02-7148. Notice of Intent To Seek Approval To Collect Information

AGENCY:

Nutrient Data Lab (NDL), Beltsville Human Nutrition Research Center, Agricultural Research Service, USDA.

ACTION:

Notice and request for comments.

SUMMARY:

In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13) and Office of Management and Budget (OMB) regulations at 5 CFR (60 FR 44978, August 29, 1995), this notice announces the Nutrient Data Laboratory's intent to request approval for a new information collection from consumers of municipal and tap water supplies throughout the U.S. The study will provide data on the fluoride content of the U.S. water supply for development of a comprehensive database of the fluoride concentration of beverages and foods consumed in the U.S., to be released on USDA-NDL's website.

DATES:

Comments on this notice must be received by the agency 30 days after date of publication in the Federal Register to be assured of consideration.

ADDRESSES:

Address all public comments concerning this notice to Dr. Pamela Pehrsson, Nutrient Data Lab, U.S. Department of Agriculture, Room 309A Bldg. 005, 10300 Baltimore Ave., Beltsville, MD 20705, 301-504-0716 (v) or 301-504-0713 (f). Submit electronic comments to [e-mail].

FOR FURTHER INFORMATION CONTACT:

Dr. Pamela Pehrsson, Nutrient Data Lab, U.S. Department of Agriculture, Room 309A Buldg. 005, 10300 Baltimore Ave., Beltsville, MD 20705, 301-504-0716 (v) or 301-504-0713 (f), [e-mail] or Rena Cutrufelli, Nutrient Data Lab, U.S. Department of Agriculture, Room 208A Bldg. 005, 10300 Baltimore Ave., Beltsville, MD 20705, 301-504-0693 (v) or [e-mail].

SUPPLEMENTARY INFORMATION:

Title: Tap Water Sampling for the USDA Fluoride Database.

OMB Number: Not yet assigned.

Expiration Date: N/A.

Type of Request: Approval for collection of water samples and supporting information from U.S. consumers in the who use water from the tap (including a municipal water supply, well water, etc.) for drinking and cooking.

Abstract: NDL will develop a database of the fluoride content of public drinking water supplies and other beverages and foods in the U.S. The proposed work is a collaborative effort between investigators at the Nutrition Coordinating Center (NCC) at the University of Minnesota, and at the Nutrient Data Laboratory at the Agricultural Research Service, US Department of Agriculture (USDA-NDL). This research is designed as a national analytical survey of fluoride in chief contributors to the U.S. diet and based on preliminary work done at USDA-NDL and NCC. This national fluoride database will be released on USDA-NDL's website and will be adapted to support the NCC fluoride assessment methodology. These products will provide an important data resource for nutrition-related research, planning, and policy nationwide. Development of the fluoride database is underway and funded by The National Institute of Dental and Craniofacial Research (NIDCR), NIH.

The fluoride content of the U.S. water supply is important in research of the dental health of children who may be at risk for dental caries (too little fluoride) or overexposure to fluoride, which results in permanent mottling of the teeth. Individuals of all ages are affected by the fluoride content of the water supply because water, in addition to being a highly consumed beverage by itself, is the base of many other high consumption beverages (e.g., carbonated beverages, teas, coffee, and processed fruit drinks). The level of fluoride supplementation and filtration practices for municipal water and for water-based beverages has not always been documented so the analytical results of previous studies may not be meaningful. In addition, previously determined data on the fluoride content of drinking water are local or regional and not the result of a statistically determined, nationally representative approach to sample collection. No seasonal (over time) variability assessment has been documented using national data.

The fluoride of household tap water used for cooking and drinking is the core of this database and detailed documentation about the source and use of the water is critical in the validation the resulting data. The need for this type of information in developing a database usable to the dental research and service communities is pressing.

The sampling approach and frame for this study were developed by statisticians at the National Agricultural Statistics Service, USDA. All county samples were drawn using a minimum replacement probability proportional to size procedure (PMR). The county sizes were taken from 2000 Census county population files given on the Census web site. Each sample contains 72 counties for use in picking up two water samples per county. Within each county, two participants, yielding a total of 144, will be recruited through a phone survey using a randomized listing of all county residents.

Adult individuals, who are considered in a position of responsibility for the household and have agreed to participate will complete a questionnaire which focuses on their source of drinking/cooking water and any treatment of the water. They will fill two 250 ml bottles with tap water from the kitchen faucet.

The bottles and survey will be shipped in a prepaid, prelabeled package (provided to the consumer) to Virginia Polytechnic Institute and State University for analysis. The fluoride survey was modified and abbreviated from a test study of tap water to more effectively phrase the questions and eliminate questions which were not, in retrospect, providing useful information. All responses will be confidential. To ensure confidentiality, fluoride data attached to a consumer code to prevent identification of individuals will be reported only in table format. The data will not be used to assess the quality of a family's socioeconomic status or any other characteristic of that individual's home. Individual consumers will be informed of these confidentiality assurances in the precollection letters. Participants will be awarded an incentive which will be an emergency or travel pack for their automobile (value estimated around $12) for each collection. The pack will not display a company endorsement, but will display a USDA logo. The choice of a similar product equal to or slightly higher in value will be offered as a choice for the second collection.

Estimate of Burden: For the fluoride survey in this study, burden on the respondents will consist of completing the questionnaire along with collection of water samples in two bottles supplied by NDL. The total time for survey completion and water collection is estimated to take 30 minutes or less.

Respondents: Randomly selected consumers in the U.S. public within statistically defined areas (Census-based).

Estimated Number of Respondents: 144 in total, each participating in the information and water collection twice over a 3-6 month period.

Estimated Total Annual Burden on Respondents: 144 × 30 minutes × 2 collections = 144 hours of time and effort across the U.S. contributed to this collection of tap water.

Comments: 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 will have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and the assumptions made; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on the respondents, including the use of appropriate automated, electronic, mechanical, or other technology. Comments should be sent to the address in the preamble. All responses to this notice will be summarized and included in the request for Office of Management and Budget (OMB) approval. All comments will also become a matter of public record.

Dated: January 31, 2002.

Phyllis Johnson,

Director, Beltsville Area Research Center.