Page 1 SECTION 1.

A. SUPPORTING STATEMENT 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) TITLE Health Effects of Microbial Pathogens in Recreational Waters; National Epidemiological and Environmental Assessment of Recreational ( NEEAR) Water Study ( Renewal). EPA ICR Number 2081.02, OMB Control Number 2080 0068.

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. 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 ( 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, 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. Page 2 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). There is no sampling strategy as a complete census ( de facto) at the beach selection site will be utilized for this data collection. Households ( families/ individuals) at selected beaches will be interviewed on the beach about a variety of exposures including those to recreational water ( Appendix C). Ten to twelve ( 10 12) days later, families/ individuals will be contacted by telephone and interviewed on the occurrence of selected symptomatology since swimming at the beach ( Appendix D). 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 5,250 hours and $ 76,912 The estimated annual agency cost for conducting this study is 28,116 hours and $ 2,607,120. This study requires no maintenance of records by the respondents.

1( c) TERMS OF CLEARANCE Each data collection season the survey tool was reviewed by the project team and modified in non substantial ways to improve design and vocabulary usage. After the survey tool was reviewed and modified by the project team, it was forwarded to Jim Laity with the Office of Management and Budget to receive approval. Additional questions and modifications received prior approval through the study's designated institutional review board. The changes made to the interview tools are thematically the same as the original questionnaires submitted with the original Information Collection Request ( ICR). As a note of reference, it is important to recall that there was one questionnaire conducted on the beach and the other was conducted by telephone10 12 day later. This is important as some questions were moved from the beach Page 3 interview to the telephone interview to ease respondent burden in the beach area. This change took place on the 2005 questionnaire. This was the only change made to the telephone questionnaire that was not grammatical.

2003 Questionnaires For the 2003 data collection season, the beach questionnaire was only changed slightly to make it easier to read and understand.

2004 Questionnaires In the 2004 beach questionnaire, the questions concerning cleansing showers and use of soap with those showers were removed from the questionnaire. They were not useful in the data analysis and only collected data that was extraneous to this study. Other more substantial changes included the following:

! Deleted redundant question Q5 asking if they have any children between 2 and 10 years of age. This information is collected as part of the household demographics.

! Added sunburn to Q10 for more accurate environmental exposure ! Combined water related activities in Q17f to reduce interviewer burden ! Added question asking about SPF rating of sunblock and reapplication of sunblock utilized by participant ! Eliminated questions about use of soap in showers ! Added consumption of red or raw meat, runny eggs to food consumption list 2005 Questionnaires In 2005, the beach questionnaire was modified to include more detailed questions about sunburn exposure. This change allows the collection of more accurate data ! Added Q14c. to collect specific data about length of sunburn duration ! Eliminated question estimating the amount of water swallowed by the participants ! Combined swimming activities in Q16f and Q16c to reduce respondent burden ! Moved Q17, Q18, and Q19 to telephone interview to reduce respondent burden Page 4 in beach area ! Added question that specified where sunblock was used on the participants body ! Added question that identified skin type of participants The 2005 telephone interview gained some additional questions that came from the beach interview. As stated previously, this change was motivated by respondent burden in the beach interview.

! Questions Q17, Q18, and Q19 from the beach interview were moved to telephone interview to reduce respondent burden in beach area 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 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 Page 5 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 E), 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 14, 2005 ( 70 FR 7496). See Appendix B for Text copy of the Federal Register notice. The first Federal Register may be found online via GPO Access ( http:// www. gpoaccess. gov/ index. html) also provides a copy. No responses to the first Federal Register notice, " Health Effects of Microbial Pathogens in Recreational Waters; National Epidemiological and Environmental Assessment of Recreational Water Study ( NEEAR)," were received by April 15, 2005.

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 Page 6 The questionnaire information may be collected from an individual household once every 28 days. The frequency of the study questionnaire attempts to reduce the amount of information collection without compromising data quality. It is estimated that an individual household will be eligible for the study a maximum of three times in a study season. Because some households visit the beach frequently, their exposure may have different symptomatic effects important to the study analysis. This interviewing strategy allows the data collection of households that visit the beach study site regularly without duplicating illness cycles.

In the pilot study conducted in the summer of 2002, there were a total of two telephone interviews. One at 4 7 days followed by one at 10 14 days. The pilot analysis indicated that data from the 10 12 day telephone interview range were most useful for the focus of this study.

The first telephone interview was deleted in the survey process after the utility of the information was reviewed by panelists in the 2003 Study Peer Review. The remaining telephone interview time frame was changed to 10 12 days.

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.

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 households who are at the selected beaches around the country. Based on previous studies, it is anticipated a maximum of 7,000 households 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. Page 7 4( b) INFORMATION REQUESTED ( viii) Data Items:

Each questionnaire will ask a single adult member of the household to provide the information listed for all members of the household. The questionnaires can be found in Appendix C and D. 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 households will be interviewed on the beach and then will be interviewed via telephone ten to twelve ( 10 12) days later.

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 The initial interview questionnaire that contains household demographics and usual beach activities will be collected using computer assisted personal interviews ( CAPI). The telephone interview that collect illness information about the household ten to twelve ( 10 12) days later will utilize computer assisted telephone interviews ( CATI).

The water quality measurements will be collected under the same EPA research project in concurrence with the health data collection. 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 results 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 Page 8 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 CAPI/ 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). Two backup data files will be stored separately from data that is used to create the analytical database.

These back up files will contain unedited raw data and will be write protected. 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 interview have been designed to minimize the burden to the households who agree to participate in the study.

5( d) COLLECTION SCHEDULE The study has currently completed 3 years of data collection.

Pilot Study ° West Beach, Indiana Dunes National Lakeshore, Portage, Indiana   2002 Full Scale Study   Freshwater ° West Beach, Indiana Dunes National Lakeshore, Portage, Indiana   2003 ° Huntington Beach, Bay Village, Ohio   2003 ° Washington Park, Michigan City, Indiana   2004 ° Silver Beach, St. Joseph, Michigan   2004 The marine full scale study will be conducted in the summers of 2005 2011. Water quality samples for measurement, will be collected at the same beaches concurrently with beach interviews. Preliminary data sets will be delivered to the EPA by 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 Page 9 6( a). ESTIMATING RESPONDENT BURDEN Beach 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 household will spend an average of 30 minutes completing both parts of 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 15 minutes completing the 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 14.65 Head of household Beach Interview Part A 7000 0.25 hr. 1 1750 hr $ 25,638 a Head of household Beach Interview Part B 7000 0.25 hr. 1 1750 hr $ 25,638 a Head of household Home Telephone Interview 7000 0.25 hr. 1 1750 hr $ 25,638 a Totals 5,250 hr $ 76,912 a $ 14.65/ hour ( average hourly wage for women)

ANNUAL REPORTING BURDEN: 5,250 hours ANNUAL RESPONDENT COST: $ 76,912 NO ANNUAL RECORD KEEPING BURDEN 6( b) ESTIMATING RESPONDENT COSTS Beach Interview Part A: 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 ( January 2005) at $ 14.65 per hour. Given the 0.25 hour burden, the respondent cost for each family is $ 3.66. Beach Interview Part B: 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 ( January 2005) at $ 14.65 per hour. Given the 0.25 hour burden, the respondent cost for each family is $ 3.66. Home Telephone Interview: 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 ( January 2005) at $ 14.65 per hour. Given the 0.25 hour burden, the respondent cost for each family is $ 3.66. Page 10 NO CAPITAL COSTS ARE INVOLVED.

NO O& M COSTS ARE INVOLVED.

6( c) ESTIMATING AGENCY BURDEN AND COST TABLE 2. AGENCY COST ANNUAL BURDEN Burden Hours Cost ($)

AGENCY ACTIVITIES Contractor EPA Total Hours Contractor $ 79/ hr EPA $ 39.00/ hr*

Prepare and format questionnaires 600.00 80.00 680 $ 47,400 $ 3,120 Prepare computers 2400.00 8.00 2408 $ 189,600 $ 312 Plan logistics & coordination 2000.00 120.00 2120 $ 158,000 $ 4,680 Recruit and interview on beach 11000.00 0.00 11000 $ 869,000 $ 0 Telephone interview I 5000.00 0.00 5000 $ 395,000 $ 0 IRB package preparation & submission 80.00 10.00 90 $ 6,320 $ 390 Quality Assurance & Quality Control 800.00 10.00 810 $ 63,200 $ 390 Convert database 2600.00 0.00 2600 $ 205,400 $ 0 Contractor $ 198/ hr EPA $ 39.00/ hr Collect/ analyze water quality data 3400.00 8.00 3408 $ 673,200 $ 312 28116 $ 2,607,120 $ 9,204 * Average hourly pay for Human Studies Division Health Scientist ( Information provided by Barbara Howard of OARM RTP AGENCY TOTAL ANNUAL BURDEN: 28,116 hours AGENCY TOTAL ANNUAL COST: $ 2,607,120 +$ 9,204 =$ 2,616,324 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 COST Based on current studies conducted in the 2003 and we estimated that the maximum respondent universe for each recreational water season is 7000 households for beach interview Part A, 7000 households for beach interview Part B, and 7000 for telephone follow up. Thus the total estimated respondent burden for this study is 5,250 hours from 7000 families and $ 76,912. Page 11 Total number of responses for this document reflect a change in how the responses were calculated in the previous supporting statement. The calculation in this supporting statement reflects maximum number of responses possible at each stage of the interviewing process rather than the original estimation of attrition in participants. Additionally, the original response time (. 9 hours) was estimated higher than the actual average time (. 75 hours) experienced during the current interview process.

Because of increased pressure to expeditiously complete the study, the study team may complete more than one beach per year, thus increasing the number of participants enrolled in the study annually. The tables in Sections 6( a) and 6( c) reflect the estimated respondent burden and agency burden and cost for two beaches, whereas the original supporting statement estimates ( EPA ICR Number 2081.01) these items for only one beach. This change substantially increased the number of respondents expected annually.

Although there is an increase of 2,500 annual respondents, there is only an increase of 250 burden hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This is due to the fact that the original ICR ( EPA ICR Number 2081.01) included a second telephone survey which has been eliminated in this renewal ICR and consequently has reduced the total burden hours for each respondent.

6( e) BOTTOM LINE BURDEN HOURS AND COSTS / BURDEN TABLES The estimated respondent burden for this study is 5,250 hours and $ 76,912. The estimated agency cost for conducting this study is 28,116 hours and $ 2,607,120.

6( f) BURDEN STATEMENTS Beach Interview: Parental reporting burden for this collection of information is estimated to average 30 minutes for Parts A and B and will require no record keeping. This includes two 15 minute (. 25 hours) responses. 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 15 minutes (. 25 hours) per family. This includes time for reviewing information collected on the beach interview and answering questions.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average .38 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 Page 12 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.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. ORD 2004 0023, which is available for public viewing at the Office of Research and Development ( ORD) Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center 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 Office of Research and Development Docket is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public 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 above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington,

DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. ( ORD

2004 0023) and OMB control number ( 2080 0068) in any correspondence. Page 13 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). Current estimates are that a minimum of three marine beaches will be evaluated with a potential for six marine beaches. Four freshwater beaches have been previously included and are currently being evaluated. We do not expect to do any further freshwater beaches as we have reached the number of individuals required to complete analysis. 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 There are four key variables considered in this study; health status, water quality measures,

environmental exposures and potential confounders. Each of these variables were considered in the development of the study objectives.

Health status of the household accounts for illness prior, during, and after the beach visit ( 10 12 days). This includes both acute and chronic illness for household members present or absent at the beach. Acute illness may include diarrhea, urinary tract infection, vomiting, sore throat earache, eye infection, rash, sunburn, and fever. Chronic illness may include Crohn's disease, asthma, non drug allergies, and eczema. These conditions may indicate illness not related to the environmental exposure.

Water quality measures will be collected in the same beach areas on the same days as the health data collection. These are new tests and indicators that require correlation modeling prior to use as a water quality indicator. These are rapid measurement tests ( 2 hours or less).

Environmental exposures include activities in the designated beach area. These include digging in the sand, swimming in the water, snorkeling, collecting seashells, or length of time in the water. These exposures will be used to develop mathematical relationships between health status of households after their beach visit and water quality measurements taken at the same beach.

Potential confounders are possible other symptom determinants that are not related to the Page 14 environmental exposure of interest ( coastal recreational water). These include acute and chronic conditions as mentioned in the health status. Acute illness may include diarrhea, urinary tract infection,

vomiting, sore throat earache, eye infection, rash, sunburn, and fever. Chronic illness may include Crohn's disease, asthma, non drug allergies, and eczema. These also include other exposures not related to recreational water exposure such as food consumption, other water exposures outside this study and household size,

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 all eligible household groups within an identified beach area. The beach area is defined according to the criteria outlined in A. 1.( b). The sampling base may change for each beach depending on size. The households 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 semi individual) 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.

1( d) FEASIBILITY Obstacles: Based on previous experience with beach studies, the major problem has been nonresponse 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. The marine beaches are expected to be completed 2005 2009 with a potential of 6 beaches. Page 15 2. SURVEY DESIGN 2( a) Target Population and Coverage The target population will all eligible household groups within an identified beach area exposed to various levels of water pollutants from point sources fresh ( Great Lakes) and marine beaches in the continental United States. At this time, no further freshwater coastal areas are planned for data collection.

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

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

( ii) Sample size.

The sample size for this study is constrained by the numbers of households 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 ( i) Precision targets.

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

( ix) Non sampling error.

Most health and epidemiology studies are concerned with errors resulting from 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 Page 16 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 underreporting 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,

background demographic information and current or historical health status. 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).

Questions contained in the beach interview and the telephone follow up survey are included in Appendix C and D respectively. The interview forms may be modified based on use in previous survey seasons.

The questionnaires are comprised of five main components; personal identifying/ demographic information, health status, environmental exposure, other potential confounders and health burden. The questionnaire was designed to reduce respondent time in the beach area.

The personal identifying/ demographic information in the beach interview ( name, address, phone number, prescheduled telephone interview) are required to ensure efficient follow up. Verbal consent is documented through the electronic collection of these data. This information will be recorded electronically and allows preservation of confidentiality through limited access data files. The personal identifying information will be physically separated and not become part of the statistical database. Page 17 Because they are not part of the statistical database, they are not assigned questionnaire enumeration.

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 health status of each household member is important in the quality of the data. Existing illness before and during the beach visit is a potential confounder for illness that may be associated with swimming exposures. Both acute and chronic illness are identified in this survey. They include diarrhea, urinary tract infection, vomiting, sore throat, earache, eye infection, rash, sunburn, Crohn's disease, asthma, non drug allergies, and psoriasis.

The health status of each of the household members is also collected during the telephone survey.

These data enable US EPA scientists to ascertain credible illnesses and symptoms that become apparent after participants have visited the beach area.

Environmental exposure at the beach study area is the main focus of this study. The study participant is asked about the family's activities at the beach and specific details about the extent of water contact and the amount of time allotted to swimming activities. Other factors such as sand and sun exposure are included.

Information for other potential confounders such as consumption of food, collection of seashells and animal contact are also collected.

Health Burden found in telephone. 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). Data such physician visits, missed employment, and reduction in daily activities as are collected to represent health burden effects associated with swimming associated illness.

Style of questions Most questions have initial forced choice between multiple responses or two choices ( Yes, No). The secondary level of response for most questions includes choices for " Don't Know" and " Refuse." Most questions The number of free form questions are limited to facilitate the CATI process. Page 18 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. 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 and Prevention, 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 was evaluated after the beach trials in 2002. Modifications of questionnaire wording were made based on that experience. It is anticipated that questionnaire modifications after this date will not vary from the current format.

4. COLLECTION METHODS AND FOLLOW UP 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 Saturday and Sunday ( Friday and Monday considered on holiday weekends) during the recreational season ( April to mid September depending on the geographic location).

Trained interviewers will be deployed on the beach and will visually identify households eligible to participate. Interviews will begin late morning to late afternoon to try and catch households just prior to their leaving the beach for the day. Partial recruitment ( enrollment) occurs on the beach and exposure data collection is completed when the household stops by an interview center near the parking area as they are leaving the beach.

Ten to fourteen days from leaving the beach, households will be recontacted by telephone at the Page 19 most convenient times for the household. Health status and confirmation of recreational and other potential exposures will be obtained over the phone.

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 90% 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 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, 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. Page 20 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 21 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 22 APPENDIX B: Federal Register 1 [ Federal Register: February 14, 2005 ( Volume 70, Number 29)] [ Notices] [ Page 7496 7498] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr14fe05 52]

ENVIRONMENTAL PROTECTION AGENCY [ ORD 2004 0023, FRL 7872 5]

Agency Information Collection Activities: Proposed Collection; Comment Request; Health Effects of Microbial Pathogens in Recreational Waters; National Epidemiological and Environmental Assessment of Recreational ( NEEAR) Water Study, EPA ICR Number 2081.02, OMB Control Number 2080.0086 AGENCY: Environmental Protection Agency.

ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that EPA is planning to submit a continuing Information Collection Request ( ICR) to the Office of Management and Budget ( OMB). This is a request to renew an existing approved collection. This ICR is scheduled to expire on August 31, 2005. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below.

DATES: Comments must be submitted on or before April 15, 2005.

ADDRESSES: Submit your comments, referencing docket ID number ORD 2004 0023, to EPA online using EDOCKET ( our preferred method), by e mail to oei. docket@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Office of Environmental Information Docket, Mail Code 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT: Susan Auby, Environmental Protection Agency, Office of Information Collection, Office of Environmental Information, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 202) 566 1672; fax number: ( 202) 566 1753; e mail address: auby. susan@ epa. gov.

SUPPLEMENTARY INFORMATION: EPA has established a public docket for this ICR under Docket ID number ORD 2004 0023, which is available for public Page 23 viewing at the Office of Research and Development Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center 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 [[ Page 7497]]

Reading Room is ( 202) 566 1744, and the telephone number for the Docket is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( DOCKET) at http:// www. epa. gov/ dOCKET.

Use DOCKET to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the public 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 above. Any comments related to this ICR should be submitted to EPA within 60 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in DOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in DOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in DOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov./ dOCKET.

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: The purpose of this study is to examine the health effects of families in recreational water beach 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, 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 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. Health effects data collection was previously conducted in a pilot study and four freshwater coastal sites under OMB number 2080.0068 ( expires August 31, Page 24 2005), ICR number 2081.01. The results will be used to develop mathematical relationships that will be used for the generation 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. 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 in 40 CFR are listed in 40 CFR part 9. 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; ( 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. Burden Statement: 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. The annual public reporting and recordkeeping burden for this collection of information is estimated to average about fifteen minutes per response. If a participant completes all portions of the data collection, a total 45 minutes. Beach Interviews & Telephone Followups 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 recordkeeping. 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 recordkeeping. 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.

[[ Page 7498]]

  Page 25 Estimated Respondent activities number of Burden Frequency Total burden Total burden respondents hours hours cost   Beach Interview and Phone Interview..... 7,000 0.25 1 1,750 a 25,760 Beach Interview ( Part A)................ 7,000 0.25 1 1,750 a 25,760 Phone Interview......................... 7,000 0.25 1 1,750 a 25,760  Total............................... 21,000 0.75 3 5,250 a 77,280   a $ 14.72/ hour.

There is no direct respondent costs for this data collection. Estimated Total Annualized Capital, O& M Cost Burden: $ 0.

Dated: January 27, 2005. Harold Zenick, Associate Director of Health. [ FR Doc. 05 2793 2 11 05; 8: 45 am] BILLING CODE 6560 50 P 26 APPENDIX C: Beach Interview BEACH INTERVIEW OMB Control No.: 2080 0068 Expiration Date: xx/ xx/ xxxx Site ID ______

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

1. Have you been interviewed by the National Beaches Survey in the last 28 days?

2. 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)

2a. Our survey is primarily for households of one or more persons that live together at the same address; Do you all live at the same address?

3. How many members in your party are at the beach today including yourself?

4. What time did you and your household arrive at the beach today?

5. We are interested in asking about the health of your household during the few weeks following your beach visit. Could you please give me your telephone number so we can get in touch with you in 10 12 days from now?

5a. If " NO" Is it fro one of the following reasons? Too busy, no longer interested, will not be available, specify other reason?

5b. 10 12 days from now which phone number( s) should we call?

5c. Is this your home, vacation, or cell phone number?

6. What are the best times to reach you during week days?

6a. Can I please have your mailing address so that we can send you your $ 25 Thank you check? We will destroy your identifying information after we mail the check.

7. Please tell me the first name of the members of your household at the beach today, their birth dates, gender race ethnicity, and whether they are in diapers.

8. Will ( you/ all these people with you at the beach today) be living ( with you) at the same address ( es) during the next two weeks?

9. Have any of these household members at the beach today been ill in the past 3 days with Diarrhea or loose bowels 27 Urinary tract infection or burning sensation Throwing up or vomiting Sore throat or cough Earache, ear infection or runny ears Eye infection Rash or itchy skin Sunburn Ask for all persons in household.

10. Are there any household members NOT present at the beach today?

11. Have any household members NOT present at the beach today been ill in the past 3 days with Diarrhea or loose bowels Urinary tract infection or burning sensation Throwing up or vomiting Sore throat or cough Earache, ear infection or runny ears Eye infection Rash or itchy skin Sunburn 12. How many times do you usually come to this beach each summer ( Memorial Day to Labor Day)

13. How may miles did you travel to the beach today?

14. During the past two weeks, did you ( anyone in your household at the beach today) go bathing or swimming anywhere  at this or some other beach, pool or lake?

14a. Did you go bathing or swimming anywhere in the past one week ( Monday through Friday) at this or some other beach, pool or lake?

14b. Did you actually get your head or face wet?

14c. During the past 2 weeks, did you get a sunburn that lasted more that 12 hours?

Please go to the exit station when you leave the beach today, before 5: 30 PM, to complete Part B of the Beach Interview and pick up your beach gift. Thank you for participating n this portion of the study.

PART B B Exit Beach Interview 15. Were you the person that we interview on the beach or earlier today?

16. Did you or anyone in your household wade, swim, or play in the water today?

16a1. Did you immerse your body, not necessarily you head, in the water today? Ask for all persons in household. 28 16a2. Did you put your face in the water or submerge head in the water today? Ask for all persons in household.

16a3. Did you get water in the mouth today? Ask for all persons in household.

16b. Did you swallow the water? Ask for all persons in household.

16c. Were you in the water at the following times today? If " YES" what part of the beach did you swim in? Ask for all persons in household.

16d. What total time did you stay in the water? We are only interested in time actually in the water, not the total time at the beach? Ask for all persons in household.

16e. Did you engage in any of the following water related activities while at the beach today? Ask for all persons in household.

Body surfing, rafting/ tubing/ floating on an air mattress? Swimming, swimming laps, snorkeling? Surfing, windsurfing? Non circulating pool or tidal pool?

17b. What would you estimate your total time in direct sunlight was? This does not include being indoors or under umbrellas, etc.? Ask for all persons in household.

18. Did you engage in any of the following activities while at the beach today? Ask for all persons in household. Collecting sea shells, rocks, feathers, etc? Digging in sand or building sand castles? Had their body buried in the sand? Playing with algae or seaweed?

19. Did yo cut yourself today or have an open cut when you came to beach today? Ask for all persons in household.

20. Did you wear sunscreen/ sunblock today? Ask for all persons in household.

21. What was the SPF rating of the sunscreen/ sunblock you used most often today? Ask for all persons in household.

21a. When you used sunscreen/ sunblock today, how did you apply it? Only to certain areas of my body? All exposed skin? Ask for all persons in household.

22. Did you reapply at least once today? Ask for all persons in household.

23. Did you wear a hat today? Ask for all persons in household.

23a. Did the hat have a wide brim or another way to shade face, ears, and back of the neck from the sun? Ask for all persons in household. 29 23a1. Did you use protective equipment such as a canopy, umbrella or other type of sunshade today? Ask for all persons in household.

23b. Did you wear protective clothing, such as a long sleeved shirt or cover up? Ask for all persons in household.

24. During the summer, if you go out in the sun repeatedly without sunscreen or protective clothing which one of these things most usually happens to your skin? Ask for all persons in household. A dark tan Some tanning No tan, maybe some freckles Repeated sunburns Other ( specify) Never go out in the sun 25. Did you wear insect repellant today? Ask for all persons in household.

26. Did your or any member of your household consume food while at the beach today? Ask for all persons in household.

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

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average about a 30 minutes 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.

Beach Interviews: 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 15 minutes each for Part A and Part B for the beach interview and will require no record keeping. This includes the time for reviewing the information pamphlet and answering the questions.

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 OMB Control number 2080 0068 in any correspondence. Do not send the completed survey to this address. Page 30 APPENDIX D: Telephone Interview Telephone Interview  follow up ( 10 12 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 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:

A1. May I have your first name please?

During your beach visit where you enrolled in this study on __________

A2. Did you wear ear plugs while in the water? Ask for all household members at the beach.

A3. Did you wear nose plugs while in the water? Ask for all household members at the beach.

A4. Did you wear eye goggles while in the water? Ask for all household members at the beach.

A5. During the beach interview, did you have contact with an animal? Ask for all household members at the beach.

A6. Between your beach visit on ______ date and today were you menstruating or pregnant? Ask for all household members at the beach.

We are now going to switch and ask you questions about activities that have occurred since the Beach Interview.

B1. Have you, or any of the people I just mentioned, gone bathing or swimming anywhere since we talked to you at the beach interview on ______? Please include any bathing or swimming such as at a beach, waterpark, public pool, private pool, or wading pool.

B2. Who was it that went bathing or swimming? A2. Ask for all household members at the beach.

Ask B3 through B5 about each person who was marked in B2. Begin with the first person in the list who was marked and continued with all other marked. Page 31 B3a. Did you go bathing or swimming at the beach ( where the interview was taken) since the beach interview on this date { BEACH INTERVIEW DATE}.

B3b. Did you go bathing or swimming at any other beach since the beach interview on this date { BEACH INTERVIEW DATE}.

B3c. Was this beach at a:

Lake River Ocean Other, specify B3d. Did you go bathing or swimming at a waterpark?

B3e. Did you go bathing or swimming at a public pool?

B3f. Did you go bathing or swimming at a private pool?

B3g. Did you go bathing or swimming in a wading pool?

B3h. Did you go bathing or swimming any other place?

B3i. Swim location of any other place?

B4. Did you actually get your face wet while bathing or swimming? Ask for all household members at the beach.

B5. On which days did you go bathing or swimming? Ask for all household members at the beach.

B6. Have you or anyone else had a stomachache or abdominal cramping since the interview at { STUDY BEACH}

ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B6a. Who had a stomachache or abdominal cramping since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B7. Have you or anyone else had diarrhea or loose bowels since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach. Page 32 B7a. Who had diarrhea or loose bowels since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B8. Have you or anyone else had nausea since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B8a. Who had nausea since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B9. Have you or anyone else had throwing up or vomiting since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B9a. Who had throwing up or vomiting since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B10. Have you or anyone else had urinary tract infection or burning sensation when urinating since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B10a. Who had urinary tract infection or burning sensation when urinating since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B11. Have you or anyone else had fever since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B11a. Who had fever since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B12. Have you or anyone else had headache lasting more than a few hours since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B12a. Who had headache lasting more than a few hours since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B13. Have you or anyone else had sore throat since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B13a. Who had sore throat since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach. Page 33 B14. Have you or anyone else had a bad cough since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B14a. Who had a bad cough since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B15. Have you or anyone else had a cold since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B15a. Who had a cold since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B16. Have you or anyone else had a runny or stuffy nose since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B16a. Who had a runny or stuffy nose since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B17. Have you or anyone else had an earache, ear infection, or runny ears since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B17a. Who had an earache, ear infection, or runny ears since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B18. Have you or anyone else had watery eyes since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B18a. Who had watery eyes since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B19. Have you or anyone else had an eye infection since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B19a. Who had an eye infection since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}?

Ask for all household members at the beach.

B20. Have you or anyone else had an infected cut since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach. Page 34 B20a. Who had an infected cut since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B21. Have you or anyone else had a rash or itchy skin since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B21a. Who had a rash or itchy skin since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}?

Ask for all household members at the beach.

B22. Have you or anyone else had a sunburn since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B22a. Who had a sunburn since the interview at { STUDY BEACH} ON { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

We will now ask about some activities people may have done since the day of the beach interview on the { BEACH INTERVIEW DATE}

B23a. Since the day of the beach interview, have you or anyone else come in contact wit any animals? Ask for all household members at the beach.

B23b. Who came into contact with animals since { BEACH INTERVIEW DATE}? Ask for all household members at the beach.

B23c. ASK FOR EACH PERSON IN A23a. Was this animal or any of these animals unfamiliar to you?

B23d. What kind of animals were they?

Dropdown list B24a. Since the day of the beach interview has anyone come into contact with someone who has complained of diarrhea, vomiting, or stomach illness?

B24b. Who had contact with someone complaining of diarrhea, vomiting, or stomach illness since { BEACH INTERVIEW DATE}?

B25a. Since the day of the beach interview has anyone eaten raw shell fish, such as oysters, clams, mussels, crabs?

B25b. Who has eaten raw shell fish, such as oysters, clams, mussels, crabs since { BEACH INTERVIEW DATE}? Page 35 B26a. Since the day of the beach interview has anyone rare or raw meat? This includes pink in the center for fish,

beef, chicken, and pork.

B26b. Who has eaten rare or raw meat since { BEACH INTERVIEW DATE}? This includes pink in the center for fish, beef, chicken, and pork.

B27a. Since the day of the beach interview has anyone eaten raw or runny eggs?

B27b. Who has eaten raw or runny eggs since { BEACH INTERVIEW DATE}?

SECTION C This section is for all persons that experience symptoms.

C1. On what day did your stomachache or abdominal cramping start?

C1a. Do you still have a stomachache or abdominal cramping?

C1b. ( For persons that still have symptom) For how many days did you have a stomachache or abdominal cramping?

C2. On what day did your diarrhea or loose bowels start?

C2a. Do you still have a diarrhea or loose bowels cramping?

C2b. ( For persons that still have symptom) For how many days did you have a diarrhea or loose bowels cramping?

C2c. What was the maximum number of bouts or episodes of diarrhea experienced in a 24 hour period? Ask for each person with symptom.

C3. On what day did your nausea start?

C3a. Do you still have a nausea?

C3b. ( For persons that still have symptom) For how many days did you have a nausea?

C4. On what day did your throwing up or vomiting start? Page 36 C4a. Do you still have throwing up or vomiting ?

C4b. ( For persons that still have symptom) For how many days did you have throwing up or vomiting?

C4c. What was the maximum number of bouts or episodes of throwing up or vomiting experienced in a 24 hour period? Ask for each person with symptom.

C5. On what day did your urinary tract infection or burning sensation start?

C5a. Do you still have a urinary tract infection or burning sensation?

C5b. ( For persons that still have symptom) For how many days did you have urinary tract infection or burning sensation?

C6. On what day did your fever start?

C6a. Do you still have a fever?

C6b. ( For persons that still have symptom) For how many days did you have a fever?

C6c. Was your temperature taken using a thermometer?

C6a. What is the highest temperature that you had since your beach interview on { BEACH INTERVIEW DATE}?

C7. On what day did your headache start?

C7a. Do you still have a headache ?

C7b. ( For persons that still have symptom) For how many days did you have headache?

C8. On what day did your sore throat start?

C8a. Do you still have a sore throat ?

C8b. ( For persons that still have symptom) For how many days did you have sore throat ?

C9. On what day did your bad cough start? Page 37 C9a. Do you still have a bad cough ?

C9b. ( For persons that still have symptom) For how many days did you have a bad cough?

C9c. Was this bad cough related to allergies?

C10. On what day did your cold start?

C10a. Do you still have a cold?

C10b. ( For persons that still have symptom) For how many days did you have a cold?

C10c. Was this cold related to allergies?

C11. On what day did your runny or stuffy nose start?

C11a. Do you still have a runny or stuffy nose?

C11b. ( For persons that still have symptom) For how many days did you have a runny or stuffy nose?

C11c. Was this runny or stuffy nose related to allergies?

C12. On what day did your earache, ear infection or runny ears start?

C12a. Do you still have a earache, ear infection or runny ears?

C12b. ( For persons that still have symptom) For how many days did you have a earache, ear infection or runny ears?

C12c. Was this earache, ear infection or runny ears related to allergies?

C13. On what day did your watery eyes start?

C13a. Do you still have watery eyes?

C13b. ( For persons that still have symptom) For how many days did you have watery eyes?

C13c. Was this watery eyes related to allergies?

C14. On what day did your eye infection start? Page 38 C14a. Do you still have eye infection?

C14b. ( For persons that still have symptom) For how many days did you have eye infection?

C15. On what day did your cut first get infected?

C15a. Do you still have an infected cut?

C15b. ( For persons that still have symptom) For how many days did you have an infected cut?

C15c. Where were you cut? Mark all that apply Drop down list C16. On what day did your rash, itchy skin, or skin infection start?

C16a. Do you still have a rash, itchy skin, or skin infection?

C16b. ( For persons that still have symptom) For how many days did you have a rash, itchy skin, or skin infection?

C16c. Where did you have a rash, itchy skin, or skin infection? Mark all that apply Drop down list C17. On which parts of the body were you sunburned? Mark all that apply Drop down list SECTION D Ask only once for each person reporting symptoms D1. When your condition began, were you working for pay either inside or outside the home? Please include jobs for which you were self employed.

D2. During your illness, did you miss any time from work, for example because you called in sick or took time off to see a doctor?

D3. How many days? Page 39 D4. Did this illness prevent you from performing daily activities such as school, recreation, or vacation activities, or work around the home?

D5. How many days?

D6. Did this illness cause other household members to lose time at work?

D7. How many days?

D8a. Did you consult a healthcare provider over the phone about this illness/ condition?

D8b. Did you visit a healthcare provider?

D8c. How many times?

D8d. What illness did the healthcare provider say you had?

D8e. Did you visit an emergency room?

D8f How many times?

D8g. Were you admitted to a hospital?

D8h. How many days were you hospitalized?

D8i. Were you given intravenous fluids?

D9a. Did you receive a prescription for an antibiotic or other drug for this illness/ condition?

D9b. About how much of your own or your household's money was spent altogether for these prescription medicines? Amount to nearest dollar.

D10a. Did you use any over the counter medications, including things like special drinks, only because of this illness/ condition D10b. About how much of your own or your household's money was spent altogether for these over the counter medications? Amount to nearest dollar. Page 40 SECTION E E1. Before today, were you aware that people could become ill by swimming at the beach?

E2. After today, will you change the way you use the water at the beach?

SECTION Q These are questions from beach interview to ensure data collection for important exposures. Ask for all households.

Q1. Did you or anyone in your household wade, swim, or play in the water on { BEACH INTERVIEW DATE}?

Q1a. 1. Did you immerse your body, not necessarily your head in the water { BEACH INTERVIEW DATE}?

Q1a. 2. Did you put your face in the water or submerge head in the water on { BEACH INTERVIEW DATE}?

Q1a. 3. Did you get water in your mouth on { BEACH INTERVIEW DATE}?

Q1a. 4. Did you gag or cough after getting water in your mouth on { BEACH INTERVIEW DATE}?

Q1a. 5. Did you swallow the water on { BEACH INTERVIEW DATE}?

This completes our telephone interview and your participation. I'd like to verify your address so we can mail a check for $ 25 to { BEACH RESPONDENT}. ( VERIFY ADDRESS ON CALL SHEET.) You will receive your check in 30 days and thank you for your participation in this study. You can find information about the results of this study by calling the toll free number or using the e mail address listed in the brochure that we gave you. Thank you for taking the time to talk with me. Goodbye.

IF RESP DOESN'T HAVE BROCHURE:

You can call 1 888 422 3072, from 8 am to 4: 30 pm, Monday through Friday, Eastern time; mention you are calling about the NEEAR study. You can also e mail near_ water_ study@ epa. gov.

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 15 minutes per response. Burden means the total time, Page 41 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 15 minutes completing the home telephone interview. The telephone interview 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 OMB Control number 2080 0068 in any correspondence. Do not send the completed survey to this address. Page 42 APPENDIX E 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.


Responses to Comments Received on Proposed Renewal of the Information Collection Request (ICR) for the User Fees for the Administration of the Toxic Substances Control Act (TSCA)

Background

On March 19, 2021 the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register (86 FR 16347), and sent consultation emails to three recipients announcing that it was planning to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for renewal of the User Fees for the Administration of the Toxic Substances Control Act (TSCA). The public comment period closed on May 18, 2021. The Agency received comments from the Environmental Defense Fund (EDF) and the Alliance for Automotive Innovation (Auto Innovators) in response to the notice.

Public Comments and EPA Responses Environmental Defense Fund (EPA-HQ-2020-0616-0008)

EPA received one comment from EDF asserting that EPA is misreading TSCA as it relates to fees. EPA believes this comment is not within the scope of this ICR renewal and will not address it under this ICR. EDF has submitted a similar comment on the proposed 2021 TSCA Fee Rule, where EPA will address the comment. Alliance for Automotive Innovation (EPA-HQ-OPPT-2020-0616-0007)

1. Comment- Rule Familiarization: Auto Innovators comment that EPA's burden estimates for rule familiarization do not reflect the real costs of rule familiarization because most entities need more than one reviewer, and reviewers are likely to spend more than 0.5 hours reviewing the rule.

      Response: EPA appreciates Auto Innovators for bringing attention to additional considerations regarding the burden estimates for rule familiarization. Because this ICR is connected to the renewal of an existing rule (i.e., 2018 Fee Rule), there are no changes requiring additional familiarization relative to 2018.  EPA will consider the issues raised in these comments when drafting burden estimates for the TSCA Fee Rule revisions which were proposed on January 11, 2021, and expected to be finalized in the coming year, and could contain changes requiring additional familiarization. Hence, EPA is confident that the burden of additional rule familiarization for potential newly affected entities is captured by the current estimate.

2. Comment- Identification of Chemicals: Auto Innovators states EPA's estimated impact analysis does not reflect the hours and costs required for companies that import chemical mixtures to reach into their supply chains and identify high priority chemicals.

      Response: EPA recognizes and appreciates Auto Innovators concerns expressed regarding the issue of chemical identification. The list of fee payers compiled by EPA was largely sourced from manufacturers who had submitted reports for Chemical Data Reporting (CDR) and the Toxics Release Inventory (TRI). Hence, most companies included here would have already identified their own association with the High Priority Substances (HPS) in question, and spent that information gathering time outside the scope of fee payment.

3. Comment- Familiarization with CDX: Auto Innovators identified a discrepancy between EPA's Central Data Exchange (CDX) guidance and the estimate given in this ICR. Auto Innovators point to EPA's CDX guidance, which mentions that programs with paper subscriber agreements and verification forms via mail may take 5-10 days to process. Auto Innovators assert that registering for CDX can take up to an hour to gather necessary information.

      Response: EPA updated the estimate in accordance with CDX guidance to maintain consistency. Regarding the 5-10 day estimate for paper subscribers, this refers to elapsed time for documents to be submitted via post. Active time spent for paper subscribers to register would conform to the 15-20 minute figure set forth in the guidance.

4. Comment- Self-Identification and Certification: Auto Innovators comment that EPA should revise the self-identification estimates to include the time required to gather the information needed to complete CDX registration.

      Response: EPA appreciates Auto Innovators for bringing attention to additional considerations regarding the burden estimates for self-identification and certification. Because this ICR is connected to the renewal of an existing rule, the 2018 Fee Rule, there are no changes requiring additional self-identification and certification relative to 2018. EPA is confident that the burden of additional self-identification and certification, for potential newly affected entities, is captured by the current estimate.

5. Comment- Estimated of Hourly Costs: Auto Innovators assert that the wage rates, based on 2001 and 2002 data, are inconsistent with current wage rates, and do not reflect the seniority of staff required to review and verify all of the components associated with reporting.

      Response: Agency burden estimates were calculated using the 2020 general schedule (GS) wage rates for the Washington-Baltimore-Arlington, DC-MD-VA-WV-PA locality pay area. The 2001 and 2002 papers mentioned refer to the methodology used for calculating agency burden estimates; for individual rules and ICRs, agency burden estimates are calculated with the framework outlined in these documents, using the most current data available at the time of publication. With the publication of the final Fee Rule, these estimates will be further updated to reflect 2021 wage rates.

      Regarding the comment on sufficient seniority of staff in calculating burden estimates: within the EPA, and throughout the federal government in general, a specific GS level does not necessarily denote whether a position is staff level or manager. A GS-13, step 5 position can refer to both a senior staff position and a managerial position, and it is EPA's position that the GS and step levels used to calculate the burden is suitable in this instance.

6. Comment- Need to Consult: Auto Innovators comment that EPA should meet with industry stakeholders to more accurately assess the time and resources required for each stage of compliance with the Fee Rule.

      Response: Under TSCA section 26(b)(4)(E), EPA is required to consult and meet with parties potentially subject to the fees or their representatives prior to establishment or amendment of TSCA fees. Similarly, under TSCA section 26(b)(4)(F), EPA is required to adjust the fees as necessary every three years after consulting with parties potentially subject to the fees and their representatives. Since the publication of the final 2018 Fee Rule, EPA has held several outreach meetings with industry stakeholders on implementation issues. All of these outreach meetings are summarized at https://www.epa.gov/tsca-fees/outreach-materials-tsca-administration-fees-rule.              EPA also conducted outreach on the proposed 2021 TSCA Fee Rule. EPA hosted a public webinar on February 18, 2021 to provide an overview to stakeholders on the proposed revisions to the Fee Rule announced in December 2020. The webinar also gave the public an opportunity to provide comment to EPA on the proposed changes. EPA also briefed the Small Business Administration regarding engagement with small businesses in a roundtable on February 5, 2021. EPA will continue to engage with the Small Business Administration on key rule developments. EPA is committed to continued stakeholder outreach and intends to engage with companies, trade associations and consortia that represent affected manufacturers and processors. Any future outreach meetings will be summarized at https://www.epa.gov/tsca-fees/outreach-tsca-administration-fees-rule.

7. Comment- Remove the Requirement for Self-Certification for Certain Activities: Auto Innovators comment and suggest that EPA should remove certain self-certification requirements (i.e., certification of cessation and certification of no manufacture) to reduce the reporting burden of companies.

      Response: EPA appreciates the comment; however, EPA believes this comment is not within the scope of this ICR renewal.     8. Comment-Conduct Current Survey of Hours Required to Respond to the Fee Rule and CDX: Auto Innovators state that the reporting burdens do not accurately reflect the burden on downstream users of mixtures and recommend that EPA address this gap by surveying the downstream users that have experience with the 2018 Fee Rule.

      Response: Generally, only chemical manufacturers (including importers) are subject to TSCA fees. For some fee-triggering events like test orders, new chemical notices, and manufacturer-requested risk evaluations, the responsible manufacturers are self-evident. Other entities, such as downstream users of a chemical who do not manufacture or import the chemical, are not subject to TSCA fees and therefore would not incur reporting burdens.


[Federal Register Volume 87, Number 6 (Monday, January 10, 2022)]
[Notices]
[Page 1135]
[FR Doc No: 2022-00190]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ22-8-000]

City of Colton, California; Notice of Filing

    Take notice that on December 29, 2021, City of Colton, California
submitted its tariff filing: 2022 Transmission Revenue Balancing
Account Adjustment/Existing Transmission Contracts update, to be
effective January 1, 2022.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (https://www.ferc.gov)
using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. At this
time, the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at https://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on January 18, 2022.

    Dated: January 4, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-00190 Filed 1-7-22; 8:45 am]
BILLING CODE 6717-01-P