Page 1 SECTION 1.

A. SUPPORTING STATEMENT 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) TITLE Health Effects of Microbial Pathogens in Recreational Waters.

1( b) ABSTRACT 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, U. S. Environmental Protection Agency ( EPA). Participation of adults and children in this collection of information is strictly voluntary.

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 ( ORD) and the Office of Water entitled " Action Plan for Beaches and Recreational Water. The Beaches Act and ORD's strategic plan have 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. EPA has broad legislative authority to establish water quality criteria and to conduct research to support these criteria. This data collection is for a series of epidemiological studies to evaluate exposure to and effects of microbial pathogens in marine and fresh ( Great Lakes) recreational waters as part of EPA's research program on exposure and health effects of microbial pathogens in recreational waters.

The results of these health effects studies will be used to document human health effects associated with recreational water use and correlate these health effects with ongoing EPA studies to identify a new generation of indicators for detection of human pathogens in recreational water and appropriate,

effective, and expeditious testing methods for these indicators ( addressed separately under Section 3( a)

( v) ( 2 & 3) of the Beaches Environmental Assessment and Coastal Health Act of 2000). The epidemiological results will be used to develop mathematical relationships that will generate of new national water quality guidelines and appropriate monitoring guidelines.

The beaches will be selected based on the potential number of beach goers, water quality parameters, and potential sources of microbial pathogens in the water ( domestic sewage vs animals).

These studies will place the emphasis on beaches that have identified point source contamination ( e. g.,

sewage treatment plants). Families at selected beaches will be interviewed on the beach about a variety of exposures including those to recreational water ( Appendix D). Four to seven days later families will Page 2 be contacted by telephone and interviewed over the phone on the occurrence of selected symptomatology since swimming at the beach ( Appendix E). During the first year, another telephone follow up interview will be conducted 10 14 days following the initial beach interview to determine the extent of illness occurring as a result of longer incubation period pathogens ( Appendix F). In addition,

selected groups of children ( boy and girl scouts, church groups, camps) who are making day trips to selected beaches for recreation will be asked to participate in a special study to identify specific microbial pathogens. Concurrently, recreational waters will be monitored with a selection of water quality indicators developed under a separate EPA research effort. The epidemiologic information will be collected electronically and stored in a computerized database.

The questionnaire health data will be compared with routinely collected water quality measurements. The information collected by this study will be used to estimate the relationship between new water quality indicators and health effects. The analysis will focus on determining whether water quality parameters are associated with increased prevalence of swimming related health effects.

The estimated annual respondent burden for this study is 5000 hours and $ 73,606. The estimated annual agency cost for conducting this study is 11,102 hours and $ 712,298. This study requires no maintenance of records by the respondents.

2. NEED FOR AND USE OF THE INFORMATION COLLECTION 2( a) NEED / AUTHORITY FOR THE INFORMATION COLLECTION The information is being collected as a part of a research program to identify and evaluate exposure to and effects of microbial contaminants of recreational water as part of the U. S. Environmental Protection Agency's research program on exposure and health effects of microbial pathogens in recreational waters. The Beaches Act of 2000 specifically authorizes such studies ( Appendix A).

These studies will provide information on the ability of water quality indicators to predict health effects associated with recreational exposures. These studies will also provide information on the level of gastrointestinal disease and other related illnesses ( skin, ear, eye, urinary tract, and respiratory infections) in adults and children that are associated with marine and fresh water ( Great Lakes)

recreational exposures.

2( b) PRACTICAL UTILITY / USERS OF THE DATA The EPA's Office of Research and Development, the Office of Water and the Centers for Disease Control and Prevention will use the information. EPA investigators will present the results of this program in a series of meetings for identified stakeholders, local and state public health officials, and EPA regional scientists. EPA investigators also will present the study results at scientific conferences Page 3 and will prepare one or more scientific papers for peer reviewed publications.

These peer reviewed scientific publications may be used by EPA's Office of Water to develop water quality criteria or guidelines. Every attempt will be made to identify a wide range of marine and fresh ( Great Lakes) water beaches so the sites will be as representative as is technically feasible. Information from the studies may be useful to local and state public health officials in the design and implementation of a beach monitoring and closure program.

3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA.

3( a) NONDUPLICATION The questionnaires do not duplicate any existing information. While this study closely follows the design and conduct of several previous studies ( see Appendix G), there are no health effects studies that have evaluated swimming related illness and correlated it with the current proposed set of microbial pathogen indicators.

3( b) FEDERAL REGISTER NOTICE This is the second announcement of a public comment period for this ICR. The first Federal Register notice, published on February 15, 2002 ( 67 FR 7150). See Appendix B for Text copy of the Federal Register notice. Federal Register 1 Online via GPO Access ( wais. access. gpo. gov) also provides a copy. Three responses to the Federal Register Notice 1 posting, " Health Effects of Microbial Pathogens in Recreational Waters," were received by April 16, 2002. The comments are summarized and addressed below. The full text of these comment can be found in Appendix C.

The beaches selected should include those having non point sources of contamination ( including domestic and wildlife contamination) and include non beach recreational waters?

These views are certainly legitimate and have support from the scientific community and from the EPA.

Although the addition of a non point source or a non beach study would certainly provide useful information, at this time they are not specifically funded by the current legislation of the Beaches Environmental Assessment and Coastal Act of 2000 ( Appendix A). EPA has interpreted the BEACH Act requirement (" an assessment a of potential human health risks resulting from exposure to pathogens in coastal recreation waters, including non gastrointestinal effects.") to mean that the epidemiologic studies referenced in the Federal Register should identify health effects of swimming in coastal beach areas ( Great Lakes and marine beaches) where the study can access and interview large numbers of people an measure subsequent health effects. Although all types of contamination are of importance,

the coastal water requirement, limited funding, and EPA's authority to regulate point sources of contamination have made point source contaminated beaches ( known and well characterized Page 4 contamination) the priority study sites. However, EPA laboratories are aggressively pursuing new methodologies designed to differentiate between human and non human sources of contamination.

Does this proposed study duplicate previous EPA studies?

The proposed study does not duplicate prior EPA studies. This data collection is for a series of epidemiological studies to evaluate exposure to and effects of microbial pathogens in marine and fresh ( Great Lakes) recreational waters as part of EPA's research program on exposure and health effects of microbial pathogens in recreational waters. The results of these health effects studies will be used to document human health effects associated with recreational water use and correlate these health effects with ongoing EPA studies to identify a new generation of indicators for detection of human pathogens in recreational water and appropriate, effective, and expeditious testing methods for these indicators ( addressed separately under Section 3( a) ( v) ( 2 & 3) of the Beaches Environmental Assessment and Coastal Health Act of 2000). No prior studies have attempted to correlate health effects with these new indicators or the methods utilized. The results will be used to develop mathematical relationships that will be used for the generation of new national water quality guidelines and appropriate monitoring guidelines.

The ICR should specify specific indicators and methods to be used.

The purpose of the ICR was to announce plans for, and receive comments on, the health effects studies that will focus on exposure and health effects of swimmers in coastal recreational areas. Its purpose was epidemiologic in nature and was not intended to cover the EPA's ongoing National Exposure Research Laboratory's ( NERL) program to develop new methods and indicators for recreational water.

Because there are other potentially reliable indicators other that the accepted standards ( E. coli,

enterococcus), EPA will utilize a variety of new indicators and methods ( including specific chemical indicators) as well as including the standard E. coli and enterococcus testing. These studies will not be restricted to previously approved standards. The Beach Act of 2000 also requires other action beyond the epidemiologic studies referenced in this ICR. Other goals of the BEACH Act that are not included in this ICR submission include: 1) provide effective microbial indicators for testing of beach water quality, 2) develop rapid protocols for monitoring microbial indicators in beach waters, and 3)

give guidance to states on how to apply these new criteria to recreational waters. EPA will strive to include a diverse group of candidate indicators and different methodologies ( candidate rapid tests that give results in several hours will be included) in order to meet partner needs for a new generation of recreational water monitoring guidelines. At this time, indicators of fecal contamination and potential agents of gastroenteritis will be the focus. This epidemiologic study will also gather information on Page 5 non enteric illness that may give some insight into the potential for development of indicators for nonenteric illness.

It is difficult to evaluate the burden of this study based on the Federal Register posting.

More detail has been added to the revised ICR, which can be requested, and the Respondent Burden table has been revised.

Data analysis: Will the data be analyzed in the same way that prior EPA studies were analyzed?

Since the completion of the studies by Dufour and Cabelli, developments in statistical theory and the availability of statistical software enable the investigation of other approaches to analysis in order to obtain the best possible fit and shortest prediction intervals. It is the EPA's intention to use methods that do clearly depict uncertainty around the indicator density and their relationships to illness.

Model fitting analyses performed in the original EPA studies by Dufour ( 1984) and Cabelli et al.

( 1982) were based on grouped data using least squares regression. Developments in statistical theory and in the availability of statistical software in the ensuing years will, in addition, enable the investigation of other approaches to analysis in order to obtain the best possible fit and shortest prediction intervals.

The analysis of this multilevel study will be conducted in two stages. In the first stage, the adjusted prevalence of the health outcome of interest is estimated for swimmers and non swimmers. The symptom rate as a difference between the two groups is calculated. This rate difference value is used to develop a statistical relationship with water quality indicators. In the second stage of the analysis,

the uncertainty of the beach specific estimates of illness rates for swimmers and for the rate difference between swimmers and non swimmers will be evaluated by considering linear and nonlinear statistical models that will consider adjustment for potential confounders such as age, beach, gender, and race.

Analyses will be conducted by comparing gastrointestinal symptoms and illness to water quality parameters. Regression analysis will be conducted in a similar manner as in previous studies and will use a two step analysis to correct for beach variability. In the first step, swimming associated illnessspecific adjusted logits of symptom prevalence will be calculated from a logistic regression model for the gastrointestinal symptoms of interest controlling for age, sex, family size, socioeconomic status, and other potential confounders ( other recreational exposures). In the second step, these beach specific adjusted logits will be regressed against the beach specific water pollutant concentrations.

Water quality indicator concentrations for each methodology would be entered as continuous variables into the model. Water pollution concentrations would be based on actual measurements at Page 6 each beach. Direct measurements of water quality pollution concentration at all beaches will be conducted. It is expected the monitoring scheme may allow the development of models to consider upper and lower bound parameters for inclusion in the model.

Our experience with the new water quality indicators is, to date, limited. Current assumptions are that they will be at a minimum as good as, if not better, than current EPA or state indicators ( e. g.,

enterococci, E. coli, and fecal coliforms).

3( c) CONSULTATIONS The following people have been consulted:

Michael Beach, Epidemiologist, CDC, National Center for Infectious Diseases Abdel el Shaawari, National Water Research Institute, Canada Center for Inland Waters,

Burlington, Canada David Parkhurst, Indiana University, School of Public and Environmental Affairs, Bloomington,

IN Richard O. Gilbert, Private Consultant, Rockville, MD Paul Succop, University of Cincinnati, Cincinnati, OH Public Meetings: The proposed studies have been publicly discussed at the following meetings:

East Coast Regional Beach Conference  October 18 19, 1999 West Coast Regional Beach Conference  August, 1999 Great Lakes Beach Conference  February 5, 2000 The response from these individuals and organizations has been favorable.

3( d) EFFECTS OF LESS FREQUENT COLLECTION The questionnaire information will be collected only once during the summer from a family. This factor, therefore, does not apply to this study.

3( e) GENERAL GUIDELINES We have adhered to all of OMB's general guidelines.

3( f) CONFIDENTIALITY We will adhere to all standard steps to maintain confidentiality. These include the exclusion of personal identifiers from the database following completion of the phone interviews and storage of hard copies in locked files. Contractor involvement will be monitored by requiring hard and/ or electronic copies to be stored at EPA after the contractor has completed data processing. The contractor has agreed to observe the rules of confidentiality regarding the health information provided by individuals and their families. Page 7 3( g) SENSITIVE QUESTIONS No questions of a sensitive nature will be required.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) RESPONDENTS / SIC CODES This study will be conducted among families who are at the selected beaches around the country.

Based on previous studies, it is anticipated about 4500 families will be enrolled from all sites in a single recreational season.

Children constitute a susceptible subpopulation due to the immaturity of their immune system and their lack of lifetime exposure experience. Pregnant women also constitute a susceptible subpopulation for severe disease due to dehydration associated with gastroenteritis.

4( b) INFORMATION REQUESTED ( i) Data Items:

Each questionnaire will ask a single adult member of the family to provide the information listed for all members of the family. The questionnaires can be found in Appendix D, E and F. The requested information includes questions specific to past illnesses, recreational experience, other risk information and general household characteristics.

This study will use water quality monitoring data and meteorologic data that will be routinely collected by EPA and EPA contractors under separate EPA research efforts.

There are no maintenance of records by respondents required for this study.

( ii) Respondent Activities The representative member of the family will be given a brochure describing the study's risks and benefits and will be asked for verbal consent to enroll them in the study. The families will be interviewed on the beach and then will be followed via telephone interview 4 to 7 days later. In the first year, a second follow up 10 to 14 days after the initial beach visit will also be attempted. The utility of a second interview will be reviewed after the first year for possible deletion.

5. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) AGENCY ACTIVITIES EPA's Epidemiology and Biomarkers Branch and an EPA contractor will be responsible for administering the questionnaire, answering respondent questions, reviewing respondent answers,

developing and maintaining the database, analyzing the data and storing and reviewing the data.

5( b) COLLECTION METHODOLOGY AND MANAGEMENT Page 8 The initial interview questionnaire that contains family demographics and usual beach activities will be collected using computer assisted technology ( CATI) that contains the questionnaire ( Appendix D).

The water quality measurements will be collected by EPA's National Exposure Research Laboratory under a separate ongoing EPA research project. The water quality parameters will include real time measurement of fecal indicators ( e. g., enterococci, E. coli, chemical indicators) and/ or measurement of fecal indicators and/ or microbial pathogens with methods that give answers in two hours or less. Beach monitoring sites will be selected to support a regulatory program and are located in areas representative of geographic differences and a range of exposures associated with point source fecal contamination of recreational waters. These sites are intended to support an epidemiological study and therefore have been designed to provide sufficient information on the gradient of exposures to fecal contamination found in recreational waters. No additional burden will be placed on the local water pollution agencies in the selected areas.

All data will be reviewed for unusual or unacceptable values. The CATI questionnaire data will be verified through the daily data verification programs. Statistical data will be maintained in electronic format using the Statistical Analysis System ( SAS). We will control access to the data in accordance with Federal privacy regulations and OMB Circular A 110.

5( c) IMPACT ON SMALL BUSINESSES OR OTHER SMALL ENTITIES The procedures for beach interview and follow up telephone interviews, have been designed to minimize the burden to the families who agree to participate in the study.

5( d) COLLECTION SCHEDULE The timeline for this study is to ( a) conduct pilot studies the summer of 2002, ( b) conduct full scale studies the summers of 2003, 2004 and 2005, and ( c) collect water quality measurements at the beaches concurrently with beach interviews. Preliminary data sets will be delivered by the end of December for each recreational season. These preliminary data sets will be extensively reviewed for quality assurance prior to any analysis.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a). ESTIMATING RESPONDENT BURDEN Interview & Telephone Follow up: Based on consultation with the individuals listed in Section 3( c),

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 will spend an average of 30 minutes completing the first home telephone interview and Page 9 20 minutes completing the second home telephone interview. The telephone inteviews will require no record keeping.

TABLE 1. ESTIMATED ANNUAL RESPONDENT BURDEN Type of Respondent Respondent Activities Estimated Number of Respondents Burden Hours Frequency Annual Reporting Burden Annual Cost X 14.72 Parent Beach Interview 4500 0.50 hr. 1 2250 hr $ 33,120 a Parent Complete home interview I ( 80%) 3600 0.50 hr. 1 1800 hr $ 26,496 a Parent Complete home Interview II ( 80%) 2880 0.33 hr. 1 950 hr $ 13,990 a Totals 5,000 hr $ 73,606 a $ 14.72/ hour ( average hourly wage)

ANNUAL REPORTING BURDEN: 5,000 hours ANNUAL RESPONDENT COST: $ 73,606 NO ANNUAL RECORD KEEPING BURDEN 6( b) ESTIMATING RESPONDENT COSTS Beach Interview: The wage estimate for the parental respondent is based on the average salary for women who work full time reported by the US Bureau of Labor and Statistics Employment Cost Trends ( March 1999) at $ 14.72 per hour. Given the 0.50 hour burden, the respondent cost for each family is $ 7.36. Home Telephone Interview I: The wage estimate for the parental respondent is based on average salary for women who work full time reported by the US bureau of Labor and Statistics employment Cost Trends ( March 1999) at $ 14.72 per hour. Given the 0.50 hour burden, the respondent cost for each family is $ 7.36. Home Telephone Interview II: The wage estimate for the parental respondent is based on average salary for women who work full time reported by the US bureau of Labor and Statistics employment Cost Trends ( March 1999) at $ 14.72 per hour. Given the 0.33 hour burden, the respondent cost for each family is $ 4.85. NO CAPITAL COSTS ARE INVOLVED.

NO O& M COSTS ARE INVOLVED. Page 10 6( c) ESTIMATING AGENCY BURDEN AND COST TABLE 2. AGENCY COST ANNUAL BURDEN Burden Hours Cost ($)

AGENCY ACTIVITIES Contractor EPA Freq Total Hours Contractor $ 66/ hr EPA $ 49/ hr Prepare and format questionnaires 60.00 80.00 1 140.00 $ 3,960 $ 3,920 Prepare computers 120.00 8.00 1 128.00 $ 7,920 $ 392 Plan logistics & coordination 40.00 40.00 8 640.00 $ 21,120 $ 15,680 Recruit and interview on beach 480.00 60.00 8 4320.00 $ 253,440 $ 23,520 Telephone interview I 160.00 0.00 8 1280.00 $ 84,480 $ 0 Telephone interview II 160.00 0.00 8 1280.00 $ 84,480 $ 0 Prepare statistical data sets and reports 160.00 0.00 1 160.00 $ 10,560 $ 0 Collect/ analyze water quality data 240.00 8.00 8 1984.00 $ 126,720 $ 3,136 IRB package preparation & submission 40.00 10.00 1 50.00 $ 2,640 $ 490 Quality Assurance & Quality Control 40.00 10.00 8 400.00 $ 21,120 $ 3,920 Convert data to electronic form 10.00 0.00 8 80.00 $ 5,280 $ 0 Perform statistical analysis 480.00 160.00 1 640.00 $ 31,680 $ 7,840 11102.00 $ 653,400 $ 58,898 AGENCY TOTAL ANNUAL BURDEN: 11,102 hours AGENCY TOTAL ANNUAL COST: $ 653,400 +$ 58,898 =$ 712,298 These agency burden estimates were based on our prior experience in developing and gathering information for research purposes. The agency costs have been based on a GS 13( 6) for the primary investigator and include benefits. The contractor costs are based on a composite cost given the people needed to conduct this study.

Estimated annualized hours and costs could be over estimated by 33%.

6( d) ESTIMATING THE RESPONDENT UNIVERSE AND TOTAL BURDEN AND COSTS Based on previous studies conducted in the 1970s and 1980s, we estimate that the respondent universe for each recreational water season is 4500 families for the beach interview, 3600 telephone interview follow up and 2880 for the second telephone follow up ( assuming 80% completion rates). Thus the total estimated respondent burden for this study is 5,000 hours from 4500 families and $ 73,606.

6( e) BOTTOM LINE BURDEN HOURS AND COSTS / BURDEN TABLES The estimated respondent burden for this study is 5,000 hours and $ 73,606. The estimated agency cost for Page 11 conducting this study is 11,102 hours and $ 712,298.

6( f) BURDEN STATEMENTS Beach Interview: Parental reporting burden for this collection of information is estimated to average 30 minutes and will require no record keeping. This includes the time for reviewing the informational brochure,

obtaining verbal consent, and answering the questions.

Telephone Interview Follow up: The respondent's reporting burden for this collection of information is estimated to average 30 minutes per family. This includes times for reviewing information collected on the beach and answering questions.

Telephone Interview Follow up II: The respondent's reporting burden for this collection of information is estimated to average 20 minutes per family. This includes times for reviewing information collected on the first telephone interview and answering questions.

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;

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. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates,

and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822T), 1200 Pennsylvania Ave., NW, Washington, D. C. 20460; and to the Office of Information and Regulatory Affairs,

Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number 2081.01 and OMB control number in any correspondence. Page 12 B. STATISTICAL APPROACH 1. SURVEY OBJECTIVES, KEY VARIABLES, AND OTHER PRELIMINARIES 1( a) SURVEY OBJECTIVES The objective of the study is to conduct health effects studies to evaluate exposure to microorganisms in recreational waters and their subsequent health effects. The beaches will be chosen to consider a range of exposures and will primarily consider fecal contamination from point sources ( e. g., sewage treatment plants).

For the first year, preliminary pilot work will be done at a single beach. Subsequent years of study will evaluate three or four beaches. Current estimates are that a minimum of three marine beaches will be evaluated and a minimum of six fresh water beaches will be evaluated. The results of these health effects studies will be used to document human health effects associated with recreational water use and correlate these health effects with ongoing EPA studies to identify a new generation of indicators for detection of human pathogens in recreational water and appropriate, effective, and expeditious testing methods for these indicators ( addressed separately under Section 3( a) ( v) ( 2 & 3) of the Beaches Environmental Assessment and Coastal Health Act of 2000). The results will be used to develop mathematical relationships that will be used for the generation of new national water quality guidelines and appropriate monitoring guidelines.

1( b) KEY VARIABLES The beach interview will collect the standard demographic variables of age, race and gender. The survey will collect the health information mentioned below in Section B. 2 ( d) Questionnaire Design . Questionnaires can be found in Appendices D, E, F.

1( c) STATISTICAL APPROACH The health status of the study population will be evaluated along with the water quality in the local beach area in which they will be visiting. Statistical associations between health effects and water quality parameters will be calculated. The targeted population will be families with children approximately age 2 to 10. The sampling base may change for each beach depending on size. The families will be identified as such by the beach interviewers. A single respondent that is an adult member of the household ( e. g., mother) will be asked to participate in the study.

The proposed data collection is designed as a multilevel analytic study ( also called semi ecological or semiindividual using both ecological level information on environmental exposures and individual level information on health status and potential confounders. The multilevel design has particular utility whenever a common environmental exposure is shared by individuals clustered within a geographic area. The questionnaire obtains individual level information on health status and potential confounders, such as age, sex, race, Hispanic status,

housing characteristics, family characteristics and behaviors, and other variables. Environmental exposures are to be independently measured for each beach based cluster. Page 13 1( d) FEASIBILITY Obstacles: Based on previous experience with beach studies, the major problem has been non response primarily related to catching families just prior to leaving the beach area. This is usually improved by providing a minimal incentive to participate such as a beach ball, cooler, or tote bag.

Sufficient funds: This study has been budgeted with sufficient funds for the first year of pilot work.

Remaining years of funding have been requested and is pending the budget process. In the event a dramatic cut in the beaches research program were to take place, the study could be downsized to fewer beaches.

Time line: The beach studies will be completed by the end of September of the appropriate recreational season. Processing of recreational season data sets will be completed by December of the same calendar year.

2. SURVEY DESIGN 2( a) Target Population and Coverage The target population for this study will be families with children ages 2 to 10 exposed to various levels of water pollutants from point sources at fresh ( Great Lakes) and marine beaches in the continental United States.

2( b) Sample Design ( i) Sampling frame.

The sampling frame will be families on the beach currently being monitored. The beaches that will be monitored must have historical data suggesting the appropriate population size to support sampling families. It is estimated 80 125 families per weekend per site will be needed.

( ii) Sample size.

The sample size for this study is constrained by the numbers of families visiting the beach under consideration. From earlier studies, we estimate that this sample size will provide 90% power to detect, with 95%

confidence, the expected association between water quality indicators and associated gastrointestinal health effects.

( iii) Stratification variables.

The primary variables used for stratification will be demographic variables. Additional stratification may be assessed by beach, by level of water exposure, and by level of water quality indicator if the data is robust enough for such analysis. Our experience to date is limited with the new water quality indicators. Current assumptions are that they will be at a minimum as good as, if not better, than current EPA or state indicators ( e. g., enterococci, E. coli, and fecal coliforms).

( iv) Sampling method.

A complete sample of all eligible families for each day and beach under study will be attempted.

( v) Multi stage sampling.

Not applicable.

2( c) PRECISION REQUIREMENTS Page 14 ( i) Precision targets.

The survey is designed to show, with 80% confidence, the statistical relationship associated specifically with a water quality indicator.

( ii) Non sampling error.

Most health and epidemiology studies are concerned with errors resulting from the misclassification of both disease and exposure. Exposure misclassification will be minimized by collecting water quality measurements on new indicators. The precision or predictability of the new indicators is estimated to be at least as good as the previous indicators. There is some concern over misclassification of gastrointestinal symptoms and illness since we are relying on self reporting. The standard practice to account for this potential error has been to weigh, or place the reporting of symptoms, in categories of credibility. Groups of symptoms reported together are more credible, and symptoms that require a person to alter their normal routine ( stay home, stay in bed or seek medical care) are the most credible. Although some parents may fail to fully report gastrointestinal symptoms and illness among their children, the propensity to report should not be associated with the exposures of interest. Parental under reporting of gastrointestinal conditions that are not associated with the exposures of interest (

nondifferential misclassification) will reduce the statistical power of the study, and bias the observed association of interest towards the null ( no difference) and therefore increase the variance in the modeled relationship between illness and water quality indicator.

Confounding of the association of interest is always an important issue in observational studies.

Any determinant of the health outcome of interest that is non causally associated with the exposure of interest may confound the association under study. Since the children in this study have not been randomly assigned to differing recreational water exposures, differences in the distribution of various independent determinants of gastrointestinal disease, across the study area, may be potential confounders. As detailed below, a substantial portion of the questionnaire is devoted to the determination of information on potential confounders.

2( d) QUESTIONNAIRE DESIGN The two data collection instruments in this study each serve a unique purpose. The first is the beach interview which establishes eligibility to participate in the study, recreational habits at the beach, and background demographic information. The telephone interview is to verify key pieces of information in the beach interview,

obtain symptom and illness information and determine other exposures that may confound the association ( e. g.,

other recreational exposures). Copies of the beach interview and the two telephone follow up surveys are included in Appendix D, E, and F, respectively. The interview forms may be modified based on piloting and use during the 2002 season.

The personal identifying information in the beach interview ( name, address, phone number, time to call for follow up) are required to ensure efficient follow up. This information will be recorded electronically since the interview will be done using Computer Assisted Technology Application ( CATI) and hence allows for preserving Page 15 confidentiality through limited access data files. The personal identifying information will not become part of the statistical data base.

For each member of the family it is important to determine the members of the family, their age, sex , ethnic status, race and recreational and beach activities. These variables are all potential confounders of the association of interest. The information on the beach visit date and the participant birth dates will allow us to check the direct parental report of all family member ages. Previous work has suggested little association between gastrointestinal illness and race or ethnicity, however these studies will be collecting information on non gastrointestinal illness ( e. g., urinary tract, skin, respiratory, eye and ear) associated with recreational water exposures and there has been some reporting of racial differences associated with those illnesses.

The telephone follow up requests information about several common gastrointestinal, urinary tract,

respiratory, eye, ear and skin conditions ( diarrhea, vomiting, respiratory problems, runny nose, ear infections and skin infections).

The questions in the current household members section are all related to potential confounders. Number of rooms per household is an indicator of socioeconomic status.

Style of questions Most questions have forced choice between multiple responses or two choices ( Yes, No). The number of free form questions are limited to facilitate the CATI process.

Purpose of questions The outcomes of interest are determined by questions on common gastrointestinal, urinary tract, respiratory,

eye, ear and skin conditions.

Potential confounders include age, sex, ethnic status and race ; severe preexisting health conditions of participants; and socioeconomic status as indicated by the family's residence, or family size. We also examine,

as potential confounders, other recreational exposures, eating out, contact with animals, children in diapers and other ill individuals.

3. PRETESTS AND PILOT TESTS The beach interview is based on previous questionnaires used in the studies conducted by EPA in the 1970s and 1980s. In addition, the questions have been compared to and when possible modifications made to be compatible with the Centers for Disease Control, National Center for Infectious Diseases FoodNet survey. In addition, similar questions have been used in drinking water studies ( ref Payment 1, Payment 2, Calderon,

Colford). Respiratory symptoms have been adapted from the Epidemiology Standardization Project of the American Thoracic Society and the Division of Lung Diseases. The questionnaire will be evaluated after the beach trials in 2002. Modifications may be made based on that experience. It is anticipated that most of the modifications will come in the area of questions on non gastrointestinal illnesses and symptoms.

4. COLLECTION METHODS AND FOLLOW UP Page 16 4( a) COLLECTION METHODS An informational meeting will be held at each beach site to explain the study. It will include EPA regional scientist( s), identified state officials, the local public health officer ( if the beach is not federal or state managed),

and other interested persons. After the meeting, a letter of endorsement will be requested from the party charged with managing the recreational site. In the stakeholder meetings held by EPA, many potential beaches have expressed an interest in having their beaches chosen for study.

Beach interviews will be done on Friday, Saturday, Sunday, and Mondays during the recreational season ( June to mid September depending on the geographic location). Trained interviewers will be deployed on the beach and will visually identify families eligible to participate. Interviews will begin late morning to late afternoon to try and catch families just prior to their leaving the beach for the day. Other types of recruitment such as partial recruitment on the beach and then having the family stop by an interview center near the parking area at the beach will be considered in the first year.

Four to seven days from leaving the beach, families will be recontacted by telephone at the agreed upon time. Health status and confirmation of recreational and other potential exposures will be obtained over the phone. An additional follow up will be attempted 10 14 days after visiting the beach. This second interview will be evaluated the first year as to efficiency and value of information. This second follow up is based on discussions with CDC and based on acknowledgment of microbial pathogens that have incubation periods longer than the four to seven days used for the first telephone interview ( e. g., Cryptosporidum has a mean incubation period of 7 days).

4( b) SURVEY RESPONSE AND FOLLOW UP Response rates to the beach interview have historically ranged from 60 to 80% among those families eligible.

The follow up response rate is estimated to average 80% for the whole study. Similar studies in the United Kingdom, Hong Kong and Canada have had similar response rates using a similar study design and methodology.

5. ANALYZING AND REPORTING SURVEY RESULTS 5( a) DATA PREPARATION The completed interviews will verify that data submitted is internally consistent, as entered. The CATI program will flag missing items prior to terminating the interview and will also flag erroneous responses as well to allow the interviewer to obtain the correct information while interviewing the family. The CATI system will also eliminate errors associated with data entry.

5( b) ANALYSIS The analysis of a multilevel study is conducted in two stages. In the first stage, the adjusted prevalence of the health outcome of interest is estimated for swimmers and non swimmers. The symptom rate as a difference between the two groups is calculated. This rate difference value is used to develop a statistical relationship with Page 17 water quality indicators. In the second stage of the analysis, the uncertainty of the beach specific estimates of illness rates for swimmers and for the rate difference between swimmers and non swimmers will be evaluated by considering linear and nonlinear statistical models that will consider adjustment for potential confounders such as age, beach, gender and race.

Analyses will be conducted by comparing gastrointestinal symptoms and illness to water quality parameters. Regression analysis will be conducted in a similar manner as in previous studies and will use a twostep analysis to correct for beach variability. In the first step, swimming associated illness specific adjusted logits of symptom prevalence will be calculated from a logistic regression model for the gastrointestinal symptoms of interest controlling for age, sex, other potential confounders ( other recreational exposures) and family size. In the second step, these beach specific adjusted logits will be regressed against the beach specific water pollutant concentrations.

Water quality indicator concentrations for each methodology would be entered as continuous variables into the model. Water pollution concentrations would be based on actual measurements at each beach. Direct measurements of water quality pollution concentrations at all beaches will be conducted. It is expected the monitoring scheme may allow the development of models to consider upper and lower bound parameters for inclusion in the model.

In our subsequent publications, we will explicitly report the results for associations between health characteristics and ( a) the directly measured concentrations for all beaches and ( b) the modeled concentrations as a summary for all marine beaches together and all fresh water beaches together. This will allow an assessment of the role of the modeling of water quality indicator concentrations on our results.

5( c) REPORTING RESULTS A report on each of the beaches water quality monitoring data will be developed and available to the managers of the beach, as well as appropriate state authorities if the beach is not a state managed beach. At the completion of the entire program, an overall report will be produced that synthesizes all the information. An EPA report will be produced for Agency and public use. A manuscript for each recreational season will be submitted for publication in a peer reviewed scientific journal. Page 18 APPENDIX A: Clean Water Act Beaches Environmental Assessment and Coastal Health Act of 2000 ( Public Law 106 284   October 10, 2000)

TITLE 42  PUBLIC HEALTH CHAPTER 85  FEDERAL WATER POLLUTION CONTROL ACT Section 303. Revisions to water quality criteria ( a) STUDIES CONCERNING PATHOGEN INDICATORS IN COASTAL RECREATION WATERS.

Section 104 of the Federal Water Pollution Control Act ( 33 U. S. C. 1254) is amended by adding at the end the following:

( v) STUDIES CONCERNING PATHOGEN INDICATORS IN COASTAL RECREATION WATERS.   Not later than 18 months after the date of the enactment of this subsection, after consultation and in cooperation with appropriate Federal, State, tribal, and local officials ( including local health officials), the Administrator shall initiate, an, not later than 3 years after the date of the enactment of this subsection, shall complete, in cooperation with the heads of other Federal agencies, studies to provide additional information for use in developing:

( 1) an assessment of potential human health risks resulting from exposure to pathogens in coastal recreation waters, including nongastrointestinal effects;

( 2) appropriate and effective indicators for improving detection in a timely manner in coastal recreation waters of the presence of pathogens that are harmful to human health;

( 3) appropriate, accurate, expeditious, and cost effective methods ( including predictive models) for detecting in a timely manner in coastal recreation waters the presence of pathogens that are harmful to human health; and ( 4) guidance for State application of criteria for pathogens and pathogen indicators to be published under Section 304( a)( 9) to account for the diversity of geographic and aquatic conditions. Page 19 APPENDIX B: Federal Register 1 [ Federal Register: February 15, 2002 ( Volume 67, Number 32)]

[ Notices]

[ Page 7150 7151]

From the Federal Register Online via GPO Access [ wais. access. gpo. gov]

[ DOCID: fr15fe02 68]

=======================================================================

ENVIRONMENTAL PROTECTION AGENCY [ FRL 7146 6]

Office of Research and Development; Agency Information Collection Activities: Proposed Collection; Comment Request; Health Effects of Microbial Pathogens in Recreational Waters AGENCY: Environmental Protection Agency ( EPA).

ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this notice announces that the EPA is planning to submit the following Information Collection Request ( ICR) to the Office of Management and Budget ( OMB).

TITLE: Health Effects of Microbial Pathogens in Recreational Waters.

Before submitting the ICR to OMB for review and approval, the EPA is soliciting comments on specific aspects of the proposed information collection as described below.

DATES: Comments must be submitted on or before April 16, 2002.

ADDRESSES: Public comments should be submitted to: Dr. Rebecca L.

Calderon, US EPA ( M D 58 C), Research Triangle Park, NC 27711.

FOR FURTHER INFORMATION CONTACT: Interested persons may obtain a copy of the ICR without charge by contacting: Dr. Rebecca L. Calderon, ( 919)

966 0617, FAX: ( 919) 966 0655, E mail:

calderon. rebecca@ epamail. epa. gov, or by mailing a request to the address above. Page 20 SUPPLEMENTARY INFORMATION:

Affected entities: Entities potentially affected by this action are families frequenting fresh and marine water beaches in the continental United States.

Title: Health Effects of Microbial Pathogens in Recreational Waters.

Abstract: 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, U. S. Environmental Protection Agency ( EPA). Participation of adults and children in this collection of information is strictly voluntary.

This information is being collected as part of a research program consistent with the Sec. 3( a)( v)( 1) of the Beaches Environmental Assessment and Coastal Health Act of 2000 and the strategic [[ Page 7151]]

plan for EPA's Office of Research and Development ( ORD) and the Office of Water entitled    Action Plan for Beaches and Recreational Water.''

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. This data 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. The research plan includes piloting the collection of both recreational information and water quality information during the summer months of 2002. Multiple sites with refined study design will be conducted in 2003, 2004 and 2005. The information collected by this study program will be used to estimate the relationship between water quality indicators and health effects.

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 Burden means the total time, effort, or financial resources Page 21 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;

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.

Table 1. Estimated Annual Respondent Burden

Estimated Annual Type of respondent Respondent number of Burden Frequency reporting Annual cost activities respondents hours burden

Parent......................... Beach Interview... 1500 0.40 1 600 \ a\ $ 8,832 Parent......................... Complete home 1200 0.33 1 396 \ a\ 5,830 interview I ( 80%).

Parent......................... Complete home 960 0.17 1 163 2,400 interview II ( 80%).

Totals..................... .................. ........... ......... ......... 1,159 hr 17,062

\ a\ $ 14.72/ hour ( average hourly wage).

There are no direct respondent costs for this data collection.

No Annual Record Keeping Burden An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

The EPA would like to solicit comments to:

( i) Evaluate 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;

( ii) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; Page 22 ( iii) Enhance the quality, utility, and clarity of the information to be collected; and ( iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e. g., permitting electronic submission of responses.

Dated: February 4, 2002.

Linda Birnbaum,

Director, Human Studies Division, National Health & Environmental Effects Research Laboratory, Office of Research and Development.

[ FR Doc. 02 3771 Filed 2 14 02; 8: 45 am]

BILLING CODE 6560 50 P [ EPA Home | FR Home | Comments | FR Search ]

Last Updated: Friday, February 15, 2002 11: 03: 33 URL: http:// www. epa. gov/ fedrgstr/ EPA WATER/ 2002/ February/ Day 15/ w3771. htm Page 23 APPENDIX C: Comments and Response to Federal Register I Rebecca Calderone US Environmental Protection Agency RE: Health Effects of Microbial Pathogens in Recreational Waters April 12, 2002 Dear Ms. Calderone The has reviewed a document entitled " Health Effects of Microbial Pathogens in Recreational Waters. We wholeheartedly support the this study and are pleased to note that health outcomes such as skin, eye and ear infections in addition to gastrointestinal issues, will be included. We do, however, have some concerns that need to be addressed in the protocol.

It appears that this study will only be conducted at beaches with known point sources of pollution. It is important that studies also be conducted at beaches with non point sources, especially where the contamination is of non human origin.

The protocol states that the " water quality parameters will include real time measurement of fecal indicators ( e. g. enterococci) and or measurement of fecal indicators and/ or microbial pathogens with methods that give answers in two hours or less." The organisms that will be reviewed should be specified within the protocol. In addition, we are unaware of any testing for those indicators commonly associated with bathing water quality that will provide results within two hours that are presently approved.

Thank you for your consideration Page 24 April 16, 2002 Dr. Rebecca L. Calderon U. S. Environmental Protection Agency ( M D 58 C) Research Triangle Park, NC 27711 SUBJECT: Comments: EPA's Health Effects of Microbial Pathogens in Recreational Waters; Federal Register: February 15, 2002 ( Volume 67, Number 32)

Dear Dr. Calderon:

The appreciates the opportunity to comment on EPA's Agency Information Collection Activities: Proposed Collection: Health Effects of Microbial Pathogens in Recreational Waters, February 15, 2002.

EPA has solicited comments regarding the collection of information that will be required by the proposed study. The following areas were identified: ( i) Evaluate 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; ( ii) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methods and assumptions used; ( iii) Enhance the quality, utility, and clarity of the information to be collected; and ( iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated... technology.

The supports these additional efforts to study the epidemiology of swimmer associated illnesses in recreational waters. Our responses to the items listed above are as follows: ( i) We believe that the collection of the information in the proposed study is necessary for the proper performance of the Agency's functions, particularly in light of the recent passage of PL 106 284   The BEACH ACT of 2000. Additional comments regarding the proposed study will follow the Department's comments on items ( i iv). ( ii) Based on the information presented, it is difficult to evaluate the burden of the proposed collection without additional information on the scope of the study and any modification to the study that may occur. ( iii) The quality, utility and clarity of the information provided will directly depend on the exact scope of work defined in the study. Please see the comments following response ( iv). ( iv) We have no suggestion on how to minimize the burden of the collection of information on those who are to respond.

Although the proposed study was not addressed in any detail in this announcement, we offer the following concerns and issues for your consideration in developing the final scope of work for this extremely important study. The has been actively participating in the development of EPA's Implementation Guidance for Ambient Water Quality Criteria for Bacteria and the National Beach Guidance and Grant Performance Criteria for Recreational Waters. During recent discussions at each of these workgroups, it was indicated that your study would address areas much broader than the designated bathing beach areas, specifically areas where either bathing was relatively infrequent or areas where only non anthropogenic sources of fecal pollution potentially exist. Based on the information in the current notice, the scope of the study implies that this effort will only address the designated bathing beach areas during multiple summer seasons.

Bathing beaches are a small subset of all recreational waters. There is a need to know the relative risk of exposure to indicators from human sources, domestic animal sources, and wildlife sources. Health impacts have been documented for each of these sources and may play a significant role is how we ultimately define public health protection. We encourage you to expand the scope of this study to include areas with a variety of impacts at both Page 25 beach and non beach areas.

One issue not addressed in the previous studies used as the basis of the 1986 criteria was the certainty of the source of the indicators. It was mentioned that the polluted waters were know to be under the influence of human associated pollution, but the characteristics of the discharge ( e. g., the size of the municipal WWTP, the flow volumes, treatment level and time in transit) were not identified. In order to use data for predictive impacts and levels of protection, there needs to be some measure of certainty about the source of the indicator and thus the potential source and presence of the pathogen.

The 1986 criteria dropped fecal coliform in favor of E. coli as an indicator. However, the fecal coliform indicator included Klebsiella which is an opportunistic pathogen causing respiratory illness. The exclusion of Klebsiella as a cause of gastrointestional illness fit the model of the 1986 criteria but it overlooks a potential source of illness to immuno compromised bathers. We encourage you to include Klebsiella sp. in the proposed study, particularly if a recreational water is under the influence of pulp and paper mill discharge.

We encourage you to also address non human sources of the indicator and the potential health effects that may result. The study should look at more than gastrointestinal illness effects. Perhaps indicators from different sources contribute to different illnesses in humans, not all of them gastrointestinal. In order to be protective, the list of indicators may need to be expanded. This study could offer an excellent opportunity to evaluate this need.

We have concerns about how the data were averaged in the studies by Dufour and Cabelli to derive the 1986 ambient water quality criteria. The data for fresh water beaches were averaged by season resulting in a single point representing the geometric mean of all indicator data collected at a specific beach for an entire season and the average number of illnesses per 1000 bathers for the entire season. These nine seasonal points were plotted to establish an indicator density to illness relationship. The plot fails to represent the true variability of the daily test results. Similar data analyses were performed on the saltwater beaches data, but not on a seasonal basis. We encourage you to analyze the data collected in your studies in a manner that clearly depicts the uncertainty around the indicator density to illness relationships.

We appreciate this opportunity to comment on the Health Effects of Microbial Pathogens in Recreational Waters. If you wish to discuss these comments further or require additional information, please contact either of us at the following telephone numbers: Page 26 RE: Health Effects of Microbial Pathogens in Recreational Waters We have the following comments on the ICR for the above referenced document. The main point may be that we are unsure of what EPA's objective is. Since EPA often has stated that the work of Cabelli and Dufour has been supported by the findings of many other studies, it seems that another confirmatory investigation is not needed. On the other hand, if it is to test new indicators ( biological or chemical) that have a much quicker turnaround time, then there may be merit in repeating the earlier work assuming the results do not conflict with the previous findings. The latter outcome will cause confusion and lead to requests for more definitive investigations, which is fine for such a result will tell us that we do need more information. At the same time, this will work only if those studies are forthcoming.

More detailed comments: The proposal raises several general questions. The first is, given the work of Cabelli and Dufour, would not a study assessing the health risk from non point sources provide a better return for the efforts than what appears to be a refinement of existing work? One would like to know how many bathing waters are affected by only non point sources of bacterial contamination. These could represent a far greater percentage of the swimming beaches or bather days than those areas affected by wastewater from human sources and thus be of greater import from a public health point of view. Few beaches in Massachusetts, especially fresh water ones, have known impacts from sources of human sewage.

The rates of affliction for outcomes such as eye infections would seem likely to be even more prevalent than for gastroenteritis given the general exposure upon immersion in bathing water. The public may find the current risk levels for enteritis associated with EPA's proposed criteria unpalatable and essentially work towards closing beaches affected by human sewage or removing the sources. While this is desirable, it leaves open the question of what risk is associated with animal sources, which likely cannot be eliminated. This again argues for orienting the study towards non point sources with some capability of being able to distinguish between human and other origins of the indicators.

Having said this, it is not clear if assessing the new outcomes but including the already studied gastroenteritis, is the object or are the more rapid tests for indicators the primary object for assessment. The question of whether tests already accepted by EPA or as standard methods are to be used. Also, only enterococci and fecal coliform are mentioned. Why is fecal coliform included and what about E. coli? It is not clear if chemical indicators, e. g., caffeine, caprostanol, are being considered as well. If so, they should be identified. OMB Control No.: 2080 XXXX Expiration date XX/ XX/ XX 27 APPENDIX D: Beach Interview BEACH INTERVIEW Site ID ______

Friday _______ Saturday _______ Sunday______ Monday _________ Date:________ Time: _________

1. Are you leaving the beach in the next 30 minutes?

2. Have you been interviewed before by us this summer? Yes_____ No_____ When?

3. Would you be willing to participate in a study on illnesses associated with recreation at the beach?

Yes ( give brochure with consent form, inform about 2 follow up calls) No ( Terminate Interview)

4. How many members in your party are at the beach today? _________

5. What time did you and your party arrive at the beach today?

6. Are there any children in your family at the beach today between 2 and 10 years of age? Yes ( continue) No ( Terminate Interview)

7. We are interested in whether or not anyone who is at the beach with you today becomes ill in the next few weeks with stomach trouble, respiratory illness, sore throat or cough, eye or ear infection or skin problems. Could you please give me your complete address and telephone number so we can get in touch with you next week and then again for the following week?

Yes ( Go to 8) No If no, is it for one of the following reasons: 1. Too busy 2. No longer interested 3. Will not be available 4. Other reason_______________ 5. Didn't specify 8. Permanent home address Name:_________________________________________________________ Address:_______________________________________________________ City:____________________ Zip_________________ Home Phone _____________ Cell/ other phone_________________ Set appointment time for phone call____________

Are you here on vacation ( vacation home, rental property, etc.)?

If yes, Will you be at home or still on vacation during the next week or the week after. 28 If they won't be home in time for first follow up call.

Can I please have the address of your vacation residence so that we may contact you there?

Name:_________________________________________________________ Address:_______________________________________________________ City:____________________ Zip_________________ Home Phone _____________ Other phone_________________ Set appointment time for phone call____________

9. List members of family at beachRelationship Date of Birth Gender Race Ethnicity 10. Will all these people at the beach with you today also be living with you at the address( es) above during the next two weeks: ( List Persons) Yes No 11. List members of family not at beach Relationship Date of Birth Gender RaceEthnicity [ For family members under age 4 ask if still in diapers?]

12. Have any of these family members been ill in the past 3 days with:

A. Diarrhea or loose bowels ( three or more loose stools in a 24 hour period)? B. Throwing up or vomiting? C. Sore throat or Cough? D. Earache, ear infection or runny ears? E. Eye infection? F. Rash, skin infection or itchy skin? G. Skin or sun burn?

12a. Do you suffer from any of the following chronic, long term conditions?. A. Gastrointestinal ( Crohn's disease, irritable bowel syndrome) B. Allergies C. Skin problems ( psoriasis, eczema)

[ Repeat for all members of family at beach]

13. How many times do you usually come to the beach each summer ( Memorial Day to Labor Day)

14. What distance is it from this beach to your home or the place you are currently staying?

15. During the past two weeks, did ( person) go bathing or swimming anywhere B at this or some other beach, pool or lake?

Yes ( continue) No ( Go to question 16)

15a. Who was that? 15b. Did they swim in the past week ( between Monday and Friday).

15c. Did ( person) actually get their head or face wet?

[ Repeat for all members of family at beach] 29 I would now like to ask you about how much you were in the water and the types of activities you participated in on today's trip.

[ Repeat questions 16 17 for all members of family going in water]

16. Did ( person) go into the water at all today?

Yes ( ask 17) No ( Go to 18)

17a. Did ( person) wade in or play in the water Yes ( continue), No ( Go to 18)

get water in face Yes ( continue), No ( Go to 17c)

immerse body ( not necessarily head) in water put face in water or submerse head in water Yes ( continue), No ( Go to 17c)

get water in mouth Yes ( continue), No ( Go to 17c) Did you swallow the water How much do you estimate you swallowed 17b. Did ( person) gag or cough after swallowing or getting water in their mouth?

17c. What part of the beach did ( person) swim in? Indicate all areas on map ( preassign area designations for each beach)

17d. did you avoid swimming in certain areas?

17e. Did ( person) swim in any shallow non circulating water in temporary pools on sandbars or at low tide 17f. Was ( person) in the water at the following times today:

Time 1 Yes No Time 2 Yes No Time 3 Yes No Time 4 Yes No 17g. What total time did ( person) stay in the water? _____________( hours) or _____________( minutes). We are only interested in time actually in the water, not the total time at the beach.

18. What would ( person) estimate their total time in direct sunlight was? _____ hours or _____ minutes. This does not include being indoors or under umbrellas, etc.

19. Did ( person) cut themselves today or have an open cut when they came?

20. Did ( person) engage in any of the following activities while at the beach today? body surfing, swimming, surfing, boogie boarding, snorkeling, scuba diving, rafting, sea shell collection, digging in and/ or building with sand, crabbing, playing with seaweed We would now like to ask a few questions about things that may help protect swimmers from becoming ill. 30 21. Did ( person) wear ear plugs while in the water?

22. Did ( person) wear nose plugs while in the water?

23. Did ( person) wear eye goggles or use a face mask while you were in the water?

24. Did ( person) use a wet suit while in the water?

25. Did ( person) wear suntan lotion?

26. Did ( person) wear insect repellant?

27. Did ( person) take a cleansing shower before leaving the beach?

[ The following information is recorded based on visual appearance.]

For ( person) check one of the following: 1. Head and suit wet 2. Head wet 3. Suit wet 4. Neither wet 5. Dressed 6. Not present 28. Did you and your family consume food while at the beach today?

Was the food: Brought from home? Yes No Purchased from a vender at the beach? Yes No Purchased from a vender outside the beach? Yes No 29. In the last 48 hours has anyone done the following: Come into contact with an unfamiliar animal ( give example)? Come into contact with someone who is sick with diarrhea or vomiting? Specify type of illness Consumed raw shell fish?

Thank you for your help. You can contact us regarding information about the study at the toll free number in the booklet.

Following are entered by the interviewer: How cooperative was this family? 1. Very 2. Somewhat 3. Not at all Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average about a half hour 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; 31 adjust the existing ways to comply with any previously applicable instructions and requirements; 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.

Interview & Telephone Follow ups: 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 will spend an average of 30 minutes completing the first home telephone interview and 20 minutes completing the second home telephone interview. The telephone interviews will require no record keeping.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822T), 1200 Pennsylvania Ave., NW, Washington, D. C. 20460. Include the EPA ICR number 2081.01 in any correspondence. Do not send the completed survey to this address. OMB Control No.: 2080 XXXX Expiration date XX/ XX/ XX Page 32 APPENDIX E: Telephone Interview I Telephone Interview First follow up ( 4 7 days)

Is this person ( primary respondent from beach interview)?

Yes ( continue)

No ( reschedule or continue)

Were you at the beach on ( give date) with ( primary respondent)?

Yes  Continue No  Please ask ( primary respondent) to call this number at their earliest convenience. TERMINATE INTERVIEW I'm going to ask questions about any swimming you've done and illnesses you've experienced in the last week for the following people: List person( s)

1. Have you or any of the listed people gone bathing or swimming anywhere since being interviewed at ( Name beach)?

Yes: Same beach?

Different beach? If yes have them specify: Lake? River? Ocean?

Water park?

Public pool?

Private pool?

Wading pool?

Other? Specify__________________

Did ( person) actually get their face wet?

Which days did person go to beach? Mon Tues Wed Thurs Fri Sat Sun 2. I'm going to go through a list of symptoms, please let me know if any of the above listed people have had them.

A. Stomach ache or abdominal cramping Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

B. Diarrhea or loose bowels? ( 3 or more loose or watery stools in a 24 hour period)

Starting on what day?

Maximum number of bouts/ episodes per day?

Lasting how many days? _____ Still experiencing symptom ____ Page 33 C. Nausea Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

D. Throwing up or vomiting?

Starting on what day?

How many times or episodes the first day?

Lasting how many days? _____ Still experiencing symptom ____

E. Fever Starting on what day?

Measured? ( Give exact measure)

Perceived?

Lasting how many days? _____ Still experiencing symptom ____

F. Head ache lasting more than a few hours?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

G. Sore throat?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

H. Bad Cough?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

I. Cold?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

J. Runny or stuffy nose?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

K. Earache, outer ear infection or runny ears? ( Note not inner ear infections)

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

L. Watery or itchy eyes?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

If Yes to G thru L: Where any of these symptoms related to allergies? Yes No.

Which symptoms?

M. Eye infection? Page 34 Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

N. Infected cut?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

O. Rash , itchy or other skin infection?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

P. Skin or sun burn?

List parts of body:

Q. Urinary tract infection:

Lasting how many days? _____ Still experiencing symptom ____

3. If Yes to any did they:

A. Stay at home?

How many days?

B. Stay in bed?

C. Seek medical help?

Visit a physician or other health care provider?

Visit an emergency room?

Require hospitalization for more than 24 hours?

D. Did ( person) take any medications for the symptoms?

If yes, what medications?

List:_____________________

This completes our telephone interview? We will call again in a week for the last telephone interview. Will you still be at this telephone number next week when we call? What would be a good time to call?

Schedule time:______________

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average about a half hour 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; 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. Interview & Telephone Follow ups: 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. Page 35 This includes the time for reviewing the information pamphlet and answering the questions. We estimate that each family will spend an average of 30 minutes completing the first home telephone interview and 20 minutes completing the second home telephone interview. The telephone interviews will require no record keeping.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822T), 1200 Pennsylvania Ave., NW, Washington, D. C. 20460. Include the EPA ICR number 2081.01 in any correspondence. Do not send the completed survey to this address. OMB Control No.: 2080 XXXX Expiration date XX/ XX/ XX Page 36 APPENDIX F: Telephone Interview II Telephone Interview Second follow up ( 10 14 days)

Is this person ( primary respondent from beach interview)?

Yes ( continue)

No ( reschedule or continue)

Were you at the beach on ( give date) with ( primary respondent)?

Yes  Continue No  Please ask ( primary respondent) to call this number at their earliest convenience. TERMINATE INTERVIEW I'm going to ask questions about any swimming you've done and illnesses you've experienced in the last week SINCE THE LAST PHONE CALL ON ( give date) for the following people: List person( s)

1. Have you or any of the listed people gone bathing or swimming anywhere since we last called?

Yes: Same beach ( name original beach)?

Different beach? If yes have them specify: Lake? River? Ocean?

Waterpark?

Public pool?

Private pool?

Wading pool?

Other? Specify__________________

Did ( person) actually get their face wet?

Which days did person go to beach? Mon Tues Wed Thurs Fri Sat Sun Mon Tues Wed Thurs Fri Sat Sun 2. At the previous telephone interview you reported that __________ had been ill with ___________. Is that person( s)

still ill?

3. I'm going to go through a list of symptoms, please let me know if any of the above listed people have had them since the last phone call on ( repeat date and time).

A. Stomach ache and/ or abdominal cramping?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____ Page 37 B. Diarrhea or loose bowels? ( 3 or more loose or watery stools in a 24 hour period)

Starting on what day?

Maximum number of bouts/ episodes per day?

Lasting how many days? _____ Still experiencing symptom ____

C. Nausea Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

D. Throwing up or vomiting?

Starting on what day?

How many times or episodes the first day?

Lasting how many days? _____ Still experiencing symptom ____

E. Fever Starting on what day?

Measured? ( Give exact measure)

Perceived?

Lasting how many days? _____ Still experiencing symptom ____

F. Head ache lasting more than a few hours?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

G. Sore throat?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

H. Bad Cough?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

I. Cold?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

J. Runny or stuffy nose?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

K. Earache, outer ear infection or runny ears? ( Do not include inner ear infections)

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

L. Watery or itchy eyes?

Starting on what day? Page 38 Lasting how many days? _____ Still experiencing symptom ____

If Yes to G thru L: Where any of these symptoms related to allergies? Yes No.

Which symptoms?

M. Eye infection?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

N. Infected cut?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

O. Rash or itchy skin?

Starting on what day?

Lasting how many days? _____ Still experiencing symptom ____

P. Skin and/ or sun burn?

List parts of body:

Q. Urinary tract infections:

Lasting how many days? _____ Still experiencing symptom ____

3. If Yes to any did they:

A. Stay at home?

How many days?

B. Stay in bed?

C. Seek medical help?

Visit a physician or other health care provider?

Visit an emergency room?

Require hospitalization for more than 24 hours?

D. Did ( person) take any medications for the symptoms?

If yes what medications?

List:_____________________

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average about a half hour 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; 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. Page 39 Interview & Telephone Follow ups: 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 will spend an average of 30 minutes completing the first home telephone interview and 20 minutes completing the second home telephone interview. The telephone interviews will require no record keeping.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822T), 1200 Pennsylvania Ave., NW, Washington, D. C. 20460. Include the EPA ICR number 2081.01 in any correspondence. Do not send the completed survey to this address. Page 40 APPENDIX G References Cabelli VJ " Health Effects Criteria for Marine Recreational Waters" EPA 600/ 1 80 031. August 1983.

Calderon RL, Mood EW and Dufour AP. " Health Effects and Nonpoint Sources of Pollution", Int. J. Environ. Hlth 1: 21 31, 1991.

Colford JM, Rees JR, Wade TJ, Khalakdina A, Hilton JF, Ergas IJ, Burns S, Benker A, Ma C, Bowen C, Mills DC, Vugia DJ, Juranek DD, and Levy DA. " Participant Blinding and Gastrointestinal Illness in a Randomized, Controlled Trial of an In Home Drinking Water Intervention" Emerging Infectious Diseases 8: ( 1) 2001.

Dufour AP. " Health Effects Criteria for Fresh Recreational Waters" EPA 600/ 1 84 004. August 1984.

Payment P, Siemiatycki J, Richardson L. et al. A Prospective Epidemiological Study of Gastrointestinal Health Effects due to the Consumption of Drinking Water. Intl J Environ. Hlth Res. 7: 5 31, 1997.

Payment P, Richardson L, Siemiatycki J, et al. A Randomized Trial to Evaluate the Risk of Gastrointestinal Disease due to Consumption of Drinking Water Meeting Current Microbiological Standards. Amer. J. Pub. Hlth 81: 703 708 , 1991.