Introduction
On February 17 and 18, 2005, the Office of Science, National
Center for Environmental Health and the Agency for Toxic
Substances and Disease Registry (NCEH/ATSDR) convened a
scientific panel to deliberate the feasibility and usefulness
of conducting additional human health studies of populations
potentially exposed to drinking water contaminated with
volatile organic compounds (VOCs) at the U.S. Marine Corps
Base at Camp Lejeune, North Carolina. The panel meeting
was open to the public and ample time was set aside for
public participation. The final report of the panel was
completed on June 24, 2005. Transcripts of the proceedings
and the final report of the panel were posted on the ATSDR
Web site for ATSDR's Camp Lejeune health-related activities.
The final report contained several recommendations for
the agency's consideration. The panel addressed the charge
given to it (recommendations #3 and #4). However, they also
went beyond their charge and recommended additional actions
related to ATSDR's interactions with the affected community
(recommendations #1, #2, #6), revision of a previous public
health assessment of Camp Lejeune (recommendation #5), and
funding of future Camp Lejeune-related activities conducted
by ATSDR (recommendation #7). The panel's recommendations
were summarized in the Executive Summary of the report as
follows:
- Future studies should be conducted in full partnership
with the exposed community. Agency Response
- An advisory panel, with long-term stability, should
be established to oversee health studies of persons with
potential exposure to volatile organic compounds (VOCs)
at Camp Lejeune. Agency Response
- Identify cohorts of individuals with potential exposure,
including adults who lived on base; adults who resided
off base, but worked on base (civilian and military);
children who lived on base; and those who may have been
exposed while in utero. Agency Response
- Initiation of recommended research activities need
not await completion of current ATSDR activities to better
characterize past exposure, but should be conducted in
parallel with the current work. Agency Response
- The 1997 ATSDR Public Health Assessment of Camp
Lejeune should be amended with a recognition that adult
exposures to VOCs may result in adverse health outcomes,
and also include updated information on potential exposures
and estimates of the risk they pose. Agency
Response
- All persons potentially affected by exposure to
VOC in the drinking water at Camp Lejeune should be notified.
Agency Response
- Future funding for Camp Lejeune health studies should
come through direct Congressional action, not DOD, to
avoid even the appearance of a conflict of interest. Agency
Response
ATSDR has carefully considered the panel's recommendations
and has prepared the following responses to each of these
recommendations.
Panel Recommendation #1. Future
studies should be conducted in full partnership with the
exposed community.
Agency Response:
ATSDR considers interaction with the community an important
aspect of its onsite work. ATSDR will continue to work closely
with those members of the affected community who have remained
active on this issue (e.g., "THE STAND"; "The Few, The Proud,
The Forgotten"). ATSDR will create a community assistance
panel (CAP) to increase this partnership (see response to
#2). Although the CAP will not direct ATSDR's activities,
ATSDR will seriously consider and be responsive to all recommendations
from the CAP.
Panel Recommendation #2. An
advisory panel, with long-term stability, should be established
to oversee health studies of persons with potential exposure
to volatile organic compounds (VOCs) at Camp Lejeune.
Agency Response:
ATSDR enthusiastically agrees that representatives of the
affected community should participate in the decisions concerning
future epidemiological studies at Camp Lejeune. In the past,
the mechanism used by ATSDR for community participation
at National Priority List (NPL) sites has been the community
assistance panel (CAP). CAPs are panels established by ATSDR
as set forth in a Federal Register notice (see Vol. 57.
No. 120, June 22, 1992, p. 27779).
A CAP consists of representatives of the community affected
by an NPL site. A CAP may also include representatives from
other interested stakeholders in the affected community,
such as the local government or local businesses. A CAP
meets regularly and makes recommendations to ATSDR. A CAP
does not oversee ATSDR's activities, but its recommendations
are carefully considered by the agency and made available
to the public.
ATSDR proposes that a CAP be established for the Camp Lejeune
site and that the CAP hold its first meeting in early 2006.
One agenda item for the CAP will be to discuss the recommendations
of the Scientific Panel and ATSDR's response. The CAP will
likely review any assessment of the feasibility of conducting
additional epidemiological studies of the affected community
and make recommendations on methods to identify individuals
who lived or worked at the base. If the agency decides to
conduct an epidemiological study, then the CAP will be asked
to provide input on protocol development, study implementation,
and information dissemination.
The CAP should consist of five or more representatives
from the affected community. Since additional epidemiological
studies will likely be on the agenda of the CAP, it is important
that the CAP also have access to, or include, 1-2 scientists
with appropriate expertise who are trusted by the community
representatives and who have experience in environmental
and/or occupational epidemiological research. If necessary,
ATSDR will reimburse the travel expenses of the CAP's members.
The CAP also would involve ex officio members,
including representatives of the Navy. ATSDR will seek recommendations
from the CAP about meeting location and frequency. ATSDR
will be responsible for the creation, administration, and
dissolution of the CAP.
Panel Recommendation #3. Identify
cohorts of individuals with potential exposure, including
adults who lived on base; adults who resided off base, but
worked on base (civilian and military); children who lived
on base; and those who may have been exposed while in utero.
Agency Response:
ATSDR agrees that efforts should be undertaken to evaluate
the feasibility of identifying potential databases to enumerate
adults who lived or worked on the base and children who
lived on the base. ATSDR believes that the cohort exposed
while in utero has already been identified as completely
as possible for the years 1968-1985. ATSDR collected data
from birth certificates during the Camp Lejeune study of
adverse birth outcomes and from the survey conducted as
part of the current case-control study of specific birth
defects and childhood cancers. ATSDR will not go further
back in time for the in utero cohort because birth
certificates were not computerized before 1968.
ATSDR agrees that the first steps to assess feasibility
for these additional cohorts are to determine the proportion
of each cohort that can be identified through available
data sources and how far back in time the data are available.
In addition, ATSDR will continue its efforts to identify
available data on health outcomes that are biologically
plausible (i.e., are known or are suspected based on scientific
evidence to be associated with exposure to VOC-contaminated
drinking water) and that can be linked to the cohort data.
ATSDR agrees that mortality and cancer incidence should
receive the highest priority and are the outcomes most feasible
to study.
ATSDR agrees that epidemiological study decisions concerning
study period, study population, and study outcomes should
be made in consultation with the CAP. ATSDR will defer decisions
about additional epidemiological studies until the feasibility
studies are completed and reviewed by the CAP.
ATSDR believes that extending the study period beyond 1985
is unnecessary. This extension is unnecessary because there
were adequate numbers of people exposed and unexposed prior
to the shutdown of the wells in 1985 for ATSDR to conduct
credible epidemiological studies. A temporal relation can
be evaluated over the years before 1985 because the contamination
varied sufficiently during this time period. In addition,
extending a study beyond 1985 may introduce biases because
of changes over time (e.g., the availability during the
most recent years of more complete and accurate health outcome
data and more accurate water consumption information). The
period after 1985 would not be comparable to the earlier
years. Moreover, to achieve a sufficient sample size to
compare the years during and after the exposure period would
likely require expanding the study period for at least 10
years beyond 1985. However, this issue can be discussed
further with the CAP.
As part of its effort to determine what health outcomes
are biologically plausible and feasible to study, ATSDR
will continue its ongoing review of the health effects literature
on the drinking water contaminants found at the base and
present this information to the CAP. ATSDR will also present
to the CAP its assessment of the biological plausibility
and feasibility of conducting an epidemiological study of
each health outcome mentioned in the Scientific Panel's
report.
Panel Recommendation #4. Initiation
of recommended research activities need not await completion
of current ATSDR activities to better characterize past
exposure, but should be conducted in parallel with the current
work.
Agency Response:
ATSDR will continue to press forward to complete its ongoing
case-control study as quickly as possible, while addressing
the recommendations made by the panel. ATSDR's highest priority
considering existing staff resources is to complete the
current case-control study before the end of 2007. ATSDR
recognizes that additional efforts to create a CAP and to
explore the feasibility of additional studies likely will
require additional staffing and resources. ATSDR will identify
additional resources that are required and communicate these
needs to DOD.
Panel Recommendation #5. The
1997 ATDSR Public Health Assessment of Camp Lejeune should
be amended with a recognition that adult exposures to VOC
may result in adverse health outcomes, and also include
updated information on potential exposures and estimates
of the risk they pose.
Agency Response:
The 1997 PHA acknowledges the current, inconclusive state-of-the-science
regarding TCE exposure at the levels found at Camp Lejeune
in this statement, "not enough scientific information on
humans is available to rule out the possibility of cancerous
health effects from low-dose exposure to VOCs." ATSDR agrees
that the information provided to the public must be based
on up-to-date scientific information, and is continuing
to increase its understanding of the health risks at Camp
Lejeune by monitoring the developments of the ongoing U.S.
Environmental Protection Agency's (EPA) trichloroethylene
(TCE) risk assessment and other new research. At this time,
however, ATSDR does not believe the 1997 PHA should be amended.
Unrelated to the panel recommendation, ATSDR revised the
PHA on the agency's Camp Lejeune Web site in November 2004.
This new material clarifies information presented in Table
3, page 26 of the 1997 PHA and reiterates the uncertainty
of the science.
The purpose of a PHA is to identify potentially exposed
populations, make recommendations to stop, prevent, or reduce
exposure, and to make recommendations for follow-up public
health actions. In the 1997 PHA, ATSDR made recommendations
for health studies to address the need for more scientific
information regarding non-occupational exposures to VOCs
in drinking water. One study was published in 1998 and another
study is currently being carried out with the possibility
for additional studies in the future. Should new information
result in a change of the agency's conclusions or recommendations,
ATSDR may revise the 1997 document.
Panel Recommendation #6. All
persons potentially affected by exposure to VOC in the drinking
water at Camp Lejeune should be notified.
Agency Response:
ATSDR does seek ways to notify the affected community about
its work and study findings. ATSDR will seek recommendations
from the CAP on the most effective ways to disseminate information
about the current study and any future epidemiological studies.
In addition, ATSDR will post the results of its historical
exposure reconstruction work on the agency's Web site, publicize
the availability of these data by issuing a press release,
and work closely with the CAP to identify other methods
of effective outreach to the affected community concerning
ATSDR work. ATSDR plans to make the Web site user-friendly
so that a person can easily discover the estimated concentrations
of the contaminants in the drinking water that served a
particular location (e.g., street address or housing area)
by date.
Panel Recommendation #7. Future
funding for Camp Lejeune health studies should come through
direct Congressional action, not DOD, to avoid even the
appearance of a conflict of interest.
Agency Response:
ATSDR recognizes that the affected community has a level
of distrust of ATSDR and DOD. To address issues of trust
and transparency, ATSDR proposes the establishment of a
CAP. By working closely and respectfully with representatives
of the affected community, ATSDR will be able to conduct
the best science possible and at the same time carefully
consider the views of the community, regardless of the funding
sources used by the agency. ATSDR's past and future work
is conducted independently of the funding source, and DOD
has no say in final decision making about study design,
analysis, or reporting.
Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA) funds, commonly known as Superfund,
are not currently available to conduct additional studies
at Camp Lejeune, and funds from CERCLA are not anticipated.
Therefore, it is likely that additional funds from DOD will
be necessary to conduct new health-related activities at
the base. The appearance of conflict of interest can be
avoided if the agency is seen by the community to be transparent
in its decision-making and to be making a serious attempt
to be attentive and to seek input from the community.
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