2016 Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Proposed Rules

DEPARTMENT OF VETERANS disease where there is ‘‘at least limited/ The basis of the Under Secretary’s AFFAIRS suggestive evidence that an increased recommendation regarding establishing risk of such disease is associated with a presumption of service connection for 38 CFR Part 3 service involving detention or osteoporosis for former POWs was a RIN 2900–AN16 internment as a prisoner of war and an study conducted by Dr. Stanley M. association between such detention or Garn, Ph.D. of the University of Presumption of Service Connection for internment and the disease is Michigan Center for Human Growth and Osteoporosis for Former Prisoners of biologically plausible.’’ 38 CFR 1.18(b). Development that found that, while in War The term ‘‘limited/suggestive evidence’’ captivity, U.S. Air Force personnel is defined in § 1.18(b)(1) to mean imprisoned in North Vietnam, who were AGENCY: Department of Veterans Affairs. ‘‘evidence of a sound scientific or subject to malnutrition, protein- ACTION: Proposed rule. medical nature that is reasonably deficiency, recurrent dysenteries, suggestive of an association between vitamin deficiencies, and a variety of SUMMARY: The Department of Veterans prisoner-of-war experience and the infectious diseases, suffered from Affairs (VA) proposes to amend its disease, even though the evidence may serious bone loss long after their release adjudication regulation to establish a be limited because matters such as from captivity. Stanley M. Garn, presumption of service connection for chance, bias, and confounding could not ‘‘Researcher Says POWs Sustained Bone osteoporosis for former Prisoners of War be ruled out with confidence or because Loss,’’ 23 U. of Mich. Hospital Star (Oct. (POWs) who were detained or interned the relatively small size of the affected 1975). Garn and his associates examined for at least 30 days and whose population restricts the data available the skeletal x-rays of 108 former POWs osteoporosis is at least 10 percent for study.’’ Section 1.18(d) of title 38, and found that, although the POWs disabling. The proposed amendment Code of Federal Regulations, explains seemed to be in relative ‘‘good health’’ would implement a decision by the that ‘‘the requirement in paragraph (b) upon release from captivity, the POWs Secretary to establish such a of this section that an increased risk of nonetheless had ‘‘far less bone structure presumption based on scientific studies. disease be ‘associated’ with prisoner-of- than is usual for their age, with bone DATES: Comments must be received by war service may be satisfied by evidence losses averaging 10 percent and going as VA on or before February 13, 2009. that demonstrates either a statistical high as 45.8 percent.’’ Id. The study also ADDRESSES: Written comments may be association or a causal association.’’ found that many of the former male submitted through http:// This proposed rule would establish a POWs ages 30 to 40 exhibited ‘‘a www.Regulations.gov; by mail or hand- presumption of service connection for skeletal structure which might be delivery to the Director, Regulations osteoporosis for any former prisoner of expected in an 80-year old man.’’ Id. Management (00REG), Department of war (POW) who was interned or Although not published in peer- Veterans Affairs, 810 Vermont Avenue, detained for a period of at least 30 days reviewed literature, the study was NW., Room 1068, Washington, DC while on active duty and develops presented as a paper on August 9, 1975, 20420; or by fax to (202) 273–9026. osteoporosis that manifests to a degree at the 10th International Congress of (This is not a toll-free number). of 10 percent or more at any time after Nutrition, in Kyoto, Japan. Id. Comments should indicate that they are discharge from active military, naval or The Under Secretary also cited a 2001 submitted in response to ‘‘RIN 2900– air service even though there is no abstract of a study conducted at the AN16—Presumption of Service record of such disease during service. Robert Mitchell Center for Prisoner of Connection for Osteoporosis for Former Osteoporosis is a disease War Studies, Navy Personnel Command, Prisoners of War.’’ Copies of comments characterized by inadequate bone that reported increased rates of received will be available for public formation resulting in a decrease in osteopenia among former POWs with inspection in the Office of Regulation bone mass and increased bone posttraumatic stress disorder (PTSD). Policy and Management, Room 1063B, weakness. The Merck Manual of Kenneth P. Sausen et al., ‘‘The between the hours of 8 a.m. and Diagnosis & Therapy 469 (17th ed. Relationship Between PTSD & 1999). The major clinical manifestations 4:30 p.m., Monday through Friday Osteopenia,’’ 63 Psychosomatic of osteoporosis are bone fractures. Id. at (except holidays). Please call (202) 461– Medicine 144 (2001), http:// 470. The cause of osteoporosis is 4902 for an appointment. (This is not a navmedmpte.med.navy.mil/nomi/rpow/ generally related to a number of risk toll-free number). In addition, during centcolresproj.cfm. Study participants factors, including low calcium, the comment period, comments may be included 131 repatriated male POWs in phosphorus, and vitamin D intake, viewed online through the Federal an ongoing medical follow-up program. advanced age, hormone deficiency, Docket Management System (FDMS) at The study showed that POW genetic factors, and immobilization. Id. participants with PTSD were twice as http://www.Regulations.gov. On October 8, 2008, the Under likely to be osteopenic as POW FOR FURTHER INFORMATION CONTACT: Secretary for Health advised the participants without PTSD. In addition, Nancy Copeland, Regulations Staff Secretary of Veterans Affairs that ‘‘there the study showed that, without proper (211D), Compensation and Pension is at least limited/suggestive evidence identification and intervention, POWs Service, Veterans Benefits that an increased risk of osteoporosis is with PTSD may be at risk for Administration, Department of Veterans associated with service involving osteoporosis and its attendant physical Affairs, 810 Vermont Avenue, NW., detention or internment as a POW’’ and disabilities. ‘‘The Relationship Between Washington, DC 20420, (202) 461–9685. recommended establishing a PTSD & Osteopenia,’’ 63 Psychosomatic SUPPLEMENTARY INFORMATION: The presumption of osteoporosis for former Medicine, at 144. standard for creating a presumption of POWs. The Secretary of Veterans Affairs An unpublished study by M.R. service connection for former POWs is agrees that the following reports Ambrose et al., referenced by the Under set out in 38 CFR 1.18, ‘‘Guidelines for constitute evidence of a sound scientific Secretary showed increased rates of establishing presumptions of service or medical nature that is reasonably osteopenia in aviators who were POWs connection for former prisoners of war.’’ suggestive of an association between in Vietnam. The Secretary may establish a prisoner-of-war experience and The Under Secretary’s presumption of service connection for a osteoporosis. recommendation also cited an article,

VerDate Nov<24>2008 16:42 Jan 13, 2009 Jkt 217001 PO 00000 Frm 00069 Fmt 4702 Sfmt 4702 E:\FR\FM\14JAP1.SGM 14JAP1 sroberts on PROD1PC70 with PROPOSALS Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Proposed Rules 2017

Jerri W. Nieves, ‘‘Osteoporosis: the role Rep. Series 921, ‘‘Prevention and above, nutritional deficiencies play a of micronutrients,’’ 81 Am. Journal of Management of Osteoporosis’’ (2003). primary role in the incurrence of Clinical Nutrition 1232S (2005), The report stated that ‘‘[e]arly osteoporosis. The 1975 study finding reporting that ‘‘[o]steoporosis and low osteoporosis is not usually diagnosed increased bone loss among former bone mass are currently estimated to be and remains asymptomatic; it does not POWs discussed the bone loss observed a major public health threat’’ for U.S. become clinically evident until fractures in persons who had been interred as men and women age 50 and older. The occur.’’ Id. at 2. WHO also stated that, POWs for periods of years and suggested article explored the significance of ‘‘[u]ntil recently, osteoporosis was an that nutritional deficiencies over such adequate nutrition in the prevention under-recognized disease’’ and periods may be the cause of the and treatment of osteoporosis and stated ‘‘[i]mprovements in diagnostic observed bone loss. VA has reviewed that calcium and vitamin D are the two technology over the past decade now the scientific literature on osteoporosis key micronutrients of ‘‘greatest means that it is possible to detect the and it does not disclose how long a importance.’’ Id. Nieves discussed the disease before fractures occur.’’ Id. at 7. period of malnutrition may cause the potential importance of Vitamin D in The referenced studies are suggestive disease. Although we have no specific peak bone mass and recommended at of a link between osteoporosis and scientific information upon which to least 600 International Units (IU) of internment or detention as a POW for a define the duration of malnutrition vitamin D in persons over age 70 for period sufficient to result in nutritional necessary to cause osteoporosis, we also optimal bone health. Id. at 1236S. deficiency. Further, the fact that have no scientific basis for Another source cited by the Under osteoporosis has been shown in the distinguishing osteoporosis from the Secretary for Health, the National medical literature to be associated with other nutrition-related disabilities Osteoporosis Foundation (NOF) Web nutritional deficiency establishes the identified in 1112(b)(3), for which site, states that calcium is a ‘‘building biological plausibility of a link between Congress has determined that a 30-day block of bone’’ and vitamin D helps the osteoporosis and internment or period is appropriate. In the absence of ‘‘body use calcium.’’ http:// detention as a POW. After careful evidence supporting a different result, www.nof.org/prevention/risk.htm. consideration of the scientific evidence treating osteoporosis the same as other Without vitamin D, a person is ‘‘at much referenced above, the Secretary of nutrition-related disabilities is the greater risk for bone loss and Veterans Affairs believes there is fairest result. Therefore, VA proposes to osteoporosis.’’ Id. Although calcium and limited/suggestive evidence that an set a 30-day internment requirement for vitamin D are the two most significant increased risk of osteoporosis is this presumption. If new scientific nutrients related to bone development associated with detention or internment evidence shows that a shorter or longer and prevention of bone loss, NOF also as a POW and that an association period of malnutrition may cause reports that magnesium, vitamin K, between such detention or internment osteoporosis, VA reserves the right to vitamin B6, and vitamin B12 are other and osteoporosis is biologically change the required internment period. key minerals that enhance bone health plausible. The Secretary therefore is Accordingly, consistent with other and may prevent bone loss. Id. establishing a presumption of service presumptions for diseases associated Dietary deficiencies have been connection for osteoporosis for former with nutritional deficiencies, the recognized as a common feature of POWs who were interned or detained presumption for osteoporosis would prisoner of war captivity across different for not less than 30 days and whose apply to periods of at least 30 days conflicts. See H.R. Rep. No. 91–1166 osteoporosis is manifest to a degree of internment as a POW. (1970), reprinted in 1970 U.S.C.C.A.N. 10 percent or more at any time after This presumption would be rebutted 3723, 3727–28 (noting prevalence of discharge or release from active service. if there is affirmative evidence that dietary deficiencies among POWs in 38 CFR 1.18; 38 U.S.C. 501(a)(1). osteoporosis was not incurred during or World War II, the Korean Conflict, and Accordingly, this proposed rule aggravated by such service or the Vietnam War); Acree v. Republic of would amend 38 CFR 3.309(c)(2) to add affirmative evidence that osteoporosis Iraq, 271 F. Supp. 2d 179, 185, 186 osteoporosis as a presumptive disease was caused by the veteran’s own willful (D.D.C. (2003) (finding that U.S. POWs for former POWs who were interned or misconduct. 38 U.S.C. 1113; 38 CFR held by Iraq between January 17, 1991, detained for not less than 30 days and 3.307(d) and 3.309(c)(2)(ii). and March 1991 ‘‘were systematically whose osteoporosis is manifested to a starved’’ and suffered nausea, severe degree of 10 percent or more at any time Administrative Procedure Act weight loss, dysentery), vacated 370 after discharge from active duty service. The Secretary has determined that F.3d 41 (D.C. Cir. 2004). As a result of such presumption, there is good cause to limit the public The Under Secretary for Health osteoporosis would be considered to comment period on this rule to 30 days. advised the Secretary of Veterans Affairs have been incurred in or aggravated by This proposed rule is necessary to that osteoporosis has apparently not internment or detention for at least 30 implement the Secretary’s decision to been a major health and disability issue days, even though there is not evidence establish a presumption of service among former POWs until recently, of osteoporosis during such service. The connection for osteoporosis for veterans probably because this condition usually requirement of internment for at least 30 who are former POWs. Due to the does not manifest as a major medical days would conform to policies advanced age of many veterans who condition until later in life. Since most embodied in current statutes and would benefit from this presumption, former POWs are now in their 80’s, it is regulations, which require at least 30 any delay in implementing this much more of a health problem among days of internment as a POW as a presumption would be contrary to the this cohort of veterans now than in the prerequisite for presumptive service public interest. In April 2006, the VA past. Undiagnosed and untreated connection for diseases associated with Office of Policy and Planning identified osteoporosis may result in progressive nutritional deficiencies, but require no 29,350 living POWs. Statistical data bone loss and eventual fracture. minimum period of internment for shows that development of osteoporosis Finally, the Under Secretary relied on presumptive service connection of is correlated to advanced age, thus any a 2003 World Health Organization diseases associated with acute physical delay in implementation would be (WHO) report on osteoporosis. World or psychological trauma. 38 U.S.C. extremely detrimental particularly to Health Org. Scientific Group, Technical 1112(b); 38 CFR 3.309(c). As explained former POWs of World War II, Korea,

VerDate Nov<24>2008 16:42 Jan 13, 2009 Jkt 217001 PO 00000 Frm 00070 Fmt 4702 Sfmt 4702 E:\FR\FM\14JAP1.SGM 14JAP1 sroberts on PROD1PC70 with PROPOSALS 2018 Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Proposed Rules

and Vietnam, who are currently afflicted Paperwork Reduction Act Authority: 38 U.S.C. 501(a) and 1112(b). with osteoporosis. Therefore, in order to This document contains no provisions [FR Doc. E9–587 Filed 1–13–09; 8:45 am] ensure that as many former POWs as constituting a collection of information BILLING CODE 8320–01–P possible benefit from this presumption, under the Paperwork Reduction Act of it is critical that VA take action as soon 1995 (44 U.S.C. 3501–3521). as practicable. Accordingly, the ENVIRONMENTAL PROTECTION Secretary has provided a 30-day Regulatory Flexibility Act AGENCY comment period for this rule. The Secretary hereby certifies that 40 CFR Part 52 Unfunded Mandates this proposed rule will not have a significant economic impact on a [EPA–R08–OAR–2007–1031; FRL–8754–6] The Unfunded Mandates Reform Act substantial number of small entities as of 1995 requires, at 2 U.S.C. 1532, that they are defined in the Regulatory Approval and Promulgation of Air agencies prepare an assessment of Flexibility Act, 5 U.S.C. 601–612. This Quality Implementation Plans; Utah’s anticipated costs and benefits before proposed rule would not affect any Emission Inventory Reporting issuing any rule that may result in an small entities. Only VA beneficiaries Requirements expenditure by State, local, and tribal could be directly affected. Therefore, AGENCY: Environmental Protection pursuant to 5 U.S.C. 605(b), this governments, in the aggregate, or by the Agency (EPA). private sector, of $100 million or more proposed rule is exempt from the initial ACTION: Proposed Rule. (adjusted annually for inflation) in any and final regulatory flexibility analysis given year. This rule would have no requirements of sections 603 and 604. SUMMARY: EPA is proposing to approve such effect on State, local, and tribal Catalog of Federal Domestic Assistance State Implementation Plan (SIP) governments, or on the private sector. revisions submitted by the State of Utah The Catalog of Federal Domestic Executive Order 12866 on September 7, 1999, and December 1, Assistance program numbers and titles 2003. The revisions add the for this rule are as follows: 64.109, Executive Order 12866 directs requirements of EPA’s Consolidated Veterans Compensation for Service- agencies to assess all costs and benefits Emission Reporting Rule (CERR) to the Connected Disability; and 64.110, of available regulatory alternatives and, State’s SIP. The intended effect of this Veterans Dependency and Indemnity when regulation is necessary, to select action is to approve only those portions Compensation for Service-Connected regulatory approaches that maximize from the State’s submittals that add Death. net benefits (including potential CERR requirements. This action is being economic, environmental, public health List of Subjects in 38 CFR Part 3 taken under section 110 of the Clean Air and safety, and other advantages; Act. Administrative practice and In the ‘‘Rules and Regulations’’ distributive impacts; and equity). The procedure, Claims, Disability benefits, Executive Order classifies a ‘‘significant section of this Federal Register, EPA is Health care, Pensions, Veterans, approving the State’s SIP revisions as a regulatory action’’ requiring review by Vietnam. the Office of Management and Budget, direct final rule without prior proposal as any regulatory action that is likely to Approved: November 5, 2008. because the Agency views these as non- controversial SIP revisions and result in a rule that may: (1) Have an James B. Peake, anticipates no adverse comments. A annual effect on the economy of $100 Secretary of Veterans Affairs. detailed rationale for taking this action million or more or adversely affect in a For the reasons set forth in the is set forth in the preamble to the direct material way the economy, a sector of preamble, VA proposes to amend 38 final rule. If EPA receives no adverse the economy, productivity, competition, CFR part 3 as follows: comments, EPA will not take further jobs, the environment, public health or action on this proposed rule. If EPA safety, or State, local, or tribal PART 3—ADJUDICATION receives adverse comments, EPA will governments or communities; (2) create withdraw the direct final rule and it will Subpart A—Pension, Compensation, a serious inconsistency or interfere with not take effect. EPA will address all and Dependency and Indemnity an action taken or planned by another public comments in a subsequent final Compensation agency; (3) materially alter the rule based on this proposed rule. EPA budgetary impact of entitlements, 1. The authority citation for part 3, will not institute a second comment grants, user fees, or loan programs or the subpart A continues to read as follows: period on this action. Any parties rights and obligations of entitlement interested in commenting must do so at recipients; or (4) raise novel legal or Authority: 38 U.S.C. 501(a), unless this time. Please note that if EPA otherwise noted. policy issues arising out of legal receives adverse comment on an mandates, the President’s priorities, or 2. Amend § 3.309(c)(2) by: amendment, paragraph, or section of the principles set forth in the Executive (a) In the list of diseases, adding this rule and if that provision may be Order. ‘‘Osteoporosis.’’ after ‘‘Cirrhosis of the severed from the remainder of the rule, VA has examined the economic, liver.’’. EPA may adopt as final those provisions interagency, budgetary, legal, and policy (b) Revising the authority citation at of the rule that are not the subject of an implications of this proposed rule and the end of the paragraph. adverse comment. has concluded that it is a significant The revision reads as follows: DATES: Any written comments on this regulatory action under Executive Order proposal must be received on or before 12866 because it is likely to result in a § 3.309 Disease subject to presumptive February 13, 2009. service connection. rule that may raise novel legal or policy ADDRESSES: Submit your comments, issues arising out of legal mandates, the * * * * * identified by Docket ID No. EPA–R08– President’s priorities, or the principles (c) * * * OAR–2007–1031, by one of the set forth in the Executive Order. (2) * * * following methods:

VerDate Nov<24>2008 16:42 Jan 13, 2009 Jkt 217001 PO 00000 Frm 00071 Fmt 4702 Sfmt 4702 E:\FR\FM\14JAP1.SGM 14JAP1 sroberts on PROD1PC70 with PROPOSALS