04-10049. Proposed Data Collections Submitted for Public Comment and Recommendations

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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 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.

Respondents	Number of respondents	Number of responses per respondent	Average burden per response (in hrs.)
Cases	33	1	45/60
Controls	167	1	45/60

Dated: April 26, 2004.

Alvin Hall,

Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.