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HomeMy WebLinkAbout10 - Health Risk Assessment for Newport BayAgenda Item No. 10 ---- - - - - -- - - -- ------ FROM: Dave Kiff, Assistant City Manager SUBJECT: The Health Risk Assessment for Newport Bay RECOMMENDED (1) Authorize the Mayor to send a letter to the Regional Board stating the City of ACTION: Newport Beach's official position that the Health Risk Assessment for the Newport Bay Watershed: a) Is based on poor science and is therefore fatally flawed; and b) Should not be used by the Regional Board to determine policy relating to the Fecal Coliform TMDL; and c) Should beset aside, with no further resources being spent upon it (2) Authorize the Assistant City Manager to co -sign a letter from the watershed partners stating the City's formal position and also stating the partners' collective belief that the Assessment ('s): a) Is based on poor science and may have fatal flaws; b) Should not be used by the Regional Board to determine policy relating to the Fecal Coliform TMDL; and C) May, if recommended by a majority of the partners, be subject to a 3rd Party review and that this 3�d Party review should be done by the State Department of Health Services (DHS). d) Review by DHS should be a launching point for further studies of Newport Bay that more accurately examine the health risks of swimming in the Bay. QUICK SUMMARY: The Irvine Ranch Water District (IRWD) and the Irvine Company, as partners in the Newport Bay watershed, convinced the Regional Board and the remaining watershed partners (including the City) to fund an assessment of the health risks of swimming in Newport Bay. The Assessment was criticized from inception by Defend the Bay and others, who said that the basic science of the Assessment was flawed and that the ultimate goal of the Assessment was to weaken the Fecal Coliform TMDL so that bacteria -laden inputs at San Diego Creek wouldn't have to be cleaned up. The Assessment is about done. Its draft final report concluded that the Bay is quite clean. It concluded that the biggest bang for the buck would be to spend dollars on an education campaign that would cut illegal vessel waste discharges into the Bay. Defend the Bay and others - arguing that spending good money after bad makes no sense - want the City to formally abandon the Assessment before it's finalized. Others want the Assessment to be reviewed by a 3�d party and then, due to its controversy, set aside and only be used to launch additional (and more appropriate) studies about health risks in the Bay. Page 2 THIS AGENDA This Agenda Item asks the Council to take a formal position on "what to do next' ITEM: with the draft final Health Risk Assessment. DETAILED Newport Bay is designated under Section 303(d) of the federal Clean Water Act as BACKGROUND: an impaired water body, meaning that its beneficial uses (like swimming and wading[REC -1], kayaking, and shellfish harvesting [SHEL]) are impaired by specific contaminants. The Clean Water Act provides two major mechanisms to clean up water quality limited bodies: • Watershed Restoration Action Strategies. This mechanism provides a comprehensive, regional approach to improving water quality throughout a water body's tributary system. • Total Maximum Daily Loads. This mechanism focuses restoration activities within specific waters by requiring a reduction of pollutants in order to meet the applicable water quality standards needed to protect "beneficial uses." TMDLs. TMDLs received new emphasis in the early 1990s as citizens' organizations brought legal action against the federal Environmental Protection Agency (US EPA) to comply with the Clean Water Act by listing waters as water quality limited and by developing TMDLs. Eighteen suits nationwide, including one brought by Defend the Bay to enforce the Clean Water Act, have forced development of TMDLs. Defend the Bay's Consent Decree with the U.S. EPA created a timeline for the establishment of Newport Bay's TMDLs. Nationwide, more than 2,000 TMDLs are under development. About 1,250 have already been established by the EPA or its state partners (in California, the State Water Resources Control Board is the state partner). Ultimately, almost 40,000 TMDLs will have to be established nationwide. Newport Bay has the distinction of having the TMDL adopted into its basin plan. Implementation plans for TMDLs are not regulated under federal law and therefore can be moving targets as issues are negotiated locally and established at the discretion of the Regional boards. Newport Bay will have at least four TMDLs: • Sediment. Adopted on October 9,1998, the Sediment TMDL requires local partners (stakeholders in the watershed) to survey the Bay regularly and to reduce annual sediment coming into the Bay from 250,000 cubic yards to 125,000 cubic yards (a 50% reduction) by 2008. The TMDLs' goal is to reduce dredging frequency in the Bay to once every 20 to 30 years. • Nutrients. Approved by US EPA on April 16,1999, the Nutrient TMDL limits nitrogen and phosphorus inputs to the Bay. The Nutrient TMDL attempts to reduce the annual loading of nitrogen by 50% — from 1,400 pounds per day today to approximately 850 to 802 pounds per day at San Diego Creek - by 2012. Phosphorus loading must fall from 86,912 pounds per year in 2002 to 62,080 pounds by 2007. • Fecal Coliform. Approved on December 30,1999, the Fecal Coliform TMDL will attempt to make the Bay meet water contact recreation (RECD standards Page 3 (swimming, wading, surfing) by 2014 and shellfish harvesting (SHEL) standards (where waters support shellfish acceptable for human consumption) by 2020. • Toxics. Under development today and planned for implementation in 2002, the Toxics TMDL will address Bay inputs like heavy metals (chromium, copper, lead, cadmium, zinc) and priority organics (endosulfan, DDT, Chlordane, PCBs, Toxaphene, diazinon, chlorpyriphos, and more). The Fecal Coliform TMDL. The Fecal Coliform TMDL is among the most challenging of the TMDLs developed to date. The TMDL's monitoring provisions measure whether or not the Bay has met REC -1 and SHEL standards by testing for fecal coliform, an indicator bacteria whose presence may also indicate the presence of human pathogens like viruses and other bacteria that can make humans sick. The best way to test for the presence of human viruses is to test for the viruses themselves - but such tests are expensive and there is only marginal consensus on the best methodology to use. A cheaper alternative is to look for indicator bacteria. Experts disagree on whether fecal coliform is the best indicator bacteria to use. For example, fecal coliform is typically present in the fecal matter of warm- blooded creatures like ducks, cats, dogs, feral animals, humans and more. It is also present in some soils and many fertilizers. Fecal coliform from a non -human source may or may not have any pathogen associated with it that is harmful to humans. But while fecal coliform may not be the perfect indicator of human pathogens, experts again disagree on what might be better. The Health Risk Assessment. As the Regional Board considered adopting the Fecal Coliform TMDL in April 1999, some of the Newport Bay watershed partners - specifically the County, the Irvine Company, and IRWD - asked the Board to conduct a Health Risk Assessment Of the Bay's waters. The $261,000 assessment would attempt to model the flow of a human virus down the Bay by using another indicator -f specific coliphage. The Assessment would then attempt to measure a Bay user's relative health risk in using the Bay by looking at levels of coliphage in the waters. Specifically, the Assessment had seven components: • A survey of Bay users (an assessment of beneficial uses); • The configuration of a model that shows how f specfc coliphage and coliform may get transported down the Bay (the modeling); • Routine testing for f specific coliphage and coliform between July 1999 and July 2001; • An evaluation (via a survey) of the "no discharge" limitations on vessel waste; • A characterization of a Bay user's risk of getting sick from a human enteric virus associated with either fspedffc coliphage or fecal coliform; • A comparison of this illness risk with risks in other water quality environments; and • A comparison of benefits and costs associated with programs thatwould limit pathogen inputs to the Bay as tempered by relative improvements in human health risks. Payment for the Assessment was intended to be as follows: State of California $205,002 The Irvine Company 5,000 IRWD 5,000 Cities of: — Newport Beach 3,714 —Costa Mesa 3,714 - -Irvine 3,714 —lake Forest 3,714 —Santa Ana 3,714 —Tustin 3,714 County of Orange /NPDES 23,714 Total $261,000 Page 4 The Regional Board designated the Irvine Ranch Water District (IRWD) as the project manager for the Assessment. In January 1999, IRWD hired Eisenberg, Olivieri, & Associates (EOA) to complete the Assessment using a bacteria transport model developed by a second firm, Resource Management Associates (RMA). A 15- member Health Advisonj Committee (HAC) was to advise EOA in the effort. Larry Honeyboume of OC Health Care Agency and Dr. Jack Skinner were named as ex officio members of the HAC. The ex officio members attended only the first meeting all other meetings were conducted without their attendance. Dogged by Controversy. Almost from its inception, Mr. Bob Caustin and Defend the Bay and Dr. Jack Skinner have criticized the Assessment and questioned its value. Defend the Bay's questions and concerns included: • Is f specific coliphage an appropriate indicator of human pathogens? F specific coliphage is a virus that infects E. coli bacteria but does not cause human infection. 98% of fecal matter does not contain any f specific coliphage, but the fecal matter still could contain significant numbers of viruses harmful to humans. Typically, f specific coliphage indicates the presence of treated wastewater (where the virus has multiplied thanks to the presence of E. coh). Because it is most often found in the treatment process, f specific coliphage is not likely to be present with untreated human waste. Therefore, the Assessment might understate the health risk of swimming in the Bay by understating a presence of untreated human waste. • Do user surveys provide appropriate data? The Bay user surveys — asked of swimmers, beachgoers, surfers, and boat owners - may not be answered truthfully. Nor would the survey reach people who have stopped using the Bay because of perceived water quality problems. Would the survey results inappropriately skew the results of the overall Assessment? • Is the methodology of the Assessment valuable? The Assessment uses a transport model (estimating the path and life off specific coliphage down the Bay) and a complex risk assessment that projects the incidence of illness in Bay users. The Assessment's model assumes one human enteric virus for each f specific coliphage found. This assumption and others may not be as accurate as a full-scale epidemiological study like the one done in Santa Monica Bay in 1996. • What's the end motive? Will the results of the Assessment - even with assumptions subject to debate - be used by upstream local partners to convince the Regional Board to modify the Fecal Coliform TMDL to allow water exceeding bacteria standards into Upper Newport Bay at San Diego Creek? While the Assessment can fairly be subject to criticism about its assumptions (criticism that EOA itself has acknowledged), some have defended the Assessment by offering the following points: • Is there a better alternative? No one has yet proposed a more appropriate indicator to track than f specific coliphage. The indicator has a limited "track record" because this type of Assessment and modeling is somewhat unprecedented. • Helping with the TMDL itself. At least three aspects of the Assessment - the modeling, the review of beneficial uses and users, and the sampling program - satisfy portions of the Fecal Coliform TMDL's monitoring requirements. Page 5 Arguably, the City would be hard - pressed to complete these same tasks individually for less than the $3,714 it paid for the Assessment. • EPA and the Regional Board still matter. Assuming that the Assessment shows that swimmers don't get sick from a San Diego Creek bacteria or virus and upstream partners argue for a modified TMDL that doesn't require water clean- up at the Creek, that may not be good enough for US EPA and the Regional Board. Both may still require the Creek's waters to meet the TMDL's standards as it enters the Bay. The Assessment's Draft Results. In May 2001 EOA released their draft final report of the Assessment. Generally, the draft final report says that: • More recreation occurs at Newport Dunes than at any other recreational site in the Bay (247 -920 bay users in one hour at any one day) (p3 -2 and 3 -6). • The impact of bather loading on the waters is negligible, except for the Dunes (p3 -7). • For the purposes of the Assessment 10% of the Harbor's boaters are assumed to illegally discharge waste -- discharging 1.2 x 1016 infective virus particles /day into the Bay (p4 -9). • Rigorous calibration of the coliphage model "was not possible' based on the limited amount of quantifiable coliphage data (p54). • Eliminating coliphage loading from San Diego Creek would lower coliphage at lower Bay testing sites from 6-30 %. Eliminating coliphage loading from the Santa Ana /Delhi Channel would lower coliphage at lower Bay testing sites from 2 -11 %. Reducing bather loading by 50% would have no significant impact. Reducing vessel waste loading to 10% of the estimated amountwould have "the largest impact" and reduce coliphage levels by 50-80% at the 25 Bay testing sites (p5 -8). • The risk of disease by swimming in the Bay is 15 /1000 (15 swimmers per 1,000 will get an illness), which is less than the median of 19/1000 used by US EPA as the acceptable level of illness (p6 -23). • Even if the estimated concentrations of enteric viruses in Newport Bay were several orders of magnitude higher and that are currently estimated to be, the predicted number of diseased cases per swimming event would be within the level of risk considered acceptable by EPA for recreational activities (p7 -5). • Even if the levels of viruses contributed to Newport Bay via vessel waste loading were 100 times higher than estimated or if bather loading were 200 times higher than estimated, the estimated risk to an individual per swimming event would still be within the levels considered acceptable by US EPA (p7 -7). The Assessment also analyzed various projects or programs that might reduce pathogen loading in Newport Bay. EOA examined the estimated benefits and costs for these projects and presented them this way (p9 -13): A:. a AlmLK Dmnplw .d esses Pa mswm Evnt Keau • Esm wV10.000 C ot l swrn 9ve s APcmhleEwdDnlg i ly G oW a 0 ExlsOng Conditions -- no change 9.3/10,000 N/A 1 Divert Back Bay Drain (BBD) 1 6.3/10,000 N/A $ 15,000 High 2 Divert BBD and San Diego Creek 5.2/10,000 1.1 $ 2,359,000 High 3 Divert BBD and Santa Ana /Delhi Channel 5.9/10,000 0.4 $ 1,405,000 High 4 IDivert BBD and all UNB storm dmins I 6.3/10,000 0 $ 219,000 High 5 Divert BBD and cut vessel loadings by 90% 2.8/10,000 3.5 to $70,000 Unknown 6 Divert BBD and cut bather loading b 50% 6.1/10,000 0.2 1 to $50,000 Unknown Page 6 As the table shows, EOA concluded - at least in the draft final report - that the most cost - effective way to continue to clean up an already clean Bay would be to conduct a boater education program that cut illegal vessel waste discharges to 10% of what may be discharged today. Diversion of the major tributaries to the Bay - the San Diego Creek and the Santa Ana /Delhi Channel - were deemed to be very expensive and to not result in significant reductions in swimmer illness. As an important note to the EOA draft conclusions, Dr. Skinner and others say that the HAC to which they were appointed was not consulted much - if at all - in the Assessment's development. Dr. Skinner strongly believes that the HAC was neglected by EOA as a resource to the Assessment and that his participation was a waste of his time. Divergent Views Over What to Do Next. The draft final report is ready to be completed by EOA and sent to the contract manager (either 1RWD or the County of Orange) in its final form. We can assume that, when the report is finalized, it will be sent to the Regional Board for consideration. Several watershed partners who co- funded the Assessment would like to see the Assessment subject to an independent 3�d party review - a review convened by the California Department of Health Services (DHS). So would Ms. Joanne Schneider, the Environmental Program Manager for the Santa Ana Regional Board (Ms. Schneider's letter of September 18, 2001, is Attachment A). Others - like Mr. Caustin and Dr. Skinner - believe that the Assessment is now and always has been based on flawed science (due to its use of f specific coliphage as an indicator of human pathogens) and is therefore worthless. As such, Mr. Caustin believes that no further time or resources should be spent on it (a letter from Mr. Caustin, attaching further correspondence from Defend the Bay's consultants, is Attachment B and Dr. Skinner's letter is Attachment C). At its meeting on September 13, the Harbor Quality Committee had a healthy discussion about the Assessment and voted to recommend to the City Council that the Council send a letter to the Regional Board stating that the Assessment is based on flawed science and should not be considered further by the Regional Board or by any regulatory agency. Respectfully, l have a minor but significant disagreement with Mr. Caustin and the members of HQAC. I agree that the Assessment is flawed - probably fatally. I firmly agree that it should never be considered by the Regional Board to determine policy for the Fecal Coliform TMDL. But 1 also believe that the City - as a watershed partner - cannot unilaterally pull away from the Assessment. If we do so, it is likely that other watershed partners will submit the Assessment to a 3�d party review and bring it before the Board regardless of our dislike of the document. The 3,d party review - if convened without the City's input — may be used by others to validate the Assessment and then to convince the Regional Board to weaken the TMDL. As such, l have suggested that the City take a bifurcated position as follows: • Mayors Letter. The Mayor should be authorized to write the Regional Board and state the City's formal position that the Assessment is flawed and not worthy of any further review. • Watershed Partners' Letter. I ask via the Recommended Actions that the Council permit me to co -sign a letter to the Regional Board with the rest of the watershed Page 7 partners (IRWD, The Irvine Company, the County, and the cities of Irvine, Lake Forest, Tustin, Santa Ana, and Costa Mesa) that states that: The Health Risk Assessment portion of EOA's work is based on poor science. Other parts of EOA's effort, including RMA's modeling and the assessment of beneficial uses in Newport Bay, are acceptable tasks that have met the obligations required of us under the Fecal Coliform TMDL. — The Health Risk Assessment should never be used by the Regional Board to determine policy relating to the Fecal Coliform TMDL. The majority of the watershed partners, though not the City of Newport Beach, may wish to send the Assessment to a 3�d Party review. The 3rd Party review should be convened by a DHS -based panel - focusing on key issues like the validity of using f specific coliphage as an indicator of human pathogens. — The Review should additionally suggest further studies - possibly an epidemiological study - that more accurately characterize health risks from swimming in the Bay. ATTACHMENTS: Attachment A - Ms. Schneider's Letter Attachment B - Letter from Mr. Caustin w /comments from Drs. Gersberg and Haas Attachment C - Dr. Skinner's Letter 09/24/01 13:20 FAX 949 476 1187 Sent By: EOA,INC.; Sent by!.00 PFRO ENV RESOURCES IM WATER QUALITY 510 832 2856; SOP -21 -01 1:OSPM; 716 567 6220; 09/20/01 13 :58; jHDUL_; Attachment A It:!% California Regional Water Quality Control Board AMk Sants Ana Region Inkme111d4mL Wlayrle�n � B.,H� k tSOX hnP:1h ww.3x1 eh.asoV1r* tt paw 3779 Ariw Stae tYe 6ee,Rlvmade, Crra 31.9748 Gw Ef,Wrmwennl Paaat (V9) 7824130 -FAX (909) 7314 -48 Fraaedm YU mealy el,allcoo do Ca6foma 6rml Every Caltiwnw —do bsale bw4ftV anb+ ro nNn. anWee"WLV0.. Fw a lu, of dwpL weyvloa rm eaq,n &bmmddad ew yma AY rear. nee m WbLree m vw., rcb.oayaVhwgn6a September 18, 2001 Mr, Chris Crompton Manager, Environmental Resources Public Facilities and Resources Deparvnent County of Orange 1750 S. Douglass Road Anaheim, CA 92906 Dear Mr. Crompton, COMMENT'S ON Tim FINAL DRAFT EOA REPORT We have reviewed the draft Final EOA report entitled Public Health Fisk Assessment far the eew,part Bay Washed: Recreational Co at and Mierobioloaical R isle May, 2001, and offer t le following commeau. As you know, the work conducted by EOA aryl its subountractor, Resource Management Associates (RATA), included tasks specifically required by the fecal eolifatm TMD These included the development of a water quality model capable of analysis of the transport anc fatc of fecal eoliform bacteria, and at1 assessment of the water contact recreation (REC -1) beneficial t sa in Newport Bay. We believe that these tasks have been satisfactorily completed_ The EOA work also included an assessment of the public health risks of water contact recreation the Bay, and of various management alternatives and their costs. This part of the study was not required by the TMDL. The stated intent of this element of the study was to assist the Regional Board in making informed, reasonable risk management decisions, i.e., whether, where and in W priority control measures should be implemented. As you are well aware, there has been, and remains, considerable concern and controversy about the scientific approach employed in this pa the study, leading to recommendations for review of the study Wan tndopettdent panel of expert We agree that such independent review is necessary and appropriate. We recognize that the sclettcc of pathogens, pathogen indicators and public health risk is highly complex and fraught with uncertainly. Given this, we believer that it is imperative that the BOA results be viewed with caution, unless and until the study is subjected to peer review and the val i of its results arc confirmed, to the extent that is possible. Moreover, we believe that the FAA sea results must be considered in the context of the results of other studies that are being conducted i or will be conducted in the future. These studies must also be subjected to peer review. Ideally, independent rcv)cty panel would also provide guidance and direction concerning the nature of investigations that should be conducted to assess public health concerns in the Bay and to evalue SEP -24 -2001 14:09 California Envfrorrmenraf PrOW06n Agency Re0Wed/gan 949 476 1187 96i P -01 09/24/01 13:20 FAX 949 476 1187 IRWD WATER QUALITY f)ij002 Sent By: EOA,INC.; 510 832 2858; Sep•21.01 1:05PM; Page 2/2 __... ,.r, ..- �.. neawm6ca /14 b67 8220; 09/20/01 13;SB; JA[EYa_ #Bl11;Page 313 Mr. C RD Cmnpton -2- Seprambar 19, 700) appropriate control measures. As we have discussed with you, we believe that it would be appropriate for the Rcgiooal Hoard to solicit the assistance of the California Department of Hea Services in the formation and overaigbt of such an independent review panel, and we have initis contact with the Department on this matter. We appreciate the oppornmity to comment on the MAL report, and we also appreciate the efforts the watershed stakeholders to fulfill the requirements of the TNIDL. If [bore are any questions concerning these comments, please contact me at (909) 792 -3287 or Wanda Smith, Chief of Goes Planning,at(909) 792 -4469. Sincerely, ?""' gr Joanne E. Schneider, Environmental Program Manager Ca4yornia Environmental Protection Agency OV %cp x�rrraP4+r, SEP -24 -2001 14:09 949 476 1187 96% P.02 10 -02 -2001 12:470M Fram- NATURAL RESOURCES DEFENSE COUNCIL October 2, 2001 Members of the Newport Beach City Council City Hall P.O. Box 1768 Newport Beach, CA 92658 -8915 3239341210 T-366 Attachment B Re: Public Health Risk Assessment for Newport Bay Dear Members of the Newport Beach City Council: 1 am submitting this letter on behalf of Defend the Bay to express my organization's serious concems with the Public Health Risk Assessment conducted by EOA, Inc. Specifically, due to inherent flaws in the approach taken in the study, we have numerous concerns about any attempt to use this study to evaluate the impairment of beneficial uses of the Bay or to make public policy determinations concerning the health risk of swimming in the waters of Newport Bay. Defend the Bay has spent tuts of thousands of dollars on public health and technical experts to review and comment on the various stages of this health risk assessment in an attempt to identify the flaws up front and to make constructive comments suggesting alternative approaches that would be more sound from both a scientific and a public policy perspective. As you can see from the attached letters from Richard M. Gersberg, PIT.D., Professor of Environmental Health at UCSD, Charles N. Haas, Ph.D., Professor of Environmental Engineering at Drexel University, and David W. Dilks, Ph.D., a principal at Limno-Tech, Inc., who participated in the technical review panel set up by EOA, Inc., the very issues we are now still very concerned with were raised from the beginning of this process, and yet were completely ignored by EOA. In fact, all parries appear to concede that the technical review panel process utilized in this case was an uner failure, with most of the participants feeling marginalized and ignored throughout the process. Recently, Dr. Mark Gold and Mitzy Taggart provided comprehensive comments summarizing the same fatal flaws in the final draft public health risk assessment conducted by EOA, Inc. Dr. Gold and Ms. Taggart both specialize in the area of microbiological contamination at beaches and the associated health risks. Their comments are also attached to This letter for your convenience. Their comments emphasize the main point here — the study is fundamentally flawed in its reliance on attempting To estimate levels of human enteric viruses using coliphage instead of using data derived from epidemiological studies. Coliphage has not been quantitatively linked to human health risk and Thus its use as an indicator of health risk associated with swimming is not scientifically defensible. OCT -02 -2001 14:40 3239341210 9ex, P.02 10-02-2001 12:47om Fram- NATURAL RESOURCES DEFENSE COUNCIL 3239341210 T-366 P.003 F-574 What is even more troubling is that this study ever went forward given that California recently completed an exhaustive examination of the appropriate indicators of the presence of pathogens at levels that pose health risks to humans. These indicators are set forth in AB 411 passed in 1999, and include total coliform, fecal coliform and enteroccocus. EPA has approved a similar standard for enteroccocus. The standards for these indicators were derived through well - documented epidemiological studies that specifically establish a quantitative relationship between the levels of these indicators in water and human health risk from swimming in that water. As stated above, this has never been done for coliphage. In fact, if the TMDL were modified as suggested by EOA, Inc. to adopt a coliphage limit in place of fecal coliform, it would result in the absurd scenario where the TMDL is met but the beaches would still be closed as exceeding both state and federal bathing water standards. In other words, there would still be an unacceptable health risk associated with swimming in the Bay. In addition to the fundamental flaw of using coliphage as an indicator, the study is based on a series of compounding assumptions that have not been validated with data specific to Newport Bay and by their very nature underestimate the true risk of swimming in Newport Bay. For instance, this study relies on an erroneously low number of users in its attempt to assess the risk to public health of recreating in the Bay. The inputs to the "use assessment" portion of this model are not even remotely sufficient or acceptable as a baseline for further analysis or decisions as to actual uses or the valuation of those uses in Newport Bay. As an example of this, in making its estimates of use, the study fails to account for (1) those people who choose not recreate to the Say due to present contamination, and (2) use of all of the usable portions of the Bay, including private beachfront, docks, and boats moored in the Bay. Defend the Bay's goal for Newport Bay is identical to the goal of the City of Newport Beach. We would like the Bay cleaned up so that we, and more importantly, our children can safely swim and recreate at the beaches. Given the fundamental flaws inherent in EOA's health risk assessment, the expenditure of additional quantities of rime and money —not to mention the associated delay in solving the underlying problem of contaminated waters —in continuing to review and push ahead this study that benefits certain dischargers at the expense of the Bay are entirely unwarranted. We think- you will agree that these resources would be much better spent on more proactive activities to solve the impairment such as source identification, characteri2ation and reduction activities in Newport Bay. Sincerely, AR.ber,�Caustin Founding Director Defend the Bay Enclosures OCT -02 -2001 14 =41 3239341210 96% P_M Comments of Charles Ar Haas on EDA, Inc. Proposal offDlay 5 1999 The proposal rects a desire to per a large -scale detailed model of disease dynamics ofbathers, and populations with whom they interact. This is an ambitious fort. Given the number of necessary inputs (model parameters/ required which are only poorly understood, it must be guestloned whether or not the proposed effort represents overkill': With a number of lnputparameters required there may be a great deal of potentialfiexibility of the outcome results (d e., some particular choices of !louts or ranges may yield to particular conclusions, whlle other - possibly equally plausible choices of inputs or parameters - may yield dferent conclusions') EDH refers to discussions on the ILSlframework, which the author of this review has been extensively involved in At the f➢fay 1999 meeting to review this framework, one of the desired attributes is transparency. In the interests of transparency, it is suggested that a deliverable of any modeling effort be computer code sufcient for an interested and competent risk analyst to replicate and uerfy the results attalned. There are a number of particular dfculties with the nature of the analysispr000sed. 1/ It is suggested to use coliohage as an intermediary to get from coliform measurements to human infectious ulrus measurements. Theprocess whereby this will be done has not been sped led in detail. While there is the possibility that site -sped nc correlatlons between conform and cohphage (types of bacterial virus/ may be established, there is no basis for supposing that collohage levels may then be correlated to human infectious virzis 2/ The population dynamic modelproposed by EDH requlres as an input a dose - response relationship (depicted as AW) in their documentation,) The process whereby this is estimated from the available dose - response information has not been described (nor is it well described in any of the prior EDH work /. Furthermore, the potency of human infectious viruses (infectivity/ spans many orders of magnitude, and the resulting risk estimate would be particularly sensitive to the nature of the distributions of infectivity that the modelers utilize. 3/ To employ a realistic dynamic model over the wide geographic range which is depleted would regulre some very detailed assumptions about how bathers from one community (utilizing a particular beach) interact with pooulationsfrom both the same area and other areas (to produce possible secondary cases /. It is far from clear how the populations will be subdiulded geographically, and more importantly how the data describing interactlons among diverse suboopulations will be obtained. 4) The jiourchart describing the proposed model and most of the prior work of the ZOHgroup uses an approach in which the distribution of times in each Of the states (incubation time prior to illness, time with symptomatic illness, etc./ is exponential This is unreallstic, and contradicted by much of the past literature. A more realistic approach (which makes the computation of the model much slower,) is to assume that the time distributions are lognormal, or some other simllar slreured distribution (Haas, Rose et al. 1999/. However such approaches may make Monte Carlo simulation currently impracticable on all butparallel computers or supercomputers 5/ On page 10 ZOHproposes to use an 'informal informatlonal survey': The apparent purpose of this is to obtaln residential information and perhaps surimmlag behavior This is important data input for computations, and considerably more attention needs to be devoted to obtaining representative samples (considering temporal and spatial variation /. 6/ Reglonal sensitivity analysis as proposed hk the authors is a./arm of Monte Carlo analysis. The authors should pay attention to the guidelines advanced for Burmaster and Anderson for this approach(2urmaster and Anderson 1994/, and in particular the thorough documentation of input distributions It is recommended that the input distributions beforrnulated and rior to running model simulations that these inputs bejust.lied and reviewed by appropriate scienti is committees and stakeholders R1,'F1,'RZA,rC1,S Burrnastel, D. Z. and P. D. Anderson (1994 /. Princoles of Good Practice for the Use of Monte Carlo Technlgues In Human Health and ZoologicalRtskAssessment. "RlslrAnalysis 14(41).• 477 -481, Haas, C. N., J. B. Rose, et al (1999 /. Vaantltative Allcrobial Rlsk Assessment Near York, John Wlleg• August 10, 1999 Mr. Robert Caustin Founding Director Defend the Bay 471 N. Newport Blvd., Ste. 200 Newport Beach, CA 92663 0=n This memo will briefly summarize some of the items discussed at the Newport Bay Watershed Management Committee meeting held at Irvine Ranch Water District on July 28, 1999. I will also critique the Project Status Update for the Human Health Risk Assessment (HHRA) for Newport Bay released by EOA, Inc. on July 28, 1999, which was marked as Agenda Item #6 of the Management Committee's Meeting. Unfortunately, at this meeting, Ken Thompson (IRWD) was not prepared to present the Risk Assessment Project Update since it had not been released in a timely manner. Therefore, the update to the Work Plan and any modifications of the HHRA were not discussed fully at this Meeting. In this regard, my services as a technical consultant were not utilized as efficiently as if the Management Committee had been able to follow its agenda as planned. I have reviewed the Project Status Update for the HHRA (EOA, Inc., 1999), and will now provide a rebuttal to EOA's "Response to Comments" contained in the Project Status Update and a critical analysis of the current Work Plan. I will not go into the rather convoluted technical details of much of what is presented by EOA, Inc. in the Project Status Update, but I will emphasize that my finding of a "fatal flaw" in the risk assessment study proposed by EOA, Inc. remains, and the "Response to Dr. Gersberg's Comments" in the Project Status Update did nothing to ease my serious concern for EOA's approach. Briefly stated, my concern is that there is a tremendous level of uncertainty in using coliphage as a surrogate for enteric viruses in Newport Bay, and indeed coliphage levels have never been significantly correlated to human virus levels in recreational marine waters. In this regard, the information presented by EOA, Inc. in the Project Status Update (page 11, 6`h paragraph) that coliphages have been shown to be "a good index of enteric viruses .... in estuarine waters and marine water" is misleading. The support for this statement is cited by EOA, Inc. in two papers by Borrego et al. 1987 and Calci et al. 1998. However, careful review of both of these papers, reveals that neither actually measured human virus levels nor correlated these levels with coliphage. Indeed, Calci et al.(1998) measured only coliphage in animal and human wastes and wastewaters, and Borrego et al. (1987) measured and correlated only levels of coliphage and E. coli. My statement that " coliphage levels have never been significantly correlated with levels of human virus in recreational marine waters" remains without contradiction by the EOA "Respone to Comments." In plain truth, there has only been a single study done by Arie Havelaar (1993) that measured both coliphage and human virus together and statistically correlated the levels, and this study was done on freshwaters in Europe. Even Havelaar (1993) stated clearly in his paper that "the prediction equations given in this paper....were obtained in a limited geographical region and by using only samples from fresh waters. More data are needed before the suitability of FRNA phages as virus models can be assessed on an international basis." Therefore, contrary to what is stated by EOA, Inc., there is absolutely no other data to support using coliphage in a predictive model for human virus in seawater. Of more concern, is the fact that Havelaar (1993) found that in certain waters tested, enterovirus could be isolated in the absence of FRNA phages. Havelaar himself stated "this is a more serious shortcoming of the phages as model organisms. "In this case, the EOA, Inc. model which uses coliphage as a surrogate for human virus, would actually underpredict the risk to human health. Such model performance would not be conservatively protective of human health, and contrary to standard public health policy. Other concerns I have about EOA's risk assessment modeling approach include the following: 1. Many of the major symptoms of bathing- associated disease from recreational waters are skin, eye, and ear infections caused by a variety of bacteria. The emphasis of EOA's model on predicting risk based on human enteric virus (even if coliphage could be used as a viral surrogate), will totally miss the quantitative contribution to human disease from these skin, eye, and ear infections, since there exists no data that coliphage levels correlate in any way to levels of such disease - causing bacteria. In this way, the EOA model would again be underpredictive of actual disease risk and contrary to public health policy. 2. Coliphage does not meet two of the important characteristics of a good indicator of fecal contamination and disease risk in humans. First, coliphages are not human- specific, and therefore cannot be used to distinguish between the risk from animal vs, human fecal contamination, the latter which no doubt exerts a somewhat reduced risk level. Second, the level of coliphages has never been significantly associated with actual human disease risk as measured in an epidemiological study. 3. In recreational waters contaminated by a variety of sources including urban runoff, boating discharges, and other swimmers, there is certainly a chance that other non -viral pathogens such as Cryptosporidiuni could cause waterborne disease. Indeed, there is strong evidence that Cryptosporidium (which forms encysted eggs) can resist environmental inactivation more readily than can virus and bacteria. In this case, the EOA model which does not have a surrogate for such infection, will again be underpredictive of actual human disease risk. I think I have aired many of my serious concerns about the model. In sum, I think there are too many uncertain and even erroneous assumptions in EOA's approach to make their model output of any quantitative value to health regulators and public policyrnakers. Sincerely, Richard M. Gersberg, PhD Professor of Environmental Health FROM : Panasonic TAD/FAX PHONE NO. 0c John E Skinner, M.D. 1724 Highland Drive Newport Beach, Califomia 92660 Phone/Fax (949) 650.5588 October 2, 2001 VIA FACSIMILE Newport Beach City Council 3300 Newport Boulevard Newport Beach, CA 92663 RF.: EOA's Health Risk Assessment for Newport Bay Dear Mayor Adams and Members of the Council: Attachment C W 1,0NA7a AM UCAN80Aa0OYNWRNALMMICM I strongly support the recommendation of the Harbor Quality Committee to send a letter to the Regional Board asking that they not consider the EOA health risk assessment study in any future policy decisions. I believe the EOA study is not scientifically defensible and, therefore, the study should not be used to relax the current bacterial standards for urban runoff entering Newport Bay from San Diego Creek and the Delhi Channel. At the invitation of Eisenberg, Olivieri and Associates (EOA), the environmental consulting firm conducting the Newport Bay health risk study, I attended the first Health Advisory Committee (HAC) meeting held on May 17, 1999, in Oakland. The IiAC was convened to review the design of EOA's proposed health risk study. I vigorously expressed my concerns that the proposed design was fatally flawed and would not stand up to scientific scrutiny. Several nationally known scientists provided similar concens at the initial meeting. In spite of the concems voiced by experts in the field, EOA and their consultants were determined to move ahead with their flawed study. The major flaw of the study is the reliance on the number of f= specific coliphage organisms (viruses that infect bacteria but not humans) to calculate illness rates of swimmers. To my knowledge, there is no scientific evidence that the rate of swimmer illness can be predicted by measuring the number of colipliage particles present in marine waters such as Newport Bay. After reviewing EOA's draft final report, I regret that 1 cannot draw any meaningful conclusions from the study regarding the safety of swimming in Newport Bay. 1 agree with the National Resources Defense Council that the EOA study is a "complete waste of time and resources." Sincerely, A� HN F. SKINNER; M.D. OCT -02 -2001 12:13 aaz P M1