Diseases Associated With Exposure to Contaminants in the Water Supply at Camp Lejeune, 62419-62426 [2016-21455]

Download as PDF 62419 Proposed Rules Federal Register Vol. 81, No. 175 Friday, September 9, 2016 This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 3 RIN 2900–AP66 Diseases Associated With Exposure to Contaminants in the Water Supply at Camp Lejeune Department of Veterans Affairs. Proposed rule. AGENCY: ACTION: The Department of Veterans Affairs (VA) proposes to amend its adjudication regulations relating to presumptive service connection to add certain diseases associated with contaminants present in the base water supply at U.S. Marine Corps Base Camp Lejeune (Camp Lejeune), North Carolina, from August 1, 1953 to December 31, 1987. The chemical compounds involved have been associated by various scientific organizations with the development of certain diseases. This proposed rule would establish that veterans, former reservists, and former National Guard members, who served at Camp Lejeune for no less than 30 days (consecutive or nonconsecutive) during this period, and who have been diagnosed with any of eight associated diseases, are presumed to have a service-connected disability for purposes of entitlement to VA benefits. In addition, VA proposes to establish a presumption that these individuals were disabled during the relevant period of service, thus establishing active military service for benefit purposes. Under this proposed presumption, affected former reservists and National Guard members would have veteran status for purposes of entitlement to some VA benefits. This proposed amendment would implement a decision by the Secretary of Veterans Affairs that service connection on a presumptive basis is warranted for claimants who served at Camp Lejeune during the relevant period and for the requisite amount of time and later develop certain diseases. The ehiers on DSK5VPTVN1PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 15:27 Sep 08, 2016 Jkt 238001 Secretary’s decision is supported by the conclusions of internationally recognized scientific authorities that strong evidence exists establishing a relationship between exposure to certain volatile organic compounds (VOCs) that were in the water at Camp Lejeune and later development of certain disabilities. DATES: Comment Date: Comments must be received on or before October 11, 2016. ADDRESSES: Written comments may be submitted through www.Regulations.gov; by mail or handdelivery to Director, Regulation Policy and Management (00REG), Department of Veterans Affairs, 810 Vermont Avenue NW., Room 1068, Washington, DC 20420; or by fax to (202) 273–9026. Comments should indicate that they are submitted in response to ‘‘RIN 2900– AP66—Diseases Associated with Exposure to Contaminants in the Water Supply at Camp Lejeune.’’ Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1068, between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call (202) 461–4902 for an appointment. (This is not a toll-free number.) In addition, during the comment period, comments may be viewed online through the Federal Docket Management System (FDMS) at www.Regulations.gov. FOR FURTHER INFORMATION CONTACT: Eric Mandle, Policy Analyst, Regulations Staff (211D), Compensation Service, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461–9700. (This is not a toll-free telephone number.) SUPPLEMENTARY INFORMATION: I. Background In the early 1980s, in response to new Environmental Protection Agency standards, the Marine Corps monitored its water quality for volatile organic compounds (VOCs). In 1982, the Marine Corps discovered elevated levels of the VOCs trichloroethylene (TCE), a metal degreaser, and perchloroethylene (PCE), a dry cleaning agent, in two of the eight on-base water supply systems at Camp Lejeune. U.S. General Accounting Office, Defense Health Care: Activities Related to Past Drinking Water Contamination at Marine Corps Base Camp Lejeune (2007) (GAO 2007). PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 Subsequent investigations found that the main source of TCE contamination was on-base industrial activities, while the main source of PCE was an off-base dry cleaning facility. Id. Benzene and vinyl chloride were also found in the water supply systems. Committee on Contaminated Drinking Water at Camp Lejeune; National Research Council, Contaminated Water Supplies at Camp Lejeune, Assessing Potential Health Effects 4 (National Academies Press, 2009) (NRC 2009). These water systems served housing, administrative, and recreational facilities, as well as the base hospital. GAO 2007. The contaminated wells supplying the water systems were shut down by February 1985. Id. Although the Agency for Toxic Substances and Disease Registry (ATSDR), an agency of the Department of Health and Human Services, conducted an initial Public Health Assessment of Camp Lejeune in 1997, additional information led ATSDR to conduct a number of follow-up studies focused on a variety of specific aspects of potential exposure and their implications for specific health endpoints (see: http:// www.atsdr.cdc.gov/sites/lejeune/ activities.html). Potentially exposed individuals who served at Camp Lejeune are encouraged to participate in a registry to receive information from new health-related scientific studies initiated by the Navy. See Camp Lejeune Historic Drinking Water, U.S. Marine Corps, https://clnr.hqi.usmc.mil/ clwater/Home.aspx (last visited Aug. 12, 2016). II. Scientific Evidence and VA’s Presumptive Analysis A. The National Research Council Review of 2009 Based on a congressional mandate in section 318 of Public Law 109–364, the Navy requested that the National Research Council (NRC) undertake a study to assess the potential long-term health effects for individuals who served at Camp Lejeune during the period of water contamination. In generating its 2009 report, ‘‘Contaminated Water Supplies at Camp Lejeune, Assessing Potential Health Effects’’, the NRC evaluated scientific studies regarding the potential health conditions associated with TCE, PCE, and other VOCs. NRC 2009 at 5. NRC also examined information relating to E:\FR\FM\09SEP1.SGM 09SEP1 62420 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Proposed Rules exposures at Camp Lejeune, including research conducted by ATSDR. Id. at 195. The NRC categorized fourteen health conditions that have limited/suggestive evidence of an association with TCE, PCE, or a solvent mixture. Id. at 8. Limited/suggestive evidence of an association was defined as: ‘‘[e]vidence from available studies suggests an association between exposure to a specific agent and a specific health outcome in human studies, but the body of evidence is limited by the inability to rule out chance and bias, including confounding, with confidence’’ (emphasis added). Id. at 6. The fourteen diseases categorized by the NRC report as having limited/suggestive evidence of an association with the VOCs at issue at Camp Lejeune are: • Esophageal cancer (PCE) • lung cancer (PCE) • breast cancer (PCE) • bladder cancer (PCE) • kidney cancer (PCE and TCE) • adult leukemia (solvent mixtures) • multiple myeloma (solvent mixtures) • myelodysplastic syndromes (solvent mixtures) • renal toxicity (solvent mixtures) • hepatic steatosis (solvent mixtures) • female infertility (with concurrent exposure to solvent mixtures) • miscarriage, with exposure during pregnancy (PCE) • scleroderma (solvent mixtures) • neurobehavioral effects (solvent mixtures). Id. at 8. The NRC based this categorization on its conclusion that ‘‘the epidemiologic studies give some reason to be concerned that sufficiently high levels of the chemical may cause the disease, but the studies do not provide strong evidence that they actually do so’’. Id. at 7. Specific to the research studies conducted by the ATSDR, the NRC stated that they may not have produced definitive results because of the difficulties inherent in attempting to reconstruct past events and determine the amount of exposure experienced by any given individual. Id. at 195. ehiers on DSK5VPTVN1PROD with PROPOSALS B. Honoring America’s Veterans and Caring for Camp Lejeune Families Act of 2012 On August 6, 2012, Congress enacted the Honoring America’s Veterans and Caring for Camp Lejeune Families Act of 2012, Public Law 112–154 (hereinafter ‘‘Camp Lejeune Act’’). Section 102 of the Camp Lejeune Act established health care entitlement for veterans who served on active duty at Camp Lejeune for at least thirty days during the period between January 1, 1957, through VerDate Sep<11>2014 15:27 Sep 08, 2016 Jkt 238001 December 31, 1987, for treatment of the fourteen conditions identified by the NRC as well as non-Hodgkin’s lymphoma. Honoring America’s Veterans and Caring for Camp Lejeune Families Act of 2012, Public Law 112– 154, section 102(a), 126 Stat. 1165, 1167 (2012) (codified at 38 U.S.C. 1710(e)(1)(F)). Congress later amended this time period to expand health care eligibility to those serving at Camp Lejeune from August 1, 1953 through December 31, 1987. Consolidated and Further Continuing Appropriations Act, 2015, Public Law 113–235, Div. I, Title II, section 243. The Camp Lejeune Act also extended healthcare benefits in the form of reimbursements to certain family members of veterans who also resided at Camp Lejeune during the qualifying period. Camp Lejeune Act, section 102(b) (codified at 38 U.S.C. 1787). The Camp Lejeune Act noted that medical care is being afforded ‘‘notwithstanding that there is insufficient medical evidence to conclude that such illnesses or conditions are attributable to such service’’ or ‘‘residence.’’ Id. Section 102(a) and (b) (codified at 38 U.S.C. 1710(e)(1)(F) and 1787(a)). Despite the NRC’s report noting the difficulty of establishing direct scientific evidence of causation between the contaminated drinking water and the development of disease over time, Congress sought a policy that ‘‘gives sick veterans and their families the benefit of the doubt their illness or condition was caused by the water at Camp Lejeune so they can finally get the healthcare they need.’’ Honoring America’s Veterans and Caring for Camp Lejeune Families Act of 2012, Proceedings and Debates of the 112 Congress, Second Session, 158 Cong. Rec. S5154–04, 2012 WL 2923422 (2012) (statement of Sen. Murray). This law, however, is limited to the provision of healthcare for the named disabilities. It does not establish a presumption of service connection for purposes of entitlement to VA disability compensation and other benefits. C. VA’s Method of Analysis On August 3, 2015, the Secretary of Veterans Affairs announced that he had met with members of Congress, as well as the Director of ATSDR, to discuss the possibility of creating presumptions of service connection for those who served at Camp Lejeune and may have been exposed to the contaminated water supply. News Release, U.S. Department of Veterans Affairs, VA Expands Review of Chemical Exposure in Drinking Water at Marine Corps Base Camp Lejeune (August 3, 2015). Following that PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 announcement, VA began a deliberative process to determine whether available scientific evidence was sufficient to support a presumption of service connection for any health conditions as a result of exposure to the chemicals found in the contaminated drinking water at Camp Lejeune. At VA’s request, ATSDR collaborated with VA’s Camp Lejeune Science Liaison Team (CLSLT). The CLSLT was chaired by the Chief Medical Officer of the Veterans Health Administration (VHA) and consisted of representatives from VHA’s Post-Deployment Health Services (Office of Patient Care Services) and the Veterans Benefits Administration’s Compensation Service. The purpose of ATSDR’s collaboration with the CLSLT was to provide VA with its evaluation of the scientific literature regarding the potential hazards generally associated with the contaminants found in the water at Camp Lejeune during the contamination period (but not specifically associated with exposures at Camp Lejeune). The CLSLT presented its hazard evaluation to a newly formed VA Technical Workgroup (TWG), represented by subject matter experts in disability compensation, health care, environmental medicine, toxicology, epidemiology, Federal rulemaking, communications, and veterans benefits law. The CLSLT presented the VA TWG with its findings based on the CLSLT’s independent review of the scientific literature and discussions with ATSDR staff. In this review, the CLSLT summarized the weight of evidence for all health conditions for which an association with the chemicals of interest has been suggested. The environmental health experts on the TWG then conducted their own assessment of the scientific evidence. The TWG’s assessment focused on the strength of the evidence that a chemical is capable of causing a given health condition (commonly referred to as a hazard evaluation); the TWG’s assessment did not take into account the estimated levels of contamination in the water during the period of contamination at Camp Lejeune. As such, the TWG did not attempt to characterize the risk associated with the estimated exposures of those who resided at Camp Lejeune during the period of contamination. The TWG evaluation relied upon comprehensive hazard evaluations conducted by the following internationally respected expert bodies: The Environmental Protection Agency’s Integrated Risk Information System (EPA/IRIS), the National Institute of Health’s National Toxicology Program E:\FR\FM\09SEP1.SGM 09SEP1 ehiers on DSK5VPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Proposed Rules (NIH/NTP), the World Health Organization’s International Agency for Research on Cancer (WHO/IARC), and the National Academies of Sciences’ National Research Council and Institute of Medicine (NAS/NRC/IOM). These organizations were chosen for their rigorous expert selection and peer review processes to ensure objective and nuanced conclusions. As previously discussed, the findings of a report on the contaminated water at Camp Lejeune published by the NRC in 2009 reviewed the health effects associated with TCE, PCE, and solvent mixtures and were the basis of the 2012 Camp Lejeune Act. Starting with the findings of the 2009 NRC study, the TWG analyzed additional scientific data to determine if additional evidence existed to support a causal relationship between various conditions and the contaminants found in the water supply at Camp Lejeune. The TWG review evaluated the hazards associated with not only these chemicals, but benzene and vinyl chloride as well, thus broadening the scope beyond that of the 2009 NRC assessment. The TWG was particularly interested in weight of evidence evaluations conducted since the 2009 study, as they incorporate scientific information that was not available when the NRC’s 2009 report was being developed. Furthermore, because each of these expert bodies reviewed the literature through different scientific perspectives, this approach provided the TWG with increased confidence in its conclusions. The TWG examined the results of EPA’s Toxicological Reviews for the IRIS program (TCE, 2011; PCE, 2012; benzene, 2002; and vinyl chloride, 2000), the WHO’s IARC Monographs on the Evaluation of Carcinogenic Risks to Humans (TCE, 2014; PCE, 2014; benzene, 2012; and vinyl chloride, 2013), and the NIH’s NTP Report on Carcinogens (TCE, 2015; PCE, 2014; benzene, 2014; and vinyl chloride, 2014). In addition to the 2009 NRC report, the TWG drew on two other NAS reports, both published by the IOM: Gulf War and Health, vol. 2: Insecticides and Solvents (2003) and Review of the VA Clinical Guidance for Health Conditions Identified by the Camp Lejeune Legislation (2015). Section E below contains full references for all scientific literature reviewed by the TWG. D. Results of the TWG Analysis The TWG found that at least one of the internationally recognized scientific authorities cited above recently concluded that there is strong evidence supporting a causal relationship VerDate Sep<11>2014 15:27 Sep 08, 2016 Jkt 238001 between kidney cancer and TCE (EPA 2011, IARC 2014, NTP 2015), adult leukemia and benzene (EPA 2002, IARC 2012, IOM 2003, NTP 2014), nonHodgkin’s lymphoma and TCE (NTP 2015), and liver cancer and vinyl chloride (EPA 2000, IARC 2012, NTP 2014). Note that this list includes liver cancer, which was not named in the Camp Lejeune Act. Liver cancer was included in the list of health conditions as studies have established a causal relationship exists between liver cancer and vinyl chloride, and because the effects of vinyl chloride were not included in the 2009 NRC report’s review of adverse health effects resulting from exposure, although it was identified in the water at Camp Lejeune. The TWG also noted that both the EPA (2002) and the IOM (2003) concluded that there is evidence supporting a causal relationship between aplastic anemia and other myelodysplastic syndromes and benzene, which appears to be supported by NTP (2012). The TWG also found that at least one of the internationally recognized scientific authorities cited above recently concluded that there is a positive association between bladder cancer and PCE (EPA 2012, IARC 2014, IOM 2003) and between multiple myeloma and PCE (EPA 2012) and benzene (IARC 2012). In the context of providing VA with clinical guidance for implementing the 2012 Camp Lejeune Act, the IOM (2015) identified four published scientific analyses that address solvent exposure that had not been available during the NAS 2009 study. The IOM committee concluded that ‘‘Parkinson’s disease is a neurobehavioral effect that may have resulted from consumption of contaminated drinking water at Camp Lejeune.’’ IOM (2015) at 39. Although the CLSLT recommended to VA that they propose the creation of a presumption for scleroderma, additional reviews by the TWG concluded that the evidence is currently not strong enough to establish a positive association between any of the VOCs of interest and the development of scleroderma. Evaluations conducted by EPA (2011), IARC (2014), and NRC/IOM (2009) discuss a probable link between exposure to TCE and autoimmune diseases in general; however, none of the internationally recognized scientific authorities cited above concluded that there is positive association between scleroderma and the VOCs of interest, due in part to insufficient sample sizes and uncertainties about the cause of gender-specific differences. Therefore, the TWG did not recommend the creation of a presumption for PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 62421 scleroderma at this time, even though it was included in the Camp Lejeune Act. Likewise, none of the internationally recognized scientific authorities cited above concluded that there is a positive association between breast cancer, lung cancer, or esophageal cancer and the VOCs of interest. As such, the TWG concluded that the evidence was not strong enough to support recommending the creation of presumptions for these conditions at this time, even though they were included in the Camp Lejeune Act. Because the TWG analysis was conducted in the context of a rulemaking to establish presumptions of service connection for diseases associated with exposure to the VOCs of interest, the TWG did not recommend establishing presumptions for health effects that are not themselves diagnosed diseases or clearly associated with a specific diagnosis and therefore do not represent a disability for the purposes of VA compensation benefits. See 38 U.S.C. 1110. This is consistent with VA’s practice in establishing presumptions of service connection for diseases arising potentially years after exposures of interest. For the purposes of entitlement to disability compensation and related benefits, the health endpoint must be associated with a diagnosis of a chronic disability. The TWG concluded that, at this time, there is not a specific or generalizable diagnosis of a disability related to renal toxicity or hepatic steatosis that may have been caused by exposure to the contaminants. Similarly, neither female infertility nor miscarriage, in and of themselves, are disabilities for which VA can provide disability compensation. Further, the NRC findings regarding female infertility and miscarriage were limited to exposure concurrent with those health effects and therefore would not provide a basis for presuming current health effects of this type to be associated with past exposure. E. Weight-of-Evidence Analyses Considered by the TWG • EPA. IRIS Toxicological Review of Benzene. U.S. Environmental Protection Agency, Washington, DC, EPA/635/R–02/001F, 2002. (EPA 2002) • EPA. IRIS Toxicological Review of Tetrachloroethylene. U.S. Environmental Protection Agency, Washington, DC, EPA/635/R–08/ 011F, 2012. (EPA 2012) • EPA. IRIS Toxicological Review of Trichloroethylene. U.S. Environmental Protection Agency, E:\FR\FM\09SEP1.SGM 09SEP1 62422 • • • • • • • • Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Proposed Rules Washington, DC, EPA/635/R–09/ 011F, 2011. (EPA 2011) EPA. IRIS Toxicological Review of Vinyl Chloride. U.S. Environmental Protection Agency, Washington, DC, EPA/635R–00/004, 2000. (EPA 2000) IARC Working Group on the Evaluation of Carcinogenic Risk to Humans. Chemical Agents and Related Occupations. Lyon (FR): International Agency for Research on Cancer; 2012. (IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, No. 100F.) (IARC 2012) IARC Working Group on the Evaluation of Carcinogenic Risk to Humans. Trichloroethylene, Tetrachloroethylene, and Some Other Chlorinated Agents. Lyon (FR): International Agency for Research on Cancer; 2014. (IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, No. 106.) (IARC 2014) Institute of Medicine. Gulf War and Health: Volume 2. Insecticides and Solvents. Washington, DC: The National Academies Press, 2003. (IOM 2003) Institute of Medicine. Review of VA Clinical Guidance for the Health Conditions Identified by the Camp Lejeune Legislation. Washington, DC: The National Academies Press, 2015. (IOM 2015) National Research Council. Contaminated Water Supplies at Camp Lejeune: Assessing Potential Health Effects. Washington, DC: The National Academies Press, 2009. National Toxicology Program. 2014. Report on Carcinogens, Thirteenth Edition. Research Triangle Park, NC: U.S. Department of Health and Human Services, Public Health Service. http://ntp.niehs.nih.gov/ pubhealth/roc/roc13/ National Toxicology Program. 2015. Report on Carcinogens, Monograph on Trichloroethylene. http:// ntp.niehs.nih.gov/ntp/roc/ monographs/finaltce_508.pdf III. Secretary’s Proposal ehiers on DSK5VPTVN1PROD with PROPOSALS A. Secretary’s Authority Section 501(a)(1) of title 38, United States Code, provides that ‘‘[t]he Secretary has authority to prescribe all rules and regulations which are necessary or appropriate to carry out the laws administered by [VA] and are consistent with those laws, including . . . regulations with respect to the nature and extent of proof and evidence and the method of taking and furnishing them in order to establish the right to benefits under such laws.’’ This broad authority encompasses the establishment of an evidentiary VerDate Sep<11>2014 15:27 Sep 08, 2016 Jkt 238001 presumption of service connection and exposure under specified circumstances, provided there is a rational basis for the presumptions. In this case, the Secretary has determined that proof of qualifying service at Camp Lejeune, consistent with the statute providing health care coverage for Camp Lejeune veterans, and the subsequent development of one or more of the eight disabilities identified by the TWG is sufficient to support proposing a presumption that the resulting disability was incurred in the line of duty during active military, naval, or air service, to include qualifying reserve or National Guard service, to establish entitlement to service connection. See 38 U.S.C. 1110. VA notes it is well-established that the Secretary’s authority under 38 U.S.C. 501(a)(1) includes issuing discretionary regulations for presumptive service connection, as evidenced by past rulemakings (issued in response to National Academy of Sciences’ studies of exposures) to establish presumptive service connection for Amyotrophic Lateral Sclerosis (see 73 FR 54691), presumptive service connection for exposure to herbicides for certain qualifying individuals aboard C–123 aircraft (see 80 FR 35246), and presumptive service connection for various diseases in veterans with exposure to specified vesicant agents (see 59 FR 42497). B. Presumptive Conditions Based upon the results of the TWG analysis, the Secretary proposes that VA acknowledge the relationship between exposure to contaminants in the water supply at Camp Lejeune (in unknown quantities) and the subsequent development of the following health conditions: Kidney cancer, nonHodgkin’s lymphoma, adult leukemia, liver cancer, bladder cancer, multiple myeloma, Parkinson’s disease, and aplastic anemia and other myelodysplastic syndromes. Because these health conditions represent a disability, VA proposes to amend 38 CFR 3.307 to establish presumptions of service connection associated with exposure to contaminants in the water supply at Camp Lejeune. VA also proposes to amend 38 CFR 3.309 to prescribe the conditions that are subject to presumptive service connection in relation to exposure to the contaminants in the Camp Lejeune water supply. At this time, VA does not propose to establish presumptions of service connection for any other conditions. VA may consider additional rulemaking in PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 the future, consistent with the available science at that time. C. Exposure Requirements VA proposes to presume exposure to contaminants in the water supply at Camp Lejeune for all active duty, reserve, and National Guard personnel who served for no less than 30 days (consecutive or nonconsecutive) at Camp Lejeune during the period beginning August 1, 1953, and ending on December 31, 1987. VA proposes to include both consecutive and nonconsecutive days in the calculation of the 30-day requirement to clarify that VA will presume exposure to contaminants in the water supply at Camp Lejeune for veterans who may have served at Camp Lejeune on multiple occasions that total no less than 30 days. VA based its determination to require no less than 30 days of service at Camp Lejeune to establish a presumption of exposure to contaminants in the water supply based on both the available scientific evidence and prior implementation of the provisions of section 102 of the Camp Lejeune Act. As previously discussed, the TWG’s assessment relied on a hazard evaluation model, focusing on the conclusions of internationally respected expert scientific bodies. The TWG did not take into account the estimated levels of contamination in the water at Camp Lejeune and therefore could not characterize any risk associated with a specific level of exposure to contaminated water. As the available scientific evidence does not provide specific data on exposure levels, VA proposes to use its prior implementation of the health care provisions of Public Law 112–154 as a guide. While section 102 of Public Law 112– 154 requires that the veteran served at Camp Lejeune for at least 30 days, it does not specify whether these days must be consecutive. VA’s implementation of the provisions of section 102, contained in 38 CFR 17.400, requires that a veteran served at least 30 days at Camp Lejeune to establish entitlement to health care. 78 FR 55671. Section 17.400 specifically notes that the 30 days may be consecutive or non-consecutive. While VA is not bound by Public Law 112–154 or 38 CFR 17.400 in proposing the current presumptions of exposure and service connection, VA has determined that inclusion of the 30-day requirement would ensure consistency and parity with both its healthcare regulations and the statute. However, the enactment of Public Law 112–154, by itself, does not provide E:\FR\FM\09SEP1.SGM 09SEP1 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Proposed Rules ehiers on DSK5VPTVN1PROD with PROPOSALS a legal requirement for prescribing a 30day service requirement for the purposes of disability compensation. Further, Congress did not provide any scientific references for prescribing a 30day service requirement when it enacted Public Law 112–154. VA acknowledges that current science establishes a link between exposure to certain chemicals found in the water supply at Camp Lejeune and later development of one of the proposed presumptive conditions. However, VA experts agree that there is no science to support a specific minimum exposure level for any of the conditions. Therefore, VA welcomes comments on this requirement and will consider other practical alternatives when drafting the final rule. VA also notes that the proposed 30day requirement serves to establish eligibility for service connection on a presumptive basis; nothing in this proposed regulation prohibits consideration of service connection on a non-presumptive basis. Veterans without the requisite 30 days of service at Camp Lejeune may still establish service connection for any disease or disability on a direct basis. Direct service connection for any disease alleged to have been caused by contaminants in the water supply at Camp Lejeune requires evidence of a current disease or disability, evidence of exposure to the contaminated water at Camp Lejeune, and a medical nexus between the two, supported by a sufficient scientific explanation. D. Application to Reservists and National Guard Basic eligibility for VA benefits requires that an individual be a ‘‘veteran’’ as that term is defined in 38 U.S.C. 101(2): ‘‘The term ‘veteran’ means a person who served in the active military, naval, or air service, and who was discharged or released therefrom under conditions other than dishonorable.’’ Reserve or National Guard service during a period of active duty for training or inactive duty training generally does not qualify an individual as a ‘‘veteran’’ because it does not constitute ‘‘active military, naval or air service,’’ unless the individual is disabled or dies during that period of service as prescribed by 38 U.S.C. 101(24)(B) and (C). This proposed rule would establish presumptions that former reservists and National Guard members were exposed to contaminants in the water supply between August 1, 1953 and December 31, 1987, if their military personnel record includes orders or other records of no less than 30 days service (consecutive or nonconsecutive) at VerDate Sep<11>2014 15:27 Sep 08, 2016 Jkt 238001 Camp Lejeune during the contamination period, and would allow them to establish veteran status by presuming that a covered disability was incurred in the line of duty and arose during the qualifying period of service. Although 38 U.S.C. 101(24) requires a period of active duty for training or inactive duty training ‘‘during which the individual concerned was disabled or died’’ for a period of active duty for training or inactive duty training to constitute ‘‘active military, naval, or air service,’’ the latent effects of exposures to certain harmful chemicals were unrecognized when section 101(24) was enacted in 1958. The legislative history regarding the enactment of section 101(24) does not specifically explain Congress’ intent in requiring that the individual ‘‘was disabled or died’’ during the period of service. It is probable that Congress required a reserve component member to have been disabled ‘‘during’’ training because the medical science of the time understood that, if an in-service injury were to result in disability, at least some aspect of that disability generally would be manifest contemporaneous with the injury. However, subsequent developments with regard to medical understanding of the health effects of harmful chemical exposures, such as the VOCs that contaminated the Camp Lejeune water supply, raise a question regarding the application of section 101(24) to disability associated with such exposure. Viewing the generally beneficial purpose of section 101(24) in light of an evolved medical understanding, the Secretary believes it is reasonable to propose a factual presumption that disability occurred during the period of service as required under section 101(24) when an individual has a present disability from: Kidney cancer, liver cancer, adult leukemia, nonHodgkin’s lymphoma, bladder cancer, multiple myeloma, aplastic anemia and other myelodysplastic syndromes, and Parkinson’s disease. Specifically, the proposed disease presumptions enumerated in 38 CFR 3.309, coupled with the potential for clinical uncertainty regarding when such diseases first manifested, provide a reasonable basis for presuming that disability occurred during a period of reserve or National Guard service for purposes of satisfying the requirements under section 101(24)(B) or (C) in order to ensure compensation and health care for reservists and National Guard personnel disabled as a result of exposure to the contaminants in the water supply at Camp Lejeune on PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 62423 qualifying reserve and National Guard duty. IV. Application of Rulemaking to Previously Adjudicated Claims This proposed rule would apply to claims received by VA on or after the date of publication of the final rule in the Federal Register and to claims pending before VA on that date. This proposed rule would not apply retroactively to claims previously adjudicated. VA would adhere to the provisions of its change of law regulation, 38 CFR 3.114, which states, ‘‘[w]here pension, compensation, dependency and indemnity compensation, . . . is awarded or increased pursuant to a liberalizing law, or a liberalizing VA issue approved by the Secretary or by the Secretary’s direction, the effective date of such award or increase shall be fixed in accordance with the facts found, but shall not be earlier than the effective date of the act or administrative issue.’’ See also 38 U.S.C. 5110(g). This proposed regulation is based on the Secretary’s broad authority under 38 U.S.C. 501(a) to ‘‘prescribe all rules and regulations which are necessary or appropriate to carry out the laws administered by the Department and are consistent with those laws, including— . . . regulations with respect to the nature and extent of proof and evidence . . . in order to establish the right to benefits under such laws.’’ This rulemaking authority does not explicitly afford the Secretary authority to assign retroactive effect to the regulations created thereunder. It is well-settled that ‘‘[r]etroactivity is not favored in the law. . . . [A] statutory grant of legislative rulemaking authority will not, as a general matter, be understood to encompass the power to promulgate retroactive rules unless that power is conveyed by Congress in express terms.’’ Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208 (1988). As there is no explicit statutory authority to apply this proposed regulation retroactively, the Secretary, based on the current state of the scientific evidence, will take into consideration the evidentiary burden on claimants for certain Camp Lejeune contaminated water related claims pending (for the diseases specified in the proposed regulation) at the time of publication of the final rule and for all future claims. Although this proposed regulation would not apply retroactively, a claimant whose claim was previously and finally denied may file a new claim to obtain a new determination of entitlement under the final regulation. See Spencer v. Brown, 17 F.3d 368, 372 E:\FR\FM\09SEP1.SGM 09SEP1 62424 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Proposed Rules ehiers on DSK5VPTVN1PROD with PROPOSALS (Fed. Cir. 1994) (‘‘‘When a provision of law or regulation creates a new basis of entitlement to benefits, as through liberalization of the requirements for entitlement to a benefit, an applicant’s claim of entitlement under such law or regulation is a claim separate and distinct from a claim previously and finally denied prior to the liberalizing law or regulation.’’’) (quoting Spencer v. Brown, 4 Vet. App. 283, 288–89 (1993)). V. Regulation Amendments VA proposes to amend the § 3.307 heading to read ‘‘Presumptive service connection for chronic, tropical or prisoner-of-war related disease, disease associated with exposure to certain herbicide agents, or disease associated with the contaminants in the water supply at Camp Lejeune; wartime and service on or after January 1, 1947.’’ Likewise, VA proposes to revise paragraph (a) of § 3.307 to add the phrase ‘‘, or disease associated with the contaminants in the water supply at Camp Lejeune’’ after the words ‘‘herbicide agents.’’ Both of these proposed amendments are necessary to inform the public that certain diseases associated with contaminants in the water supply at Camp Lejeune are now included among those covered by VA’s proposed presumptive service connection regulations. Paragraph (a)(1) of § 3.307 establishes service criteria necessary to establish entitlement to presumptive treatment of a disease related to particular types of exposure. VA proposes to amend this paragraph to specify that any period of service is sufficient for purposes of presumptive service connection of conditions associated with service at Camp Lejeune, as long as the service also satisfies the requirements to establish a presumption of exposure to contaminants in the water supply at that facility under § 3.307(a)(7)(iii). As noted above, VA previously implemented health care benefits for veterans who served on active duty at Camp Lejeune for at least thirty days (consecutive or nonconsecutive) during the contamination period through 38 CFR 17.400. To maintain consistency and parity with VA’s interpretation of Public Law 112–154 in implementing its healthcare regulations, VA proposes that a veteran, or former reservist or National Guard member, must have a record of no less than 30 days of service (consecutive or nonconsecutive) at Camp Lejeune for any period between the prescribed dates to establish service connection on a presumptive basis for the eight conditions addressed in this proposed rule. Service at Camp Lejeune, for the purpose of establishing service VerDate Sep<11>2014 15:27 Sep 08, 2016 Jkt 238001 connection on a presumptive basis, means that the veteran, or former reservist or National Guard member, as established by military orders or other official service department records, lived or worked within the confines of the Camp Lejeune border. Any such veteran, or former reservist or National Guard member, could have been exposed to contaminants in the water supply through drinking, bathing or other activities. We believe that military orders or other official service department records documenting no less than 30 days of service at Camp Lejeune provide a rational basis for presuming that the individual likely had more than isolated and minimal opportunity for contact with the relevant VOCs. VA also proposes adding paragraph (a)(7) to § 3.307 to describe entitlement criteria for diseases associated with exposure to contaminants in the water supply at Camp Lejeune. Paragraph (a)(7)(i) defines ‘‘contaminants in the water supply’’ to mean the on-base water-supply systems located at Camp Lejeune that were contaminated with TCE, PCE, benzene, and vinyl chloride during the period beginning August 1, 1953, and ending December 31, 1987. Proposed paragraph (a)(7)(ii) crossreferences proposed § 3.309(f), which lists the diseases that are presumptively service connected based on exposure to contaminants in the water supply at Camp Lejeune, and requires that they manifest to a compensable degree at any time after service for VA to award presumptive service connection. Proposed paragraph (a)(7)(iii) describes the population covered by the presumption of exposure. Proposed paragraph (a)(7)(iii) applies the presumption of exposure to a veteran, reservist, or National Guard member who had no less than 30 days of service (consecutive or nonconsecutive) at Camp Lejeune at any time during the period beginning August 1, 1953, and ending December 31, 1987. Such individuals are presumed to have been exposed to the contaminants in the water supply at Camp Lejeune, unless there is affirmative evidence to establish that there was no such exposure. Affirmative evidence showing that there was no exposure is likely to be rare, but if there is evidence showing that the veteran was not actually exposed to contaminants in the water supply, the veteran must establish that the disability is related to military service in some other way (e.g., had its onset during service). The disability will not be presumed to have been caused by PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 contaminants in the water supply at Camp Lejeune. VA proposes to prescribe the same contamination period as 38 U.S.C. 1710(e)(1)(F). As noted above, section 1710(e)(1)(F) was amended by Public Law 113–235 to change the Camp Lejeune contamination period to August 1, 1953, through December 31, 1987. The legislative history does not explain why Congress selected this contamination period, but it is likely based on some of the earliest assessments of the Camp Lejeune water supply noted in the NRC report. Contaminated Water Supplies, at 60. This period represents the ATSDR’s best estimate of the period of contamination at Camp Lejeune and likely captures all potentially affected veterans. Paragraph (a)(7)(iii) also defines ‘‘service at Camp Lejeune’’ as any service within the borders of the entirety of the United States Marine Corps Base Camp Lejeune and Marine Corps Air Station New River, North Carolina, during the relevant period, as established by military orders or other service department records. Neither the statute nor the legislative history of Public Law 112–154 indicates Congress’ intent as to the geographic area covered by reference to ‘‘Camp Lejeune, North Carolina’’ in 38 U.S.C. 1710(e)(1)(F). VA acknowledges that it would be too difficult to determine with specificity which residential or workplace facilities were serviced with the contaminated water, or whether and to what degree the veteran would have come into contact with that facility during active service. Therefore, this proposed rule covers any veteran, reservist, or member of the National Guard, whose military orders or records establish their presence within the borders of the entirety of the United States Marine Corps Base Camp Lejeune border, which includes Marine Corps Air Station New River, for no less than 30 days (consecutive or nonconsecutive) and therefore could potentially have come into physical contact (e.g., by drinking or bathing) with contaminants in the water supply on more than an isolated and minimal basis. VA specifically included Marine Corps Air Station New River in the definition of service Camp Lejeune to clarify that official military records indicating service at Marine Corps Air Station New River are sufficient to establish service at Camp Lejeune for the purposes of this rulemaking. This would ensure consistency with the definition of Camp Lejeune in 38 CFR 17.400(b) for purposes of health care. Proposed paragraph (a)(7)(iv) prescribes that the presumed exposure E:\FR\FM\09SEP1.SGM 09SEP1 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Proposed Rules ehiers on DSK5VPTVN1PROD with PROPOSALS to contaminants in the water supply is an ‘‘injury’’ under section 101(24)(B) and (C). In turn, if an individual develops a presumptive disease listed in 38 CFR 3.309(f), ‘‘VA will presume that the individual concerned became disabled during that service for purposes of establishing that the individual served in the active military, naval, or air service.’’ As explained previously, this is consistent with section 101(24) because exposure to contaminants in the water supply at Camp Lejeune is associated with latent adverse health effects that were largely unrecognized in 1958. Covered individuals may therefore establish veteran status for purposes of VA’s disability compensation, dependency and indemnity compensation, medical care, and burial benefits related to any Camp Lejeune-related presumptive condition. VA also proposes to amend 38 CFR 3.309 by adding paragraph (f). This proposed paragraph is titled ‘‘Disease associated with exposure to contaminants in the water supply at Camp Lejeune.’’ The primary purpose of this proposed amendment is to list the diseases that are presumptively service connected based on exposure to contaminants in the water supplies at Camp Lejeune during the exposure period. For the reasons described above, the diseases are as follows: Kidney cancer, liver cancer, non-Hodgkin’s lymphoma, adult leukemia, multiple myeloma, Parkinson’s disease, aplastic anemia and other myelodysplastic syndromes, and bladder cancer. Proposed paragraph (f) notes that the provisions of 38 CFR 3.307(d), regarding circumstances in which presumptions of service connection may be rebutted, apply to these presumptions. Administrative Procedure Act The Secretary of Veterans Affairs is providing a 30 day period for public comment. Kidney cancer, liver cancer, non-Hodgkin’s lymphoma, adult leukemia, multiple myeloma, Parkinson’s disease, bladder cancer, and aplastic anemia and other myelodysplastic syndromes are debilitating and life-threatening illnesses, and any delay in implementing a final rule could have severe detrimental impact on Veterans exposed to contaminants in the water supply at Camp Lejeune now suffering from these diseases. Based on the age of the individuals affected by this proposed rule and the severity of the disabilities associated with their exposure, it is likely that affected individuals would have significant and urgent financial and medical needs. In VerDate Sep<11>2014 15:27 Sep 08, 2016 Jkt 238001 the absence of a shortened public comment period and publication of a final rule, these Veterans may not receive proper health care or assistance with daily functions due to financial hardship or the absence of serviceconnected status for their disability. While VA believes the severity of the conditions and the age of the individuals affected themselves justify a 30 day period for public comment, there is an even more acute basis for the Secretary’s decision. VA is aware of roughly thirty individuals who are terminally ill, and would be covered by the presumptions in the event they become effective. Provision of a 60-day comment period would increase the likelihood that some affected veterans who have incurred or will incur one or more of the covered illnesses will die from the disease before a final rule could be issued. In order for these individuals to have access to VA health care, some for the first time, and disability compensation benefits, it is critical that VA establish these presumptions as soon as possible. Therefore, the Secretary is providing a public comment period of 30 days. VA invites public comments on this proposed rule and notes that it will fully consider and address any comments received. Executive Orders 12866 and 13563 Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a ‘‘significant regulatory action,’’ requiring review by the Office of Management and Budget (OMB), unless OMB waives such review, as ‘‘any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 62425 Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in this Executive Order.’’ The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined to be a significant regulatory action under Executive Order 12866 because it is likely to result in a rule that may have an annual effect on the economy of $100 million or more and may raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in this Executive Order. VA’s impact analysis can be found as a supporting document at http:// www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of this rulemaking and its impact analysis are available on VA’s Web site at http:// www.va.gov/orpm/, by following the link for ‘‘VA Regulations Published from FY 2004 Through Fiscal Year to Date.’’ Regulatory Flexibility Act The Secretary hereby certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601–612). This proposed rule would directly affect only individuals and would not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the regulatory flexibility analysis requirements of sections 603 and 604. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This proposed rule would have no such effect on State, local, and tribal governments, or on the private sector. Paperwork Reduction Act This proposed rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3521). E:\FR\FM\09SEP1.SGM 09SEP1 62426 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Proposed Rules Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.109, Veterans Compensation for Service-Connected Disability; 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death. Signing Authority The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on August 30, 2016, for publication. Dated: September 1, 2016. Michael Shores, Acting Director, Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs. List of Subjects in 38 CFR Part 3 Administrative practice and procedure, Claims, Disability benefits, Veterans. For the reasons stated in the preamble, the Department of Veterans Affairs proposes to amend 38 CFR part 3 as follows: PART 3—ADJUDICATION Subpart A—Pension, Compensation, and Dependency and Indemnity Compensation 1. The authority citation for part 3, subpart A continues to read as follows: ■ Authority: 38 U.S.C. 501(a), unless otherwise noted. 2. Amend § 3.307 by revising the section heading and paragraphs (a) introductory text and (a)(1), and adding paragraph (a)(7) to read as follows: ■ ehiers on DSK5VPTVN1PROD with PROPOSALS § 3.307 Presumptive service connection for chronic, tropical or prisoner-of-war related disease, disease associated with exposure to certain herbicide agents, or disease associated with contaminants in the water supply at Camp Lejeune; wartime and service on or after January 1, 1947. (a) General. A chronic, tropical, prisoner of war related disease, a disease associated with exposure to certain herbicide agents, or a disease associated with contaminants in the water supply at Camp Lejeune listed in § 3.309 will be considered to have been incurred in or aggravated by service under the circumstances outlined in this section even though there is no VerDate Sep<11>2014 17:14 Sep 08, 2016 Jkt 238001 evidence of such disease during the period of service. No condition other than one listed in § 3.309(a) will be considered chronic. (1) Service. The veteran must have served 90 days or more during a war period or after December 31, 1946. The requirement of 90 days’ service means active, continuous service within or extending into or beyond a war period, or which began before and extended beyond December 31, 1946, or began after that date. Any period of service is sufficient for the purpose of establishing the presumptive service connection of a specified disease under the conditions listed in § 3.309(c) and (e). Any period of service is sufficient for the purpose of establishing the presumptive service connection of a specified disease under the conditions listed in § 3.309(f), as long as the period of service also satisfies the requirements to establish a presumption of exposure to contaminants in the water supply at Camp Lejeune under paragraph (a)(7)(iii) of this section. * * * * * (7) Diseases associated with exposure to contaminants in the water supply at Camp Lejeune. (i) For the purposes of this section, contaminants in the water supply means the volatile organic compounds trichloroethylene (TCE), perchloroethylene (PCE), benzene and vinyl chloride, that were in the on-base water-supply systems located at United States Marine Corps Base Camp Lejeune, during the period beginning on August 1, 1953, and ending on December 31, 1987. (ii) The diseases listed in § 3.309(f) shall have become manifest to a degree of 10 percent or more at any time after service. (iii) A veteran, or former reservist or member of the National Guard, who had no less than 30 days (consecutive or nonconsecutive) of service at Camp Lejeune during the period beginning on August 1, 1953, and ending on December 31, 1987, shall be presumed to have been exposed during such service to the contaminants in the water supply, unless there is affirmative evidence to establish that the individual was not exposed to contaminants in the water supply during that service. The last date on which such a veteran, or former reservist or member of the National Guard, shall be presumed to have been exposed to contaminants in the water supply shall be the last date on which he or she served at Camp Lejeune during the period beginning on August 1, 1953, and ending on December 31, 1987. For purposes of this section, service at Camp Lejeune means PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 any service within the borders of the entirety of the United States Marine Corps Base Camp Lejeune and Marine Corps Air Station New River, North Carolina, during the period beginning on August 1, 1953, and ending on December 31, 1987, as established by military orders or other official service department records. (iv) Exposure described in paragraph (a)(7)(iii) of this section is an injury under 38 U.S.C. 101(24)(B) and (C). If an individual described in paragraph (a)(7)(iii) of this section develops a disease listed in 38 CFR 3.309(f), VA will presume that the individual concerned became disabled during that service for purposes of establishing that the individual served in the active military, naval, or air service. (Authority: 38 U.S.C. 501(a)) ■ 3. Add § 3.309(f) to read as follows: § 3.309 Disease subject to presumptive service connection. * * * * * (f) Disease associated with exposure to contaminants in the water supply at Camp Lejeune. If a veteran, or former reservist or member of the National Guard, was exposed to contaminants in the water supply at Camp Lejeune during military service and the exposure meets the requirements of § 3.307(a)(7), the following diseases shall be serviceconnected even though there is no record of such disease during service, subject to the rebuttable presumption provisions of § 3.307(d). (1) Kidney cancer. (2) Liver cancer. (3) Non-Hodgkin’s lymphoma. (4) Adult leukemia. (5) Multiple myeloma. (6) Parkinson’s disease. (7) Aplastic anemia and other myelodysplastic syndromes. (8) Bladder cancer. (Authority: 38 U.S.C. 501(a)) [FR Doc. 2016–21455 Filed 9–8–16; 8:45 am] BILLING CODE 8320–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 70 [EPA–R07–OAR–2016–0453; FRL–9951–85– Region 7] State of Iowa; Approval and Promulgation of the Title V Operating Permits Program, the State Implementation Plan, and 112(l) Plan Environmental Protection Agency (EPA). AGENCY: E:\FR\FM\09SEP1.SGM 09SEP1

Agencies

[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Proposed Rules]
[Pages 62419-62426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21455]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / 
Proposed Rules

[[Page 62419]]



DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 3

RIN 2900-AP66


Diseases Associated With Exposure to Contaminants in the Water 
Supply at Camp Lejeune

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Department of Veterans Affairs (VA) proposes to amend its 
adjudication regulations relating to presumptive service connection to 
add certain diseases associated with contaminants present in the base 
water supply at U.S. Marine Corps Base Camp Lejeune (Camp Lejeune), 
North Carolina, from August 1, 1953 to December 31, 1987. The chemical 
compounds involved have been associated by various scientific 
organizations with the development of certain diseases. This proposed 
rule would establish that veterans, former reservists, and former 
National Guard members, who served at Camp Lejeune for no less than 30 
days (consecutive or nonconsecutive) during this period, and who have 
been diagnosed with any of eight associated diseases, are presumed to 
have a service-connected disability for purposes of entitlement to VA 
benefits. In addition, VA proposes to establish a presumption that 
these individuals were disabled during the relevant period of service, 
thus establishing active military service for benefit purposes. Under 
this proposed presumption, affected former reservists and National 
Guard members would have veteran status for purposes of entitlement to 
some VA benefits. This proposed amendment would implement a decision by 
the Secretary of Veterans Affairs that service connection on a 
presumptive basis is warranted for claimants who served at Camp Lejeune 
during the relevant period and for the requisite amount of time and 
later develop certain diseases. The Secretary's decision is supported 
by the conclusions of internationally recognized scientific authorities 
that strong evidence exists establishing a relationship between 
exposure to certain volatile organic compounds (VOCs) that were in the 
water at Camp Lejeune and later development of certain disabilities.

DATES: Comment Date: Comments must be received on or before October 11, 
2016.

ADDRESSES: Written comments may be submitted through 
www.Regulations.gov; by mail or hand-delivery to Director, Regulation 
Policy and Management (00REG), Department of Veterans Affairs, 810 
Vermont Avenue NW., Room 1068, Washington, DC 20420; or by fax to (202) 
273-9026. Comments should indicate that they are submitted in response 
to ``RIN 2900-AP66--Diseases Associated with Exposure to Contaminants 
in the Water Supply at Camp Lejeune.'' Copies of comments received will 
be available for public inspection in the Office of Regulation Policy 
and Management, Room 1068, between the hours of 8:00 a.m. and 4:30 
p.m., Monday through Friday (except holidays). Please call (202) 461-
4902 for an appointment. (This is not a toll-free number.) In addition, 
during the comment period, comments may be viewed online through the 
Federal Docket Management System (FDMS) at www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eric Mandle, Policy Analyst, 
Regulations Staff (211D), Compensation Service, Department of Veterans 
Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-9700. 
(This is not a toll-free telephone number.)

SUPPLEMENTARY INFORMATION:

I. Background

    In the early 1980s, in response to new Environmental Protection 
Agency standards, the Marine Corps monitored its water quality for 
volatile organic compounds (VOCs). In 1982, the Marine Corps discovered 
elevated levels of the VOCs trichloroethylene (TCE), a metal degreaser, 
and perchloroethylene (PCE), a dry cleaning agent, in two of the eight 
on-base water supply systems at Camp Lejeune. U.S. General Accounting 
Office, Defense Health Care: Activities Related to Past Drinking Water 
Contamination at Marine Corps Base Camp Lejeune (2007) (GAO 2007). 
Subsequent investigations found that the main source of TCE 
contamination was on-base industrial activities, while the main source 
of PCE was an off-base dry cleaning facility. Id. Benzene and vinyl 
chloride were also found in the water supply systems. Committee on 
Contaminated Drinking Water at Camp Lejeune; National Research Council, 
Contaminated Water Supplies at Camp Lejeune, Assessing Potential Health 
Effects 4 (National Academies Press, 2009) (NRC 2009). These water 
systems served housing, administrative, and recreational facilities, as 
well as the base hospital. GAO 2007. The contaminated wells supplying 
the water systems were shut down by February 1985. Id.
    Although the Agency for Toxic Substances and Disease Registry 
(ATSDR), an agency of the Department of Health and Human Services, 
conducted an initial Public Health Assessment of Camp Lejeune in 1997, 
additional information led ATSDR to conduct a number of follow-up 
studies focused on a variety of specific aspects of potential exposure 
and their implications for specific health endpoints (see: http://www.atsdr.cdc.gov/sites/lejeune/activities.html). Potentially exposed 
individuals who served at Camp Lejeune are encouraged to participate in 
a registry to receive information from new health-related scientific 
studies initiated by the Navy. See Camp Lejeune Historic Drinking 
Water, U.S. Marine Corps, https://clnr.hqi.usmc.mil/clwater/Home.aspx 
(last visited Aug. 12, 2016).

II. Scientific Evidence and VA's Presumptive Analysis

A. The National Research Council Review of 2009

    Based on a congressional mandate in section 318 of Public Law 109-
364, the Navy requested that the National Research Council (NRC) 
undertake a study to assess the potential long-term health effects for 
individuals who served at Camp Lejeune during the period of water 
contamination. In generating its 2009 report, ``Contaminated Water 
Supplies at Camp Lejeune, Assessing Potential Health Effects'', the NRC 
evaluated scientific studies regarding the potential health conditions 
associated with TCE, PCE, and other VOCs. NRC 2009 at 5. NRC also 
examined information relating to

[[Page 62420]]

exposures at Camp Lejeune, including research conducted by ATSDR. Id. 
at 195.
    The NRC categorized fourteen health conditions that have limited/
suggestive evidence of an association with TCE, PCE, or a solvent 
mixture. Id. at 8. Limited/suggestive evidence of an association was 
defined as: ``[e]vidence from available studies suggests an association 
between exposure to a specific agent and a specific health outcome in 
human studies, but the body of evidence is limited by the inability to 
rule out chance and bias, including confounding, with confidence'' 
(emphasis added). Id. at 6. The fourteen diseases categorized by the 
NRC report as having limited/suggestive evidence of an association with 
the VOCs at issue at Camp Lejeune are:

 Esophageal cancer (PCE)
 lung cancer (PCE)
 breast cancer (PCE)
 bladder cancer (PCE)
 kidney cancer (PCE and TCE)
 adult leukemia (solvent mixtures)
 multiple myeloma (solvent mixtures)
 myelodysplastic syndromes (solvent mixtures)
 renal toxicity (solvent mixtures)
 hepatic steatosis (solvent mixtures)
 female infertility (with concurrent exposure to solvent 
mixtures)
 miscarriage, with exposure during pregnancy (PCE)
 scleroderma (solvent mixtures)
 neurobehavioral effects (solvent mixtures). Id. at 8.

    The NRC based this categorization on its conclusion that ``the 
epidemiologic studies give some reason to be concerned that 
sufficiently high levels of the chemical may cause the disease, but the 
studies do not provide strong evidence that they actually do so''. Id. 
at 7. Specific to the research studies conducted by the ATSDR, the NRC 
stated that they may not have produced definitive results because of 
the difficulties inherent in attempting to reconstruct past events and 
determine the amount of exposure experienced by any given individual. 
Id. at 195.

B. Honoring America's Veterans and Caring for Camp Lejeune Families Act 
of 2012

    On August 6, 2012, Congress enacted the Honoring America's Veterans 
and Caring for Camp Lejeune Families Act of 2012, Public Law 112-154 
(hereinafter ``Camp Lejeune Act''). Section 102 of the Camp Lejeune Act 
established health care entitlement for veterans who served on active 
duty at Camp Lejeune for at least thirty days during the period between 
January 1, 1957, through December 31, 1987, for treatment of the 
fourteen conditions identified by the NRC as well as non-Hodgkin's 
lymphoma. Honoring America's Veterans and Caring for Camp Lejeune 
Families Act of 2012, Public Law 112-154, section 102(a), 126 Stat. 
1165, 1167 (2012) (codified at 38 U.S.C. 1710(e)(1)(F)). Congress later 
amended this time period to expand health care eligibility to those 
serving at Camp Lejeune from August 1, 1953 through December 31, 1987. 
Consolidated and Further Continuing Appropriations Act, 2015, Public 
Law 113-235, Div. I, Title II, section 243. The Camp Lejeune Act also 
extended healthcare benefits in the form of reimbursements to certain 
family members of veterans who also resided at Camp Lejeune during the 
qualifying period. Camp Lejeune Act, section 102(b) (codified at 38 
U.S.C. 1787).
    The Camp Lejeune Act noted that medical care is being afforded 
``notwithstanding that there is insufficient medical evidence to 
conclude that such illnesses or conditions are attributable to such 
service'' or ``residence.'' Id. Section 102(a) and (b) (codified at 38 
U.S.C. 1710(e)(1)(F) and 1787(a)). Despite the NRC's report noting the 
difficulty of establishing direct scientific evidence of causation 
between the contaminated drinking water and the development of disease 
over time, Congress sought a policy that ``gives sick veterans and 
their families the benefit of the doubt their illness or condition was 
caused by the water at Camp Lejeune so they can finally get the 
healthcare they need.'' Honoring America's Veterans and Caring for Camp 
Lejeune Families Act of 2012, Proceedings and Debates of the 112 
Congress, Second Session, 158 Cong. Rec. S5154-04, 2012 WL 2923422 
(2012) (statement of Sen. Murray). This law, however, is limited to the 
provision of healthcare for the named disabilities. It does not 
establish a presumption of service connection for purposes of 
entitlement to VA disability compensation and other benefits.

C. VA's Method of Analysis

    On August 3, 2015, the Secretary of Veterans Affairs announced that 
he had met with members of Congress, as well as the Director of ATSDR, 
to discuss the possibility of creating presumptions of service 
connection for those who served at Camp Lejeune and may have been 
exposed to the contaminated water supply. News Release, U.S. Department 
of Veterans Affairs, VA Expands Review of Chemical Exposure in Drinking 
Water at Marine Corps Base Camp Lejeune (August 3, 2015). Following 
that announcement, VA began a deliberative process to determine whether 
available scientific evidence was sufficient to support a presumption 
of service connection for any health conditions as a result of exposure 
to the chemicals found in the contaminated drinking water at Camp 
Lejeune.
    At VA's request, ATSDR collaborated with VA's Camp Lejeune Science 
Liaison Team (CLSLT). The CLSLT was chaired by the Chief Medical 
Officer of the Veterans Health Administration (VHA) and consisted of 
representatives from VHA's Post-Deployment Health Services (Office of 
Patient Care Services) and the Veterans Benefits Administration's 
Compensation Service. The purpose of ATSDR's collaboration with the 
CLSLT was to provide VA with its evaluation of the scientific 
literature regarding the potential hazards generally associated with 
the contaminants found in the water at Camp Lejeune during the 
contamination period (but not specifically associated with exposures at 
Camp Lejeune). The CLSLT presented its hazard evaluation to a newly 
formed VA Technical Workgroup (TWG), represented by subject matter 
experts in disability compensation, health care, environmental 
medicine, toxicology, epidemiology, Federal rulemaking, communications, 
and veterans benefits law. The CLSLT presented the VA TWG with its 
findings based on the CLSLT's independent review of the scientific 
literature and discussions with ATSDR staff. In this review, the CLSLT 
summarized the weight of evidence for all health conditions for which 
an association with the chemicals of interest has been suggested. The 
environmental health experts on the TWG then conducted their own 
assessment of the scientific evidence.
    The TWG's assessment focused on the strength of the evidence that a 
chemical is capable of causing a given health condition (commonly 
referred to as a hazard evaluation); the TWG's assessment did not take 
into account the estimated levels of contamination in the water during 
the period of contamination at Camp Lejeune. As such, the TWG did not 
attempt to characterize the risk associated with the estimated 
exposures of those who resided at Camp Lejeune during the period of 
contamination.
    The TWG evaluation relied upon comprehensive hazard evaluations 
conducted by the following internationally respected expert bodies: The 
Environmental Protection Agency's Integrated Risk Information System 
(EPA/IRIS), the National Institute of Health's National Toxicology 
Program

[[Page 62421]]

(NIH/NTP), the World Health Organization's International Agency for 
Research on Cancer (WHO/IARC), and the National Academies of Sciences' 
National Research Council and Institute of Medicine (NAS/NRC/IOM). 
These organizations were chosen for their rigorous expert selection and 
peer review processes to ensure objective and nuanced conclusions.
    As previously discussed, the findings of a report on the 
contaminated water at Camp Lejeune published by the NRC in 2009 
reviewed the health effects associated with TCE, PCE, and solvent 
mixtures and were the basis of the 2012 Camp Lejeune Act. Starting with 
the findings of the 2009 NRC study, the TWG analyzed additional 
scientific data to determine if additional evidence existed to support 
a causal relationship between various conditions and the contaminants 
found in the water supply at Camp Lejeune. The TWG review evaluated the 
hazards associated with not only these chemicals, but benzene and vinyl 
chloride as well, thus broadening the scope beyond that of the 2009 NRC 
assessment. The TWG was particularly interested in weight of evidence 
evaluations conducted since the 2009 study, as they incorporate 
scientific information that was not available when the NRC's 2009 
report was being developed. Furthermore, because each of these expert 
bodies reviewed the literature through different scientific 
perspectives, this approach provided the TWG with increased confidence 
in its conclusions.
    The TWG examined the results of EPA's Toxicological Reviews for the 
IRIS program (TCE, 2011; PCE, 2012; benzene, 2002; and vinyl chloride, 
2000), the WHO's IARC Monographs on the Evaluation of Carcinogenic 
Risks to Humans (TCE, 2014; PCE, 2014; benzene, 2012; and vinyl 
chloride, 2013), and the NIH's NTP Report on Carcinogens (TCE, 2015; 
PCE, 2014; benzene, 2014; and vinyl chloride, 2014). In addition to the 
2009 NRC report, the TWG drew on two other NAS reports, both published 
by the IOM: Gulf War and Health, vol. 2: Insecticides and Solvents 
(2003) and Review of the VA Clinical Guidance for Health Conditions 
Identified by the Camp Lejeune Legislation (2015). Section E below 
contains full references for all scientific literature reviewed by the 
TWG.

D. Results of the TWG Analysis

    The TWG found that at least one of the internationally recognized 
scientific authorities cited above recently concluded that there is 
strong evidence supporting a causal relationship between kidney cancer 
and TCE (EPA 2011, IARC 2014, NTP 2015), adult leukemia and benzene 
(EPA 2002, IARC 2012, IOM 2003, NTP 2014), non-Hodgkin's lymphoma and 
TCE (NTP 2015), and liver cancer and vinyl chloride (EPA 2000, IARC 
2012, NTP 2014). Note that this list includes liver cancer, which was 
not named in the Camp Lejeune Act. Liver cancer was included in the 
list of health conditions as studies have established a causal 
relationship exists between liver cancer and vinyl chloride, and 
because the effects of vinyl chloride were not included in the 2009 NRC 
report's review of adverse health effects resulting from exposure, 
although it was identified in the water at Camp Lejeune.
    The TWG also noted that both the EPA (2002) and the IOM (2003) 
concluded that there is evidence supporting a causal relationship 
between aplastic anemia and other myelodysplastic syndromes and 
benzene, which appears to be supported by NTP (2012). The TWG also 
found that at least one of the internationally recognized scientific 
authorities cited above recently concluded that there is a positive 
association between bladder cancer and PCE (EPA 2012, IARC 2014, IOM 
2003) and between multiple myeloma and PCE (EPA 2012) and benzene (IARC 
2012).
    In the context of providing VA with clinical guidance for 
implementing the 2012 Camp Lejeune Act, the IOM (2015) identified four 
published scientific analyses that address solvent exposure that had 
not been available during the NAS 2009 study. The IOM committee 
concluded that ``Parkinson's disease is a neurobehavioral effect that 
may have resulted from consumption of contaminated drinking water at 
Camp Lejeune.'' IOM (2015) at 39.
    Although the CLSLT recommended to VA that they propose the creation 
of a presumption for scleroderma, additional reviews by the TWG 
concluded that the evidence is currently not strong enough to establish 
a positive association between any of the VOCs of interest and the 
development of scleroderma. Evaluations conducted by EPA (2011), IARC 
(2014), and NRC/IOM (2009) discuss a probable link between exposure to 
TCE and autoimmune diseases in general; however, none of the 
internationally recognized scientific authorities cited above concluded 
that there is positive association between scleroderma and the VOCs of 
interest, due in part to insufficient sample sizes and uncertainties 
about the cause of gender-specific differences. Therefore, the TWG did 
not recommend the creation of a presumption for scleroderma at this 
time, even though it was included in the Camp Lejeune Act.
    Likewise, none of the internationally recognized scientific 
authorities cited above concluded that there is a positive association 
between breast cancer, lung cancer, or esophageal cancer and the VOCs 
of interest. As such, the TWG concluded that the evidence was not 
strong enough to support recommending the creation of presumptions for 
these conditions at this time, even though they were included in the 
Camp Lejeune Act.
    Because the TWG analysis was conducted in the context of a 
rulemaking to establish presumptions of service connection for diseases 
associated with exposure to the VOCs of interest, the TWG did not 
recommend establishing presumptions for health effects that are not 
themselves diagnosed diseases or clearly associated with a specific 
diagnosis and therefore do not represent a disability for the purposes 
of VA compensation benefits. See 38 U.S.C. 1110. This is consistent 
with VA's practice in establishing presumptions of service connection 
for diseases arising potentially years after exposures of interest. For 
the purposes of entitlement to disability compensation and related 
benefits, the health endpoint must be associated with a diagnosis of a 
chronic disability. The TWG concluded that, at this time, there is not 
a specific or generalizable diagnosis of a disability related to renal 
toxicity or hepatic steatosis that may have been caused by exposure to 
the contaminants. Similarly, neither female infertility nor 
miscarriage, in and of themselves, are disabilities for which VA can 
provide disability compensation. Further, the NRC findings regarding 
female infertility and miscarriage were limited to exposure concurrent 
with those health effects and therefore would not provide a basis for 
presuming current health effects of this type to be associated with 
past exposure.

E. Weight-of-Evidence Analyses Considered by the TWG

 EPA. IRIS Toxicological Review of Benzene. U.S. Environmental 
Protection Agency, Washington, DC, EPA/635/R-02/001F, 2002. (EPA 2002)
 EPA. IRIS Toxicological Review of Tetrachloroethylene. U.S. 
Environmental Protection Agency, Washington, DC, EPA/635/R-08/011F, 
2012. (EPA 2012)
 EPA. IRIS Toxicological Review of Trichloroethylene. U.S. 
Environmental Protection Agency,

[[Page 62422]]

Washington, DC, EPA/635/R-09/011F, 2011. (EPA 2011)
 EPA. IRIS Toxicological Review of Vinyl Chloride. U.S. 
Environmental Protection Agency, Washington, DC, EPA/635R-00/004, 2000. 
(EPA 2000)
 IARC Working Group on the Evaluation of Carcinogenic Risk to 
Humans. Chemical Agents and Related Occupations. Lyon (FR): 
International Agency for Research on Cancer; 2012. (IARC Monographs on 
the Evaluation of Carcinogenic Risks to Humans, No. 100F.) (IARC 2012)
 IARC Working Group on the Evaluation of Carcinogenic Risk to 
Humans. Trichloroethylene, Tetrachloroethylene, and Some Other 
Chlorinated Agents. Lyon (FR): International Agency for Research on 
Cancer; 2014. (IARC Monographs on the Evaluation of Carcinogenic Risks 
to Humans, No. 106.) (IARC 2014)
 Institute of Medicine. Gulf War and Health: Volume 2. 
Insecticides and Solvents. Washington, DC: The National Academies 
Press, 2003. (IOM 2003)
 Institute of Medicine. Review of VA Clinical Guidance for the 
Health Conditions Identified by the Camp Lejeune Legislation. 
Washington, DC: The National Academies Press, 2015. (IOM 2015)
 National Research Council. Contaminated Water Supplies at Camp 
Lejeune: Assessing Potential Health Effects. Washington, DC: The 
National Academies Press, 2009.
 National Toxicology Program. 2014. Report on Carcinogens, 
Thirteenth Edition. Research Triangle Park, NC: U.S. Department of 
Health and Human Services, Public Health Service. http://ntp.niehs.nih.gov/pubhealth/roc/roc13/
 National Toxicology Program. 2015. Report on Carcinogens, 
Monograph on Trichloroethylene. http://ntp.niehs.nih.gov/ntp/roc/monographs/finaltce_508.pdf

III. Secretary's Proposal

A. Secretary's Authority

    Section 501(a)(1) of title 38, United States Code, provides that 
``[t]he Secretary has authority to prescribe all rules and regulations 
which are necessary or appropriate to carry out the laws administered 
by [VA] and are consistent with those laws, including . . . regulations 
with respect to the nature and extent of proof and evidence and the 
method of taking and furnishing them in order to establish the right to 
benefits under such laws.'' This broad authority encompasses the 
establishment of an evidentiary presumption of service connection and 
exposure under specified circumstances, provided there is a rational 
basis for the presumptions. In this case, the Secretary has determined 
that proof of qualifying service at Camp Lejeune, consistent with the 
statute providing health care coverage for Camp Lejeune veterans, and 
the subsequent development of one or more of the eight disabilities 
identified by the TWG is sufficient to support proposing a presumption 
that the resulting disability was incurred in the line of duty during 
active military, naval, or air service, to include qualifying reserve 
or National Guard service, to establish entitlement to service 
connection. See 38 U.S.C. 1110.
    VA notes it is well-established that the Secretary's authority 
under 38 U.S.C. 501(a)(1) includes issuing discretionary regulations 
for presumptive service connection, as evidenced by past rulemakings 
(issued in response to National Academy of Sciences' studies of 
exposures) to establish presumptive service connection for Amyotrophic 
Lateral Sclerosis (see 73 FR 54691), presumptive service connection for 
exposure to herbicides for certain qualifying individuals aboard C-123 
aircraft (see 80 FR 35246), and presumptive service connection for 
various diseases in veterans with exposure to specified vesicant agents 
(see 59 FR 42497).

B. Presumptive Conditions

    Based upon the results of the TWG analysis, the Secretary proposes 
that VA acknowledge the relationship between exposure to contaminants 
in the water supply at Camp Lejeune (in unknown quantities) and the 
subsequent development of the following health conditions: Kidney 
cancer, non-Hodgkin's lymphoma, adult leukemia, liver cancer, bladder 
cancer, multiple myeloma, Parkinson's disease, and aplastic anemia and 
other myelodysplastic syndromes.
    Because these health conditions represent a disability, VA proposes 
to amend 38 CFR 3.307 to establish presumptions of service connection 
associated with exposure to contaminants in the water supply at Camp 
Lejeune. VA also proposes to amend 38 CFR 3.309 to prescribe the 
conditions that are subject to presumptive service connection in 
relation to exposure to the contaminants in the Camp Lejeune water 
supply. At this time, VA does not propose to establish presumptions of 
service connection for any other conditions. VA may consider additional 
rulemaking in the future, consistent with the available science at that 
time.

C. Exposure Requirements

    VA proposes to presume exposure to contaminants in the water supply 
at Camp Lejeune for all active duty, reserve, and National Guard 
personnel who served for no less than 30 days (consecutive or 
nonconsecutive) at Camp Lejeune during the period beginning August 1, 
1953, and ending on December 31, 1987. VA proposes to include both 
consecutive and nonconsecutive days in the calculation of the 30-day 
requirement to clarify that VA will presume exposure to contaminants in 
the water supply at Camp Lejeune for veterans who may have served at 
Camp Lejeune on multiple occasions that total no less than 30 days.
    VA based its determination to require no less than 30 days of 
service at Camp Lejeune to establish a presumption of exposure to 
contaminants in the water supply based on both the available scientific 
evidence and prior implementation of the provisions of section 102 of 
the Camp Lejeune Act. As previously discussed, the TWG's assessment 
relied on a hazard evaluation model, focusing on the conclusions of 
internationally respected expert scientific bodies. The TWG did not 
take into account the estimated levels of contamination in the water at 
Camp Lejeune and therefore could not characterize any risk associated 
with a specific level of exposure to contaminated water. As the 
available scientific evidence does not provide specific data on 
exposure levels, VA proposes to use its prior implementation of the 
health care provisions of Public Law 112-154 as a guide.
    While section 102 of Public Law 112-154 requires that the veteran 
served at Camp Lejeune for at least 30 days, it does not specify 
whether these days must be consecutive. VA's implementation of the 
provisions of section 102, contained in 38 CFR 17.400, requires that a 
veteran served at least 30 days at Camp Lejeune to establish 
entitlement to health care. 78 FR 55671. Section 17.400 specifically 
notes that the 30 days may be consecutive or non-consecutive. While VA 
is not bound by Public Law 112-154 or 38 CFR 17.400 in proposing the 
current presumptions of exposure and service connection, VA has 
determined that inclusion of the 30-day requirement would ensure 
consistency and parity with both its healthcare regulations and the 
statute.
    However, the enactment of Public Law 112-154, by itself, does not 
provide

[[Page 62423]]

a legal requirement for prescribing a 30-day service requirement for 
the purposes of disability compensation. Further, Congress did not 
provide any scientific references for prescribing a 30-day service 
requirement when it enacted Public Law 112-154. VA acknowledges that 
current science establishes a link between exposure to certain 
chemicals found in the water supply at Camp Lejeune and later 
development of one of the proposed presumptive conditions. However, VA 
experts agree that there is no science to support a specific minimum 
exposure level for any of the conditions. Therefore, VA welcomes 
comments on this requirement and will consider other practical 
alternatives when drafting the final rule.
    VA also notes that the proposed 30-day requirement serves to 
establish eligibility for service connection on a presumptive basis; 
nothing in this proposed regulation prohibits consideration of service 
connection on a non-presumptive basis. Veterans without the requisite 
30 days of service at Camp Lejeune may still establish service 
connection for any disease or disability on a direct basis. Direct 
service connection for any disease alleged to have been caused by 
contaminants in the water supply at Camp Lejeune requires evidence of a 
current disease or disability, evidence of exposure to the contaminated 
water at Camp Lejeune, and a medical nexus between the two, supported 
by a sufficient scientific explanation.

D. Application to Reservists and National Guard

    Basic eligibility for VA benefits requires that an individual be a 
``veteran'' as that term is defined in 38 U.S.C. 101(2): ``The term 
`veteran' means a person who served in the active military, naval, or 
air service, and who was discharged or released therefrom under 
conditions other than dishonorable.'' Reserve or National Guard service 
during a period of active duty for training or inactive duty training 
generally does not qualify an individual as a ``veteran'' because it 
does not constitute ``active military, naval or air service,'' unless 
the individual is disabled or dies during that period of service as 
prescribed by 38 U.S.C. 101(24)(B) and (C).
    This proposed rule would establish presumptions that former 
reservists and National Guard members were exposed to contaminants in 
the water supply between August 1, 1953 and December 31, 1987, if their 
military personnel record includes orders or other records of no less 
than 30 days service (consecutive or nonconsecutive) at Camp Lejeune 
during the contamination period, and would allow them to establish 
veteran status by presuming that a covered disability was incurred in 
the line of duty and arose during the qualifying period of service.
    Although 38 U.S.C. 101(24) requires a period of active duty for 
training or inactive duty training ``during which the individual 
concerned was disabled or died'' for a period of active duty for 
training or inactive duty training to constitute ``active military, 
naval, or air service,'' the latent effects of exposures to certain 
harmful chemicals were unrecognized when section 101(24) was enacted in 
1958. The legislative history regarding the enactment of section 
101(24) does not specifically explain Congress' intent in requiring 
that the individual ``was disabled or died'' during the period of 
service. It is probable that Congress required a reserve component 
member to have been disabled ``during'' training because the medical 
science of the time understood that, if an in-service injury were to 
result in disability, at least some aspect of that disability generally 
would be manifest contemporaneous with the injury. However, subsequent 
developments with regard to medical understanding of the health effects 
of harmful chemical exposures, such as the VOCs that contaminated the 
Camp Lejeune water supply, raise a question regarding the application 
of section 101(24) to disability associated with such exposure.
    Viewing the generally beneficial purpose of section 101(24) in 
light of an evolved medical understanding, the Secretary believes it is 
reasonable to propose a factual presumption that disability occurred 
during the period of service as required under section 101(24) when an 
individual has a present disability from: Kidney cancer, liver cancer, 
adult leukemia, non-Hodgkin's lymphoma, bladder cancer, multiple 
myeloma, aplastic anemia and other myelodysplastic syndromes, and 
Parkinson's disease. Specifically, the proposed disease presumptions 
enumerated in 38 CFR 3.309, coupled with the potential for clinical 
uncertainty regarding when such diseases first manifested, provide a 
reasonable basis for presuming that disability occurred during a period 
of reserve or National Guard service for purposes of satisfying the 
requirements under section 101(24)(B) or (C) in order to ensure 
compensation and health care for reservists and National Guard 
personnel disabled as a result of exposure to the contaminants in the 
water supply at Camp Lejeune on qualifying reserve and National Guard 
duty.

IV. Application of Rulemaking to Previously Adjudicated Claims

    This proposed rule would apply to claims received by VA on or after 
the date of publication of the final rule in the Federal Register and 
to claims pending before VA on that date. This proposed rule would not 
apply retroactively to claims previously adjudicated. VA would adhere 
to the provisions of its change of law regulation, 38 CFR 3.114, which 
states, ``[w]here pension, compensation, dependency and indemnity 
compensation, . . . is awarded or increased pursuant to a liberalizing 
law, or a liberalizing VA issue approved by the Secretary or by the 
Secretary's direction, the effective date of such award or increase 
shall be fixed in accordance with the facts found, but shall not be 
earlier than the effective date of the act or administrative issue.'' 
See also 38 U.S.C. 5110(g).
    This proposed regulation is based on the Secretary's broad 
authority under 38 U.S.C. 501(a) to ``prescribe all rules and 
regulations which are necessary or appropriate to carry out the laws 
administered by the Department and are consistent with those laws, 
including-- . . . regulations with respect to the nature and extent of 
proof and evidence . . . in order to establish the right to benefits 
under such laws.'' This rulemaking authority does not explicitly afford 
the Secretary authority to assign retroactive effect to the regulations 
created thereunder. It is well-settled that ``[r]etroactivity is not 
favored in the law. . . . [A] statutory grant of legislative rulemaking 
authority will not, as a general matter, be understood to encompass the 
power to promulgate retroactive rules unless that power is conveyed by 
Congress in express terms.'' Bowen v. Georgetown Univ. Hosp., 488 U.S. 
204, 208 (1988). As there is no explicit statutory authority to apply 
this proposed regulation retroactively, the Secretary, based on the 
current state of the scientific evidence, will take into consideration 
the evidentiary burden on claimants for certain Camp Lejeune 
contaminated water related claims pending (for the diseases specified 
in the proposed regulation) at the time of publication of the final 
rule and for all future claims.
    Although this proposed regulation would not apply retroactively, a 
claimant whose claim was previously and finally denied may file a new 
claim to obtain a new determination of entitlement under the final 
regulation. See Spencer v. Brown, 17 F.3d 368, 372

[[Page 62424]]

(Fed. Cir. 1994) (```When a provision of law or regulation creates a 
new basis of entitlement to benefits, as through liberalization of the 
requirements for entitlement to a benefit, an applicant's claim of 
entitlement under such law or regulation is a claim separate and 
distinct from a claim previously and finally denied prior to the 
liberalizing law or regulation.''') (quoting Spencer v. Brown, 4 Vet. 
App. 283, 288-89 (1993)).

V. Regulation Amendments

    VA proposes to amend the Sec.  3.307 heading to read ``Presumptive 
service connection for chronic, tropical or prisoner-of-war related 
disease, disease associated with exposure to certain herbicide agents, 
or disease associated with the contaminants in the water supply at Camp 
Lejeune; wartime and service on or after January 1, 1947.'' Likewise, 
VA proposes to revise paragraph (a) of Sec.  3.307 to add the phrase 
``, or disease associated with the contaminants in the water supply at 
Camp Lejeune'' after the words ``herbicide agents.'' Both of these 
proposed amendments are necessary to inform the public that certain 
diseases associated with contaminants in the water supply at Camp 
Lejeune are now included among those covered by VA's proposed 
presumptive service connection regulations. Paragraph (a)(1) of Sec.  
3.307 establishes service criteria necessary to establish entitlement 
to presumptive treatment of a disease related to particular types of 
exposure. VA proposes to amend this paragraph to specify that any 
period of service is sufficient for purposes of presumptive service 
connection of conditions associated with service at Camp Lejeune, as 
long as the service also satisfies the requirements to establish a 
presumption of exposure to contaminants in the water supply at that 
facility under Sec.  3.307(a)(7)(iii).
    As noted above, VA previously implemented health care benefits for 
veterans who served on active duty at Camp Lejeune for at least thirty 
days (consecutive or nonconsecutive) during the contamination period 
through 38 CFR 17.400. To maintain consistency and parity with VA's 
interpretation of Public Law 112-154 in implementing its healthcare 
regulations, VA proposes that a veteran, or former reservist or 
National Guard member, must have a record of no less than 30 days of 
service (consecutive or nonconsecutive) at Camp Lejeune for any period 
between the prescribed dates to establish service connection on a 
presumptive basis for the eight conditions addressed in this proposed 
rule. Service at Camp Lejeune, for the purpose of establishing service 
connection on a presumptive basis, means that the veteran, or former 
reservist or National Guard member, as established by military orders 
or other official service department records, lived or worked within 
the confines of the Camp Lejeune border. Any such veteran, or former 
reservist or National Guard member, could have been exposed to 
contaminants in the water supply through drinking, bathing or other 
activities. We believe that military orders or other official service 
department records documenting no less than 30 days of service at Camp 
Lejeune provide a rational basis for presuming that the individual 
likely had more than isolated and minimal opportunity for contact with 
the relevant VOCs.
    VA also proposes adding paragraph (a)(7) to Sec.  3.307 to describe 
entitlement criteria for diseases associated with exposure to 
contaminants in the water supply at Camp Lejeune. Paragraph (a)(7)(i) 
defines ``contaminants in the water supply'' to mean the on-base water-
supply systems located at Camp Lejeune that were contaminated with TCE, 
PCE, benzene, and vinyl chloride during the period beginning August 1, 
1953, and ending December 31, 1987. Proposed paragraph (a)(7)(ii) 
cross-references proposed Sec.  3.309(f), which lists the diseases that 
are presumptively service connected based on exposure to contaminants 
in the water supply at Camp Lejeune, and requires that they manifest to 
a compensable degree at any time after service for VA to award 
presumptive service connection. Proposed paragraph (a)(7)(iii) 
describes the population covered by the presumption of exposure.
    Proposed paragraph (a)(7)(iii) applies the presumption of exposure 
to a veteran, reservist, or National Guard member who had no less than 
30 days of service (consecutive or nonconsecutive) at Camp Lejeune at 
any time during the period beginning August 1, 1953, and ending 
December 31, 1987. Such individuals are presumed to have been exposed 
to the contaminants in the water supply at Camp Lejeune, unless there 
is affirmative evidence to establish that there was no such exposure. 
Affirmative evidence showing that there was no exposure is likely to be 
rare, but if there is evidence showing that the veteran was not 
actually exposed to contaminants in the water supply, the veteran must 
establish that the disability is related to military service in some 
other way (e.g., had its onset during service). The disability will not 
be presumed to have been caused by contaminants in the water supply at 
Camp Lejeune.
    VA proposes to prescribe the same contamination period as 38 U.S.C. 
1710(e)(1)(F). As noted above, section 1710(e)(1)(F) was amended by 
Public Law 113-235 to change the Camp Lejeune contamination period to 
August 1, 1953, through December 31, 1987. The legislative history does 
not explain why Congress selected this contamination period, but it is 
likely based on some of the earliest assessments of the Camp Lejeune 
water supply noted in the NRC report. Contaminated Water Supplies, at 
60. This period represents the ATSDR's best estimate of the period of 
contamination at Camp Lejeune and likely captures all potentially 
affected veterans.
    Paragraph (a)(7)(iii) also defines ``service at Camp Lejeune'' as 
any service within the borders of the entirety of the United States 
Marine Corps Base Camp Lejeune and Marine Corps Air Station New River, 
North Carolina, during the relevant period, as established by military 
orders or other service department records. Neither the statute nor the 
legislative history of Public Law 112-154 indicates Congress' intent as 
to the geographic area covered by reference to ``Camp Lejeune, North 
Carolina'' in 38 U.S.C. 1710(e)(1)(F). VA acknowledges that it would be 
too difficult to determine with specificity which residential or 
workplace facilities were serviced with the contaminated water, or 
whether and to what degree the veteran would have come into contact 
with that facility during active service. Therefore, this proposed rule 
covers any veteran, reservist, or member of the National Guard, whose 
military orders or records establish their presence within the borders 
of the entirety of the United States Marine Corps Base Camp Lejeune 
border, which includes Marine Corps Air Station New River, for no less 
than 30 days (consecutive or nonconsecutive) and therefore could 
potentially have come into physical contact (e.g., by drinking or 
bathing) with contaminants in the water supply on more than an isolated 
and minimal basis. VA specifically included Marine Corps Air Station 
New River in the definition of service Camp Lejeune to clarify that 
official military records indicating service at Marine Corps Air 
Station New River are sufficient to establish service at Camp Lejeune 
for the purposes of this rulemaking. This would ensure consistency with 
the definition of Camp Lejeune in 38 CFR 17.400(b) for purposes of 
health care.
    Proposed paragraph (a)(7)(iv) prescribes that the presumed exposure

[[Page 62425]]

to contaminants in the water supply is an ``injury'' under section 
101(24)(B) and (C). In turn, if an individual develops a presumptive 
disease listed in 38 CFR 3.309(f), ``VA will presume that the 
individual concerned became disabled during that service for purposes 
of establishing that the individual served in the active military, 
naval, or air service.'' As explained previously, this is consistent 
with section 101(24) because exposure to contaminants in the water 
supply at Camp Lejeune is associated with latent adverse health effects 
that were largely unrecognized in 1958. Covered individuals may 
therefore establish veteran status for purposes of VA's disability 
compensation, dependency and indemnity compensation, medical care, and 
burial benefits related to any Camp Lejeune-related presumptive 
condition.
    VA also proposes to amend 38 CFR 3.309 by adding paragraph (f). 
This proposed paragraph is titled ``Disease associated with exposure to 
contaminants in the water supply at Camp Lejeune.'' The primary purpose 
of this proposed amendment is to list the diseases that are 
presumptively service connected based on exposure to contaminants in 
the water supplies at Camp Lejeune during the exposure period. For the 
reasons described above, the diseases are as follows: Kidney cancer, 
liver cancer, non-Hodgkin's lymphoma, adult leukemia, multiple myeloma, 
Parkinson's disease, aplastic anemia and other myelodysplastic 
syndromes, and bladder cancer. Proposed paragraph (f) notes that the 
provisions of 38 CFR 3.307(d), regarding circumstances in which 
presumptions of service connection may be rebutted, apply to these 
presumptions.

Administrative Procedure Act

    The Secretary of Veterans Affairs is providing a 30 day period for 
public comment. Kidney cancer, liver cancer, non-Hodgkin's lymphoma, 
adult leukemia, multiple myeloma, Parkinson's disease, bladder cancer, 
and aplastic anemia and other myelodysplastic syndromes are 
debilitating and life-threatening illnesses, and any delay in 
implementing a final rule could have severe detrimental impact on 
Veterans exposed to contaminants in the water supply at Camp Lejeune 
now suffering from these diseases. Based on the age of the individuals 
affected by this proposed rule and the severity of the disabilities 
associated with their exposure, it is likely that affected individuals 
would have significant and urgent financial and medical needs. In the 
absence of a shortened public comment period and publication of a final 
rule, these Veterans may not receive proper health care or assistance 
with daily functions due to financial hardship or the absence of 
service-connected status for their disability.
    While VA believes the severity of the conditions and the age of the 
individuals affected themselves justify a 30 day period for public 
comment, there is an even more acute basis for the Secretary's 
decision. VA is aware of roughly thirty individuals who are terminally 
ill, and would be covered by the presumptions in the event they become 
effective. Provision of a 60-day comment period would increase the 
likelihood that some affected veterans who have incurred or will incur 
one or more of the covered illnesses will die from the disease before a 
final rule could be issued. In order for these individuals to have 
access to VA health care, some for the first time, and disability 
compensation benefits, it is critical that VA establish these 
presumptions as soon as possible. Therefore, the Secretary is providing 
a public comment period of 30 days. VA invites public comments on this 
proposed rule and notes that it will fully consider and address any 
comments received.

Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 direct agencies to assess the 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and other advantages; distributive impacts; 
and equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review) emphasizes the importance of quantifying both costs and 
benefits, reducing costs, harmonizing rules, and promoting flexibility. 
Executive Order 12866 (Regulatory Planning and Review) defines a 
``significant regulatory action,'' requiring review by the Office of 
Management and Budget (OMB), unless OMB waives such review, as ``any 
regulatory action that is likely to result in a rule that may: (1) Have 
an annual effect on the economy of $100 million or more or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities; (2) 
Create a serious inconsistency or otherwise interfere with an action 
taken or planned by another agency; (3) Materially alter the budgetary 
impact of entitlements, grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) Raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in this Executive Order.''
    The economic, interagency, budgetary, legal, and policy 
implications of this regulatory action have been examined, and it has 
been determined to be a significant regulatory action under Executive 
Order 12866 because it is likely to result in a rule that may have an 
annual effect on the economy of $100 million or more and may raise 
novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in this Executive 
Order. VA's impact analysis can be found as a supporting document at 
http://www.regulations.gov, usually within 48 hours after the 
rulemaking document is published. Additionally, a copy of this 
rulemaking and its impact analysis are available on VA's Web site at 
http://www.va.gov/orpm/, by following the link for ``VA Regulations 
Published from FY 2004 Through Fiscal Year to Date.''

Regulatory Flexibility Act

    The Secretary hereby certifies that this proposed rule would not 
have a significant economic impact on a substantial number of small 
entities as they are defined in the Regulatory Flexibility Act (5 
U.S.C. 601-612). This proposed rule would directly affect only 
individuals and would not directly affect small entities. Therefore, 
pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the 
regulatory flexibility analysis requirements of sections 603 and 604.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. This proposed rule would have no such 
effect on State, local, and tribal governments, or on the private 
sector.

Paperwork Reduction Act

    This proposed rule contains no provisions constituting a collection 
of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3521).

[[Page 62426]]

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are 64.109, Veterans 
Compensation for Service-Connected Disability; 64.110, Veterans 
Dependency and Indemnity Compensation for Service-Connected Death.

Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this 
document and authorized the undersigned to sign and submit the document 
to the Office of the Federal Register for publication electronically as 
an official document of the Department of Veterans Affairs. Gina S. 
Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, 
approved this document on August 30, 2016, for publication.

    Dated: September 1, 2016.
Michael Shores,
Acting Director, Regulation Policy & Management, Office of the 
Secretary, Department of Veterans Affairs.

List of Subjects in 38 CFR Part 3

    Administrative practice and procedure, Claims, Disability benefits, 
Veterans.

    For the reasons stated in the preamble, the Department of Veterans 
Affairs proposes to amend 38 CFR part 3 as follows:

PART 3--ADJUDICATION

Subpart A--Pension, Compensation, and Dependency and Indemnity 
Compensation

0
1. The authority citation for part 3, subpart A continues to read as 
follows:

    Authority:  38 U.S.C. 501(a), unless otherwise noted.

0
2. Amend Sec.  3.307 by revising the section heading and paragraphs (a) 
introductory text and (a)(1), and adding paragraph (a)(7) to read as 
follows:


Sec.  3.307  Presumptive service connection for chronic, tropical or 
prisoner-of-war related disease, disease associated with exposure to 
certain herbicide agents, or disease associated with contaminants in 
the water supply at Camp Lejeune; wartime and service on or after 
January 1, 1947.

    (a) General. A chronic, tropical, prisoner of war related disease, 
a disease associated with exposure to certain herbicide agents, or a 
disease associated with contaminants in the water supply at Camp 
Lejeune listed in Sec.  3.309 will be considered to have been incurred 
in or aggravated by service under the circumstances outlined in this 
section even though there is no evidence of such disease during the 
period of service. No condition other than one listed in Sec.  3.309(a) 
will be considered chronic.
    (1) Service. The veteran must have served 90 days or more during a 
war period or after December 31, 1946. The requirement of 90 days' 
service means active, continuous service within or extending into or 
beyond a war period, or which began before and extended beyond December 
31, 1946, or began after that date. Any period of service is sufficient 
for the purpose of establishing the presumptive service connection of a 
specified disease under the conditions listed in Sec.  3.309(c) and 
(e). Any period of service is sufficient for the purpose of 
establishing the presumptive service connection of a specified disease 
under the conditions listed in Sec.  3.309(f), as long as the period of 
service also satisfies the requirements to establish a presumption of 
exposure to contaminants in the water supply at Camp Lejeune under 
paragraph (a)(7)(iii) of this section.
* * * * *
    (7) Diseases associated with exposure to contaminants in the water 
supply at Camp Lejeune. (i) For the purposes of this section, 
contaminants in the water supply means the volatile organic compounds 
trichloroethylene (TCE), perchloroethylene (PCE), benzene and vinyl 
chloride, that were in the on-base water-supply systems located at 
United States Marine Corps Base Camp Lejeune, during the period 
beginning on August 1, 1953, and ending on December 31, 1987.
    (ii) The diseases listed in Sec.  3.309(f) shall have become 
manifest to a degree of 10 percent or more at any time after service.
    (iii) A veteran, or former reservist or member of the National 
Guard, who had no less than 30 days (consecutive or nonconsecutive) of 
service at Camp Lejeune during the period beginning on August 1, 1953, 
and ending on December 31, 1987, shall be presumed to have been exposed 
during such service to the contaminants in the water supply, unless 
there is affirmative evidence to establish that the individual was not 
exposed to contaminants in the water supply during that service. The 
last date on which such a veteran, or former reservist or member of the 
National Guard, shall be presumed to have been exposed to contaminants 
in the water supply shall be the last date on which he or she served at 
Camp Lejeune during the period beginning on August 1, 1953, and ending 
on December 31, 1987. For purposes of this section, service at Camp 
Lejeune means any service within the borders of the entirety of the 
United States Marine Corps Base Camp Lejeune and Marine Corps Air 
Station New River, North Carolina, during the period beginning on 
August 1, 1953, and ending on December 31, 1987, as established by 
military orders or other official service department records.
    (iv) Exposure described in paragraph (a)(7)(iii) of this section is 
an injury under 38 U.S.C. 101(24)(B) and (C). If an individual 
described in paragraph (a)(7)(iii) of this section develops a disease 
listed in 38 CFR 3.309(f), VA will presume that the individual 
concerned became disabled during that service for purposes of 
establishing that the individual served in the active military, naval, 
or air service.


(Authority: 38 U.S.C. 501(a))


0
3. Add Sec.  3.309(f) to read as follows:


Sec.  3.309  Disease subject to presumptive service connection.

* * * * *
    (f) Disease associated with exposure to contaminants in the water 
supply at Camp Lejeune. If a veteran, or former reservist or member of 
the National Guard, was exposed to contaminants in the water supply at 
Camp Lejeune during military service and the exposure meets the 
requirements of Sec.  3.307(a)(7), the following diseases shall be 
service-connected even though there is no record of such disease during 
service, subject to the rebuttable presumption provisions of Sec.  
3.307(d).
    (1) Kidney cancer.
    (2) Liver cancer.
    (3) Non-Hodgkin's lymphoma.
    (4) Adult leukemia.
    (5) Multiple myeloma.
    (6) Parkinson's disease.
    (7) Aplastic anemia and other myelodysplastic syndromes.
    (8) Bladder cancer.


(Authority: 38 U.S.C. 501(a))


[FR Doc. 2016-21455 Filed 9-8-16; 8:45 am]
BILLING CODE 8320-01-P