[Federal Register Volume 68, Number 138 (Friday, July 18, 2003)]
[Notices]
[Pages 42732-42733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18225]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-03-97]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call the CDC Reports
Clearance Officer on (404) 498-1210.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Send comments to Seleda Perryman, CDC
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24,
Atlanta, GA 30333. Written comments should be received within 60 days
of this notice.
Proposed Project
Exposure to Volatile Organic Compounds in Drinking Water and
Specific Birth Defects and Childhood Cancers at United States Marine
Corps Base Camp Lejeune, North Carolina--New--The Agency for Toxic
Substances and Disease Registry (ATSDR).
ATSDR is mandated pursuant to the 1980 Comprehensive Environmental
Response, Compensation, and Liability Act (CERCLA) and its 1986
Amendments, the Superfund Amendments and Re-authorization Act (SARA),
to prevent or mitigate adverse human health effects and diminished
quality of life resulting from exposure to hazardous substances in the
environment. ATSDR plans activities to address these issues which
include conducting health studies at sites on the Environmental
Protection Agency's (EPA) National Priorities List (NPL) to determine
whether and to what degree exposure to hazardous substances at these
sites are harmful to human health.
The United States Marine Corps Base Camp Lejeune, North Carolina,
is one of the federal facilities on EPA's National Priorities List. In
1982, periodic sampling of drinking water sources began at Camp Lejeune
to comply with regulations of the national Safe Drinking Water Act. The
sample results showed that the drinking water supplied to some of the
base housing units was contaminated with volatile organic compounds
(VOCs). The specific chemicals of concern were trichloroethylene (TCE),
tetrachloroethylene (or perchloroethylene) (PCE), dichloroethylene, and
methylene chloride. These chemicals are used as solvents to clean
machinery and weapons and in dry cleaning operations. A 1997 ATSDR
public health assessment (PHA) of the base recommended that an
epidemiological study be considered to determine if mothers exposed to
VOCs in drinking water during their pregnancies were at higher risk of
giving birth to a child with health problems such as a birth defect or
a childhood cancer. ATSDR's initial response to the PHA recommendation
was to conduct a study at Camp Lejeune to evaluate whether mothers who
were exposed to the contaminated drinking water during pregnancy were
at higher risk of having a child which was ``small for gestational
age'' (i.e., an infant weighing less than the 10th percentile based on
published sex-specific growth curves). This study was completed in 1998
and found an association between mothers' exposures to the contaminated
drinking water during pregnancy and small for gestational age infants.
The association between birth defects and drinking
[[Page 42733]]
water contaminated with TCE or PCE could not be reasonably evaluated in
the 1998 study because of extreme under-ascertainment of cases using
data from birth certificates.
In response to the PHA recommendation, ATSDR began the multi-step
process of determining the appropriateness of conducting an
epidemiological study of specific childhood cancers and birth defects
at Camp Lejeune. Based on the scientific literature, ATSDR decided to
focus on specific childhood cancers and birth defects: Childhood
leukemia, childhood non-Hodgkin's lymphoma, spina bifida, anencephaly,
cleft lip and cleft palate. ATSDR conducted a survey in 1999-2002 (OMB
No. 0923-0023) to identify all cases of the specific birth defects and
childhood cancers. About an 80 percent participation rate was achieved
among the approximately 16,000 to 17,000 births that occurred among
women who were pregnant while living at Camp Lejeune during the study
period 1968-1985. These years were chosen because 1968 is the first
year that birth certificates were computerized in North Carolina, and
1985 is the last year that VOC contamination was detected at the base.
All of the participants who took part in the Camp Lejeune Survey in
1999-2002 gave permission to be contacted for future studies.
Additionally, many survey participants have telephoned ATSDR to request
the results of the survey and inquire about future studies.
The overall objective of the proposed case-control study is to
examine whether there is an association between maternal exposures
during pregnancy to TCE and PCE in drinking water at Camp Lejeune
during the period of 1968-1985 and the risk of specific birth defects
(spina bifida, anencephaly, cleft lip and cleft palate) and childhood
cancers (childhood leukemia and Non-Hodgkin's Lymphoma) in offspring.
ATSDR is in the process of verifying that the child had the birth
defect or childhood cancer reported by the parents in the survey. The
parents of the children with possible birth defects or childhood
cancers of concern were contacted and asked to sign a medical records
release form so that ATSDR could gain access to the medical records for
their children. If the child had reached 18 years of age, he or she was
contacted and asked to sign a medical records release form.
Once the review of medical records is complete, the final step is
to conduct an epidemiological study that includes all the cases of
birth defects and childhood cancers of concern. The study will also
include a control sample of children who did not have a birth defect or
a childhood cancer and whose mothers lived at Camp Lejeune during their
pregnancy over the period 1968-1985. The study plans to enroll 100
cases and 500 controls over the course of one year. The epidemiological
study will require the computer modeling of the drinking water system
at Camp Lejeune over the period 1968-1985 in order to determine as
accurately as possible which mothers were exposed to the VOCs in the
drinking water during their pregnancy and which mothers were not
exposed during their pregnancy.
To reduce the amount of time required by the respondents, Computer
Assisted Telephone Interviews (CATI) will be conducted. Following
completion of all respondent interviews, the data will be tabulated and
analyzed (the case group will be compared with the control group).
Because only a very small number of studies have looked at the risk of
birth defects and childhood cancers among children born to mothers
exposed during pregnancy to VOCs in drinking water, the proposed study
will aid in developing or contributing to generalizable knowledge.
Other than their time to participate, there is no cost to the
respondents.
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Number of Average burden
Respondents Number of responses per per response (in Total burden (in
respondents respondent hrs.) hrs.)
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Cases................................... 100 1 45/60 75
Controls................................ 500 1 45/60 375
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Total........................... ................ ................ ................ 450
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Dated: July 14, 2003.
Thomas A. Bartenfeld,
Acting Associate Director for Policy, Planning and Evaluation, Centers
for Disease Control and Prevention.
[FR Doc. 03-18225 Filed 7-17-03; 8:45 am]
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