classified as a lymphoma, but it is closely related biologically to B-cell NHL (the most frequent type of NHL). RESPIRATORY CANCERS (LUNG, BRONCHUS, LARYNX, TRACHEA) - Lung cancer is a common disease in Americans, primarily due to the high prevalence of smoking in the past. However, it has also been associated with certain industrial exposures. Radon and asbestos interact with smoking to produce a multiplicative effect on the risk of lung cancer. Laryngeal cancers differ clinically from lung and bronchogenic cancers but likewise have been shown to be related to smoking, alcohol, and industrial exposures. Many studies have been done on lung cancer, some of which cover laryngeal. The NAS concluded that there was limited/suggestive (rather than sufficient) evidence for an association because of the inconsistent pattern of positive findings and because all studies did not fully control for or evaluate cigarette smoking. The VA Task Force had an extensive and prolonged discussion about the association between respiratory cancers and herbicide exposure. Among the points considered were high relative risks in production workers (who most likely had the highest exposures to herbicides among the groups studied), some evidence of increased risks with increased exposure among production workers, and doubts that major differences in smoking were likely to have occurred compared to control groups. While recognizing the difficulties inherent in this determination, the Task Force concludes that the credible evidence for a positive association is as least as strong as the credible evidence against such as association. PROSTATE CANCER - Prostate cancer is a very common male genitourinary cancer which shows marked increased prevalence with age. Most studies have shown an elevated risk for farm and forestry workers. Only one study indicates any risk associated with herbicides in these workers. There are significant studies which show no association. In those few production studies which do, the association is relatively weak and not statistically significant. The Task Force concludes that the credible evidence for an association between herbicides and prostate cancer does not equal or outweigh the evidence of no association. The panel recommends that special attention be paid to the prostate cancer in the next NAS review. MULTIPLE MYELOMA (MM) - MM is a malignant proliferation of plasma cells, cells which are derived from B lymphocytes. The NAS concluded that there was limited/suggestive evidence of an association between an exposure to major herbicides used in Vietnam and the development of MM. VA reviewers, however, were impressed that evidence in the NAS report for an association between exposure to herbicides and the development of MM appeared to be at least as strong as for HD. Also, the VA reviewers were concerned that the NAS report discounted some studies of MM (e.g., in farmers) because of possible exposure to other chemicals while apparently accepting these same studies for other disease associations. Moreover, MM is closely related biologically to B-cell NHL, and VA reviewers were strongly influenced by clinical considerations in addition to their epidemiogical evidence. The Task Force concludes that the credible evidence for an association between herbicides and MM outweighs the evidence of no association. Category III - Health Outcomes with Inadequate/Insufficient Evidence to Determine Whether an Association Exists The panel looked at this category and the diseases within it. NAS determined that the studies relating to the diseases within this category are of insufficient quality, consistency, or statistical power to permit a conclusion. The sum total of studies of this nature cannot be interpreted to constitute "credible" evidence for an association, in the opinion of the panel members. The one condition in this category for which other evidence not directly addressed by NAS existed with peripheral neuropathy. The panel spent considerable effort addressing that. The Veterans' Advisory Committee on Environmental Hazards had recommended to the Secretary in May 1991, that peripheral neuropathy be accepted as a condition for which a significant statistical association with TCDD exposure exists. However, this conclusion was based on case reports and studies that did not apply consistent methods to define a comparison group, determine exposure, evaluate clinical deficits or use standard definitions of peripheral neuropathy. In the judgment of the Task Force the most credible studies argue against the relationship. The Task Force concludes that the credible evidence for an association between herbicides and peripheral neuropathy does not equal or outweigh the evidence of no association. The Task Force recommends that the NAS review this matter further and closely examine the literature regarding acute and subacute effects that led the Advisory Committee to make its recommendation in 1991. NAS also reviewed the literature with respect to possible associations between herbicides used in Vietnam and various reproduction effects which are not diseases, i.e., spontaneous abortion, birth defects, still births and neonatal deaths, and low birth weigh, as well as childhood cancers in offspring of exposed parents. Although these conditions are discussed below, VA currently has no statutory authority to compensate for them. Given the pane;s conclusions that the evidence does not demonstrate an association, it does not recommend that such authority be sought from Congress. HEPATOBILIARY CANCERS - Hepatobiliary (liver and bile duct) cancers are relatively frequent in the U.S. There are a variety of risk factors including hepatitis B and C, alcohol, cirrhosis, PCBs and smoking. Angiosarcomas of the liver are associated with vinyl chloride, thoratrast and arsenicals. The studies are relatively few, small in size, and have not controlled for other risk factors. The Task Force concludes that the credible evidence for an association between herbicides and hepatobiliary cancers does not equal or outweigh the evidence of no association. BONE CANCER - The NAS considered bone and joint cancers together, considering the primary bone cancers of osteosarcoma, Ewing's sarcoma, and chondrosarcoma. The cancers are more common in the young and the elderly but because of their rarity, most studies have been too small to detect a statistically significant risk. There has not been a consistent finding of bone cancer in exposed groups and the relatively few studies that demonstrate a positive relationship are not sadistically significant and have large confidence limits. The Task Force concludes that the credible evidence for an association between herbicides and bone cancers does not equal or outweigh the evidence of no association. FEMALE REPRODUCTIVE CANCERS - Female reproductive cancers includes a variety of individual cancers: breast, uterus, cervix, ovary and other genital malignancies. The data related to women and herbicides is extremely limited. Women are often excluded from the larger studies. Generally, the breast cancer studied showed no association. One small case control study showed an association with ovarian cancer but the confidence intervals were very wide and the larger occupational and farm workers all showed lower mortality ratios. Likewise, studies of uterus and cervix cancer show no clear association with herbicides. The Task Force concludes that the credible evidence for an association between herbicides and female reproductive cancers does not equal or outweigh the evidence of no association. RENAL CANCERS - Cancers of the kidney have been increasing in incidence in recent years, with peak incidence in middle age. Cancer of the renal pelvis is less common and affects older people. The leather industry, asbestos, cadmium, petroleum products, analgesics, smoking and obesity have been associated with cancer of the kidney. Two studies of agricultural and forest workers showed increased risk of death from renal cancer but the preponderance of studies, including the two largest, show no increased risk. The Task Force concludes that the credible evidence for an association between herbicides and renal cancers does not equal or outweigh the evidence of no association. TESTICULAR CANCER - Testicular cancer is a cancer of younger males with a predilection for white males. A major risk factor is undescended testis and factors which produce atrophy and dysfunction. One study showed an elevated risk ratio for service in Vietnam but no information on herbicide exposure. In general the other veteran studies and the occupational studies have shown no association between exposure and outcome but the numbers are small. Other studies have been inconsistent. The Task Force concludes that the credible evidence for an association between herbicides and testicular cancers does not equal or outweigh the evidence of no association. LEUKEMIA - Leukemia covers several malignant disorders of the blood-forming cells in bone marrow and the lymph system. The two principal types, lymphocytic an myeloid, occur in both acute and chronic forms (ALL, CLL, AML, CML). Leukemia is increased in atomic bomb survivors and chemical workers with exposure to benzene and aromatic hydrocarbons. Evidence for an association comes primarily from studies of farmers and residents of Seveso. The studies of farmers did not control for other confounding exposures and when farmers were stratified by suspected herbicide use, the incidence of leukemia was generally not elevated. It is felt that the suggestive evidence from Seveso requires more time to determine if the association is real. The Task Force concludes that the credible evidence for an association between herbicides and leukemia does not equal or outweigh the evidence of no association. SPONTANEOUS ABORTION - Approximately 10 - 15% of all recognized pregnancies result in a recognized spontaneous abortion. About 35 - 40% of the loesses have chromosomally abnormal embryos or fetuses. A wide range of maternal factors are related to spontaneous abortions, the major two being maternal and history of previous miscarriage. The studies involving occupational and environmental herbicide exposure generally reported no association with spontaneous abortion. The available studies of veterans suggest an association. However, all the studies (both positive and negative) are II. Options Option 1: Accept the NAS evaluation and continue the Agent Orange Registry program. (Pro) A system of clinical data collection and evaluation already exists, therefore no further efforts are required to implement the NAS recommendation. (Con) Agent Orange Registry data do not include all clinical data obtained from all Vietnam veterans examined and treated in VA medical facilities. Option 2: In addition to the Agent Orange Registry, VA's Patient Treatment File (PTF) can be evaluated for the purpose stated in Section 6 of P.L. 102-4 (Pro) A system of clinical data collection for hospitalized veterans already exists in VA. The PTF data have been periodically evaluated by the Environmental Epidemiology Service and the results published in scientific journals. (Con) At the present time, Vietnam service status of each hospitalized Vietnam era veteran has to be determined by reviewing military personnel records. However, once VA completes the "Flagging" of Vietnam service in the computerized index of NPRC records in accordance with Research Recommendation 2, this task becomes much easier and more cost- effective. -33- III. Recommendation The VA Agent Orange Task Force recommends approval of both Option 1 & 2. IV. Implementation Plan 1. The Environmental Epidemiology Service (116E) will continue the evaluation of the Agent Orange Registry and the PTF data for the purposes described in Section 6. 2. The Environmental Epidemiology Service (116E) will prepare annual reports to Congress as required by P.L. 102-4. Section 7, Public Law 102-4: The Secretary of Veterans Affairs shall establish and maintain a system for the collection and storage of voluntarily contributed samples of blood and tissue of Vietnam veterans. I. Background The NAS believes that a system of archiving specimens for future research efforts offers some promise. However, the NAS feels that such a system has scientific value only to the extent that it is a component of specific well designed studies. II. Options Accept the NAS evaluation and not initiate an archiving system. (Pro) No valuable resources are expended on a project that has limited or doubtful scientific value. (Con) None III. Recommendation The VA Agent Orange Task Force recommends that no tissue archiving system be implemented. Section 8, Public Law 102-4: The secretary of Veterans Affairs shall establish a program to provide for the conduct of studies of the feasibility of conducting additional scientific research on health hazards resulting from 1) exposure to dioxin, 2) herbicides, or 3) military service in Vietnam. -34- I. Background The NAS believes that a series of epidemiologic studies of Vietnam veterans could yield valuable information if a new valid exposure reconstruction model can be developed. The NAS also finds value in continuing the existing Air Force Ranch Hand Study and expanding VA's Army Chemical Corps Vietnam Veterans Study as described in Research Recommendation 1. II. Options Implement the NAS research Recommendations 1-6. (Pro) These approaches will be in keeping with the NAS recommendations in a timely and cost-effective manner. (Con) Some research projects may be viewed as not being as comprehensive as the NAS envisioned. III. Recommendation The VA Agent Orange Task Force recommends that HAS research Recommendations 1-6 be implemented. Section 9, Public Law 102-4: The Secretary of Veterans Affairs shall, upon a veteran's request, obtain a sufficient amount of blood and conduct a test of blood for the level of 2,3,7,8- TCDD. I. Background The NAS does not believe analysis of blood for TCDD level outside of a specific well designed study is useful and recommends against such a program. For example, the NAS recommends collection and analysis of blood samples from Army Chemical Corps Vietnam veterans as a part of a study. II. Options Accept the NAS evaluation and not initiate a program for collection and analysis of blood specimens for 2,3,7,8-TCDD levels among Vietnam veterans receiving medical care or filing a disability compensation claim. (Pro) This approach will be in keeping with the NAS recommendation. (Con) Some Vietnam veterans may not understand the scientific basis for this decision and perceive that they are not afforded full medical service. III. Recommendation The VA Agent Orange Task Force recommends that VA not initiate a program for the collection and analysis of blood specimens for 2,3,7,8-TCDD levels among Vietnam veterans receiving medical care or filing a disability compensation claim. DECISION ON TASK FORCE RECOMMENDATIONS Approve ( ) Disapprove ( ) ______________________ ______________ Secretary Date APPENDICES A - Public Law 102-4 B - Executive Summary, NAS Report C - Memorandum from Chief of Staff establishing internal Task Force D - Membership of Task Force E - News release regarding NAS report and VA action F - Congressional testimony of July 27, 1993 G - American Legion comments on NAS report H - NVLSP comments on NAS report I - VVA comments on NAS report