[Federal Register Volume 72, Number 164 (Friday, August 24, 2007)]
[Notices]
[Pages 48734-48741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16733]


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DEPARTMENT OF VETERANS AFFAIRS


Determinations Concerning Illnesses Discussed in National Academy 
of Sciences Report on Gulf War and Health

AGENCY: Department of Veterans Affairs.

ACTION: Notice.

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SUMMARY: As required by law, the Department of Veterans Affairs (VA) 
hereby gives notice that the Secretary of Veterans Affairs, under the 
authority granted by 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), has determined not to establish a presumption of 
service connection at this time, based on exposure to insecticides or 
solvents during service in the Persian Gulf during the Persian Gulf 
War, for any of the diseases, illnesses, or health effects discussed in 
the February 18, 2003, report of the National Academy of Sciences, 
titled ``Gulf War and Health, Volume 2. Insecticides and Solvents.'' 
This determination does not in any way preclude VA from granting 
service connection for any disease, including those specifically 
discussed in this notice, nor does it change any existing rights or 
procedures.

FOR FURTHER INFORMATION CONTACT: David Barrans, Attorney, Office of the 
General Counsel, Department of Veterans Affairs, 810 Vermont Avenue, 
NW., Washington, DC 20420, telephone (202) 273-6332.

SUPPLEMENTARY INFORMATION:

I. Statutory Requirements

    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 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

[[Page 48735]]

service in the Persian Gulf during the Gulf War. Congress prescribed 
the inquiry it expected NAS to carry out in the event such an agreement 
was reached. Congress directed NAS to identify agents, hazards, 
medicines, and vaccines to which service members may have been exposed 
during service in the Persian Gulf during the Gulf War, but also 
directed NAS to consider a number of specific substances, including 
solvents and several insecticides used during the Gulf War. Congress 
mandated that NAS determine, to the extent possible: (1) Whether there 
is a statistical association between exposure to the agent, hazard, 
medicine, or vaccine and the illness, taking into account the strength 
of the scientific evidence and the appropriateness of the scientific 
methodology used to detect the association; (2) the increased risk of 
illness among individuals exposed to the agent, hazard, medicine, or 
vaccine; and (3) whether a plausible biological mechanism or other 
evidence of a causal relationship exists between exposure to the agent, 
hazard, medicine, or vaccine and the illness. These laws also require 
that NAS submit reports on its activities to the Veterans Affairs 
Committees of the U.S. Senate and House of Representatives and to the 
Secretary of Veterans Affairs every 2 years (as measured from the date 
of the first report) for a 10-year period.
    Section 1602 of Public Law 105-277 provides that whenever the 
Secretary receives a report from NAS, the Secretary must determine 
whether a presumption of service connection is warranted for any 
illness covered by that report. The statute provides that a presumption 
will be warranted when the Secretary determines that there is a 
positive association (i.e., the credible evidence for an association is 
equal to or outweighs the credible evidence against an association) 
between 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 Southwest Asia theater of operations during the Persian Gulf War 
and the occurrence of a diagnosed or undiagnosed illness in humans or 
animals. If the Secretary determines that a presumption of service 
connection is not warranted, he is to publish a notice of that 
determination, including an explanation of the scientific basis for 
that determination.

II. The National Academy of Sciences Report

    NAS issued its initial report, titled ``Gulf War and Health, Volume 
1. Depleted Uranium, Sarin, Pyridostigmine Bromide, Vaccines,'' on 
September 7, 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 Gulf War as a pretreatment for possible 
exposure to nerve agents. On July 6, 2001, VA published a notice in the 
Federal Register announcing the Secretary's determination that the 
available evidence did not warrant a presumption of service connection 
for any disease discussed in that report. 66 FR 35702 (2001).
    NAS issued its second report, titled ``Gulf War and Health, Volume 
2. Insecticides and Solvents,'' on February 18, 2003. In that report, 
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 N,N-diethyl-3-
methylbenzamide (DEET). NAS considered 53 solvents in 8 groups: 
aromatic hydrocarbons (including benzene), halogenated hydrocarbons 
(including tetrachloroethylene and dry-cleaning solvents), alcohols, 
glycols, glycol esters, esters, ketones, and petroleum distillates.
    In its report, NAS organized its conclusions into five categories, 
representing different degrees of association between illness and 
exposure to insecticides or solvents. The categories NAS used are 
``Sufficient Evidence of a Causal Relationship,'' ``Sufficient Evidence 
of an Association,'' ``Limited/Suggestive Evidence of an Association,'' 
``Inadequate/Insufficient Evidence to Determine Whether an Association 
Exists,'' and ``Limited/Suggestive Evidence of No Association.''
    NAS found ``Sufficient Evidence of a Causal Association'' between 
chronic exposure to the solvent benzene and two diseases, acute 
leukemia and aplastic anemia. NAS found the criteria for its next-
highest category, ``Sufficient Evidence of an Association'' satisfied 
for three associations: (1) Chronic exposure to benzene and adult 
leukemia; (2) chronic exposure to solvents and acute leukemia; and (3) 
exposure to the solvent propylene glycol and allergic contact 
dermatitis resulting from sensitization to the compound and subsequent 
reexposure. NAS listed 16 findings in the category ``Limited/Suggestive 
Evidence of an Association'': (1) Chronic exposure to 
tetrachloroethylene and dry-cleaning solvents and bladder cancer; (2) 
chronic exposure to solvents and bladder cancer; (3) chronic exposure 
to tetrachloroethylene and dry-cleaning solvents and kidney cancer; (4) 
chronic exposure to organophosphorous insecticides and non-Hodgkin's 
lymphoma; (5) chronic exposure to carbamates and non-Hodgkin's 
lymphoma; (6) chronic exposure to benzene and non-Hodgkin's lymphoma; 
(7) chronic exposure to solvents and multiple myeloma; (8) chronic 
exposure to organophosphorous insecticides and adult leukemia; (9) 
chronic exposure to solvents and adult leukemia; (10) chronic exposure 
to solvents and myelodyplastic syndromes; (11) exposure to 
organophosphorous insecticides at doses sufficient to cause poisoning 
and long-term neurobehavioral effects (i.e., abnormal results on 
neurobehavioral test batteries and symptom findings); (12) chronic 
exposure to solvents and neurobehavioral effects (i.e., abnormal 
results on neurobehavioral test batteries and symptom findings); (13) 
high-level exposure to solvents and reactive airways dysfunction 
syndrome that would be evident with exposure and could persist for 
months or years; (14) chronic exposure to solvents and hepatic 
steatosis; (15) chronic exposure to solvents and chronic 
glomerulonephritis; and (16) exposure to insecticides and allergic 
contact dermatitis that results from sensitization to the compounds and 
subsequent reexposure.
    NAS stated 48 findings in the category ``Inadequate/Insufficient 
Evidence to Determine Whether an Association Exists,'' and stated no 
findings in the category ``Limited/Suggestive Evidence of No 
Association.'' Additionally, NAS stated that it was unable to reach a 
consensus view with respect to nine exposure and disease, illness, or 
health effect associations it considered and therefore did not place 
them in any of the five categories.
    Seventeen of the 21 associations in the highest three categories 
are limited to cases involving ``chronic'' exposure to the insecticides 
or solvents involved. Although its report does not define the term 
``chronic,'' NAS stated that the studies it reviewed were primarily 
occupational studies, meaning studies of workers who were exposed to 
the

[[Page 48736]]

substances in question in the course of their employment, such as in a 
chemical plant or in a position requiring routine use of solvents or 
insecticides. Of the four remaining associations in those categories, 
one was limited to cases involving exposure to organophosphorous 
insecticides at doses sufficient to cause poisoning at the time of 
exposure and another involved an association between high-level 
exposure to organic solvents and reactive airways dysfunction syndrome 
which would be evident with exposure or shortly thereafter. The other 
two involve allergic contact dermatitis that would be present with 
exposure and may resolve with cessation of exposure.

III. VA's Actions in Response to the Second NAS Report

    After receiving and reviewing the second NAS report, VA determined 
that the report presented uniquely difficult issues as compared to the 
first NAS report and similar NAS reports provided to VA under the Agent 
Orange Act of 1991, Public Law 102-4. The second NAS report was unique 
in that the substances considered in that report were not substances 
used exclusively or predominantly in combat deployments or operations, 
but were substances commonly present in military and civilian life. It 
was also unique in that most of the associations NAS identified were 
limited to circumstances involving chronic occupational exposure to the 
insecticides and solvents in question, as distinguished from acute or 
subchronic exposures. Although the NAS report did not define the term 
``chronic,'' that term commonly means ``marked by long duration'' 
(Webster's Third New International Dictionary 402 (1976)) or 
``persisting over a long period of time'' (Dorland's Illustrated 
Medical Dictionary 328 (38th ed 1994)). Further, virtually all of the 
health effects identified by NAS were previously well known.
    VA determined that these circumstances raised questions concerning, 
among other things, whether exposure to these common substances during 
the Persian Gulf War differed significantly from exposures experienced 
by other military and civilian populations, and whether military 
personnel could be expected to have experienced ``chronic'' exposure to 
such substances during service in the Persian Gulf War. For that 
reason, and also because VA's determinations regarding the health 
effects of relatively common exposures might be viewed as having 
broader implications for public health policy, VA determined that it 
was necessary to seek additional information before making its 
determinations under Public Law 105-277.
    VA met with representatives of NAS and requested that NAS conduct 
an additional review to address issues pertaining to the correlation 
between exposures of different types and durations and the increased 
risk of health effects. Although NAS gave serious consideration to VA's 
request, it ultimately declined to provide any further information 
requested by VA.

 IV. VA's Determination

    This notice conveys the Secretary's determination that a 
presumption of service connection is not warranted at the present time 
for any disease, illness, or health effect discussed in the NAS report, 
based on association with any substance known or suspected to be 
associated with service in the Gulf War. The Secretary has determined 
that there is not sufficient evidence available to support a conclusion 
that the insecticides and solvents covered in the NAS report are, in 
isolation, agents ``known or presumed to be associated with service in 
the Southwest Asia theater of operations during the Persian Gulf War,'' 
for purposes of section 1602 of Public Law 105-277 (codified in 
pertinent part at 38 U.S.C. 1118(a)(2)(A) and (b)(1)(B)).
    As an initial matter, we want to make clear that VA's determination 
does not in any way preclude VA from granting service connection for 
any disease, including those specifically discussed in this notice, nor 
does it change any existing rights or procedures. VA generally may 
grant service connection either on a ``direct'' basis or, in some 
circumstances, on a ``presumptive'' basis. ``Direct'' service 
connection means simply that the evidence in relation to a claim makes 
it as likely as not that a disease or injury was incurred or aggravated 
in service. ``Presumptive'' service connection means that a statute or 
regulation creates a special rule allowing VA to presume that a 
particular disease was incurred or aggravated in service even if the 
evidence does not directly establish that fact. Pursuant to 38 U.S.C. 
1110, VA may grant direct service connection for any disease that was 
incurred or aggravated in service. Accordingly, if the evidence in 
connection with any benefit claim makes it as likely as not that a 
disease was caused or aggravated by exposure to insecticides or 
solvents in service, VA may grant service connection. As required by 
law, VA will assist claimants in obtaining evidence necessary to 
substantiate their claims. The recent NAS report does not limit this 
authority in any way. In fact, the report itself may assist claimants 
seeking to establish service connection, by providing evidence linking 
certain diseases with exposure to certain insecticides and solvents. 
This notice is intended only to explain that VA will not, at this time, 
establish a new presumption of service connection for any disease.
    Section 1602 of Public Law 105-277 requires presumptions of service 
connection for illnesses that have a ``positive association with 
exposure 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.'' This standard 
refers to two distinct types of association necessary to a presumption. 
First, it must be determined that the agent, hazard, medicine, or 
vaccine is known or presumed to be associated with service in the 
Southwest Asia theater of operations during the Persian Gulf War. 
Second, it must be determined that an illness is associated with 
exposure to such agent, hazard, medicine, or vaccine. With respect to 
the first NAS report on Gulf War and Health, it was clear that the 
substances NAS considered (depleted uranium, sarin, vaccinations 
against botulism toxin and anthrax, and pyridostigmine bromide) were 
associated with service in the Persian Gulf during the Gulf War because 
the presence and use of those substances during such service was 
documented and resulted in exposures unique to veterans of such 
service. Accordingly, the notice of VA's determinations concerning that 
NAS report focused exclusively on the second element of association--
i.e., the association between illnesses and exposure to the substances 
in question. With respect to the second NAS report, however, we believe 
it is necessary to address the threshold matter of whether the 
insecticides and solvents considered by NAS properly may be considered 
substances associated with service in the Southwest Asia theater of 
operations during the Persian Gulf War within the meaning of Public Law 
105-277. In section 1603 of Public Law 105-277, Congress directed NAS 
to consider the health effects of solvents and several specific 
pesticides, although Congress did not provide an indication as to 
whether or how those substances were used in the Gulf War. NAS focused 
its review on solvents and pesticides that the Department of Defense 
shipped to the Persian Gulf during the Persian Gulf

[[Page 48737]]

War. As discussed below, however, there is insufficient information 
concerning the use of such solvents and pesticides during service in 
the Persian Gulf War upon which to conclude that veterans of such 
service may have encountered exposures unique to such service.
    In contrast to the substances addressed in the first NAS report 
(depleted uranium, sarin, vaccinations against botulism toxin and 
anthrax, and pyridostigmine bromide), the insecticides and solvents 
that Congress identified in Public Law 105-277 and NAS discussed in the 
second report, are not unique to service in the Gulf War or to any 
particular period or location of service. Rather, those insecticides 
and solvents are prevalent in military and civilian life outside the 
Gulf War theater of operations. For example, the solvent benzene, which 
is included either by name or by general reference to ``solvents'' in 
13 of the 21 findings in the 3 highest NAS categories of association, 
is 1 of the 20 most commonly produced chemicals in the United States 
and is present in many consumer solvents and paint products, gasoline, 
automobile exhaust, and tobacco smoke. Most Americans are exposed to 
small amounts of benzene on a daily basis through breathing air 
containing gasoline fumes, automobile exhaust, tobacco smoke, and 
industrial emissions. (Agency for Toxic Substances and Disease Registry 
(ATSDR), Public Health Statement for Benzene CAS71-43-2 (U.S. 
Dept. of Health and Human Services, Public Health Service, ATSDR, Sept. 
1997)). Dry-cleaning solvents are included in 12 of the 21 findings in 
the top 3 categories, either specifically or as a component of the 
general class of solvents. Military and civilian personnel who use dry 
cleaning services or reside near dry cleaning businesses are exposed to 
those substances. The solvent propylene glycol, which fits into 10 of 
the 21 findings in the top 3 categories, is present commercially in 
cosmetics and food and is used as a vehicle for drug delivery. Other 
solvents considered by NAS are commonly used in the United States as 
fumigants for food products, as flavoring agents, as components of 
antifreeze, brake fluids, deicing fluids, paints, typewriter correction 
fluid, cosmetics, lacquers, and adhesives, or as solvents available for 
household use in degreasing and cleaning. The NAS report notes that 
little information is available to characterize the use of solvents in 
the Gulf War. Military uses of solvents include vehicle maintenance, 
cleaning and degreasing, and NAS noted that wartime use of solvents in 
these capacities probably paralleled stateside military or civilian 
uses, although operating conditions (such as ventilation and the use of 
masks) may have varied widely from stateside working conditions.
    All insecticides shipped to the Gulf War had been approved by the 
U.S. Environmental Protection Agency or the U.S. Food and Drug 
Administration for general use in the United States at that time, 
although EPA has since placed restrictions on some of the insecticides 
used during the Gulf War. Most of those insecticides are available in 
consumer pest-control products sold for home use. The two insecticides 
distributed to service members during the Gulf War for individual use--
DEET and permethrin--are common components of consumer insect 
repellents, and were not linked to any diseases in the top three NAS 
categories other than allergic contact dermatitis.
    Of the 21 health effects NAS identified in its 3 highest 
categories, 17 are generally well known health risks of chronic 
occupational exposure to the insecticides and solvents in question. 
(The other four health effects are also generally well known, but are 
associated with certain non-chronic exposures.) For example, the fact 
that chronic occupational exposure to benzene is associated with an 
increased risk of aplastic anemia and acute leukemia is widely 
recognized. See 29 CFR 1910.1028 appendix A (summarizing known health 
effects of chronic benzene exposure). As NAS' findings indicate, an 
increased risk of disease may occur with chronic or sufficient exposure 
to the insecticides and solvents in question. Those conclusions are 
based on scientific studies of persons exposed to the insecticides and 
solvents in occupational settings involving the production or use of 
those substances, with frequent exposures for periods of years in most 
cases. Neither the NAS report, nor the scientific studies that NAS 
reviewed identify an increased risk of disease based on temporary or 
episodic exposure to the insecticides or solvents in question, except 
in particular circumstances of organophosphorous insecticide poisoning 
associated with long-term neurobehavioral effects, high-level solvent 
exposure associated with reactive airways dysfunction syndrome, and 
allergic dermatological reactions coincident with exposure to propylene 
glycol or insecticides. In briefing VA on its findings in February 
2003, NAS indicated that it did not limit its inquiry to health effects 
of only chronic exposure, but sought all available information on the 
health effects of exposure to the insecticides and solvents in 
question. Insofar as the NAS report states no conclusions as to whether 
many of the diseases discussed in the report are associated with less-
than-chronic exposure to insecticides or solvents, we believe the 
absence of such findings most likely reflects the absence of study data 
sufficient to make any determination.
    As indicated above, the insecticides and solvents considered by NAS 
were in common use in stateside military and civilian populations at 
the time of the Gulf War, not only with respect to workers 
occupationally exposed to those substances, but also with respect to 
the broader spectrum of persons exposed through use of consumer 
products, inhalation of polluted air, or other means. Sufficient data 
do not exist to show that exposure to those insecticides and solvents 
alone at levels below chronic occupational exposure or below levels 
sufficient to constitute poisoning is associated with the occurrence of 
disease, other than allergic contact dermatitis. Further, as explained 
below, VA believes that there is currently insufficient information 
available to indicate that the uses of insecticides and solvents during 
the Gulf War, or the risks associated with such exposure to such 
substances, differed in any substantial degree from the use of those 
substances in stateside military and civilian populations or the risk 
experienced by such stateside populations.
    The Department of Defense (DoD) has indicated that the insecticides 
and solvents considered by NAS were shipped to the Persian Gulf during 
the Gulf War, but that relatively little information is currently 
available concerning the extent to which those substances were used. 
DoD has indicated that insecticides were used in the Gulf War for their 
ordinary purposes, including personal application by individual service 
members to their bodies and clothing, as well as area spraying by 
pesticide applicators. (OSAGWI (Office of the Special Assistant for 
Gulf War Illnesses), Environmental Exposure Report--Pesticides. Final 
Report (U.S. Department of Defense, OSAGWI, April 2003)). DoD concluded 
that most soldiers were likely exposed to some amount of insecticides 
and that military personnel whose occupational specialty involved 
pesticide spraying likely incurred greater amounts of exposures. DoD 
has indicated that the most thoroughly documented exposure to solvents 
occurred during the Gulf War

[[Page 48738]]

among service members assigned to apply chemical-agent-resistant 
coating (CARC) to military vehicles, as well as in the process of 
cleaning painting equipment and tools with solvents. (OSAGWI, 
Environmental Exposure Report: Chemical Agent Resistant Coating. Final 
Report (U.S. Department of Defense, OSAGWI, July 2000). DoD also 
indicated that not all personnel were trained in these processes and 
some may not have had all the necessary personal protective equipment 
(OSAGWI, 2000). NAS indicated that the wartime use of solvents, such as 
in vehicle maintenance and repair, cleaning, and degreasing, probably 
paralleled stateside military and civilian use of solvents, but 
acknowledged the possibility of wide variations in operating 
conditions.
    DoD's Directorate for Deployment Health Support has prepared an 
``exposure assessment'' designed to estimate the possible levels of 
insecticide exposures during the Gulf War. (OSAGWI 2003 at 42, 110). 
That assessment was based on information gathered from interviews with 
Gulf War veterans and exposure-scenario models based on methodologies 
used by the Environmental Protection Agency. Id. at 110-112. Among 
other things, DoD concluded that ``[m]ost pesticide product exposures 
during the Gulf War were acute/subacute and subchronic; however, there 
were probably a small number of chronic exposures as well.'' Id. at 
151. For purposes of that analysis, DoD defined chronic exposure as 
exposure lasting more than 180 days. DoD also stated that, ``[i]n many 
cases, pesticide formulation exposures during deployment would have 
been very similar to exposures normally occurring in the U.S. at the 
time. On the other hand, there were certainly conditions existing some 
of the time that would have contributed to higher-than-normal, or 
otherwise unusual exposures for some servicemembers.'' Id. at 143. For 
instance, DoD indicated that higher exposures may have occurred in 
areas of extreme pest infestation or in the delousing of prisoners of 
war conducted by approximately 200 service members.
    DoD also concluded that ``It is likely that at least 41,000 service 
members overall may have had some overexposure to pesticides.'' Id. at 
57. That conclusion was based in part on the results of a survey asking 
veterans to recollect their pesticide experiences 7 to 9 years after 
the fact. Id. at 111. DoD stated that its analysis involved significant 
levels of uncertainty, due to the lack of direct exposure data, and 
that it relied on assumptions that tended to overestimate exposures. 
Id. at 57, 111. Further, DoD's conclusions regarding potential 
overexposures do not, in our view, clearly indicate that pesticide 
exposures in the Persian Gulf War differed significantly from other 
civilian and military populations. The largest group of potential 
overexposures identified by DoD consisted of approximately 30,500 
veterans who ``may have been at elevated risk for short-term health 
effects because of exposure to pest strips'' containing the pesticide 
dichlorvos. Id. at 57. In the survey of Gulf War veterans, 
approximately 7% of veterans interviewed reported using or observing 
use of pest strips, and approximately 5% to 8% of those who had used 
pest strips reported using them in a manner exceeding the 
manufacturer's recommendation of one strip per 1000 cubic feet of 
space. (Fricker, RD et al., Pesticide Use During the Gulf War: A Survey 
of Gulf War Veterans (Rand 2000)). DoD concluded that ``[e]ven when 
dichlorvos-containing pest strips are used according to current label 
directions and military guidance, many personnel may be exposed to 
unhealthful levels'' of dichlorvos. (OSAGWI 2003 at 65). DoD noted that 
its conclusion was similar to a finding by the Environmental Protection 
Agency's Office of Pesticide Programs, which found that all residential 
use of pest strips was of concern. Id. at 65. Pest strips have long 
been available for residential use in the United States, and DoD's 
finding does not suggest that Gulf War exposures to pest strips 
differed significantly from stateside exposures. The conclusion that 
use of pest strips in accordance with the label directions may cause 
overexposure would appear to be equally applicable to stateside use. 
DoD also noted that approximately 3,500 to 4,500 pesticide applicators 
probably made up one of the more highly exposed groups, and that as 
many as 7,000 service members may have been overexposed to pesticides 
as the result of spraying operations. Id. at 57. However, DoD also 
noted that ``[m]ost pesticide product exposures during the Gulf War 
were acute/subacute and subchronic'' rather than chronic in nature, and 
that ``veteran interviews suggest that fewer than 10 veterans sought 
treatment for pesticide exposure.'' Id. at 56, 151. For these reasons, 
the DoD report's findings regarding possible overexposures during the 
Gulf War do not, in our view, establish that potential exposures to 
pesticides during the Gulf War differed significantly from exposures in 
other civilian and military populations. With respect to service 
members who were exposed to pesticides due to their military occupation 
as pesticide applicators, we note that the potentially chronic nature 
of such occupational exposures, coupled with the findings in the NAS 
report and other medical literature documenting potential health 
effects of chronic exposure, as well as the effects of 
organophosphorous insecticide poisoning (acute cholinergic syndrome), 
may provide a sufficient basis for awarding direct service connection 
for such health effects under existing law.
    Although there is little direct data on pesticide use in the Gulf 
War, we note that DoD had issued comprehensive directives and policies 
governing pesticide use. In a 1996 report, the Presidential Advisory 
Committee on Gulf War Veterans' Illnesses (PAC) noted that DoD policies 
and directives on pesticide use at the time of the Gulf War closely 
paralleled or exceeded those established by regulations of the 
Environmental Protection Agency and the Food and Drug Administration 
for domestic pesticide use.

(Presidential Advisory Committee on Gulf War Veterans' Illnesses: 
Final Report (Washington, DC, U.S. Government Printing Office, 
December 1996).

The PAC reported that, according to DoD policy, the majority of U.S. 
service members had access to two pesticides: Permethrin in a spray can 
(for treating uniforms) and DEET liquid or stick for use as a personal 
mosquito and fly repellant. By DoD policy, all other pesticides shipped 
to the Gulf region were to be used only by specifically trained 
pesticide applicators or for special applications. For example, lindane 
was apparently used by security personnel almost exclusively on Iraqi 
prisoners of war as a delousing agent. In contrast, no similar 
restrictions applied to home use of those pesticides within the United 
States. There is little information concerning the extent to which 
there may have been departures from DoD policy in particular instances 
during the Persian Gulf War.
    The PAC also noted that only limited data exists on the exposure of 
Gulf War veterans to solvents, including benzene. The PAC described one 
study by the Centers for Disease Control and Prevention that involved 
chemical analysis of biological samples collected from troops or other 
personnel residing in Kuwait about two months after the cease-fire 
while the oil well fires were burning. (Etzel, RA and Ashley, DL, 
Volatile Organic Compounds in the Blood of Persons in Kuwait During the 
Oil Fires, International Archives of Occupational and Environmental

[[Page 48739]]

Health, 66:125-29, 1994). The study focused on possible exposure of 
U.S. military employees to the oil-well fire smoke, which is known to 
contain benzene. They reported that although blood levels of volatile 
organic compounds (VOCs) including benzene were higher in firefighters 
than in a reference population of U.S. civilians, DoD employees in 
nearby Kuwait City had VOC levels about the same or lower than the 
reference population. Benzene levels in the DoD employees in Kuwait 
City were about half those of the U.S. civilian reference population. 
This data is limited by small sample size, the short half-life of VOCs 
in service members' blood and the focus specifically on potential 
exposure from oil-well fires rather than overall environmental 
exposure. Nevertheless, the report stated that ``VOC's are also 
widespread in the modern environment. Americans are exposed to numerous 
volatile organic compounds in the home and at work environment, but 
exposure to some of them was not prevalent in post-war Kuwait City, 
where many American personnel were temporarily housed in local hotel 
rooms.''
    The PAC report described a second relevant study conducted by DoD 
during the Gulf War, which among other things measured VOCs including 
benzene in blood samples collected from a group of U.S. service members 
before, during, and after their 1991 deployment to Kuwait. (U.S. Army 
Hygeine Agency, Final Report: Kuwait Oil Fire Health Risk Assessment, 5 
May--3 December 1991, Report No. 39-26-L192-91, February 1994). The 
population studied in this report consisted of as many as 4,700 
soldiers who were deployed from Germany to the Kuwait theater on or 
around September 20, 1991. Blood samples from a small subset of this 
group were taken before and after deployment, and during deployment in 
August 1991, and were analyzed for VOCs including benzene. Benzene 
levels were found to be slightly lower during deployment as compared to 
pre and post-deployment levels. Other solvents, including ethylbenzene, 
chlorobenzene, and styrene, were substantially elevated in 
predeployment blood samples when compared to reference levels in the 
United States. Some solvents, including ethylbenzene, xylene isomers, 
styrene, and toluene, were lower in the blood samples taken during 
deployment. Tetrachloroethylene levels were significantly higher in the 
blood samples taken during deployment. However, the mean level of the 
solvent in the blood was ``orders of magnitude below those levels noted 
in the literature as causing health effects with short term exposure.'' 
The report concluded that ``the levels of VOCs measured in blood 
specimens of soldiers while in Kuwait are denotative of miniscule 
exposures'' and that ``[t]he exposure to most compounds that can be 
inferred from these measurements is, in fact, very similar to accepted 
U.S. normal background levels.''
    The limited data available do not provide a basis for concluding at 
this time that potential exposures to insecticides and solvents during 
the Gulf War differed significantly from potential exposures in other 
military and civilian populations at that time. We recognize the 
possibility that conditions of use may have varied in some 
circumstances, but we have insufficient evidence to infer that 
variations, such as those resulting from failure to use prescribed 
protective equipment, were common or resulted in exposures 
significantly different from those in other military and civilian 
populations. Although DoD noted that one pesticide (lindane) was used 
for the unique purpose of delousing enemy prisoners of war, it also 
noted that only about 200 service members engaged in that duty. 
Additionally, we do not believe that insecticide or solvent exposure 
during the Gulf War can be equated as a general matter with the type of 
chronic occupational exposure involved in most of the associations 
found by NAS. With respect to insecticides, as noted above, DoD has 
indicated that most exposures in the Gulf War were non-chronic. As in 
civilian populations, service members whose military occupation 
involved consistent exposure to insecticides or solvents may have 
incurred above-average exposures. The likelihood of such occupational 
exposures, however, is not unique to service in the Southwest theater 
of operations during the Persian Gulf War. As discussed below, any 
veteran who had chronic or sufficient exposure to insecticides or 
solvents during service may be eligible for direct service connection 
for the known health effects of such exposure, whether or not such 
service was in the Persian Gulf during the Gulf War.
    Public Law 105-277 requires the Secretary to determine whether a 
presumption of service connection is warranted by reason of a disease 
having a positive association with exposure 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.'' Public Law 105-277 1602 (codified in pertinent 
part at 38 U.S.C. 1118(a)(2)(A) and (b)(1)(B)). The statute does not 
explain the meaning of the phrase ``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 there is no legislative 
history explaining the meaning of that phrase.
    We conclude that the statutory phrase ``associated with service in 
the Armed Forces in the Southwest Asia theater of operations during the 
Persian Gulf War'' is most reasonably construed to refer to a 
relationship between the substance or hazard and the specific 
circumstance of service in the Southwest Asia theater of operations 
during the Persian Gulf War, as distinguished from features of military 
or civilian life in general that are not unique to service in the Gulf 
War. The phrase ``associated with'' clearly connotes a direct 
relationship, and the requirement that the substance or hazard be 
associated with service at a particular time and place indicates an 
intent to distinguish between substances and hazards associated with 
general military or civilian life and those unique to service at the 
specified time and place. If civilian and military populations are 
commonly exposed to a substance, we believe it would be unreasonable to 
conclude that the substance is ``associated with'' service in the 
Persian Gulf during the Gulf War merely because it was present and used 
for its ordinary purpose, and exposures occurred in an ordinary way, 
during such service. We do not believe that Congress intended VA to 
establish presumptions for the known health effects of all substances 
common to military or civilian life. Rather, the requirement that the 
substance be ``associated with'' Gulf War service makes clear that VA's 
task is to focus on the unique exposure environment in the Persian Gulf 
during the Persian Gulf War.
    This reading of the statutory language comports with the clear 
purpose of both Public Law 105-277 and Public Law 105-368. Both 
statutes reflect the Government's commitment to addressing the unique 
health issues presented by Gulf War veterans, by establishing a process 
for identifying diseases and illnesses that may be associated with Gulf 
War Service. It is by now well known that many Gulf War veterans have 
reported a variety of similar symptoms that cannot presently be 
identified with a known diagnosis or cause and that were not considered 
``diseases'' for the purposes of the statutes generally authorizing VA 
to pay compensation for service-connected

[[Page 48740]]

disability or death due to disease or injury. Congress responded 
initially to that situation by authorizing VA to pay compensation for 
``undiagnosed illness'' in such veterans. The process established by 
Public Law 105-277 and Public Law 105-368 reflects a further effort to 
bridge the existing gaps in medical and scientific knowledge and to 
ensure that Gulf War veterans may obtain compensation for diagnosed or 
undiagnosed illnesses that may have been caused by the unique exposures 
or hazards of service during the Gulf War. Establishing presumptions of 
service connection for illnesses associated with exposures or hazards 
specifically related to Gulf War service obviously would further that 
objective. In contrast, establishing presumptions of service connection 
for the exclusive benefit of Gulf War veterans based solely on the 
well-known health effects of exposures shared in common with the 
general veteran population would not significantly further the purposes 
of those statutes. Moreover, establishing such presumptions would 
create significant inequities in the veterans' benefits system that 
Congress could not have intended.
    Public Law 105-277 requires VA to establish presumptions of service 
connection, when the statutory requirements are met, exclusively for 
veterans who served in the Southwest Asia theater of operations during 
the Persian Gulf War. If the statute were construed to require 
presumptions based on exposure in the Persian Gulf War to substances to 
which other veterans serving at other times and places are commonly 
exposed at similar levels, it would raise significant concerns of 
fairness and reasonableness. For example, veterans exposed or 
presumably exposed to insecticides during the Gulf War might be 
entitled to presumptive service connection for certain diseases 
associated with insecticide exposure, while veterans who served 
stateside and had equal or greater insecticide exposure--including 
veterans who served as pesticide applicators--would not be entitled to 
presumptive service connection for those diseases. Similarly, veterans 
exposed or presumably exposed to benzene during Gulf War service might 
be entitled to presumptive service connection for acute leukemia or 
other disease by virtue of such exposure, while veterans exposed to 
benzene during service at other times or places would not be entitled 
to presumptive service connection for the same diseases, even though 
they may have had significantly greater potential for benzene exposure 
due to their military occupation (e.g., as a mechanic). The fact that 
most service members, and most civilians, routinely incur some degree 
of background exposure to benzene and certain other substances NAS 
considered in accordance with Public Law 105-277 further underscores 
the arbitrariness that would attach to establishing presumptions for a 
limited class of veterans based on such common exposures.
    Apart from the fact--discussed in greater detail below--that it is 
generally unnecessary to establish presumptions of service connection 
for health effects that are well documented in the medical literature, 
establishing presumptions applicable only to a small percentage of the 
veteran population potentially exposed to the relevant substances would 
have significant adverse effects on the veterans benefits system. 
Providing by statute and regulation for the disparate treatment of 
similarly situated veterans would substantially undermine confidence in 
the objectivity and fairness of the veterans benefits system. 
Additionally, establishing different adjudicative rules for the claims 
of similarly situated veterans without any reasoned basis for the 
distinction would undoubtedly cause confusion to the VA personnel 
responsible for deciding claims, as well as to veterans and their 
representatives in presenting and supporting their claims.
    We do not believe that Congress intended VA to establish 
presumptions unique to Gulf War veterans based on the well-known health 
effects of exposures common to military and civilian life outside the 
Gulf War theater of operations. As explained above, the language and 
purpose of Public Law 105-277 and Public Law 105-368 indicate that 
Congress did not intend such a result, and we believe it is reasonable 
to presume that Congress did not intend arbitrary or unfair 
distinctions. We note that statutes generally must be construed to 
avoid serious constitutional concerns. See Edward J. DeBartolo Corp. v. 
Florida Gulf Coast Building & Construction Trades Council, 485 U.S. 
568, 575 (1988). We cannot say it is beyond Congress' power to 
establish presumptions exclusively for Gulf War veterans based on 
exposures not known to differ significantly from service outside the 
Gulf War. However, the apparent unfairness, in our view, of that result 
supports the conclusion that Congress did not intend such a result.
    We recognize that even common substances might be used in certain 
circumstances, such as in combat situations, in an uncommon manner that 
may create a unique risk. As explained above, however, there is 
presently insufficient evidence to indicate that the solvents or 
insecticides considered by NAS were used in the Gulf War in a manner 
that differed significantly from their usage in other military and 
civilian populations. Of course, if evidence is found indicating that 
insecticide or solvent use during the Gulf War differed significantly 
in kind or degree from use elsewhere in military service or civilian 
life, such information could provide a basis for concluding that such 
insecticides or solvents are substances associated with service in the 
Persian Gulf during the Gulf War.
    We also recognize that Public Law 105-277 and Public Law 105-368 
both required NAS to consider the health effects of exposure to 
insecticides and solvents as part of its investigations of illnesses 
potentially associated with Gulf War service. However, the direction to 
consider those substances does not compel the conclusion that those 
substances, considered in isolation, are themselves agents ``known or 
presumed to be associated with service in the Southwest Asia theater of 
operations during the Persian Gulf War'' for purposes of VA's duty to 
establish presumptions of service connection. Section 1603 of Public 
Law 105-277 describes the scope of NAS' inquiry. Section 1603(c)(1) 
directs NAS to ``identify the 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.'' Section 1603(d) of that 
statute provides that, in identifying substances to which Gulf War 
veterans ``may have been exposed,'' NAS will consider, among other 
things, solvents and several specifically enumerated pesticides. In 
contrast, section 1602 of Public Law 105-277 does not direct the 
Secretary to establish presumptions of service connection for the 
health effects of every substance to which Gulf War veterans ``may have 
been exposed,'' but requires presumptions only for the health effects 
of exposure to substances known or presumed to be ``associated with'' 
service in the Gulf War. Congress used different language in section 
1602 and 1603 of Public Law 105-277, and we must conclude that the 
different language was intended to have different meanings. See Bank of 
America National Trust & Savings Ass'n v. 203

[[Page 48741]]

N. LaSalle St. Partnership, 526 U.S. 434, 450 (1999); Russello v. 
United States, 464 U.S. 16, 23 (1983). Congress reasonably defined the 
scope of NAS' inquiry broadly, to include consideration of all 
substances to which veterans may have been exposed during the Gulf War, 
irrespective of whether the exposures were unique to Gulf War service 
or common to all service. In defining VA's regulation-writing 
obligations, however, Congress reasonably required VA to establish 
presumptions of service connection only for the health effects of 
substances that are ``associated with'' Gulf War service. As noted 
above, that limitation furthers Congress' purpose of establishing 
presumptions for the unique health concerns of Gulf War veterans and 
also avoids the inequity of establishing presumptions exclusively for 
Gulf War veterans based on exposures that are common to most veterans.
    Although the Secretary has determined that presumptions of service 
connection cannot be made at this time for the health effects of 
exposure to insecticides and solvents discussed in the NAS report, we 
want to make clear that this determination will not preclude the 
granting of service connection for those health effects. The health 
effects which NAS found to be supported by sufficient or limited/
suggestive evidence are generally well-known health effects of exposure 
to the insecticides and solvents in question and were documented in the 
medical literature prior to the NAS' review, which essentially 
summarizes and synthesizes the existing literature. The established 
associations between insecticide or solvent exposure and certain 
diseases provide a sufficient basis for examining physicians and VA 
adjudicators to determine whether a veteran's disease is associated 
with exposure to insecticides or solvents in service. As noted, the 
insecticides and solvents discussed in the report generally are not 
associated with diseases unless the exposure was chronic in nature or 
due to organophosphorous insecticide poisoning. If any veteran had 
chronic or sufficient exposure to the insecticides or solvents in 
question, as may occur where the veteran worked as a mechanic or 
pesticide applicator in service, and developed a disease associated 
with such exposure, the veteran could pursue a claim for direct service 
connection regardless of the existence of a presumption. Additionally, 
insofar as certain NAS findings relate to conditions that would be 
present concurrent with exposure, as in the case of allergic contact 
dermatitis, acute pesticide poisoning, and reactive airways dysfunction 
syndromes, the fact that such conditions are observable at the time of 
exposure in service would ordinarily be sufficient to establish service 
connection, irrespective of any presumption.
    We note further that our conclusion that the solvents and 
insecticides in question, in isolation, cannot at this time be 
determined to be ``associated with'' Gulf War service is not intended 
to suggest that they are irrelevant to further investigations of Gulf 
War veterans' health or that they may not in any circumstance form the 
basis for presumptions of service connection under Public Law 105-277. 
Several authorities, including NAS, have noted the possibility that the 
synergistic effects of exposure to multiple substances could lead to 
risks that would not be associated with exposure to the substances 
individually. NAS noted the existence of two studies suggesting that 
combined exposure to pyridostigmine bromide and certain pesticides may 
produce greater neurotoxicity than exposure to comparable doses of 
those substances individually. A 1996 report of the Presidential 
Advisory Committee on Gulf War Veterans' Illnesses and a 2003 Report 
from DoD's Office of the Special Assistant for Gulf War Illnesses 
suggested the need for further research on the possible effects of such 
multiple exposures. (OSAGWI 2003); (Presidential Advisory Committee on 
Gulf War Veterans' Ilnnesses 1996). In the event future evidence links 
any illnesses to a combination of exposures associated with Gulf War 
service, whether or not including exposure to insecticides or solvents, 
VA may establish presumptions of service connections for such illnesses 
pursuant to Public Law 105-277.

IV. Conclusion

    For the reasons stated above, the Secretary has determined that a 
presumption of service connection is not warranted at this time for any 
of the diseases, illnesses, or health effects discussed in the NAS 
report issued on February 18, 2003, titled ``Gulf War and Health, 
Volume 2. Insecticides and Solvents.''

    Approved: August 17, 2007.
R. James Nicholson,
Secretary of Veterans Affairs.
 [FR Doc. E7-16733 Filed 8-23-07; 8:45 am]
BILLING CODE 8320-01-P