[Federal Register Volume 69, Number 86 (Tuesday, May 4, 2004)]
[Notices]
[Pages 24602-24603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10049]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-50-04]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 498-1210. Send written 
comments to CDC, Desk Officer, Human Resources and Housing Branch, New 
Executive Office Building, Room 10235, Washington, DC 20503 or by fax 
to (202) 395-6974. Written comments should be received within 30 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 24603]]

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 continues to verify 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 33 cases 
and 167 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.
    The estimated annualized burden is 150 hours.

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                                                                                                      Average
                                                                     Number of       Number of      burden per
                           Respondents                              respondents    responses per   response  (in
                                                                                    respondent         hrs.)
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Cases...........................................................              33               1           45/60
Controls........................................................             167               1           45/60
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    Dated: April 26, 2004.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-10049 Filed 5-3-04; 8:45 am]
BILLING CODE 4163-18-P