[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Notices]
[Pages 47924-47928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19635]
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DEPARTMENT OF VETERANS AFFAIRS
Determinations Concerning Illnesses Discussed in National Academy
of Sciences Report: Veterans and Agent Orange: Update 2010
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 Agent Orange Act of 1991, codified at 38
U.S.C. 1116, has determined that there is no basis to establish a
presumption of service connection at this time, based on exposure to
herbicide agents, including the substance commonly known as Agent
Orange, for several health effects discussed in the September 29, 2011,
National Academy of Sciences (NAS) report titled: Veterans and Agent
Orange: Update 2010 (hereinafter, ``Update 2010''). 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. In a separate
rulemaking, VA will propose to expand the current presumption for
peripheral neuropathy.
FOR FURTHER INFORMATION CONTACT: Tom Kniffen, Chief, Regulations Staff
(211D), Compensation and Pension Service, Veterans Benefits
Administration, Department of Veterans Affairs, 810 Vermont Avenue NW.,
Washington, DC 20420, telephone (202) 461-9700. (This is not a toll-
free number.)
SUPPLEMENTARY INFORMATION:
I. Statutory Requirements
The Agent Orange Act of 1991, Public Law 102-4 (codified in part at
38 U.S.C. 1116), directed the Secretary to seek to enter into an
agreement with the National Academy of Sciences (NAS) to conduct a
comprehensive review of scientific and medical literature on
[[Page 47925]]
potential health effects of exposure to Agent Orange. Congress mandated
that NAS determine, to the extent possible: (1) Whether there is a
statistical association between suspect diseases and herbicide
exposure, 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 disease among individuals
exposed to the herbicides during service in the Republic of Vietnam
during the Vietnam era; and (3) whether a plausible biological
mechanism or other evidence of a causal relationship exists between
exposure to herbicides and suspect disease.
Section 2 of Public Law 102-4, codified in pertinent part at 38
U.S.C. 1116(b) and (c), provides that whenever the Secretary
determines, based on sound medical and scientific evidence, that a
positive association (i.e., the credible evidence for the association
is equal to or outweighs the credible evidence against the association)
exists between exposure of humans to an herbicide agent (i.e., a
chemical in an herbicide used in support of the United States and
allied military operations in the Republic of Vietnam during the
Vietnam era) and a disease, the Secretary will publish regulations
establishing presumptive service connection for that disease. 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.
Although 38 U.S.C. 1116 does not define ``credible,'' it does
instruct the Secretary to ``take into consideration whether the results
[of any study] are statistically significant, are capable of
replication, and withstand peer review.'' The Secretary reviews studies
that report a positive relative risk and studies that report a negative
relative risk of a particular health outcome. He then determines
whether the weight of evidence supports a finding that there is or is
not a positive association between herbicide exposure and the
subsequent health outcome. The Secretary does this by taking into
account the statistical significance, capability of replication, and
whether that study will withstand peer review. Because of differences
in statistical significance, confidence levels, control for confounding
factors, bias, and other pertinent characteristics, some studies are
more credible than others. The Secretary gives weight to more credible
studies in evaluating the overall evidence concerning specific health
outcomes.
II. Prior NAS Reports
NAS has issued nine previous biennial reports under the Agent
Orange Act. Based on those reports and the requirements of the Agent
Orange Act, VA has established presumptions of service connection for
14 categories of disease, which are listed at 38 CFR 3.307(e).
Additionally, following each prior NAS report, VA has published a
notice explaining the Secretary's determination that presumptions of
service connection are not warranted for several diseases discussed in
those reports. Those notices are published at: 59 FR 341 (Jan. 4,
1994), 61 FR 41442 (Aug. 8, 1996), 64 FR 59232 (Nov. 2, 1999), 67 FR
42600 (Jun. 4, 2002), 68 FR 27630 (May 30, 2003), 72 FR 32395 (May 20,
2007), 75 FR 32540 (Jun. 8, 2010), and 75 FR 81332 (Dec. 27, 2010). The
Secretary's determination that there is not a positive association
between herbicide exposure and the diseases addressed in this notice is
based upon the prior NAS reports, as discussed in VA's prior Federal
Register notices, and upon the additional information and analysis in
Update 2010, as discussed below.
III. Veterans and Agent Orange: Update 2010
On September 29, 2011, NAS publicly released Veterans and Agent
Orange: Update 2010, which describes the relevant scientific and
medical evidence identified subsequent to the last prior NAS review,
Veterans and Agent Orange: Update 2008 (hereinafter, ``Update 2008'').
NAS reviewed, evaluated, and summarized scientific and medical
literature addressing several conditions and the health status of
veterans.
Consistent with its prior reviews, NAS concentrated its review on
epidemiologic studies to fulfill its charge of assessing whether
specific human health effects are associated with exposure to at least
one of the herbicides utilized or to a chemical component of
herbicides, such as TCDD (2,3,7,8-tetrachlorodibenzo-p-dioxin; referred
to as TCDD to represent a single--and the most toxic--congener of the
tetrachlorodibenzo-p-dioxins, also commonly referred to as dioxin). NAS
also considered controlled laboratory investigations that provided
information on whether the association between the chemicals of
interest and a given effect is biologically plausible.
In Update 2010, NAS endeavored to emphasize and clarify the
relationship among the succession of publications that have provided
ever increasing insight into the health responses of particular exposed
populations that have been studied for many years. The information that
the present Committee reviewed was identified through a comprehensive
search of relevant databases, including databases covering biologic,
medical, toxicologic, chemical, historical, and regulatory information.
NAS conducted a comprehensive search of all medical and scientific
studies on health effects of herbicides used in the Vietnam War,
including more than 6,600 potentially relevant studies, of which 1,300
were carefully reviewed, and about 65 ultimately contributed new
information. Relevant animal studies, as with previous biennial ``Agent
Orange Updates,'' were also reviewed to determine biological
plausibility and possible mechanisms of action.
The epidemiologic information evaluated in Update 2010 was
integrated with that previously assembled included veterans studies,
occupational studies, and environmental studies. NAS reviewed three
studies of veterans published since Update 2008. One study on Army
Chemical Corps personnel produced findings related to causes of
mortality, while another study on Australian veterans evaluated the
prevalence of a multitude of self-reported health outcomes, including
cancers, circulatory diseases, respiratory diseases, diabetes, and
digestive disorders. A third study examined the progression of prostate
cancer in a case-control study of veterans with previous Agent Orange
exposure.
Since Update 2008, several occupational studies have been
published. For example, recent reports from the Agricultural Health
Study examined the incidence of pancreatic cancer, hearing loss,
melanoma, thyroid disease, adult onset asthma, myocardial infarction,
and rhinitis in private pesticide applicators (farmers), their spouses,
and commercial pesticide applicators. Additionally, circulatory
diseases and neurologic outcomes were studied in a 40-year follow-up of
Czech production workers who were exposed to TCDD during the production
of 2,4,5-T.
Since Update 2008, numerous studies from environmental exposures to
chemicals of interest have been published. Reproductive outcomes,
including birth weight, birth defects, childhood cancer, neonatal
thyroid function, and development of childhood obesity were studied in
offspring of mothers exposed to TCDD and other chemicals with dioxin-
like biologic activity from incinerator emissions in France, the
industrial accident at
[[Page 47926]]
Seveso, Italy, and dietary intake in Taiwan, Italy, Belgium, the
Netherlands, and Japan. Cancer outcomes were evaluated in follow-up
studies of residents of Seveso, Italy, and farmers and pesticide
applicators/users in Canada and the US. Diabetes and conditions
associated with metabolic syndrome were assessed in Great Lakes sport-
fish consumers, Taiwanese residents near a pentachlorophenol factory,
Finnish fisherman, Japanese men and women, and the general US
population via the National Health and Nutrition Examination Survey.
New case-control studies examined environmental exposures to the
chemicals of interest and endometriosis and Parkinson's disease.
As in its prior reports, NAS placed each health outcome it reviewed
in one of four categories based on the strength of the evidence of
association between herbicide exposure and the health outcome. The four
categories are: Sufficient Evidence of Association; Limited or
Suggestive Evidence of Association; Inadequate or Insufficient Evidence
to Determine Whether an Association Exists; and Limited or Suggestive
Evidence of No Association. VA has established presumptions of service
connection for all diseases NAS placed in the first category and for
most of the diseases NAS placed in the second category. This notice
explains the basis for VA's determination that presumptions of service
connection are not warranted for the remaining diseases discussed in
Update 2010.
Limited or Suggestive Evidence of an Association
NAS has defined this category of association to mean that the
``evidence suggests an association between exposure to herbicides and
the outcome, but a firm conclusion is limited because chance, bias, and
confounding could not be ruled out with confidence.''
Hypertension
NAS placed hypertension in the ``Limited or Suggestive Evidence of
Association'' category. Hypertension affects more than 70 million adult
Americans and is a major risk factor for coronary artery disease,
myocardial infarction, stroke, and heart and renal failure. A recent
study of the Framingham cohort (The Seventh Report of the Joint
National Committee on Prevention, Detection, Evaluation, and Treatment
of High Blood Pressure 2004) showed that in both 55 and 65-year-old
participants, the cumulative lifetime risk for the development of
hypertension (at or above 140/90 mm Hg, regardless of treatment) was
90%. The lifetime risk statistic is the probability that an individual
will develop a disease over a lifetime. Major risk factors are well
established and include tobacco use, diet, physical inactivity,
obesity, diabetes mellitus, alcohol, and heredity.
In its reports prior to 2006, NAS placed hypertension in the
``Inadequate or Insufficient Evidence'' category. In Veterans and Agent
Orange: Update 2006 (hereinafter, ``Update 2006'') and Update 2008, NAS
elevated hypertension to the ``Limited or Suggestive Evidence''
category, but could not clearly distinguish the possibility of a small
increased risk for hypertension due to herbicide exposure from more
prevalent scientifically established risk factors in evaluating the
risk to individual veterans. NAS noted the limitations of the studies
regarding hypertension. In the Federal Register of June 8, 2010, and
December 27, 2010, VA explained why the studies reviewed in Update 2006
and Update 2008 did not, in VA's view, warrant a presumption of service
connection for hypertension in veterans exposed to herbicides in
service. 75 FR 32540 (Jun. 8, 2010); 75 FR 81332 (Dec. 27, 2010).
In Update 2010, NAS reviewed and weighed previous literature from
its prior reports and five new epidemiology studies published since
Update 2008. To varying degrees, a limitation of all the new studies
was an inability to adjust for known risk factors for hypertension. A
study of Army Chemical Corps veterans found a statistically
nonsignificant increase in hypertension mortality and was unreliable
due to the small sample size. Another study found a 13% increase in
self-reported hypertension among Australian Vietnam veterans. However,
NAS found that report unreliable because it was based solely on self-
reports, it was not based on exposure information, and did not account
for confounding risk factors. NAS further noted that a study of Czech
workers exposed to herbicides was unreliable due to the small sample
size, lack of a well-defined comparison population, and lack of
comparison data between the exposed and non-exposed populations.
Another study examined the relationship between metabolic syndrome and
the body burden of dioxin and related compounds in the Japanese general
population. This study found that subjects in the highest quartile of
serum levels of dioxin-like polychlorinated biphenyls (PCBs) from
environmental exposure had a significant increased prevalence of
hypertension. The cross-sectional design of this study (in which
subjects are assessed at a single time in their lives) limits its
ability to quantify risk, establish a causal relationship, and rule out
confounding factors. Important risk factors that could account for the
increased incidence of hypertension, such as body weight, sodium
intake, and dietary exposure, were not adjusted for. The fifth new
study examined newly diagnosed hypertension and its relationship to
serum levels of persistent organic pollutants from the National Health
and Nutrition Examination Survey (NHANES) 1999-2002. This study was
also cross-sectional in design, limiting its ability to quantify risk,
establish a causal relationship, and rule out confounding factors. This
study adjusted for only some confounders and used the lowest serum
measures of pollutants as the referent population. No association
between dioxin-like PCBs and hypertension was found in men even at the
highest serum levels. In addition, there were no indications of a
positive trend towards an association. Women had a significant
association for some persistent organic pollutants but not dioxin-like
PCBs. Significant variation is seen across dioxin-like compounds in
these studies. Researchers have grouped dioxin-like compounds for their
cancer induction effects, but these variations in hypertension results
bring uncertainty to this grouping for non-cancer effects.
VA has reviewed this additional information in relation to the
information in prior NAS reports analyzing studies concerning
hypertension. Based on this review, the Secretary has determined that
the available evidence presented in Update 2010 is not sufficient to
establish a new presumption of service connection for hypertension in
veterans exposed to herbicides. As noted in VA's evaluation of prior
NAS reports, 75 FR 32540 (Jun. 8, 2010), the evidence overall includes
a wide variety of results. While some veteran studies have reported
increased incidence of hypertension, others have found no increase.
Similarly, numerous environmental and occupational studies have found
no significant increased risk of hypertension. The consistently
negative findings of occupational studies are of interest because, at
least in studies of chemical-production workers, the magnitude and
duration of exposures in occupational studies generally would be
greater than in Vietnam veteran studies. Further, as noted above,
several of the studies that provide evidence of an increased risk are
limited by the failure to control for significant confounders or by
other methodological concerns. Accordingly,
[[Page 47927]]
the Secretary has determined that the available evidence does not at
this time establish a positive association between herbicide exposure
and hypertension that would warrant a presumption of service
connection.
Inadequate or Insufficient Evidence To Determine an Association
NAS has defined this category of association to mean that available
epidemiologic studies are of insufficient quality, consistency, or
statistical power to permit a conclusion regarding the presence or
absence of an association. For example, studies fail to control for
confounding factors, have inadequate exposure assessment, or fail to
address latency.
Consistent with its findings in Update 2008, NAS in Update 2010,
found inadequate or insufficient evidence to determine whether an
association exists between herbicide exposure and the following
conditions: (1) Cancers of the oral cavity (including lips and tongue),
pharynx (including tonsils), and nasal cavity (including ears and
sinuses); (2) cancers of the pleura, mediastinum, and other unspecified
sites within the respiratory system and intrathoracic organs; (3)
cancers of the digestive organs (esophageal cancer; stomach cancer;
colorectoral cancer (including small intestine and anus), hepatobiliary
cancers (liver, gallbladder, and bile ducts), and pancreatic cancer);
(4) bone and joint cancer; (5) melanoma; (6) non-melanoma skin cancer
(basal cell and squamous cell); (7) breast cancer; (8) cancers of the
reproductive organs (cervix, uterus, ovary, testes, and penis;
excluding prostate); (9) urinary bladder cancer; (10) renal cancer
(kidney and renal pelvis); (11) cancers of the brain and nervous system
(including eye); (12) endocrine cancers (including thyroid and thymus);
(13) leukemia (other than all chronic B-cell leukemias including
chronic lymphocytic leukemia and hairy cell leukemia); (14) cancers at
other and unspecified sites (other than those as to which the Secretary
has already established a presumption); (15) reproductive effects
(including infertility; spontaneous abortion other than after paternal
exposure to TCDD; and--in offspring of exposed people--neonatal death,
infant death, stillborn, low birth weight, birth defects [other than
spina bifida], and childhood cancer [including acute myeloid
leukemia]); (16) neurobehavioral disorders (cognitive and
neuropsychiatric); (17) neurodegenerative diseases (including
amyotrophic lateral sclerosis (ALS) but excluding Parkinson's disease);
(18) chronic peripheral nervous system disorders (other than early-
onset peripheral neuropathy); (19) respiratory disorders (wheeze or
asthma, chronic obstructive pulmonary disease, and farmer's lung); (20)
gastrointestinal, metabolic, and digestive disorders (including changes
in liver enzymes, lipid abnormalities, and ulcers); (21) immune system
disorders (immune suppression, allergy, and autoimmunity); (23)
circulatory disorders (other than hypertension and ischemic heart
disease); (24) endometriosis; and (25) effects on thyroid homeostasis.
Further, NAS found inadequate or insufficient evidence to determine
whether an association exists between herbicide exposure and the
following three conditions, which were evaluated for the first time in
Update 2010: (1) hearing loss; (2) eye problems; and (3) bone
conditions.
With respect to the 25 categories of disease considered in its
prior reports, NAS found that the studies published since Update 2008
generally did not contain statistically significant findings or other
significant evidence of association between herbicide exposures and
those health outcomes, with a few exceptions discussed below.
NAS noted that a follow-up study of residents environmentally
exposed to dioxin following an accidental release in Seveso, Italy,
found a ``barely significant'' increased risk of biliary cancer in
residents of the moderately-exposed zone, but that no excess was found
in the high or low exposure zones. Additionally, two new occupational
studies found no statistically significant increased risk of
hepatobiliary cancers in exposed workers. NAS concluded that the
isolated finding among the moderately-exposed group in the Seveso study
did not establish a consistent pattern of risk and that the overall
evidence was insufficient to link the chemicals of interest with
hepatobiliary cancers.
NAS noted that the Seveso study also found a statistically
significant increase in the incidence of breast cancer among female
residents of the high exposure zone 10-14 years after the accident.
However, NAS also noted that a recent occupational study and a 2008
study of female Vietnam veterans did not support an increased risk of
breast cancer mortality in exposed populations. Overall, NAS concluded
that the evidence remains inadequate or insufficient to determine
whether an association exists.
NAS noted that a study of herbicide production workers reported an
``infinitely large'' hazard ratio for risk of renal cancer based on
eight deaths in the exposed group and none in the control group, but
NAS also stated that the moderate size of the cohort limited the
study's ability to detect an increase in this relatively rare cancer.
Further, the findings of that study were not supported by several other
new occupational and environmental studies, which found no increased
risk of renal cancer or found moderate but not statistically
significant increases. Accordingly, NAS found the evidence overall
inadequate or insufficient to determine whether an association exists.
NAS noted that the Seveso follow-up study reported a statistically
significant increased incidence of myeloid leukemia in the moderately
exposed group but not in the group with the highest exposure. NAS noted
that the significance of this finding was limited by concerns about
possible misclassification of that type of leukemia and the erratic
correlation between intensity of exposure and degree of risk. Further,
that finding was not supported by other new occupational and Vietnam
Veteran studies, which generally found no increased risk of leukemia in
exposed populations.
NAS noted that two new studies reported statistically significant
evidence of association between herbicide exposure and chronic
obstructive pulmonary disease (COPD). A study of Army Chemical Corps
veterans reported a statistically significant excess mortality from
COPD. However, NAS found the significance of that finding to be
significantly constrained by the inability to fully control for
cigarette smoking, the major risk factor for COPD. NAS noted that prior
studies of American Vietnam veterans did not find evidence of increased
mortality due to noncancerous respiratory conditions. NAS noted that
concerns regarding misclassification of COPD on death certificates and
misdiagnosis of COPD further limit the conclusion that can be drawn
from such mortality data. The other new study found a statistically
significant increase in self-reported incidence of emphysema and
bronchitis, which are conditions consistent with COPD, among Australian
Vietnam veterans. NAS noted that this finding was limited by recall
bias and other methodological considerations and expressed general
skepticism about the significance of this study's findings due to its
low response rate and the study's nearly uniform findings of
statistically increased prevalence for nearly 50 health conditions. NAS
further noted that prior studies of the full cohort of male Australian
Vietnam veterans showed no suggestion of increased
[[Page 47928]]
mortality from COPD or other noncancerous respiratory conditions and
that a number of occupational studies failed to detect an increased
risk of COPD or other noncancerous respiratory conditions. Accordingly,
NAS found the evidence overall inadequate or insufficient to determine
whether an association exists between herbicide exposure and COPD or
other noncancerous respiratory conditions.
With respect to immune system disorders, NAS noted that the only
potentially relevant new study was the above-referenced Australian
veteran study, which found that several conditions in which immune
function may play a role--including infectious and parasitic diseases,
respiratory disorders, and skin disorders--were significantly more
prevalent in Australian Vietnam veterans, based on self-reports, than
among the general population. For the same reasons discussed above, NAS
found the reliance that could be placed on that report to be
significantly limited by numerous methodological concerns. Accordingly,
NAS found that there was inadequate or insufficient evidence to
determine whether an association exists between herbicide exposure and
immune system disorders.
In notices following prior NAS reports, cited in section II above,
VA has explained the basis for the Secretary's determination that a
positive association does not exist between herbicide exposure and the
health conditions identified in Update 2010 in the ``inadequate or
insufficient evidence'' category (other than the three new conditions
discussed below). For the reasons explained above, VA has determined
that the additional studies discussed in Update 2010 do not change the
Secretary's determination that a positive association does not
currently exist between herbicide exposure and those health conditions.
In Update 2010, NAS for the first time evaluated available studies
regarding the possible association of hearing loss with herbicide
exposure. The NAS found two potentially relevant studies, both of which
were based on self-reports of hearing loss. In the study of Australian
Vietnam veterans, discussed above, Vietnam veterans had an increased
risk of diseases of the ear, tinnitus, or deafness, compared to the
general population. As previously discussed, NAS had serious concerns
that the results of this study were compromised due to recall bias and
several other methodological concerns. The second study found an
increased risk of hearing loss among licensed pesticide applicators
overall, although analyses by pesticide class did not show strong
associations with hearing loss. Moreover, although applicators who
reported insecticide use had a higher rate of self-reported hearing
loss compared to those with no reported insecticide use, applicators
who reported more than 651 days of lifetime herbicide use had no
increase in self-reported hearing loss compared to non-exposed persons.
Accordingly, the study does not provide evidence of an association
between herbicide exposure and hearing loss. NAS further noted that
both studies were limited by the lack of clinical confirmation of
hearing loss, among other factors. Accordingly, NAS concluded that the
evidence was inadequate or insufficient to determine whether an
association exists between herbicide exposure and hearing loss.
Update 2010 also addressed eye problems for the first time. The
sole study potentially relevant to eye conditions was the previously
described Australian Veteran study, which found increases in self-
reported incidence of cataracts, presbyopia, color blindness, and other
diseases of the eye among Australian Vietnam veterans compared to the
general population. Again, NAS noted that it had serious concerns that
the results of this study were compromised by several methodological
issues. Accordingly, the NAS did not regard this report as providing
evidence that could indicate whether an association exists between
herbicide exposure and eye problems.
Update 2010 also addressed bone disorders for the first time. The
sole potentially relevant study identified by NAS was a study of
forearm bone mass density among individuals who may have had exposure
to dioxin like polychlorinated biphenyls from fish consumption. The
study found that one of the PCBs under examination had a positive
association with bone mass density in women but not in men and that,
when low bone mass density was treated as a variable, a positive
association was observed in men, but not in women. NAS found that this
report provided a relatively small amount of information, was limited
to the effect on one dioxin-like PCB, and indicated no consistent
pattern on which to determine whether herbicide exposure is associated
with bone disorders.
Based on the analysis in Update 2010, the Secretary has determined
that the available studies generally do not provide credible evidence
of an association between exposure to an herbicide agent and an
increased risk of hearing loss, eye problems, or bone conditions. The
Secretary therefore finds that a positive association does not
currently exist between herbicide exposure and those conditions and
that no presumption of service connection is warranted for those
conditions at this time.
Limited or Suggestive Evidence of No Association
NAS has previously concluded that there is limited or suggestive
evidence of no association between paternal herbicide exposure and
spontaneous abortion. In Update 2010, NAS identified no new studies
relevant to that health outcome. Accordingly, the Secretary has
determined that there is no positive association between paternal
herbicide exposure and spontaneous abortion.
Detailed information on NAS' findings may be found at http://www.iom.edu/Reports/2011/Veterans-and-Agent-Orange-Update-2010.aspx.
After selecting the link titled: ``Read Report Online for Free,''
report findings, organized by category, may be found under the heading,
``Table of Contents.''
Conclusion
After careful review of the findings of the 2010 NAS report,
Veterans and Agent Orange: Update 2010, the Secretary has determined
that based on the scientific evidence presented in this report and
prior NAS reports, no new presumptions of service connection are
warranted at this time for any of the conditions discussed in this
notice.
Signing Authority
The Secretary of Veterans Affairs, or designee, approved this
document and authorized the undersigned to sign and submit the document
to the Office of the Federal Register for publication electronically as
an official document of the Department of Veterans Affairs. John R.
Gingrich, Chief of Staff, Department of Veterans Affairs, approved this
document on June 6, 2012, for publication.
Dated: August 7, 2012.
Robert C. McFetridge,
Director, Regulation Policy and Management, Office of the General
Counsel, Department of Veterans Affairs.
[FR Doc. 2012-19635 Filed 8-9-12; 8:45 am]
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