http://www1.va.gov/ogc/docs/PREC_4-2002.doc

Department of Memorandum
Veterans Affairs

Date: May 14, 2002 VAOPGCPREC 4-2002

From: General Counsel (022)

Subj: Meaning of “Injury” for Purposes of Active Service – 38 U.S.C. § 101(24)
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To: Director, Compensation and Pension Service (21)


QUESTION PRESENTED:

Whether a former member of the Army Reserve who received two anthrax inocu-lations during inactive duty training and who alleges suffering from chronic fa-tigue and chronic Lyme-like disease as a result of these inoculations may be considered to have been disabled by an injury in determining whether the mem-ber incurred disability due to active service.

DISCUSSION:

1. The claimant had active duty service in the United States Army from May 29, 1995, to June 18, 1999, and was then assigned to the Army Reserve. In prepa-ration for a required two-week tour of duty in Korea, the claimant received three anthrax inoculations, the first two of which were received while on inactive duty training on February 12 and March 11, 2000. The claimant received the third in-oculation on March 25, 2000, while in civilian status. The claimant was deployed to Korea from April 10, 2000, to April 24, 2000. The claimant has filed a claim with the Department of Veterans Affairs (VA) seeking service connection for chronic fatigue and chronic Lyme-like illness claimed to have resulted from the anthrax inoculations.

2. Pursuant to 38 U.S.C. §§ 1110 and 1131, service-connected disability com-pensation may be paid for disability resulting from injury suffered or disease con-tracted in line of duty “in the active military, naval, or air service.” Sec-tion 101(24) defines the term “active military, naval, or air service” as including “active duty, any period of active duty for training during which the individual con-cerned was disabled or died from a disease or injury incurred or aggravated in line of duty, and any period of inactive duty training during which the individual concerned was disabled or died from an injury incurred or aggravated in line of duty.” (Emphasis added.) Thus, in the case of inactive duty training, only if the individual suffered an “injury” during such service can disability resulting from such service provide a basis of eligibility for disability compensation.

3. The question of what constitutes an “injury” for purposes of section 101(24) must be considered in light of three previous General Counsel opinions in which we analyzed the distinction between “injury” and “disease” under that statute. One such opinion, VAOPGCPREC 86-90 (O.G.C. Prec. 86-90), concerned whether a heart attack sustained following heavy exertion while on inactive duty training was an injury within the meaning of section 101(24). Medical evidence in that case indicated that the heart attack was the result of coronary artery dis-ease, which existed prior to the training period, although the event may have been precipitated by physical exertion. On those facts, we concluded that the claimant’s heart attack was not caused by an injury, but rather was attributable to disease.

4. In VAOPGCPREC 86-90, we examined the medical cause of the heart attack. We noted the consensus among medical specialists that excessive effort and strain cannot damage a normal heart and concluded that the heart attack was the result of a disease process. We further concluded that Congress intended to ex-clude “nontraumatic incurrence or aggravation of a disease process, and that manifestations of cardiovascular disease, such as heart attacks of nontraumatic origin, fall within the excluded class of disability, i.e., do not constitute injuries under the statute.” In Brooks v. Brown, 5 Vet. App. 484, 487 (1993), aff’d, 26 F.3d 141 (Fed. Cir. 1994), the United States Court of Veterans Appeals con-cluded that VAOPGCPREC 86-90 is consistent with the governing statutes and Congress’ policy reflected in those statutes. We note that the focus of our hold-ing in VAOPGCPREC 86-90 was clearly on the non-traumatic nature of the cause of the heart attack. We may assume that a heart attack caused by a traumatic external event that is independent of a disease process, e.g., an elec-tric shock, may be considered an injury.

5. VAOPGC 6-86 (3-27-86) followed and relied upon what was formerly Op. G.C. 1-81 (subsequently reissued and redesignated as VAOPGCPREC 86-90). Although VAOPGC 6-86 is not precedential, it illustrates how the opinion now designated VAOPGCPREC 86-90 has been applied. In VAOPGC 6-86, we de-termined that a claimant who received an influenza vaccination by injection while on inactive duty training and subsequently developed Guillain-Barre syndrome did not incur a disability resulting from an injury for purposes of section 101(24). Referencing what is now VAOPGCPREC 86-90, we reasoned that the term “in-jury” denotes harm from external trauma, while the term “disease” refers to some type of internal infection or degenerative process. The opinion cited several sources for the proposition that the term “trauma” commonly refers to the applica-tion of external force or violence. We further reasoned that, under modern medi-cal practice, the routine insertion of a hypodermic needle into the body is not commonly considered to involve application of external force or violence that is characteristic of injury. However, we recognized that an injection could be con-sidered to have caused a traumatic injury if contact with the needle caused last-ing nerve or tissue damage.

6. Most recently, in VAOPGCPREC 8-2001, we held that an individual who suf-fers from post-traumatic stress disorder (PTSD) as a result of a sexual assault that occurred during inactive duty training may be considered disabled by an “in-jury” for purposes of section 101(2) and (24). This conclusion was based upon the analysis of the preceding General Counsel opinions indicating that “injury” refers to the results of an external trauma rather than a degenerative process and the fact that, according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, of the American Psychiatric Association, at 427 (diag-nostic criterion A), a diagnosis of PTSD requires experiencing a traumatic event.

7. The concept exemplified by these VA General Counsel opinions is that
“injury” refers to the results of an external trauma, rather than a degenerative process. While, as noted in VAOPGC 6-86, “trauma” frequently is defined with reference to external force or violence, the term may commonly be considered to encompass injury to living tissue caused by an extrinsic agent. Webster’s Ninth New Collegiate Dictionary 1256 (1990). In this regard, we believe that considera-tion of the nature of vaccines is helpful in resolving the issue of whether introduc-tion of a vaccine into the body may constitute trauma for purposes of determining the nature of harm resulting from the vaccine.

8. A vaccine is a suspension of attenuated or killed microorganisms or of anti-genic proteins derived from them. Dorland’s Illustrated Medical Dictionary 1787 (28th ed. 1994). Vaccines artificially induce the immune system to produce anti-bodies that will attack invading organisms and prevent disease. National Institute of Allergy and Infectious Diseases, How Vaccines Work, available at http://www.niaid.nih.gov/daids/vaccine/how.htm. Although vaccines and mass immunization programs have been extremely successful in protecting the public health against dangerous diseases, “available data indicate that some vaccines are associated with rare but serious adverse effects.” The Anthrax Vaccine: Is It Safe? Does It Work? at 85. An adverse event following a vaccination may be either local or systemic. Id. at 86. The duration of these events may be acute or chronic, and adverse health effects may range from mild to severe. Id.

9. The foregoing discussion indicates that inoculation with a vaccine involves the intro-duction of a foreign substance into the body and that, while the substance is intended to and generally does have a beneficial effect, adverse reactions, sometimes of a severe nature, may result. Further, based on the above discussion, we believe that the term “injury” in section 101(24) may be interpreted to include harm not only from a violent en-counter but also from exposure to a foreign substance, such as a vaccine. We recog-nize that in our non-precedential opinion VAOPGC 6-86 we concluded that harm result-ing from an influenza vaccination would not be considered to have resulted from an in-jury. However, VAOPGC 6-86 focused on harm caused by the “routine insertion of a hypodermic needle into the body” and on the absence of external force or violence, rather than on the introduction of an extrinsic agent to body tissue. We believe the common understanding of the concept of “trauma,” which is recognized as the cause of “injury,” encompasses a broader definition than the one applied in VAOPGC 6-86 and that such broader definition includes serious adverse effects on body tissue or systems resulting from introduction of a foreign substance. Thus, an adverse reaction to a vac-cination may be considered an “injury” as that term is used in 38 U.S.C. § 101(24).

10. This conclusion is consistent with VAOPGCPREC 86-90, in which the harm suffered (a heart attack) did not result from an external force or substance, but rather from a pre-existing disease. This conclusion is also consistent with VA-OPGCPREC 8-2001, in which we recognized that a condition (in that case PTSD) that has characteristics of a disease may be considered to be the result of an injury, where it resulted from an external assault.


HELD:

If evidence establishes that an individual suffers from a disabling condition as a result of administration of an anthrax vaccination during inactive duty training, the individual may be considered disabled by an “injury” incurred during such training as the term is used in 38 U.S.C. § 101 (24), which defines “active military, naval, or air service” to include any period of inactive duty training during which the indi-vidual was disabled or died from an injury incurred or aggravated in line of duty.
Consequently, such an individual may be found to have incurred disability in ac-tive military, naval, or air service for purposes of disability compensation under 38 U.S.C. § 1110 or 1131.


Tim S. McClain

http://www.vetscommission.org/july_22_2005/establishing_new_presumptions_ogc.pdf

Procedures and Considerations Relevant to Determining Whether to
Establish New Presumptions of Service Connection
EXECUTIVE SUMMARY
A presumption is a rule relieving a party of the burden of producing evidence that directly establishes a fact that would otherwise be necessary to substantiate a claim. It provides that, if certain “predicate” facts are established, the “ultimate” fact necessary to substantiate the claim will be taken as established, even if there is no evidence directly establishing the ultimate fact.
Presumptions may simplify adjudications by obviating the need to gather evidence and render decisions on complex issues. They may fill evidentiary gaps in cases where it is infeasible or unduly burdensome to obtain direct evidence on an issue. They also may promote accuracy and consistency in agency adjudications.
Although Congress may establish presumptions primarily to further a policy goal, VA generally may establish presumptions only where there is a rational connection between the facts necessary to invoke the presumption and the fact to be presumed. In establishing regulatory presumptions of service connection, therefore, VA generally must have a rational basis for concluding that the presumed fact of service connection is sufficiently likely to follow from the predicate facts that it is reasonable to consider service connection to be established unless the evidence proves otherwise. Presumptions of service connection are most commonly used to reflect established medical principles that otherwise might not be well understood or consistently applied by adjudicators. Presumptions of service connection also may be appropriate where there are significant obstacles to a claimant’s ability to obtain evidence directly establishing service connection.
VA has not established specific procedures for determining whether new presumptions of service connection are warranted. In statutes governing presumptions based on herbicide exposure and Gulf War service, Congress has prescribed procedures to govern VA’s determination as to whether new presumptions are warranted. Under those procedures, the National Academy of Sciences (NAS) reviews the scientific literature regarding the health effects of exposure to herbicides and hazards of Gulf War service and provides biennial reports to VA assessing the existence and strength of any statistical association between those substances or hazards and the occurrence of specific diseases. On receipt of each report, VA determines whether there is a “positive association” between exposure to the substances or hazards in question and the occurrence of any disease, and establishes new presumptions of service connection if a positive association exists. The statutes define “positive association” to mean that the credible evidence for an association is equal to or outweighs the credible evidence against an association.
Although the statutory procedures provide a degree of consistency and external validity to VA’s determinations regarding presumptions, they also may raise concerns. The VA Task Force responsible for reviewing the NAS reports on herbicides has noted that scientific evidence does not easily lend itself to analysis under the statutory standard requiring the weighing of evidence “for” and “against” an association. The Task Force noted that the tendency of scientific journals to publish positive findings rather than negative or inconclusive findings may result in an abundance of “positive” findings that tends to overemphasize the likelihood that an association actually exists. The Task Force further noted that it is often difficult to characterize the findings of a particular study as evidence either “for” or “against” an association. Additionally, the Task Force stated that the statutory “positive association” standard is more liberal than the standards ordinarily used for purposes of scientific inquiry or medical care and that evidence sufficient to meet the “positive association” standard might not suffice to establish an association under generally-accepted standards for detecting associations between potential risk factors and disease.
Using the “positive association” standard to establish presumptions also may tend to ignore other factors affecting the connection between the facts established and the fact presumed. Under the Agent Orange Act, for example, VA found a positive association between herbicide exposure and respiratory cancers and therefore established a presumption of service connection. However, because tobacco use is known to be a potent and prevalent risk factor for respiratory cancers, it is questionable whether there would be a sound basis for concluding that respiratory cancers in Vietnam veterans are likely to have been caused by herbicide exposure rather than factors such as tobacco use.
The statutory procedures relating to presumptions based on herbicide exposure and Gulf War service appear to be based in part on policy determinations by Congress designed to facilitate the provision of benefits despite scientific uncertainty regarding the health risks of herbicide exposure and Gulf War service. The statutory “positive association” standard establishes a lower threshold for establishing presumptions than the standard generally governing an agency’s authority to establish presumptions only where there is a sound and rational connection between the proven facts and the presumed facts. Because VA does not have the same authority as Congress to establish presumptions on policy grounds, the current statutory procedures may provide an imperfect model for establishing regulatory presumptions in areas not covered by the existing statutes.
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Procedures and Considerations Relevant to Determining Whether to
Establish New Presumptions of Service Connection
This paper discusses the nature and function of presumptions, discusses the issue of when a new presumption of service connection may be necessary or appropriate, and summarizes existing procedures prescribed by statute to govern VA’s determinations as to whether new presumptions of service connection are warranted for diseases associated with exposure to herbicide agents or hazards of Gulf War service.
1. Nature of Presumptions
A legal presumption is a rule relieving a party of the burden of producing evidence that directly establishes one or more facts that would otherwise be necessary to substantiate a claim. A presumption is essentially a direction that, if certain “predicate” facts (i.e., the facts necessary to invoke the presumption) are established, the “ultimate fact” necessary to substantiate the claim will be taken as established, even if there is no evidence directly establishing the ultimate fact. Under 38 U.S.C. § 1112(a)(1), for example, if evidence establishes that a chronic disease was manifest to a degree of disability of 10 percent or more within one year after separation from service (the “predicate fact”), VA will presume that the disease was incurred in or aggravated by service (the “ultimate fact”), even if there is no evidence directly showing service incurrence or aggravation.
If a presumption is rebuttable -- as all current presumptions of service connection are -- the effect of the presumption is to shift the burden of proof on the relevant issue. In claims for service-connected veterans benefits, claimants ordinarily bear the burden of proof, and such benefits may be granted only if the claimant establishes that the disease or injury was incurred in or aggravated by service. Where evidence establishes that a presumption applies, however, the claimant is relieved of the burden of proving service incurrence or aggravation, and VA must grant service connection unless the evidence affirmatively shows that the disease or injury was not incurred in or aggravated by service.
2. When a Presumption May Be Necessary or Appropriate
There are a number of reasons why it may be considered necessary or appropriate to establish a presumption. Presumptions may simplify administrative proceedings by eliminating the need to gather evidence and render decisions on complex issues. Presumptions may fill evidentiary gaps in cases where it is infeasible or unduly burdensome for a party to obtain direct evidence of a fact essential to a claim, such as service incurrence of a disease. Presumptions also may promote accuracy and consistency in agency adjudications by ensuring similar treatment of similar cases. Further, as discussed below, statutory presumptions sometimes implement policy judgments
by allocating burdens of proof in a way that favors claimants with respect to particular issues.
The General Counsel has previously concluded that VA has authority to establish evidentiary presumptions of service connection by regulation. See VAOPGCPREC 69-91 (incorporating and adopting VAOPGCADV 28-90). However, “unlike a legislative body, which is free to adopt presumptions for policy reasons, an agency may only establish a presumption if there is a sound and rational connection between the proved and inferred facts.” Chemical Manufacturers Ass’n v. Department of Transportation, 105 F.3d 702, 705 (D.C. Cir. 1997) (citations omitted). Accordingly, although Congress may establish presumptions primarily to further a policy goal, VA generally may establish presumptions only to the extent there is a rational connection between the facts necessary to invoke the presumption and the fact to be presumed.
Presumptions of service connection are most commonly used to reflect established medical principles that otherwise might not be well understood or consistently applied in adjudicating claims for VA benefits. For example, many of the presumptions of service connection for chronic and tropical diseases in 38 U.S.C. § 1112(a) are based in part on medical principles establishing that, if such diseases are manifest to a degree of ten percent or more within a specified period following service, they are likely to have had their onset during service, even though they may not have been noted or diagnosed in service. In the absence of the presumption, different adjudicators might reach different conclusions based on the absence of diagnosis in service and the time lapse between service and initial diagnosis. When Congress in 1988 added systemic lupus erythematosus (SLE) to the list of chronic diseases that will be presumed to be service connected under 38 U.S.C. § 1112(a), it explained the need for a presumption to ensure accurate and consistent application of medical principles:
[P]resumptions are based on the need to ensure that diseases and disabilities incurred in or aggravated during service are, in fact, determined to be service connected. This need arises most clearly in the case of diseases that have a latency period of varying length causing early manifestations to be easily overlooked or misdiagnosed or diseases that are otherwise difficult to diagnose.
SLE is such a disease. . . . Although the disease may start acutely, the course is usually chronic and irregular with periods of activity alternating with periods of remission, thereby making diagnosis very difficult and the manifestations quite diverse. . . . SLE is instigated by a combination of genetic predisposition and environmental factors. Current data stress the importance of various environmental factors as accelerating or causal elements to a greater degree than previously had been assumed. Accordingly, factors present during the veteran’s service may trigger onset of the disease and yet not appear on the veteran’s service record.
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S. Rep. No. 100-215, 73 (1987). The presumption thus serves to ensure consistency in claim adjudication and to obviate the need for difficult factual determinations regarding the time of onset of a disease.
Inasmuch as the presumptions for chronic and tropical diseases are based on medical knowledge regarding the progressive nature of the diseases, they apparently reflect a relatively high degree of confidence that the presumed fact of service incurrence follows from the predicate fact of manifestation within the specified presumptive period. With respect to SLE, for example, Congress noted the “significant likelihood” that SLE developing to a 10-percent degree of disability within one year after service had its onset during service. S. Rep. No. 100-215 at 73.
Presumptions of service connection also may be appropriate in circumstances where there are significant obstacles to a claimant’s ability to obtain evidence directly establishing service incurrence or aggravation. For example, in 1992, VA issued a regulation establishing a presumption of service connection for certain diseases in veterans who underwent full-body exposure to mustard gas during their service. See 38 C.F.R. § 3.316. In issuing that regulation, VA explained that a number of veterans underwent such exposure in connection with experimental testing programs during World War II and that the medical records associated with such tests were generally unavailable. See 57 Fed. Reg. 1699 (1992). VA indicated that the available medical literature supported the conclusion that the diseases covered by the presumption were associated with full-body exposure to mustard gas and concluded that the special circumstances surrounding the military testing programs warranted the creation of an evidentiary presumption for veterans involved in those programs.
The presumption of service connection for diseases associated with full-body exposure to mustard gas is an open-ended presumption, in that it presumes service connection for certain diseases manifest at any time after service rather than requiring manifestation within a specified period based on established medical principles. As compared to the time-limited presumptions for chronic and tropical diseases, this broader, open-ended presumption may be viewed as involving a somewhat lower degree of confidence that the presumed fact of service incurrence for a disease manifested potentially many years after service follows from the proven facts of full-body exposure to mustard gas in service. In these cases, the relatively lower threshold of association between the proven and presumed facts may be viewed as justified by the special circumstances of the affected veterans, whose service medical records pertaining to their mustard gas exposure are unavailable. Although there must always be a reasonable connection between the proven and presumed facts, we believe that VA may take into account such considerations as the unavailability of contemporaneous medical records for certain classes of veterans in determining whether or to what extent a presumption of service connection is warranted. VA generally could not,
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however, establish a presumption where the relationship between the proven and presumed fact is essentially speculative and is primarily based on a desire to benefit a particular class of veterans. That type of presumption, based primarily on policy concerns, should be left to Congress.
It may be fair to say that most current presumptions of service connection are based on some combination of the foregoing concerns involving the desire for administrative efficiency, the need for accuracy and consistency in the application of medical principles, and the goal of relieving claimants of difficult burdens of proof where there is a reasonable basis for doing so. In all cases, there must be a sound and rational connection between the facts established and the fact presumed. Certainty is not required, but only a rational basis for concluding that the inferred fact is sufficiently likely that it is reasonable to consider the fact established unless the evidence proves otherwise.
3. Current Procedures for Determining Whether Presumptions Should Be Established for Diseases Associated with Exposure to Herbicide Agents or Hazards of Gulf War Service.
Congress and VA have established statutory and regulatory presumptions of service connection for several categories of disease and illness, including chronic diseases, tropical diseases, diseases of former prisoners of war, undiagnosed illnesses in Gulf War veterans, and diseases associated with exposure to ionizing radiation, herbicide agents, or mustard gas. VA has not established any specific procedures or guidelines for determining whether a new presumption of service connection is warranted for diseases in these or any other categories. In two circumstances – involving exposure to herbicide agents and exposure to hazards of Gulf War service – Congress has prescribed procedures to govern VA’s determinations as to whether new presumptions of service connection are warranted. Those procedures are discussed below.
A. Presumptions Based on Exposure to Certain Herbicide Agents
The Agent Orange Act of 1991, Pub. L. No. 102-4, which is codified in part at 38 U.S.C. § 1116, established standards to govern VA’s determinations as to which diseases would be presumptively service connected based on herbicide exposure. The Agent Orange Act directed VA to seek to enter into a contract with the National Academy of Sciences (NAS) for a biennial review of the scientific literature concerning the effects of herbicide exposure. Pursuant to its contract with VA, NAS reviews the available scientific and medical literature and evaluates the evidence as to whether exposure to herbicide agents is associated with an increased risk or incidence of specific diseases. Under the provisions of the Agent Orange Act, NAS must determine, to the extent possible, for each disease it reviews: (1) whether a statistical association exists between herbicide exposure and the disease, taking into account the strength of the scientific evidence and the appropriateness of the scientific methods used to detect the
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association; (2) the increased risk of the disease among those exposed to herbicides during service in the Republic of Vietnam during the Vietnam era; and (3) whether there exists a plausible biological mechanism or other evidence of a causal relationship between herbicide exposure and the disease.
Upon receipt of reports from NAS under the Agent Orange Act, VA must determine whether a presumption of service connection is warranted for each disease discussed in the report. 38 U.S.C. § 1116(c)(1)(A). The Act provides that a presumption will be warranted whenever there is a “positive association” between exposure to an herbicide agent and the occurrence of the disease in humans. 38 U.S.C. § 1116(a)(1)(B). The Act states that an association will be considered positive “if the credible evidence for the association is equal to or outweighs the credible evidence against the association.” 38 U.S.C. § 1116(b)(3). In determining whether a positive association exists, VA must consider the NAS report and “all other sound medical and scientific information and analyses available to the Secretary.” 38 U.S.C. § 1116(b)(2). In evaluating any particular study, VA must consider “whether the results are statistically significant, are capable of replication, and withstand peer review.” Id.
If VA determines that a presumption of service connection is warranted for any disease, VA must issue regulations, through notice-and-comment procedures, to establish the presumption. 38 U.S.C. § 1116(c)(1)(A). If VA determines that a presumption of service connection is not warranted for any disease covered by the NAS report, VA must publish a notice of that determination in the Federal Register, including an explanation of the scientific basis for the determination. 38 U.S.C. § 1116(c)(1)(B).
VA has received six reports from NAS under the Agent Orange Act (five biennial reports and one special interim report) and has established presumptions of service connection for eight diseases based on those reports. Following VA’s response to the first NAS report, received in 1993, a petition was filed in the United States Court of Appeals for Federal Claims challenging VA’s decision not to establish presumptions of service connection for three diseases. The court upheld VA’s decision, and noted that VA’s determinations regarding whether to establish presumptions of service connection would be reviewed deferentially and would be reversed only upon an “extremely strong showing of error.” LeFevre v. Secretary of Veterans Affairs, 66 F.3d 1191, 1199 (Fed. Cir. 1995), cert. denied, 517 U.S. 1188 (1996).
B. Presumptions Based on Gulf War Service
The Persian Gulf War Veterans Act of 1998, Pub. L. 105-277, title XVI (codified in part at 38 U.S.C. § 1118), established procedures substantially similar to those in the Agent Orange Act to govern VA determinations as to which diseases would be presumptively service connected based on Gulf War service. The Act directed VA to seek to enter into a contract with NAS to “identify the
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biological, chemical, or other toxic agents, environmental or wartime hazards, or preventive medicines or vaccines to which members of the Armed Forces who served in the Southwest Asia theater of operations during the Persian Gulf War may have been exposed by reason of such service,” and to “identify the illnesses (including diagnosed illnesses and undiagnosed illnesses) that are manifest in such members.” As in the Agent Orange Act, Congress directed NAS to determine, to the extent feasible, whether there was a statistical association between exposure to the hazards of Gulf War service and the occurrence of illnesses, the strength of the association, and whether there is a plausible biological mechanism or other evidence of a causal relationship.
Upon receipt of each NAS report, VA must determine whether a presumption of service connection is warranted for each illness by reason of a “positive association” between “the exposure of humans or animals to a biological, chemical, or other toxic agent, environmental or wartime hazard, or preventive medicine or vaccine known or presumed to be associated with service in the Armed Forces in the Southwest Asia theater of operations during the Persian Gulf War; and the occurrence of a diagnosed or undiagnosed illness in humans or animals.” 38 U.S.C. § 1118(b)(1)(B). The statute defines the term “positive association” and describes VA’s duties in the same manner as the Agent Orange Act.
VA has received two reports from NAS under the Persian Gulf War Veterans Act. The first report, received in 2000, assessed the health effects of exposure to depleted uranium, the chemical warfare agent sarin, vaccinations against botulism toxin and anthrax, and pyridostigmine bromide, which was used in the Gulf War as a pretreatment for possible exposure to nerve agents. The second report, received in 2003, addressed the health effects of exposure to insecticides and solvents. VA has not established any presumptions of service connection based on those reports.
C. VA’s Experience with the Congressionally-Prescribed Procedures
The procedures established by the Agent Orange Act and the Persian Gulf War Veterans Act necessarily provide a degree of consistency to VA determinations as to whether new presumptions of service connection are warranted in the areas covered by those statutes. Additionally, the provision for receiving reports from NAS assists VA in ensuring that its determinations are based on thorough information and analyses. Nevertheless, some aspects of the procedures required by those statutes may raise concerns.
The VA Task Force designated to assist the Secretary in reviewing the NAS reports under the Agent Orange Act has expressed concerns regarding the “positive association” standard mandated by that statute. In its 2003 report to the Secretary, for example, the Task Force explained:
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The medical and scientific evidence reviewed by the NAS and the Task Force does not easily lend itself to analysis under the statutory standard requiring weighing of the evidence “for” and “against” an association. Generally, studies with positive findings and statistically significant findings are more likely to be published than studies with negative or inconclusive findings. Accordingly, although the available studies concerning a particular health outcome may entail a proportionately greater amount of “positive” evidence, the prevalence of such “positive” evidence may tend to overemphasize the likelihood that an association between herbicide exposure and the health outcome actually exists.
Additionally, the Task Force believes that it is difficult in many cases to characterize epidemiological study findings as evidence either “for” or “against” an association. Studies showing a weak or statistically insignificant association may be viewed either as evidence “for” and association, in the sense that the data reflect a slightly increased risk or rate of occurrence, or conversely they could be viewed as evidence “against” an association, in the sense that the absence of a strong or statistically significant increased risk tends to suggest that an association does not exist. Moreover, methodological questions may be raised about some statistically significant studies.
The Task Force also noted that the “positive association” standard was more liberal than the standards ordinarily used for purposes of scientific inquiry and medical care, and emphasized that its determinations under the Agent Orange Act “do not reflect a judgment that a particular health outcome has been caused by, or in some cases even definitely associated with, herbicide exposure under the standards ordinarily governing such determinations.”
It should also be noted that the current statutory procedures do not expressly provide for consideration of prevalent non-service-connected risk factors in deciding whether to establish a presumption of service connection.
For example, in applying the Agent Orange Act, VA determined that there was a positive association between exposure to herbicide agents and the occurrence of respiratory cancers. Based on that determination, VA established a presumption of service connection for respiratory cancers. Because tobacco use is well known to be a potent and prevalent risk factor for respiratory cancers, it is questionable whether there is a strong factual basis for a general presumption that respiratory cancers in Vietnam veterans were likely caused by exposure to herbicide agents in service rather than factors such as tobacco use. In this respect, the standards prescribed in the Agent Orange Act, as well as the Persian Gulf War Veterans Act, may be viewed as more liberal than the standard generally governing an agency’s authority to establish an evidentiary
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presumption, which requires a sound and rational connection between the proven facts and the presumed fact.
The procedures in the Agent Orange Act and the Persian Gulf War Veterans Act appear to be based in part on policy grounds. Both statutes address matters as to which there has historically been, and continues to be, a significant degree of scientific and medical uncertainty. See Pub. L. No. 98-542, § 2(2), 98 Stat. 2725 (1984) (noting that “[t]here is scientific and medical uncertainty regarding [the] long-term adverse health effects” of herbicide exposure). The standard established in both statutes, requiring a “positive association” between exposure to certain substances or hazards and the occurrence of disease, does not as a practical matter require a finding that such exposure was likely to have been the cause of any veteran’s disease. Rather, that standard suggests a policy decision to establish a relatively low threshold for creating new presumptions, to relieve veterans of the burden of scientific uncertainty affecting their claims. This purpose is reflected in the legislative history of the Agent Orange Act. For example, during floor debates on this legislation, one Senator stated:
There are those who say that the evidence is not conclusive. Let me say that I agree with them – those doubts are not baseless. But when there is inconclusive evidence, shouldn’t the benefit of the doubt be given to our veterans? As long as there remains a possibility – if not a probability – that agent orange is the cause of cancer in many veterans, the benefit of the doubt should be given to those who were in the field . . . .
137 Cong. Rec. S1276 (Jan. 30, 1991) (Statement of Senator Biden).
As noted above, VA does not have the same authority as Congress to establish presumptions on policy grounds. Accordingly, the standards imposed by the Agent Orange Act and the Persian Gulf War Veterans Act may provide an imperfect model for establishing regulatory presumptions in areas not covered by those statutes.
Prepared for the Veterans’ Disability Benefits Commission by: David J. Barrans, Deputy Assistant General Counsel for Professional Staff Group 2 of the Department of Veterans Affairs Office of the General Counsel, July 2005
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