[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Notices]
[Pages 7860-7861]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02264]


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DEPARTMENT OF VETERANS AFFAIRS


Initial Research on the Long-Term Health Consequences of Exposure 
to Burn Pits in Iraq and Afghanistan

ACTION: Notice.

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SUMMARY: This notice announces the preliminary plans of the Department 
of Veterans Affairs (VA) to conduct a longitudinal cohort study of 
adverse health effects related to military deployment to Iraq and 
Afghanistan, to include potential exposure to airborne hazards and burn 
pits, and to take related actions to promote the effective monitoring 
and assessment of deployment-related exposures and potential health 
effects of deployments. The planned actions are based in part on VA's 
review of the analysis and recommendations in an October 31, 2011, 
report of the Institute of Medicine (IOM) of the National Academy of 
Sciences (NAS) concerning the potential long-term health consequences 
of exposure to burn pits in Iraq and Afghanistan.

FOR FURTHER INFORMATION CONTACT: Dr. Paul Ciminera, Department of 
Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, 
telephone (202) 461-1020. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: 
    On October 31, 2011, at VA's request, IOM issued a study titled, 
``Long-Term Health Consequences of Exposure to Burn Pits in Iraq and 
Afghanistan'' (IOM report). The IOM reviewed a wide range of data 
sources including peer-reviewed literature on the subject of 
respiratory exposures in general, information on types of materials and 
quantities burned during burn pit use in Iraq and Afghanistan, and 
analyses of ambient air sampling collected by the Department of Defense 
(DoD). IOM concluded that there was limited but suggestive evidence of 
an association between exposure to combustion products and reduced 
pulmonary function, but inadequate or insufficient evidence of an 
association between exposure to combustion products and cancer, 
respiratory diseases, circulatory diseases, neurologic diseases, and 
adverse reproductive and developmental outcomes in the populations 
studied. After careful review of the IOM report, the Secretary has 
directed the Veterans Health Administration to conduct a long-term 
prospective study on all adverse health effects potentially related to 
military deployment to Iraq and Afghanistan, to include health effects 
potentially related to exposure to airborne hazards and burn pits. In 
addition, the Secretary has requested participation by DoD in VA's 
proposed study, joint participation in long-term cohort studies for 
every future major deployment, priority staffing in support of the VA/
DoD Environmental Exposure Data Transfer Agreement (DTA), and continued 
collaboration on a Joint VA/DoD Action Plan to address clinical and 
research issues associated with deployment. Additional efforts include 
inviting DoD to support a joint VA/DoD post-deployment health annual 
symposium to disseminate lessons learned to health care teams (and 
other stakeholders) and bring key subject matter and policy experts 
together to guide joint strategic research plans on post-deployment 
health related issues. VA intends, in conjunction with DoD, to 
establish clinical evaluation protocols for exposure to burn pit 
emissions and other airborne pollutants encountered by servicemembers 
deployed to Iraq and Afghanistan, and conduct research on the long-term 
health effects of exposure to burn pits.
    Background. This IOM report was not required by law. It was 
requested by VA in response to increasing concerns about the long-term 
health of U.S. servicemembers who served in Iraq or Afghanistan who may 
have been exposed to potentially hazardous materials from open burn 
pits, which were commonly used for waste disposal. Specifically, VA 
asked IOM to examine potential exposures and long-term health risks 
arising from exposure to smoke created from open pit burning of solid 
waste and other materials in Iraq and Afghanistan. Using the Joint Base 
Balad (JBB) burn pit as an example, IOM was asked to evaluate the long-
term health risks based on a review of a wide range of sources such as 
epidemiologic studies conducted either by or under the auspices of VA 
or DoD; other available epidemiologic literature on populations exposed 
to similar hazards; as well as relevant environmental studies, relevant 
toxicologic studies, veteran-specific clinical/pathologic studies, and 
the effects related to short-term peak exposures, as well as chronic 
exposures. In addition, IOM was asked to make recommendations for 
epidemiologic research initiatives for VA and DoD to further study 
potential long-term health effects.
    IOM first assessed the types and quantities of materials burned 
during the time of pit use and analyzed air monitoring data collected 
at JBB during 2007 and 2009. It then examined anticipated health 
effects from exposure to air pollutants found at JBB and studies of 
health effects in similar populations with similar exposures, grading 
the quality of those studies as key or supportive. IOM then performed a 
synthesis of key information on potential long-term health effects in 
military personnel potentially exposed to burn pits and developed 
design elements and feasibility considerations for an epidemiologic 
study.
    IOM concluded that there is limited but suggestive evidence of an 
association between exposure to combustion products and reduced 
pulmonary function in the populations studied. Pulmonary function tests 
are frequently used to diagnose respiratory disease, and changes can be 
observed in the absence of clinical symptoms or disease. However, this 
IOM finding focused on pulmonary function, not respiratory disease, and 
noted that further studies, including longitudinal studies, are 
required. The studies conducted to this point have been limited in 
scope and duration, and many focus on non-veterans in other

[[Page 7861]]

(not completely similar) settings, including firefighters, residents 
living near incinerators, and incinerator workers.
    IOM also concluded that there is inadequate or insufficient 
evidence of an association between exposure to combustion products and 
cancer, respiratory diseases, circulatory diseases, neurologic 
diseases, and adverse reproductive and developmental outcomes in the 
populations studied.
    As previously noted, IOM relied on peer reviewed studies of 
surrogate patient populations (firefighters and incinerator workers) 
because there were limited studies, long or short term, of 
servicemembers exposed to burn pits or similar contaminants while in an 
operational area. VA believes such studies would be helpful in properly 
assessing affected veterans for compensation purposes as well as for 
medical evaluation, treatment and follow up. The following precursor 
actions will facilitate such future studies:
    (1) Development of a standardized post-deployment evaluation 
protocol. VA and DoD believe that the post-deployment evaluation of 
servicemembers and veterans with respiratory complaints should be 
standardized across the Departments. VA recognizes that burn pits may 
not be the main cause of any long-term health effects related to 
deployment to Iraq and Afghanistan. Military operations in these areas 
also expose servicemembers to other air pollutants, predominately 
particulate matter (PM), which might be associated with long-term 
health effects, particularly in highly exposed or susceptible 
populations. Developing a standardized screening and diagnostic 
evaluation protocol will facilitate appropriate assessment and medical 
care as needed. VA intends to work jointly with DoD to develop expert 
consensus on these evaluation protocols.
    (2) Development of validated exposure assessment instruments. VA 
will continue to work in a supporting role with DoD to attempt to 
develop exposure assessment instruments for use in both research and 
clinical evaluation. This will aid in identifying any health outcomes 
potentially associated with burn pit emissions by identifying sources 
of exposure as well as the chemicals associated with burning waste and 
other pollution sources. Accurate assessment of exposure potential 
requires identifying possible toxicants, detailed deployment 
information, duration of deployment, job duties, and in the case of 
burn pits, the distance from the burn pit and whether the individual 
lived and worked upwind or downwind from the burn pit. VA relies on DoD 
to provide these confirmatory data, and is actively pursuing a Data 
Transfer Agreement (DTA) to include more specific data elements.
    (3) Supporting an integrated DoD/VA clinical informatics system. VA 
recognizes that assessment of health outcomes is best done 
collaboratively using the clinical informatics systems of DoD and VA. 
An integrated VA-DoD electronic medical record is the optimal solution. 
The issue of integration is being addressed through several ongoing 
initiatives. The VA-DoD Deployment Health Work Group is sponsoring a 
DTA that will enable DoD exposure data to be transferred to VA. In 
addition, VA plans to link outcome data with self-reported 
questionnaire data from DoD's Millennium Cohort Study (MCS), which 
includes a large veteran population that deployed in support of current 
operations in Iraq and Afghanistan. VA is working to embed personnel in 
the MCS office to conduct joint research and provide VA medical record 
reviews of conditions self-reported from veterans participating in the 
MCS.
    To address the need for further study of the long-term health 
effects of exposure to airborne hazards (such as pollution and burn pit 
emissions) in Iraq and Afghanistan, VA intends to take the following 
steps:
    Design appropriate studies. The long-term health effects related to 
exposure to burn pit emissions should be assessed. Early markers of 
respiratory disease, via measurable changes in the respiratory system, 
should be examined through a research-based physical examination 
component of a broader research program. As a first step, VA intends to 
develop research goals and objectives, structures, and establish 
essential study design features. Existing research studies, such as the 
Million Veteran Program, the Cooperative Studies Program, the Gulf War 
Veteran studies, the MCS, and the National Health Study for a New 
Generation of U.S. Veterans, will be evaluated to determine whether any 
of these can be used to support burn pit exposure studies, or whether 
modifications to these studies may be necessary to meet the overall 
goals of a research plan. In 2005, DoD formed the Joint Particulate 
Matter Work Group to investigate the composition of PM across 
USCENTCOM. The Pulmonary Working Group was established in 2010 to 
investigate reports of specific respiratory conditions found in 
returning veterans. VA and DoD continue to collaborate and support 
ongoing activities that may be leveraged in the study of long-term 
health effects related to exposure to airborne hazards such as burn pit 
emissions.
    Establish an independent oversight mechanism. VA intends to 
establish an independent oversight committee to provide guidance and to 
review specific research objectives, study designs, research and 
evaluation protocols, and results from burn pit emissions research. VA 
has established independent advisory bodies that could potentially 
provide the required level of external oversight. These bodies include 
standing review committees that provide peer review for VA researchers. 
The committees should include external subject matter experts recruited 
from academia, internal VA experts, and experts from other government 
agencies, and should be modeled after the National Institutes of 
Health's Center for Scientific Review.
    Conduct a cohort study. VA intends to work jointly with DoD to 
develop and conduct a cohort study of veterans and servicemembers to 
assess potential long-term effects related to burn pit emissions in the 
context of other ambient exposures. This will likely involve a 
population-based prospective study that includes baseline and repeated 
clinical examinations with sufficient follow up to address the 
potential long-term health effects of deployment to Iraq and 
Afghanistan as well as potential burn pit exposure.

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 December 26, 2012, for publication.

    Dated: January 29, 2013.
William F. Russo,
Deputy Director, Office of Regulation Policy and Management, Office of 
the General Counsel, Department of Veterans Affairs.
[FR Doc. 2013-02264 Filed 2-1-13; 8:45 am]
BILLING CODE 8320-01-P