Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Health Effects of Microbial Pathogens in Recreational Waters: National Epidemiological and Environmental Assessment of Recreational (NEEAR) Water Study (Renewal); EPA ICR No. 2081.04, OMB Control No. 2080-0068

Summary:

In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost.

Dates:

Additional comments may be submitted on or before October 23, 2008.

Addresses:

Submit your comments, referencing Docket ID No. EPA-HQ-ORD-2004-0023, to (1) EPA online using www.regulations.gov(our preferred method), by e-mail to ord.docket@epa.gov, or by mail to: EPA Docket Center, ORD Docket, Environmental Protection Agency, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB, Attention: Desk Officer for EPA), 725 17th Street, NW., Washington, DC 20503.

For further information contact:

Elizabeth Sams, Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory, Human Studies Division, Epidemiology and Biomarkers Branch, MD 58-C, 109 T.W. Alexander Dr., Research Triangle Park, North Carolina 27711; telephone number: 919-843-3161; fax number: 919-966-0655; e-mail address:sams.elizabeth@epa.gov.

Supplementary information:

EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On May 14, 2008 (73FR27818) EPA sought comments on this ICR pursuant to 5 CFR 1320.8 (d). EPA received no comments during the comment period. Any additional comments on this ICR should be submitted to EPA and OMB within 30 days of this notice.

EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-ORD-2004-0023, which is available for online viewing at www.regulations.gov, or in person viewing at the Office of Research and Development Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is 202-566-1744, and the telephone number for the ORD Docket is 202-566-1752.

Use EPA's electronic docket and comment system at www.regulations.gov to submit or view public comments, access the index listing of the contents of the docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified in this document. Please note that the EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing at www.regulations.gov as EPA receives them and without change, unless the comment contains copyrighted material, confidential business information (CBI), or other information whose public disclosure is restricted by statute. For further information about the electronic docket, go to www.regulations.gov.

Title: Health Effects of Microbial Pathogens in Recreational Waters: National Epidemiological and Environmental Assessment of Recreational (NEEAR) Water Study (Renewal).

ICR numbers: EPA ICR No. 2081.04, OMB Control No. 2080-0068.

ICR Status: This ICR is currently scheduled to expire on September 30, 2008. Under OMB regulations, the Agency may continue to conduct or sponsor, the collection of information while this submission is pending at OMB. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register when approved, are listed in title 40 of the CFR part 9, are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: The purpose of this study is to examine the health effects associated with swimming exposure at beach sites designated as recreational areas. This study will be conducted, and the information collected, by the Epidemiology and Biomarkers Branch, Human Studies Division, National Health and Environmental Effects Research Laboratory, Office of Research and Development (ORD), U.S. Environmental Protection Agency (EPA). Participation of adults and children in this collection of information is strictly voluntary. The identity of all participants is considered strictly confidential; thus, all data collected are stored without identifiers. This information is being collected as part of a research program consistent with the Section 3(a)(v)(1) of the Beaches Environmental Assessment and Coastal Health Act of 2000 and the strategic plan for EPA's Office of Research and Development and the Office of Water entitled “Action Plan for Beaches and Recreational Water” available at http://www.epa.gov/ord/htm/documents/600r98079.pdf. The Beaches Act and ORD's strategic plan has identified research on effects of microbial pathogens in recreational waters as a high-priority research area with particular emphasis on developing new water quality indicator guidelines for recreational waters. The EPA has broad legislative authority to establish water quality criteria and to conduct research to support these criteria. Thisdata collection is for a series of epidemiological studies to evaluate exposure to and effects of microbial pathogens in marine and fresh recreational waters as part of the EPA's research program on exposure and health effects of microbial pathogens in recreational waters. Health effects data collection was previously conducted in a pilot study, four freshwater coastal sites, and three marine sites under OMB number 2080-0068. The results will be used to help inform the development of new national water quality and monitoring guidelines. The questionnaire health data will be compared with routinely collected water quality measurements. The analysis will focus on determining whether any water quality parameters are associated with increased prevalence of swimming-related health effects.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 0.25 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

The annual public reporting and record keeping burden for this collection of information is estimated to average about fifteen minutes per response. If a single household participant completes all three interviews of the data collection, a total 45 minutes is used.

The interview process consists of three interviews; Two Beach Interviews one Telephone Follow-up: Based on consultation with the individuals listed in Section 3(c) of the ICR, and our experience with similar types of information collection, we estimate that each family will spend an average of 30 minutes completing the beach interview and will require no record keeping. This includes the time for reviewing the information pamphlet and answering the questions. We estimate that each family spends an average of 15 minutes completing the home telephone interview. The telephone interviews will require no record keeping.

All human health data collection will be recorded utilizing computer-assisted personal interviews (CAPI). The telephone interview incorporates the same concept of direct data collection in a desk personal computer (PC) setting. The tablet notebooks and desk PCs are used by interviewers to collect human health data. Screens on these tablets and PCs only display current activated questions. All human health data is stored in secured locations to maintain confidentiality.

The ICR provides a detailed explanation of the Agency's estimate, which is only briefly summarized here:

Respondents/Affected Entities: Individuals frequenting fresh and marine water beaches in the United States and territories.

Estimated Number of Respondents:21,000.

Frequency of Response: On occasion.

Estimated Total Annual Hour Burden:15,750.

Estimated Total Annual Cost:$236,250. This includes an estimated burden cost of $0 and an estimated cost of $0 for capital investment or maintenance and operational costs.

Changes in the Estimates: There is an increase of 10,500 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This increase is required to provide the science necessary to help inform the development of new public health standards for recreational water.

Dated: September 16, 2008. Sara Hisel-McCoy,

Director, Collection Strategies Division.

References

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