[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Notices]
[Pages 7860-7861]
From the Federal Register Online via the Government Publishing 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