Determinations Concerning Illnesses Discussed in National Academy of Sciences Report: Veterans and Agent Orange: Update 2010, 47924-47928 [2012-19635]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[Federal Register Volume 77, Number 155 (Friday, August 10, 2012)]
[Notices]
[Pages 47924-47928]
From the Federal Register Online via the Government Printing 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 https://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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