Daily Rules, Proposed Rules, and Notices of the Federal Government
The Persian Gulf War Veterans Act of 1998, Public Law 105-277, title XVI, 112 Stat. 2681-742 through 2681-749 (codified at 38 U.S.C. 1118), and the Veterans Programs Enhancement Act of 1998, Public Law 105-368, 112 Stat. 3315, directed the Secretary of Veterans Affairs to seek to enter into an agreement with the National Academy of Sciences (NAS) to review and evaluate the available scientific evidence regarding associations between illnesses and exposure to toxic agents, environmental or wartime hazards, or preventive medicines or vaccines to which service members may have been exposed during service in the Persian Gulf during the Persian Gulf War. Congress directed the NAS to identify agents, hazards, medicines, and vaccines to which service members may have been exposed during service in the Persian Gulf during the Persian Gulf War.
Section 1118 of title 38 of the United States Code provides that whenever the Secretary determines, based on sound medical and scientific evidence, that a positive association (
The NAS issued its initial report titled, Gulf War and Health, Volume 1: “Depleted Uranium, Sarin, Pyridostigmine Bromide, Vaccines,” on January 1, 2000. In that report, NAS limited its analysis to the health effects of depleted uranium, the chemical warfare agent sarin, vaccinations against botulism toxin and anthrax, and pyridostigmine bromide, which was used in the Persian Gulf War as a pretreatment for possible exposure to nerve agents. On July 6, 2001, VA published a notice in the
The NAS issued its second report titled, “Gulf War and Health, Volume 2: Insecticides and Solvents,” on February 18, 2003. In that report, the NAS focused on the health effects of insecticides and solvents that were shipped to the Persian Gulf during the Persian Gulf War. The pesticides considered by the NAS were organophosphorous compounds (malathion, diazinon, chlorpyrifos, dichlorvos, and azamethiphos), carbamates (carbaryl, propoxur, and methomyl), pyrethrins and pyrethyroids (permethrin and d-phenothrin), lindane, and
The NAS issued an update on sarin in a report titled “Gulf War and Health: Updated Literature Review of Sarin,” on August 20, 2004. In that report, the NAS focused on the long-term health effects from exposure to the nerve agent, sarin. VA published a
The NAS issued its third report, titled “Gulf War and Health, Volume 3: Fuels, Combustion Products, and Propellants,” on December 20, 2004. In that report, the NAS focused on the health effects of hydrazines, red fuming nitric acid, hydrogen sulfide, oil-fire byproducts, diesel-heater fumes, and fuels (for
The NAS issued its fourth report, titled “Gulf War and Health Volume 4: Health Effects of Serving in the Gulf War,” on September 12, 2006. In that report the NAS focused on the health status of veterans of the 1991 Gulf War. The report was intended to inform VA about illnesses and clinical issues including possible relevant treatments, which might have been overlooked among this population, regardless of the specific underlying cause. VA is drafting a
The NAS issued its fifth report, titled “Gulf War and Health Volume 5: Infectious Diseases” on October 16, 2006. This report differs from prior NAS reports in that it implicates two tiers of possible association between a hazard and resulting health outcomes. Prior NAS reports generally addressed only one tier of possible association—
The NAS initially identified approximately 100 diseases that are known to be endemic to Southwest Asia. Because those diseases would in most instances become manifest within a relatively short time after infection, NAS eliminated from consideration any disease that had never been reported in any U.S. troops within a reasonable period following Persian Gulf deployments. The NAS also eliminated from consideration any diseases not known to produce long-term health effects. On that basis, the NAS limited the list of diseases to the nine diseases discussed below.
(1) Are prevalent in Southwest Asia,
(2) Have been diagnosed among U.S. troops serving there, and
(3) Are known to cause long-term adverse health effects.
In its previous reports, the NAS focused primarily upon health effects of exposure to hazards associated with service in the Southwest Asia theater of operations, as that area was defined for purposes of the 1991 Gulf War. That area was defined to encompass Iraq, Kuwait, Saudi Arabia, the neutral zone between Iraq and Saudi Arabia, Bahrain, Qatar, the United Arab Emirates, Oman, the Gulf of Aden, the Gulf of Oman, the Persian Gulf, the Arabian Sea, the Red Sea, and the airspace above these locations. See Executive Order 12744 (Jan. 12, 1991); 60 FR 6665 (Feb. 3, 1995); 38 CFR 3.317(d)(2). In its 2006 report, at the Secretary's request, the NAS also reviewed infectious diseases that might have affected U.S. troops who served in Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) in Southwest Asia, including service in Afghanistan, which was designated a combat zone effective September 19, 2001, by Executive Order 13239 (Dec. 12, 2001). The NAS indicated that the nine infectious diseases are endemic to the region including Afghanistan and the areas previously designated as the Southwest Asia theater of operations.
Although the NAS report focused on the association between a primary infectious disease and secondary health effects, we believe it is necessary to address the issue of the association between exposure to disease-causing pathogens in service and the development of the primary infectious diseases. We do this for two reasons. First, 38 U.S.C. 1118 contemplates that VA will establish presumptions of service connection when there is a positive association between exposure to certain pathogens in Gulf War service and the development of a disease or illness. Second, establishing presumptions of service connection for the primary infectious diseases would facilitate grants of service connection for the secondary health effects identified in the NAS report because, when VA grants service connection for a primary disease, all secondary conditions proximately caused by that disease are also service connected.
VA proposes to establish new presumptions of service connection for veterans who have served in the Southwest Asia theater of operations or Afghanistan during certain periods, and who subsequently develop one of the nine diseases known to have long-term adverse health effects.
The NAS did not state specific conclusions regarding the strength of the evidence linking the nine primary infectious diseases to Persian Gulf service. However, its report reflects the view that those diseases and the pathogens that cause them are associated with Persian Gulf service due to their prevalence in Southwest Asia and their incidence in deployed U.S. troops. As the NAS report reflects, the identified disease pathogens, which generally are specific types of bacteria, are known to cause the identified infectious diseases. Accordingly, exposure to those pathogens is necessarily associated with the incurrence of the infectious diseases.
The NAS noted that visceral leishmaniasis is endemic to Southwest Asia and is transmitted by sand fly bites, which are exceedingly common in that region. The NAS noted that malaria is endemic in portions of Southwest Asia, including many parts of Afghanistan, accounting for approximately 6 million cases and 59,000 deaths annually in Southwest and South Central Asia, and that Iraq experienced an epidemic in the wake of the 1991 Gulf War. The NAS noted that West Nile virus is endemic in Afghanistan and other countries in Southwest Asia. The NAS noted that diarrheal diseases were the most common illnesses manifest during the 1991 Gulf War and that studies had
Veterans who were diagnosed with any of these nine infectious diseases while they were serving on active duty will be able to establish direct service connection for their illness and any related health complications. Most of the infectious diseases that were the focus of the NAS were comparatively rare during the 1991 Gulf War, OEF, and OIF. Because these acute infectious diseases are generally quite serious, most cases of these infectious diseases would be diagnosed during service. For example, during the 1991 Gulf War, 20 veterans were diagnosed with cutaneous leishmaniasis, which can cause significant morbidity if left untreated. However, no additional cases have been diagnosed since the end of that conflict. Although diarrheal diseases were one of the most common major infectious disease problems for troops during the 1991 Gulf War, diagnosis of these diseases is defined in large part by their acute and obvious symptomatology.
However, some of the nine infectious diseases reviewed by the NAS might be diagnosed only after the veteran separates from active duty. Furthermore, a service member's initial, in-theater infection may not be detected or reported in the service member's treatment records. That is, in some instances, cases might be overlooked or misdiagnosed while the service member is still on active duty in Southwest Asia. For example, the NAS report describes how tuberculosis infection may remain asymptomatic such that the initial infection might not be expected to be documented in the service member's treatment record. Similarly, visceral leishmaniasis can be initially asymptomatic. Tuberculosis and visceral leishmaniasis can each manifest as an acute infectious disease years or even decades (for tuberculosis) following an initial asymptomatic infection.
Therefore, to respond to concerns of overlooked or delayed diagnoses, we propose to establish new presumptions of service connection for veterans who are initially diagnosed with one of these nine infectious diseases during the defined period discussed below following their military service in Southwest Asia. Such a presumption will benefit Southwest Asia veterans who experienced an initial asymptomatic infection that was not documented in their service treatment records, so long as the condition was later diagnosed within the presumptive period. This would be consistent with existing presumptions of service connection set forth at 38 CFR 3.307 and 3.309 and discussed in greater detail below.
We propose to make the presumptions applicable to veterans who served in the Southwest Asia theater of operations, as currently defined in 38 CFR 3.317(d) (which we propose to redesignate as 3.317(e)), and to veterans who served in Afghanistan on or after September 19, 2001, the date specified in Executive Order 13239 as the date combatant activities commenced in that country. This is based on the findings in the NAS report that the nine infectious diseases are endemic in those regions and were experienced by servicemembers in the 1991 Gulf War, OEF, and OIF.
Some of these nine infectious diseases associated with service in Southwest Asia are already recognized as presumptively service connected for veterans who served during a war period or after 1946. Although this would include veterans who served in the 1991 Gulf War, OEF, and OIF, VA believes there is value in developing new presumptions of service connection that recognize these veterans specifically.
Chronic and tropical diseases that are presumed to be service connected when they become manifest within a specified time period in certain veterans are listed at 38 CFR 3.307 and 3.309 in accordance with 38 U.S.C. 1112(a). Sections 3.307(a)(3) and 3.309(a) include active tuberculosis if manifested to a degree of 10 percent or more within 3 years from the date of separation from service, and §§ 3.307(a)(4) and 3.309(b) include leishmaniasis and malaria if manifested to a degree of 10 percent or more either within 1 year from date of separation from service “or at a time when standard accepted treatises indicate that the incubation period commenced during such service.” 38 CFR 3.307(a)(4). Because the current presumptions for tuberculosis, leishmaniasis, and malaria are available to veterans who served in the 1991 Gulf War, OEF, and OIF, it may not seem to be necessary to establish new presumptions of service connection for these three diseases. However, we find that establishing new presumptions of service connection for such veterans serves to acknowledge the specific health risks experienced by this group.
Except as provided below for three diseases, we propose that a covered infectious disease be manifest within 1 year following service in the Southwest Asia theater of operations or Afghanistan in order to qualify for presumptive service connection. This1-year period would be consistent with the general 1-year presumptive period for tropical diseases currently in 38 U.S.C. 1112(a)(2) and § 3.307(a)(4) and would be consistent with medical principles, reflected in the NAS report, that those diseases ordinarily would be manifest within a short period following infection. We believe this 1-year period would be sufficient to encompass infectious diseases that are likely to have resulted from infection during service in the Southwest Asia theater of operations or Afghanistan.
With respect to malaria, we propose to adopt the same presumptive period as provided for malaria in 38 U.S.C. 1112(a)(2) and § 3.307(a)(4), which require malaria to become manifest within 1 year of service or at a time when standard or accepted treatises indicate that the incubation period commenced during service. This standard would promote consistency with existing law and is consistent with medical principles. The NAS noted that all known cases of malaria in veterans of OEF and OIF were diagnosed between 1 and 399 days after leaving the theater of operations, but that malaria may relapse up to 5 years after initial infection.
We propose no time limit on the presumption for visceral leishmaniasis. We note that the existing presumption of service connection for leishmaniasis in 38 U.S.C. 1112(a)(2) and § 3.307(a)(4) requires the disease to become manifest within 1 year of service or at a time when standard or accepted treatises indicate that the incubation period commenced during service. That flexible standard may encompass latency periods significantly greater than 1 year. However, because the NAS noted that the period of latent infection with visceral leishmaniasis organisms may be long, and that a period of 10 years is commonly cited, we believe that an open-ended presumption period is justified and will be clearer to claimants and adjudicators. To the extent that VA receives a claim under § 3.307(a)(4), the claimant may rely on “Gulf War and Health Volume 5: Infectious Diseases” as a standard treatise indicating the potentially lengthy latency period for leishmaniasis.
The proposed presumption for tuberculosis also would not be time-
With respect to the presumptive periods for visceral leishmaniasis and tuberculosis discussed above, we solicit comments on the following matters. First, whether it would be clearer to claimants and adjudicators to have the same presumptive periods as prescribed in § 1112(a) apply to the presumptions proposed for these two diseases. Second, whether NAS's statement that the period of latent infection with visceral leishmaniasis organisms may be long, and that a period of 10 years is commonly cited, justifies an open-ended presumption period. Third, whether the risk factor of service in the Southwest Asia theater of operations or Afghanistan justifies an open-ended presumption period for tuberculosis.
In its report, the NAS identified 34 different long-term health effects that might appear weeks to years after initial infection, associated with the nine infectious diseases. Most, if not all, identified long-term health effects are well known to be associated with the initial acute infection. If service connection is granted for a primary infectious disease pursuant to this proposed rule, any secondary health effects proximately due to or caused by the primary infectious disease will also be service connected under existing regulations.
We do not propose to establish presumptions of service connection for the secondary health effects discussed in the NAS report. As explained above, the findings in the NAS report pertained to individuals who had actually developed a primary infectious disease. Those findings thus do not support a presumption that the identified secondary health effects are independently associated with in-service exposure to the disease-causing pathogen in the absence of the primary disease.
Section 1118 of title 38, United States Code, does not direct VA to establish presumptions of service connection for conditions secondarily caused by a primary service-connected disease or illness. Rather, it requires presumptions for disease or illness associated with “exposure to a biological, chemical, or other toxic agent, environmental or wartime hazard, or preventive medicine known or presumed to be associated with service in the Armed Forces in the Southwest Asia theater of operations during the Persian Gulf War.” With respect to infectious diseases endemic to the Southwest Asia theater of operations, the relevant “exposure” is exposure to the pathogens that cause the primary infectious disease. The incurrence of the primary infectious disease is not, separately, an “exposure” within the meaning of the statute.
Any long-term health effects among troops serving in Southwest Asia who suffered an initial serious acute infectious disease should in general be addressed via the conventional direct-service-connection route. For example, if an active duty service member were diagnosed with Q fever (Coxiella burnetii) while serving in Southwest Asia, and was diagnosed years later with endocarditis, which is known to be associated with Q fever infection, then that veteran would have a reasonable case for establishing a direct service connection for any related disability.
Chronic long-term health effects associated with these infectious diseases generally would be compensable under the diagnostic code assigned to the service-connected disease or would be considered proximately due to that disease under 38 CFR 3.310(a) (secondary service connection) and rated separately.
As noted above, the NAS's findings concerning the secondary health effects of the nine infectious diseases generally reflect well established medical knowledge. However, to ensure that claimants and VA raters are aware of the NAS findings regarding the potential long-term health effects of the nine infectious diseases associated with service in Southwest Asia, we propose to include information about the long-term health effects in the regulation. The table in proposed paragraph (d), entitled “Table to § 3.317—Long-Term Health Effects Potentially Associated With Infectious Diseases,” summarizes the long-term health effects that the NAS reported as associated with the nine infectious diseases. These health effects and diseases are listed alphabetically and are not categorized by the level of association stated in the NAS report. We propose to provide in the regulation that, if a veteran who has or had an infectious disease identified in column A also has a condition identified in column B as potentially related to that infectious disease, VA must determine, based on the evidence in each case, whether the column B condition was caused by the infectious disease for purposes of paying disability compensation.
After considering all of the evidence as discussed above, the Secretary has determined that there is a positive association between the exposure to a biological, chemical or other toxic agent, environmental or wartime hazard, or preventative medicine or vaccine known or presumed to be associated with service in the Armed Forces in the Southwest Asia theater of operations during certain periods and the occurrence of Brucellosis, Campylobacter jejuni, Coxiella burnetii (Q fever), Malaria, Mycobacterium tuberculosis, Nontyphoid Salmonella, Shigella, Visceral leishmaniasis, and West Nile virus. Accordingly, the Secretary has determined that a presumption of service connection for these nine diseases is warranted pursuant to 38 U.S.C. 1118. Therefore, we propose to amend 38 CFR 3.317 to incorporate the new presumptions.
• To revise the title of the regulation to better reflect the content of the regulation and better reflect the authorizing statute (38 U.S.C. 1117).
• To remove current § 3.317(a)(2)(i)(C). This statement is a blanket statement regarding service connection for diagnosed illnesses determined to be presumptively service connected. Because we are establishing presumptive service connection for specified diseases, we propose to create separate sections to address these diseases. We propose to add the new sections at new § 3.317(c) and (d) and redesignate current § 3.317(c) and (d) as § 3.317 (a)(7) and (e) respectively.
• To establish presumptions of service connection for nine infectious diseases becoming manifest within a specified time after service in the Southwest Asia theater of operations or Afghanistan during certain time periods.
This proposed rule does not reflect determinations concerning any diseases other than those discussed in this proposal. The Secretary's determinations concerning other diseases discussed in the NAS report will be addressed in other documents published in the
This document contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521).
The Secretary hereby certifies that this proposed rule will 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 not affect any small entities. Only VA beneficiaries could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this proposed rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.
Executive Order 12866 directs agencies to assess all 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, and other advantages; distributive impacts; and equity). The Executive Order classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), 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 the Executive Order.
The economic, interagency, budgetary, legal, and policy implications of this proposed rule have been examined and it has been determined to be a significant regulatory action under the Executive Order because it is likely to result in a rule that may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
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 year. This proposed rule would have no such effect on State, local, and Tribal governments, or on the private sector.
The Catalog of Federal Domestic Assistance program numbers and titles for this rule are 64.009, Veterans Medical Care Benefits; 64.100, Automobiles and Adaptive Equipment for Certain Disabled Veterans and Members of the Armed Forces; 64.101, Burial Expenses Allowance for Veterans; 64.106, Specially Adapted Housing for Disabled Veterans; 64.109, Veterans Compensation for Service-Connected Disability; and 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death.
Administrative practice and procedure, Claims, Disability benefits, Health care, Pensions, Radioactive materials, Veterans, Vietnam.
For the reasons set out in the preamble, VA proposes to amend 38 CFR part 3 as follows:
1. The authority citation for part 3, subpart A continues to read as follows:
38 U.S.C. 501(a), unless otherwise noted.
2. Revise § 3.317 to read as follows:
(i) Became manifest either during active military, naval, or air service in the Southwest Asia theater of operations, or to a degree of 10 percent or more not later than December 31, 2011; and
(ii) By history, physical examination, and laboratory tests cannot be attributed to any known clinical diagnosis.
(2)(i) For purposes of this section, a
(A) An undiagnosed illness;
(B) The following medically unexplained chronic multisymptom illnesses that are defined by a cluster of signs or symptoms:
(ii) For purposes of this section, the term
(3) For purposes of this section, “objective indications of chronic disability” include both “signs,” in the medical sense of objective evidence perceptible to an examining physician, and other, non-medical indicators that are capable of independent verification.
(4) For purposes of this section, disabilities that have existed for 6 months or more and disabilities that exhibit intermittent episodes of improvement and worsening over a 6-month period will be considered chronic. The 6-month period of chronicity will be measured from the earliest date on which the pertinent evidence establishes that the signs or symptoms of the disability first became manifest.
(5) A qualifying chronic disability referred to in this section shall be rated using evaluation criteria from part 4 of this chapter for a disease or injury in which the functions affected, anatomical localization, or symptomatology are similar.
(6) A qualifying chronic disability referred to in this section shall be considered service connected for purposes of all laws of the United States.
(7) Compensation shall not be paid under this section for a chronic disability:
(i) If there is affirmative evidence that the disability was not incurred during active military, naval, or air service in the Southwest Asia theater of operations; or
(ii) If there is affirmative evidence that the disability was caused by a supervening condition or event that occurred between the veteran's most recent departure from active duty in the Southwest Asia theater of operations and the onset of the disability; or
(iii) If there is affirmative evidence that the disability is the result of the veteran's own willful misconduct or the abuse of alcohol or drugs.
(2) Signs or symptoms involving skin.
(4) Muscle pain.
(5) Joint pain.
(6) Neurologic signs or symptoms.
(7) Neuropsychological signs or symptoms.
(8) Signs or symptoms involving the respiratory system (upper or lower).
(9) Sleep disturbances.
(10) Gastrointestinal signs or symptoms.
(11) Cardiovascular signs or symptoms.
(12) Abnormal weight loss.
(13) Menstrual disorders.
(2) The diseases referred to in paragraph (c)(1) of this section are the following:
(ii) Campylobacter jejuni.
(iii) Coxiella burnetii (Q fever).
(v) Mycobacterium tuberculosis.
(vi) Nontyphoid Salmonella.
(viii) Visceral leishmaniasis.
(ix) West Nile virus.
(3) The diseases listed in paragraph (c)(2) of this section will be considered to have been incurred in or aggravated by service under the circumstances outlined in paragraphs (c)(3)(i) and (ii) of this section even though there is no evidence of such disease during the period of service.
(i) With three exceptions, the disease must have become manifest to a degree of 10 percent or more within 1 year from the date of separation from a qualifying period of service as specified in paragraph (c)(3)(ii) of this section. Malaria must have become manifest to a degree of 10 percent or more within 1 year from the date of separation from a qualifying period of service or at a time when standard or accepted treatises indicate that the incubation period commenced during a qualifying period of service. There is no time limit for visceral leishmaniasis or tuberculosis to have become manifest to a degree of 10 percent or more.
(ii) For purposes of this paragraph (c), the term
(4) A disease listed in paragraph (c)(2) of this section shall not be presumed service connected:
(i) If there is affirmative evidence that the disease was not incurred during a qualifying period of service; or
(ii) If there is affirmative evidence that the disease was caused by a supervening condition or event that occurred between the veteran's most recent departure from a qualifying period of service and the onset of the disease; or
(iii) If there is affirmative evidence that the disease is the result of the veteran's own willful misconduct or the abuse of alcohol or drugs.
(5) If a veteran presumed service connected for one of the diseases listed in paragraph (c)(2) of this section is diagnosed with one of the diseases listed in column “B” in the table set forth in paragraph (d) of this section within the time period specified for the disease in that same table, if a time period is specified or, otherwise, at any time, VA will request a medical opinion as to whether it is at least as likely as not that the condition was caused by the veteran having had the associated disease in column “A” in that same table.
(1) The term
38 U.S.C. 1117, 1118.
This document was received in the Office of the Federal Register on March 15, 2010.