# Meeting Report for The Peer Review of EPA’s Draft Recreational Water Quality Criteria (RWQC) Document

Submitted to: Office of Water U.S. Environmental Protection Agency (EPA)

Washington, DC 20460

Submitted by: Eastern Research Group, Inc. 110 Hartwell Avenue Lexington, MA 02421

Final Meeting Report: November 1, 2011

## Notice

This report was prepared by Eastern Research Group, Inc. (ERG), a U.S. Environmental Protection Agency (EPA) contractor, as a record of discussion during the Pe er Review Meeting on EPA’s draft document Recreational Water Quality Criteria (RWQC) for the P rotection of Human Health , held September 12-13, 2011, in Arlington, Virginia. The peer review summary report was prepared by the peer reviewers, with ERG support, on the second day of the peer review meeting. T his section captures the main points and highlights of reviewers’ discussions and recommendations. The appendices include the technical charge, peer reviewers post-meeting comments organized by charge qu estion, their individual comments including biographies, the meeting agenda, and the list of reviewers a nd observers at the meeting. Statements represent the individual views of meeting participants.i 

## Contents

Introduction ........................................

................................................... ........................................ 1 Background ...........................................

................................................... ............................................1
Peer Review Process ...............................

................................................... ...........................................2 Opening Remarks ......................................

................................................... ........................................3 Meeting Discussion Process ...........................

................................................... ....................................3


### Peer Reviewers’ Summary Report .......................

................................................... ...................... 5

1. Does the document adequately present the logic and scientific support behind its conclusions? Please comment on the document’s transparency, the completene ss of the presentations, and any shortfalls in the material presented. Are uncertaint ies for technical conclusions transparent? Do you have any suggestions on how we could improve t his document? Please explain your responses. ................................

................................................... ............................... 5

2. Are you aware of any important peer reviewed literature o r applicable data that have not been incorporated in this document and should be included? ...

................................................... ............. 8

3. Do the analyses comparing the NEEAR freshwater and marine culture-based indicator data aggregated by days of similar water quality corroborat e that the NEEAR culture data are generally consistent with the 1986 regression models?........

................................................... ....... 10

4. Do the characterization and explanation of the qPCR method reflect that of the scientific literature? If not, what additional information should b e included? Is the derivation of the qPCR value using the EPA data scientifically supported and adequately explained? Please discuss why or why not. ................................

................................................... ............................ 12

5. Please provide any other general or specific comments on the doc ument, making sure to identify the section number/page number you are commenting on . ............................................... 12



### Appendix A - Technical Charge to External Peer Reviewers

.................................................. . A-1

Appendix B - Reviewers’ Post-Meeting Comments Organized by Charge Question ............. B-1

Appendix C - Individual Reviewers’ Post-Meeting Comments ............................................... C- 1

Samuel Dorevitch ....................................

................................................... ...................................... C-3 Erin K. Lipp ........................................

................................................... ......................................... C-19 Graham McBride .....................................

................................................... .................................... C-27 Rachel Noble .......................................

................................................... ........................................ C-35 Gordon Yasvinski .....................................

................................................... ................................... C-47



### Appendix D - Meeting Agenda ........................

................................................... ....................... D-1

Appendix E - List of Reviewers and Observers ..........

................................................... .......... E-1Introduction

1 

## Introduction

EPA developed the draft Recreational Water Quality Crite ria (RWQC) for the Protection of Human Health, laying out the underlying science and associated technical infor mation related to RWQC and how scientific findings were used during the development of the RWQC. The wat er quality methods associated with the RWQC are also discussed. In addition, EPA’s policy decisio ns related to RWQC as of July 4, 2011, are presented throughout the document. Eastern Research Group, I nc. (ERG), under contract to EPA, conducted an independent external peer review and meeting of the draft criteria.



### Background

An important goal of the Clean Water Act (CWA) is to protect and restore waters for swimming. Section 304(a) of the Act directs EPA to publish “advisory water qua lity guidance on the effects of the presence of pollutants in water on health and welfare”. These recomme ndations are referred to as Section 304(a) criteria. Under Section 304(a), EPA is required to issue recommended criteria and update them from time to time. Under Section 304(a)(9) of the CWA, EPA is required to update or revise the current recommended 304(a) criteria related to pathogens and pathogen indicators to prot ect swimmers from illnesses associated with pathogenic microbes in coastal and Great Lakes water bodi es.
In adopting new or revised water quality standards, State s must adopt criteria that are scientifically defensible and protective of the use, but they have flexibilit y to do so by adopting EPA’s recommended criteria, adopting criteria to reflect site-specific conditions, or adopting other criteria that are scientific ally defensible.

Once adopted into State standards, water quality crite ria express the desired ambient condition of the water to protect a designated use. State water quality standards a re used for various CWA purposes or programs that identify and address the sources of pollution with the goal of attainment of the criteria, including National Pollutant Discharge Elimination System (NPDES) permits, water body assessments to determine use attainment, and development of Total Maximum Daily Loads (TMDLs). Water quality standards are also used by States in beach monitoring and notification program s.
Historically, the federal government’s recommended criteria f or protecting people who recreate in water have been based on fecal matter in recreational waters. In the 1960’s, the Public Health Service recommended using the indicator bacteria, fecal coliforms, a s the primary contact recreational 1 water quality criterion. In the late 1970s and early 1980s, EPA conducted public health studies evaluating several organisms as possible indicators, including fecal coliform s, E. coli , and enterococci. The studies showed that Enterococcus was a good predictor of gastrointestinal illnesses in f resh and marine recreational waters, and E. coli was a good predictor of gastrointestinal illnesses in fresh waters. As a result, EPA published revised criteria in 1986 ( EPA’s Ambient Water Quality Criteria for Bacteria – 1986) for primary contact recreation. The 1986 criteria recommended the use of E. coli for freshwaters (criteria set as a geometric mean of 126 colony forming units [cfu]/100 milliliters [mL]) and enterococ ci for fresh and marine waters (criteria set as geometric means of 33 cfu/100mL in freshwater and 35 cfu/100mL i n marine water). These recommendations replaced EPA’s previously recommended bacteria criteria for fecal coliform of 200 cfu/100mL. Most strains of E. coli and Enterococcus do not cause human illness (that is, they are not human pathogens); rather, in many settings they are thought to i ndicate fecal contamination, and the assumption is that pathogens co-occur with incidences of fecal contami nation.

1 Primary contact recreation - EPA’s §304(a) RWQC recom mendations are national recommendations for all surf ace waters of the United States designated for swimming, bathing, surfing, or similar water contact activities.Introduction

2

Since EPA issued its recreational criteria over 20 years ago, there have been significant scientific advances, particularly in the areas of molecular biology, microbiology , analytical chemistry, the application of predictive models, and improved sanitary survey techniques. EP A believes that these new scientific and technical advances need to be factored into the development of new or revised 304(a) criteria for recreation. To this end, EPA has been conducting research and assessing relevant scientific and technical information to provide the scientific foundation for the development of new o r revised criteria. The enactment of the Beaches Environmental Assessment and Coastal Health (BEAC H) Act of 2000 (which amended the CWA) required EPA to conduct new studies and issue new or revis ed criteria, specifically for Great Lakes and coastal marine waters.

On March 21, 2007 and April 7, 2008, the United States District Court of Central California ruled that EPA failed to perform its mandatory duties to complete the required studies under Section 104(v) of the CWA, 33 U.S.C § 1254(v), by October 10, 2003, and to publish water quality criteria under CWA § 304(a)(9)(A), 33 U.S.C. § 1314(a)(9)(A), by October 10, 2005. A consent decree wa s issued and it was agreed by both the plaintiff and the defendant, EPA, that new or revised wat er quality criteria for pathogens and pathogen indicators pursuant to 33 U.S.C. § 1314(a)(9)(A) would be signed for publication in the Federal Register by October 15, 2012. Also included in the terms of the consent dec ree was that epidemiological studies be completed in marine waters impacted by urban runoff in a t emperate region and in a tropical region. At the same time, EPA also signed a settlement agreement with the plaintiffs, agreeing to conduct additional research and science studies. For full documentation on how EPA met the terms of the settlement agreement and consent decree visit EPA’s Recreational Water Qualit y Criteria website. http://water.epa.gov/scitech/ swguidance/standards/criteria/health/recreation/index.cfm



### Peer Review Process

In summer/fall of 2011, Eastern Research Group, Inc. (ERG) , an EPA contractor, organized an independent peer review of EPA’s draft document , “ Recreational Water Quality Criteria (RWQC) for the P rotection of Human Health” to assess its scientific soundness and utility. Five experts were secured as peer reviewers (Appendix E) to conduct this review:

• Samuel Dorevitch, University of Illinois at Chicago, IL

• Erin Lipp, University of Georgia, GA

• Graham McBride, National Institute of Water & Atmospheri c Research Ltd., New Zealand

• Rachel Noble, University of North Carolina, Chapel Hill , NC

• Gordon Yasvinski, Health Canada, Canada

ERG provided the reviewers with the draft RWQC document, a charge (Appendix A), which asked for reviewer comments on the various aspects of the document, and a CD with all reference materials used in developing the criteria.

In the first stage of the review, the experts worked individ ually to prepare individual written pre-meeting comments to address the charge questions. To kick off thi s stage of the review, ERG organized and facilitated a conference call to brief reviewers and o ffer them the opportunity to obtain clarifications from EPA on the peer review materials. In addition, ERG asked EPA to present background on the context for developing the criteria document and provide the context for th e review and the charge questions. Reviewers then worked individually to prepare and submit their pre-meeti ng comments addressing the charge questions, which ERG then provided to all reviewers and EPA prior to t he meeting.

In the second stage, ERG convened a two-day peer review mee ting, on September 12-13, 2011, in Arlington, Virginia. Appendix D provides the meeting agenda and Appendix E pro vides the list of meeting attendees.Introduction

3 On the second day of the meeting, ERG worked with reviewer s to prepare a draft peer reviewer summary report highlighting the key issues and recommendations from their comments and discussions. After the meeting, reviewers were asked to provide post-meeting comment s, amending their pre-meeting comments, as appropriate, in light of their comments and discussions at the meeting. Reviewer post-meeting comments are provided in Appendices B and C.

This report summarizes the peer review as follows:

• ERG and EPA Opening Remarks

• Peer Reviewers’ Summary Report

• Appendix A: Charge to Peer Reviewers

• Appendix B: Reviewers’ Post-Meeting Comments Organized by Charge Question

• Appendix C: Reviewers’ Individual Post-Meeting Comments

• Appendix D: Meeting Agenda

• Appendix E: List of Reviewers and Observers



### Opening Remarks

Kate Schalk (ERG), the meeting facilitator, opened the meeting by welcoming the reviewers and asking the reviewers and EPA representatives to introduce themselves. Ms. Schalk reviewed the meeting agenda (Appendix D). She noted that the pre-meeting comments were developed by reviewers working individually prior to the meeting, and that reviewers may express diffe rent opinions during the meeting. Ms. Schalk briefly reviewed the ground rules for the meeting, making cle ar that all discussions were to be among reviewers only; however, reviewers could request, and EPA could offer, clarifications where relevant.

Ms. Schalk then asked Beth Doyle, Branch Chief, Human H ealth Risk Assessment Branch, Health and Ecological Criteria Division (HECD), EPA Office of Scie nce and Technology, Office of Water, to offer some brief welcoming remarks. Also present from EPA were Shamima Akhter, John Ravenscroft, and Sharon Nappier from HECD. Jeff Soller (Soller Environmenta l), a consultant working with EPA to develop the criteria document also attended. And present via telec onference from the EPA Office of Research and Development (ORD) were Tim Wade, Alfred Dufour, Kevin Oshi ma, and Robert Cantilli. Appendix E provides a list of meeting attendees.



### Meeting Discussion Process

Ms. Schalk then turned the meeting over to Rachel Noble, the technical review panel chair, to begin the reviewer discussions. Dr. Noble stated that the discussion would proceed following the order of the charge questions, and that each reviewer would in turn discus s his/her highest priority issue related to that question. For example, for question 1, reviewer 1 would provide his/her highest priority response to question 1, with enough background information to open the topic for discussion . Then, in turn, each reviewer would add to, debate, or highlight other important components to that spec ific topic. When that topic was completely discussed to the satisfaction of the reviewers, reviewer 2 would provide his/her highest priority issue in response to question 1, and so forth. The discussions pro ceeded until all charge questions were addressed, all points of view presented and discussed, and additional inform ation or comments that lay outside of the technical charge were presented. As needed, reviewers aske d EPA for clarifications if discussions could not move forward without further information or clarification. At the close of all discussions addressing the charge and other issues identified by the reviewers, Ms. S chalk adjourned the formal meeting. After the formal meeting was adjourned, ERG worked with the peer r eviewers to develop the peer reviewers’ summary report.Introduction

4Peer Reviewers’ Summary Report

5 

## Peer Reviewers’ 

## Summary Report

Introduction

The peer reviewers acknowledged the monumental amount of wo rk that EPA has completed to critically examine and synthesize the vast amount of water quality re lated science. They commended EPA’s efforts to develop new or revised criteria, and agreed that there is scientific support for many aspects of the proposed criteria. The reviewers provided the following comments to a ssist EPA strengthen the draft Recreational Water Quality Criteria.



### 1. Does the document adequately present the logic a nd scientific support behind its conclusions? Please comment on the document’s trans parency, the completeness of the presentations, and any shortfalls in the material p resented. Are uncertainties for technical conclusions transparent? Do you have any suggestions on how we could improve this document? Please explain your response s.

General

1.1. Add an executive summary to the criteria document that co ntains a "road map". Emphasize what is staying the same from the 1986 criteria and what is changing.

1.2. It would be useful to the reader for EPA to explain the c omponents of a criterion. Provide basic definitions/explanations. In doing so, avoid using “criteria” as the microbe being measured and the density of the microbe not to be exceeded. Have a glossar y to define terms and define the term when first used in the document.

1.3. Stress that fecal indicator bacteria (FIB) are health r isk indicators, not necessarily pathogen indicators. The later portions of the criteria document focused on t he link between FIB and health, so there is little need for emphasis in the earlier portion of the document on an FIB pathogen relationship. Statements regarding FIB pathogen relationship in the water body type se ction might be better placed in the quantitative microbial risk assessment (QMRA) section.

1.4. Release the topic specific guidance documents at the s ame time as the RWQC. If these won’t be available, there should be some indication of the basic conte nts of the topic specific guidance (TSG) documents.

1.5. Write the document from the perspective of the end user, who is more interested in implementation than in the process/history by which the criteria were de veloped. Rather than writing in a retrospective framework, be prospective about the findings and science.

1.6. Add text to the Introduction indicating that water quality m onitoring and notification programs are critical but are not the only elements to protecting public heal th. Water quality monitoring is one component in a beach management strategy.



### Application of Criteria to Inland W aters

1.7. Reorganize the structure of the "Waterbody Type" section (3.4) to emphasize public health protection first. De-emphasize the suggested similarity of coastal and inland waters. As written, the RWQC suggests that the variability in FIB (or FIB-pathogen asso ciations) in inland versus coastal water distinctions is smaller than the variability across co astal sites. This discussion is most appropriate in Section 5.2.2 under QMRA.Peer Reviewers’ Summary Report

6

1.8. The reviewers endorsed extending coastal water criteria t o inland waters, based upon protection of public health. However, they recommend that EPA acknowledge the pauc ity of health data upon which to base the extension of coastal derived indicator criteria to inland waters. The information presented on this topic in the RWQC should consider the findings present ed in the Inland Waters Workshop, including the conclusion of workshop experts that coastal-de rived criteria should be protective of public health in inland waters impacted by publicly owned treatm ent works (POTWs). Proceed with using coastal water criteria in the interest of protect ing public health based on the best available information available at this time.



### Tropical and Subtropical Waters

1.9. Be transparent about the lack of usable data from the Nation al Epidemiological and Environmental Assessment of Recreational Water (NEEAR) studies in tro pical waters.

1.10. Cite findings from the Tropical Indicator Workshop. Mention di fferent season lengths that could impact sampling requirements.

1.11. Have a separate section addressing specific issues facing tropical (and subtropical) waters. It would be appropriate to include studies from Hawaii on this issue.

1.12. States that currently implement more stringent criteri a should be encouraged to continue doing so. Given the lack of useable data from NEEAR tropical sites, EPA should partner with tropical and subtropical states to develop new indicators, particularly rapi d ones, as potential criteria. This is important given the high level of beach usage in these stat es.


### Quiescent and High Energy Beaches

1.13. Acknowledge that all NEEAR studies, as well as the Mission Bay study, have been done in enclosed beach or embayments, except for Surfside Beach, SC. The pro posed criteria should be applicable at high energy beaches but the differences should be noted.

1.14. Acknowledge the possibility that had NEEAR studies been conducte d at high energy beaches, respiratory illness may have been more frequent.

1.15. Work to ensure that Southern California Coastal Water Research Project (SCCWRP) studies are included in the RWQC because they include good information about high energy beaches.

1.16. EPA may wish to explain its rationale for selecting be aches for NEEAR studies. Such an explanation - the requirement of a range of FIB levels and POTW proxim ity - may explain the absence of highenergy marine sites.



### Single Sample Maximum (SSM) vs. Statistical Thresho ld Value (STV)

1.17. Needs to be more clearly presented. Highlight what has c hanged and what is staying the same.

1.18. Justify the assumption of log normal distribution of FIB data (for both culture-based and quantitative polymerase chain reaction [qPCR] data) as related to ca lculation of STV.

1.19. The discussion needs to be more clearly laid out for the loss of tiers. Address the impact resulting from the loss of tiers.

1.20. The uses of geometric mean (GM) versus STV for beach notif ication vs. other CWA purposes need to be clarified.Peer Reviewers’ Summary Report

7 1.21. The change in sampling frequency for the GM from at least 5 per 30 days should translate to at least 15 per 90 days, rather than 12 per 90 days.

1.22. Specify acceptance of other water quality assessment appr oaches, such as the frequency of beach closure approach used by the State of California, dependent upon increased stringency.

1.23. Provide guidance on sampling frameworks that promote ac curate representation of beaches over wide ranging conditions (e.g., wet weather vs. dry weather).

1.24. There was general agreement that the concept of STV – which a substantial percent of single samples would be expected to exceed the GM – is more appropriate t han the term “single sample maximum”, which may be misconstrued to mean FIB densities that sho uld never be violated.



### Minimum Sampling Requirements (Wet Weather)

1.25. A poorly designed sampling framework can result in under-protec tion of public health and inaccurate 303(d) listing. Strive for a common set of minimum sampling r equirements across states for all CWA purposes. In other words, sampling requirements informed b y site-specific variability in FIB values would be useful, though more challenging from an implementa tion standpoint.

1.26. States should be directed to sample at locations and dur ing periods of high use, such as weekends, regardless of antecedent weather conditions. Minimum spati al and temporal sampling frequencies should be specific enough so that it would not be possible for water samples to be collected (for GM calculation) selectively on days expected to have low FIB values (i.e., we do not want beach managers to avoid sampling the day or two following rainfall).



### E. coli

1.27. Be transparent about the lack of NEEAR E. coli qPCR study data.

1.28. Acknowledge the strength of health risk as related to E. coli by culture concentrations in fresh water epidemiology studies.

1.29. More fully address the options for rapid method implementa tion for E. coli

.
1.30. Increase consistency of messages about the use of E. coli as an effective indicator in fresh waters.



### qPCR

1.31. Increase the amount of information regarding strength of relationship between qPCR for Enterococcus and health outcomes at NEEAR fresh water beaches. Include visual representation.

1.32. Failure to propose mandatory qPCR criteria at Great Lake s beaches is surprising given the results of the NEEAR studies. Because prior day culture measures are poor predictors of illness, explain why culture based methods are being put forward as the first cho ice and qPCR as an option.

1.33. If the proposed RWQC are not revised to mandate qPCR moni toring at Great Lakes beaches, justification for failing to promote the better and faste r method is necessary.

1.34. Reviewers like the inclusion of the indicator bacteria and methods section (Section 3.1), but the written material needs to be more detailed and in relation to c ulture-based methods versus rapid methods needs to be more balanced. Inhibition information is too detailed and presented too early in the document. Reverse the order of Sections 3.1 and 3.2.Peer Reviewers’ Summary Report

8



### QMRA

1.35. Explain “scientifically defensible” as related to QMRA in developing site-specific criteria.

1.36. Acknowledge that EPA did not deliver a side-by-side QMRA wit h the NEEAR Boquerón study.

1.37. Without a QMRA/epidemiology validation study, the accuracy of QMRA estimates remains to be determined.

1.38. Need to justify QMRA as an alternative to epidemiology st udies in developing site specific criteria rather than a water body management tool. QMRA is a good mana gement tool, encourage states to use it as a way to evaluate options for water management, but the option to use QMRA to develop criteria should be backed up by validation studies.

1.39. EPA has an opportunity to take the lead in QMRA science, particularly in the development of accurate quantification approaches for pathogens.

1.40. Need to provide a conceptual framework figure and examples/ca se studies.

1.41. Increase breadth of potential “tools” to include resuspens ion and regrowth studies, as presented in Section 5.2.

1.42. Technical support documents will be critical for appropria te use of specific QMRA modeling approaches and inputs.

1.43. Text about sources of fecal contamination as related to Q MRA is missing.



### 2. Are you aware of any important peer reviewed lit erature or applicable data that have not been incorporated in this document and should be in cluded?

Reviewers recommended adding the following references to the RWQC:

2.1. WHO/EPA Annapolis protocol (WHO 1999, WHO 2003)

• Explain why not being used, but note that extension to 90 days for GM calculation takes these criteria close toward that protocol's beach grading compone nt. Also discuss consideration of a "traffic light" notification approach.

2.2. Kay et al. (2004)—including discussion (Wymer et al., 2005) and r eply (Kay et al., 2006)

• Explain reasons for not adopting the "UK ecologic exposure model " for "guideline" development.

2.3. Dufour et al. (2006)

• Children more at risk than adults.

2.4. Heaney (2009)

• NEEAR study swimmers illness may be influenced by sand e xposure.

2.5. Pratap et al. (2011)

• Need for effective communication also needed for disease pr evention.Peer Reviewers’ Summary Report

9 2.6. Bambic et al. (2011)

• Bacteroidales measured by qPCR as alternate indicator and fecal sour ce identifier were highly correlated with Enteroccoccus and E. coli when either traditional (cultivation dependent) or qPCR methods were used.

• Norovirus GI and GII were reasonable predictors of other pat hogens like Adenovirus 40/41, Adenovirus C, Giardia and Cryptosporidium measured by qPCR.

2.7. Fewtrell et al. (1992), Harrington et al. (1992)

• Health effects (respiratory) of white-water canoeing a nd surfing.

2.8. Sinton et al. (2002), Noble et al. (2004)

• Differing interpretations on relative microbial inactiva tion rates in freshwater cf. coastal waters.

2.9. French et al. (2011)

• Wild bird feces (via Campylobacter ) demonstrated to be less virulent to humans, cf. feces from farmed animals.

2.10. SCCWRP epidemiology studies/Colford et al., submitted

• SCCWRP results to be used as soon as available.

2.11. Lavender & Kinzelman (2009)

• Implementation of already available rapid methods, especia lly equivalence between culture based and rapid methods for E. coli.

2.12. Viau et al. (2011)

• Example of application of QMRA in tropical waters.

2.13. Dorevitch et al. (2011) (Added to the list during the October review of the final draft.)

• Epidemiologic study of limited contact water recreation at i nland waters.



### References

Bambic, D.; McBride, G.; Miller, W.; Stott, R.; Wuertz , S. (2011). Final Report: Quantification of Pathogens and Sources of Microbial Indicators for QMRA in Recreat ional waters. Report by University of California (Davis), AMEC Earth and Environmental and NIWA to WERF (USA Water Environment Research Foundation) for the project PATH2R08. 375 p.
Dorevitch S, Pratap P, Wroblewski M, Hrohorczuk DO, Li H, Liu LC, Scheff PA: Health risks of limited contact water recreation. Environmental Health Perspectives, 2011, in press.
Fewtrell, L.; Godfree, A.F.; Jones, F.; Kay, D.; Sal mon, R.L.; Wyer, M.D. (1992). Health effects of whitewater canoeing. The Lancet 339 : 1587–1589. Their results for Site B refer.
French, N.P.; Marshall, J.; Mohan, V. (2011). Campylobacter in food and the environment: new and emerging data on typing of Campylobacter strains in anima ls, environmental matrices and humans. Final report 07-10436, Molecular Epidemiology and Public Health L aboratory, Massey University, Palmerston North, New Zealand. Prepared for the New Zea land Food Safety Authority and Ministry for the Environment. http://www.foodsafety.govt.nz/elibrary/industry/examining-link-w ith-publichealth/new-and-emerging-data-on-typing-of-campylobacter.pdf

.Peer Reviewers’ Summary Report

10

Harrington, J.F.; Wilcox, D.N.; Giles, P.S.; Ashbolt, N .J.; Evans, J.C.; Kirton, H.C. (1993). The health of Sydney surfers: an epidemiological study. Water Science and Technology 27(3–4) : 175–181.
Heaney, C.D.; Sams, E.; Wing, S.; Marshall, S.; Brenner , K.; Dufour, A.P.; and Wade, T.J. (2009). Contact With Beach Sand Among Beachgoers and Risk of Illness. American Journal of Epidemiology 70(2) : 164–172.
Kay, D.; Bartram, J.; Prüss, A.; Ashbolt, N.; Wyer, M.D .; Fleisher, J.M.; Fewtrell, L.; Rogers, A.; Rees, G. (2004). Derivation of numerical values for the World Heal th Organization guidelines for recreational
waters. Water Research 38 : 1296–1304.
Kay, D.; Ashbolt, N.; Wyer, M.D.; Fleisher, J.M.; Fe wtrell, L.; Rogers, A.; Rees, G. (2006). Reply to comments on "Derivation of numerical values for the Worl d Health Organization guidelines for recreational waters". Water Research 40 : 1921–1925.
Lavender, J.S.; Kinzelman, J.L. (2009). A cross comparison o f QPCR to agar-based or defined substrate methods for determination of Escherichia coli and enterococci in municipal water quality monitoring
programs. Water Research 43(19):4967–4979.
Noble, R.T.; Lee, I.M.; Schiff, K.C. (2004). Inactivati on of indicator micro-organisms from various sources of fecal contamination in seawater and freshwater. Journal of Applied Microbiology 96 : 464–472
Pratap, P.L.; Desai, P.; and Dorevitch S. (2011). Beach c ommunications: a need for evaluation of current approaches. Journal of Water and Health 9(3) : 556-568.
Sinton, L.W.; Hall, C.H.; Lynch, P.A.; Davies-Colley, R.J. (2002). Sunlight inactivation of fecal indicator bacteria and bacteriophages from waste stabilization pond eff luent in fresh and saline water. Applied and Environmental Microbiology 68(3) : 1122–1131.
Viau, E.J.; Lee, D.; Boehm, A.B. (2011). Swimmer Risk of Ga strointestinal Illness from Exposure to Tropical Coastal Waters Impacted by Terrestrial Dry-W eather Runoff. Environmental Science & Technology . dx.doi.org/10.1021/es200984b
WHO (1999). Health-based monitoring of recreational waters: the feasibility of a new approach (the “Annapolis Protocol”). World Health Organization, Geneva ( http://www.who.int/water_sanitation_ health/bathing/Annapolis.pdf )
WHO (2003). Guidelines for safe recreational waters volume 1 - Coastal and fresh waters. World Health Organization, Geneva (http://www.who.int/water_sanitation _health/bathing/srwe1/en/).
Wymer, L.J.; Dufour, A.P.; Calderon, R.L.; Wade, T.J.; Be ach, M. (2005). Comment on "Derivation of numerical values for the World Health Organization gui delines for recreational waters". Water Research 39 : 2774–2777.



### 3. Do the analyses comparing the NEEAR freshwater a nd marine culture-based indicator data aggregated by days of similar water quality co rroborate that the NEEAR culture data are generally consistent with the 1986 regress ion models?

3.1. Much needed clarity was provided during the peer review for c omparing freshwater and marine culture data to 1986 data. Since the purpose is to establish t he targeted level of risk used in developing the 1986 criteria to qPCR methods, the RWQC should be clarified/reorganized. Change the title of Section 3.2.4 to “Establishing a comparable target level of risk for defining culture and qPCR criteria values”.Peer Reviewers’ Summary Report

11 3.2. Peer reviewers found that some aspects of the section, es pecially Figures 1a and 1b, undermine EPA’s effort to arrive at a targeted level of risk tha t applies to both PCR and culture measures of water quality. Specifically, the information currently in the document suggests an inverse/negative relationship between culture measures of indicator bacteri a and health risk when analyzed using the seasonal aggregation approach.

3.3. EPA could acknowledge that the raw data used to establish t he 1986 criteria are no longer available for analysis. For that reason the two data sets (1986 an d NEEAR) cannot both be analyzed using NEEAR methods. This limits EPA’s ability to identify qP CR values associated with the same targeted level of risk defined by specific CFU values.

3.4. Given the unavailability of data used to develop the 1986 cri teria EPA faced two options: 1) to analyze the NEEAR culture data using the 1986 approach and compare it to the 1986 data analysis or 2) analyze culture data only from the NEEAR study using t he same methods published by Wade et al. for the qPCR data.

• Results of Option 1 are presented in the RWQC. The limitat ions of that analytic method were not clearly acknowledged. Specifically, these analyses do no t include individual level covariates. Given that a variety of exposures, such as di gging in sand, are associated with gastrointestinal (GI) illness, and that these are not accounted for in the analysis, confounding is a significant possibility.

• ORD staff clarified that EPA has conducted the option 2 a nalyses, but has not reported them. Those analyses reportedly show weak relationships between culture measures of indicators and GI illness. Those results should be presented in the RWQC

. 3.5. Since the ORD analysis (Option 2) shows a weak associati on between culture measures of FIB and health outcome, EPA must acknowledge that any targeted leve l of risk selected is inherently imprecise (i.e., it is difficult to establish with con fidence the FIB CFU or qPCR calibrator cell equivalent [CCE] values associated with a narrowly- defined targeted risk level). Figures presenting results of those analyses (analogous to Figure 1 of Wade 2008 a nd Figure 2 of Wade 2010) should be included in the document.

3.6. Since a clear threshold between safe and unsafe levels of FIB is not apparent in the data, EPA may want to consider other graded approaches (e.g., red, yellow , green) for beach notification purposes.

3.7. Since the criteria values of 33 and 35 CFU/100 ml are not cha nging, justification of these numbers is less important than if EPA had proposed alternate v alues. In Wade 2008 (Table 6) and Wade 2010 (Table 6) data are presented that support these culture-ba sed criteria values, including tables in the RWQC would bolster EPA’s decision to retain those th resholds.

3.8. In order to establish threshold values of qPCR Enterococcus , EPA could define expected case of illness per 1,000 swimmers at 33 and 35 CFU using NEEAR culture data analyzed the same way as NEEAR qPCR data. Then apply those targets to establish q PCR thresholds.

3.9. Figures 2 and 3 should present confidence intervals inste ad of prediction intervals. Figure 2 of Wade 2010 and Figure 1 of Wade 2008 present graphs of Enterococcus data in marine and freshwater, respectively. It would be useful to include the m in the RWQC document.Peer Reviewers’ Summary Report

12



### 4. Do the characterization and explanation of the q PCR method reflect that of the scientific literature? If not, what additional information sho uld be included? Is the derivation of the qPCR value using the EPA data scientifically su pported and adequately explained? Please discuss why or why not.

4.1. Be more transparent about the strength of the relationship between NEEAR-GI (NGI) risk and qPCR and health risk measures in NEEAR freshwater studi es as compared to culture methods.

4.2. Investigate possible incorporation of SCCWRP study results for marine waters.

4.3. Even though qPCR in the RWQC is not specified as a “crite ria”, EPA could specifically note that associations between qPCR and illness are stronger than those between culture methods and illness in freshwater.

4.4. Present graphical representation of qPCR data in relat ion to illness for freshwater and marine beaches.

4.5. Acknowledge the similarity between cell equivalent (CE) a nd CCE quantification approaches in predicting health outcomes.

4.6. Acknowledge relationships observed with Bacteroidales qPCR. Specify potential use of Bacteroidales qPCR for future.

4.7. Describe range of quantification approaches for qPCR brief ly. Place CCE in the context of available quantification approaches.

4.8. Since EPA did not mandate use of qPCR in the draft, EPA c ould promote use of qPCR by making the method simple, user friendly, and as rapid as possible.



### 5. Please provide any other general or specific com ments on the document, making sure to identify the section number/page number you are com menting on.

5.1. Be more transparent about the fact that Virtual Beach doe s not work well in marine waters.

5.2. Move appropriate information from Section 3.4 about indicator path ogen relationship, sources of contamination, and differences in risk as a function of contamination source to the QMRA discussion in Section 5.

5.3. Section 5.2.3 needs to give examples of novel microorganisms.

5.4. The process for evaluating new methods needs to be more cle arly defined. Lines 2026-2029 should suggest that alternate methods be at least as protective ra ther than generating the same beach notification result.

5.5. Suggested additional TSG

• Sampling guidance for compliance purposes

 Minimum requirements

 Consideration of composite samples

 Spatial sampling frequency

 Temporal sampling frequency

 Sampling depth

 How does wet weather influence sampling requirements

 Location in relation to activity/use

 Time of dayA-1 

## Appendix A

Technical Charge to External Peer ReviewersTechnical Charge to Peer Reviewers

A-3 

## Technical Charge to External Peer Reviewers

Contract No. EP-C-07-059 Task Order No. 3-11 August 18, 2011

Peer Review of the Recreational Water Quality Criteria (RWQC)

Goal: The Recreational Water Quality Criteria (RWQC) meet the requirements of the BEACH Act, to maintain water quality pursuant of the CWA 304(a), protect public health, provide means for timely beach notification in advance of exposure by allowing rapid methods and predictive models, and to introduce new tools for application to water quality protection.

Purpose: The RWQC in this peer review package provides EPA’s proposed recommended CWA § 304(a) Recreational Water Quality Criteria (RWQC) for State s, Tribes, and Territories. In this document, EPA lays out the underlying science and associated technical information related to RWQC and how scientific findings were used during the development of the RWQC. The wat er quality methods associated with the RWQC are also discussed. In addition, EPA’s policy decisio ns related to RWQC as of July 4, 2011, are presented throughout the document.

The criteria document is organized as follows:

• Section 1 provides introductory and background information.

• Section 2 explains the scope of the 2012 RWQC.

• Section 3 describes the scientific aspects that were con sidered during the development of the 2012 RWQC, such as sources of fecal contamination, types of bodie s of water, human health endpoints, target populations, indicators of fecal contamination, and t he expression of the 2012 RWQC.

• Section 4 presents the numerical values used for developing the 2012 RWQC.

• Section 5 describes the tools that can be used to assess a nd manage recreational waters, derive sitespecific criteria, and provide flexibility to States. The tools listed in Section 5 will not only provide States with flexibility in their adoption of the 2012 RWQC, but will also help States gain a better understanding of their surrounding watersheds.

A series of appendices will be sent to you on a CD:

• Appendix A provides additional information on indicators and enum eration methods.

• Appendix B describes data and information used to evaluate the linking of water quality and health.

• Appendix C contains information on sources of fecal contamin ation.

• Appendix D provides additional information on flexibility tools.

A CD will be provided to you with the final draft document, the appendices, reference documents, and the technical charge to reviewers.

Background : An important goal of the CWA is to protect and resto re waters for swimming. Section 304(a) of the Act directs EPA to publish “advisory water quality guidance on the effects of the presence of pollutants in water on health and welfare”. These recomme ndations are referred to as Section 304(a) criteria. Under Section 304(a), EPA is required to issue recommended criteria and update them from time to time. Under Section 304(a)(9) of the CWA, EPA is required to update or revise one of the current recommended 304(a) criteria related to pathogens and pathogen indicators to protect swimmers from illnesses associated with pathogenic microbes in coastal and Great Lakes wate r bodies.Technical Charge to Peer Reviewers

A-4

In adopting new or revised water quality standards, State s must adopt criteria that are scientifically defensible and protective of the use, but they have flexibilit y to do so by adopting EPA’s recommended criteria, adopting criteria to reflect site-specific conditions, or adopting other criteria that are scientific ally defensible.

Once adopted into State standards, water quality crite ria express the desired ambient condition of the water to protect a designated use. State water quality standa rds are used for various CWA purposes or programs that identify and address the sources of pollution with the goal of attainment of the criteria, including National Pollutant Discharge Elimination System (NPDES) permits, water body assessments to determine use attainment, and development of Total Maximum Daily Lo ads (TMDLs). In addition, these water quality standards are used by States in beach monitoring and not ification programs.

Historically, the federal government’s recommended criteria f or protecting people who recreate in water have been based on fecal matter in recreational waters. In the 1960’s, the Public Health Service recommended using the indicator bacteria, fecal coliforms, a s the primary contact recreational 1 criterion. In the late 1970s and early 1980s, EPA conducted public health studies evaluating several organisms as possible indicators, including fecal coliforms, E. coli , and enterococci. The studies showed that Enterococcus is a good predictor of gastrointestinal illnesses in f resh and marine recreational waters, and E. coli is a good predictor of gastrointestinal illnesses in f resh waters. As a result, EPA published in 1986 revised criteria ( EPA’s Ambient Water Quality Criteria for Bacteria – 1986) for primary contact recreation recommending the use of E. coli for fresh recreational waters (criteria set as a geom etric mean of 126 cfu/100mL) and enterococci for fresh and marine recreation waters (criteria set as geometric means of 33/100mL in freshwater and 35 cfu/100mL in marine water). These recommendations replaced EPA’s previously recommended bacteria criteria for fecal colifor m of 200 cfu/100mL. Most strains of E. coli and all enterococci do not cause human illness (that is, th ey are not human pathogens); rather, they merely indicate fecal contamination, and the assumption is that pathogens co-occur with incidences of fecal contamination.

Since EPA issued its recreational criteria over 20 years ago, there have been significant scientific advances, particularly in the areas of molecular biology, microbiology , analytical chemistry, the application of predictive models, and improved sanitary survey techniques. EP A believes that these new scientific and technical advances need to be factored into the development of new or revised 304(a) criteria for recreation. To this end, EPA has been conducting research and assessing relevant scientific and technical information to provide the scientific foundation for the development of new o r revised criteria. The enactment of the BEACH Act of 2000 (which amended the CWA) required EPA to cond uct new studies and issue new or revised criteria, specifically for Great Lakes and c oastal marine waters.

On March 21, 2007 and April 7, 2008, the United States District Court of Central California ruled that EPA failed to perform its mandatory duties to complete the required studies under Section 104(v) of the CWA, 33 U.S.C § 1254(v), by October 10, 2003, and to publish water quality criteria under CWA § 304(a)(9)(A), 33 U.S.C. § 1314(a)(9)(A), by October 10, 2005. A consent decree wa s issued and it was agreed by both the plaintiff and the defendant, EPA, that new or revised wat er quality criteria for pathogens and pathogen indicators pursuant to 33 U.S.C. § 1314(a)(9)(A) would be signed for publication in the Federal Register by October 15, 2012. Also included in the terms of the consent dec ree was that epidemiological studies be completed in marine waters impacted by urban runoff in a t emperate region and in a tropical region. At the same time, EPA also signed a settlement agreement with the plaintiffs, agreeing to conduct additional research and science studies. For full documentation on how EPA met the terms of the settlement agreement

1 Primary contact recreation includes activities that could be expected to result in ingestion of water or immer sion. These activities include swimming, water skiing, surfing, and other activities where contact and immersion in wat er is likely.Technical Charge to Peer Reviewers

A-5 and consent decree visit EPA’s Recreational: Water Quali ty Criteria website. http://water.epa.gov/scitech/ swguidance/standards/criteria/health/recreation/index.cfm ERG, under contract to EPA, is conducting this peer review under work assignment 3-11. ERG requests the revie wers to read the draft Recreational Water Quality Criteria (RWQC) document and refer to the exten sive Appendices and reference materials as needed. Please respond to each charge questions below and pr ovide any other feedback or recommendations that will improve the overall soundness of the science and the development of the criteria.

When writing your comments, please cut and paste each questi on into your document, and write your response under each question and subquestion. Please put your name in a header and paginate your review comments. See the end of the charge for further guidance on t he preparation and submission of your
comments.


### Charge Questions for the Criteria Document

1. Does the document adequately present the logic and scientific support behind its conclusions? Please comment on the document’s transparency, the completene ss of the presentations, and any shortfalls in the material presented. Are uncertaintie s for technical conclusions transparent? Do you have any suggestions on how we could improve this document? Please explain your responses.

2. Are you aware of any important peer reviewed literature o r applicable data that have not been incorporated in this document and should be included?

3. Do the analyses comparing the NEEAR freshwater and marine culture-based indicator data aggregated by days of similar water quality corroborat e that the NEEAR culture data are generally consistent with the 1986 regression models?

4. Do the characterization and explanation of the qPCR method reflect that of the scientific literature? If not, what additional information should be included? Is th e derivation of the qPCR value using the EPA data scientifically supported and adequately explaine d? Please discuss why or why not.

5. Please provide any other general or specific comments on the doc ument, making sure to identify the section number/page number you are commenting on.B-1 

## Appendix B

Reviewers’ Post-Meeting Comments Organized by Charge QuestionReviewers’ Comments by Charge Question

B-3 

### Introduction to Comments

Reviewer Comments

Dorevitch EPA scientists and policy-makers, as well as those tha t assisted in the development of the

draft RWQC are to be commended. The task they faced was m onumental, in large part because of the tremendous amount of information about microbia l measures of water quality and associated health risks that EPA has developed in the past 10 years. The National Environmental and Epidemiological Assessment of water Recreat ion (NEEAR) was a very sophisticated study that presented numerous implementati on and analytic challenges. Furthermore, EPA researchers developed, refined, and publ ished details of molecular methods that allow the timely measurement of fecal indicator bacte ria. EPA’s research team succeeded in completing this ambitious study, and findings perti nent to criteria development have been published in peer-reviewed journals.
EPA staff and consultants have developed draft “Recreati onal Water Quality Criteria” (RWQC), the subject of this peer review. Efforts were m ade to summarize a wealth of data used to develop both the 1986 Ambient Water Quality Criteria, a s well as the present draft RWQC. The peer reviewers commend the EPA team on their effo rts to produce such a document in a timeframe that meets all that is requir ed of EPA. The comments offered by the peer review panel are meant to assist EPA in its ef forts to develop new or revised criteria that are grounded in science and can be implemented in order to protect public health while meeting all requirements of the Clean Water Act.

Lipp In general, this document represents an extraordinary amou nt of work conducted by the

EPA to revise the national water quality criteria. The authors have managed to synthesize a broad collection of results and provide analyses that su pport their recommendations. This was not an easy task and the document represents a critical body of work. The comments provided here are meant to strengthen the document, increase clarity and provide more transparency in how the revision of the RWQC was developed.

McBride The EPA and its advisers have performed an admirable tas k of sifting through the literature

on the health of recreational water users, including many as pects of aquatic microbiology, epidemiology and risk analysis. The end result of their anal ysis is a generally well-argued case for the proposed revised water quality criteria.
I am in agreement with all the comments made by the Review Panel. The following responses should be viewed as elaborations of those findings

.

Noble Overall, EPA has successfully synthesized a document to c onvey their current directions in

development of new criteria for ambient waters. The docume nt was generally well written, and most of the scientific arguments within were made with appropriate scientific support and documentation. In particular, EPA is to be commended f or the sheer amount of water quality related science that they have conducted in the pa st 5 years. They have gained much new information that is relevant to criteria development. One of the most important overarching critiques of the criteria document is that the y sell their excellent recent science short in that they do not use it to its potential for cr iteria development.

Yasvinski None provided.Reviewers’ Comments by Charge Questions

B-4



### 1. Does the document adequately present the logic a nd scientific support behind its conclusions? Please comment on the document’s trans parency, the completeness of the presentations, and any shortfalls in the material p resented. Are uncertainties for technical conclusions transparent? Do you have any suggestion s on how we could improve this document? Please explain your responses.

Reviewer Comments

Dorevitch Conclusion 1: Coastal-derived criteria can be extended to inl and waters

This seems to be the most significant change proposed in the RWQC (since the qPCR method was not proposed as a requirement). If epidemiolo gic data were available to suggest that coastal-derived criteria afford swimmers a simil ar level of protection in inland waters, justifying this change would be simple. Data regarding the hea lth risks of swimming in inland waters are very limited; the most relevant publishe d information probably comes from Marion et al., 2010 and the Keystone Lake, OK study (conduc ted by EPA more than 30 years ago). Given that this extension of RWQC to inland wa ters represents a change from the prior application of AWQC to Great Lakes/coastal wat ers, the reason(s) for this change should be clear and compelling.
The Draft RWQC provides a justification for this change t hat includes a discussion of indicators, pathogens, sources, and cites several published studies, EPA reports, and other reports. This approached should be revised, as it did not seem particularly compelling, and some portions of the text did not seem to be consistent wi th other portions of the draft RWQC.
Some specifics:
The EPA 2010 (g) report on the applicability of the Great La kes NEEAR data to inland waters does not include a “conclusion” and the “Executive Summar y” does not include an assessment of whether or to what degree NEEAR data co uld be applied to inland waters. Given the many differences between inland and Great Lakes/co astal waters summarized in that report, it’s not clear what serves as the basis of EPA’s determination (in the AWQC document lines 1307-1308) that the 2012 AWQC would be applicable to inl and waters. Appendix C.4, however does include conclusions. Among these is that “ Sufficient data do not exist to extended NEEAR epidemiology findings to non-POTW im pacted inland waters.” This is not consistent with the draft 2012 AWQC, which does not appear to differentiate between inland waters impacted vs. not im pacted by POTW sources.
The discussion of indicators, and whether site-specific c haracteristics are better predictors of fecal indicator bacteria (FIB) densities than is the dist inction between inland vs. coastal locations is a bit beside the point. Indicator bacteria have been established as criteria pollutants and specific criteria values have been establ ished based on EPA’s epidemiologic studies. Thus, E. coli and enterococci are direct indicators of health risk, rather than indicators of pathogen presence or density. Thus, the effo rts to justify extension of RWQC to inland waters need not (and given the limited and inconsi stent relationship between indicators and pathogens described in the RWQC probably should not) be included. Likewise discussion of FIB persistence need not be presente d, as the criteria indicators and criteria values of those indicators have been established directly from studies of health risk.
Instead of the “site specific differences are more impor tant than inland vs. coastal differences” argument, EPA may wish to put forward one or more of the followingReviewers’ Comments by Charge Question

B-5 rationales for extending the criteria to inland waters. Th ese are:
A) The WERF Inland Water Workshop report and the subsequen t “Meeting Report” publication suggest that the criteria should protect public heal th by preventing sporadic cases of gastrointestinal illness. Thus, the use of FIB as cr iteria pollutants in inland waters should useful in making “recreation in and on the water” less r isky at inland settings.
B) The “Meeting Report” (not listed in the reference s, Dorevitch et al., 2010) notes that outbreaks of severe recreational waterborne disease have be en reported almost entirely in inland waters, perhaps because of limited dilution capacity of receiving waters and proximity of recreation (and exposure) to fecal sources. Th us there is a need for public health protections in such settings. Although epidemiologic st udies have not addressed outbreak prevention through FIB monitoring, it seems prudent to use FIB monitoring as way of reducing the occurrence of outbreaks of severe illness, a s well as the sporadic cases of illness that occur among coastal swimmers.
C) Millions of people per year use inland waters for recr eation – see Outdoor Recreation for 21 st Century America , 2004, Cordell et al., Venture Publishing, State College PA.
Perhaps a better formulation would be to revise the lang uage used in draft 2012 RWQC, lines 1449-1451 to: “The application by States of the AWQC to inla nd water would be expected to improve public health protection to the millions of people who use inland waters, where, unlike coastal waters, numerous outbreaks of severe illness have been reported.”
Given the impact of the potential extension of RWQC to inl and waters on the regulated community, EPA may wish to address potential criticism s of this change. These include:
The WERF report raised the possibility of the criteria could be overprotective (i.e., a given level of a fecal indicator may imply a lesser degree of health risk in inland waters). Second, it is not known if the application of NEEAR-derived criteria would in fact prevent outbreaks of severe disease as these are (fortunately) rare events , which makes it very difficult study the impact of an FIB monitoring program on rates of severe di sease (or outbreaks) in inland waters. Finally, particularly if enterococci are used as a criteria pollutant, many inland waters without obvious anthropogenic sources may abruptly be “listed” for 303(d) purposes. Clearly the options prevented in Section 5 are intended for this purpose, and having options is reasonable.
Some information presented that is considered to be support for the extension of RWQC to inland waters is speculative. An example:

EPA concluded (lines 1214-1216) that differences in FIB survival “could be different in different waters, but those differences could be due to site-specific characteristics and not because of fundamental differences between coastal and non -coastal waters.” That survival “could be different” and the differences “could be” due t o factors other than the coastal/noncoastal distinction is quite different from demonstrating t hat there is no difference in survival in relation to waterbody type. Even if that were the case s, it’s still a leap to conclude that indicator-health risk relationships would be the same in i nland vs. other coastal water. As noted previously, the state of the science may better suppor t removing from this section all discussion of FIB survival (and indicator-pathogen rela tionships).
If the discussion of indicator-pathogen relationships is not mo ved to the QMRA section, the RWQC could be updated regarding the conclusion that the co- occurrence or correlation between FIB and pathogens is neither predictable nor consistent , which is very different thanReviewers’ Comments by Charge Questions

B-6 concluding that there is no difference in those relations hips in coastal and inland waters. First, correlations between FIB and protozoan pathogens ha ve been described in several studies with some consistency (Dorevitch Doi, et al., 2011, which was cited elsewhere within the RWQC). Furthermore, the literature review in that paper makes clear that the relationship between FIB and protozoa does depend on whether t he waters are heavily impacted by wastewater or not. Thus, at least in the ca se of Giardia and Cryptosporidium

, there are fairly consistent/predictable relationship s with FIB, particularly in waters not dominated by wastewater.
Conclusion 2: Optional qPCR criteria will be the same in fr eshwater and marine water

Wade et al., 2010 noted (discussion section) that associati ons were stronger between Enterococcus CCE and GI illness than at NEEAR freshwater beaches th an at NEEAR marine beaches, consistent with the Dufour/Cabelli studies o f FIB measured by culture. Overlap of the confidence intervals in the NEEAR qPCR marine and freshwater curves are noted in the 2011 paper. However the finding reported in the RWQC (line 716) is unpublished and – because of the policy implications - should be the subject of peer review, particularly because this reflects a change from the way EP A interpreted findings of the Dufour/ Cabelli studies. If such peer reviewed publication is not available in time, the RWQC should describe the methods and findings of the analyse s in detail.
Conclusion 3: No need to change the FIB criteria, in fresh or marine waters, measured by culture
See discussion below on “Charge Question 3”
In general, it may be helpful to the readers of the RWQC i f EPA distinguishes in an executive summary which elements of the 2012 RWQC are found in the 1986 AWQC (i.e., they haven’t changed) and which elements are new or differen t. Elements that have not changed need little if any discussion, while changes do. Th is approach should result in less discussion of how the 1986 criteria were developed, including the culture methods, criteria pollutants and criteria values for fresh and marine wate r. Conclusion 4: No need to develop source-specific criteria

The discussion makes clear that the evidence is insuffici ent to change from the 1986 precedent of not differentiating among sources. Again, since this is not a change, the amount of discussion could be reduced.

Conclusion 5: The translation of HCGI to NGI and the fact or of 4.5 (HCGI 8/1000 ~ NGI 36/1000)
This is reasonable and supported by the text.
Conclusion 6: The development of the qPCR threshold of 475 CCE (pa ges 28-29)
See “Charge question 3” regarding EPA’s efforts to demon strate that the level of protection afforded by qPCR is comparable (in terms of cases per il lness expected at the threshold value of enterococci CCE) to that at the culture-bas ed criteria value. Consider creating a subheading (something like “3.3 The development of criteria valu es for enterococci by qPCR”) for this section.
Lines 993-998 require clarification. If this material is to be retained in the RWQC, describe the methods of each of the “additional analyses that were not used directly”, what were the results of those methods, and what were the limitations and interpretation of those results.Reviewers’ Comments by Charge Question

B-7 What does it mean that the additional results “support the un derlying basis” (line 994) of the approach to deriving the number 475 CCE/100mL? The Wymer trans lation is not “support” for the number 475; it’s part of the methods used in calcula ting that number.
Conclusion 7: The development of criteria using the study populat ion overall, rather than potentially “sensitive subgroups” (section 3.3)
Consider renaming Section 3.3 “Potentially sensitive subgr oups”

The Parkin 2003 reference (line 1057) does not establish what the citation suggests: that immune system of children can leave them vulnerable to the e ffects of environmental agents. The paper presents a modeling approach to water management, in which it is assumed that children are sensitive, to assess the impact of that as sumption on model outputs. It would be circular to think of this as evidence of the vulnerability of children. An alternative is to cite some of the primary literature noted in Parkin, namely Kee 1994 and D’Allesio 1981. However, those studies do not demonstrate (nor were they designed to evaluate) whether, for a given level of indicator bacteria, children are more l ikely than adults to develop HCGI (or NGI). Best to leave this out and discuss, based on NEEAR da ta, whether or not the microbehealth risk association (slope) is different for adults and children.
Lines 1049-1052 seem to conflict with 1064-1075. Suggest: delete lines 1049-1052 and introduce the rest of that paragraph with a sentence s aying something like “There are two reasons to be concerned that for a given level of indicator bacteria in recreational water children would be more likely than adults to develop gastr ointestinal illness.” Then note: 1) a suggestion of greater water ingestion during swimming (Duf our 2006) and 2) the observation from the NEEAR study that children spend more ti me in the water. Despite the theoretical reasons which suggest children might be at inc reased risk, the NEEAR study did not find this to be the case. First, in the analyses that used microbe density as a continuous variable (fresh and marine) lacked power to identify subtle differences between adults and children. Second, indicator density dichotomized at 33 CFU/100m L seems to have been a comparable predictor for adults and kids in freshwater (Wa de 2008, Table 6). It would be very informative if the statistical significance of intera ction terms (child/adult * microbe level) or (child/adult * above/below threshold) were reporte d.

Lines 1095-1096: The above information does not indicate that childre n are more susceptible. The above information suggests that despite t heoretical concerns about ingestion rates, duration of recreation and perhaps naïve immune sy stems, the epidemiologic data do not support (given sample size) differences in risk betwe en adults and children. Consider deleting this paragraph.
Consider moving paragraph lines 1027-1037 to just prior to the paragr aph that begins on line 1109. As currently organized, the discussion of over-represent ation of children in NEEAR enrollment is broken up by the discussion of NEEAR results re garding children vs. adults.
Lines 1112-1113: I’m not sure what is meant by “in a robust mann er.” Consider revising the final two sentences of this paragraph to “In the NEE AR study, children are over-represented (compared to the general population) and therefore have a dispr oportionally large influence on the overall relationship between microbe density and health risk derived from NEEAR study data.”
Lines 1116-1130: This is a very important point and could be emp hasized better as its own section, perhaps something like “Disease prevention through ra pid notification.” As noted under “Charge Question 5” below, it would important for t he public and stakeholders toReviewers’ Comments by Charge Questions

B-8 know that the 2012 RWQC provide for the first time, guidance t o afford the public the benefits of same-day notification.
Conclusion 8: qPCR methods for monitoring recreational waters are optional
This is a surprise and a disappointment, as the NEEAR s tudy suggests that public health protections could be improved at Great Lake settings thro ugh the use of qPCR monitoring. The method can provide same-day results – a huge advance toward protecting the public form gastrointestinal illness using prior-day measures of water quality to predict health outcomes. Futhermore, the NEEAR study demonstrated the super iority of same-day qPCR measures to culture measures as predictors of NGI.
Page 44 of the draft RWQC notes that Method A can be used as a site-specific alternative, pending the release of the “topic-specific guidance.” For inland waters several reasons were proposed in Appendix B.6 to suggest that inland waters may have different qPCR-health risk relationships than Great Lakes/coastal waters. For th at reason it seems that such sites would need evaluations of method performance. However, given the va st amount of health and qPCR data collected at Great Lakes sites (and to a l esser degree, from marine sites), there seems to be enough data to apply the NEEAR results (and t he 475/1,207 CCE/100mL criteria values) to Great Lakes/coastal waters. Any “site specific performance characterization” (line 1617) would not include the collection of health data, which NEEAR did collect, it’s hard to see how such characterization of method performance will provide better qPCR-health data than did the NEEAR study. It not realistic to expect that the NEEAR study could have been conducted at a wide range of com binations of waterbody type and pollutant source. When establishing the 1986 criteria, d ata from a limited number of sites were used, even though not all water types had been studied. The same could be done for (mandatory) qPCR criteria, applying the best avail able information.
The term “site-specific performance characterization” should be clarified. The intent may be to evaluate qPCR inhibition and to support the development of a site-specific plan for addressing inhibition (such as dilution or some sort of samp le processing). However, it should be clear that the performance being characterize d is not the relationship between qPCR results and health risk, which has been done in sever al types of settings by the NEEAR study.

Conclusion 9: Statistical threshold values will be used r ather than single-sample maximum values
This change is an improvement of the 1986 AWQC. The term “maxi mum” implies a value never to be exceeded, while it is expected that about 25% o f individual measures will exceed the STV. This change should be beneficial to beach manager in the efforts to communicate the meaning of an exceedance.
The RWQC could be improved by explaining the basis for sam pling required for calculating a geometric mean. Ideally, the variability in water qual ity should be known before estimating the number of samples required to calculate a GM. Furthermore, by choosing to sample only on days for which relatively low values of indic ator bacteria are expected (no rain for several days, perhaps in the afternoon of day wit h much sunlight, the calculated GM could be lower than if samples were collected at random or on a fixed schedule (i.e., every Friday, Saturday, Sunday, and holiday, reflecting recre ational use). Provisions to prevent selection of sampling days based on expected low values woul d improve the public health protection of the criteria.
Conclusion 10: Section 5.2.2: Flexibility available to statesReviewers’ Comments by Charge Question

B-9 The draft RWQC offers states two types of tools: Thos e not part of state water quality standards but which may enhance assessment/management/noti fication, and those that are designed to develop alternative water quality criteria. That QMRA (section 5.2.2) has been categorized as a pathway to alternative criteria rath er than as an assessment/management tool requires evidence-based justification.
Unlike another innovative aspect of the RWQC – the use of qPC R – very little is known about how well QMRA would actually protect swimmers from GI illness. Through the painstaking efforts of EPA/the NEEAR study team, we now ca n say quite a lot about how qPCR should (and should not) be done, and more importantly, how well qPCR methods can be used to predict health risk and provide timely informati on to the public. By contrast, it is unknown how well QMRA predictions (model outputs) of health risk appr oximate observed (i.e., epi study) health risks – we just know the model outputs. Fur thermore, we don’t know how precise QMRA estimates of health risks really are, r egardless of the confidence intervals provide by simulations. If a QMRA model estima te that a given degree of water quality is expected to result in 30 cases of NGI, that m ight mean somewhere between 5 and 75 cases, with 95% confidence. It’s very hard to know, given th at QMRA models have not been validated against observational data of swimmers at beaches. The studies cited in the draft RWQC – Soller, Schoen and Ashbolt- are estimates of risk/illness that have not been confirmed through observational studies. Although EPA had hoped to have a QMRA conducted in parallel with one of the NEEAR sites, apparen tly no comparisons have been reported. Many assumptions of QMRA – notably dose-response – a re very uncertain, having been based on very limited data. Thus, although the theory be hind QMRA is sound, the 5.2.2 provision is unvalidated. QMRA should instead be considered a method for evaluating management options – which would provide estimates of relative risk, rather than estimates of absolute risk which would be required for any method t hat would be an alternative to an epidemiologic study.
The Inland Waters Workshop (Appendix B.6) report and the subse quent Meeting Report note that QMRA methods require “grounding” (validation agai nst observational data). If any validation has been done since the Workshop, this should be re ported in the RWQC. Because the application of QMRA could allow localities/sta tes to potentially produce lower site-specific/region-specific standards, it is impor tant to know with confidence that the health of the public is not being compromised (and that undue burde ns are not placed on regulated entities.
Lines 1905-1907 (if non-human sources predominate) and lines 1432-1436: If t he data are insufficient to propose national criteria for waterbodie s impacted by non-human sources, are the data sufficient to support the development of site-specif ic standards for such waterbodies?

Conclusion 10: Section 5.2.3: Alternate criteria
The concept here is very good, in particular the emphasis on e stablishing a relationship between new methods and existing methods at the criterion den sity.

Since Wade et al., 2008 demonstrated that at Great Lakes beaches the qPCR method of measuring enterococci performed better than the culture method in predicting NGI, why not specify that equivalency should be demonstrated between the new method and best available approved method (i.e., enterococci qPCR)?
Lines 2026-2027 note “that a consistent and predictable relati onship “should exist between established and new methods. Furthermore whether the new or e stablished methods would be used “beach notification and attainment decisions....would be similar” (lines 2028-2029).Reviewers’ Comments by Charge Questions

B-10 In order to reduce confusion down the road, spelling out, i t would be helpful to explicitly state what is meant by “consistent” “predictable” and “si milar” . A 2x2 table could be constructed with rows “new method” and “established method” an d columns, “exceeds criteria value” vs “does not exceed criteria value.” Doe s it mean a chi square p-value of p<0.05 even if the new method misses some percent of exceeda nces? If EPA were to specify the sensitivity and/or positive predictive value it would be clear what states/municipalities must demonstrate. Furthermore, how much data is needed? P erhaps a season (Memorial Day-Labor Day) of 5x/week measurements or some other gener al specification, otherwise, a “consistent, predictable relationship” could be claimed base d on a much smaller set of observations.
Last, the RWQC notes that this approach could be used t o establish “regional or state-wide alternate criteria” (line 1993). If this is the case, aga in EPA should specify that the data collected to establish the equivalence of an alternate c riteria must match the scale of data presented. In other words, data from one beach can’t est ablish state-wide criteria, and statewide data can’t establish regional criteria, etc.
Other aspects of Charge Question 1:
Some specifics are noted in response to other charge que stions. Otherwise, no significant issues regarding transparency, shortfalls, uncertainties , suggestions for improving the document.

Lipp In all this was a thorough and well laid presentation of the justification for the recreational

water quality criterion. The authors provide a well-organi zed framework to understand the justification and implementation of the RWQC and provide a muc h needed section on how States can proceed with their own alternate criteria. More emphasis, however, should be focused on the new criterion and not the history of the curren t AWQC. It would also be helpful (from a structural/organizational perspective) to bet ter cross reference specific appendices in the document rather than broad groups (e.g., appe ndix A.2 rather than appendix A, etc.). The addition of an executive summary would also improve the document.

While the uncertainties for the technical conclusions are provided, limitations in applying this criterion to “all” water bodies should be better ac knowledged. The RWQC is meant to be for all water bodies in the US but the data that EPA pre sents does not support this call. Namely, the RWQC appear to be robust for temperate POTW-i mpacted marine and freshwater coastal areas, with possible application to PO TW-impacted inland waters; however, there are no compelling data that support its use in tropical (or subtropical) waters or in non-POTW impacted waters (coastal or inland). As a general note I was struck that to date all NEEAR studies at marine beaches were conducted i n embayments or estuaries (with the exception of Surfside, SC), that were relatively quiesc ent. This may not be a good representation of the bulk of marine beaches, which tend to be open water beaches and is a limitation of the sites selected for the health effects assessments. This should be better acknowledged and information presented on site selection. Suc h information would help states/locales judge whether they should look at their own si te specific assessments for other types of beaches.
The use of predictive models and the great amount of work th at has gone into developing an easy to adapt format (e.g., Virtual Beach) is to be com mended. The ability to use pre-emptive strategies to protect public health should be a goal for a ll beach managers. While Virtual Beach works quite well for Great Lakes Beaches, its pe rformance for marine beaches was not impressive (which may be have been exacerbated by the fe w days of exceedance for theReviewers’ Comments by Charge Question

B-11 beaches tested). This sho uld be clarified in the document.

While the final criterion uses culturable E. coli, culturable enterococci and qPCR enterococci (CCE)for freshwater and culturable enteroco cci and qPCR enterococci (CCE) for marine water, there was significant effort put into the confirmation and validation of the qPCR for Bacteriodales it appears that this will not be used as a criterion. Is this one of the tools that States can suggest as an effective alternate indicator? If so, it may be helpful to state that explicitly somewhere. While the final RWQC wil l continue to rely on the same FIB criterion as suggested in 1986, the improvement in risk det ermination (and confirmation that risk levels are equivalent between fresh and mar ine waters) is a great step forward as is the specific guidance on qPCR (even if is not a required element).
Another strength of this document is that it allows states to update and find alternatives for their specific areas. The technical support guidelines will nee d to be complete to ensure good translation of information. While it is outside the scop e of this document, states should be able to compete for grants to develop these site specific alternatives.
Some specific comments on logic and support for conclusions in this document:

Line 720. For clarification the reason that there is a focus in this analysis/review on temperate POTW-impacted beaches needs to be stated earl y (namely, that EPA dropped the epi studies from run-off impacted and tropical beaches becaus e of lack of correlation between FIB measured and health effect end points)
Line 759-769 (see above statement about placement of this text). These studies were dropped because the results were inconclusive. Given the th at the temperate POTWimpacted beaches all fit well into a single analysis i t makes some sense to exclude these studies, but the fact that they did not fit the trends note d for the other studies should suggest that: 1) the current RWQC will not be adequate for these ar eas, 2) some other as yet untested FIB may be better suited for a single FIB for all wate r bodies (although this scenario would require many more studies, time, effort and money) or that additional epi studies are warranted to better determine the applicability (or lack thereof) the suggested RWQC. While there is sufficient language to allow states to address this issu e on their own, this seems like a potentially large problem that may need additional federal ( EPA) assistance. [Line 784-788. Following up on the issue noted above, this review of stu dies also shows a paucity of epi studies focused in tropical areas. Additional work is cle arly needed in this area.] To this end, a separate section on issues associated with tropical/ subtropical waters may be warranted and should include studies completed in Hawaii on this i ssue.

McBride The document presents a well-argued case. I agree wit h its general approach, in particular:

• coalescing the risks associated with marine and freshwat er criteria;

• extending the compliance assessment period;

• allowing for flexibility in implementation (e.g., QMRA, novel indicators, predictive models).
By and large the text seems clear. In the following I have noted those occasions when it seems not to be so. However, I do suggest that some matte rs need to be addressed or clarified:

• No guidance is given on the desirable features of sampling programs, especially with respect to wet weather. I note that this is to be incl uded in follow-up technical supportReviewers’ Comments by Charge Questions

B-12 guidance (TSG). Nevertheless, it should be helpful for there to b e at least some mention of this issue in the criteria document—after all, the 1986 cr iteria did do so. 1 And if this former position is to be abandoned (i.e., restricting sam pling to dry weather), it would seem appropriate to say so and give the rationale for it. In my view wet weather sampling (or sampling shortly after rainfall) may be appropriate if recreational contact occurs at that time. I don't see lot of point in sampling during conditions that are not conducive to recreation.

• Likewise I didn't see any reference to guidance on sampling de pths (knee depth, chest depth...).

• I wonder if respiratory illnesses have been dismissed too easily. Yes, it is true that in some studies GI can be the stronger endpoint, but that may not be so for water skiers, canoeists or for beaches with an energetic wave climate suc h that aerosolisation is rather stronger. After all some studies have detected respiratory effects but not GI: England (Fewtrell et al., 1992); 2 Australia (Corbett et al., 1993, Harrington et al., 1993); New Zealand (McBride et al., 1998).

• Has the case really been made that feces of all animal groups should be treated as posing the same risk as human feces? For example, there is evi dence—in the New Zealand setting at least—of substantial differential virulence bet ween Campylobacter jejuni carried by farmed animals (sheep, cattle, poultry) versus w ild birds, and yet wild bird strains can predominate in recreational waters (French et al., 2011).

• The distinction between SSM and STV is not sufficient ly clear, especially because for beach notifications (lines 1542

– 1545) the STV can act as maxima not to be exceeded (i.e., acting as a SSM) but for WQS attainment "no more than 25% of the observations can exceed the STV" (acting as a percentile limit). I also have difficulty understanding how the STV (if it is interpreted as a SSM) can be used in devising permit limits, especially if used alone (as suggested on line 1548). In my vi ew stating only a limit never to be exceeded is next-to-useless in designing wastewater infr astructure. In contrast a GM (or median) accompanied by a high percentile (but not a maxi mum) tells designers and operators of wastewater facilities what is expected under normal and under unusual circumstances. In that regard a 75%ile seems rather l ow; international practice increasingly uses 90%iles or 95%iles.

• Lines 1494

– 1503. This is timely and well-stated. But the last senten ce begs a "so what's the consequence of that?" question. I presume it means that EPA is prepared to tolerate a moderate degree of STV exceedances and hence notificati ons (interpreting STV as a SSM, as is proposed for Beach Notifications)—even when the GM is way below its limit.

• Line 1559 is ambiguous: '...i.e., no "excursions" acceptable. "' I think refers to the GM, but I first read it as applying to the STV.

• Given that the WHO, Europe and Australasia have adopted the " Annapolis protocol", its non-appearance in this document seems surprising. I understand that the CWA is

1 At page 8 of EPA'S Ambient Water Quality Criteria for Bacteria –1986 : EPA440/5-84-002 (cited as "U.S. EPA 1986" in the draft RWQC) we have: "In general, samples shoul d be collected during dry weather periods to establish so -called "steady-state" conditions. Special studies may be necess ary to evaluate the effects of wet weather conditions on waters of interest especially if sanitary surveys indicate the a rea may be subject to storm water effects". The crite ria themselves (in EPA 44/5-86-001, Quality Criteria for Water 1986 ) contained a similar message: "These densities are for steady state dry weather conditions."
2 All references in this section are listed in Section 2 of the Review Panel's report.Reviewers’ Comments by Charge Question

B-13 considered to pose an impediment to its adoption in the USA . But it would be helpful to explain why that is the case. And I note that the proposed extension of the compliance assessment period (recommended to be 90 days) takes the USEP A criteria closer to the "beach grading" component of that protocol.

Noble General comments: The criteria document as assembled succe ssfully accomplishes the

following:

1. Presents the history behind previous criteria development.

2. Discusses a range of aspects of 304 (a) criteria development as related to a range of water quality standards/procedures (i.e., does not focus solely on beach warnings and postings).

3. Presents the scope of the science.

4. Presents the linkage b/w water quality and health and expla ins epidemiological studies.

5. Attempts to outline a framework for connection of recent e pidemiological studies to those conducted in the 70s and 80s.

6. Presents results of epidemiological studies conducted recen tly and subsequent data analyses.

7. Attempts to show the reader a transitive approach toward link age of current studies to older studies, bringing in results from rapid methods.

8. Outlines a few other ways that waterbodies can be managed i n the USA.
The way the document is written is generally a treatise on the “process” that EPA used to develop or revise criteria. The document is not written i n a forward thinking tone (prospective), it is rather retrospective. It is this r eviewer’s opinion that detailed explanation, use of case studies, and providing of examples where relevant could greatly help EPA in paving a path forward for adoption of new criteria.
There are serious shortcomings in the document in the followi ng areas: A) The existence of the FIB to pathogen relationship is spec ifically stated in a wide range of places in the document. It is also noted that there is a lack of pathogen relationships to FIB, especially viruses. Why continue with the notion that FI B predict pathogens? There is ample evidence at this time that the numerical relationships be tween pathogens and FIB in waterbodies - freshwater and marine - exists only in certa in cases, and often times does not exist. Typically, strong relationships have been shown betw een viral pathogens and FIB in cases of studies of direct discharge of sewage. It is likel y that the poor relationship is a function of methodologies, statistical variability, lack of consistent study approaches, and/or lack of data using like methods, but this is not important to the current thinking in criteria development. EPA has clearly shown, as well as others, th at FIB (measured using either culture- or molecular-based methods) can be linked to human health outcomes using epidemiology studies. EPA has stated that they are using the FIB-health outcomes relationship wholly to establish and defend and develop new c riteria. The addition of information, and attempt at literature review of pathogen s only complicates this criteria document. If anything this information presented about FIB to pathogen relationships should be placed in the QMRA section of the document (or in Sectio n 5.0 broadly), to demonstrate to the reader the paucity of good, scientifically relevant information. Therefore, paving the way for a consistent, statistically rigorous QMRA appro ach to be presented by EPA.
B) There is a complete lack of guidance on subtropical and tropical waters criteriaReviewers’ Comments by Charge Questions

B-14 development. EPA attempted one epidemiolog ical study in tropical waters, and has not conducted any others. Given the importance of beach visitor ship in FL, HI, and PR alone, this issue remains important. Hawaii has been urging EPA for decades to examine and assist them with development of other standards, citing serious issues with attempting to quantify Enterococcus solely as an appropriate indicator. Lack of information abo ut Tropical Areas means that these areas should either be able to develop the ir own approaches OR that they can use the 1986 criteria. However simple use of the 1986 criteri a means that they are using science that is nearly 40 years old, and has not been upda ted. Tropical Workshop attendees in 2002 hoped that EPA would develop new indicators that wor ked in all areas. This clearly is not the case for subtropical and tropical waters. Theref ore, EPA should be required to assist these areas in developing an approach that will be successful for them, even if it represents a departure from the national standard. Tropica l waters need to be specifically called out in the criteria document.
C) There is no stated requirement for QPCR, which is a good thing as it is not the answer for some State’s monitoring needs. However, EPA misses an opportunity to stress the importance of rapid methods in providing more accurate means to protect public health at beaches. There are serious issues with public perception of the costs and difficulties seen with rapid QPCR based methods. That is, most people thin k that QPCR is more cumbersome and expensive than it really is. EPA could do a better job of demonstrating the tractability of these methods to stakeholders. They use Griffith and Weisbe rg, 2011 several times as an example. However, it would be useful to explain the costs a nd advantages of rapid methods versus culture based methods, and to provide more specific exa mples of where it has been used successfully to manage recreational waters (southern California, Great Lakes). EPA is unlikely to revise criteria in the next decade, therefore, the y should consider recommendations of the following for QPCR: a) implementation at high use beaches (this has been very successful in southern California), b) implem entation in areas that have high numbers of beach going families including children. EPA is making the right decision in not requiring QPCR to be conducted nationwide, but there are meri ts to its use, particularly important is the speed of management decisions. The case could be made by EPA to strengthen its recommendations for the use of QPCR (possi bly some sort of incentive program?). Finally, EPA’s Method A is very complete and detailed. Is it possible for EPA to create a shortened, Cliff’s Notes version of Method A to provide to stakeholders so that they can visualize the process? (i.e., collect water sample, filter, bead beat, create master mix, load machine). A simplified version of the method would assist EPA greatly in bridging the next steps of rapid methods implementation.
D) The intended switch from SSM to STV is not clearly presented and does not permit coastal and non- coastal States that use other managemen t approaches to incorporate any flexibility in their current ways of managing and listing i mpaired waters. Some states use frequency of beach closures to manage their impaired wa ter status, implementing a comparison between reference beaches and contaminated bea ches. EPA needs to clearly state the minimum sampling frequencies (this is done but the sampling frequencies are actually less stringent than before?), they need to provide guidance on sampling during wet versus dry periods and over seasons. The frequency of beach c losures approach, which compares like beaches to like beaches, is an important in terpretation of beach management framework. Flexibility in the use of other more stringent approaches for compliance purposes needs to be included in the document. Sampling vari ability across states will lead to inconsistency in the way that the new STV approach is utilized for TMDL listings. EPA should strive now to make this approach consistent across st ates and provide succinct guidance on the minimum approaches. Currently, States that do the most monitoring spend the most money on TMDL implementation and development. These states also suffer from the fact that more monitoring equals more listings. EPA ne eds to create equality in theReviewers’ Comments by Charge Question

B-15 system by mandating specific levels of monitoring.
E) There are major shortcomings in QPCR/rapid methods as presented. There are major holes in the recommendations on rapid methods that deserve to be addressed in the document. EPA needs to more transparently state that the y did not include rapid E. coli QPCR nor culture-based measures of E. coli in the freshwater NEEARS Studies. E. coli is an important indicator in a range of different non-EPA ep idemiology studies, and the lack of data for the NEEARS freshwater studies needs to be stres sed. Second, EPA is suggesting an extrapolation of E. coli standards to inland waters based upon old science (1986 science ), this needs to be clearly stated and transparently discus sed in the document. EPA has either not done or has not presented the appropriate data analysis a cross quantification approaches for QPCR to demonstrate that the more variable CCE qua ntification approach is superior to the cell equivalent (CE) quantification approach. In sou thern California, CE based quantification approaches have been used for two consecutive summers to rapidly measure beach water quality via Enterococcus quantification with some success. The approaches have demonstrated very strong relationships to existing culture- based methods. SCCWRP epidemiology studies have also shown that both CE and CCE quan tification approaches have yielded significant relationships to human health outcom es. EPA has also shown that this relationship is significant for both quantification me thods, but they are not transparent about this in the criteria document. EPA has not included relevant rapid methods data from a range of methods for SCCWRP conducted southern CA studies (i ncluding QPCR but also highlighting other methods like IMS-ATP). Some of this data i s already in publication format (submitted to journal) and easily interpretable. T he rapid methods information that is presented can be related with some difficulty to the cul ture based methods, but there are locations where both equivalency (numerical correlation) and/or health relationships exist that are different from the criteria development stated by EPA. Clearly, EPA will pick only one quantification approach, but addressing both quantificat ion approaches will be important for understanding how modifications of the EPA QPCR methods cou ld be implemented by others in the future.
F) EPA has not fully utilized all of the epidemiological da ta available for informing their new criteria. In particular, as stated above the SCCWRP co nducted epidemiological studies provide important information on the importance of asses sing inhibition, on the use of cell equivalent (CE) based quantification approaches, epidemiology at non POTW impacted high energy beaches, and comparisons of EPA methods to other avai lable rapid methods. EPA needs to take advantage of this available body of work.
G) In places it appears that the criteria document is di fficult to read and vague. The following issues exist, a) sections could be reorganized to flow better, b) that specific sections have not had the benefit of consideration as total ly as others (specifically the sections about waterbody type and criteria setting across c oastal and non-coastal waters, and c) that EPA is presenting the “process” of how they arri ved at the criteria, but they are providing very little foresight as to actual implementation . In this way, they miss out on an opportunity to provide specific guidance on a) successful i mplementation of QMRA, b) what constitutes enough side by side sampling between culture based methods and QPCR, c) what constitutes a similar enough method to Method A and how they go about presenting that information, d) examples of the use of STV in TMDL impair ment listings, and how the new approach will change existing approaches.

Yasvinski It is clear that a tremendous amount of effort has been put in to developing these recommendations and their supporting documentation. In terms o f adequate and transparent presentation of the conclusions, I would say nearly. In genera l, the conclusions are rooted in logic the depth of the literature reviewed scientific ally supported, and EPA has gathered/Reviewers’ Comments by Charge Questions

B-16 reviewed and produced sufficient information to support its risk assessment decisions.

1. There are some decisions that need to be better illus trated and supported or defended in the 2012 document. Chiefly, the ones I would highlight are:

• The findings around the fresh/marine equivalency would benef it from further illustration (question #3)

• Stronger supporting discussion should be provided as to why the st ronger qPCR results were not used to drive the criteria as opposed to the culture-based results (question #4)

• Supporting discussion as to why the qPCR criteria remain expre ssed as NGI illness, while the culture based criteria are expressed as HCGI, e ven though the discussion seemed to suggest an easy conversion or interchangeability be tween the two (question #4)

• More specific discussion around why E. coli , though not included in the NEEAR analyses is retained and justified in its role as the primary
2. Additionally on the subject of transparency and completenes s, the review panel discussed at the meeting that on the topics of:

• Coastal vs. Inland waters

• Tropical/subtropical vs. Temperate waters
and perhaps to a slightly lesser extent:

• Human source fecal material vs. Non-human source fecal material

The basic assessment seemed valid - that the data va riability and gaps were sufficient so as to suggest that the health risks for each type were similar enough and could not be independently characterized. However taking the direction of similarity in the discussion was done at the expense of acknowledging that there are also some real apparent differences between each comparison pair, but that the impa ct of this differences is not known or it is not known how significant. Acknowledging these differ ences and the data limitations is required to convey to the reader that EPA is aware of and has considered all the available information in presenting their decisions.

The review panel further discussed that a more intuitive app roach would be to structure the basis of the argument that extension of criteria acro ss recreational water types was done to be protective of public health in the lack of sufficien t information. This decision would be rooted in logic and allow EPA to acknowledge the differ ences and the data
gaps.
3. Another issue discussed by the review panel that was not addressed in my draft comments, but was captured in my specific comments concerned t he clarity of the guidance for applying the criteria. It is proposed that this section needs to be rewritten in a more clear and straightforward manner. Currently, the explanation of the statistics, the rationale, the calculation of the statistics and the guid ance as to application are all intertwined. It is recommended that these be separated f or easy of understanding, and specifically that the application guidance be specifical ly laid out in manner that is simple and easy for the intended recipient (responsible recreati onal water authority or beachReviewers’ Comments by Charge Question

B-17 manager) to understand.

The following editorial comments are also submitted:
1. It is clear to me that the EPA has completed a tre mendous amount of work in preparing the newly proposed 2012 criteria. So much so, that it appear s that the EPA should be able to confidently defend its conclusions and decisions. In the criteria document there appears to be some instances where the text in presenting a point, follows up with what might be a response to what expected criticism might be. Or similarly, uses a small point to point out consistency with EPA findings, rather than having a more complete, organized discussion of additional material that supports E PA’s decisions. As examples:

• In 3.1, it is introduced that EPA is allowing for a qPCR method, but then immediately following the text focuses on the issue of possible interferen ces and how they have been resolved.

• In 3.2.3 in discussing the body of epidemiological litera ture, after mentioning the Marion, 2010 study, it states that the E. coli findings support EPAs 1986 criteria, rather than having a more coordinated discussion of how the o utside body of evidence is also in line with EPA’s conclusions.
I understand this is an extremely complex document with many issues that need to be addressed, and doing so in a logical and easy-to-read form at is challenging. However I believe with the major issues to be addressed (e.g., the criteria itself, water body type, source of fecal contamination), the work put into this endea vour is such that the EPA should be able to present its findings and recommendations an d then follow up with short explanations for each major issue - yes, here are the known challenges or shortcomings...and we believe these are addressed/justifie d because we have done this or have the following information which supports it.
2. Another suggestion is that it would be valuable to have a brief opening summary or executive summary of the key decisions or the “need-to-know” i nformation for the states, tribes and readers. The criteria has a lot of components and a lot of questions to be answered and it is difficult to tease out the key conc lusions from the individual sections.Reviewers’ Comments by Charge Questions

B-18



### 2. Are you aware of any important peer reviewed lit erature or applicable data that have not been incorporated in this document and should be in cluded?

Reviewer Comments

Dorevitch Waterbody type (pages 33-36): See charge question 1.

Support for idea that recreational criteria applied to inl and waters should be protective: Inland Water Meeting report: Dorevitch, Ashbolt et al., 2010.
Millions of people use inland waters for recreation:

Cordell, H.K., Betz, C.J., Green, G.T., Mou, S., Leew orthy, V.R., Wiley, P.C., Barry, J.J., Hellerstein, D., 2004. Outdoor Recreation for 21st Century A merica: A Report to the Nation: The National Survey on Recreation and the Environment. V enture Publishing, Inc., State College, PA.
Heaney 2009: Suggests that a substantial portion of illness am ong swimmers enrolled in the NEEAR study may be due to sand exposure. This is significan t, in that it means that some of the illness incidence among NEEAR study swimmers may be du e to sand, rather than to water exposure and water quality. If this study is not addr essed in the RWQC, it’s possible that it could be considered by others to be an oversight tha t falsely inflated the importance of beach water quality on health risk (“the problem isn’t the water, it’s the sand.”) The study should be acknowledged, along with the fact that the NEEAR fr eshwater (Wade 2009) and marine study (Wade et al., 2011) did adjust for digging in the s and should be noted as well.
The basis for thinking that children would be at greate r risk than adults (lines 1052-1053): A citation that would be relevant here is Dufour et al., 2006.
Pratap et al., J Water and Health 2011: Even if extensive e fforts aimed at measuring FIB and identifying conditions of elevated risk are applied, dise ase will not be prevented if effective communications do not follow. Pratap et al. noted substan tial variability among states/tribes/territories in their approaches toward noti fying the public, which have not been systematically evaluated for effectiveness. While not an element of identifying an indicator or establishing criteria values, perhaps it could be noted (perhaps in section 5.1 or in the general introduction to indicators in section 1.1) that ind icator measurement is a critical, but not the only critical element, in a chain of steps tha t is intended to result in disease prevention. Efforts to modify behavior (i.e., don’t go in t he water when a notification/swim ban/beach closure or advisory is in effect).

Lipp The authors have been thorough in their review of material s, especially when taken as a

whole with all appendices.

McBride A number of extra references have been identified and ar e all included in the Review Panel's

responses to this question. With regard to the lack of a "road map" (Review Panel's comment 1.1), the recent WERF QMRA study (Bambic et al., 2011, not cited in the RWQC—but listed in the Review Panel's report) has a conceptua l diagram of a sort that may be appropriate as a decision tree for RWQC implementation, viz.Reviewers’ Comments by Charge Question

B-19 Noble There are four major missing sets of documentation. Fi rst, the epidemiological studies

conducted by SCCWRP on the west coast are mentioned. Howeve r, these studies are not incorporated at all into the discussion, except under the conte xt of NPS contaminated beaches and the literature produced as part of the Mission Bay, CA study (e.g., Colford et al., 2005). The beaches studied in CA are 1) major beaches for recreation, 2) representative largely of beaches found in southern California, 3) well s tudied and have results at this point assembled into the framework of journal articles that have been submitted or are ready to submit, and 4) represent high energy beaches that are not wi dely represented by other published epidemiological studies. Therefore, the data from t hese studies is far enough along that EPA could more effectively make use of the results. SCCWRP has been active in sharing all of the data generated from these studies, and i t is to EPA’s benefit to take advantage of this information. EPA has full access to t his data, and the beaches studied in southern California represent a vital subset of beaches th at have not been adequately addressed by EPA (i.e., beaches that are recipients of NPS pollution). That is, those beaches that are high use, high energy (wave energy), have significant contributions of diffuse pollution (specifically San Juan Creek and Malibu Creek ar e two major conduits of concern), and are not impacted by any direct POTW point sour ce. These types of beaches dominate southern California and Florida waters, and whil e Florida waters are subtropical in nature, the data collected from these beaches is a vita l part of the package of information that EPA should be examining. Additionally, more emphatic inclusion of the Epibathe data, including a serious examination of the E. coli data and a presentation to the reader for how that data relates or differs to other studies that have been conducted in the US would be useful, as the omission of E. coli from this document is a serious issue (as noted below).
Second, EPA has been seriously remiss in their inclusion of E. coli in freshwater studies. The criteria document is full of broad level statements a bout E. coli being adequately addressed. On page 22, EPA states that the reason that t he E. coli testing was not done was because EPA was taking an approach of a single indicator to be used for all purposes. If the approach is to link current criteria to historical cri teria, measurements of E. coli were anReviewers’ Comments by Charge Questions

B-20 obvious necessity. The omission of E. coli in both the culture based format and molecular format (qPCR) in the Great Lakes NEEAR studies is of major concern. In other parts of documents, EPA has written about the fact that their omis sion of E. coli measurements is warranted (see Appendix A, where the lack of E. coli based information is rationalized). The results of Epibathe, Marion et al., 2010, and other studies conducted in freshwaters recently indicates that this is clearly untrue. It is this revie wer’s opinion that the EPA must be transparent about the lack of new science in relation to E. coli, specifically relating to rapid E. coli QPCR methods. They must address, with transparency, thei r lack of foresight in not measuring E. coli

during the NEEAR freshwater studies. In 2006, there were s everal offers to EPA by outside entities to analyze the existing archive d filters from the NEEAR freshwater studies using E. coli qPCR. EPA originally indicated interest in conducting the se analyses, and but never pursued them fully. The lack of cult ure based E. coli work conducted in the other studies is another major issue. At t he very least, E. coli should have clearly been measured by MF methods for the NEEAR Great L akes Studies. EPA could create a section in this criteria document that is spec ifically for freshwater systems, and clearly delineate for the reader what will be accepted, and also clearly delineate that there

are E. coli

qPCR assays that exist for use in recreational water quality. EPA must also clearly state that they have not conducted the science to upda te the E. coli criteria, therefore those criteria remain the same as previously suggested in t he 1986 document.
Third, the presented analysis of the relationships between FIB and sources of contamination in coastal and non coastal waters is poorly written. I t is this reviewer’s opinion that there are three general sets of data a) marine, b) freshwater-grea t lakes, and c) inland lakes, rivers and streams. EPA does not have the inland waters data to compare at any significant level to the coastal and Great Lakes data, it simply does not exist. EPA is only confusing the issue with the weakly presented analysis. Furthermore, EPA does not describe what portion of the assembled literature was used for their assessments in this section, only refers to Appendices A and B broadly. Without presenting any of the assembled i nformation, where it came from and how it was preferentially selected from the large b ody of literature, about waterbody type and sources, FIB occurrence, FIB survival, and FIB associations with pathogens, the reader is left with a poor description of the summary of this huge literature review. It is this reviewer’s opinion that EPA must either completely redo this section, or they must state clearly what articles are being used to summarize inform ation and present it specifically and quantitatively. For example, there are vast difference s simply between decay rates in seawater and freshwaters, how can EPA state that these differences are not due to the water matrix, but due to site-specific differences?
Fourth, EPA has preferentially selected a few epidemi ological studies to highlight in the criteria document, on the freshwater side Epibathe, Ferley e t al., Weidenmann et al., and Marion 2010. They have also highlighted information about sources of fecal contamination in relation to human health outcomes (spec ifically stating that many epi studies of NPS contamination have found weak or inexistent relationships with FIB). EPA speaks to relationships between E. coli and human health, but this information is sporadic and not presented with any consistency or clarity. EPA must clearly state that the previously stated studies (listed above) have found significant relat ionships to E. coli in freshwater, and that EPA has not conducted the necessary science to change the E. coli

criteria substantially from 1986. EPA need to clearly state the need for E. coli based water quality assessments and epidemiological studies to be conducted so as to update the science in a similar way to what has been accomplished with Enterococcus , including the implementation of already available rapid methods (Lavender and Kinzelman, 2009).

Yasvinski No. The data analysis and the literature review conducted for the multiple components theReviewers’ Comments by Charge Question

B-21 criteria document considers (e. g., epidemiological studies, QMRA and other publications in the appendices) are very comprehensive and appear to be sufficient ly exhaustive. I feel comfortable that the body of information has been suitably rev iewed. The odd paper could be included to provide reference for specific points, as other reviewers have indicated, but I believe that no crucial streams of evidence have been ove rlooked. Two general comments I would have are as follows:

1. It is proposed that better linkage of individual points or conclusions to the respective Appendix subsections would be extremely valuable and help improve tra nsparency.
2. It is also felt that an important opportunity to addr ess the concept of the move worldwide towards a harmonized approach to risk management a nd the move away from reliance on numerical values of fecal indicator bact eria as the sole criterion for determining recreational water safety was missed. Altho ugh it is recognized that this is a criteria document and not a beach management document, the concept is in-line with EPA thinking. It is therefore important to highlight and ingrain this idea in the public consciousness and to also use the opportunity to point out the interconnectiveness between related EPA documents (e.g., sanitary survey a nd predictive model documents) to authorities and managers.

Suitable citations for the Harmonized concept include:
Microbiological Water Quality Guidelines for Marine and Fre sh Water Recreational Areas. New Zealand Ministry for the Environment. 2002

EU (2006). Official Journal of the European Union. Directive 2006/7/EC of the European Parliament and of the Council of 15 February 2006 concerning t he management of bathing water quality and repealing Directive 76/160/EEC

NHMRC (2008). Guidelines for managing risks in recreational water. National Health and Medical Research Council of Australia, Government of Austra lia, Canberra.

Health Canada (2009). Guidelines for Canadian recreational water quality. (Draft) Document for Public Comment. Water Quality and Health Bur eau, Healthy Environments and Consumer Safety Branch, Health Canada, O ttawa, Ontario. Available at: http://www.hc-sc.gc.ca/ewh-semt/consult/_2009/water_rec-eau/ draftebauche-eng.phpReviewers’ Comments by Charge Questions

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### 3. Do the analyses comparing the NEEAR freshwater a nd marine culture-based indicator data aggregated by days of similar water quality co rroborate that the NEEAR culture data are generally consistent with the 1986 regress ion models?

Reviewer Comments

Dorevitch It’s unclear why this issue is so prominently discussed in the draft AWQC. The document (Section 3.2.4) seems to frame the discussion of the 1986 numer ic values vs. the NEEAR numeric values for indicators by culture as a “confirma tion” of the 1986 numbers. The rationale for the comparison is never made clear: lines 853-855 s tate that this was done “to provide a comparison” – but why?
Perhaps the intention is to establish that the qPCR res ults of the NEEAR study were developed in settings and with participants that generated a similar culture-health risk relationship as the Cabelli/Dufour studies. If this is the case, that should be made clear. However, the methods used to make this point are poor substitut es for analyzing both data sets (Cabelli/Dufour and NEEAR) using the NEEAR approach (whic h addresses individual-level confounders). Support for the comparability of the Cabelli/Dufo ur studies and the NEEAR study can be found in Table 6 of Wade et al., 2008 and Tabl e 6 of Wade et al., 2010. This information (or these tables) could be presented in the R WQC in support of utility of the 1986 criteria values for enterococci; for justification of the continued use of those criteria values; and for demonstrating some comparability of findings o f the NEEAR and Cabelli/Dufour studies.
If EPA were to nevertheless decide to include the re-analysi s of NEEAR data using the 1986 approach:
I have significant concerns with the interpretation of Figur e 1 (page 26) provided in lines 897-899. To say that the plotted datapoints from the NEEAR stud y are “generally fell within the predicted range” of the earlier studies is somewhat dece ptive. The datapoints from the NEEAR study, particularly the freshwater (Figure 1a) study, suggest a relationship that is inverse (a line from about 20/1,000 swimmers on the Y axis through log10 entero=2 /100mL on the x-axis and that provides some fit for the NEEAR data ). A less convincing case can be made for marine water (draw a line from about 5/1,000 swimmers on the Y axis and log10 entero=2). NEEAR results are “in the predicted range” but are inverse, suggesting that the NEEAR results are NOT consistent with the Cabelli/Dufour results. The use of data this aggregated, essentially ecologic, is problematic because of the ecologic fallacy: that the individuals who got sick at beaches with a seasonal aver age of “good water quality” were swimming in water with good water quality – perhaps those who got sick used the beach on days of poor water quality. It may be best to avoid prese nting this analysis. If it does remain in the RWQC, the statement (lines 898-899) that “the NEEAR he alth and water quality data are consistent with those statistical models” must be dele ted, though the following sentence “this analysis proved to be insufficient” – should be re tained. As it stands, it’s problematic that the approach is insufficient yet a conclusion has been drawn.
The “binning” approach is certainly better than the “beach s eason” ecologic approach. The binning approach, however, does not produce results that, as n oted in lines 921-924 corroborate “the previous conclusion that the NEEAR data w ere generally consistent with the 1986 regression models.” Again, like Figure 1, it is not esp ecially meaningful that the datapoints fall “within the range” of the 1986 datapoints. If both the 1986 and the NEEAR data had similar slopes the findings would support what E PA wants to say. However, the 1986 data do suggest a significant positive slope for both fre shwater and marine water whileReviewers’ Comments by Charge Question

B-23 t here does not appear to be a slope in the NEEAR data

. Likewise, Table 2 does not suggest within-beach trends. Were tests for trend done on those re sults? Either way, the 1986 method did not adjust for confounders as the NEEAR study did . It is possible that associations observed in the Cabelli/Dufour studies would be d ifferent if adjustment were made for recent exposures, digging in sand, etc.
The discussion on page 28 and Figure 3, again, are problematic . Was a test of statistical significance done for the slopes of the NEEAR marine and f reshwater regression lines? I suspect that such slopes may not be statistically signi ficant, given the wide confidence intervals around the slope and the limited number of datapoints fo r a relatively small slopes (the freshwater slope is almost 0).
Additionally, the statement (lines 947-948) that “...the recommende d RWQC values are similarly protective of public health in both marine and fres hwaters” is based on an assumption that the slopes and intercepts of the freshwate r and marine indicator-HCGI relationships are similar. Since there seems to be no sl ope to the freshwater line, and perhaps no statistically significant slope to the marine line, thi s statement does not appear justified. Furthermore, the wide confidence intervals around the slope no ted in association with the 1986 estimates of risk (line 943-947) seem to be quite wide here (Figure 3). If there really is not slope, water quality measures are not needed to estim ate the level of risk, which simply would be the mean level of risk at all levels of water qu ality.
One of the intended purposes of this section may be to identi fy a comparable level of target risk for establishing qPCR criteria. If this is the cas e, the section should be re-written to make that clear.
It may be worth emphasizing that:

1. Analysis of the NEEAR culture data by the methods used to e stablish the 1986 criteria show comparability of the culture data-health risk associati on in the NEEAR and the Cabelli/ Dufour studies (at least when assessed using the d ichotomous “FIB above the thresholds of 33 and 35 CFU/100mL) (see above-noted reference to T able 6 of Wade et al., 2008 and Wade et al., 2010.

2. Presenting the relationships of enterococci CFU vs. healt h risk generated from the NEEAR study using the same approach to multivariate modeling that was done for qPCR would be better than using the 1986 approaches. If that relationship is weak, potential responses to that observation include:

a. Conclude that the qPCR models are better predictors of ill ness and therefore the method should be mandatory, rather than optional. Enteroc occi CCE criteria values should be those associated with a targeted level of risk of 8/1,000, same as the 1986 freshwater criteria. The need for harmonizing the targeted risk levels has been emphasized many times previously (Airlie workshop, Boehm 2009). The use of the more protective target (freshwater rather than marine wat er) would be preferred from a public health standpoint.

b. Present data similar to that found in Figures 1-2 of Wade et al., 2008 and Figure 2 (right panel) of Wade et al., 2010. If in fact the slopes of these lines are similar in marine and freshwater, and if the slopes are similar fo r adults and children, the information can be combined into a single graph. A enter ococci CCE criteria value providing the same level of protection as the culture values c an then be selected by using 8 cases of AGI (or the NGI equivalent)/1,000.

c. Given the limited precision of expected risk for given mi crobe density (the wideReviewers’ Comments by Charge Questions

B-24 confidence intervals and the small slope, the relationship be tween enterococci CCE and NGI may be too weak to reasonably differentiate qP CR CCE values to that are associated with, for example, 8 or 10 or 12 or 14 cases /1,000. This would suggest that the selection of a single targeted risk level c annot be supported. In this case, ordinal categories may be more appropriate. This could ta ke the form of the CCE values corresponding to risk of <8 cases/1,000 could be consider ed “green”; 8 to (arbitrarily) 12 could be considered “yellow” and >12 cou ld be considered “red” (as examples). The use of graded categories defined by ordinal r anges of risk is probably a better reflection of the science (i.e., the li mited precision in predictions of health risk based on microbe density or vice versa) t han the use of discrete categories dichotomized by an imprecise estimate wat er quality for a given level of targeted risk.

Lipp When aggregated by days of similar water quality, the da ta do support consistency with the

1986 criteria; however, given the wide variability among data po ints the following issues should be considered:
Line 897-899. In attempting to develop a quantitative mechanism to compare NEEAR data with the 1986 criteria based on culturable enterococci, differ ent methods of data binning were used. This sentence refers to the results when the seasonal GM is taken for the seven beaches used in the NEEAR study. The report states that the data points generally fell within the predicted range of the 1986 regressions. This is a rather optimistic view of these points (as shown in Figure 1). For freshwater, the NEEAR data po ints (4) actually look to be negatively correlated with HCGI rate and no relationship is noted in marine water (3 data points). While they do technically fall within the confidence intervals of the regression this is not a robust measure (which is also acknowledged in the re port) especially in light of the few data points. Binning by water quality levels provided a be tter point for comparison (as shown in next paragraph in the report).
Line 950. The trends lines for these data seem particularly weak, especially for freshwater beaches (which in previous figures seemed to have a stronger relationship than marine water). The data in general seem to show a very high degree of variability.
Line 961 - 968. Report states that results from marine and fres hwater studies are sufficiently similar to allow combining in the new criteria. I do wonder if they are sufficiently similar only because all of the data are so highly variable (there seems to be a large spread); however the regression using the combined freshwater and marine data is stronger than when the water types are separated. The marine data point s (alone) show an almost vertical regression line (appendix B.5) where a very small change in C CE results in a large change in # GI/1000.
It is also not entirely clear why the NEARR data must be co rroborated by 1986 analyses, given the difference in study design.

McBride • This is a crucial issue, because this analysis has ena bled the adoption of the same

numerical limits on culturable fecal indicator bacteria as currently apply (under the 1986 criteria). The general approach taken seems sound, but I c oncur with the caveats made by the Review Panel's responses to this question. I presume that EPA staff will urgently promote a peer-reviewed publication of this important anal ysis?

• A particular feature of this analysis is seen by contras ting Figures 2a and 2b. In Figure 2a the "1986 freshwater data" and the "NEEAR freshwater data" are positioned similarly (with respect to the X

and Y axes). In contrast on Figure 2b we see that the "1986 marineReviewers’ Comments by Charge Question

B-25 data" and the "NEEAR marine data" differ in that the former tend to exhibit higher HCGI rates. Some explanation of this contrast would be helpful, be cause it is the cause of the reduced estimate of HCGI risk associated with the mar ine criterion.

• It may be appropriate here to recall some history of the de velopment of the 1986 criteria, especially for marine waters. In 1984 USEPA proposed an "a cceptable risk" of 6 HCGI cases per 1000 swimming events and advertised that notion (see Federal Register 49(102) , 21987–21988 May 1984). Furthermore, in the FR , EPA used the Cabelli HCGI relationship with that illness risk giving rise to a lim it of 3 enterococci per 100 mL (interpreted as a GM limit). Later, after various submi ssions pointed out that such a low limit was not generally attainable, the idea was raised t hat since a GM limit of 200 fecal coliforms per 100 mL had served well, let us translate tha t limit back to enterococci (giving 35 per 100 mL) and then read the Cabelli graph in the revers e direction to calculate the associated risk (19 per 1000 swimming events), as explained in Federal Register 51(45) , 8012–8016, March 1986. That is, "acceptable risk" was not selected , it

was calculated . That stance has now changed in the proposed revisions, in that an acceptable risk level has now been found to be consistent w ith both the freshwater and the marine criteria limits. Presentation of this change i n the RWQC might be helpful.

Noble EPA has made an attempt to link across studies in a tra nsitive argument, and they present

one way of examining the information. However, issues exist wi th the following that deserve to be explained.

1. Models used in 1986 are different from the models used for the N EEARS studies that include confounding factors. EPA should be transparent as to why the modeling approaches are different (assume that raw data from 1986 is not available?) and explain clearly why they are using the cross walking approach given thi s reason. EPA could be more proactive in stating that the criteria development i s linked to protection of public health.

2. Few data points make it difficult to assess the similari ties across studies (Is it possible to remove the seasonal aggregation presentation?), there are other possible ways to present and analyze the data, why has EPA chosen only these exampl es?

3. It is generally unclear to the reader what final dat a was combined data and what final data was specific to a study or beach? Also, it is unclear w hat modeling approaches were used to generate the health risk assessments for each spe cific study.

4. Why no presentation of Bacteroidales information? Can it be used as a tool in Section 5.0? This indicator may have particular relevance in t ropical waters, where regrowth of E. coli and Enterococcus has been shown to be a serious issue (e.g. Hawaii).

5. It would help the reader to see information from Wade et a l., 2008 and 2010 showing relationships to human health above and below specific stan dards.

6. No mention or incorporation of SCCWRP studies makes it di fficult to understand what selection process was for the epidemiological information? H ow do the SCCWRP results relate to the marine NEEAR studies? Are there la rge differences in rapid method and culture method results? How about presenting a table, fo r transparency, that shows what studies individually showed a relationship to human heal th for what methods and what studies didn’t? In relation to EPA conducted studies, t he SCCWRP studies are some of the most extensive, and they specifically followed EPA experimental design, soReviewers’ Comments by Charge Questions

B-26 the lack of inclusion of this information is curious.

7. EPA does a poor job of explaining why they have included certai n studies in their considerations and not others, is it possible that these other studies generated information that make this aggregation of data and cross talk across criteria establishment confounded? It generally appears that the EPA st udies only have been included in the final criteria development. While this is a decision for EPA to make, it needs to be justified and made clear throughout the document . There is a strong comparison between the Marion et al. study and EPA studies i n the Appendices, but it is not clear why that kind of comparison is not conducted with a n array of recent rigorous studies conducted by others.

Yasvinski Not quite. My initial comments to this question were to propose that the findings that

prompted the decisions of equivalency needs to be illustrated further, through a combination of graphical data showing the marine and freshwater data combined and an indication of the statistical calculations showing no statistical difference . Further to this, a valuable discussion would be as to how although the water quality da ta at the beaches was shown to be very good, it was felt that there was sufficient data captured at points where swimmers would be at elevated risk so as to make the data sets and observed relationships robust.
EPA’s desire for pursuing unified illness rates for fres h and marine waters for public health protection and for application and implementation purposes is understood. At the meeting the review panel discussed that Figure 1. could be regarded a s doing a disservice to the argument of marine/freshwater equivalency, but since it i s addressed as being insufficient to refine the illness estimates, it’s inclusion was considered valuable for transparency purposes. The reviewers further addressed that in the absence of a suitably-illustrated supporting discussion, the apparent lack of relationships in Figure 2 qu estions whether the NEEAR data and the 1986 data are sufficiently similar. Ultimately the review panel suggested (and I support) that the NEEAR study data be used on its own be used to determine conclusions regarding fresh and marine water illness rate similari ty.
Guidelines or criteria can have several components beyond the st raight scientific data component. These additional components can also impact or s hape the way the final recommendations are presented:

• Historical component

• Public health decision component

• Jurisdictional component

• Practicality of Implementation component.
In my experience on the work done in developing the (draft) recom mendations for the Guidelines for Canadian Recreational Water Quality , the current fecal indicator recommendations were similarly based on assessment of the be st available scientific data. However, because of the data limitations, and the lack of a n exact parameter-to-illness causative relationship, the recommendations are not identifie d as illness thresholds, but rather as risk management values intended to be protecti ve of public health.
Whatever EPA’s decision regarding a tolerable illness rat e and marine-freshwater rate equivalency – whether it be weighted heavier or data relat ionships or on policy/risk management/public health decisions – it is recommended that it provided that it appears logical, transparent, acknowledges it’s limitations and fits within EPA’s scope of authority, it will be capable of being defended. If not, it will give the appearance of potentially hiding something, and therefore will likely be subject to critici sm, whether it is warranted or not.Reviewers’ Comments by Charge Question

B-27 

### 4. Do the characterization and explanation of the q PCR method reflect that of the scientific literature? If not, what additional information sho uld be included? Is the derivation of the qPCR value using the EPA data scientifically suppor ted and adequately explained? Please discuss why or why not.

Reviewer Comments

Dorevitch Given that the qPCR laboratory and calculation methods ut ilized in the NEEAR study were

the ones that established the enterococci CCE-NGI risk as sociation, I would be reluctant to see that method revised. Revisions to the calculation approa ch of NEEAR study water quality data that were found to improve health predictions within the NEEAR dataset would be valuable. Revised laboratory methods in isolation (that is, not linked to health outcomes data) would be difficult to assess.

Lipp More data are needed to confirm the use of the qPCR (CCE) between labs and among many

different water types. This work appears to be on-going but re sults are critical to fully assess the utility of this alternate indicator. Given the specifi c need for developing rapid methods to assess water quality (per BEACH Act and lawsuit) data are needed to provide states with specific recommendations about implementing this tool, along with resources for set up and training. Specific questions/issues are noted below:
Line 414-415 (and elsewhere). Given the variability in water t ypes both within and between beaches (over space and time), it might be expected that P CR failures (inhibition) will happen with some regularity. There needs to be specific g uidance for how to handle these occurrences (especially where some beaches routinely face this problem).
Line 458-464. While qPCR methods (CCE) show excellent promise as a rapid tool for measuring water quality the limitations in validation of this method are cause for some concern. More work is needed to provide guidance to states on how best to implement and trouble shoot this approach
Line 1116-1130. What happened to qPCR for Bacteroidales ? Will this be an option for states with marine beaches if they choose to adopt another target?
Line 1613. The guidelines for states on determining the performanc e characteristics of the rapid (qPCR) methods will be critical for successful impl ementation. Has any headway been made on drafting such a document?
Apppendix A.2 Single lab validation of EPA method A (qPCR for e nterococci)

• Variability in the copy number of the 23S rRNA gene between species and over the course of a growth cycle is a potential problem in corre ct quantification using this method. Currently, EPA is using a copy number of 4 (repor ted for E. faecalis ) as a reference point. Is any work anticipated to determine the broader range of copy numbers in other species (e.g., E. faecium has 6 copies)? If so, and average copy number could be used for quantification.

• In this single lab validation, the recovery was very consist ent among samples in PBS but seems to have a fair amount of variation in both marine and freshwater. Is EPA evaluating methods to improve recovery consistency?

• It will be helpful to see results from multi lab validati on.Reviewers’ Comments by Charge Questions

B-28 Appendix A.4. Parameters that affect performance of qPCR me thod for enterococci

• Study temperatures tested here are reflective of seasona l conditions in temperate areas, not tropical or subtropical (i.e., spring 15 – 17 C, summer 20 – 23 C, winter 4 – 8 C). In all seasons, these temperatures are cooler than would b e expected in tropical/subtropical waters. Especially at the higher temperature scale (e.g ., 30 C in the summer) may have a strong effect on persistence/decay of enterococci which c ould inform the use of this indicator in warm (hot) tropical waters.
Appendix A.6. Suitability of indicators and methods for differe nt CWA programs

• The limit of detection information present in Table 2 is s omewhat confusing. For qPCR (CCE and CSE) a 50% limit of detection is used. This a te rm generally used for evaluation of presence/absence data, not quantifiable result s. While the data are derived from Chern et al., 2009, it is not clear in the Chern paper how the 50% LOD was derived. In most studies, the actually LOD varies with processi ng parameters but in general a theoretical limit of detection can be derived for an ‘o ptimal scenario.’ It is not clear why that approach was not taken here (for both culture and qPC R methods).

McBride As this is not my particular expertise I defer to Panel c olleagues on this question.

Noble EPA presents a method that is highly successful to quantify ing Enterococcus in water. The

information, however, is lacking in several specific areas.

1. QPCR criteria has been shown, but the linkage between this criteria for actual studies conducted recently and illness has not been shown. EPA needs to specifically show that QPCR relationships to human health in freshwaters are st ronger than those for culture based methods. The reader should be presented with the ac tual illness rates that would have resulted in a range of EPA and non EPA studies if th is selected criteria was retrospectively applied. As a matter of fact, it would be useful to see this done for every epidemiological study conducted recently that utilized Enterococcus qPCR.

2. The scientific literature is full of a range of quanti fication approaches for qPCR. The rationalization and explanation for the selection of the C CE or calibrated cell equivalent quantification approach for QPCR is not adequate. The la ck of inclusion of the results of the SCCWRP epidemiological studies is vital in this rationaliz ation, along with other work that has been conducted in the Great Lakes using E. coli QPCR assays. EPA is missing a valuable opportunity to explain this to the public/st akeholders. They also must present their epidemiology data in both the cell equivalent a nd the calibrated cell equivalent format, in the context of inhibition, and at least let the reader see that there are serious advantages and disadvantages to each approach. T here are other general approaches (using the CE approach with inhibition flagged) to m anage beach waters that have been presented by the State of CA, and while these are mentioned they are not explained. EPA should present this information and be tran sparent. EPA must address these issues and present a sequence of rational argument s for selecting the calibrated cell equivalent approach.

3. EPA presents the method, but provides almost no guidance as t o how others can use similar methods, like IMS ATP, are there possibilities f or methods like IMS ATP?

4. The presentation of method specific details is limited t o Appendix A, where EPA quantifies cross laboratory variability, and 50% limit o f detection. EPA must provide a better example of what type of variability they expect fr om rapid methods as compared to culture based methods. This is vital when considering post ing a beach based upon aReviewers’ Comments by Charge Question

B-29 single suggested value. Possibly a section that compares the methods and shows a shortened version of the methods comparisons that have been do ne and the variability observed.

Yasvinski As this is not my specific area of expertise, and others on the review panel are more

qualified than I to comment on the accuracy and appropriatenes s of the methods, I will withhold from commenting on this particular area. However, in terms of the derivation of the qPCR value, this does not quite feel adequately explaine d. Illustration showing comparison of NEEAR data to the calibration curves with e xplanation of how the relationships observed are felt to be valid would be hel pful.
Additionally, an expanded explanation to the reader as to why the qPCR criteria seem considerably elevated relative to the culture criteria, a nd how these are logical and are justified, would be useful.Reviewers’ Comments by Charge Questions

B-30



### 5. Please provide any other general or specific com ments on the document, making sure to identify the section number/page number you are com menting on.

Reviewer Comments

Dorevitch Some suggestions for organization of the document:

• Start with an executive summary that highlights:
- The CWA and the background for reviewing/revising AWQC/ RWQC
- NEEAR study (# beaches, participants, years)
- What stays the same (no changes to culture method crit eria values) in relation to current requirements
- What changes are proposed One huge change: inland waters, One small change: the option for data collection to support f uture use of qPCR The Section 5 provisions

- How the 2012 RWQC can improve public health (rapid notification, more waters now covered/protected).
Has EPA estimated the number (or percent) of days of beach use that, following application of rapid methods, will be appropriately closed when prior da y culture methods would leave the beach inappropriately open (or without an advisory/noti fication)?

Has EPA estimated to number or inland water recreato rs (or person-days of recreation) that for the first time, fall under the protection of the RWQC?

Miscellaneous comments/edits/corrections:
Lines 309-310: Consider revising “State of the science review on occurrence and crossinfectivity of specific pathogens associated with anima ls.” To “State of the science review on the occurrence and human health risks of specific water borne zoonotic pathogens.”
Lines 342-343: Consider revising “... considered all of the indicators of fecal contamination...” to “...considered indicators of fecal contami nation” or better still, “...considered indicators of health risk...”
Line 358: Consider revising “These particular FIB are not pathoge nic...” to “These particular FIB are generally not pathogenic...” (since some E. coli are pathogenic).
Line 359: Again, the previously noted suggestion that over-emp hasizing FIB as pathogen indicators rather than health risk indicators, given that the document elsewhere notes that FIB are poor indicators of pathogen presence.
Lines 366-373: Text is confusing. Consider first explaining that th e membrane filtration method generates CFU/volume while the defined substrate method ge nerates MPN/volume. The defined substrate method does not involve counting colonies, but rather relies upon probabilities. Neither method includes counting of microbes in a water sample, but rather, generate results following culturing those microbes for 18-24 h ours.Reviewers’ Comments by Charge Question

B-31 Line 383: Change viable to “culturable” as bacteria in the VBNC (viable but not culturable) state would not be counted using culture methods.
Line 390: Consider changing “methods in water” to “methods in a specific waterbody or beach”
Line 401: Suggest that there’s an qPCR more recently develop ed (? since Method A was published?). Consider deleting the word “more.”
Line 418: Change both uses of “incidences” to “instances”
Line 419-422: This isn’t definite. Chern 2011 suggests that the SPC and target DNA have similar amplification efficiencies.
Lines 440-447: Why not refer to this as the ddCT approach?
Lines 471, 487: FIB “occurrence” sounds like FIB “presence.” Si nce FIB are essentially always present, albeit sometimes in low concentration/dens ity, “occurrence of FIB” isn’t informative. Consider changing to “density” or “concentrat ion.”
Line 517: For the sake of completeness could add that the 1986 differed for marine and freshwater in part because of the different levels of “acc eptable risk.”
Line 578: Consider revising “actual increase in the burden of il lness swimmers experience” to “actual increase in the incidence of illness among swi mmers” (as “burden” is more general and could refer both to the incidence rate and the severity of illness).
Line 596: consider changing “an eye infection” to “a self-repo rted eye infection”. Similarly, Line 598: consider changing “wound that became infected” to “ wound that was reported to have become infected” In both cases, it may not be clear that “infection” was based on selfreport, rather than diagnosis by a physician or other healt h care provider.
Lines 600-610: Not really. It would be true that that a larg er percent of epi study participants experiences GI illness than other health outcomes. However, that’s no reason to assume that preventing GI illness would also prevent non-GI illness. It m ight, but “a similar level of protection” implies that a similar proportion of GI and non-GI illnesses would be prevented. We don’t know if that’s true. It might be better to state t hat NEEAR and previous epi studies found that the health outcome with the highest incidence was G I illness. Preventing GI illness may or may not result in a comparable reduction in he alth outcomes, but it will prevent the most type of recreational waterborne illness.
Line 635-626: Consider revising to “...RWQC because neither possible r elationships between these microbes and FIB, nor relationships between FIB and these health outcomes, have been the subject of observational studies.”
Line 651: Change “incidences” to “incidence”
Line 670-671: Revise “time issues” to “short-term (ho urs) variability”
Line 689: Suggest changing “particular sensitive subpopulations” to eit her “potentially sensitive subpopulations” or “particular subpopulations” (since in the end, there wasn’t sufficient evidence to support that assumption that children are in fact “sensitive”
Lines 715-716: change “rate of increase in risk per unit incr ease in enterococci” to “change in risk per unit change in enterococci”. Also: This an alysis (p=0.44) is unpublished but has substantial policy implications. Consider elaborating on the source of this info and ifReviewers’ Comments by Charge Questions

B-32 possible, the status of the EPA report or the publication st atus (submitted, in revision, etc).
Lines 739-741: As written this suggests that Wade 2010 evaluated the use of Bacteroidales in marine and freshwater and found that indicator to be as sociated with GI illness in marine waters only. Because Wade 2010 only addressed marine waters, be tter to revise as “GI illness in swimmers at marine waters was also associa ted with exposure to levels of anaerobic bacteria of the order Bacteroidales enumerated with EPA’s Bacteroidales qPCR method (Wade 2010).”
Lines 764-767: The very low indicator levels is likely an impor tant (perhaps the most important) reason for the absence of a relationship be tween FIB and health at both Boqueron and Surfside. This information, rather than inhibition ( which would not impact the enterococci culture data) should be noted.

Lines 790-795: The end of this section states that E. coli levels “correlated with HCGI in a similar manner as in EPA’s 1970s” studies. First, the Ohio reservoir study reported an association with GI symptoms but not with HCGI. Second, the t erm “correlation” is used in several places in the RWQC to mean “association” or “sta tistically significant relationship”. This is one such example. The Ohio study reported the resul ts of a multivariate regression, not a correlation analysis.
Lines 810-813: Please justify that statement that a limitat ion of the RCTs is smaller sample size. From a practical standpoint, it’s actually an ad vantage that smaller sampler sizes are needed. The reason sample sizes can be smaller is that randomization should generate 2 groups (exposed and unexposed) that are similar in all w ays other than the exposure. Because the observational designs do not randomize, much large r sample sizes are needed to adjust for confounders. It could be noted instead that t he most significant limitation of the RCTs is that participants who are randomized to “exposure” have been asked to immerse their head in water 3 times over a short duration (10 minute s). This is not swimming. It may result in rates of water ingestion that are greater or less than swimming, but it is not swimming. There is an assumption that the risks of GI ill ness in the RCTs are the risks associated with swimming; they are the risks associate d with head immersion.
Line 832: Change “swimmers” to “those randomized to head imme rsion.”
Related: Lines 1275-1294 refer to Epibathe. This was a series o f studies that evaluated the health risks of controlled exposure (head immersion), not swi mming. Any conclusions about the relevance of Epibathe to EPA criteria development should note that Epibathe did not evaluate the health risks of swimming, but rather, head im mersion (3 times).

Lipp The text should discuss the notion that FIB are used in pract ice as indicators of health risk

and not specifically correlates of pathogens. There ar e many papers showing no correlation between FIB and enteric viruses, or other pathogens. Howeve r, understanding the relationship of FIBs to pathogens will become more importan t if using a QMRA approach. This topic would be best discussed in the QMRA section.
Line 675. The summer season focus makes sense for temperat e waters but in tropical waters, where beaches are used year round, epi studies done at other s easons may be important. While it is speculative, high water temperatures and UV ir radiation during the summer tropical beach epi study might help to explain the very low numbers of FIB observed.

Line 1064. It should be made clear that this statement is referring only to freshwater studies.
Line 1135. The first line of this paragraph states that this RWQC are nationalReviewers’ Comments by Charge Question

B-33 recommendations for all surface waters in the US, but data reported here and in the appendix does not support this. Ongoing questions remain about the use of this criterion for nonPOTW impacted beaches and inland waters and tropical wat ers. This should be acknowledged and special considerations given for these areas in section 5 (for implementing site specific criteria).
Line 1189-1191. Report states that based on the review of liter ature and the overall site to site variability of FIB concentrations that the RWQC w ill be applicable to both coastal and non coastal sites. But, this is in contrast to the EPA s tudy (Appendix C.4) that states that epidemiological studies to date do NOT support extending these cri teria to inland waters NOT impacted by POTW discharge.
Line 1307. This statement is not consistent with findings repo rted in Appendix C.4 (see above comment on same issue)
Line 1428. While based on QMRA (Appendix C.3) and other studies, i nputs from animal feces can result in similar risks as human fecal con tamination, it should be pointed out that not all animals present the same risk levels (e.g., Appendi x C.3 - pigs and poultry showing lower risks)
Line 1747-1751. The development of these models and software for mode l development are a great addition to allow rapid assessments; however, while the Great Lakes Beaches models have been successful it is important to note in this doc ument that the results for marine beaches are currently inadequate. This likely reflects the fact that the models are predicting FIB levels, which tend to be lower at marine beaches, even with health effects are noted. As any work been done to adjust these tools to predict health ef fects directly rather than the FIB levels?
Line 1893-1900. Given the inconclusive results of the non-POTW impacte d beach and tropical beach, is the EPA anticipating that states/reg ions address these on a short time frame? Does the EPA anticipate providing any assistance fo r these regions? This is a critical gap in knowledge.
Line 1986-1997. Does the EPA plan to update or offer technical gu idance to the states on this issue periodically? It seems that EPA might be in a better position to offer new methods/technology options with appropriate QC behind the method.
Appendix B.4 is identical to Appendix B.1

Typos:
Line 257. There is a typo. WERF is Water Environment Research Foundation (not “experts” as written)
Line 316. The word ‘Water’ is missing from National Epidemiol ogical and Environmental Assessment of Recreational ...
Line 848. Typo .. “if” should be “of” (“...terms OF indicator density ...”)
Line 885. Typo, ‘trail’ should be ‘TRIAL’
Line 1165. Typo. There is a word missing from this sentence or the structure is awkward. “Loadings and hydrodynamics of FIB in human POTW coastal and non-coastal waters ...” Human POTW?Reviewers’ Comments by Charge Questions

B-34 Line 1205-1207. “salinity’ should be removed from this sentence given salinity would have a lot to do with whether a beach was coastal or non-coas tal (e.g., coastal marine beaches will be saline and non coastal beaches will be fresh)
Line 1251. Typo. Remove the word “was”. Sentence should read “ ...a retrospective study in the French Alps ...”

McBride Line Comment

183 "...recommended fecal coliform criteria..." should be "...recommended log mean fecal coliform criteria..."

254

– 255 With regard to this text: "These projects included epidem iological studies to provide data correlating illness with indicators, site-cha racterization studies to facilitate QMRA...": To do that the epidemiological studies w ould need to assay for pathogens, not just indicators—QMRA uses dose-response re lationships for pathogens. I understand that this has not been done.

269 I note that these QMRA studies are for impacts of agricultural animals. So inferring from these that wildlife poses similar risks may lack sufficient foundation (but I do recognize that in the absence of studies on wildlife a precautionary approach may be very desirable from a public health viewpoint).

498 While true that the 1976 criteria (in USEPA Quality Criteria for Water , July

1976) recommended the same numerical limits as did NTAC, it may be helpful to note that the rationale for these limits changed (from the earlier USPHS studies of Stevenson 1953, as interpreted by NTAC), to an arg ument based on minimizing Salmonella infections (as is clearly stated in that text).

524

– 538 What is meant by "the" observed GM enterococci and "the " observed fecal

coliforms? Is it for the combined studies mentioned on line 514?

557 The word "because" is misleading here. It should be "in that". The paragraph

doesn't explain why the changed definition was adopted. Maybe it should?

603

– 604 Maybe note that the McBride et al. study found respira tory illness rates were

associated with the concentrations of enterococci but fail ed to detect an effect with gastro-intestinal rates. (So it shouldn't be cit ed in support of the opposite pattern, as has been done on line 603.) Also Fleisher et al. ( 1998) reported "Attributable proportions of illness" as 34.5% for GI but a h igher value (40.0%) for AFRI. So is the text on these two lines correc t?

716 Hypothesis tests of no difference should not "accept" that hypothesis when the

p -value exceeds the significance level. It suffices to say t hat differences were not statistically significant (there always is a diffe rence between two populations, so it makes no sense to say that there isn't ). Null hypothesis test procedures are devised by assuming that the null is true, and only reject that hypothesis if data are sufficiently convincing. On logical g rounds that procedure doesn't admit an inference that the null is true (or even likely to beReviewers’ Comments by Charge Question

B-35 true).

837

– 843 The Corbett study did detect an association with respi ratory illness however.

969 Figure 4 doesn't say which GI category is being graphed; it s hould (i.e., NGI).

977 Wymer et al., 2011 is Appendix B.3; that needs to be clarif ied.

1355 Not sure why there's an emphasis on outbreaks here. The m ajority of the

human disease burden manifests as endemic or sporadic patt erns cf. outbreaks. And, in particular, campylobacteriosis seldom appears as out breaks yet can have a high endemic rate (that's certainly the case in N ew Zealand, Till & McBride 2004).

1411

– 1412 I don't understand this text: "The few studies conducted in non-P OTW

impacted waters that also report significant health effe cts (McBride, 1998; Cheung, 1990; and Wiedenmann 2006) have ... 2) combined epidemiological data from beaches with non-human fecal source impacts wit h data from beaches impacted by human fecal contamination sources." T he New Zealand study did have beaches with human impacts and beaches wit h animal impacts, but the analysis did consider them separately (as well as combined).

1428 Suggest replace "Thus, waterbodies with substantial animal inputs" with

"Thus, waterbodies with substantial farmed animal inputs". Note too that "McBride, 1998" (lines 1409 & 1428) should be "McBride et al., 1998".

1460

– 1461 "The GM is calculated as the arithmetic mean of the log-t ransformed

densities" should be "The GM is calculated as the antilog of the arithmetic mean of the log-transformed densities".

1471 Maybe elaborate a little more on what 40 CFR 122.45 is all about?

1532 Is "log standard deviation" ambiguous? Some might interpret it to means what

it says! Should it be the mean the standard deviation of the logarithms (to base 10?) of the data?

1835

– 1838 Is Colford's Mission Beach study an exception to this huma n-impacted

category?

1918

– 1927 Another use of QMRA is to assess "what if" scenarios. I argue that's an

important use of it, one that epidemiological studies can't perform.

1944

– 1949 Were any of the epidemiological studies conducted close to an outfall? If not,

is there a case for advocating, say, QMRA in those circ umstances (as is done in the New Zealand Guidelines (at pp. 3&4): http://www.mfe.govt.nz/publications/water/microbiological-qua lity-jun03/ ).

Noble Sections 3.0, 3.1, and 3.2 are poorly written and need to b e rewritten and reorganized. The

sections on this history of criteria in the beginning of the document are much more clearly written and presented. In Appendix C: ASSESSMENT OF THE APPLICABILITY OFReviewers’ Comments by Charge Questions

B-36 EXISTING EPIDEMIOLOGY DATA TO INLAND WATERS, there are statements that are contradictory to those written in Section 3.0+ of the cr iteria document. In particular, the data analysis is not possible given the range of methods that w ere used to conduct coastal versus inland waters assessments. The document clearly states the caveats associated with interpreting the data across sites and methods. EPA clea rly states the variability observed from site to site at beaches, then there is a huge effort expended to show the linkage across coastal and non-coastal waters. It is simply not possib le to state that coastal and non coastal waters behave similarly in relation to FIB dynamics.
Specific comments: Use either Enterococcus sp. or enterococci throughout FIB = fecal indicator bacteria, typically in the literat ure, this refers to total coliforms, fecal coliforms, E. coli or Enterococcus . Where you mean FIB use FIB
Fecal indicator and fecal indicator organisms (FIO) inc lude all indicator organisms. Most typically use this as a catchall for all FIB, plus other “indicator” bacteria that can sometimes include other bacteria such as C. perfringens . It is this reviewer’s opinion that in the criteria document, in almost all instances seen the EPA should c onsistently be using FIB specifically
If going to define acronyms for all, please use them. Specifica lly use FIB please, not “fecal indicators” which could be inclusive of enteric viruses, protozoa, chemical indicators of fecal pollution etc.
EPA could please include:

• A basic example of what constitutes an adequate side by si de testing scheme for implementation of qPCR and if states have already done this , how they can “bypass” this step.

• A QMRA case study, or at least an example of what would be adequate.

• More information as to how spatial and temporal sampling frequency plays into GM and STV. There is little mention of how EPA selected to reduce (?) the required sampling frequency for STV (12 for 90 days as opposed to 5 fo r 30 days?), what information has been assembled to defend this?

• EPA needs to at least discuss frequency of beach closure s in a reference beach vs. contaminated beach context in terms of impairment listi ng, and they need to defend their approach, or specifically accept other approaches th at have been scientifically and rigorously established, also need to defend the use of mixed information in impairment assessment, can an agency mix and match QPC R and culture based data for STV assessments? What is the reasoning for accepting this approach? Not accepting this approach?

• Are all E. coli

GM and STV assessments to be conducted the same as Enterococcus ?

• What about use attainability. There is very little inform ation provided in this section. EPA has done a poor job in the past of describing how to establ ish tiered approaches. Now that they are doing away with this system, they need t o address how this will impact states that are short on resources. States migh t find themselves in a situation where they are expending resources at a beach that has 1 user per month, and reducing resources at their higher use beaches. This is an undesired effect of the tiered system, but a reality in tight budget times. This reviewer is alre ady aware of several states that have suggested that they will have to shift resources awa y from high use beaches to mostly unused beaches if the tiered system is abandoned. Th ere needs to be a clearly thought out process and presentation of the information to stake holders, as this willReviewers’ Comments by Charge Question

B-37 impact those in the water quality agencies greatly. Are t hey expe cted to maintain all of their sampling sites that they currently sample with low er frequencies at the 90 day 12 sample minimum?

• EPA is to be commended for introducing new scientific tools such as QMRA in the possible arsenal of water quality managers. EPA could more adequately explain the QMRA process and provide examples (this was already included in other comments). One major problem is that the source identification and quant ification science that needs to be done has not been done in an organized way. EPA should take the lead on this. With specific personnel at EPA (Orin Shanks) this wo rk can be completed successfully, but there must be a plan toward doing it at a national level. EPA has not specified how agencies/stakeholders sift through available s ource identification and quantification approaches to select something that is rigor ous and can be used successfully. Finally, the linkage to FIB is not clearly made in the criteria document or any guidance that EPA has published. Guidance on the linkage of source specific information specifically to either E. coli or Enterococcus has not been provided. This is a vital step toward the successful use of QMRA as an ad ditive to a management schema for surface waters.

• QPCR methods, EPA has not specified what is acceptable f or equivalency of rapid methods (i.e., use of Method A with a different QPCR pla tform, how many side by side samples need to be run to demonstrate equivalency betw een methods?). This needs to be done now before other classes of methods arrive. Set the stage for other criteria development, be novel and thoughtful about this process . If want to use a different platform, specify the acceptable criteria. If w ant to use a different available tested method, define what is acceptable. It is assumed th at much of this information will be in a Topic Specific Guidance, but some precursor inf ormation is desirable.

Yasvinski File containing marked specific comments submitted with t he draft comment file remains

unchanged.C-1 

## Appendix C

Individual Reviewers’ Post-Meeting CommentsC-3 

### Samuel Dorevitch
Visiting Associate Professor School of Public Health University of Illinois at Chicago

Chicago, ILC-4

Samuel Dorevitch received his medical degree from the Univer sity of Chicago, completed residencies in Emergency Medicine and in Occupational Medicine, and received a Masters in Public Health Degree from the University of Illinois at Ch icago (UIC). He is an Associate Professor in the UIC School of Public Health, Division of O ccupational and Environmental Health Sciences. Dr. Dorevitch also has an appointment in the UIC Institute for Environmental Science and Policy. Dr. Dorevitch was the principal invest igator of a cohort study of recreation on inland waters. One ongoing area of research is the use o f molecular methods to rapidly identify and communicate the presence of hazardous conditions at beaches.Samuel Dorevitch

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### Peer Review of the Recreational Water Quality Criteria (RWQC)

Comments Submitted by Samuel Dorevitch

Introductory Comments

EPA scientists and policy-makers, as well as those tha t assisted in the development of the draft RWQC are to be commended. The task they faced was monumental, i n large part because of the tremendous amount of information about microbial measures of water quality and associated health risks that EPA has developed in the past 10 years. The National Environmental and Epidemiological Assessment of water Recreation (NEEAR) was a very sophisticated study that presented numerous implementation and analytic challenges. Furthermore, EPA researchers develo ped, refined, and published details of molecular methods that allow the timely measurement of fecal indica tor bacteria. EPA’s research team succeeded in completing this ambitious study, and findings pertinent to cri teria development have been published in peer-reviewed journals.

EPA staff and consultants have developed draft “Recreati onal Water Quality Criteria” (RWQC), the subject of this peer review. Efforts were made to summa rize a wealth of data used to develop both the 1986 Ambient Water Quality Criteria, as well as the present draft RWQC. The peer reviewers commend the EPA team on their efforts to produce such a document in a timeframe that meets all that is required of EPA. The comments offered by the peer review panel are mea nt to assist EPA in its efforts to develop new or revised criteria that are grounded in science and can be implemented in order to protect public health while meeting all requirements of the Clean Water Act.



### 1. Does the document adequately present the logic a nd scientific support behind its conclusions?

Conclusion 1: Coastal-derived criteria can be extended to inl and waters

This seems to be the most significant change proposed in the RWQC (since the qPCR method will not be a requirement). If epidemiologic data were available to s uggest that coastal-derived criteria afford swimmers a similar level of protection in inland waters , justifying this change would be simple. Data regarding the health risks of swimming in inland waters a re very limited; the most relevant published information probably comes from Marion et al., 2010 and the Keys tone Lake, OK study (conducted by EPA more than 30 years ago). Given that this extension of RWQC to inland waters represents a change from the prior application of AWQC to Great Lakes/coastal wa ters, the reason(s) for this change should be clear and compelling.

The Draft RWQC provides a justification for this change t hat includes a discussion of indicators, pathogens, sources, and cites several published studies, EPA r eports, and other reports. This approached should be revised, as it did not seem particularly compell ing, and some portions of the text did not seem to be consistent with other portions of the draft RWQC.Samuel Dorevitch

C-6

Some specifics:

The EPA 2010 (g) report on the applicability of the Great La kes NEEAR data to inland waters does not include a “conclusion” and the “Executive Summary” does not incl ude an assessment of whether or to what degree NEEAR data could be applied to inland waters. Given the many differences between inland and Great Lakes/coastal waters summarized in that re port, it’s not clear what serves as the basis of EPA’s determination (in the AWQC document lines 1307-1308) that the 2012 AW QC would be applicable to inland waters. Appendix C.4, however does include conclusions. A mong these is that “Sufficient data do not exist to extended NEEAR epidemiology findings to non-POTW i mpacted inland waters.” This is not consistent with the draft 2012 AWQC, which does not appear to differentiate between inland waters impacted vs. not impacted by POTW sources.

The discussion of indicators, and whether site-specific c haracteristics are better predictors of fecal indicator bacteria (FIB) densities than is the distinc tion between inland vs. coastal locations is a bit beside the point. Indicator bacteria have been established as cri teria pollutants and specific criteria values have been established based on EPA’s epidemiologic studies. Thus, E. coli and enterococci are direct indicators of health risk, rather than indicators of pat hogen presence or density. Thus, the efforts to justify extension of RWQC to inland waters need not (and given the limited and inconsistent relationship described in the RWQC probably should not) be included. Likewi se discussion of FIB persistence need not be presented, as the criteria indicators and criteri a values of those indicators have been established directly from studies of health risk.

Instead of the “site specific differences are more impor tant than inland vs. coastal differences” argument, EPA may wish to put forward one or more of the following ra tionales for extending the criteria to inland waters. These are:

A) The WERF Inland Water Workshop report and the subsequen t “Meeting Report” publication suggest that the criteria should protect public health by preventing sporadic disease. Thus, the use of FIB as criteria pollutants in inland waters should useful in making “recreation in and on the water” less risky at inland settings.

B) The “Meeting Report” (not listed in the reference s, Dorevitch et al., 2010) notes that outbreaks of severe recreational waterborne disease have been reporte d almost entirely in inland waters, perhaps because of limited dilution capacity of receiving waters and proximity of recreation (and exposure) to fecal sources. Thus there is a need for public health prot ections in such settings. Although epidemiologic studies have not addressed outbreak prevention through FIB mon itoring, it seems prudent to use FIB monitoring as way of reducing the occurrence of outbreaks of severe illness, as well as the sporadic cases of illness that occur among coastal swimmers.

C) Millions of people per year use inland waters for recr eation – see “Outdoor Recreation for21 st Century America, 2004, Cordell et al., Venture Publishing, State Col lege PA.

Perhaps a better formulation would be to revise the lang uage used in draft 2012 RWQC, lines 1449-1451 to: “The application by States of the AWQC to inland wat er would be expected to improve public healthSamuel Dorevitch

C-7 protection to the millions of people who use inland waters, w here, unlike coastal waters, numerous outbreaks of severe illness have been reported.”

Given the impact of the potential extension of RWQC to inl and waters on the regulated community, EPA may wish to address potential criticisms of this change. These include:

The WERF report raised the possibility of the criteria could be overprotective (i.e., a given level of a fecal indicator may imply a lesser degree of health risk in inland waters). Second, it is not known if the application of NEEAR-derived criteria would in fact prevent outbreaks of severe disease as these are (fortunately) rare events, which makes it very difficult s tudy the impact of an FIB monitoring program on rates of severe disease (or outbreaks) in inland waters. Finally, particularly if enterococci are used as a criteria pollutant, many inland waters without obvious anthr opogenic sources may abruptly be “listed” for 303(d) purposes. Clearly the options prevented in Section 5 are intended for this purpose, and having options is reasonable.

Some information presented that is considered to be support for the extension of RWQC to inland waters is speculative. An example:

EPA concluded (lines 1214-1216) that differences in FIB survival “could be different in different waters, but those differences could be due to site-specific cha racteristics and not because of fundamental differences between coastal and non-coastal waters.” Th at survival “could be different” and the differences “could be” due to factors other than the co astal/non-coastal distinction is quite different from demonstrating that there is no difference in survival in re lation to waterbody type. Even if that were the cases, it’s still a leap to conclude that indicator-healt h risk relationships would be the same in inland vs. other coastal water. As noted previously, the state of t he science may better support removing from this section all discussion of FIB survival (and indicator-pathogen relationships).

If the discussion of indicator-pathogen relationships is not mo ved to the QMRA section, the RWQC could be updated regarding the conclusion that the co-occurrence or correlation between FIB and pathogens is neither predictable nor consistent is very different than c oncluding that there is no difference in those relationships in coastal and inland waters. First, cor relations between FIB and protozoan pathogens have been described in several studies with some consistency ( Dorevitch 2011, which was cited elsewhere within the RWQC). Furthermore, the literature review in that paper makes clear that the relationship between FIB and protozoa does depend on whether the waters are heavily impacted by wastewater or not. Thus, at least in the case of Giardia and Cryptosporidium , there are fairly consistent/predictable relationships with FIB, particularly in waters not domin ated by wastewater.

Conclusion 2: Optional qPCR criteria will be the same in fr eshwater and marine water

Wade et al., 2010 noted (discussion section) that associati ons were stronger between Enterococcus CCE and GI illness than at NEEAR freshwater beaches than at NEEAR marine beaches, consistent with the Dufour/Cabelli studies of FIB measured by culture. Overlap of the confidence intervals in the NEEAR qPCR marine and freshwater curves are noted in the 2011 paper. However the finding reported in the RWQC (line 716) is unpublished and – because of the policy implic ations - should be the subject of peer review, particularly because this reflects a change from t he way EPA interpreted findings of theSamuel Dorevitch

C-8

Dufour/Cabelli studies. If such peer reviewed publication is not available in time, the RWQC should describe the methods and findings of the analyses in detail

.
Conclusion 3: No need to change the FIB criteria, in fresh or marine waters, measured by culture

See discussion below on “Charge Question 3”

In general, it may be helpful to the readers of the RWQC i f EPA distinguishes in an executive summary which elements of the 2012 RWQC are found in the 1986 AWQC (i. e., they haven’t changed) and which elements are new or different. Elements that have not ch anged need little if any discussion, while changes do. This approach should result in less discussion of how the 1986 criteria were developed, including the culture methods, criteria pollutants and criteria values f or fresh and marine water.

Conclusion 4: No need to develop source-specific criteria

The discussion makes clear that the evidence is insuffici ent to change from the 1986 precedent of not differentiating among sources. Again, since this is not a c hange, the amount of discussion could be reduced.

Conclusion 5: The translation of HCGI to NGI and the fact or of 4.5 (HCGI 8/1000 ~ NGI 36/1000)

This is reasonable and supported by the text.

Conclusion 6: The development of the qPCR threshold of 475 CCE (pa ges 28-29)

See “Charge question 3” regarding EPA’s efforts to demon strate that the level of protection afforded by qPCR is comparable (in terms of cases per illness expect ed at the threshold value of enterococci CCE) to that at the culture-based criteria value. Consider creat ing a subheading (something like “3.3 The development of criteria values for enterococci by qPCR” ) for this section.

I’m not sure what is meant by lines 993-998. If this materi al is to be retained in the RWQC, describe the methods of each of the “additional analyses that were no t used directly”, what were the results of those methods, and what were the limitations and interpretati on of those results. What does it mean that the additional results “support the underlying basis” (line 994) of t he approach to deriving the number 475 CCE/100mL? The Wymer translation is not “support” for the num ber 475; it’s part of the methods used in calculating that number.

Conclusion 7: The development of criteria using the study populat ion overall, rather than potentially “sensitive subgroups” (section 3.3)

Consider renaming Section 3.3 “Potentially sensitive subgr oups”

The Parkin 2003 reference (line 1057) does not establish what the citation suggests: that immune system of children can leave them vulnerable to the effects of envi ronmental agents. The paper presents a modeling approach to water management, in which it is assum ed that children are sensitive, to assess the impact of that assumption on model outputs. It would be circula r to think of this as evidence of theSamuel Dorevitch

C-9 vulnerability of children. An n alternative is to cite some of the primary literature noted in Parkin , namel y Kee 1994 and D’Allesio 1981. However, those studies do not demonstra te (nor were they designed to evaluate) whether, for a given level of indicator bacteria, children are more likely than adults to develop HCGI (or NGI). Best to leave this out and discuss, based on NEEAR data, whether or not the microbehealth risk association (slope) is different for adults and children.

Lines 1049-1052 seems to conflict with 1064-1075. Suggest: delete lines 1049 -1052 and introduce the rest of that paragraph with a sentence saying something like “There are two reasons to be concerned that for a given level of indicator bacteria in recreational w ater children would be more likely than adults to develop gastrointestinal illness.” Then note: 1) a suggestion of greater water ingestion during swimming (Dufour 2006) and 2) the observation from the NEEAR study that c hildren spend more time in the water. Despite the theoretical reasons which suggest children migh t be at increased risk, the NEEAR study did not find this to be the case. First, in the analyses that used microbe density as a continuous variable (fresh and marine), it lacked power to identify subtle differences between adults and children. Second, indicator density dichotomized at 33 CFU/100mL seems to have been a compa rable predictor for adults and kids in freshwater (Wade 2008 Table 6).. It would be very informative if the statistical significance of interaction terms (child/adult * microbe level) or (child/adult * above/below threshold) were reported.

Lines 1095-1096: The above information does not indicate that childre n are more susceptible. The above information suggests that despite theoretical concerns about ingestion rates, duration of recreation and perhaps naïve immune systems, the epidemiologic data do not suppo rt (given sample size) differences in risk between adults and children. Consider deleting this paragraph.

Consider moving paragraph lines 1027-1037 to just prior to the parag raph that begins on line 1109. As currently organized, the discussion of over-representation of children in NEEAR enrollment is broken up by the discussion of NEEAR results regarding children vs. adults.

Lines 1112-1113: I’m not sure what is meant by “in a robust manner .” Consider revising the final two sentences of this paragraph to “In the NEEAR study, child ren are over-represented (compared to the general population) and therefore have a disproportionally la rge influence on the overall relationship between microbe density and health risk derived from NEEAR study data.”

Lines 1116-1130: This is a very important point and could be emp hasized better as its own section, perhaps something like “Disease prevention through rapid notifi cation.” As noted under “Charge Question 5” below, it would important for the public and s takeholders to know that the 2012 RWQC provide for the first time, guidance to afford the public the benefits of same-day notification.

Conclusion 8: qPCR methods for monitoring recreational waters are optional

This is a surprise, and a disappointment, as the NEEAR study suggests that public health protections could be improved at Great Lake settings through the use of qPCR monitoring. The method can provide same-day results – a huge advance toward protecting the public form gastrointestinal illness using priorday measures of water quality to predict health outcomes. Furthermore, the NEEAR study demonstrated the superiority of same-day qPCR measures to culture measur es as predictors of NGI.Samuel Dorevitch

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Page 44 of the draft RWQC notes that Method A can be used as a site-specific alternative, pending the release of the “topic-specific guidance.” For inland wat ers several reasons were proposed in Appendix B.6 to suggest that inland waters may have different qPCR- health risk relationships than Great Lakes/coastal waters. For that reason it seems that such sites would need evaluations of method performance. However, given the vast amount of health and q PCR data collected at Great Lakes sites (and to a lesser degree, from marine sites), there seems to be enough data to apply the NEEAR results (and the 475/1,207 CCE/100mL criteria values) to Great Lakes/coastal w aters. Any “site specific performance characterization” (line 1617) would not include the collection of health data, which NEEAR did collect, it’s hard to see how such characterization of method perf ormance will provide better qPCR-health data than did the NEEAR study. It not realistic to expect th at the NEEAR study could have been conducted at a wide range of combinations of waterbody type and pollutant sour ce. When establishing the 1986 criteria, data from a limited number of sites were use d, even though not all water types had been studied. The same could be done for (mandatory) qPCR criteria.

The term “site-specific performance characterization” should be clarified. The intent may be to evaluate qPCR inhibition and to support the development of a site-sp ecific plan for addressing inhibition (such as dilution or some sort of sample processing). However, it sho uld be clear that the performance being characterized is not the relationship between qPCR results and health risk, whic h has been done in several types of settings by the NEEAR study.

Conclusion 9: Statistical threshold values will be used r ather than single-sample maximum values.

This change is an improvement of the 1986 AWQC. The term “maxi mum” implies a value never to be exceeded, while it is expected that about 25% of individual m easures will exceed the STV. This change should be beneficial to beach manager in the efforts to communicate the meaning of an exceedance.

The RWQC could be improved by explaining the basis for sam pling required for calculating a geometric mean. Ideally, the variability in water quality should b e known before estimating the number of samples required to calculate a GM. Furthermore, by choosing to s ample only on days for which relatively low values of indicator bacteria are expected (no rain for s everal days, perhaps in the afternoon of day with much sunlight, the calculated GM could be lower than if sa mples were collected at random or on a fixed schedule (i.e., every Friday, Saturday, Sunday, and holi day). Provisions to prevent selection of sampling days based on expected low values would improve the public healt h protection of the criteria.

Conclusion 10: Section 5.2.2: Flexibility available to states

The draft RWQC offers states two types of tools: Thos e not part of state water quality standards but which may enhance assessment/management/notification, and those that are designed to develop alternative water quality criteria. That QMRA (section 5.2.2) has been categorized as a pathway to alternative criteria rather than as an assessment/man agement tool requires evidence-based justification.

Unlike another innovative aspect of the RWQC – the use of qPC R – very little is known about how well QMRA would actually protect swimmers from GI illness. T hrough the painstaking efforts of EPA/the NEEAR study team, we now can say quite a lot about how qPCR should (and should not) be done, and more importantly, how well qPCR methods can be used to pre dict health risk and provide timelySamuel Dorevitch

C-11 information to the public. By contrast, it is unknown how well QMRA predictions (model outputs) of health risk approximate observed (i.e., epi study) health risk s – we just know the model outputs. Furthermore, we don’t know how precise QMRA estimates of healt h risks really are, regardless of the confidence intervals provide by simulations. If a QMRA model estimate that a given degree of water quality is expected to result in 30 cases of NGI, that m ight mean somewhere between 5 and 75 cases, with 95% confidence. It’s very hard to know, given that QMRA models have not been validated against observational data of swimmers at beaches. The studies ci ted in the draft RWQC – Soller, Schoen and Ashbolt – are estimates of risk/illness that have not bee n confirmed through observational studies. Although EPA had hoped to have a QMRA conducted in parallel with one of the NEEAR sites, apparently no comparisons have been reported. Many assumptio ns of QMRA – notable dose-response – are very uncertain, having been based on very little data . Thus, although the theory behind QMRA is sound, the 5.2.2 provision is unvalidated. QMRA should inste ad be considered a method for evaluating management options – which would provide estimates of relative risk,, rather than the absolute measures of risk which would be required for any method that wou ld be an alternative to an epidemiologic study.

The Inland Waters Workshop (Appendix B.6) report and the subseq uent Meeting Report note that QMRA methods require “grounding” (validation against observationa l data). If any validation has been done since the Workshop, this should be reported in the RWQC. Be cause the application of QMRA could allow localities/states to potentially produce lower sit e-specific/region-specific standards, it is important to know with confidence that the health of the public is not being compromised (and that undue burdens are not placed on regulated entities.

Lines 1905-1907 (if non-human sources predominate) and lines 1432-1436: If t he data are insufficient to propose national criteria for waterbodies impacted by non-hum an sources, are the data sufficient to support the development of site-specific standards for such waterbodies?

Conclusion 10: Section 5.2.3: Alternate criteria

The concept here is very good, in particular the emphasis on e stablishing a relationship between new methods and existing methods at the criterion density.

Since Wade et al., 2008 demonstrated that at Great Lakes beaches the qPCR method of measuring enterococci performed better than the culture method in pre dicting NGI, why not specify that equivalency should be demonstrated between the new method and best avail able approved method (i.e., enterococci qPCR)?

Lines 2026-2027 note “that a consistent and predictable relati onship “should exist between established and new methods. Furthermore the whether the new or establis hed methods would be used “beach notification and attainment decisions....would be similar” (li nes 2028-2029). In order to reduce confusion down the road, spelling out, it would be helpful to explicitl y state what is meant by “consistent” “predictable” and “similar”. A 2x2 table could be constructed with rows “new method” and “established method” and columns, “exceeds criteria value” vs “does n ot exceed criteria value.” Does it mean a chi square p-value of p<0.05 even if the new method misses some per cent of exceedances? If EPA were to specify the sensitivity and/or positive predictive value i t would be clear what states/municipalities must demonstrate. Furthermore, how much data is needed? Perhaps a s eason (Memorial Day-Labor Day) ofSamuel Dorevitch

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5x/week measurements or some other general specification, othe rwise, a “consistent, predictable relationship” could be claimed based on a much smaller s et of observations.

Last, the RWQC notes that this approach could be used t o establish “regional or state-wide alternate criteria” (line 1993). If this is the case, again EPA shou ld specify that the data collected to establish the equivalence of an alternate criteria must match the s cale of data presented. In other words, data from one beach can’t establish state-wide criteria, and state-w ide data can’t establish regional criteria, etc.

Other aspects of Charge question 1:

Some specifics are noted in response to other charge que stions. Otherwise, no significant issues regarding transparency, shortfalls, uncertainties, suggestions for improving the document.



### 2. Are you aware of any important peer reviewed lit erature or applicable data that have not been incorporated in this document and should b e included?

Waterbody type (pages 33-36): See charge question 1.

Support for idea that recreational criteria applied to inl and waters should be protective: Inland Water Meeting report: Dorevitch, Ashbolt et al., 2010.

Millions of people use inland waters for recreation:

Cordell, H.K., Betz, C.J., Green, G.T., Mou, S., Leew orthy, V.R., Wiley, P.C., Barry, J.J., Hellerstein, D., 2004. Outdoor Recreation for 21st Century America: A Report t o the Nation: The National

Survey on Recreation and the Environment. Venture Publishing, Inc. , State College, PA.

Heaney 2009: Suggests that a substantial portion of illness am ong swimmers enrolled in the NEEAR study may be due to sand exposure. This is significant, i n that it means that some of the illness incidence among NEEAR study swimmers may be due to sand, rather tha n to water exposure and water quality. If this study is not addressed in the RWQC, it’s possible tha t it could be considered by others to be an oversight that falsely inflated the importance of beach water quality on health risk (“the problem isn’t the water, it’s the sand.”) The study should be acknowledged, along with the fact that the NEEAR freshwater (Wade 2009) and marine study (Wade et al., 2011) did adjust for digging in the sand should be noted as well.

The basis for thinking that children would be at greate r risk than adults (lines 1052-1053): A citation that would be relevant here is Dufour et al., 2006.

Pratap et al., J Water and Health 2011: Even if extensive e fforts aimed at measuring FIB and identifying conditions of elevated risk are applied, disease will not be prevented if effective communications do not follow. Pratap et al. noted substantial variability among s tates/tribes/territories in their approaches toward notifying the public, which have not been systematically evalua ted for effectiveness. While not an element of identifying an indicator or establishing criteri a values, perhaps it could be noted (perhaps inSamuel Dorevitch

C-13 section 5.1 or in the general introduction to indicators in section 1.1) that indicator measurement is a critical, but not the only critical element, in a chain of steps that is intended to result in disease prevention

. Efforts to modify behavior (i.e., don’t go in the water whe n a notification/swim ban/beach closure or advisory is in effect).



### 3. Do the analyses comparing the NEEAR freshwater a nd marine culture-based indicator data aggregated by days of similar water quality corroborate that the NEEAR culture data are generally consistent with th e 1986 regression models?

It’s unclear why this issue is so prominently discussed in the draft AWQC. The document (Section 3.2.4) seems to frame the discussion of the 1986 numeric values vs. the NEEAR numeric values for indicators by culture as a “confirmation” of the 1986 numbers. The rati onale for the comparison is never made clear: lines 853-855 state that this was done “to provide a comparison” – but why?

Perhaps the intention is to establish that the qPCR res ults of the NEEAR study were developed in settings and with participants that generated a similar culture-he alth risk relationship as the Cabelli/Dufour studies. If this is the case, that should be made clear . However, the methods used to make this point are poor substitutes for analyzing both data sets (Cabelli/Duf our and NEEAR) using the NEEAR approach (which addresses individual-level confounders). Support for the comparability of the Cabelli/Dofour studies and the NEEAR study can be found in Table 6 of Wa de et al., 2008 and Table 6 of Wade et al., 2010. This information (or these tables) could be presented in the RWQC in support of utility of the 1986 criteria values for enterococci; for justification of the continued use of those criteria values; and for demonstrating some comparability of findings of the NEEAR and Cabelli/Dufour studies.

If EPA were to nevertheless decide to include the re-analysi s of NEEAR data using the 1986 approach:

I have significant concerns with the interpretation of Figur e 1 (page 26) provided in lines 897-899. To say that the plotted datapoints from the NEEAR study are “gener ally fell within the predicted range” of the earlier studies is somewhat deceptive. The datapoints from the NEEAR study, particularly the freshwater (Figure 1a) study, suggest a relationship that is inverse (a line from about 20/1,000 swimmers on the Y axis through log10 entero=2 /100mL on the x-axis and that provides s ome fit for the NEEAR data). A less convincing case can be made for marine water (draw a line from about 5/1,000 swimmers on the Y axis and log10 entero=2). NEEAR results are “in the predicted ra nge” but are inverse, suggesting that the NEEAR results are NOT consistent with the Cabelli/Dufour results. The use of data this aggregated, essentially ecologic, is problematic because of the ecologic fallacy: that the individuals who got sick at beaches with a seasonal average of “good water quality” wer e swimming in water with good water quality – perhaps those who got sick used the beach on days of poor water quality. It may be best to avoid presenting this analysis. If it does remain in the RWQC, the statement (lines 898-899) that “the NEEAR health and water quality data are consistent with those statistical models” must be deleted, though the following sentence “this analysis proved to be insufficien t” – should be retained. As it stands, it’s problematic that the approach is insufficient yet a conclus ion has been drawn.

The “binning” approach is certainly better than the “beach s eason” ecologic approach. The binning approach, however, does not produce results that, as noted in lines 921-924 corroborate “the previousSamuel Dorevitch

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conclusion that the NEEAR data were generally consistent w ith the 1986 regression models.” Again, like Figure 1, it is not especially meaningful that the datapoin ts fall “within the range” of the 1986 datapoints. If both the 1986 and the NEEAR data had similar slopes the findings would support what EPA wants to say. However, the 1986 data do suggest a significant positive sl ope for both freshwater and marine water while there does not appear to be a slope in the NEEAR data. Likewise, Table 2 does not suggest withinbeach trends. Were tests for trend done on those results? E ither way, the 1986 method did not adjust for confounders as the NEEAR study did. It is possible that asso ciations observed in the Cabelli/Dufour studies would be different if adjustment were made for r ecent exposures, digging in sand, etc.

The discussion on page 28 and Figure 3, again, are problematic . Was a test of statistical significance done for the slopes of the NEEAR marine and freshwater regress ion lines? I suspect that such slopes may not be statistically significant, given the wide confidence inte rvals around the slope and the limited number of datapoints for a relatively small slopes (the freshwate r slope is almost 0).

Additionally, the statement (lines 947-948) that “...the recommend ed RWQC values are similarly protective of public health in both marine and freshwaters” is based on an assumption that the slopes and intercepts of the freshwater and marine indicator-HCGI re lationships are similar. Since there seems to be no slope to the freshwater line, and perhaps no statistica lly significant slope to the marine line, this statement does not appear justified. Furthermore, the wide c onfidence intervals around the slope noted in association with the 1986 estimates of risk (line 943-947) seem to be quite wide here (Figure 3). If there really is not slope, water quality measures are not neede d to estimate the level of risk, which simply would be the mean level of risk at all levels of water qu ality.

One of the intended purposes of this section may be to identi fy a comparable level of target risk for establishing qPCR criteria. If this is the case, the sec tion should be re-written to make that clear.

It may be worth emphasizing that:

1. Analysis of the NEEAR culture data by the methods used to establish the 1986 criteria show comparability of the culture data-health risk association i n the NEEAR and the Cabelli/Dufour studies (at least when assessed using the dichotomous “FIB above the th resholds of 33 and 35 CFU/100mL) (see above-noted reference to Table 6 of Wade et al., 2008 an d Wade et al., 2010.

2. Presenting the relationships of enterococci CFU vs. hea lth risk generated from the NEEAR study using the same approach to multivariate modeling that was do ne for qPCR would be better than using the 1986 approaches. If that relationship is weak, potential re sponses to that observation include:

3. Conclude that the qPCR models are better predictors of i llness and therefore the method should be mandatory, rather than optional. Enterococci CCE crite ria values should be those associated with a targeted level of risk of 8/1,000, same as the 1986 freshwater c riteria. The need for harmonizing the targeted risk levels has been emphasized many times previ ously (Airlie workshop, Boehm 2009). The use of the more protective target (freshwater rather than marine water) would be preferred from a public health standpoint.Samuel Dorevitch

C-15 a. Present data similar to that found in Figures 1-2 of Wade et al., 2008 and Figure 2 (right panel) of Wade et al., 2010. If in fact the slopes of these lines ar e similar in marine and freshwater, and if the slopes are similar for adults and children, the inf ormation can be combined into a single graph. A enterococci CCE criteria value providing the same level of protection as the culture values can then be selected by using 8 cases of AGI (or the NGI equivalent)/1,000.

b. Given the limited precision of expected risk for given microbe density (the wide confidence intervals and the small slope, the relationship between e nterococci CCE and NGI may be too weak to reasonably differentiate qPCR CCE values to tha t are associated with, for example, 8 or 10 or 12 or 14 cases /1,000. This would suggest that the sel ection of a single targeted risk level cannot be supported. In this case, ordinal categories may be more appropriate. This could take the form of the CCE values corresponding to risk of <8 cases/1,000 c ould be considered “green”; 8 to (arbitrarily) 12 could be considered “yellow” and >12 could be considered “red” (as examples). The use of graded categories defined by ordinal ranges of risk is probably a better reflection of the science (i.e., the limited precision in predictions o f health risk based on microbe density or vice versa) than the use of discrete categories dichotomized by an imprecise estimate water quality for a given level of targeted risk.



### 4. Do the characterization and exploration of the q PCR method reflect that of the scientific literature? If not, what additional info rmation should be included? Is the derivation of the qPCR value using the EPA data sci entifically supported and adequately explained? Please discuss why or why not

.

Given that the qPCR laboratory and calculation methods ut ilized in the NEEAR study were the ones that established the enterococci CCE-NGI risk association, I would be reluctant to see that method revised. Revisions to the calculation approach of NEEAR study water q uality data that were found to improve health predictions within the NEEAR dataset would be valua ble. Revised laboratory methods in isolation would be difficult to assess in relation to health out come prediction.



### 5. Please provide any other general or specific com ments on the document, making sure to identify the section number/page number you are commenting on.

Some suggestions for organization of the document.
- Start with an executive summary that highlights:

- The CWA and the background for reviewing/revising AWQC/RWQ C - NEEAR study (# beaches, participants, years) - What stays the same (no changes to culture method criter ia values) - What changes are proposed One huge change: inland waters, One small change: the option for data collection to support future use of qPCR The Section 5 provisions

- How the 2012 RWQC can improve public health (rapid notification, more waters now covered/protected).Samuel Dorevitch

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Has EPA estimated the number (or percent) of days of beach use that, following application of rapid methods, will be appropriately closed when prior day cultur e methods would leave the beach inappropriately open (or without an advisory/notification)?

Has EPA estimated to number or inland water recreato rs (or person-days of recreation) that for the first time, fall under the protection of the RWQC?

Miscellaneous comments/edits/corrections

Lines 309-310: Consider revising “State of the science review on occurrence and cross-infectivity of specific pathogens associated with animals.” To “State of the science review on the occurrence and human health risks of specific waterborne zoonotic pathogens.”

Lines 342-343: Consider revising “... considered all of the indicators of fecal contamination...” t o “...considered indicators of fecal contamination” or better still, “...considered indicators of health risk...”

Line 358: Consider revising “These particular FIB are not pathoge nic...” to “These particular FIB are generally not pathogenic...” (since some E. coli are pathogenic).

Line 359: Again, the previously noted suggestion that over-emp hasizing FIB as pathogen indicators rather than health risk indicators, given that the document els ewhere notes that FIB are poor indicators of pathogen presence.

Lines 366-373: Text is confusing. Consider first explaining that th e membrane filtration method generates CFU/volume while the defined substrate method generates MPN/vo lume. The defined substrate method does not involve counting colonies, but rather relies upon probabiliti es. Neither method includes counting of microbes in a water sample, but rather, generate res ults following culturing those microbes for 18-24 hours.

Line 383: Change viable to “culturable” as bacteria in the VBNC (viable but not culturable) state would not be counted using culture methods.

Line 390: Consider changing “methods in water” to “methods in a specific waterbody or beach”

Line 401: Suggest that there’s an qPCR more recently develop ed (? since Method A was published?). Consider deleting the word “more.”

Line 418: Change both uses of “incidences” to “instances”

Line 419-422: This isn’t definite. Chern 2011 suggests that the SPC and target DNA have similar amplification efficiencies.

Lines 440-447: Why not refer to this as the ddCT approach?Samuel Dorevitch

C-17 Lines 471, 487: FIB “occurrence” sounds like FIB “presence.” Si nce FIB are essentially always present, albeit sometimes in low concentration/density, “occurrence of FIB” isn’t informative. Consider changing to “density” or “concentration.”

Line 517: For the sake of completeness could add that the 1986 differed for marine and freshwater in part because of the different levels of “acceptable risk.”

Line 578: Consider revising “actual increase in the burden of il lness swimmers experience” to “actual increase in the incidence of illness among swimmers” (as “burden” is more general and could refer both to the incidence rate and the severity of illness).

Line 596: consider changing “an eye infection” to “a self-repo rted eye infection”. Similarly, Line 598: consider changing “wound that became infected” to “wound th at was reported to have become infected” In both cases, it may not be clear that “infection” wa s based on self-report, rather than diagnosis by a physician or other health care provider.

Lines 600-610: Not really. It would be true that that a larg er percent of epi study participants experiences GI illness than other health outcomes. However, that’s no r eason to assume that preventing GI illness would also prevent non-GI illness. It might, but “a similar level of protection” implies that a similar proportion of GI and non-GI illnesses would be prevented. We don’t know if that’s true. It might be better to state that NEEAR and previous epi studies found that the health outcome with the highest incidence was GI illness. Preventing GI illness may or may not res ult in a comparable reduction in health outcomes, but it will prevent the most type of recreational waterborne illness.

Line 635-626: Consider revising to “...RWQC because neither possible r elationships between these microbes and FIB, nor relationships between FIB and thes e health outcomes, have been the subject of observational studies.”

Line 651: Change “incidences” to “incidence”

Line 670-671: Revise “time issues” to “short-term (hours) var iability”

Line 689: Suggest changing “particular sensitive subpopulations” to eit her “potentially sensitive subpopulations” or “particular subpopulations” (since in the end, the re wasn’t sufficient evidence to support that assumption that children are in fact “sensit ive”

Lines 715-716: change “rate of increase in risk per unit incr ease in enterococci” to “change in risk per unit change in enterococci”. Also: This analysis (p=0.44) is unpublished but has substantial policy implications. Consider elaborating on the source of this i nfo and if possible, the status of the EPA report or the publication status (submitted, in revision, etc).

Lines 739-741: As written this suggests that Wade 2010 evaluated the use of Bacteroidales in marine and freshwater and found that indicator to be associated wit h GI illness in marine waters only. Because Wade 2010 only addressed marine waters, better to revise as “GI illness in swimmers at marine waters was alsoSamuel Dorevitch

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associated with exposure to levels of anaerobic bacteria of the order Bacteroidales enumerated with EPA’s Bacteroidales qPCR method (Wade 2010).”

Lines 764-767: The very low indicator levels is likely an impor tant (perhaps the most important) reason for the absence of a relationship between FIB and health at both Boqueron and Surfside. This information, rather than inhibition (which would not impact the enteroc occi culture data) should be noted.

Lines 790-795: The end of this section states that E. coli levels “correlated with HCGI in a similar manner as in EPA’s 1970s” studies. First, the Ohio reservoir study reported an association with GI symptoms but not with HCGI. Second, the term “correlation” is used in s everal places in the RWQC to mean “association” or “statistically significant relationshi p”. This is one such example. The Ohio study reported the results of a multivariate regression, not a correla tion analysis.

Lines 810-813: Please justify that statement that a limitat ion of the RCTs is smaller sample size. From a practical standpoint, it’s actually an advantage that smaller sampler sizes are needed. The reason sample sizes can be smaller is that randomization should generate 2 groups (exposed and unexposed) that are similar in all ways other than the exposure. Because the observational designs do not randomize, much larger sample sizes are needed to adjust for confounders. I t could be noted instead that the most significant limitation of the RCTs is that participants w ho are randomized to “exposure” have been asked to immerse their head in water 3 times over a short durat ion (10 minutes). This is not swimming. It may result in rates of water ingestion that are greater or less than swimming, but it is not swimming. There is an assumption that the risks of GI illness in the RCTs a re the risks associated with swimming; they are the risks associated with head immersion.

Line 832: Change “swimmers” to “those randomized to head imme rsion.”

Related: Lines 1275-1294 refer to Epibathe. This was a series o f studies that evaluated the health risks of controlled exposure (head immersion), not swimming. Any conclus ions about the relevance of Epibathe to EPA criteria development should note that Epibathe did not evaluate the health risks of swimming, but rather, head immersion (3 times).C-19 

### Erin K. Lipp

Associate Professor Department of Environmental Health Science

College of Public Health The University of Georgia Athens, GAC-20

Erin Lipp is an associate professor in the Department of Environmental Health Science at the University of Georgia, where she is also the department Gra duate Coordinator and Director of the Georgia Oceans and Health Initiative. Her research focus is the ecology of human pathogens in ambient waters and the role of environmental exposures in disease transmission. Her research incorporates molecular biology, microbial ecology, epidemiol ogy and climate research to better understand the fate of bacteria and viruses introduced from wastewater to aquatic environments and their potential for transmission to humans and ot her hosts. She has been an invited participant and report author for a variety of workshops r elated to waterborne disease, marine water quality and climate change effects on health.Erin K. Lipp

C-21 

### Peer Review of the Recreational Water Quality Criteria (RWQC)

Comments Submitted by Erin K. Lipp

Introductory Comments

In general, this document represents an extraordinary amou nt of work conducted by the EPA to revise the national water quality criteria. The authors have manage d to synthesize a broad collection of results and provide analyses that support their recommendations. This was not an easy task and the document represents a critical body of work. The comments provided he re are meant to strengthen the document, increase clarity and provide more transparency in how the revision of the RWQC was developed.



### 1. Does the document adequately present the logic a nd scientific support behind its conclusions? Please comment on the document’s trans parency, the completeness of the presentations, and any shortfalls in the material p resented. Are uncertainties for technical conclusions transparent? Do you have any suggestions on how we could improve this document? Please explain your response s.

In all this was a thorough and well laid presentation of the justification for the recreational water quality criterion. The authors provide a well-organized framework to understand the justification and implementation of the RWQC and provide a much needed section on how States can proceed with their own alternate criteria. More emphasis, however, should be focused on the new criterion and not the history of the current AWQC. It would also be helpful (f rom a structural/organizational perspective) to better cross reference specific appendices in the documen t rather than broad groups (e.g., appendix A.2 rather than appendix A, etc.). The addition of an executive sum mary would also improve the document.

While the uncertainties for the technical conclusions are provided, limitations in applying this criterion to “all” water bodies should be better acknowledged. The RWQC is meant to be for all water bodies in the US but the data that EPA presents does not support this call . Namely, the RWQC appear to be robust for temperate POTW-impacted marine and freshwater coastal areas, with possible application to POTWimpacted inland waters; however, there are no compelling dat a that support its use in tropical (or subtropical) waters or in non-POTW impacted waters (coast al or inland). As a general note I was struck that to date all NEEAR studies at marine beaches were c onducted in embayments or estuaries (with the exception of Surfside, SC), that were relatively quiesce nt. This may not be a good representation of the bulk of marine beaches, which tend to be open water beaches and is a limitation of the sites selected for the health effects assessments. This should be better acknowledged and information presented on site selection. Such information would help states/locales judge whether they should look at their own site specific assessments for other types of beaches.

The use of predictive models and the great amount of work th at has gone into developing an easy to adapt format (e.g., Virtual Beach) is to be commended. The abil ity to use pre-emptive strategies to protect public health should be a goal for all beach managers. While Virtual Beach works quite well for Great Lakes Beaches, its performance for marine beaches was no t impressive (which may be have beenErin K. Lipp

C-22

exacerbated by the few days of exceedance for the beaches te sted). This should be clarified in the document.

While the final criterion uses culturable E. coli, culturable enterococci and qPCR enterococci (CCE)for freshwater and culturable enterococci and qPCR enterococci (CCE) for marine water, there was significant effort put into the confirmation and validation of the qPCR for Bacteriodales it appears that this will not be used as a criterion. Is this one of the tools that States can suggest as an effective alternate indicator? If so, it may be helpful to state that explic itly somewhere. While the final RWQC will continue to rely on the same FIB criterion as suggested in 1986, the i mprovement in risk determination (and confirmation that risk levels are equivalent between fr esh and marine waters) is a great step forward as is the specific guidance on qPCR (even if is not a required element).

Another strength of this document is that it allows states to update and find alternatives for their specific areas. The technical support guidelines will need to be comple te to ensure good translation of information. While it is outside the scope of this documen t, states should be able to compete for grants to develop these site specific alternatives.

Some specific comments on logic and support for conclusions in this document:

Line 720. For clarification the reason that there is a focus in this analysis/review on temperate POTWimpacted beaches needs to be stated early (namely, tha t EPA dropped the epi studies from run-off impacted and tropical beaches because of lack of correlat ion between FIB measured and health effect end points)

Line 759-769 (see above statement about placement of this text). These studies were dropped because the results were inconclusive. Given the that the temperate POT W-impacted beaches all fit well into a single analysis it makes some sense to exclude these studies, but the fact that they did not fit the trends noted for the other studies should suggest that: 1) the current RWQC w ill not be adequate for these areas, 2) some other as yet untested FIB may be better suited for a s ingle FIB for all water bodies (although this scenario would require many more studies, time, effort and money) or that additional epi studies are warranted to better determine the applicability (or lack thereof) the sugges ted RWQC. While there is sufficient language to allow states to address this issue on their own , this seems like a potentially large problem that may need additional federal (EPA) assistance. [Line 784-788. Following up on the issue noted above, this review of studies also shows a paucity of epi studies focus ed in tropical areas. Additional work is clearly needed in this area.] To this end, a separate section on i ssues associated with tropical/subtropical waters may be warranted and should include studies completed in Hawaii on this issue.



### 2. Are you aware of any important peer reviewed lit erature or applicable data that have not been incorporated in this document and should b e included?

The authors have been thorough in their review of material s, especially when taken as a whole with all appendices.Erin K. Lipp

C-23 

### 3. Do the analyses comparing the NEEAR freshwater a nd marine culture-based indicator data aggregated by days of similar water quality corroborate that the NEEAR culture data are generally consistent with th e 1986 regression models?

When aggregated by days of similar water quality, the da ta do support consistency with the 1986 criteria; however, given the wide variability among data points the foll owing issues should be considered:

Line 897-899. In attempting to develop a quantitative mechanism to compare NEEAR data with the 1986 criteria based on culturable enterococci, different methods of data binning were used. This sentence refers to the results when the seasonal GM is taken for the se ven beaches used in the NEEAR study. The report states that the data points generally fell within the pre dicted range of the 1986 regressions. This is a rather optimistic view of these points (as shown in Figure 1). Fo r freshwater, the NEEAR data points (4) actually look to be negatively correlated with HCGI rate and no relationship is noted in marine water (3 data points). While they do technically fall within the con fidence intervals of the regression this is not a robust measure (which is also acknowledged in the report) esp ecially in light of the few data points. Binning by water quality levels provided a better point for com parison (as shown in next paragraph in the report).

Line 950. The trends lines for these data seem particularly weak, especially for freshwater beaches (which in previous figures seemed to have a stronger relationship than marine water). The data in general seem to show a very high degree of variability.

Line 961 - 968. Report states that results from marine and fres hwater studies are sufficiently similar to allow combining in the new criteria. I do wonder if they are sufficiently similar only because all of the data are so highly variable (there seems to be a large s pread); however the regression using the combined freshwater and marine data is stronger than when the wate r types are separated. The marine data points (alone) show an almost vertical regression line (appendix B.5) w here a very small change in CCE results in a large change in # GI/1000.

It is also not entirely clear why the NEARR data must be corroborated by 1986 analyses, given the difference in study design.



### 4. Do the characterization and explanation of the q PCR method reflect that of the scientific literature? If not, what additional info rmation should be included? Is the derivation of the qPCR value using the EPA data sci entifically supported and adequately explained? Please discuss why or why not

.

More data are needed to confirm the use of the qPCR (CCE) between labs and among many different water types. This work appears to be on-going but results ar e critical to fully assess the utility of this alternate indicator. Given the specific need for developing rapid methods to assess water quality (per BEACH Act and lawsuit) data are needed to provide states w ith specific recommendations about implementing this tool, along with resources for set up and training.Erin K. Lipp

C-24

Specific questions/issues are noted below:

Line 414-415 (and elsewhere). Given the variability in water t ypes both within and between beaches (over space and time), it might be expected that PCR failures (inhibition) will happen with some regularity. There needs to be specific guidance for how to handle these occurrences (especially where some beaches routinely face this problem).

Line 458-464. While qPCR methods (CCE) show excellent promise as a rapid tool for measuring water quality the limitations in validation of this method are c ause for some concern. More work is needed to provide guidance to states on how best to implement and tr ouble shoot this approach

Line 1116-1130. What happened to qPCR for Bacteroidales ? Will this be an option for states with marine beaches if they choose to adopt another target?

Line 1613. The guidelines for states on determining the performanc e characteristics of the rapid (qPCR) methods will be critical for successful implementation. Has any headway been made on drafting such a document?

Apppendix A.2 Single lab validation of EPA method A (qPCR for e nterococci)

• Variability in the copy number of the 23S rRNA gene between species and over the course of a growth cycle is a potential problem in correct quantific ation using this method. Currently, EPA is using a copy number of 4 (reported for E faecalis) as a reference point. Is any work anticipated to determine the broader range of copy numbers in other species (e.g., E faecium has 6 copies)? If so, and average copy number could be used for quantification.

• In this single lab validation, the recovery was very consist ent among samples in PBS but seems to have a fair amount of variation in both marine and fres hwater. Is EPA evaluating methods to improve recovery consistency?

• It will be helpful to see results from multilab validation

Appendix A.4. Parameters that affect performance of qPCR me thod for enterococci

• Study temperatures tested here are reflective of seasona l conditions in temperate areas, not tropical or subtropical (i.e., spring 15 – 17 C, summer 20 – 23 C, winter 4 – 8 C). In all seasons, these temperatures are cooler than would be expected in tropi cal/subtropical waters. Especially at the higher temperature scale (e.g., 30 C in the summer) may have a strong effect on persistence/decay of enterococci which could inform the use of this indicato r in warm (hot) tropical waters.

Appendix A.6. Suitability of indicators and methods for differ ent CWA programs

• The limit of detection information present in Table 2 is s omewhat confusing. For qPCR (CCE and CSE) an 50% limit of detection is used. This a term genera lly used for evaluation of presence/absence data, not quantifiable results. While the data are derived from Chern et al., 2009, it is not clear in the Chern paper how the 50% LOD was derived . In most studies, the actually LODErin K. Lipp

C-25 varies with processing parameters but in general a theoret ical limit of detection can be derived for an ‘optimal scenario.’ It is not clear why that approac h was not taken here (for both culture and qPCR methods)



### 5. Please provide any other general or specific com ments on the document, making sure to identify the section number/page number you are commenting on.

The text should discuss the notion that FIB are used in pract ice as indicators of health risk and not specifically correlates of pathogens. There are many papers showing no correlation between FIB and enteric viruses, or other pathogens. However, understanding the relationship of FIBs to pathogens will become more important if using a QMRA approach. This topic would be best discussed in the QMRA section.

Line 675. The summer season focus makes sense for temperat e waters but in tropical waters, where beaches are used year round, epi studies done at other seasons m ay be important. While it is speculative, high water temperatures and UV irradiation during the sum mer tropical beach epi study might help to explain the very low numbers of FIB observed.

Line 1064. It should be made clear that this statement is referring only to freshwater studies.

Line 1135. The first line of this paragraph states that this RWQC are national recommendations for all surface waters in the US, but data reported here and in t he appendix does not support this. Ongoing questions remain about the use of this criterion for non-POT W impacted beaches and inland waters and tropical waters. This should be acknowledged and special consi derations given for these areas in section 5 (for implementing site specific criteria).

Line 1189-1191. Report states that based on the review of liter ature and the overall site to site variability of FIB concentrations that the RWQC will be applicable t o both coastal and non coastal sites. But, this is in contrast to the EPA study (appendix C.4) that states th at epidemiological studies to date do NOT support extending these criteria to inland waters NOT impacte d by POTW discharge.

Line 1307. This statement is not consistent with findings repo rted in Appendix C.4 (see above comment on same issue)

Line 1428. While based on QMRA (Appendix C.3) and other studies, i nputs from animal feces can result in similar risks as human fecal contamination, it shoul d be pointed out that not all animals present the same risk levels (e.g., appendix C.3 - pigs and poultry showi ng lower risks)

Line 1747-1751. The development of these models and software for mode l development are a great addition to allow rapid assessments; however, while the Grea t Lakes Beaches models have been successful it is important to note in this document th at the results for marine beaches are currently inadequate. This likely reflects the fact that the models are predicting FIB levels, which tend to be lower at marine beaches, even with health effects are noted. A s any work been done to adjust these tools to predict health effects directly rather than the FIB level s?Erin K. Lipp

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Line 1893-1900. Given the inconclusive results of the non-POTW impacte d beach and tropical beach, is the EPA anticipating that states/regions address these on a short time frame? Does the EPA anticipate providing any assistance for these regions? This is a crit ical gap in knowledge.

Line 1986-1997. Does the EPA plan to update or offer technical gu idance to the states on this issue periodically? It seems that EPA might be in a better posit ion to offer new methods/technology options with appropriate QC behind the method.

Appendix B.4 is identical to appendix B.1.

Typos:

Line 257. There is a typo. WERF is Water Environment Research Foundation (not “experts” as written)

Line316. The word ‘Water’ is missing from National Epidemiol ogical and Environmental Assessment of Recreational ...

Line 848. Typo .. “if” should be “of” (“...terms OF indicator density ...”)

Line 885. Typo, ‘trail’ should be ‘TRIAL’

Line 1165. Typo. There is a word missing from this sentence or the structure is awkward. “Loadings and hydrodynamics of FIB in human POTW coastal and non-coastal waters ...” Human POTW?

Line 1205-1207. “salinity’ should be removed from this sentence given salinity would have a lot to do with whether a beach was coastal or non-coastal (e.g., coastal marine beaches will be saline and non coastal beaches will be fresh)

Line 1251. Typo. Remove the word “was”. Sentence should read “ ...a retrospective study in the French Alps ...”C-27 

### Graham McBride
Principal Scientist National Institute of Water and Atmospheric Research L td. (NIWA)

Hamilton, New ZealandC-28

Graham McBride is a Principal Scientist in the National Institute of Water and Atmospheric Research of New Zealand. His specialist fields are wat er quality modeling and statistics, including their application to water resource management a nd the setting of environmental guidelines and standards. He has lead epidemiological stud ies of swimmers' health and was one of the authors of his country's drinking water standards a nd also the water quality guidelines for recreational waters. Graham has published a number of pee r-reviewed papers, book chapters and a text on water resources science and management.Graham McBride

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### Peer Review of the Recreational Water Quality Criteria (RWQC)

Comments Submitted by Graham McBride

Introductory Comments

The EPA and its advisers have performed an admirable tas k of sifting through the literature on the health of recreational water users, including many aspects of aq uatic microbiology, epidemiology and risk analysis. The end result of their analysis is a gener ally well-argued case for the proposed revised water quality criteria.

I am in agreement with all the comments made by the Review Panel. The following responses should be viewed as elaborations of those findings.



### 1. Does the document adequately present the logic a nd scientific support behind its conclusions? Please comment on the document’s trans parency, the completeness of the presentations, and any shortfalls in the material p resented. Are uncertainties for technical conclusions transparent? Do you have any suggestions on how we could improve this document? Please explain your response s.

The document presents a well-argued case. I agree wit h its general approach, in particular:

• coalescing the risks associated with marine and freshwat er criteria;

• extending the compliance assessment period;

• allowing for flexibility in implementation (e.g., QMRA, novel indicators, predictive models).

By and large the text seems clear. In the following I have noted those occasions when it seems not to be so. However, I do suggest that some matters need to be add ressed or clarified:

• No guidance is given on the desirable features of sampling programs, especially with respect to wet weather. I note that this is to be included in follow-up te chnical support guidance (TSG). Nevertheless, it should be helpful for there to be at leas t some mention of this issue in the criteria document—after all, the 1986 criteria did do so. 1 And if this former position is to be abandoned (i.e., restricting sampling to dry weather), it would seem appropriate to say so and give the rationale for it. In my view wet weather sampling (or sampling shor tly after rainfall) may be appropriate if recreational contact occurs at that time . I don't see lot of point in sampling during conditions tha t are not conducive to recreation.

1 At page 8 of EPA'S Ambient Water Quality Criteria for Bacteria –1986 : EPA440/5-84-002 (cited as "U.S. EPA 1986" in the draft RWQC) we have: "In general, samples sho uld be collected during dry weather periods to establish so-called "steady-state" conditions. Special s tudies may be necessary to evaluate the effects of wet weather conditions on waters of interest especially if sanitary surveys indicate the area may be subject to st orm water effects". The criteria themselves (in EPA 44/5-86 -001, Quality Criteria for Water 1986 ) contained a similar message: "These densities are for steady state dry wea ther conditions."Graham McBride

C-30

• Likewise I didn't see any reference to guidance on sampling de pths (knee depth, chest depth,...).

• I wonder if respiratory illnesses have been dismissed too easily. Yes, it is true that in some studies GI can be the stronger endpoint, but that may not be so for water skiers, canoeists or for beaches with an energetic wave climate such that aerosolisation is rather stronger. After all some studies have detected respiratory effects but not GI: England (Fewt rell et al., 1992); 2 Australia (Corbett et al., 1993, Harrington et al., 1993); New Zealand (McBride et al ., 1998).

• Has the case really been made that feces of all animal groups should be treated as posing the same risk as human feces? For example, there is evidence—in the New Zealand setting at least—of substantial differential virulence between Campylobacter jejuni carried by farmed animals (sheep, cattle, poultry) versus wild birds, and yet wild bird str ains can predominate in recreational waters (French et al., 2011).

• The distinction between SSM and STV is not sufficient ly clear, especially because for beach notifications (lines 1542

– 1545) the STV can act as maxima not to be exceeded (i.e., a cting as a SSM) but for WQS attainment "no more than 25% of the observ ations can exceed the STV" (acting as a percentile limit). I also have difficulty understandi ng how the STV (if it is interpreted as a SSM) can be used in devising permit limits, especially i f used alone (as suggested on line 1548). In my view stating only a limit never to be exceeded is next-to -useless in designing wastewater infrastructure. In contrast a GM (or median) accompanied by a high percentile (but not a maximum) tells designers and operators of wastewater facilities what is expected under normal and under unusual circumstances. In that regard a 75%ile seems rat her low; international practice increasingly uses 90%iles or 95%iles.

• Lines 1494

– 1503. This is timely and well-stated. But the last senten ce begs a "so what's the consequence of that?" question. I presume it means that EPA is prepared to tolerate a moderate degree of STV exceedances and hence notifications (interpret ing STV as a SSM, as is proposed for Beach Notifications)—even when the GM is way below its l imit.

• Line 1559 is ambiguous: '...i.e., no "excursions" acceptable."' I think refers to the GM, but I first read it as applying to the STV.

• Given that the WHO, Europe and Australasia have adopted the " Annapolis protocol", its nonappearance in this document seems surprising. I understand tha t the CWA is considered to pose an impediment to its adoption in the USA. But it would be help ful to explain why that is the case. And I note that the proposed extension of the compliance asse ssment period (recommended to be 90 days) takes the USEPA criteria closer to the "beach gr ading" component of that protocol.



### 2. Are you aware of any important peer reviewed lit erature or applicable data that have not been incorporated in this document and should b e included?

A number of extra references have been identified and ar e all included in the Review Panel's responses to this question. With regard to the lack of a "road map" (Review Panel's comment 1.1), the recent WERF

2 All references in this section are listed in Section 2 of the Review Panel's report.Graham McBride

C-31 QMRA study (Bambic et al., 2011, not cited in the RWQC—but l isted in the Review Panel's report) has a conceptual diagram of a sort that may be appropriate as a dec ision tree for RWQC implementation, viz.Graham McBride

C-32



### 3. Do the analyses comparing the NEEAR freshwater a nd marine culture-based indicator data aggregated by days of similar water quality corroborate that the NEEAR culture data are generally consistent with th e 1986 regression models?

• This is a crucial issue, because this analysis has ena bled the adoption of the same numerical limits on culturable fecal indicator bacteria as currently apply (unde r the 1986 criteria). The general approach taken seems sound, but I concur with the caveats m ade by the Review Panel's responses to this question. I presume that EPA staff will urgentl y promote a peer-reviewed publication of this important analysis?

• A particular feature of this analysis is seen by contras ting Figures 2a and 2b. In Figure 2a the "1986 freshwater data" and the "NEEAR freshwater data" are positioned similarly (with respect to the X and Y axes). In contrast on Figure 2b we see that the "1986 marine d ata" and the "NEEAR marine data" differ in that the former tend to exhibit higher HCGI rates. Some explanation of this contrast would be helpful, because it i s the cause of the reduced estimate of HCGI risk associated with the marine criterion.

• It may be appropriate here to recall some history of the de velopment of the 1986 criteria, especially for marine waters. In 1984 USEPA proposed an "a cceptable risk" of 6 HCGI cases per 1000 swimming events and advertised that notion (see Federal Register 49(102) , 21987–21988 May 1984). Furthermore, in the FR , EPA used the Cabelli HCGI relationship with that illne ss risk giving rise to a limit of 3 enterococci per 100 mL (inter preted as a GM limit). Later, after various submissions pointed out that such a low limit was not generall y attainable, the idea was raised that since a GM limit of 200 fecal coliforms per 100 mL h ad served well, let us translate that limit back to enterococci (giving 35 per 100 mL) and then read the C abelli graph in the reverse direction to calculate the associated risk (19 per 1000 swimm ing events), as explained in Federal Register 51(45) , 8012–8016, March 1986. That is, "acceptable risk" was not selected , it was calculated . That stance has now changed in the proposed revisions, in that an acceptable risk level has now been found to be consistent with both the freshwater and the marine criteria limits. Presentation of this change in the RWQC might be helpful.



### 4. Do the characterization and explanation of the q PCR method reflect that of the scientific literature? If not, what additional info rmation should be included? Is the derivation of the qPCR value using the EPA data sci entifically supported and adequately explained? Please discuss why or why not

.

As this is not my particular expertise I defer to Panel c olleagues on this question.Graham McBride

C-33 

### 5. Please provide any other general or specific com ments on the document, making sure to identify the section number/page number you are commenting on.

Line Comment

183 "...recommended fecal coliform criteria..." should be "...recommended l og

mean fecal coliform criteria..."

254

– 255 With regard to this text: "These projects included epidem iological studies to

provide data correlating illness with indicators, site-cha racterization studies to facilitate QMRA...": To do that the epidemiological studies w ould need to assay for pathogens, not just indicators—QMRA uses dose-response rel ationships for pathogens. I understand that this has not been done.

269 I note that these QMRA studies are for impacts of agricultural animals. So inferring from these that wildlife poses similar risks may lack sufficient foundation (but I do recognize that in the absence of studies on wildlife a precautionary approach may be very desirable from a public health viewpoint).

498 While true that the 1976 criteria (in USEPA Quality Criteria for Water


### , July

1976) recommended the same numerical limits as did NTAC, it may be helpful to note that the rationale for these limits changed (from the earlier USPHS studies of Stevenson 1953, as interpreted by NTAC), to an argument based on minimizing Salmonella infections (as is clearly stated in that text).

524

– 538 What is meant by "the" observed GM enterococci and "the" observed fecal

coliforms? Is it for the combined studies mentioned on line 514?

557 The word "because" is misleading here. It should be "in t hat". The paragraph

doesn't explain why the changed definition was adopted. Maybe it should?

603

– 604 Maybe note that the McBride et al. study found respirato ry illness rates were

associated with the concentrations of enterococci but fail ed to detect an effect with gastro-intestinal rates. (So it shouldn't be cit ed in support of the opposite pattern, as has been done on line 603.) Also Fleisher et al. ( 1998) reported "Attributable proportions of illness" as 34.5% for GI but a h igher value (40.0%) for AFRI. So is the text on these two lines correct?

716 Hypothesis tests of no difference should not "accept" that hypothesis when the p

value exceeds the significance level. It suffices to say th at differences were not statistically significant (there always is a differen ce between two populations, so it makes no sense to say that there isn't). Null hypothe sis test procedures are devised by assuming that the null is true, and only reject that hypothesis if data are sufficiently convincing. On logical grounds that proced ure doesn't admit an inference that the null is 

### true (or even likely to be true).

837

– 843 The Corbett study did detect an association with respira tory illness however.

969 Figure 4 doesn't say which GI category is being graphed; it s hould (i.e., NGI).

977 Wymer et al., 2011 is Appendix B.3; that needs to be clarified

.Graham McBride

C-34

1355 Not sure why there's an emphasis on outbreaks here. The maj ority of the human

disease burden manifests as endemic or sporadic patterns cf. outbreaks. And, in particular, campylobacteriosis seldom appears as outbreaks yet can have a high endemic rate (that's certainly the case in New Zealand, Till & McBride 2004).

1411

– 1412 I don't understand this text: "The few studies conducted in non-P OTW impacted

waters that also report significant health effects (McB ride, 1998; Cheung, 1990; and Wiedenmann 2006) have ... 2) combined epidemiological data from b eaches with non-human fecal source impacts with data from beac hes impacted by human fecal contamination sources." The New Zealand study did ha ve beaches with human impacts and beaches with animal impacts, but the a nalysis did consider them separately 

### (as well as combined)

.
1428 Suggest replace "Thus, waterbodies with substantial animal inputs" with "Thus,

waterbodies with substantial farmed animal inputs". Note too that "McBride, 1998" (lines 1409 & 1428) should be "McBride et al., 1998".

1460

– 1461 "The GM is calculated as the arithmetic mean of the log-t ransformed densities"

should be "The GM is calculated as the antilog of thearithmetic mean of the logtransformed densities".

1471 Maybe elaborate a little more on what 40 CFR 122.45 is all a bout?

1532 Is "log standard deviation" ambiguous? Some might interpret it to means what it

says! Should it be the mean the standard deviation of the log arithms (to base 10?) of the data?

1835

– 1838 Is Colford's Mission Beach study an exception to this huma n-impacted category?

1918

– 1927 Another use of QMRA is to assess "what if" scenarios. I argue that's an important

use of it, one that epidemiological studies can't perform.

1944

– 1949 Were any of the epidemiological studies conducted close to an o utfall? If not, is

there a case for advocating, say, QMRA in those circums tances (as is done in the New Zealand Guidelines (at pp. 3&4): http://www.mfe.govt.nz/publications/water/microbiological-qua lity-jun03/ ).C-35 

### Rachel Noble

Associate Professor UNC-Chapel Hill Institute of Marine Sciences Morehead City, NCC-36

Dr. Noble is an Associate Professor at the University of North Carolina at Chapel Hill, Institute of Marine Sciences in Morehead City, North Carolina. S he shares joint appointments with the Institute for the Environment, the Department of Marine Scienc es (within the College of Letters, Arts and Sciences), and the Department of Envir onmental Sciences and Engineering (within the Gillings School of Global Public Health). Her r esearch program currently bridges the connections between the fields of environmental microbiology and microbial ecology. She is currently studying the hydrological patterns of stormwater as related to microbial contaminant fate and transport, with a focus the microbial contamina nt impact on North Carolina’s vital recreational and shellfish harvesting waters. She is also working in eastern North Carolina estuaries to study the ecology of pathogens such as Vibrio vulnificus and Vibrio parahaemolyticus . These bacteria are relatives of Vibrio cholera , and are native to estuarine environments. Noble’s work with other UNC investigators is t o elucidate the role of climate change and extreme events on the incidence of these pathogens, and the relationship to human health risk. Other components of Dr. Noble’s research are to quantify enteric and bacterial human pathogens in a variety of environments including stormw ater runoff, wastewater effluents, and nuisance flows with a focus on coastal a reas. Dr. Noble has also been strongly interested in the development of rapid (<3 hours) real-time quantification methods for bacteria such as E. coli

and Enterococcus in surface waters. She has developed a suite of Quantita tive Polymerase Chain Reaction-based assays that are current ly being evaluated for monitoring of coastal, estuarine, and inland waters.

Other strong interests of Dr. Noble are the burgeoning field of the “Ecology of Marine Infectious Disease” in which she was recently convened an NSF-funded workshop, and the advancement of minority students to technically adept position s in science through her work with the HBCU-RISE NSF Program (Historically Black C olleges and Universities-Research Infrastructure in Science and Engineering) through which she has a current award with Florida A&M University.Rachel Noble

C-37 

### Peer Review of the Recreational Water Quality Criteria (RWQC)

Comments Submitted by Rachel Noble

Introductory Comments

Overall, EPA has successfully synthesized a document to c onvey their current directions in development of new criteria for ambient waters. The document was gene rally well written, and most of the scientific arguments within were made with appropriate scientific s upport and documentation. In particular, EPA is to be commended for the sheer amount of water quality relate d science that they have conducted in the past 5 years. They have gained much new information that i s relevant to criteria development. One of the most important overarching critiques of the criteria do cument is that they sell their excellent recent science short in that they do not use it to its potential for criteria development. Some of the comments in the following sections are “bold” formatted in order to hig hlight importance.



### 1. Does the document adequately present the logic a nd scientific support behind its conclusions? Please comment on the document’s trans parency, the completeness of the presentations, and any shortfalls in the material p resented. Are uncertainties for technical conclusions transparent? Do you have any suggestions on how we could improve this document? Please explain your response s.

General comments: The criteria document as assembled succe ssfully accomplishes the following

• presents the history behind previous criteria development

• discusses a range of aspects of 304 (a) criteria development a s related to a range of water quality standards/procedures (i.e., does not focus solely on beach warnings and postings)

• presents the scope of the science

• presents the linkage b/w water quality and health and explains epidemiological studies

• attempts to outline a framework for connection of recent epi demiological studies to those conducted in the 70s and 80s

• presents results of epidemiological studies conducted recently and subsequent data analyses

• attempts to show the reader a transitive approach toward li nkage of current studies to older studies, bringing in results from rapid methods

• outlines a few other ways that waterbodies can be manage d in the USA

The way the document is written is generally a treatise on the “process” that EPA used to develop or revise criteria. The document is not written in a forw ard thinking tone (prospective), it is rather retrospective. It is this reviewer’s opinion that detai led explanation, use of case studies, and providing of examples where relevant could greatly help EPA in paving a path forward for adoption of new criteria.Rachel Noble

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There are serious shortcomings in the document in the followi ng areas:

A. The existence of the FIB to pathogen relationship is s pecifically stated in a wide range of places in the document. It is also noted that there is a lack of pathoge n relationships to FIB, especially viruses. Why continue with the notion that FIB predict pathogens? There is ample evidence at this time that the numerical relationships between pathogens and FIB in waterbod ies, freshwater and marine, exists only in certain cases, and often times does not exist. Typically, strong relationships have been shown between viral pathogens and FIB in cases of studies of direct discha rge of sewage. It is likely that the poor relationship is a function of methodologies, statistical varia bility, lack of consistent study approaches, and/or lack of data using like methods, but this is not i mportant to the current thinking in criteria development. EPA has clearly shown, as well as others, th at FIB (measured using either culture- or molecular-based methods) can be linked to human health outc omes using epidemiology studies. EPA has stated that they are using the FIB-health outcomes relation ship wholly to establish and defend and develop new criteria. The addition of information, and atte mpt at literature review of pathogens only complicates this criteria setting. If anything this infor mation presented about FIB to pathogen relationships should be placed in the QMRA section of the document (or in Section 5.0 broadly), to demonstrate to the reader the paucity of good, scientifically relevant information. Therefore, paving the way for a consistent, statistically rigorous QMRA appro ach to be presented by EPA.

B. There is a complete lack of guidance on subtropical a nd tropical waters criteria development. EPA attempted one epidemiological study in tropical waters, and h as not conducted any others. The one study they did conduct was conducted almost entirely with QPCR based methods, a mistake given the levels of inhibition that were identified in these tropical water s. Given the importance of beach visitorship in FL, HI, and PR alone, this issue remains important. Hawai i has been urging EPA for decades to examine and assist them with development of other standards, citing serious issues with attempting to quantify
Enterococcus solely as an appropriate indicator. Lack of information abo ut Tropical Areas means that these areas should either be able to develop their own approache s OR that they can use the 1986 criteria. However simple use of the 1986 criteria means that they are us ing science that is nearly 40 years old, and has not been updated. Tropical Workshop attendees in 2002 said that EPA would develop new indicators that worked in all areas. This clearly is not the case for subtropical and tropical waters. Therefore, EPA should be required to assist these areas in developing an approach that will be successful for them, even if it represents a departure from the national standard. Tr opical waters need to be specifically called out in the criteria document.

C. There is no stated requirement for QPCR, which is a good thing as it is not the answer for some State’s monitoring needs. However, EPA misses an opportunity to stres s the importance of rapid methods in providing more accurate means to protect public health at bea ches. There are serious issues with public perception of the costs and difficulties seen with rapid QPCR based methods. That is, most people think that QPCR is more cumbersome and expensive than it real ly is. EPA could do a better job of demonstrating the tractability of these methods to stakeholder s. They use Griffith and Weisberg, 2011 several times as an example. However, it would be useful to explain the costs and advantages of rapid methods versus culture based methods, and to provide more spec ific examples of where it has been used successfully to manage recreational waters (southern Cali fornia, Great Lakes). EPA is unlikely to revise criteria in the next decade, therefore, they should conside r recommendations of the following for QPCR:Rachel Noble

C-39 a) implementation at high use beaches (this has been very s uccessful in southern California), b) implementation in areas that have high numbers of beach going families including children. EPA is making the right decision in not requiring QPCR to be conduct ed nationwide, but there are merits to its use, particularly important is the speed of management de cisions. The case could be made by EPA to strengthen its recommendations for the use of QPCR (possi bly some sort of incentive program?). Finally, EPA’s Method A is very complete and detailed. Is it possible for EPA to create a shortened, Cliff’s Notes version of Method A to provide to stakeholders so that they can visualize the process? (i.e., collect water sample, filter, bead beat, create master mix, load mac hine). A simplified version of the method would assist EPA greatly in bridging the next steps of rapid methods implementation.

D. The intended switch from SSM to STV is not clearly pr esented and does not permit coastal and noncoastal States that use other management approaches to inco rporate any flexibility in their current ways of managing and listing impaired waters. Some states use fre quency of beach closures to manage their impaired water status, implementing a comparison between reference beaches and contaminated beaches. EPA needs to clearly state the minimum sampling frequenci es (this is done but the sampling frequencies are actually less stringent than before?), they need t o provide guidance on sampling during wet versus dry periods and over seasons. The frequency of beach closures approach, which compares like beaches to like beaches, is an important interpretation of beach manageme nt framework. Flexibility in the use of other more stringent approaches for compliance purposes needs to be i ncluded in the document. Sampling variability across states will lead to inconsistency in the way that the new STV approach is utilized for TMDL listings. EPA should strive now to make this approach consistent across states and provide succinct guidance on the minimum approaches. Currently, State s that do the most monitoring spend the most money on TMDL implementation and development. These st ates also suffer from the fact that more monitoring equals more listings. EPA needs to create equal ity in the system by mandating specific levels of monitoring.

E. There are major shortcomings in QPCR/rapid methods as presented. There are major holes in the recommendations on rapid methods that deserve to be addressed in the document. EPA needs to more transparently state that they did not include rapid E. coli QPCR nor culture-based measures of E. coli in the freshwater NEEARS Studies. E. coli is an important indicator in a range of different non-E PA epidemiology studies, and the lack of data for the NEEARS f reshwater studies needs to be stressed. Second, EPA is suggesting an extrapolation of E. coli standards to inland waters based upon old science (1986 science), this needs to be clearly stated and trans parently discussed in the document. EPA has either not done or has not presented the appropriate data analysis a cross quantification approaches for QPCR to demonstrate that the more variable CCE quantification appro ach is superior to the cell equivalent (CE) quantification approach. In southern California, CE based quantification approaches have been used for two consecutive summers to rapidly measure beach water q uality via Enterococcus quantification with some success. The approaches have demonstrated very strong re lationships to existing culture-based methods. SCCWRP epidemiology studies have also shown that both CE and CCE quantification approaches have yielded significant relationships to human hea lth outcomes. EPA has also shown that this relationship is significant for both quantification me thods, but they are not transparent about this in the criteria document. EPA has not included relevant rapid methods data from a range of methods for SCCWRP conducted southern CA studies (including QPCR but also highlighting other methods like IMS-ATP). Some of this data is already in publication for mat (submitted to journal) and easilyRachel Noble

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interpretable. The rapid methods information that is presen ted can be related with some difficulty to the culture based methods, but there are locations where both equiv alency (numerical correlation) and/or health relationships exist that are different from the cr iteria development stated by EPA. Clearly, EPA will pick only one quantification approach, but addressing both quantification approaches will be important for understanding how modifications of the EPA QPCR methods could be implemented by others in the future.

F. EPA has not fully utilized all of the epidemiological data available for informing their new criteria. In particular, as stated above the SCCWRP cond ucted epidemiological studies provide important information on the importance of assessing in hibition, on the use of cell equivalent (CE) based quantification approaches, epidemiology at non POT W impacted high energy beaches, and comparisons of EPA methods to other available rapid me thods. EPA needs to take advantage of this available body of work.

G. In places it appears that the criteria document is di fficult to read and vague. The following issues exist, a) sections could be reorganized to flow better, b) tha t specific sections have not had the benefit of consideration as totally as others (specifically the sect ions about waterbody type and criteria setting across coastal and non-coastal waters, and c) that EPA is pre senting the “process” of how they arrived at the criteria, but they are providing very little foresight as t o actual implementation. In this way, they miss out on an opportunity to provide specific guidance on a) succes sful implementation of QMRA, b) what constitutes enough side by side sampling between culture based methods and QPCR, c) what constitutes a similar enough method to Method A and how they go about presenting that information, d) examples of the use of STV in TMDL impairment listings, and how the new approach will change existing approaches.



### 2. Are you aware of any important peer reviewed lit erature or applicable data that have not been incorporated in this document and should b e included?

There are four major missing sets of documentation. Fi rst, the epidemiological studies conducted by SCCWRP on the west coast are mentioned. However, these st udies are not incorporated at all into the discussion, except under the context of NPS contaminated beaches and the literature produced as part of the Mission Bay, CA study (e.g., Colford et al., 2005). The beaches studied in CA are 1) major beaches for recreation, 2) representative largely of beaches found in southern California, and 3) well studied and have results at this point assembled into the framework of journal articles that have been submitted or are ready to submit. Therefore, the data from these studies is far enough along that EPA could more effectively make use of the results. SCCWRP has been act ive in sharing all of the data generated from these studies, and it is to EPA’s benefit to take advant age of this information. EPA has full access to this data, and the beaches studied in southern California repr esent a vital subset of beaches that have not been adequately addressed by EPA (i.e., beaches that are recipi ents of NPS pollution). That is, those beaches that are high use, high energy (wave energy), have significant contributions of diffuse pollution (specifically San Juan Creek and Malibu Creek are two maj or conduits of concern), and are not impacted by any direct POTW point source. These types of beaches dominate southern California and Florida waters, and while Florida waters are subtropical in nat ure, the data collected from these beaches is a vitalRachel Noble

C-41 part of the package of information that EPA should be exami ning. Additionally, more emphatic inclusion of the Epibathe data, including a serious examination of the E. coli data and a presentation to the reader for how that data relates or differs to other studies th at have been conducted in the US would be useful, as the omission of E. coli

from this document is a serious issue (as noted below).

Second, EPA has been seriously remiss in their inclusion of E. coli in freshwater studies. The criteria document is full of broad level statements about E. coli being adequately addressed. On page 22, EPA states that the reason that the E. coli testing was not done was because EPA was taking an approach of a single indicator to be used for all purposes. If the approach is to link current criteria to historical criteria, measurements of E. coli

were an obvious necessity. The omission of E. coli in both the culture based format and molecular format (qPCR) in the Great Lakes NEEAR studies is of major concern. In other parts of documents, EPA has written about the fact that their omission of E. coli measurements is warranted (see Appendix A, where the lack of E. coli based information is rationalized). The results of Epibathe, Marion et al., 2010, and other studies conducted in f reshwaters recently indicates that this is clearly untrue. It is this reviewer’s opinion that the EPA must be transparent about the lack of new science in relation to E. coli, specifically relating to rapid E. coli QPCR methods. They must address, with transparency, their lack of foresight in not measuring E. coli during the NEEAR freshwater studies. In 2006, there were several offers to EPA by outside entities t o analyze the existing archived filters from the NEEAR freshwater studies using E. coli qPCR. EPA originally indicated interest in conducting these analyses, and but never pursued them fully. The lack of cult ure based E. coli work conducted in the other studies is another major issue. At the very least, E. coli should have clearly been measured by MF methods for the NEEAR Great Lakes Studies. EPA could cr eate a section in this criteria document that is specifically for freshwater systems, and clearly deline ate for the reader what will be accepted, and also clearly delineate that there are E. coli qPCR assays that exist for use in recreational water quality. EPA must also clearly state that they have not conducted the sc ience to update the E. coli criteria, therefore those criteria remain the same as previously suggested in t he 1986 document.

Third, the presented analysis of the relationships between FIB and sources of contamination in coastal and non coastal waters is poorly written. It is this reviewe r’s opinion that there are three general sets of data a) marine, b) freshwater-great lakes, and c) inland lakes, ri vers and streams. EPA does not have the inland waters data to compare at any significant level to the c oastal and Great Lakes data, it simply does not exist. The comparison between freshwater and marine water s is what needs to be made, as most studies are separated out by this delineation. EPA is only confusing the issue with the weakly presented analysis. Furthermore, EPA does not describe what portion of the assem bled literature was used for their assessments in this section, only refers to Appendices A and B broadly. Without presenting any of the assembled information, where it came from and how it was preferentially selected from the large body of literature, about waterbody type and sources, FIB occurrenc e, FIB survival, and FIB associations with pathogens, the reader is left with a poor description of the summary of this huge literature review. It is this reviewer’s opinion that EPA must either completely r edo this section, or they must state clearly what articles are being used to summarize information and pres ent it specifically and quantitatively. For example, there are vast differences simply between deca y rates in seawater and freshwaters, how can EPA state that these differences are not due to the water m atrix, but due to site-specific differences? The line of reasoning in this section is completely unfounded, and is problematic to the FIB and pathogen occurrence section and the other sections. EPA has done a poor job in specifying exactly what patterns have beenRachel Noble

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seen where, and a very poor job in stating what reference s have been used to make their statements and how any metadata analysis was done.

Fourth, EPA has preferentially selected a few epidemi ological studies to highlight in the criteria document, on the freshwater side Epibathe, Ferley et al., W eidenmann et al., and Marion 2010. They have also highlighted information about sources of fecal contamina tion in relation to human health outcomes (specifically stating that many epi studies of NPS contam ination have found weak or inexistent relationships with FIB). EPA speaks to relationships bet ween E. coli and human health, but this information is sporadic and not presented with any consist ency or clarity. EPA must clearly state that the previously stated studies (listed above) have found significa nt relationships to E. coli in freshwater, and that EPA has not conducted the necessary science to change the E. coli

criteria substantially from 1986. EPA need to clearly state the need for E. coli based water quality assessments and epidemiological studie s to be conducted so as to update the science in a similar wa y to what has been accomplished with
Enterococcus , including the implementation of already available rapid m ethods (Lavender and Kinzelman, 2010).



### 3. Do the analyses comparing the NEEAR freshwater a nd marine culture-based indicator data aggregated by days of similar water quality corroborate that the NEEAR culture data are generally consistent with th e 1986 regression models?

EPA has made an attempt to link across studies in a tra nsitive argument, and they present one way of examining the information. However, issues exist with the fo llowing that deserve to be explained.

• Models used in 1986 are different from the models used for the N EEARS studies that include confounding factors. EPA should be transparent as to why the modeling approaches are different (assume that raw data from 1986 is not available?) and expla in clearly why they are using the cross walking approach given this reason. EPA could be more proact ive in stating that the criteria development is linked to protection of public health

• Few data points make it difficult to assess the similari ties across studies (Is it possible to remove the seasonal aggregation presentation?), there are other possible ways to present and analyze the data, why has EPA chosen only these examples?

• It is generally unclear to the reader what final data was combined data and what final data was specific to a study or beach? Also, it is unclear what modeling approaches were used to generate the health risk assessments for each specific study.

• Why no presentation of Bacteroidales information? Can it be used as a tool in section 5.0? Thi s indicator may have particular relevance in tropical wate rs, where regrowth of E. coli and
Enterococcus has been shown to be a serious issue.

• It would help the reader to see information from Wade et a l., 2008 and 2010 showing relationships to human health above and below specific standards.Rachel Noble

C-43 • No mention or incorporation of SCCWRP studies makes it di fficult to understand what selection process was for the epidemiological information? How do the S CCWRP results relate to the marine NEEAR studies? Are there large differences in rapid method and culture method results? How about presenting a table, for transparency, that shows what studies individually showed a relationship to human health for what methods and what s tudies didn’t? In relation to EPA conducted studies, the SCCWRP studies are some of the most e xtensive, and they specifically followed EPA experimental design, so the lack of inclusion o f this information is curious.

• EPA does a poor job of explaining why they have included certai n studies in their considerations and not others, is it possible that these other studies ge nerated information that make this aggregation of data and cross talk across criteria e stablishment confounded? It generally appears that the EPA studies only have been included in the final c riteria development. While this is a decision for EPA to make, it needs to be justified and made clear throughout the document. There is a strong comparison between the Marion et al. study and EPA studies in the Appendices, but it is not clear why that kind of comparison is not conducted w ith an array of recent rigorous studies conducted by others.



### 4. Do the characterization and explanation of the q PCR method reflect that of the scientific literature? If not, what additional info rmation should be included? Is the derivation of the qPCR value using the EPA data sci entifically supported and adequately explained? Please discuss why or why not

.

EPA presents a method that is highly successful to quantify ing Enterococcus in water. The information, however is lacking in several specific areas.

• QPCR criteria has been shown, but the linkage between this criteria for actual studies conducted recently and illness has not been shown. EPA needs to speci fically show that QPCR relationships to human health in freshwaters are stronger than those for culture based methods. The reader should be presented with the actual illness rates that would have resulted in a range of EPA and non EPA studies if this selected criteria was retrospectively a pplied. As a matter of fact, it would be useful to see this done for every epidemiological study con ducted recently that utilized Enterococcus qPCR.

• The scientific literature is full of a range of quanti fication approaches for qPCR. The rationalization and explanation for the selection of the C CE or calibrated cell equivalent quantification approach for QPCR is not adequate. The la ck of inclusion of the results of the SCCWRP epidemiological studies is vital in this rationaliza tion, along with other work that has been conducted in the Great Lakes using E. coli QPCR assays. EPA is missing a valuable opportunity to explain this to the public/stakeholders. They also must present their epi data in both the cell equivalent and the calibrated cell equivalent format, in the context of inhibition, and at least let the reader see that there are serious advant ages and disadvantages to each approach. There are other general approaches (using the CE approach with inhib ition flagged) to manage beach waters that have been presented by the State of CA, and while these are mentioned they are not explained. EPA should present this information and be tran sparent. EPA must address these issues and present a sequence of rational arguments for sele cting the calibrated cell equivalent approach.Rachel Noble

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• EPA presents the method, but provides almost no guidance as t o how others can use similar methods, like IMS ATP, are there possibilities for method s like IMS ATP?

• The presentation of method specific details is limited t o Appendix A, where EPA quantifies cross laboratory variability, and 50% limit of detection. EPA m ust provide a better example of what type of variability they expect from rapid methods as compared t o culture based methods. This is vital when considering posting a beach based upon a single suggested val ue. Possibly a section that compares the methods and shows a shortened version of the methods comparisons that have been done and the variability observed.



### 5. Please provide any other general or specific com ments on the document, making sure to identify the section number/page number you are commenting on.

Sections 3.0, 3.1, and 3.2 are poorly written and need to b e rewritten and reorganized. The sections on this history of criteria in the beginning of the document are much more clearly written and presented. In Appendix C: ASSESSMENT OF THE APPLICABILITY OF EXISTING EPIDEMIOLOGY DATA TO INLAND WATERS, there are statements that are contra dictory to those written in section 3.0+ of the criteria document. In particular, the data analysis is not possible given the range of methods that were used to conduct coastal versus inland waters assessments. The document clearly states the caveats associated with interpreting the data across sites an d methods. EPA clearly states the variability observed from site to site at beaches, then there is a huge effort expended to show the linkage across coastal and non-coastal waters. It is simply not possible to state that coastal and non coastal waters behave similarly in relation to FIB dynamics.

Specific comments: Use either Enterococcus sp. or enterococci throughout FIB = fecal indicator bacteria, typically in the literat ure, this refers to total coliforms, fecal coliform s, E. coli or Enterococcus . Where you mean FIB use FIB

Fecal indicator and fecal indicator organisms (FIO) inc lude all indicator organisms. Most typically use this as a catchall for all FIB, plus other “indicator” bacteria that can sometimes include other bacteria such

as C. perfringens . It is this reviewer’s opinion that in the criteria do cument, in almost all instances seen the EPA should consistently be using FIB specifically.

If going to define acronyms for all, use them! Specifically us e FIB please, not “fecal indicators” which could be inclusive of enteric viruses, protozoa, chemica l indicators of fecal pollution etc.

EPA could please include:

• A basic example of what constitutes an adequate side by si de testing scheme for implementation of qPCR and if states have already done this, how they can “bypa ss” this step.

• A QMRA case study, or at least an example of what would be adequate.Rachel Noble

C-45 • More information as to how spatial and temporal sampling frequency plays into GM and STV. There is little mention of how EPA selected to reduce (? ) the required sampling frequency for STV (12 for 90 days as opposed to 5 for 30 days?), what informati on has been assembled to defend this?

• EPA needs to at least discuss frequency of beach closure s in a reference beach vs. contaminated beach context in terms of impairment listing, and they ne ed to defend their approach, or specifically accept other approaches that have been scientifically and rigorously established, also need to defend the use of mixed information in impairment assessment, c an an agency mix and match QPCR and culture based data for STV assessments? What is the re asoning for accepting this approach? Not accepting this approach?

• Are all E. coli

GM and STV assessments to be conducted the same as Enterococcus ?

• What about use attainability. There is very little inform ation provided in this section. EPA has done a poor job in the past of describing how to establish tiered approaches. Now that they are doing away with this system, they need to address how this will impact states that are short on resources. States might find themselves in a situation where they are expending resources at a beach that has 1 user per month, and reducing resources at their higher use b eaches. This is an undesired effect of the tiered system, but a reality in tight budget times. Thi s reviewer is already aware of several states that have suggested that they will have to shift resources away from high use beaches to mostly unused beaches if the tiered system is abandoned. There need s to be a clearly thought out process and presentation of the information to stakeholders, as t his will impact those in the water quality agencies greatly. Are they expected to maintain all of their sampling sites that they currently sample with lower frequencies at the 90 day 12 sample minimum?

• EPA is to be commended for introducing new scientific tools such as QMRA in the possible arsenal of water quality managers. EPA could more adequately explai n the QMRA process and provide examples (this was already included in other comments). One major problem is that the source identification and quantification science that needs to be done has not been done in an organized way. EPA should take the lead on this. With specific pe rsonnel at EPA (Orin Shanks) this work can be completed successfully, but there must be a plan toward doi ng it at a national level. EPA has not specified how agencies/stakeholders sift through available s ource identification and quantification approaches to select something that is rigorous and can be used successfully. Finally, the linkage to FIB is not clearly made in the criteria document or any guidance that EPA has published. Guidance on the linkage of source specific information specifically to either E. coli or Enterococcus has not been provided. This is a vital step toward the successful use of QMRA as an additive to a management schema for surface waters.

• QPCR methods, EPA has not specified what is acceptable for equivalency of rapid methods (i.e., use of Method A with a different QPCR platform, how many s ide by side samples need to be run to demonstrate equivalency between methods?). This needs to be done now before other classes of methods arrive. Set the stage for other criteria developm ent, be novel and thoughtful about this process. If want to use a different platform, specify t he acceptable criteria. If want to use a different available tested method, define what is acceptable. It is assumed that much of this information will be in a Topic Specific Guidance, but some precursor informati on is desirable.C-47 

### Gordon Yasvinski

Scientific Evaluator Health Canada Ottawa, Ontario CanadaC-48

Gordon Yasvinski graduated from the University of Guelph wi th an Honours degree in Microbiology and has been with the Water, Air and Climat e Change Bureau since 2003. His responsibilities include the preparation of health risk asse ssments for microbiological contaminants specific to drinking water and recreational water. Publications he has contributed to the development or review of include the Guideline Technica l Documents for: Bacterial waterborne pathogens, Enteric protozoa, E. coli, Total coliforms and Turbidity. Gordon also led the update of Health Canada’s Guidelines for Canadian Recreational Water Quality with a Federal-Provincial-Territorial Working Group on Recreationa l Water Quality made up of representatives from Health Canada, provincial and terr itorial departments responsible for water quality, Environment Canada and the U.S. EPA.Gordon Yasvinski

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### Peer Review of the Recreational Water Quality Criteria (RWQC)

Comments Submitted by 

### Gordon Yasvinski

1. Does the document adequately present the logic a nd scientific support behind its conclusions? Please comment on the document’s trans parency, the completeness of the presentations, and any shortfalls in the material p resented. Are uncertainties for technical conclusions transparent? Do you have any suggestions on how we could improve this document? Please explain your response s.

It is clear that a tremendous amount of effort has been put in to developing these recommendations and their supporting documentation. In terms of adequate and tran sparent presentation of the conclusions, I would say nearly. In general, the conclusions are rooted i n logic the depth of the literature reviewed scientifically supported, and EPA has gathered/ reviewed and produced sufficient information to support its risk assessment decisions.

1. There are some decisions that need to be better illus trated and supported or defended in the 2012 document. Chiefly, the ones I would highlight are:

• The findings around the fresh/marine equivalency would benef it from further illustration (question #3)

• Stronger supporting discussion should be provided as to why the st ronger qPCR results were not used to drive the criteria as opposed to the culture-based r esults (question #4)

• Supporting discussion as to why the qPCR criteria remain expre ssed as NGI illness, while the culture based criteria are expressed as HCGI, even though t he discussion seemed to suggest an easy conversion or interchangeability between the two (qu estion #4)

• More specific discussion around why E. coli , though not included in the NEEAR analyses is retained and justified in its role as the primary

2. Additionally on the subject of transparency and completenes s, the review panel discussed at the meeting that on the topics of:

• Coastal vs. Inland waters

• Tropical/subtropical vs. Temperate waters

and perhaps to a slightly lesser extent:

• Human source fecal material vs. Non-human source fecal material

The basic assessment seemed valid — that the data var iability and gaps were sufficient so as to suggest that the health risks for each type were similar enou gh and could not be independently characterized. However taking the direction of similarity in the discussion was done at the expense of acknowledging that there are also some real apparent differences betwe en each comparison pair, but that the impact ofGordon Yasvinski

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this differences is not known or it is not known how signific ant. Acknowledging these differences and the data limitations is required to convey to the reader that EPA is aware of and has considered all the available information in presenting their decisions.

The review panel further discussed that a more intuitive app roach would be to structure the basis of the argument that extension of criteria across recreational water types was done to be protective of public health in the lack of sufficient information. This decis ion would be rooted in logic and allow EPA to acknowledge the differences and the data gaps.

3. Another issue discussed by the review panel that was not addressed in my draft comments, but was captured in my specific comments concerned the clarity of the guidance for applying the criteria. It is proposed that this section needs to be rewritten in a mor e clear and straightforward manner. Currently, the explanation of the statistics, the rationa le, the calculation of the statistics and the guidance as to application are all intertwined. It is r ecommended that these be separated for easy of understanding, and specifically that the application guidance be specifically laid out in manner that is simple and easy for the intended recipient (responsible r ecreational water authority or beach manager) to understand.

The following editorial comments are also submitted:

1. It is clear to me that the EPA has completed a tre mendous amount of work in preparing the newly proposed 2012 criteria. So much so, that it appears that the EPA should be able to confidently defend its conclusions and decisions. In the criteria document there appears to be some instances where the text in presenting a point, follows up with what might be a response to what expected criticism might be. Or similarly, uses a small point to point out consist ency with EPA findings, rather than having a more complete, organized discussion of additional ma terial that supports EPA’s decisions. As examples:

• In 3.1, it is introduced that EPA is allowing for a qPCR method, but then immediately following the text focuses on the issue of possible interferences and how they have been resolved.

• In 3.2.3 in discussing the body of epidemiological literature, a fter mentioning the Marion, 2010 study, it states that the E. coli findings support EPA’s 1986 criteria, rather than having a m ore coordinated discussion of how the outside body of evidence is also in line with EPA’s conclusions.

I understand this is an extremely complex document with many issues that need to be addressed, and doing so in a logical and easy-to-read format is challe nging. However I believe with the major issues to be addressed (e.g., the criteria itself, water body type, source of fecal contamination), the work put into this endeavour is such that the EPA should be able to present its findings and recommendations and then follow up with short explanations for each major is sue - yes, here are the known challenges or shortcomings...and we believe these are addressed/ju stified because we have done this or have the following information which supports it.

2. Another suggestion is that it would be valuable to have a brief opening summary or executive summary of the key decisions or the “need-to-know” information for the states, tribes and readers. The criteria has a lot of components and a lot of questi ons to be answered and it is difficult to tease out the key conclusions from the individual sections.Gordon Yasvinski

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### 2. Are you aware of any important peer reviewed lit erature or applicable data that have not been incorporated in this document and should b e included?

No. The data analysis and the literature review conducted for the multiple components the criteria document considers (e.g., epidemiological studies, QMRA and ot her publications in the appendices) are very comprehensive and appear to be sufficiently exhaustive. I feel comfortable that the body of information has been suitably reviewed. The odd paper could b e included to provide reference for specific points, as other reviewers have indicated, but I believe tha t no crucial streams of evidence have been overlooked. Two general comments I would have are as follows:

1. It is proposed that better linkage of individual points or conclusions to the respective Appendix subsections would be extremely valuable and help improve transpa rency.
2. It is also felt that an important opportunity to addr ess the concept of the move worldwide towards a harmonized approach to risk management and the move away fr om reliance on numerical values of fecal indicator bacteria as the sole criterion for determ ining recreational water safety was missed. Although it is recognized that this is a criteria documen t and not a beach management document, the concept is in-line with EPA thinking. It is therefore impo rtant to highlight and ingrain this idea in the public consciousness and to also use the opportunity to point o ut the interconnectiveness between related EPA documents (e.g., sanitary survey and predic tive model documents) to authorities and

managers.
Suitable citations for the Harmonized concept include:

Microbiological Water Quality Guidelines for Marine and Fre sh Water Recreational Areas. New Zealand Ministry for the Environment. 2002
EU (2006). Official Journal of the European Union. Directive 2006/7/EC of the European Parliament and of the Council of 15 February 2006 concerning the management of bat hing water quality and repealing Directive 76/160/EEC
NHMRC (2008). Guidelines for managing risks in recreational water. National Health and Medical Research Council of Australia, Government of Australia, Canberra.
Health Canada (2009). Guidelines for Canadian recreational water quality. (Draft) Document for Public Comment. Water Quality and Health Bureau, Healthy Environmen ts and Consumer Safety Branch, Health Canada, Ottawa, Ontario. Available at: http:// www.hc-sc.gc.ca/ewhsemt/consult/_2009/water_rec-eau/draft-ebauche-eng.phpGordon Yasvinski

C-52



### 3. Do the analyses comparing the NEEAR freshwater a nd marine culture-based indicator data aggregated by days of similar water quality corroborate that the NEEAR culture data are generally consistent with th e 1986 regression models?

Not quite. My initial comments to this question were to propose that the findings that prompted the decisions of equivalency needs to be illustrated further, through a combination of graphical data showing the marine and freshwater data combined and an indication of the statistical calculations showing no statistical difference. Further to this, a valuable dis cussion would be as to how although the water quality data at the beaches was shown to be very good, it was felt that there was sufficient data captured at points where swimmers would be at elevated risk so as to ma ke the data sets and observed relationships robust.

EPA’s desire for pursuing unified illness rates for fres h and marine waters for public health protection and for application and implementation purposes is understood. At the meeting the review panel discussed that Figure 1. could be regarded as doing a disservice to the argument of marine/freshwater equivalency, but since it is addressed as being insufficient to refine the illness estimates, it’s inclusion was considered valuable for transparency purposes. The reviewers further addressed that in the absence of a suitablyillustrated supporting discussion, the apparent lack of relation ships in Figure 2 questions whether the NEEAR data and the 1986 data are sufficiently similar. Ul timately the review panel suggested (and I support) that the NEEAR study data be used on its own be used to determine conclusions regarding fresh and marine water illness rate similarity.

Guidelines or criteria can have several components beyond the st raight scientific data component. These additional components can also impact or shape the way the fi nal recommendations are presented:

• Historical component

• Public health decision component

• Jurisdictional component

• Practicality of Implementation component.

In my experience on the work done in developing the (draft) recom mendations for the Guidelines for Canadian Recreational Water Quality , the current fecal indicator recommendations were simila rly based on assessment of the best available scientific data. Ho wever, because of the data limitations, and the lack of an exact parameter-to-illness causative relationship, the recommendations are not identified as illness thresholds, but rather as risk management values intended t o be protective of public health.

Whatever EPA’s decision regarding a tolerable illness rat e and marine-freshwater rate equivalency – whether it be weighted heavier or data relationships or on policy/risk management/public health decisions – it is recommended that it provided that it appears logical, transparent, acknowledges it’s limitations and fits within EPA’s scope of authority, it will be capable of being defended. If not, it will give the appearance of potentially hiding something, and therefore wil l likely be subject to criticism, whether it is warranted or not.Gordon Yasvinski

C-53 

### 4. Do the characterization and explanation of the q PCR method reflect that of the scientific literature? If not, what additional info rmation should be included? Is the derivation of the qPCR value using the EPA data sci entifically supported and adequately explained? Please discuss why or why not

.

As this is not my specific area of expertise, and others on the review panel are more qualified than I to comment on the accuracy and appropriateness of the methods, I w ill withhold from commenting on this particular area. However, in terms of the derivation of the qPCR value, this does not quite feel adequately explained. Illustration showing comparison of NEEAR data to the calibration curves with explanation of how the relationships observed are felt to be valid would be helpful.

Additionally, an expanded explanation to the reader as to why the qPCR criteria seem considerably elevated relative to the culture criteria, and how these a re logical and are justified, would be useful



### 5. Please provide any other general or specific com ments on the document, making sure to identify the section number/page number you are commenting on.

File containing marked specific comments submitted with t he draft comment file remains unchanged.D-1 

## Appendix D

Meeting AgendaD-3 United States Environmental Protection Agency Office of Water 

# Peer Review Meeting for EPA’s Draft Recreational Wa ter Quality Criteria for the Protection of Human Health

September 12-13, 2011 Arlington, VA



# Agenda

Monday, September 12, 2011

8:30 a.m. Registration/Check-in

9:00 a.m. Welcome and Announcements

................................................. ............................ **Kate Schalk, ERG**

9:05 a.m. EPA Remarks

.................................................. ................................. **Elizabeth Doyle, EPA/OW/HHRA**

9:15 a.m. Introductions, Meeting Format and Ground Rules

.................................................. **Kate Schalk, ERG**

9:30 a.m. Technical Chair’s Remarks

.................................................. ................ **Rachel Noble, UNC-Chapel Hill**

9:35 a.m. BREAK

10:00 a.m. Reviewer Discussions

.................................................. .................. **Rachel Noble (Chair) & Reviewers**

1. Does the document adequately present the logic and scientific support behind its conclusions? Please comment on the document’s trans parency, the completeness of the presentations, and any shortfalls in the material p resented. Are uncertainties for technical conclusions transparent? Do you have any suggestion s on how we could improve this document?

2. Are you aware of any important peer reviewed lit erature or applicable data that have not been incorporated in this document and should be in cluded?

12:00 p.m. LUNCH

1:15 p.m. 3. Do the analyses comparing the NEEAR fr eshwater and marine culture-based indicator data

aggregated by days of similar water quality corrobo rate that the NEEAR culture data are generally consistent with the 1986 regression model s?

2:45 p.m. BREAKD-4 

# Agenda

Monday, September 12, 2011 (continued)

3:00 p.m. 4. Do the characterization and explanatio n of the qPCR method reflect that of the scientific

literature? If not, what additional information sho uld be included? Is the derivation of the qPCR value using the EPA data scientifically su pported and adequately explained?

4:15 p.m. 5. Other general or specific comments not addressed in the charge questions will be

discussed.

4:50 p.m. Wrap Up and Plans for Writing Session

.................................................. ....................... **Rachel Noble**

5:15 p.m. ADJOURN (Formal meeting closes)



# Writing Session

Tuesday, September 13, 2011

8:30 a.m. Review of Yesterday’s Discussions and Plans for Rep ort Summary

... **Rachel Noble and Kate Schalk**

8:45 a.m. Writing Session .........................

................................................... ........................ **Reviewers and ERG**

10:15 a.m. BREAK

10:30 a.m. Writing Session ........................

................................................... ......................... **Reviewers and ERG**

12:00 p.m. LUNCH (working lunch if needed)

1:30 p.m. Writing Session ........................

................................................... ......................... **Reviewers and ERG**

3:30 p.m. Wrap Up Writing Session and Instructions for Post Meeting Work ............................

....... **Kate Schalk**

3:45 p.m. Writing Session ClosesE-1 

## Appendix E

List of Reviewers and ObserversE-3 United States Environmental Protection Agency Office of Water 

# Peer Review Meeting for EPA’s Draft Recreational Water Quality Criteria for Human Health

September 12-13, 2011



# Peer Reviewers

Samuel Dorevitch Associate Professor Division of Environmental and Occupational Health Sciences School of Public Health Institute for Environmental Science and Policy University of Illinois at Chicago Chicago, IL



### Erin K. Lipp Associate Professor Department of Environmental Health Science College of Public Health The University of Georgia Athens, GA



### Graham McBride Principal Scientist National Institute of Water and Atmospheric Research Ltd. (NIWA) Hamilton, New Zealand 

### Rachel Noble (Technical Chair) Associate Professor University of North Carolina - Chapel Hill Institute of Marine Sciences Morehead City, NC



### Gordon Yasvinski Scientific Evaluator Health Canada Ottawa, Ontario CanadaE-4 United States Environmental Protection Agency Office of Water



# Observers

Shamima Akhter U.S. Environmental Protection Agency Office of Water Health and Ecological Criteria Division Washington, DC



### Elizabeth Doyle U.S. Environmental Protection Agency Office of Water Health and Ecological Criteria Division Washington, DC



### Sharon Nappier U.S. Environmental Protection Agency Office of Water Health and Ecological Criteria Division Washington, DC



### John Ravenscroft U.S. Environmental Protection Agency Office of Water Health and Ecological Criteria Division Washington, DC



### Jeff Soller Soller Environmental Berkeley, CA



### Contractor Staff

Kate Schalk Eastern Research Group, Inc. Lexington, MA



### Michelle Arbogast Eastern Research Group, Inc. Lexington, MA 

### Remote Observers

Alfred Dufour U.S. Environmental Protection Agency Office of Research and Development National Exposure Research Laboratory Cincinatti, OH



### Robert Cantilli U.S. Environmental Protection Agency Office of Research and Development Office of Science Policy Washington, DC



### Kevin Oshima U.S. Environmental Protection Agency Office of Research and Development National Exposure Research Laboratory Cincinatti, OH



### Tim Wade U.S. Environmental Protection Agency Office of Research and Development National Health and Environmental Effects Research Laboratory Research Triangle Park, NC