03-1180. 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 [phone].

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: Epidemiologic Study Of Gastrointestinal Health Effects And Exposure To Disinfection By-products Associated With Consumption Of Conventionally Treated Groundwater—New—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC).

Background

The primary goal of drinking water treatment is the removal of microorganisms responsible for waterborne disease. The addition of disinfectants such as chlorine is one of the most important steps in pathogen inactivation and may in some cases (such as in many groundwater systems) be the only treatment employed. However, chlorine also reacts with organic compounds in the water to produce halogenated organic by-products (disinfection by-products [DBPs]). One of the most commonly measured groups of DBPs is the trihalomethanes (THMs). Human exposure to THMs has been associated with bladder and colorectal cancer. Public water providers must constantly balance the acute risks of gastrointestinal (GI) illness associated with exposure to microbial pathogens against the long-term risks associated with exposure to DBPs.

This study will estimate the risks for endemic GI illness associated with drinking conventionally treated groundwater and evaluate exposure to THMs in the same people. We plan to recruit 900 households who report that they drink unfiltered tap water from a specific public water system that treats and distributes water from a groundwater source. This utility has agreed to collaborate on the study. The study households will be randomized into one of three groups: (1) Households drinking highly treated bottled water purchased from a bottled water company, (2) households drinking groundwater that has been conventionally treated by the collaborating utility and collected and bottled at the water treatment plant (bottled plant water), or (3) households drinking municipal tap water from the distribution system of the collaborating utility (tap water). We will administer a questionnaire at the beginning of the study to collect data about water use habits and possible exposures to microbial pathogens and THMs. Each study household also will be called weekly for 52 weeks for a short telephone interview to document whether anyone in the household had any gastrointestinal symptoms during the past week. Blood and serum samples will be collected from a subset (50%) of adult household members at the beginning and end of the study. All household members will be asked to provide a saliva specimen each month for the duration of the one-year study. Stool specimens will be collected during episodes of GI symptoms. Blood samples will be analyzed for THMs, and serum, saliva, and stool samples will be stored for later analysis for enteric pathogens. Water samples will be collected from each participating household at the beginning and a subset (50%) of the households at the end of the study and analyzed for THMs. Water samples for microbial analysis will be taken routinely from the source, the finished water, and designated locations in the distribution system.

The specific aims of the study are to (1) determine the risk for GI illness associated with source water quality and treatment efficacy by comparing GI illness rates in people drinking highly treated bottled water with GI illness rates in people drinking bottled plant water; (2) determine the risk for GI illness associated with the distribution system by comparing GI illness rates in people drinking bottled plant water with GI illness rates in people drinking tap water; (3) determine water concentrations and associated blood concentrations of THMs in the study population; and (4) validate and refine existing models of THM exposure using the THM data collected at the participating households and hydraulic and water quality data collected in the distribution system at the time of household recruitment. There is no cost to respondents.

Respondents	Number of respondents	Number of responses/respondent	Average burden/response (in hours)	Total burden (in hours)
Telephone contact	2,500	1	10/60	417
Household survey	900	1	30/60	450
Blood and serum sample collection	900	2	15/60	450
Initial tap water sample collection	900	1	10/60	150
Final tap water sample collection	450	1	10/60	75
Weekly telephone interview	900	52	15/60	780
Saliva specimen collection	900	12	5/60	900
Stool specimen collection	900	2	5/60	150
Total				3,372

Dated: January 10, 2003.

Thomas Bartenfeld,

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