03-21517. Proposed Data Collections Submitted for Public Comment and Recommendations

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Proposed Project: Levels of Selected Drinking Water Disinfection By-products in Whole Blood after Showering: The Effect of Genetic Polymorphisms—NEW—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC).

Chlorine is the most commonly used chemical for disinfecting U.S. water supplies; however, chlorine reacts with organic compounds in the water to produce halogenated hydrocarbon by-products. Exposure to these disinfection by-products(DBPs) has been associated with liver and bladder cancer in humans and is suspected of other adverse health outcomes. We recently completed a study of household exposure to one class of DBPs in tap water, trihalomethanes (THMs) (Backer et al., 2000). We found an increase in whole blood levels of one class of (THMs) after people showered or bathed in tap water. We also found that the increases fell roughly into two groups; one group was clustered around a higher level, the other a lower level. It is possible that this clustering is the result of individual variations in physiological characteristics or it could be the result of differences in the ability to metabolize THMs.

Since several polymorphically expressed enzymes are linked to the metabolism of DBPs, these physiologic and genetic differences may be important in determining an individual's risk for cancer and other health risks associated with exposure to these compounds. We plan to measure the change in blood concentration of DBPs after showering. We will then examine the association between people with different enzyme variants and post-exposure blood THM levels. The study will be conducted in two parts. Part 1 will involve recruiting 250 volunteers who do not have a history of lung problems and who are willing to participate in all aspects of the study. These 250 will be asked to provide some demographic information. They will also provide a buccal cell sample that will be analyzed in order to find a pool of 100 volunteers who have the genetic polymorphisms of interest. Part 2 will involve the 100 study subjects giving three blood samples before and three blood samples after taking a shower. A urine sample will be collected and stored for future use in evaluating urine levels of haloacetic acids (HAAs), another important class of drinking water DBPs. Air and water samples will also be collected.

Subjects will complete a brief questionnaire in order to obtain personal information that might impact the dose of volatized DBPs they receive. This data will be analyzed to determine whether the physiologic and genetic differences among individuals result in differences in blood THM levels after similar exposure. There are no costs to respondents.

Respondents	No. of respondents	No. of responses/respondent	Avg. burden/response (in hours)
Screening Interview	250	1	20/60
Consent Form	100	1	20/60
Questionnaire	100	1	20/60
Blood Samples	100	6	5/60
Shower	100	1	20/60
Urine Sample	100	2	10/60
Tap Water Sample	100	1	10/60
Misc. Study Activities	100	1	40/60
Remain at Study Site	100	1	2

Dated: August 18, 2003.

Nancy E. Cheal,

Acting Deputy Director for Policy, Planning and Evaluation, Centers for Disease Control and Prevention.