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Regulations Branch, Office of drawback requested on the drawback war are decided fairly, consistently, and Regulations and Rulings, U.S. Customs entry. This is determined as follows: based on all available medical and Border Protection. However, * * * * * information concerning the diseases personnel from other offices I 4. In § 191.171, a new paragraph (c) is associated with detention or internment participated in its development. added to read as follows: as a prisoner of war. DATES: List of Subjects in 19 CFR Part 191 This interim final rule is § 191.171 General; drawback allowance. effective October 7, 2004. Comments Claims, Commerce, CBP duties and * * * * * must be received on or before November inspection, Drawback. (c) Merchandise processing fees. In 8, 2004. cases where the requirements of Amendments to the Regulations ADDRESSES: Written comments may be paragraph (b)(1) of this section have submitted by: mail or hand-delivery to I For the reasons stated above, part 191 been met, merchandise processing fees Director, Regulations Management of the CBP Regulations (19 CFR part 191) will be eligible for drawback. (00REG1), Department of Veterans is amended as follows: Approved: October 4, 2004. Affairs, 810 Vermont Ave., NW., Room Robert C. Bonner, 1068, Washington, DC 20420; fax to PART 191 — DRAWBACK Commissioner, U.S. Customs and Border (202) 273–9026; e-mail to I 1. The general authority citation for Protection. [email protected]; or, through part 191 continues to read as follows: Timothy E. Skud, http://www.Regulations.gov. Comments Deputy Assistant Secretary of the Treasury. should indicate that they are submitted Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 in response to ‘‘RIN 2900–AM09.’’ All [FR Doc. 04–22599 Filed 10–6–04; 8:45 am] (General Note 23, Harmonized Tariff comments received will be available for Schedule of the United States), 1313, 1624. BILLING CODE 4820–02–P public inspection in the Office of Regulation Policy and Management, I 2. Section 191.3(a)(4) and (b)(2) are Room 1063B, between the hours of 8 revised as follows: DEPARTMENT OF VETERANS a.m. and 4:30 p.m., Monday through AFFAIRS § 191.3 Duties and fees subject or not Friday (except holidays). Please call (202) 273–9515 for an appointment. subject to drawback. 38 CFR Parts 1 and 3 (a) Duties and fees subject to FOR FURTHER INFORMATION CONTACT: drawback include: RIN 2900–AM09 David Barrans, Deputy Assistant * * * * * General Counsel (022D), Office of Presumptions of Service Connection General Counsel, Department of (4) Merchandise processing fees (see for Diseases Associated With Service Veterans Affairs, 810 Vermont Avenue, § 24.23 of this chapter) for unused Involving Detention or Internment as a NW., Washington, DC 20420, (202) 273– merchandise drawback pursuant to 19 Prisoner of War 6332. U.S.C. 1313(j), and drawback for substitution of finished petroleum AGENCY: Department of Veterans Affairs. SUPPLEMENTARY INFORMATION: VA is derivatives pursuant to 19 U.S.C. ACTION: Interim final rule. revising its regulations to include a new 1313(p)(2)(A)(iii) or (iv). provision, codified at 38 CFR 1.18, SUMMARY: The Department of Veterans (b) * * * establishing guidelines for determining Affairs (VA) is issuing this interim final whether to establish new presumptions (2) Merchandise processing fees (see rule to establish guidelines for of service connection for any disease § 24.23 of this chapter), except where establishing presumptions of service associated with service involving unused merchandise drawback pursuant connection for diseases associated with detention or internment as a prisoner of to 19 U.S.C. 1313(j) or drawback for service involving detention or war. VA is also amending its substitution of finished petroleum internment as a prisoner of war. In adjudication regulations at 38 CFR derivatives pursuant to 19 U.S.C. accordance with those guidelines, this 3.309(c) to add atherosclerotic heart 1313(p)(2)(A)(iii) or (iv) is claimed; and interim final rule also establishes disease or hypertensive vascular disease * * * * * presumptions of service connection for and stroke to the list of diseases VA will I 3. In § 191.51, paragraph (b)(2) atherosclerotic and hypertensive heart presume to be associated with service introductory text is revised to read as disease and for stroke disease arising in involving detention or internment as a follows: former prisoners of war. These rules are prisoner of war (POW), and to reflect necessary because claims based on statutory changes. These new § 191.51 Completion of drawback claims. service involving detention or presumptions of service connection * * * * * internment as a prisoner of war present reflect VA’s determination that (b) * * * unique medical issues and because presumptions for heart disease and (2) Merchandise processing fee factors including the lack of stroke are warranted by application of apportionment calculation. Where a contemporaneous medical records the guidelines set forth in § 1.18. drawback claimant seeks unused during periods of captivity and the merchandise drawback pursuant to 19 relatively small body of available Guidelines for Identifying POW U.S.C. 1313(j), or drawback for medical information present obstacles to Presumptive Conditions substitution of finished petroleum substantiating claims for service- Statutory and regulatory standards derivatives pursuant to 19 U.S.C. connected benefits based on prisoner-of- currently exist to guide VA in 1313(p)(2)(A)(iii) or (iv), for a war service. By establishing guidelines identifying diseases associated with merchandise processing fee paid for identifying diseases associated with exposure to herbicide agents, hazards of pursuant to 19 U.S.C. 58c(a)(9)(A), the service involving detention or service in the Gulf War, and ionizing claimant is required to correctly internment as a prisoner of war, these radiation. See 38 U.S.C. 1116 and 1118; apportion the fee to that merchandise rules will help VA to ensure that claims 38 CFR 1.17. VA has determined that it that provides the basis for drawback for service-connected benefits for would be helpful to establish standards when calculating the amount of disability or death of former prisoners of to guide VA in identifying diseases

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associated with service involving prescribe all rules and regulations that for VA’s review of the medical evidence detention or internment as a POW and are necessary or appropriate to carry out concerning the association between the establishing new presumptions of the laws administered by VA, including POW experience and particular diseases service connection for such diseases. regulations with respect to the nature and to establish presumptions of service We are establishing a new provision at and extent of proof necessary to connection when the evidence 38 CFR 1.18 setting forth guidelines for establish entitlement to benefits under reasonably establishes an association. such determinations. The guidelines are such laws. Pursuant to that authority, We are setting forth the guidelines VA substantially similar to the above- the Secretary may establish reasonable will apply in a new regulation at 38 CFR referenced existing guidelines, with evidentiary presumptions of service 1.18. Paragraph (a) of § 1.18 states VA’s minor differences necessary to reflect connection for diseases. The Secretary policy to establish presumptions of considerations unique to former POWs. has determined that presumptions of service connection for former POWs VA is authorized to provide service connection are particularly when necessary to prevent denials of compensation and other benefits for appropriate for former POWs. benefits in significant numbers of disability or death due to disease or Veterans who were detained or meritorious claims. injury incurred in or aggravated by interned as POWs generally were Paragraph (b) of § 1.18 states the service. To establish service connection subjected to unique hardships including standard VA will apply in determining for a disease or injury, a claimant malnutrition, torture, physical and whether a presumption of service ordinarily must provide evidence, with psychological abuse, and a lack of connection is warranted. That paragraph VA’s assistance, establishing that the adequate medical care. Although POW states that the Secretary may establish a claimed disease or injury was incurred experiences have varied with time, presumption of service connection for a in or aggravated by service. Statutory place, and other factors, certain disease when there is ‘‘at least limited/ and regulatory presumptions of service hardships are so prevalent across the suggestive evidence that an increased connection relieve claimants of this spectrum of POW experience as to risk of such disease is associated with evidentiary burden in certain support the presumption that POWs as service involving detention or circumstances by directing VA a group have incurred similar health internment as a prisoner of war and an adjudicators to presume that certain risks. The lack of contemporaneous association between such detention or diseases were incurred in or aggravated personnel and health records to internment and the disease is by service unless evidence shows document events, injuries, or diseases biologically plausible.’’ We define the otherwise. These presumptions are during periods of captivity also provides term ‘‘limited/suggestive evidence’’ in generally based on scientific and a strong justification for relying on paragraph (b)(1) to refer to ‘‘evidence of medical data that provide a basis for evidentiary presumptions rather than a sound scientific or medical nature that inferring a connection between a requiring direct proof of service is reasonably suggestive of an particular disease and some connection. Further, presumptions may association between prisoner-of-war circumstance regarding the veteran’s simplify and expedite the claims experience and the disease, even though service. adjudication process, a particularly the evidence may be limited because Evidentiary presumptions of service significant consideration for former matters such as chance, bias, and connection serve a number of purposes. POWs, more than ninety percent of confounding could not be ruled out By codifying medical findings and whom served in World War II and are with confidence or because the principles that otherwise may not be now, on average, over eighty years old. relatively small size of the affected familiar to VA adjudicators, they Additionally, although several health population restricts the data available promote the efficient resolution of effects associated with prisoner-of-war for study.’’ Paragraph (b)(2) states, for issues of service connection without the experiences are well known and purposes of illustration, that ‘‘limited/ need for case-by-case investigation and reflected in existing presumptions of suggestive evidence’’ may be found interpretation of the available medical service connection, determining where one high-quality study detects a literature. They promote fair and whether other health effects may be statistically significant association or consistent decision making by associated with prisoner-of-war where several smaller studies detect an establishing simple adjudicatory rules to experience is not a simple task. This is association that is consistent in govern the claims of similarly situated due in part to the discrete nature of the magnitude and direction. veterans. They also may assist claimants POW experience. The effects of certain The ‘‘limited/suggestive evidence’’ who would otherwise face substantial other service-related risk factors such as standard is essentially the same difficulties in obtaining direct proof of exposure to ionizing radiation or standard that the Institute of Medicine service connection due to the herbicide agents have been extensively (IOM) of the National Academy of complexity of the factual issues, the lack studied in relation to exposures Sciences employs in reports it prepares of contemporaneous medical records occurring in occupational and other for VA analyzing the health effects of during service, or other circumstances. civilian settings in addition to studies of exposure to herbicide agents. In those Currently, 38 U.S.C. 1112(b) veteran populations. In contrast, the reports, which are mandated by statute, establishes presumptions of service effects of the POW experience have been the IOM classifies the association connection for sixteen categories of less extensively studied, because there between a particular disease and the disease that are deemed to be associated generally are not comparable civilian hazard in question as belonging to one with detention or internment as a POW. populations and the number of former of the following four categories: Eleven of those conditions are presumed POWs available for study is ‘‘Sufficient evidence of an association,’’ to be service connected only if the comparatively small. Although studies ‘‘limited/suggestive evidence of an veteran was detained or interned for a of former POWs do exist, the limited association,’’ ‘‘inadequate or insufficient period of at least thirty days, and the amount of information available evidence to determine whether an remaining five are presumed to be complicates the task of identifying association exists,’’ and ‘‘sufficient service connected if the veteran was diseases associated with the POW evidence of no association.’’ VA has detained or interned for any period. experience. In view of these established presumptions of service The Secretary of Veterans Affairs is circumstances, VA has determined that connection for each of the diseases the authorized by 38 U.S.C. 501(a) to it is appropriate to establish guidelines IOM has classified as having at least

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‘‘limited/suggestive evidence’’ of an concept of biologic plausibility in its Evidence of Association Between POW association. The ‘‘limited/suggestive reviews of the literature concerning the Experience and Stroke evidence’’ standard employed by the health effects of herbicide exposure and There are very few studies IOM is familiar to VA and has proven hazards of Gulf War service and is investigating the possible relationship to be a useful analytical framework for required by statute to consider biologic between POW experience and stroke. In assessing scientific evidence and plausibility. See Pub. L. 102–4, September 2000, the VA Advisory determining whether a presumption of § 3(d)(1)(C), and Pub. L. 105–277, Committee on Former Prisoners of War service connection may be warranted. § 1603(e)(1)(C). received the report of an Expert Panel Accordingly, we will use that standard on Stroke in Former Prisoners of War, for determining when a presumption Paragraph (c) of § 1.18 states that, in establishing a presumption of service which, based on review of the existing may be warranted for former POWs. scientific literature, found only one The IOM defines the ‘‘limited/ connection for a disease, the Secretary relevant study. That 1996 study suggestive evidence’’ standard to refer to may specify a minimum period of examined records of 475 former World circumstances in which evidence is detention or internment necessary to War II POWs and a control group of 81 suggestive of an association but is qualify for the presumption. As noted non-POW World War II veterans who limited because matters of chance, bias, above, some of the current statutory had been followed as part of a long-term and confounding cannot be ruled out presumptions apply only to former study by the Medical Follow-up Agency with confidence. Our definition adds POWs who were detained or interned of the National Academy of Sciences’ that the evidence may be limited for a period of at least thirty days. That IOM. The study found a seven-fold because the relatively small size of the requirement apparently reflects the increase in the incidence of stroke affected population may restrict the data determination that certain conditions, among the POWs as compared to the available for study. We believe this such as certain diseases associated with additional consideration is significant control group (relative risk = 7.03), and vitamin deficiency, ordinarily may arise a statistically significant nearly ten-fold with respect to former POWs. As noted only after a prolonged period of food above, the lack of a comparable civilian increase in stroke incidence among deprivation during confinement. Our POWs who had suffered extreme population for study may limit the rule is intended to allow the Secretary amount of data available for discerning malnutrition during captivity (relative to establish a similar requirement the health effects of the POW risk = 9.76). (Brass LM, Page WF. Stroke concerning the length of detention or experience. The data available for study in Former Prisoners of War. J Stroke and are also severely restricted by the fact internment for new presumptions Cerebrovascular Diseases 1996; 6:72– that there is often little or no established in the future, if warranted 78.) The study also found that the risk information about veterans’ health by sound scientific or medical evidence. of stroke was higher among former status or adverse exposures during Paragraph (d) of § 1.18 explains that POWs suffering from post-traumatic captivity. Moreover, opportunities for the requirement in paragraph (b) that a stress disorder (PTSD) than among future studies are increasingly limited disease be ‘‘associated’’ with the POW former POWs without PTSD (relative because the population of surviving experience may be satisfied by evidence risk = 1.67). The strength of those former POWs, most of whom served in demonstrating either a statistical or a findings is limited by the small size of the study population. World War II, is declining rapidly. causal association. Paragraph (e) of the Although we intend that any Two more recent studies have also rule specifies the types of evidence the addressed the relationship between presumptions VA establishes will be Secretary will consider in deciding based on sound scientific and medical POW experience and stroke. A 2001 whether a presumption is warranted. study used Federal death records to evidence, we believe that VA’s analysis This paragraph makes clear that the of the evidence should take account of obtain death data through 1996 for a Secretary need not rely exclusively on study population of 9,457 former POWs the unique circumstances and studies of former POWs, but may evidentiary hurdles affecting this and 7,178 controls. The study found consider studies concerning the health deserving group of veterans. It may be that former POWs aged 75 years and effects of circumstances or hardships unrealistic to expect the same degree of older had an increased risk of stroke data or the same number of similar to those experienced by POWs, mortality (hazard ratio = 1.13), although corroborative studies that may exist if available, as well as any other sound the risk was not statistically significant. with respect to the health effects of scientific or medical evidence the (Page WF, Brass LM. Long-Term Heart herbicide exposure or other areas of Secretary considers relevant. Disease and Stroke Mortality Among investigation. We believe that fairness to Paragraph (f) of § 1.18 states several Former American Prisoners of War of former POWs requires that VA fully factors that VA will consider in World War II and the Korean Conflict: evaluate the available data and not evaluating any scientific study Results of a 50-Year Follow-Up. Military accord undue significance to the fact concerning diseases possibly associated Medicine 2001; 166:803–08.) A that such data are comparatively limited with the POW experience. The specified subsample of the overall study by the small size of the affected factors are similar to the factors VA population had completed a population. considers in assessing studies relating to questionnaire in 1967 indicating the The requirement that the association herbicide exposure and other hazards. presence or absence of certain symptoms during their captivity. The be biologically ‘‘plausible’’ does not See 38 U.S.C. 1116(b)(2) and study authors found a statistically require proof of a casual relationship. 1118(b)(2)(B); 38 CFR 1.17(b). This is further clarified by § 1.18(d), significant increase in death due to discussed below. Rather, it requires only Paragraph (g) of § 1.18 states that the stroke among veterans who had a determination that there is a possible Secretary may contract with an experienced visual symptoms, such as biological mechanism, consistent with appropriate expert body, such as the night blindness, during their captivity sound scientific evidence, by which the IOM, to review and summarize the (hazard ratio = 3.10). Because the suspected precipitating event (POW scientific evidence or for any other presence of visual symptoms during experience) could lead to the health purpose relevant to the Secretary’s captivity may be associated with outcome. The IOM routinely applies the determinations under this rule. vitamin A deficiency (Page WF. The

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Health of Former Prisoners of War: available for study and the limited caused by a veteran’s POW experience, Results from the Medical Examination number of studies generally undertaken VA may consider the presumption to be Survey of Former Prisoners of World in this field. Accordingly, the lack of rebutted. War II and the Korean Conflict, p. 75. corroborating data does not imply the Evidence of Association Between POW Washington DC, National Academies absence of an association under these Experience and Heart Disease Press, 1992.), this finding is consistent circumstances. with the 1996 Brass and Page study in The evidence that the risk of stroke is As with stroke, there are relatively suggesting an association between increased among POWs who suffered few studies addressing the association malnutrition during POW captivity and extreme malnutrition or visual between POW experience and heart subsequent stroke. symptoms during captivity or who have disease. A series of older studies did not On the recommendation of the Expert been diagnosed with PTSD also lends find consistent evidence of an Panel on Strokes in Former Prisoners of support to the finding of an association association, as summarized in Page WF, War, VA’s Environmental Epidemiology between POW experience and stroke. As Ostfeld AM. Malnutrition and Service in 2003 conducted a study using indicated in § 1.18, VA considers stress Subsequent Ischemic Heart Disease in medical and death data from records of and malnutrition to be among the Former Prisoners of War of World War VA and the Health Care Financing hardships ordinarily associated with II and the Korean Conflict. (J Clin Administration (HCFA) of the POW experience. Evidence suggesting Epidemiol 1994; 47:1437–41.) A 1954 Department of Health and Human that the risk of stroke increases with the study found an excess of cardiovascular Services for the period from 1991 to severity of those hardships supports the deaths among World War II POWs 2002. This study, which has not yet conclusion that stroke is associated with (Cohen BM, Cooper MZ. A Follow-up been published, included 16,641 World POW experience. Study of World War II Prisoners of War. War II POWs and 1,051 Korean War Under the standards set forth in Veterans Administration Medical POWs, as well as 8,406 World War II § 1.18, the Secretary finds that the Monograph, Washington DC: controls and 3,816 Korean War controls. available evidence is suggestive of an Government Printing Office; 1954.), This study found that POWs had a association between POW experience although subsequent mortality studies significantly higher incidence of PTSD and stroke because sound scientific in 1970 and 1980 found no excess than the controls and that POWs with studies provide evidence of an deaths due to cardiovascular diseases PTSD had a higher incidence of stroke association that is consistent in (Nefzger, MD. Follow-up Studies of than POWs without PTSD (odds ratio = magnitude and direction, even though it World War II and Korean War Prisoners. 1.12 for World War II and 1.25 for is limited in some respects by the small I. Study Plan and Mortality Findings. Korean War). (Kang HK, Bullman TA. size of the affected population and the Am J Epidemiol 1970; 91:123–38; Keehn Ten Year Mortality and Morbidity correspondingly limited data available RJ. Follow-up Studies of World War II Follow-up of Former World War II and for study. The Secretary further finds and Korean War Prisoners III. Mortality Korean War Prisoners of War that an association between stroke and to January 1, 1976. Am J Epidemiol (unpublished VA Study 2003).) POW experience is biologically 1980; 111:194–211.) A 1975 morbidity Although the study did not find a plausible, as discussed below. study found a significantly higher rate significantly increased risk of stroke Accordingly, the Secretary is of hospitalization for heart disease among POWs as compared to non- establishing a presumption of service among World War II Pacific Theater POWs, the evidence for an association connection for stroke in former POWs. POWs as compared to controls. (Beebe between PTSD and stroke among POWs The interim final rule establishing GW. Follow-up Studies of World War II is consistent with findings stated in the this presumption refers generally to and Korean War Prisoners: II. Morbidity, 1996 study by Brass and Page. ‘‘stroke and its complications’’ and thus Disability, and Maladjustments. Am J The 1996 Brass and Page study noted will apply to any type of stroke. The Epidemiol 1975; 101:400–22.) Studies of that several studies have provided associations detected in the 1996 and POWs from other countries also yielded evidence suggesting an association 2001 POW studies were based on inconsistent results. between stress and stroke, although the diagnoses of all types of stroke, and the More recent studies have yielded evidence overall is not conclusive. The studies did not state separate findings intriguing findings concerning the authors also noted that the effects of for specific types of stroke. Although association between heart disease and stress on stroke may vary depending there are known differences in the three POW experience. The 1994 study by upon individual reactions to stress. As major categories of stroke (ischemic, Page and Ostfeld found a statistically stated in paragraph (e)(2) of § 1.18, the hemorrhagic, and embolic) that may significant increase in deaths due to Secretary will consider evidence suggest etiological differences in some ischemic heart disease among former concerning the effects of circumstances circumstances, the existing data do not POWs who experienced edema or hardships similar to those provide a basis for excluding any (swelling) in their lower limbs during experienced by POWs, including stress, category of stroke from the presumption, captivity (odds ratio = 2.83). Because in assessing the evidence for and we believe that any uncertainty localized edema is a symptom of establishing presumptions of service regarding the strength of the association thiamine deficiency, the authors connection. for these closely related diseases should theorized that the findings may suggest Based on the evidence discussed be resolved in favor of the former POWs. an association between malnutrition above, the Secretary has determined that Further, VA believes that the during captivity and subsequent a presumption of service connection is requirements of biologic plausibility are ischemic heart disease. Current VA warranted for stroke among former satisfied for each of the major categories regulations provide for presumptive prisoners of war. The 1996 and 2001 of stroke. Presumptions of service service connection of ischemic heart POW studies both found an increased connection for former POWs can be disease in former POWs who risk of stroke among former POWs. rebutted as provided in 38 U.S.C. experienced localized edema during Although there is an absence of other 1113(a) and 38 CFR 3.307(d). captivity. 38 CFR 3.309(c). directly corroborating studies, the lack Accordingly, if evidence in a case The 2001 study by Page and Brass of additional data is due in part to the supports a finding that a particular analyzed the increased risk of heart small size of the POW population presumptive condition was not actually disease among former POWs by age

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group and found a trend of increased limited, the link to specific aspects of Presumptions of service connection for excess risk with advanced age, with a POW experience strengthens the former POWs can be rebutted as statistically significant increased risk for evidence for an association between provided in 38 U.S.C. 1113(a) and 38 former POWs aged 75 years or over heart disease and POW service. CFR 3.307(d). Accordingly, if evidence (hazard ratio = 1.25). The authors stated Accordingly, the Secretary concludes in a case supports a finding that a that the findings may indicate that the that sound scientific studies provide particular presumptive condition was sequelae of serious, acute malnutrition limited/suggestive evidence of an not actually caused by a veteran’s POW may not appear until after many association between POW experience experience, VA may consider the decades. and heart disease. As discussed below, presumption to be rebutted. The 2003 VA study analyzed records the Secretary has also determined that The interim final rule also states that of inpatient and outpatient treatment the association between POW the presumption of service connection from VA and HCFA records to experience and heart disease is applies to the complications of determine whether POWs had an biologically plausible. Accordingly, the atherosclerotic heart disease and increased incidence of certain diseases Secretary is establishing a presumption hypertensive vascular disease, to make in comparison to the non-POW controls. of service connection for heart disease clear that congestive heart failure, The study detected small increases in in former POWs. myocardial infarction, arrhythmias, and the incidence of hypertension and The studies discussed above did not similar complications may be service myocardial infarction among some, but all investigate the same range of heart connected if they result from not all of the subpopulations examined, diseases and thus do not clearly resolve atherosclerotic heart disease or and not all of the findings were the question of which types of heart hypertensive vascular disease. statistically significant. However, the disease may be associated with POW Biologic Plausibility study did find a statistically significant experience. For purposes of this increased incidence of hypertension and presumption, we will include all The Secretary has concluded that an chronic heart disease among World War cardiovascular diseases that are association between POW experience II veterans with PTSD (odds ratio = 1.25 consistent, in terms of biologic and both heart disease and stroke is for hypertension and 1.19 for chronic plausibility, with the findings in the biologically plausible. The concept of heart disease). relevant studies in that the diseases are biologic plausibility refers to knowledge The conclusion that PTSD may be potentially capable of being caused by of the biological mechanism by which a associated with cardiovascular disorders the circumstances or hardships of POW particular event can lead to a health is also supported by a 1997 study service such as extreme stress or outcome. It does not require conclusive finding that Vietnam veterans diagnosed malnutrition. We describe these proof of a causal relationship between with PTSD had a significantly increased diseases as atherosclerotic heart disease the event and the health outcome, but risk of circulatory disease many years or hypertensive vascular disease (to requires a determination as to whether after service. (Boscarino JA. Diseases include hypertensive heart disease). there is a possible biological mechanism Among Men 20 Years After Exposure to Atherosclerotic heart disease is a term that is consistent with sound scientific Severe Stress: Implications for Clinical used to refer to a heart disease involving evidence by which the event could lead Research and Medical Care. Psychosom progressive narrowing and hardening of to the health outcome. Accordingly, to Med 1997; 59:605–14.) the arteries over time and encompasses be biologically plausible, an association Based on the evidence discussed ischemic heart disease, coronary artery must be consistent with existing above, the Secretary has determined that disease, and other diseases that may be scientific and medical knowledge, even a presumption of service connection is described by a more specific diagnosis. if current evidence does not warranted for atherosclerotic heart Hypertensive vascular disease refers to conclusively identify a specific known disease and hypertensive vascular disease associated with elevated blood mechanism by which the circumstances disease among former POWs. The 2001 pressure. The presumption would not in question cause the diseases study by Page and Brass found a extend to diseases that arise from viral associated with such circumstances. statistically significant increased risk of or bacterial causes, because we Current medical literature suggests mortality due to heart disease in former conclude that the relevant studies, and plausible, though not established, POWs aged 75 and older, based on a the evidence concerning biologic biological mechanisms by which stress relatively large population of former plausibility, do not support a finding at and/or malnutrition during POW POWs and controls, many of whom had this time that such heart diseases are captivity could contribute to heart been followed for as many as fifty years associated with POW experience. disease or stroke. by the Medical Follow-up Agency of the With respect to certain types of A number of authorities have National Academy of Sciences’ IOM. atherosclerotic heart disease or postulated that stress may contribute to The 1994 Page and Ostfeld study also hypertensive vascular disease that are to cardiovascular disease through a found a statistically significant be covered by these presumptions, there concept referred to as ‘‘allostatic load,’’ increased risk of heart disease in former is little available evidence upon which which is described as the long-term POWs who experienced edema, a to rule in or rule out the possibility that effect of the physiological response to consequence of malnutrition, and the the condition is capable of being caused stress. Through the process of allostasis, 2003 VA study found a statistically by the hardships of POW service. In the autonomic nervous system, the significant increased risk of heart those cases, we have chosen to resolve hypothalamic-pituitary-adrenal (HPA) disease among former POWs with PTSD. the doubt in favor of veterans and axis, and the cardiovascular, metabolic, As noted above with respect to stroke, include the condition within the scope and immune systems protect the body the Secretary concludes that the of the presumption. Although the by responding to stress with adaptive evidence suggesting an association necessity of inclusion of some changes. Those adaptations can cause between heart disease and specific conditions may be uncertain from a wear and tear on the systems involved hardships of POW experience— purely scientific perspective, VA has in this response and may produce a malnutrition and stress—is significant. decided as a policy matter to resolve variety of cardiovascular changes Although the available data concerning this issue in favor of veterans because associated with atherosclerosis, the health effects of POW experience are there is a reasonable basis for doing so. hypertension, cardiac arrhythmias,

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compromised coronary function, and Other Changes to § 3.309(c) under 38 U.S.C. 501(a) to establish new increased risk of myocardial infarction We are making one other change to presumptions of service connection for and stroke. (McEwen BS. Protective and § 3.309(c). Section 3.309(c) states that former POWs. These portions of the rule Damaging Effects of Stress Mediators. N the presumptions of service connection constitute a general statement of VA Engl J Med 1998; 338:171–79; Brunner apply only to veterans who were policy or, alternatively, rules of VA E. Stress Mechanisms in Coronary interned or detained for not less than 30 procedure and practice. Accordingly, Artery Disease. In: Stansfeld S, Marmot days. The 30-day requirement was they are exempt under 5 U.S.C. M (eds.). Stress and the Heart: formerly mandated by the governing 553(b)(3)(A) from the notice and Psychosocial Pathways to Coronary statutory provisions at 38 U.S.C. comment requirements of the Administrative Procedure Act. The Heart Disease. London. BMJ Books 1112(b). Effective December 16, 2003, portions of this rule revising 38 CFR 2002.) however, section 201 of the Veterans 3.309(c) to conform to the provisions of Support for the biologic plausibility of Benefits Act of 2003, Pub. L. No. 108– 38 U.S.C. 1112(b), as amended by the an association between malnutrition 183, 117 Stat. 2651, amended 38 U.S.C. Veterans Benefits Act of 2003, do not and heart disease and stroke comes from 1112(b) to eliminate the 30-day involve any change in law, but merely evidence that vitamin deficiencies may requirement for psychosis, any anxiety restate the statutory provisions of 38 cause elevated plasma levels of states, dysthymic disorders, organic U.S.C. 1112(b). Accordingly, these homocysteine, a naturally occurring residuals of frostbite and post-traumatic portions of the rule are, at most, amino acid. A number of studies suggest osteoarthritis. We are revising § 3.309(c) interpretative rules that are also exempt that elevated homocysteine levels may to conform to the current provisions of produce effects on the cardiovascular under 5 U.S.C. 553(b)(3)(A) from the section 1112(b). We are including heart notice and comment requirements of the system that can lead to heart disease or disease and stroke among the conditions stroke. (Stein, JH, McBride PE. Administrative Procedure Act. that will be presumed to be service Alternatively, pursuant to 5 U.S.C. Hyperhomocysteinemia and connected following any period of POW Atherosclerotic Vascular Disease: 553(b)(3)(B), the Secretary for good captivity. The diseases that remain cause finds that notice and an Pathophysiology, Screening, and subject to a 30-day detention or Treatment. Arch Int Med 1998; opportunity for prior public comment is internment requirement generally are unnecessary with respect to this portion 158:1301–06; Tsai J, Perrella MA, those that would be expected to be Yoshizumi M, Hseih C, Haber E, of the rule because it merely tracks a incurred only over a prolonged period statutory provision that VA is required Schlegel R, Lee M. Promotion of of detention or internment, such as Vascular Smooth Muscle Cell Growth by to follow. diseases associated with malnutrition. In accordance with 5 U.S.C. Homocysteine: A Link to Because the evidence indicates that 553(b)(3)(B), the Secretary finds that Atherosclerosis. 91 Proc Natl Acad Sci heart disease and stroke potentially may there is good cause for dispensing with 1994; 91:6369–73.) Although the be associated either with malnutrition the opportunity for prior comment with available evidence is not conclusive, it during prolonged captivity or with respect to the portions of this rule satisfies the requirement of biologic stress due to circumstances such as establishing new presumptions of plausibility for purposes of the torture or abuse, which may occur service connection for atherosclerotic Secretary’s determination. during even brief periods of captivity, heart disease, hypertensive vascular Presumptions of Service Connection we do not believe a minimum period of disease, and stroke among former detention or internment is warranted for POWs. The Secretary concludes that VA’s regulation at 38 CFR 3.309(c) these presumptions. providing an opportunity for prior identifies the diseases VA presumes to As part of a VA project to rewrite all comment is unnecessary because this be service connected for former POWs. of its adjudication regulations in part 3 portion of the rule is unlikely to We are amending this list of diseases by of title 38, Code of Federal Regulations, generate any adverse public comment, adding atherosclerotic heart disease, we published a notice of proposed rule inasmuch as it confers a benefit on a hypertensive vascular disease making in the Federal Register of July deserving class of veterans based on (including hypertensive heart disease), 27, 2004 (69 FR 44614), proposing a sound scientific evidence. The Secretary stroke, and their complications. new regulation that would implement further finds that it is impracticable to We are removing the note in current the provisions of section 201 of the delay this regulation for the purpose of § 3.309(c) specifying that the term Veterans Benefits Act of 2003 removing soliciting prior public comment because ‘‘beriberi heart disease’’ includes the 30-day detention or internment the class of veterans affected by this rule ischemic heart disease in a former POW requirement for certain POW diseases. is elderly and rapidly dwindling. More who experienced localized edema Because we are now issuing this interim than 90% of all POWs served in World during captivity. This note was added final rule to amend the list of diseases War II and are now, on average, over based on the 1994 Page and Ostfeld in § 3.309(c) effective immediately, we eighty years old. As of January 1, 2003, study finding an association between believe it is desirable to make these this population of World War II veterans the presence of lower-limb edema additional changes at this time to bring had an annual mortality rate of nine during POW captivity and subsequent the regulation into conformity with the percent. Delay in implementing these ischemic heart disease. This interim current statute. rules would have a significant adverse final rule establishes a presumption of effect and frustrate the beneficial Administrative Procedure Act service connection for heart disease, purpose of this rule in view of the high including ischemic heart disease, VA has determined that it is mortality rate among the POW without regard to whether localized appropriate to issue this rule as an population and the fact that the majority edema was present in service. interim final rule without providing an of former POWs are at an age where Accordingly, we are removing the opportunity for prior public comment. their medical and financial needs are current note to make clear that the The provisions of this rule to be likely to be at their greatest. presence of edema is no longer required codified at 38 CFR 1.18 specify the For the foregoing reasons, the in order to establish service connection procedures VA intends to follow in Secretary is issuing this rule as an for ischemic heart disease. exercising its discretionary authority interim final rule. The Secretary will

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consider and address comments that are PART 1—GENERAL PROVISIONS (e) Evidence. In making received within 30 days of the date this determinations under paragraph (b) of I interim final rule is published in the 1. The authority citation for part 1 this section, the Secretary will consider, Federal Register. continues to read as follows: to the extent feasible: Authority: 38 U.S.C. 501(a), unless (1) Evidence regarding the increased Unfunded Mandates otherwise noted. incidence of disease in former prisoners The Unfunded Mandates Reform Act I 2. Section 1.18 is added to read as of war; requires, at 2 U.S.C. 1532, that agencies follows: (2) Evidence regarding the health prepare an assessment of anticipated effects of circumstances or hardships costs and benefits before developing any § 1.18 Guidelines for establishing presumptions of service connection for similar to those experienced by rule that may result in an expenditure former prisoners of war. prisoners of war (such as malnutrition, by State, local, or tribal governments, in (a) Purpose. The Secretary of Veterans torture, physical abuse, or psychological the aggregate, or by the private sector, of Affairs will establish presumptions of stress); $100 million or more in any given year. service connection for former prisoners (3) Evidence regarding the duration of This rule will have no such effect on of war when necessary to prevent exposure to circumstances or hardships State, local, or tribal governments, or the denials of benefits in significant experienced by prisoners of war that is private sector. numbers of meritorious claims. associated with particular health effects; Executive Order 12866 (b) Standard. The Secretary may and establish a presumption of service (4) Any other sound scientific or The Office of Management and Budget connection for a disease when the medical evidence the Secretary has reviewed this document under Secretary finds that there is at least considers relevant. Executive Order 12866. limited/suggestive evidence that an (f) Evaluation of studies. In evaluating Paperwork Reduction Act increased risk of such disease is any study for the purposes of this associated with service involving section, the Secretary will consider: This document contains no provisions detention or internment as a prisoner of (1) The degree to which the study’s constituting a collection of information war and an association between such findings are statistically significant; under the Paperwork Reduction Act (44 detention or internment and the disease (2) The degree to which any U.S.C. 3501–3521). is biologically plausible. conclusions drawn from the study data Regulatory Flexibility Act (1) Definition. The phrase ‘‘limited/ have withstood peer review; suggestive evidence’’ refers to evidence (3) Whether the methodology used to The Secretary hereby certifies that of a sound scientific or medical nature obtain the data can be replicated; this regulatory amendment will not that is reasonably suggestive of an (4) The degree to which the data may have a significant economic impact on association between prisoner-of-war be affected by chance, bias, or a substantial number of small entities as experience and the disease, even though confounding factors; and they are defined in the Regulatory the evidence may be limited because (5) The degree to which the data may Flexibility Act (RFA), 5 U.S.C. 601–612. matters such as chance, bias, and be relevant to the experience of The reason for this certification is that confounding could not be ruled out prisoners of war in view of similarities these amendments will not directly with confidence or because the or differences in the circumstances of affect any small entities. Only VA relatively small size of the affected the study population. beneficiaries and their survivors will be population restricts the data available (g) Contracts for Scientific Review and directly affected. Therefore, pursuant to for study. Analysis. To assist in making 5 U.S.C. 605(b), these amendments are (2) Examples. ‘‘Limited/suggestive determinations under this section, the exempt from the initial and final evidence’’ may be found where one Secretary may contract with an regulatory flexibility analysis high-quality study detects a statistically appropriate expert body to review and requirements of sections 603 and 604. significant association between the summarize the scientific evidence, and Catalog of Federal Domestic Assistance prisoner-of-war experience and disease, assess the strength thereof, concerning even though other studies may be the association between detention or The Catalog of Federal Domestic inconclusive. It also may be satisfied internment as a prisoner of war and the Assistance program numbers are 64.109, where several smaller studies detect an occurrence of any disease, or for any and 64.110. association that is consistent in other purpose relevant to the Secretary’s List of Subjects magnitude and direction. These determinations. examples are not exhaustive. Authority: 38 U.S.C. 501(a), 1110. 38 CFR Part 1 (c) Duration of detention or Administrative practice and internment. In establishing a PART 3—ADJUDICATION procedure, Claims. presumption of service connection under paragraph (b) of this section, the Subpart A—Pension, Compensation, 38 CFR Part 3 Secretary may, based on sound and Dependency and Indemnity Administrative practice and scientific or medical evidence, specify a Compensation procedure, Claims, Disability benefits, minimum duration of detention or I 3. The authority citation for part 3, Health care, Veterans, Vietnam. internment necessary for application of subpart A continues to read as follows: Approved: September 8, 2004. the presumption. (d) Association. The requirement in Authority: 38 U.S.C. 501(a), unless Anthony J. Principi, paragraph (b) of this section that an otherwise noted. Secretary of Veterans Affairs. increased risk of disease be ‘‘associated’’ I 4. Section 3.309 (c) is amended by I For the reasons set forth in the with prisoner-of-war service may be removing the ‘‘Note’’ immediately preamble, the Department of Veterans satisfied by evidence that demonstrates following the list of diseases and by Affairs amends 38 CFR parts 1 and 3 as either a statistical association or a causal revising the paragraph and its authority follows: association. citation to read as follows:

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§ 3.309 Disease subject to presumptive POSTAL SERVICE § 501.1 Postage evidencing system/ service connection. infrastructure authorization. * * * * * 39 CFR Part 501 (a) Postage evidencing systems (c) Diseases specific as to former produce evidence of prepayment of U.S. Authorization to Manufacture and postage by any method other than prisoners of war. (1) If a veteran is a Distribute Postage Meters former prisoner of war, the following postage stamps or permit imprint. They include but are not limited to postage diseases shall be service connected if AGENCY: Postal Service. meters and PC Postage’’ systems. The manifest to a degree of disability of 10 ACTION: Final rule. percent or more at any time after Postal Service considers the infrastructure associated with such discharge or release from active SUMMARY: This final rule amends the military, naval, or air service even systems to be essential to the exercise of regulations that define a postage meter its specific powers to prescribe postage though there is no record of such and its components and a manufacturer disease during service, provided the and provide evidence of payment of and/or distributor of postage meters. postage under 39 U.S.C. 404(a)(2) and rebuttable presumption provisions of The rule also puts forth the (4). § 3.307 are also satisfied. responsibilities of any authorized (b) Due to the potential for adverse Psychosis. person or entity to notify the Postal impact upon Postal Service revenue, the Any of the anxiety states. Service upon a change in ownership or following activities may not be engaged control, or bankruptcy or insolvency, in by any person or concern without Dysthymic disorder (or depressive and identifies factors the Postal Service neurosis). prior, written approval of the Postal will consider in acting upon requests for Service: Organic residuals of frostbite, if it is changes of approval, ownership, or (1) Producing or distributing any determined that the veteran was control of an approved manufacturer or postage evidencing system that interned in climatic conditions distributor. generates U.S. postage. consistent with the occurrence of DATES: This rule is effective on October (2) Repairing, distributing, frostbite. 7, 2004. refurbishing, remanufacturing, or Post-traumatic osteoarthritis. destroying any component of a postage FOR FURTHER INFORMATION CONTACT: evidencing system that accounts for or Atherosclerotic heart disease or Wayne Wilkerson, manager of Postage authorizes the printing of U.S. postage. hypertensive vascular disease Technology Management, by fax at 703– (3) Owning or operating an (including hypertensive heart disease) 292–4050. and their complications (including infrastructure that maintains operating SUPPLEMENTARY INFORMATION: A data for the production of U.S. postage, myocardial infarction, congestive heart proposed rule was published in the failure, arrhythmia). or accounts for U.S. postage purchased Federal Register on May 10, 2004, pages for distribution through a postage Stroke and its complications. 25864–25865, with comments due on or evidencing system. (2) If the veteran: before July 9, 2004. Written comments (4) Owning or operating an (i) Is a former prisoner of war and; were received from the vendor infrastructure that maintains operating community. data that is used to facilitate licensing (ii) Was interned or detained for not The Postal Service gave thorough or registration with the Postal Service of less than 30 days, the following diseases consideration to these comments, and users of a postage evidencing system. shall be service connected if manifest to incorporated as appropriate with only (c) Any person or entity seeking a degree of 10 percent or more at any minor, non-material exception. You may authorization to perform any activity time after discharge or release from review comments received by described in paragraph (b) of this active military, naval, or air service even submitting a request of the office of section must submit a request to the though there is no record of such Postage Technology Management at Postal Service in person or in writing. disease during service, provided the 703–292–3691 or by fax at 703–292– (d) Approval shall be based upon rebuttable presumption provisions of 4073. satisfactory evidence of the applicant’s § 3.307 are also satisfied. The final plan follows. integrity and financial responsibility, Avitaminosis. and commitment to the security of the List of Subjects in 39 CFR Part 501 Beriberi (including beriberi heart postage evidencing system, and a disease). Administrative practice and determination that disclosure to the Chronic dysentery. procedure, Postal Service. applicant of the Postal Service customer, financial, or other data of a Helminthiasis. The Amendment commercial nature necessary to perform Malnutrition (including optic atrophy I For the reasons set out in this the function for which approval is associated with malnutrition). document, the Postal Service is sought would be appropriate and Pellagra. amending 39 CFR Part 501 as follows: consistent with good business practices within the meaning of 39 U.S.C. 410 Any other nutritional deficiency. PART 501—AUTHORIZATION TO (c)(2). The Postal Service may condition Irritable bowel syndrome. MANUFACTURE AND DISTRIBUTE its approval on the agreement to Peptic ulcer disease. POSTAGE METERS undertakings by the applicant that Peripheral neuropathy except where would give the Postal Service I 1. The authority citation for Part 501 directly related to infectious causes. appropriate assurance of the applicant’s continues to read as follows: ability to meet its obligations under this Cirrhosis of the liver. Authority: 5 U.S.C. 552(a); 39 U.S.C. 101, section, including but not limited to the Authority: 38 U.S.C. 1112(b). 401, 403, 404, 410, 2601, 2605; Inspector method and manner of performing * * * * * General Act of 1978, as amended (Pub. L. certain financial, security, and servicing [FR Doc. 04–22543 Filed 10–6–04; 8:45 am] 95’452, as amended), 5 U.S.C. App. 3. functions and the need to maintain BILLING CODE 8320–01–P I 2. Revise § 501.1 to read as follows: sufficient financial reserves to guarantee

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