v>EPA United States Environmental Protection Agency Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5) - Microbial Contaminants ------- Office of Water (4607M) EPA 815-R-21-007 July 2021 www. epa. gov/ safewater ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Table of Contents Table of Contents i Acronyms iii Chapter 1.0 Introduction 1 Section 1.2 Overview of Draft CCL 5 Process for Microbes 2 Chapter 2.0 Summary of CCL 5 Nominations for Microbial Contaminants 3 Section 2.1 Microbial Nominations for CCL 5 3 Section 2.2 Analysis of Nominated Microbial Contaminants 3 Chapter 3.0 Building the CCL 5 Microbial Universe 3 Section 3.1 Overview of the Microbial Universe 3 Chapter 4.0 Screening the Microbial Universe to Select the PCCL 5 4 Section 4.1 Application of Screening Criteria to the Microbial CCL Universe 9 Chapter 5.0 Determining the Draft Microbial CCL 5 10 Section 5.1 Application of Scoring Protocol to the PCCL and Selection of the Draft CCL 5 Microbes from the PCCL 14 Chapter 6.0 Microbial Data Sources for the Draft CCL 5 17 References 18 Appendix A: List of CCL 5 Microbial Nominations A1 Appendix B: The CCL 5 Microbial Universe B1 Appendix C: PCCL 5 Pathogen Scores CI Appendix D: The Draft CCL 5 for Microbes D1 Appendix E: Microbial Contaminant Information Sheets (CISs) El Acinetobacter baumannii Scoring Data E4 Adenovirus Scoring Data E8 Aeromonas hydrophila Scoring Data E12 Arcobacter butzleri Scoring Data El 5 Aspergillus fumigatus Scoring Data El9 Astrovirus Scoring Data E24 Blastocystis hominis Scoring Data E27 Calicivirus Scoring Data E30 Campylobacter jejuni Scoring Data E34 l ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Comamonas testosteroni Scoring Data E38 Cyclospora cayetanensis Scoring Data E41 Entamoeba histolytica Scoring Data E44 Enterovirus Scoring Data E48 Escherichia coli (0157)^ Scoring Data E53 Exophiala jeanselmei Scoring Data E58 Fusarium solani Scoring Data E61 Helicobacter pylori Scoring Data E65 Hepatitis A Virus Scoring Data E69 Hepatitis E Virus Scoring Data E73 Isospora belli Scoring Data E77 Legionella pneumophila Scoring Data E80 Microsporidia Scoring Data E84 Mycobacterium abscessus Scoring Data E87 Mycobacterium avium Scoring Data E91 Naegleria fowleri Scoring Data E95 Nontuberculous Mycobacteria (NTM) Scoring Data E99 Pantoea agglomerans Scoring Data El02 Plesiomonas shigelloides Scoring Data El06 Pseudomonas Aeruginosa Scoring Data El 10 Rotavirus Scoring Data El 13 Salmonella enterica Scoring Data El 17 Shigella sonnei Scoring Data El21 Toxoplasma gondii Scoring Data E125 Vibrio cholerae Scoring Data E129 Yersinia enterocolitica Scoring Data E133 Appendix F. CCL 5 Data Source Descriptions F1 li ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Acronyms CCL Contaminant Candidate List CCL 1 EPA's First Contaminant Candidate List CCL 2 EPA's Second Contaminant Candidate List CCL 3 EPA's Third Contaminant Candidate List CCL 4 EPA's Fourth Contaminant Candidate List CCL 5 EPA's Fifth Contaminant Candidate List CDC Centers for Disease Control and Prevention CIS Contaminant Information Sheet CNS Central Nervous System EPA Environmental Protection Agency GWR Ground Water Rule MAC Mycobacterium avium complex MCL Maximum Contaminant Level MCM Manual of Clinical Microbiology MMWR Morbidity and Mortality Weekly Reports NDWAC National Drinking Water Advisory Council NIH National Institute of Health NORS National Outbreak Reporting System NPDWR National Primary Drinking Water Regulation NRC National Research Council NTM Nontuberculous mycobacteria OGWDW Office of Groundwater and Drinking Water PCCL Preliminary Contaminant Candidate List PWS Public Water System SAB Science Advisory Board SDWA Safe Drinking Water Act WBDO Waterborne Disease Outbreak 111 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Chapter 1.0 Introduction The 1996 Safe Drinking Water Act (SDWA) Amendments (section 1412(b)(1)) require the United States Environmental Protection Agency (EPA) to publish every five years a list of drinking water contaminants that are known or anticipated to occur in public water systems (PWSs) and that may cause adverse health effects. SDWA specifies that the list (referred to as the Contaminant Candidate List, or CCL) must include contaminants that are not subject to any proposed or promulgated National Primary Drinking Water Regulations, are known or anticipated to occur in PWSs, and may require regulation under SDWA. EPA uses this list of unregulated contaminants to help identify priority contaminants for regulatory decision making and prioritize research and data collection efforts. SDWA also requires the agency to consult with the scientific community, including the Science Advisory Board (SAB), and provide notice and opportunity for public comment prior to the publication of the Final CCL. In addition, SDWA directs the agency to consider the health effects and occurrence information for unregulated contaminants to identify those chemicals and microbial pathogens that present the greatest public health concern related to exposure from drinking water. Section 1.1 Background to the CCL The first CCL (CCL 1), published on March 2, 1998, (63 FR 10274, USEPA, 1998a) was developed based on recommendations by the National Drinking Water Advisory Council (NDWAC) and reviewed by technical experts. CCL 1 contained 50 chemicals and 10 microbial contaminants/groups. EPA published the second CCL (CCL 2) on February 24, 2005 (70 FR 9071, USEPA, 2005). With CCL 2, EPA carried forward the 51 remaining chemical and microbial contaminants from CCL 1 (that did not have regulatory determinations). During the development of the CCL 3, EPA requested assistance from the Water Science and Technology Board of the National Academy of Sciences' National Research Council (NRC) in developing a more robust approach to identifying and prioritizing potential drinking water contaminants. NRC formed the Committee on Drinking Water Contaminants, and the committee published their recommendations in 1999 and 2001 (NRC, 1999a; NRC, 1999b; NRC, 2001). EPA used these recommendations to develop the CCL classification process implemented during CCL 3. In developing the CCL 3, EPA established and implemented a multi-step process to select contaminants (Figure 1). The steps listed below were established to select microbial contaminants specifically. The NRC also provided recommendations for chemical contaminants, the process for how EPA prioritizes chemical contaminants can be found in a separate document- Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5) - Chemical Contaminants. • Step 1. Building a broad universe of all microbes that may cause human disease. • Step 2. Screening that universe of microbial contaminants to produce a Preliminary CCL (PCCL). Page 1 of21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 • Step 3. Selecting the Draft CCL microbial list by ranking the PCCL contaminants based on occurrence in drinking water (including waterborne disease outbreaks) and human health effects. Figure 1: Draft CCL Development Process Building the Universe Universe Screening Preliminary CCL (PCCL) ro Classification/ Selection Draft CCL CO Following the process developed for CCL, CCL 3 was published October 8, 2009 (74 FR 51850, USEPA, 2009a) and contained 104 chemicals or chemical groups and 12 microbial contaminants. EPA carried forward all microbes listed on the CCL 3 to the Fourth Draft CCL (CCL 4). EPA also reviewed the nominations and supporting information provided by nominators to determine if additional microbes should be added to the Draft CCL 4. This process involved evaluating new data provided by the nominators that had not been previously evaluated for CCL 3. The agency also collected additional data for the nominated contaminants, when available, from updated CCL 3 data sources and any new data sources that were not available at the time of the CCL 3. EPA evaluated the nominated contaminants utilizing the best available health effects and occurrence data and followed the same process for screening and scoring contaminants used for the CCL 3. The agency published its final CCL 4 on November 17, 2016 (81 FR 81099, USEPA, 2016a). The final CCL 4 contained 97 chemicals or chemical groups and 12 microbial contaminants. Section 1.2 Overview of Draft CCL 5 Process for Microbes EPA developed the Draft Fifth CCL (CCL 5) using a similar process used for the CCL 3 and CCL 4 including developing a microbial universe, PCCL, and Draft CCL, as described in detail in Chapters 3, 4, and 5 of this document. Page 2 of21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Chapter 2.0 Summary of CCL 5 Nominations for Microbial Contaminants EPA sought public nominations in a Federal Register notice on October 5, 2018 for unregulated chemical and microbial contaminants to be considered for possible inclusion in the CCL 5 (83 FR 50364, USEPA, 2018). EPA compiled and reviewed the information from the nominations process to identify the contaminants nominated and any sources of supporting data submitted that could be used to supplement the data gathered by EPA to inform selection of the Draft CCL 5. Section 2.1 Microbial Nominations for CCL 5 Sixteen unique microbial nominations were submitted by the public in response to EPA's request for nominations for microbial contaminants to be considered for the Draft CCL 5. Eight microbes were nominated by more than one organization or individual. Legionella pneumophila received the most nominations, nominated by 18 organizations or individuals. Appendix A shows the organisms or group of organisms that were nominated, along with the number of nominators and any supporting information provided. Section 2.2 Analysis of Nominated Microbial Contaminants EPA reviewed the nominated microbial contaminants and the supporting information provided by nominators to determine if any new data provided had not been previously evaluated. Furthermore, the agency collected additional data for the nominated microbial contaminants by updating both the CCL 3 and the CCL 4 data sources and conducting literature searches covering the time between the CCL 4 and the CCL 5. Chapter 3.0 Building the CCL 5 Microbial Universe Section 3.1 Overview of the Microbial Universe The microbial universe was defined as any pathogen that causes human disease. The microbial CCL 5 Universe was developed based upon previous CCL universes, in particular, the CCL 3 and the CCL 4 Universes. During the development of the CCL 3, EPA followed the NDWAC's recommendation to specifically use Taylor et al. (2001) and literature reviews as the starting point for the microbial CCL 3 Universe (NDWAC, 2004). For the CCL 3, the agency added organisms to the Taylor et al. (2001) list, with input from subject matter experts and data collected through a literature search. For example, EPA reviewed fungi in drinking water literature and identified six fungal species reported to occur in drinking water distribution systems that did not appear on the Taylor et al. 2001 list. EPA also added reovirus to the CCL 3 Universe based on additional health effects information (Tyler et al., 2004). Additional microbes, Methylobacterium (with two species) and mimivirus, were added to the universe during CCL 3. Adding these two bacterial species, two viral groups (e.g., reovirus and mimivirus) and six fungal species to the microbial universe brought the CCL 3 Universe list to 1,425 microbes. These microbes remained in the CCL 4 Universe. EPA conducted a literature search, sought input from subject matter experts, and reviewed nominations for potential microbial contaminants to add to the CCL 5 Universe. As a result of the literature search, 14 organisms were added to the CCL 5 Universe (Table 1). Changes to nomenclature were made as necessary (in most cases combining two species into one organism Page 3 of21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 group), which brought the total to 1,435 microbes. EPA recognizes that given the dynamic nature of ongoing microbial research the listing of all human pathogens on the CCL universe needs to be periodically updated to keep up with the latest science. The full microbial CCL 5 Universe is presented in Appendix B. Table 1. Organisms Added to the Microbial CCL 5 Universe Organism Reference Alloscardovia omnicolens (bacteria) Brown, M. et al., 2016 Elizabethkingia anophelis (bacteria) Figueroa Castro, C.E. et al., 2017 Neoehrlichia mikurensis (bacteria) Portillo, A. et al., 2018 Parachlamydia acanthamoebae (bacteria) Greub, G., 2009 Waddlia chondrophila (bacteria) Baud, D. et al., 2014 Human bocavirus (virus) Allander, T., 2008 Human coronavirus SARS-CoV-2 (virus) Ciotti, et al., 2019 KI polyomavirus (virus) Bofill-Mas, S., etal., 2010 Kobuvirus (virus) Ramirez-Castillo et al., 2015 Lujo virus (virus) https://www.cdc.gov/vhf/luio/transmission/index.html Parvovirus 4 (virus) Sharp, C.P., et al., 2010 WU polyomavirus (virus) Bofill-Mas, S., 2010 Botrytsis cinerea (fungi) Hashimoto et al., 2017 Epiccocum purpurascens (fungi) httDs://www.insDa.ac.ca/en/moulds/fact- sheets/epicoccum-purpurascens Chapter 4.0 Screening the Microbial Universe to Select the PCCL 5 The development of the microbial Preliminary CCL 5 (PCCL 5) adhered to the process developed for the CCL 3 with additional updates described below. The CCL 3 process followed NRC recommendations to use a hierarchical framework for evaluating the potential occurrence of microbial contaminants in drinking water (NRC, 2001). For CCL 3, EPA also followed recommendations provided by NDWAC (2004) to select microbial contaminants for a PCCL based upon an assessment of occurrence and health effects attributes. This assessment related the plausibility of pathogen presence, survival, and transport through drinking water to disease manifestations from drinking water exposure. The CCL 3 screening criteria were developed based upon epidemiology, geographical distribution, and biological properties in the host and in Page 4 of21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 the environment. The screening criteria were recommended by NDWAC and amended by EPA following an external peer review resulting in 12 screening criteria used for initial screening of pathogens in the microbial CCL 3 Universe for placement on the PCCL 3 (NDWAC, 2004). Additional information on recommendations provided by NRC and NDWAC are described in EPA's Final CCL 3 Microbes: Screening to the PCCL (USEPA, 2009b) and NRC (NRC, 2001) and NDWAC reports (NDWAC, 2004). The 12 exclusion criteria were used to evaluate the five microbial groups (bacteria, viruses, fungi, helminths, and protozoa) but each criterion did not necessarily apply to every group. Some evaluation criteria would never be used to exclude microbes in a group because of fundamental characteristics of the microbes in that group. For example, Criterion 5: Microflora indigenous to the gastrointestinal tract, skin, and mucous membranes was not used to evaluate viruses and helminths. This was because viruses and helminths do not have a commensal relationship with a human host and are not considered a part of normal human microflora (Davis, 1996). Criteria that were not used are greyed out in their respective columns in the screening table presented in Appendix B. EPA restricted the PCCL to pathogens associated with source water, and recreational water (e.g., swimming pools, hot tubs) only if the source water was also utilized for drinking water. The screening criteria excluded those pathogens whose biological properties are incompatible with water transmission by ingestion, inhalation, or dermal contact, and those pathogens that are typically introduced from sources other than drinking water. For the CCL 5, EPA re-evaluated the 12 criteria utilized in the CCL 3 and the CCL 4 for applicability to microbes and reviewed certain criteria in depth per recommendations received from the SAB (USEPA, 2016c) and stakeholders during the development of the CCL 3 and CCL 4. In particular, Criterion 1 (anaerobes), Criterion 9 (natural habitat is in the environment without epidemiological evidence of drinking water-related disease) and Criterion 10 (not endemic to North America) were closely re-evaluated based on previous comments for the CCL 3 and the CCL 4 from NDWAC, SAB, and the public. Upon further evaluation, EPA did not find supporting evidence to modify Criterion 1 and Criterion 10. EPA's evaluation included literature searches for new information, internal EPA expert review, as well as feedback from subject matter experts at the Centers for Disease Control and Prevention (CDC). To determine if Criterion 1, anaerobes, should be modified, EPA conducted a literature search and found insufficient evidence supporting waterborne illnesses attributed to anaerobic microbes. Therefore, Criterion 1 remains unchanged. In response to the SAB's comments from CCL 3 and CCL 4 that Criterion 9 was too restrictive, EPA evaluated and expanded Criterion 9 to include nosocomial infections where drinking water is implicated. This expansion also recognized a growing concern for microbial contaminants within distribution systems, building water systems, and biofilms. For past CCLs, microorganisms that had outbreaks with no connection to contaminated distribution system water as their cause were screened out. Thus, outbreaks occurring due to nosocomial exposure or attributable to recreational water resulting from post-delivery contamination of drinking water were not sufficient to place a microorganism on the PCCL unless the drinking water was shown to be contaminated. A literature search was conducted for citations from 2009-2019 (post CCL 3 data collection) to look for evidence of waterborne diseases for certain microbes that were Page 5 of21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 excluded using Criterion 9. There is now evidence of either aerosol transmission from water or water-linked transmission for several microorganisms that were excluded from the PCCL 3. EPA also evaluated Criterion 10 to determine if additional microbes not previously considered endemic to North America should be passed through to the PCCL. The evaluation supported that Criterion 10 should remain unchanged. Upon completion of the re-evaluation of the 12 criteria, EPA screened all the microbes in the CCL 5 Universe with the updated Criterion 9 along with the other criteria through the exclusionary screening criteria listed and described below. Criterion 1: Anaerobes (microorganisms that cannot survive in oxygenated environments) Anaerobes are microorganisms that cannot survive in the presence of oxygen (Murray et al., 2007). Due to oxygen toxicity, anaerobes are unable to survive in the ambient water environment, and they pose a negligible threat to human health from drinking water exposure. Examples of anaerobes that were screened out based on this screening criterion included members of the bacterial genera Actinomyces, Bacteroides, Clostridium, Eubacterium, Fusobacterium, and Prevotella, among others (Murray et al., 2007). Criterion 2: Fastidious or obligate intracellular pathogens (environmental survival in water implausible) Fastidious or obligate intracellular pathogens rely upon their host to provide essential nutrients and growth factors that are not present in the environment, hence these pathogens cannot survive outside their hosts. Many fastidious or obligate intracellular pathogens have a narrow temperature and pH range as a result of host adaptation, and they cannot survive the wide range of temperatures and pH common in the ambient environment. Examples of fastidious or obligate intracellular pathogens that were screened out included members of the genera Chlamydophila, Mycoplasma, and Orientia (Murray et al., 2007). This criterion was applied only to bacteria, since all viruses are obligate intracellular pathogens (Knipe and Howley, 2007). Criterion 3: Pathogens exclusively transmitted by direct or indirect contact with blood or body fluids (including sexually transmitted diseases) Some pathogens are transmitted by direct or indirect contact with blood or body fluids, where fecal-oral transmission or transmission by aerosolized water is not observed (Mandel et al. 2005). Pathogens causing bloodborne diseases and sexually transmitted diseases are highly host adapted, fastidious, and are usually not present in feces. They do not survive under environmental conditions, and they are not transmitted by the fecal-oral route, either by direct contact with feces or indirect contact with contaminated drinking water. Examples of pathogens transmitted by blood or body fluids include the etiologic agents of gonorrhea and syphilis, Chlamydia, herpes virus, human immunodeficiency virus, and hepatitis virus B, C, D and G (Murray et al., 2007). Page 6 of21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Criterion 4: Pathogens transmitted by vectors Vectors include arthropods and rodents (Acha and Szyfres, 2001). Pathogens transmitted by vectors depend upon either insect or other bites, or close contact with rodents, and these pathogens are not transmitted by contact with drinking water. Mosquitoes, ticks, and fleas are the most common vectors of arthropod-borne diseases (Krause, et al., 2003). Examples of vector- borne pathogens include bacteria, viruses, protozoa, and helminths. The genera Babesia, Borrelia, Brugia, Dirofilaria, Ehrlichia, Leishmania, Plasmodium, Trypanosoma, Rickettsia, and all arthropod-borne viruses were not moved to the PCCL (Murray et al., 2007). Criterion 5: Microflora indigenous to the gastrointestinal tract, skin, and mucous membranes The human body is colonized with a rich and commensal microflora (Finegold et al., 1983; Drasar and Barrrow, 1985; Isenberg and D'Amato, 1995). Some microbes that colonize the human body are transitory, while others are part of the continuing normal flora of the body. Microbes comprising normal flora have a characteristic ecological niche, but sometimes conditions permit their access to areas of the body where they may exhibit pathogenic potential resulting in infection and disease. Infections with normally innocuous microbes are called opportunistic infections, because of their ability to exploit host conditions that may periodically predispose them to disease. Exposure to normal flora microbes is continuous throughout life, and because the populations of normal flora microbes exceed the number of these microbes present in drinking water by many orders of magnitude, drinking water represents an improbable source of infection and disease. Examples of normal flora include members of the genera Capnocytophaga, Corynebacterium, Staphylococcus, Streptococcus, and several yeasts (Murray et al., 2007). Criterion 6: Pathogens transmitted solely by respiratory secretions Pathogens causing respiratory disease are typically transmitted by direct contact with respiratory secretions, either by inhalation of aerosols, by direct person-to-person contact, or by contact with fomites. Drinking water is an unlikely mode of transmission because the number of pathogens in respiratory secretions and the continuity of exposure to respiratory secretions far exceed exposure through drinking water (Bennet and Brachman, 2007). Examples of pathogens transmitted by respiratory secretions include the etiologic agents of tuberculosis, diphtheria, whooping cough, measles, rubella, and influenza (Knipe and Howley, 2007; Murray et al., 2007; Mandel et al., 2005). Criterion 7: Pathogens whose life cycle is incompatible with drinking water transmission Page 7 of21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Some pathogens, such as helminths, require intermediate hosts to complete their life cycles, and incidental infection of humans results in an interruption of their life cycle with subsequent death of the pathogen (Acha and Szyfres, 2001). Some pathogens are adapted to a single route of transmission such as rabies virus, which is transmitted by animal bites. Some pathogens are specifically adapted to survive in a unique ecological niche, and they cannot withstand any alteration of conditions to which they are adapted. For example, rabies virus, Dientamoeba fragilis, Enterobius vermicularis, and many helminths remain in the microbial CCL 5 Universe and were not considered for the PCCL based on this criterion (Murray et al., 2007; Ashford and Crewe, 2003). Criterion 8: Pathogens where drinking water-related transmission is not implicated Some pathogens cause such rare occurrences of disease that only a few cases have been reported in medical literature, and these rare occurrences of disease present limited opportunity to protect public health from drinking water exposure (Acha and Szyfres, 2001; Knipe and Howley, 2007; Murray et al., 2007; Mandel et al., 2005). Some pathogens are associated with direct transmission from animals to humans, or other transmission routes that do not involve drinking water (Acha and Szyfres, 2001; Krause et al., 2003; Howard, 2003). Examples of pathogens that remained in the microbial CCL 5 Universe after application of this criterion are Leptospira, Listeria, Nosema, and the etiologic agents of several zoonotic virus infections (Knipe and Howley, 2007; Murray et al., 2007). Criterion 9: Natural habitat is in the environment without epidemiological evidence of drinking water-related disease and without evidence of drinking water-related nosocomial infection7. The environment is teeming with microorganisms, at varying concentrations, and humans are in constant contact with these microorganisms throughout their lives (Bennett and Brachman, 2007; Isenberg and D'Amato, 1995). Microorganisms naturally present in the environment are not considered a threat to public health as a result of drinking water exposure unless epidemiological evidence demonstrates a potential for water-related disease. Thus, outbreaks occurring in attributable to recreational water resulting from post-delivery contamination of drinking water are not sufficient to place a microorganism on the PCCL unless the drinking water system was shown to be contaminated (Wenzel, 2003). Gordonia, Nocardia, and most fungi were excluded from the PCCL based on this criterion (Murray et al., 2007; Howard, 2003). Criterion 10: Pathogens not endemic to North America 1 Bolded language indicates CCL 5 update to previous CCL 3 and CCL 4 Criterion 9 Page 8 of21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Some pathogens have an exclusive geographical distribution, and they are not naturally present in North America (Ashford and Crewe, 2003; Murray et al., 2007; Palmer et al., 1998). Only pathogens endemic to North America have the potential to contaminate drinking water in the U.S. Several helminths such as most Diphyllobothrium, and Paragonimus species and several viruses such as the hemorrhagic fever viruses and poxviruses would remain in the microbial CCL universe after application of this criterion. Criterion 11: A genus and species or serotype may be chosen to represent a group of closely related organisms EPA has chosen a few pathogens to represent a group based on all serotypes within a group sharing essential biological properties in common with the group. Designation of a representative group provides adequate protection of public health under the PCCL (Murray et al., 2007). Pathogens that represent other pathogens in their group are the following: Arcobacter butzleri, Campylobacter jejuni, Helicobacter pylori, Legionella pneumophila, Salmonella enterica, Shigella sonnei, Adenovirus, Astrovirus, Enterovirus, Microsporidia, and Entamoeba histolytica. For example, human adenovirus A, human adenovirus B, human adenovirus C, human adenovirus D, human adenovirus E, and human adenovirus F were listed as a group under adenovirus. Criterion 12: Current taxonomy does not support the classification listed by Taylor et al. (2001). Microbial taxonomy and nomenclature are a dynamic science, and taxonomic classifications are constantly changing. Original taxonomic classifications were based upon the phenotypic characteristics of microorganisms, but these classifications are being revised as genotypic information becomes available. New genera are formed, sometimes prematurely, based upon partial genomic data, and taxonomists do not always agree with proposed changes. Under this criterion, the genera Fluoribacter and Tatlockia were combined with the genus Legionella for screening purposes (Murray et al., 2007). Section 4.1 Application of Screening Criteria to the Microbial CCL Universe As the pathogens are screened through the 12 criteria, a pathogen needs to only to meet one criterion to be excluded from moving on to the PCCL. Some pathogens may meet multiple criteria, however, because the pathogens are evaluated through the exclusionary screening criteria sequentially, the criteria that the pathogen meets first will exclude the pathogen and the pathogen will not be further evaluated through the rest of the criteria. For example, if a pathogen could be excluded based on meeting Criteria 3 and 7, the pathogen will be screened out based on meeting Criterion 3 and not further evaluated to see if any other criterion is met. The pathogen will be documented as meeting just that one criterion. All pathogens that pass through all screening criteria are moved to the PCCL. Bacteria, viruses, protozoa, helminths, and fungi in the CCL 5 Universe are shown screened individually through the CCL exclusionary screening criteria in Appendix B. Each table identifies the pathogens in each category and indicates which screening criteria were applied to remove pathogens from Page 9 of21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 further consideration in the CCL process. Those pathogens not excluded by at least 1 of the 10 screening criteria or consolidated under Criteria 11 or 12 pass on to the PCCL. Table 2 summarized the number of microbes in the CCL 5 Universe, the number of microbes screened out by each criterion, and the resulting number of microbes passed on to the PCCL. Table 2. Summary of Screening Microbial CCL 5 Universe Pathogen Class Total Number of Microbes Excluded by Each Screening Criterion Pathogens Screened Out On PCCL 1 2 3 4 5 6 7 8 9 10 11 12 Bacteria1 545 121 16 10 38 121 7 0 29 150 2 28 5 527 18 Viruses 225 0 0 29 104 0 20 1 20 0 36 8 0 218 7 Protozoa2 66 0 0 1 29 3 0 4 7 7 0 6 0 59 7 Helminths 286 0 0 0 25 0 0 105 0 0 156 0 0 286 0 Fungi 313 0 0 0 0 12 3 0 0 295 0 0 0 310 3 Total 1,435 121 16 40 196 136 30 110 56 452 194 42 5 1,400 35 1 NTM were included on the PCCL as a group as well as individual Mycobacterium species. 2 Cryptosporidium and Giardia (protozoa) are considered to be regulated by the Long-Term Surface Water Treatment Rule (LT-2); even though counted in the microbial universe, they were not evaluated for screening. Based upon this screening exercise conducted on 1,435 pathogens in the microbial CCL universe 1,400 pathogens were excluded from consideration while 35 pathogens passed on to the PCCL. Thirteen of the 16 nominated microbial contaminants were listed on the PCCL 5. Appendix A details which nominated microbes were included on the PCCL 5. The modification made to Criterion 9 expanded the PCCL to include nosocomial infections where drinking water was implicated. This resulted in the addition of five bacteria (Aeromonas hydrophila, Acinetobacter baumannii, Comamonas testosteroni, Pseudomonas aerugionosa, and Mycobacterium abscessus) to the PCCL 5 for further evaluation of the CCL process. The specific screening decisions and references are presented in Appendix B. Chapter 5.0 Determining the Draft Microbial CCL 5 EPA used scoring protocols to rank pathogens on the PCCL to produce a Draft CCL. This section briefly describes the process developed under CCL 3 and explains the elements included in the microbial Contaminant Information Sheets (CISs). EPA derived the CCL 3 scoring process in part from recommendations of the NRC and an expert workgroup established by the NDWAC, and two external workshops (USEPA, 2009c). EPA made two minor modifications to the CCL 3 microbial scoring process regarding data sources that were used to select microbial contaminants from the PCCL for the CCL 5 as described below. For a more detailed discussion on the CCL 3 scoring process and rationale used to develop the scoring process see Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process (USEPA, 2009c). Microbes were evaluated for their occurrence in water and their ability to cause adverse health effects in humans. Pathogens on the PCCL were scored for placement on the CCL using a scoring system to assign a numerical value to each pathogen and rank the pathogens based upon both occurrence (waterborne disease outbreaks (WBDOs) and occurrence in water) and health effects. Those microbes receiving high scores were considered for placement on the CCL. Each microbe was scored using three scoring protocols, one protocol each for WBDOs, occurrence in water, and health effects (both for general and sensitive populations). Data Page 10 of 21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 collected during CCL 3 and CCL 4 were not removed from consideration and remain on the contaminant information sheets presented in Appendix E. If found, new data were added and scores were adjusted as necessary. EPA compiled data sources identified from the CCL 3 and the CCL 4, along with data sources recommended by the CCL 5 EPA workgroup and subject matter experts. EPA accessed each potential data source and evaluated them using the following assessment factors: relevance, completeness, redundancy, and retrievability. Combining WBDO information and occurrence information allowed EPA to consider: 1) pathogens that are tracked by public health surveillance programs (i.e., CDC's National Outbreak Reporting System (NORS) (CDC, 2020); and 2) pathogens that are not yet tracked by public health surveillance programs but for which occurrence information is available (i.e., emerging pathogens). To determine the WBDO score for CCL 3 and CCL 4, EPA utilized outbreak information from CDC's Morbidity and Mortality Weekly Report (MMWR) (CDC, 2017). For the CCL 5, EPA also included the CDC's NORS data for outbreak information (note, NORS was launched in 2009). CCL 3 and CCL 4 examined outbreaks that occurred between 1990 and 2004. For CCL 5, EPA determined outbreaks that occurred in and after 2009 to capture the microbes of concern. The cutoff date was updated to reflect the impact of the Long Term 2 Enhanced Surface Water Treatment Rule (71 FR 654, USEPA, 2006a), and the Ground Water Rule (GWR) (71 FR 65573, USEPA, 2006b), both promulgated in 2006 with three years to comply. WBDOs were scored on a five-level hierarchy ranging from never caused a WBDO (score of 1) to two or more documented WDBOs in the U.S. (score of 5) in the timeframe specified (Table 3). Table 3. Waterborne Disease Outbreak Scoring Protocol Category Score Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 5 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009- 2017 4 Has caused documented WBDOs at any time in the U.S. 3 Has caused documented WBDO in countries other than the U.S. 2 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease 1 The second attribute of the scoring process evaluates the occurrence of a pathogen in drinking water and source water. Because water-related illness may also occur in the absence of recognized outbreaks, EPA scored the occurrence (direct detection) of microbes using cultural, immunochemical, or molecular detection of pathogens in drinking water under the Occurrence Protocol Occurrence characterizes pathogen introduction, survival, and distribution in the environment. Occurrence implies that pathogens are present in water and that they may be capable of surviving and moving through water to cause illness in persons exposed to drinking water by ingestion, inhalation, or dermal contact. Pathogen occurrence is considered broadly to include treated drinking water, and all waters using a drinking water source for recreational purposes, ground water, and surface water bodies. This Page 11 of 21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 attribute does not characterize the extent to which a pathogen's occurrence poses a public health threat from drinking water exposure. Occurrence was scored on a three-level hierarchy ranging from not detected in the U.S. (score of 1) to detected in drinking water in the U.S. (score of 3) (Table 4). Table 4. Occurrence Scoring Protocol Category Score Detected in drinking water in the U.S. 3 Detected in source water in the U.S. 2 Not detected in the U.S. 1 The health effects scoring protocol evaluated the extent of illness produced in humans from drinking water. The severity of disease manifestations produced by a pathogen was evaluated across a range of potential endpoints. Pathogens may produce a range of illness from asymptomatic infection to severe illness progressing rapidly to death. The seven-level hierarchy developed for this protocol begins with mild, self-limiting illness (score of 1) and progresses to death (score of 7) (Table 5). The protocol scored the representative or more common clinical presentation for the specific pathogen for the population category under consideration, rather than the extremes. These scores were based on data from recent clinical microbiology manuals (Carroll et al., 2019). To obtain a representative characterization of health effects in all populations, EPA evaluated separately the general population and four sensitive populations (children, elderly, pregnant woman, and persons with chronic diseases) as to the common clinical presentation of illness for that population. EPA added the general population score to the highest score among the four sensitive populations for an overall health effects score. The resulting score acknowledged that sensitive populations have increased risk for waterborne diseases. Table 6 shows the health effects scoring protocol template for general and sensitive populations. Table 5. Health Effects Scoring Protocol for Pathogens Outcome Category Score Manifestation in Population Class General Population Children/ Infants Elderly Pregnant Women Chronic Disease Does the organism cause significant mortality (> 1/1,000 cases)? 7 Page 12 of 21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Outcome Category Score Manifestation in Population Class General Population Children/ Infants Elderly Pregnant Women Chronic Disease Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? 6 Does the illness result in long term or permanent dysfunction or disability (i.e., sequelae)? 5 Does the illness require short term hospitalization (< week)? 4 Does the illness require physician intervention? 3 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 2 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 EPA evaluated the possibility of using antibiotic susceptibility as part of the health effects scoring protocol, and/or antibiotic resistance as scoring consideration for microbes as part of the review process for the development of CCL 5. Each microbe on the CCL was evaluated for its specific antibiotic resistance and mortality rate. The results of the literature search showed that antibiotic resistance cannot be used as a scoring consideration for microbes in the CCL process at this time. There was too much variability among individual microbes and across all microbial groups to determine a criterion that would effectively apply to the universe of microbes. The highest of the individual WBDO score or occurrence score was added to the normalized health effects score to produce a composite pathogen score. Although the composite score was not shown on the CISs, the scoring summary table at the top left corner of each CIS shows the values used to calculate the composite score. The formula for the pathogen score was as follows: General Population Pathogen _ Highest Score Score + Highest Total Score between WBDO + Sensitive and Occurrence Population Page 13 of 21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 EPA normalized the health effects score so that occurrence (or WBDO) and health effects had equal value in determining the ranking of the CCL. The highest possible score for WBDO or occurrence was 5 and the highest possible health effect score was 14. To normalize this imbalance in the calculated total score, the agency multiplied the health effects score by 5/14. An example of this calculation is shown in Appendix E. The CISs that had been developed for CCL 3 were updated for each CCL 5 contaminant and new CIS sheets were developed for those microbes not previously included. The references in the CISs were also updated to reflect information that became available after EPA published the final CCL 3 and CCL 4. Scores were based on new and previous data available for each CCL 5 contaminant. The CIS tables present the final scores for each of the data types under consideration and a brief description of the data used to assign those scores with their respective references. Elements of each CIS include: Scoring Summary - shows the scores used to calculate the final composite score for each microbial contaminant which included the highest score between the WBDO and occurrence, health effects score for the general population, and the highest health effects score of the sensitive populations. Data Table - shows the categories for each potential score, the scoring data, if applicable, and reference(s) used to support a score. The highest-ranking score for each of the three scoring categories is shown in bold font. The WBDOs scoring results are presented first, followed by the occurrence results and the health effects. References - presents the full references for the data presented in the table. For more information on the microbes scoring process and the CISs, see Appendix E. Section 5.1 Application of Scoring Protocol to the PCCL and Selection of the Draft CCL 5 Microbes from the PCCL The 35 PCCL pathogens were ranked according to an equal weighting of their summed scores for normalized health effects and the higher of the individual scores for WBDO and occurrence in drinking water. EPA determined that this ranking indicated the most important pathogens to consider for the Draft CCL 5. To determine which of the 35 PCCL pathogens should be the highest priority for EPA's drinking water program and included on the draft CCL 5, EPA considered scientific factors and the opportunity to advance public health protection. These factors included the PCCL scores for WBDO, occurrence, and health effects; comments and recommendations from the various expert panels including EPA's internal workgroup and CDC's subject matter experts; and the greatest opportunity to advance public health protection. After consideration of these factors, EPA listed the 12 highest-ranked pathogens in the Draft CCL 5 (Table 6). A comparison to previous CCLs can be found in Appendix D and scores can be found in Appendix E. Page 14 of 21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Table 6. The Draft Microbial CCL 5 Microbial Name Microbial Class Adenovirus Virus Caliciviruses Virus Campylobacter jejuni Bacteria Escherichia coli (0157) Bacteria Enteroviruses Virus Helicobacter pylori Bacteria Legionella pneumophila Bacteria Mycobacterium abcessus Bacteria Mycobacterium avium Bacteria Naegleria fowleri Protozoa Pseudomonas aeruginosa Bacteria Shigella sonnei Bacteria The selection of microbial pathogens for the Draft CCL 5 was similar to the method used for CCL 3 with the exception that there were no "natural" breaks in the pathogen's scores, meaning where there were no large numerical gaps in the PCCL scores (as was for the previous PCCL 3 microbes) for the Draft CCL 5 listing. EPA determined that the overall rankings strongly reflected the best available scientific data and high-quality expert input employed in the CCL selection process, and therefore should be important factors in helping to identify the top priority pathogens for the Draft CCL 5. Section 5.2 Microbial Organisms Covered by Existing Regulations According to Section 1412(b)(1) of the 1996 SDWA Amendments, EPA must select CCL contaminants that "at the time of publication, are not subject to any proposed or promulgated national primary drinking water regulation." In promulgating regulations for contaminants in drinking water, EPA can set either a legal limit (maximum contaminant level or MCL) and require monitoring for the contaminant in drinking water or, for those contaminants that are difficult to measure, EPA can establish a treatment technique requirement. The Surface Water Treatment Rule (54 FR 27486, USEPA, 1989a) established maximum contaminant level goals (MCLGs) of zero for Legionella, Giardia, and viruses because any amount of exposure to these contaminants represents some public health risk. Since measuring disease-causing microbes in drinking water was not considered to be feasible at the time of the development of the SWTR, EPA established treatment technique requirements for these contaminants. The purpose of subsequent treatment technique requirements (Interim Enhanced Surface Water Treatment Rule (63 FR 69478, USEPA 1998a), Long Term 1 Surface Water Treatment Rule (67 FR 1813, Page 15 of 21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 USEPA, 2002a), and the Long Term 2 Surface Water Treatment Rule (71 FR 654, USEPA, 2006a), which included an MCLG of zero for Cryptosporidium, is to reduce disease incidence associated with Cryptosporidium and other pathogenic microorganisms in drinking water. These rules apply to all public water systems that use surface water or ground water under the direct influence of surface water. The Ground Water Rule (GWR) (71 FR 65573; USEPA, 2006c) set treatment technique requirements to control for viruses (and pathogenic bacteria) because it was not feasible to monitor for viruses (or pathogenic bacteria) in drinking water. Under the GWR, if systems detect total coliforms in the distribution system, they are required to monitor for a fecal indicator (E. coli, coliphage, or enterococci) in the source water. If fecal contamination is found in the source water, the system must take remedial action to address contamination. EPA considered Legionella and specific viruses in CCL even though they are regulated under the Surface Water Treatment Rules (SWTR)). In this draft document, EPA proposes to specifically list Legionella pneumophila, the primary pathogenic bacterium, on the Draft CCL 5 because it has been identified in numerous WBDOs and is the most common cause of reported drinking water-associated outbreaks in the U.S. Furthermore, reported Legionnaires' disease has increased 10-fold in the last 20 years (CDC, 2020b). A recent National Academies of Science report estimated 52,000-70,000 cases of Legionnaires' disease annually, with 3-30% mortality (NASEM, 2020). EPA is also proposing to list certain viruses on the Draft CCL 5. Viruses include a wide range of taxa and different viral taxa have been implicated in various WBDOs for which EPA did not have dose response or treatment data when promulgating its treatment technique requirements. Even though there are MCLGs for Legionella and viruses, and these contaminants are subject to limitations as a class through the treatment techniques under the Surface Water Treatment Rules, there are no monitoring, treatment, or notification requirements within those NPDWRs that are specific to Legionella pneumophila or the specific viruses listed on CCL5 (although systems may use coliphage for source water monitoring for ground water systems). Therefore, EPA considers Legionella pneumophila and the specific viruses listed on CCL5 to be unregulated contaminants for purposes of eligibility for the CCL. Additionally, EPA received public nomination for viruses and Legionella for the Draft CCL 5, with Legionella pneumophila receiving the highest number of nominations. Section 5.3 Listing Outcomes for the Nominated Microbial Contaminants All the microbes nominated for the CCL 5, except for Salmonella enterica, Aeromonas hydrophila, and Hepatitis A, were listed on the Draft CCL 5. Salmonella enterica, Aeromonas hydrophila and Hepatitis A did not produce sufficient composite scores to place them on the Draft CCL 5. Although Salmonella enterica and Hepatitis A have numerous WBDOs, the route of exposure was not explicitly waterborne. Non-tuberculous Mycobacterium (NTM) and Mycobacterium (species broadly found in drinking water) were nominated for the CCL 5 and were not listed on the Draft CCL 5 as a group; instead, they were listed as Mycobacterium avium and Mycobacterium abscessus, two species of NTM that are found in drinking water. Page 16 of 21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Chapter 6.0 Microbial Data Sources for the Draft CCL 5 Multiple data sources were used to gather the information for the development of the Draft CCL 5. The data sources used were evaluated by EPA to ensure they were authoritative and appropriate. Under the CCL 3, for microbes, the universe list was defined as all known human pathogens using the compilation of Taylor et al. (2001) as a practical starting point. This list was supplemented with literature searches and nominations from the public. The Draft CCL 5 used the previous universes from the CCL 3 and the CCL 4 and updated with literature searches of peer reviewed sources and nominations. The hierarchy of text-based resource materials begins with recently compiled authoritative reference books such as The Manual of Clinical Microbiology (MCM), 9th Edition, and Field's Virology, 5th Edition, both published in 2007. Both of these two-volume reference books have become established as the leading authoritative reference sources in their respective fields. These references have evolved through multiple editions and both publications are considered reference standards to the scientific community for their scope and depth of coverage. They were edited by world-recognized authorities, and chapters were written by an international team of subject experts. The parasites of Homo sapiens, second edition, is a comprehensive source for information on helminths. These and other compiled sources listed in the reference list in Section 7 provided the information for screening the pathogens in the microbial CCL 3 Universe. The 12th edition of the MCM was published in 2019 and was consulted for CCL 5 (Carroll et al., 2019). Web references were used to find information for screening rarely encountered viruses, protozoa, and fungi, primarily for information related to Criterion 9, "natural habitat in the environment," or Criterion 10, "pathogen not endemic to North America". Selected Web references were evaluated to ensure that the site sponsors possessed the expertise to authoritatively address the issues of habitat and geographical distribution of the pathogen in question, and that the information was presented objectively and reviewed by members of the scientific community. Emphasis was placed upon websites sponsored and supported by government agencies or academic institutions, with evidence of peer review, such as an editorial board and/or expert contributors and reviewers. Appendix B tabulates the screening decisions for the CCL 5 Microbial Universe and shows the screening reference used to support the decision. Page ranges cited and Web addresses/links provided are as narrow and specific as they can be, to identify the information related to the screening criterion used. Many pathogens could be screened by several criteria, however only one criterion is noted in the tabulation. Understanding the complete context and rationale for a screening decision often requires a review of the complete chapter from which the specified page range was taken. The MCM (Carroll et al., 2019) was one of the main sources of information used to inform the scoring of the PCCL microbes for Draft CCL 5. EPA also conducted a literature search covering the time period between CCL 4 and CCL 5 (2016-2019). The literature search focused on health effects and occurrence of the nominated microbial contaminants in water. For CCL 5 WBDOs, the primary source for scoring data was outbreak information pulled from CDC's NORS dashboard. Outbreak information was available from 2009-2017. NORS data was used as an alternative to CDC's Morbidity and Mortality Weekly Reports (MMWR) for more Page 17 of 21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 recent outbreak data (as of August 2019, the most recent MMWR report was published in 2017). Appendix F contains additional detail on data sources. References Acha, P. and Szyfres, B. 2001. Zoonoses and Communicable Diseases Common to Man and Animals, ed. Washington, DC: Organization Panamericana de la Salud, pp. 175-85. Allander, T. 2008. Human bocavirus, Journal of Clinical Virology, Volume 41, Issue 1, pp. 29- 33, ISSN 1386-6532, https://doi.org/10.1016/jjcv.2007.10.026. Ashford, R.W. and W. Crewe. 2003. The parasites of Homo sapiens: An annotated checklist of the protozoa, helminths and arthropods for which we are home. Taylor and Francis, London, UK. Baud, D. et al. 2014. Role of Waddlia chondrophila placental infection in miscarriage. Emerging infectious diseases, 20, 3: 460-464. Bennett, J.V., Jarvis, W.R. and Brachman, P.S. eds. 2007. Bennett & Brachman's hospital infections. Lippincott Williams & Wilkins. Bofill-Mas, S., Rodriguez-Manzano, J., Calgua, B. et al. 2010. Newly described human polyomaviruses Merkel Cell, KI and WU are present in urban sewage and may represent potential environmental contaminants. Virology journal, 7(1), 1-5. httos ://doi. org/10.1186/1743 -422X-7-141 Brown, M. et al. 2016. Defining the Clinical Significance of Alloscardovia omnicolens in the Urinary Tract. Journal of Clinical. Microbiology, 54(6), 1552-1556 doi: 10.1128/JCM.03084-15 Carroll, K.C., Pfaller, M.A., Landry, M. L., McAdam, A.J., Patel, R., Richter, S.S. and Warnock, D.W.(ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Centers for Disease Control and Prevention (CDC). 2013. https://www.cdc.gov/vhf/luio/transmission/index.html CDC. 2017. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water - United States, https://www.cdc.gov/mmwr/publications/index.html CDC. 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Ciotti M., Angeletti S., Minieri M., Giovannetti M., Benvenuto D., Pascarella S., Sagnelli C., Bianchi M., Bernardini S., Ciccozzi M. 2019. COVID-19 Outbreak: An Overview. Chemotherapy, 64(5-6), 215-223. doi: 10.1159/000507423 Davis, C.P. Normal Flora. In: Baron S, editor. Medical Microbiology. 4th edition. Galveston (TX): University of Texas Medical Branch at Galveston; 1996. Chapter 6. https://www.ncbi.nlm.nih.gov/books/NBK7617/ Drasar, B.S. and Barrow, P. A. 1985. Intestinal microbiology Volume 10 of Aspects of Microbiology, ISSN 0266-6642. American Society for Microbiology. Page 18 of 21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Figueroa Castro, C.E. et al. 2017. "Elizabethkingia anophelis: Clinical Experience of an Academic Health System in Southeastern Wisconsin" Open forum infectious diseases vol. 4,4 ofx251. doi:10.1093/ofid/ofx251 Finegold, S.M., Sutter, V.L. andMathisen, G.E. 1983. Normal indigenous intestinal flora. Human intestinal microflora in health and disease, 1, pp.3-31. Greub, G. 2009. Parachlamydia acanthamoebae, an emerging agent of pneumonia. Clinical Microbiology and Infection, 15(1): 18-28. doi: 10.1111/j. 1469-0691.2008.02633.x. Howard, D. H. (ed.) 2003. Pathogenic fungi in humans and animals, 2nd Edition. Marcel Dekker, Inc., New York, NY. Hashimoto et al. 2017. A Case of Pulmonary Botrytis Species Infection in an Apparently Healthy Individual. American Journal of Respiratory and Critical Care Medicine, 195:A7155 Isenberg, H. D. and R. F. D'Amato. 1995. Indigenous and Pathogenic Microorganisms of Humans. In Murray, P. R., E. J. Baron, M. A. Pfaller, F. C. Tenover, and R. H. Yolken, ed. Manual of Clinical Microbiology, 6th ed. ASM Press, Washington, DC. Institut national de sante publique du Quebec, https://www.inspq.qc.ca/en/moulds/fact- sheets/epicoccum-purpurascens Knipe, D.M., Howley, P.M., Cohen, J., Griffin, D., Lamb, R., Martin, M., Racaniello, V.R. and Roizman, B. 2007. Fields virology, vol 2 Lippincott Williams & Wilkins. Philadelphia, PA. Krause, P.J. 2003. Babesiosis diagnosis and treatment. Vector-Borne and Zoonotic Diseases, 3(1), pp. 45-51. Mandel, G.L., J.E. Bennett, and R. Dolin (ed.). 2005. Douglas and Bennett's Principles and Practice of Infectious Diseases, 6th Edition, Elsevier, Philadelphia. Murray T.J., Maffini, M.V., Ucci A.A., et al. 2007. Induction of mammary gland ductal hyperplasias and carcinoma in situ following fetal bisphenol A exposure. Reproductive toxicology, 23(3): 383-390. National Drinking Water Advisory Council (NDWAC). 2004. National Drinking Water Advisory Council Report on the CCL Classification Process to the U. S. Environmental Protection Agency, May 19, 2004 National Research Council (NRC). 1999a. Setting Priorities for Drinking Water Contaminants. National Academy Press, Washington, DC. NRC. 1999b. Identifying Future Drinking Water Contaminants. National Academy Press, Washington, DC. NRC. 2001. Classifying Drinking Water Contaminants for Regulatory Consideration. National Academy Press, Washington DC. Palmer, S.R., L. Soulsby, andD.I.H. Simpson (ed.). 1998. Zoonoses: biology, clinical practice, and public health control. Oxford University Press, Oxford, UK. Portillo, A. et al. 2018. '"Candidatus Neoehrlichia mikurensis' in Europe" New microbes and new infections vol. 22 30-36. doi: 10.1016/j.nmni.2017.12.011 Page 19 of 21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Ramirez-Castillo et al. 2015. Waterborne Pathogens: Detection Methods and Challenges. Pathogens, 4, 307-334; doi:10.3390/pathogens4020307 Sharp, C.P. et al. 2010. "Changing epidemiology of human parvovirus 4 infection in sub-Saharan Africa " Emerging infectious diseases, (16)10: 1605-1607. doi: 10.3201/eidl610.101001 Taylor, L.H., S.M. Latham, and M.E. Woolhouse. 2001. Risk factors for human disease emergence Philosophical Transactions of the Royal Society of London B. Vol. 356, pp. 983-989. Tyler, K.T., E.S. Barton, M.L. Ibach, C. Robinson, J.A. Campbell, S.M. O'Donnell, T. Valyi- Nagy, P. Clarke, J.D. Wetzel, T.S. Dermody. 2004. Isolation and molecular characterization of a novel type 3 reovirus from a child with meningitis. Journal of Infectious Diseases, 189(9): 1664-1675. United States Environmental Protection Agency (USEPA). 1989. National Primary Drinking Water Regulations; Filtration, Disinfection; Turbidity, Giardia Lamblia, Viruses, Legionella, and Heterotrophic Bacteria; Final Rule. Part 2. Federal Register. Vol. 54, No. 124, p. 27486, June 29, 1989. United States Environmental Protection Agency (USEPA). 1998a. Announcement of the Drinking Water Contaminant Candidate List. Federal Register. Vol. 63, No.49, p. 10274. March 2, 1998. United States Environmental Protection Agency (USEPA). 1998b. Interim Enhanced Surface Water Treatment; Final Rule. Federal Register. Vol. 63, No 241, p. 69478, December 16, 1998. United State Environmental Protection Agency (USEPA). 2002. Long Term 1 Enhanced Surface Water Treatment Rule; Final Rule. Federal Register. Vol. 67, No. 9, p. 1813. January 14, 2002. United States Environmental Protection Agency (USEPA). 2005. Drinking water Contaminant Candidate List 2; Final Notice. Federal Register. Vol. 70, No.36, p.9071, February 24, 2005. United States Environmental Protection Agency (USEPA) 2006a. Long Term 2 Enhanced Surface Water Treatment Rule; Final Rule. Federal Register. Vol. 71, No. 3, p. 654, January 5, 2006. United State Environmental Protection Agency (USEPA). 2006b. National Primary Drinking Water Regulations: Ground Water Rule; Final Rule. Federal Register. Vol. 71, No. 216, p.65573- 65660. November 8, 2006. United States Environmental Protection Agency (USEPA). 2009a. Drinking Water Contaminant Candidate List 3-Final Notice. Federal Register. Vol. 74, No. 194, p. 51850 October 18, 2009. United States Environmental Protection Agency (USEPA). 2009b. Final Contaminant Candidate List 3 Microbes: Screening to the PCCL. EPA 815-R-09-0005. August 2009. United States Environmental Protection Agency (USEPA). 2009c. Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. August 2009. Page 20 of 21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 United States Environmental Protection Agency (USEPA). 2016a. Drinking Water Contaminant Candidate List 4—Final. Federal Register. Vol. 81, No. 222, p. 81099 November 17, 2016. United States Environmental Protection Agency (USEPA). 2016b. Screening Document for the Fourth Preliminary Contaminant Candidate List 4 (PCCL 4). EPA 815-R-16-008. November, 2016. United States Environmental Protection Agency (USEPA). 2016c. Response to the Science Advisory Board's Recommendations on the Draft Fourth Contaminant Candidate List (CCL 4). EPA 815-R-16-005. November, 2016. United States Environmental Protection Agency (USEPA). 2018. Request for Nominations of Drinking Water Contaminants for the Fifth Contaminant Candidate List. Federal Register. Vol. 83 No. 194 p. 50364, October 5, 2018. Wenzel, R.P. (ed.). 2003. Prevention and control of nosocomial infections. Lippincott Williams & Wilkins, Philadelphia, PA. Page 21 of 21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Appendix A: List of CCL 5 Microbial Nominations Common Name Nominators) Health Effects Information Provided with Nomination Occurrence Information Provided with Nomination Additional Information Provided with Nomination CCL Universe PCCL5 Draft CCL 5 Aeromonas hydrophila C.J. Volk No information provided No information provided No information provided X X Adenovirus* G. Tracy Mehan, AWWA No information provided No information provided No information provided X X X Caliciviruses* G. Tracy Mehan, AWWA No information provided No information provided No information provided X X X Campylobacter jejuni * C.J. Volk No information provided No information provided No information provided X X X G. Tracy Mehan, AWWA No information provided No information provided No information provided CCL 4 contaminants (12 microbes)* Mae Wu and Anna Reade, NRDC Known public health threats. No information provided No information provided X X Enterovirus* G. Tracy Mehan, AWWA No information provided No information provided No information provided X X X Escherichia coli (0157)* C.J. Volk No information provided No information provided No information provided X X X G. Tracy Mehan, AWWA No information provided No information provided No information provided Helicobacter pylori * C.J. Volk No information provided No information provided No information provided X X X G. Tracy Mehan, AWWA No information provided No information provided No information provided Hepatitis A virus* G. Tracy Mehan, AWWA No information provided No information provided No information provided X X Legionella pneumophila m Anonymous No information provided Typically found in biofilms No information provided X X X Paul McDermott, PJM-HS Consulting Ltd No information provided No information provided No information provided Jason Dobranic, EMSL Analytical, Inc. No information provided No information provided No information provided Matthew Freije, hcinfo.com No information provided No information provided No information provided Anonymous No information provided No information provided No information provided Cam Pham, Enthalpy Analytical, LLC No information provided No information provided No information provided W.E. Pearson II, BPEARSON Consulting LLC No information provided No information provided No information provided C.J. Volk No information provided No information provided No information provided Page A1 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Common Name Nominators) Health Effects Information Provided with Nomination Occurrence Information Provided with Nomination Additional Information Provided with Nomination CCL Universe PCCL5 Draft CCL 5 Sharon Sweeney, Central Arkansas Water No information provided No information provided No information provided Philippe Hartemann No information provided No information provided No information provided Anonymous No information provided No information provided No information provided Patsy Root, IDEXX Laboratories, Inc. No information provided No information provided No information provided Paul R. Easley, Central Arkansas Water No information provided No information provided No information provided Stan Hazan, NSF According to the CDC, reported cases of legionella increased 286% during the time period 2000-2014. The bacterium is known to propagate in premise plumbing and other mechanical systems. This places the elderly and individuals with compromised immune systems at risk when water contaminated with the bacteria aerosolizes and disperses. No information provided Robert Bohannon, City of Moline, Illinois No information provided No information provided No information provided Mae Wu and Anna Reade, NRDC No information provided No information provided No information provided G. Tracy Mehan, AWWA No information provided No information provided No information provided Jennifer Clancy, ESPRI There are 8,000 to 18,000 people hospitalized with LD each year and estimates of ten times that many cases that are unrecognized. CDC estimates that it costs $434,000,000 to treat LD in the US annually; LD is now the #1 cause of WBDOs in the US (CDC, 2015). Based on CDC outbreak data, LD is responsible for 66% of waterborne disease outbreaks (WBDO) attributable to the distribution system. No information provided Mycobacterium avium * C.J. Volk No information provided No information provided No information provided X X X Page A2 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Common Name Nominators) Health Effects Information Provided with Nomination Occurrence Information Provided with Nomination Additional Information Provided with Nomination CCL Universe PCCL5 Draft CCL 5 G. Tracy Mehan, AWWA No information provided No information provided No information provided Mycobacterium species predominantly found in finished drinking water Anonymous No information provided Typically found in biofilms No information provided X Naegleria fowleri * G. Tracy Mehan, AWWA No information provided No information provided No information provided X X Nontuberculous mycobacteria (NTM) Jennifer Clancy, ESPRI Pseudomonas aeruginosa which is the most common cause of hospital- acquired pneumonia and nontuberculous mycobacteria (NTM), an increasing cause of lung infections in both immunocompromise d and otherwise heath individuals. In the chloraminated system, NTM colonized the pipe loops by the first sampling round and continued to be observed in the bulk water of all pipe materials, with greater numbers recovered consistently from the high use pipe loops. No information provided X X Pseudomonas aeruginosa Anonymous Typically found in biofilms X X X C.J. Volk No information provided No information provided No information provided Jennifer Clancy, ESPRI Pseudomonas aeruginosa which is the most common cause of hospital- acquired pneumonia and nontuberculous mycobacteria (NTM), an increasing cause of lung infections in both immunocompromise d and otherwise heath individuals. No information provided No information provided Salmonella enterica* C.J. Volk No information provided No information provided No information provided X X G. Tracy Mehan, AWWA No information provided No information provided No information provided Shigella sonnei * C.J. Volk No information provided No information provided No information provided X X X G. Tracy Mehan, AWWA No information provided No information provided No information provided *CCL 4 microbes Page A3 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Appendix B: The CCL 5 Microbial Universe The CCL 5 Microbial Universe Table B-l presents the CCL 5 Universe and the exclusion criteria used to keep a microbe in the universe. The source used for the exclusion criteria is listed in the reference column. Those microbes for which a source could not found to support exclusion moved forward to the PCCL. The CCL 5 Microbes Exclusion Screening Criteria: 1. All anaerobes. 2. Obligate intracellular fastidious pathogens. 3. Transmitted by contact with blood or body fluids. 4. Transmitted by vectors. 5. Indigenous to the gastrointestinal tract, skin and mucous membranes. 6. Transmitted solely by respiratory secretions. 7. Life cycle incompatible with drinking water transmission. 8. Drinking water-related transmission is not implicated. 9. Natural habitat is in the environment without epidemiological evidence of drinking water-related disease and without evidence of drinking water-related nosocomial infection. 10. Not endemic to North America. 11. Represented by a pathogen for the entire genus or species (that are closely related). 12. Current taxonomy changed from taxonomy used in Universe. Table B-l: The CCL 5 Microbial Universe and Exclusion Criteria Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Abiotrophies defectiva X MCM-H* Edition Achromobacter piechaudii l X MCM-H^ Edition Page B1 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Achromobacter xylosoxidans X MCM-H* Edition Acidaminococcus fermentans X MCM-H* Edition Acinetobacter baumannii Acinetobacter baumannii Acinetobacter calcoaceticus X MCM-H* Edition Acinetobacter haemolyticus X MCM-H* Edition Acinetobacter johnsonii X MCM-H^ Edition Acinetobacter junii X MCM-H* Edition Acinetobacter hvoffii X MCM-H* Edition Acinetobacter radioresistens X MCM-H* Edition Actinobacillus equuli X MCM-H* Edition Actinobacillus hominis X MCM-H* Edition Actinobacillus lignieresii X MCM-H* Edition Actinobacillus pleuropneumoniae X MCM-H* Edition Actinobacillus suis X MCM-H* Edition Actinobacillus ureae X MCM-H* Edition Actinomyces georgiae X MCM-H^ Edition Actinomyces gerencseriae X MCM-H^ Edition Actinomyces israelii X MCM-H^ Edition Actinomyces meyeri X MCM-H^ Edition Actinomyces naeslundii X IK MCM-H* Edition Actinomyces neuii X MCM-H* Edition Actinomyces odontolyticus X MCM-H* Edition Page B2 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Actinomyces radingae X MCM-H* Edition Actinomyces turicensis X MCM-H* Edition Aerococcus viridans X MCM-H^ Edition Aeromonas caviae X MCM-H^ Edition Aeromonas hydrophila Aeromonas hydrophila Aeromonas sobria X MCM-H* Edition Aeromonas veronii X MCM-H* Edition Aggregati bacter actinomycetemcomitans X MCM-H* Edition Aggregati bacter aphrophilus X MCM-H* Edition Alcaligenes odorans X MCM-H* Edition Alloprevotella tannerae X MCM-H* Edition Alloscardovia omnicolens X Brown, M et al., 2016 Amycolatopsis orientalis X MCM-H* Edition Anaplasma phagocy tophi lum X MCM-H* Edition Arcanobacterium heamolyticum X l MCM-H^ Edition Arcobacter butzleri (§j Arcobacter butzleri Arcobacter cryaerophilus i X MCM-H* Edition Bacillus anthracis pi X MCM-H^ Edition Bacillus cereus m X MCM-H^ Edition Bacillus circulans 11 X MCM-H* Edition Bacillus coagulans lii X MCM-H* Edition Bacillus licheniformis IK X MCM-H* Edition Bacillus mycoides Ml X MCM-H* Edition Bacillus pumilus 1 X MCM-H* Edition Bacillus subtilis ii X MCM-H* Edition Page B3 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Bacillus thuringiensis X MCM-H* Edition Bacteroides caccae X MCM-H* Edition Bacteroides eggerthii X 11 MCM-H^ Edition Bacteroides fragilis X MH MCM-H^ Edition Bacteroides galacturonicus X | MCM-H* Edition Bacteroides ovatus X iii MCM-H* Edition Bacteroides pectinophilus X 1 MCM-H* Edition Bacteroides stercoris X 11 MCM-H* Edition Bacteroides thetaiotaomicron X 1 MCM-H* Edition Bacteroides uniformis X 111 MCM-H* Edition Bacteroides vulgatus X 11 MCM-H* Edition Bartonella bacilliformis X 111 MCM-H* Edition Bartonella elizabethae X iii MCM-H* Edition Bartonella henselae X ¦ MCM-H* Edition Bartonella quintana X — MCM-H* Edition Bergeyella zoohelcum X i MCM-H^ Edition Bifidobacterium dentium X (i MCM-H^ Edition Bilophila wadsworthia X Hi MCM-H* Edition Blautia producta X Hi MCM-H* Edition Bordetella avium X ii MCM-H* Edition Bordetella bronchiseptica X 1 MCM-H* Edition Bordetella parapertussis X iii MCM-H* Edition Bordetella pertussis X MCM-H* Edition Borrelia brasiliensis X MCM-H* Edition Borrelia burgdorferi X MCM-H* Edition Borrelia caucasica X MCM-H^ Edition Borrelia crocidurae X MCM-H* Edition Page B4 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Borrelia duttonii X MCM-H* Edition Borrelia hermsii X MCM-H* Edition Borrelia hispanica X BM MCM-H^ Edition Borrelia latyschewii X (HI MCM-H^ Edition Borrelia mazzottii X H MCM-H* Edition Borrelia parkeri X 11 MCM-H* Edition Borrelia persica X IB MCM-H* Edition Borrelia recurrentis X ¦ MCM-H* Edition Borrelia turicatae X ¦il MCM-H* Edition Borrelia venezuelensis X 811 MCM-H* Edition Brevibacillus brevis ¦ X MCM-H* Edition Brevundimonas diminuta | X MCM-H* Edition Brevundimonas vesicularis 1 X MCM-H^ Edition Brucella melitensis X il MCM-H^ Edition Burkholderia cepacia 11 X MCM-H^ Edition Burkholderia mallei X MCM-H* Edition Burkholderia pseudomallei X MCM-H* Edition Campylobacter coli X MCM-H* Edition Campylobacter concisus X MCM-H* Edition Campylobacter curvus X MCM-H* Edition Campylobacter fetus X MCM-H* Edition Campylobacter gracilis X Mi MCM-H* Edition Campylobacter hyointestinalis X MCM-H* Edition Campylobacter jejuni Campylobacter jejuni Campylobacter lari X MCM-H* Edition Campylobacter rectus X MCM-H* Edition Page B5 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Campylobacter sputorum X MCM-H* Edition Campylobacter upsaliensis X MCM-H* Edition Campylobacter ureolyticus X MCM-H^ Edition Capnocytophaga canimorsus X MCM-H* Edition Capnocytophaga cynodegmi X MCM-H* Edition Capnocytophaga gingivalis X MCM-H^ Edition Capnocytophaga ochracea X MCM-H^ Edition Capnocytophaga sputigena X MCM-H* Edition Cardiobacterium hominis X MCM-H* Edition Cedecea davisae X MCM-H* Edition Cedecea lapagei X MCM-H* Edition Cedecea neteri X MCM-H* Edition Cellulomonas turbata X MCM-H* Edition Cellulosimicrobium cellulans X MCM-H* Edition Centipeda periodontii X MCM-H* Edition Chlamydia trachomatis X MCM-H* Edition Chlamydophila pneumoniae X MCM-H* Edition Chlamydophila psittaci X MCM-H* Edition Chromobacterium violaceum X MCM-H* Edition Page B6 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Chryseobacterium balustinum X MCM-H* Edition Citrobacter amalonaticus X MCM-H* Edition Citrobacter braakii X MCM-H^ Edition Citrobacter farmeri X illll MCM-H^ Edition Citrobacter freundii X MCM-H* Edition Citrobacter koseri X MCM-H* Edition Citrobacter rodentium X MCM-H* Edition Citrobacter sedlakii X MCM-H* Edition Citrobacter werkmanii X MCM-H* Edition Citrobacter youngae X MCM-H* Edition Clostridium baratii X MCM-H* Edition Paraclostridium bifermentans X MCM-H* Edition Clostridium botulinum X MCM-H* Edition Clostridium butyricum X MCM-H* Edition Clostridium chauvoei X MCM-H* Edition Clostridoides difficile X MCM-H^ Edition Clostridium fallax X MCM-H^ Edition Clostridium histolyticum X Hi MCM-H* Edition Clostridium novyi X 1 MCM-H* Edition Clostridium perfringens X MCM-H* Edition Clostridium ramosum X MCM-H* Edition Clostridium septicum X MCM-H* Edition Clostridium sordellii X 1 MCM-H* Edition Clostridium sporogenes X MCM-H* Edition Clostridium tertium X MCM-H* Edition Clostridium tetani X MCM-H* Edition Collinsella aerofaciens X MCM-H^ Edition Page B7 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Comamonas testosteroni Comamonas testosteroni Corynebacterium afermentans X MCM-H* Edition Corynebacterium argentoratense X MCM-H^ Edition Corynebacterium bovis X MCM-H* Edition Corynebacterium diphtheriae X Bill MCM-H^ Edition Corynebacterium jeikeium X MCM-H* Edition Corynebacterium kutscheri X MCM-H* Edition Corynebacterium macginleyi X MCM-H^ Edition Corynebacterium minutissimum X MCM-H* Edition Corynebacterium propinquum X MCM-H* Edition Corynebacterium pseudodiphthericum X MCM-H* Edition Corynebacterium pseudotuberculosis X MCM-H* Edition Corynebacterium striatum X MCM-H* Edition Corynebacterium ulcerans X MCM-H* Edition Corynebacterium urealyticum X MCM-H* Edition Corynebacterium xerosis X MCM-H* Edition Page B8 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria Coxiella burnetii Cronobacter sakazakii 8 10 11 12 PCCL Reference MCM-12111 Edition MCM-12111 Edition Cutibacterium acnes Cutibacterium avidum Cutibacterium granulosum Delftia acidovorans Dermatophilus congolensis Dichelobacter nodosus Edwardsiella hoshinae Edwardsiella tarda Eggerthella lenta Ehrlichia chaffeensis Ehrlichia equi Ehrlichia ewingii Eikenella corrodens Elizabethkingia anophelis Elizabethkingia meningoseptica Enterobacter amnigenus Enterobacter asburiae Enterobacter cancerogenus Enterobacter cloacae Enterobacter gergoviae Enterobacter hormaechei Enterococcus avium MCM-12111 Edition MCM-12111 Edition MCM-12111 Edition MCM-12111 Edition MCM-12 Edition MCM-12111 Edition MCM-12111 Edition MCM-12111 Edition MCM-12 Edition MCM-12111 Edition MCM-12111 Edition MCM-12111 Edition MCM-12111 Edition Figueroa Castro, Carlos E et al„ 2017 MCM-12111 Edition MCM-12111 Edition MCM-12111 Edition MCM-12 Edition MCM-12111 Edition MCM-12 Edition MCM-12111 Edition MCM-12 Edition Page B9 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Enterococcus casseliflavus X MCM-H* Edition Enterococcus durans X MCM-H* Edition Enterococcus faecalis X MCM-H* Edition Enterococcus faecium X MCM-H* Edition Enterococcus flavescens X MCM-H^ Edition Enterococcus gallinarum X MCM-H* Edition Enterococcus hirae X MCM-H* Edition Enterococcus mundtii X MCM-H* Edition Enterococcus raffmosus X MCM-H* Edition Erysipelothrix rhusiopathiae X MCM-H* Edition Escherichia coli Escherichia coli Eubacterium brachy X MCM-H* Edition Eubacterium cylindroides X MCM-H* Edition Eubacterium limosum X MCM-H* Edition Eubacterium moniliforme X MCM-H* Edition Eubacterium multiforme X MCM-H* Edition Eubacterium nodatum X MCM-H* Edition Eubacterium rectale X MCM-H^ Edition Eubacterium saburreum X MCM-H^ Edition Eubacterium saphenum X MCM-H* Edition Eubacterium sulci X MCM-H* Edition Eubacterium tenue X MCM-H* Edition Ewingella americana X MCM-H* Edition Faecalicatena contorta X MCM-H* Edition Fibrobacter intestinalis X 11 MCM-H* Edition Page BIO ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Filifactor alocis X MCM-H* Edition Finegoldia magna X MCM-H* Edition Fluoribacter bozemanae X MCM-H^ Edition Fluoribacter dumoffii X MCM-H^ Edition Fluoribacter gormanii X MCM-H* Edition Francisella tularensis X MCM-H* Edition Fusobacterium mortiferum X MCM-H* Edition Fusobacterium necrophorum X MCM-H* Edition Fusobacterium nucleatum X MCM-H* Edition Fusobacterium periodonticum X MCM-H* Edition Fusobacterium ulcerans X MCM-H* Edition Fusobacterium varium X MCM-H* Edition Gardnerella vaginalis X MCM-H* Edition Gemella morbillorum X MCM-H^ Edition Gordonia amarae X MCM-H^ Edition Gordonia bronchialis X MCM-H* Edition Gordonia rubropertincta X MCM-H* Edition Gordonia sputi X MCM-H^ Edition Gordonia terrae IBB X MCM-H^ Edition Granulicatella adiacens X MCM-H* Edition Haemophilus ducreyi X MCM-H* Edition Haemophilus haemolyticus X MCM-H* Edition Haemophilus influenzae X MCM-H* Edition Haemophilus parahaemolyticus X MCM-H* Edition Page Bll ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Haemophilus parainfluenzae X MCM-H* Edition Haemophilus paraphrophilus X MCM-H* Edition Haemophilus segnis X MCM-H^ Edition Hafnia alvei 111111 X MCM-H^ Edition Helicobacter cinaedi X MCM-H* Edition Helicobacter fennelliae X MCM-H* Edition Helicobacter heilmannii X MCM-H* Edition Helicobacter pullorum X MCM-H* Edition Helicobacter pylori Helicobacter pyori Kingella denitrificans X MCM-H* Edition Kingella kingae X MCM-H* Edition Klebsiella aerogenes X MCM-H* Edition Klebsiella granulomatis X MCM-H* Edition Klebsiella oxytoca X MCM-H^ Edition Klebsiella pneumoniae X MCM-H^ Edition Kluyvera ascorbata X MCM-H* Edition Kluyvera cryocrescens 111 X MCM-H* Edition Lactobacillus sp. X IBB MCM-H^ Edition Legionella anisa m X MCM-H* Edition Legionella birminghamensis | X MCM-H* Edition Legionella cherrii X MCM-H* Edition Legionella cincinnatiensis 1 X MCM-H* Edition Legionella feeleii X MCM-H* Edition Legionella hackeliae ill X MCM-H* Edition Legionella jordanis MM X MCM-H* Edition Legionella lansingensis 1 X MCM-H^ Edition Legionella longbeachae X MCM-H* Edition Page B12 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Legionella oakridgensis X MCM-H* Edition Legionella pneumophila Legionella pneumophila Legionella rubrilucens X MCM-H^ Edition Legionella sainthelensi X MCM-H^ Edition Legionella tucsonensis X MCM-H* Edition Legionella wadsworthii X MCM-H* Edition Leifsonia aquatica X MCM-H* Edition Leptospira borgpetersenii X MCM-H* Edition Leptospira inadai X MCM-H* Edition Leptospira interrogans X MCM-H* Edition Leptospira kirschneri X MCM-H* Edition Leptospira meyeri X MCM-H^ Edition Leptospira noguchii X MCM-H^ Edition Leptospira santarosai HI X MCM-H* Edition Leptospira weilii X MCM-H* Edition Leptotrichia buccalis X MCM-H^ Edition Listeria ivanovii X MCM-H^ Edition Listeria monocytogenes X MCM-H* Edition Listeria seeligeri |j|||g X MCM-H* Edition Listeria welshimeri X MCM-H* Edition Lysinibacillus sphaericus X MCM-H* Edition Mannheimia haemolytica X MCM-H* Edition Megamonas hypermegale X MCM-H* Edition Megasphaera sp. X MCM-H* Edition Methylobacterium mesophilicum * X MCM-H* Edition Page B13 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Methylobacterium zatmanii * X MCM-H* Edition Micromonas micros X MCM-H* Edition Mogibacterium timidum X MCM-H* Edition Moraxella atlantae X MCM-H* Edition Moraxella bovis X MCM-H^ Edition Moraxella catarrhalis X MCM-H* Edition Moraxella caviae X MCM-H* Edition Moraxella cuniculi X MCM-H* Edition Moraxella lacunata X MCM-H* Edition Moraxella lincolnii X MCM-H* Edition Moraxella liquefaciens X MCM-H* Edition Moraxella nonliquefaciens X MCM-H^ Edition Moraxella osloensis X MCM-H* Edition Moraxella ovis X MCM-H^ Edition Morganella morganii X MCM-H^ Edition Mycobacterium abscessus Mycobacterium abscessus Mycobacterium africanum X MCM-H^ Edition Mycobacterium asiaticum X MCM-H^ Edition Mycobacterium avium l Mycobacterium avium Mycobacterium bovis X MCM-H* Edition Mycobacterium celatum ill X MCM-H* Edition Mycobacterium chelonae | X MCM-H* Edition Mycobacterium conspicuum X MCM-H* Edition Page B14 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Mycobacterium fortuitum X MCM-H* Edition Mycobacterium genavense X MCM-H* Edition Mycobacterium gordonae X MCM-H^ Edition Mycobacterium haemophilum X MCM-H* Edition Mycobacterium kansasii X MCM-H* Edition Mycobacterium leprae X MCM-H* Edition Mycobacterium malmoense X MCM-H^ Edition Mycobacterium marinum X MCM-H* Edition Mycobacterium mucogenicum X MCM-H* Edition Mycobacterium peregrinum X MCM-H* Edition Mycobacterium porcinum X MCM-H* Edition Mycobacterium scrofulaceum X MCM-H* Edition Mycobacterium senegalense X MCM-H* Edition Mycobacterium shimoidei X MCM-H* Edition Mycobacterium simiae iilllll X MCM-H* Edition Mycobacterium smegmatis X MCM-H* Edition Mycobacterium szulgai X MCM-H* Edition Page B15 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Mycobacterium tuberculosis X MCM-H* Edition Mycobacterium ulcerans X MCM-H* Edition Mycobacterium xenopi X MCM-H^ Edition Mycoplasma fermentans X ¦ MCM-H^ Edition Mycoplasma genitalium X MCM-H^ Edition Mycoplasma hominis X MCM-H* Edition Mycoplasma pneumoniae X MCM-H* Edition Mycoplasma salivarium X MCM-H* Edition Myroides odoratus X MCM-H* Edition Neisseria cinerea X MCM-H* Edition Neisseria elongata X MCM-H* Edition Neisseria flava X MCM-H* Edition Neisseria flavescens X MCM-H* Edition Neisseria gonorrhoeae X MCM-H^ Edition Neisseria lactamica X MCM-H^ Edition Neisseria meningitidis X MCM-H* Edition Neisseria mucosa X Mi MCM-H* Edition Neisseria perflava X 111 MCM-H^ Edition Neisseria sicca X II MCM-H^ Edition Neisseria subflava X III MCM-H* Edition Neisseria weaveri X IB MCM-H* Edition Neoehrlichia mikurensis X M Portillo, A et al., 2018 Neorickettsia sennetsu X WKH MCM-H* Edition Nocardia asteroides 111 X MCM-H* Edition Nocardia brasiliensis BW X MCM-H* Edition Nocardia caviae 1J1 X MCM-H^ Edition Nocardia farcinica — X MCM-H* Edition Page B16 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Nocardia nova X MCM-H* Edition Nocardia otitidiscaviarum X MCM-H* Edition Nocardia pseudobrasiliensis X MCM-H* Edition Nocardia transvalensis X MCM-H^ Edition Ochrobactrum anthropi X MCM-H* Edition Odoribacter splanchnicus X MCM-H* Edition Oligella ureolytica X MCM-H* Edition Oligella urethralis X MCM-H* Edition Orientia tsutsugamushi X MCM-H* Edition Paenibacillus alvei X MCM-H* Edition Paenibacillus macerans X MCM-H* Edition Pantoea agglomerans Pantoea agglomerans Parabacteroides distasonis X MCM-H* Edition Parabacteroides merdae X MCM-H^ Edition Parachlamydia acanthamoebae X Greub, G., 2009 Pasteurella aerogenes X MCM-H* Edition Pasteurella caballi X MCM-H* Edition Pasteurella canis X MCM-H^ Edition Pasteurella dagmatis X MCM-H^ Edition Pasteurella multocida X MCM-H* Edition Pasteurella stomatis X MCM-H* Edition Peptococcus niger X MCM-H* Edition Peptostreptococcus anaerobius X MCM-H* Edition Page B17 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Peptostreptococcus asaccharolyticus X MCM-H* Edition Peptostreptococcus lactolyticus X MCM-H* Edition Peptostreptococcus prevotii X MCM-H^ Edition Peptostreptococcus vaginalis X MCM-H* Edition Photobacterium damselae X MCM-H* Edition Plesiomonas shigelloides Plesiomonas shigelloides Porphyromonas asaccharolytica X MCM-H^ Edition Porphyromonas catoniae X MCM-H* Edition Porphyromonas circumdentaria X MCM-H* Edition Porphyromonas endodontalis X MCM-H* Edition Porphyromonas gingivalis X MCM-H* Edition Porphyromonas levii X MCM-H* Edition Porphyromonas macacae X MCM-H* Edition Prevotella bivia X MCM-H* Edition Prevotella buccae X MCM-H* Edition Prevotella buccalis X MCM-H* Edition Prevotella corporis X 111 MCM-H* Edition Prevotella dentalis X 1 MCM-H^ Edition Prevotella denticola X Hi MCM-H^ Edition Page B18 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Prevotella disiens X MCM-H* Edition Prevotella enoeca X MCM-H* Edition Prevotella heparinolytica X l MCM-H^ Edition Prevotella intermedia X M MCM-H* Edition Prevotella loescheii X —B MCM-H^ Edition Prevotella melaninogenica X 1 MCM-H* Edition Prevotella nigrescens X mil MCM-H* Edition Prevotella oralis X lit MCM-H* Edition Prevotella oris X flk MCM-H* Edition Prevotella oulora X m MCM-H* Edition Prevotella ruminicola X MCM-H* Edition Prevotella veroralis X MCM-H* Edition Prevotella zoogleoformans X MCM-H* Edition Propionibacterium propionicus X MCM-H* Edition Proteus mirabilis X MCM-H^ Edition Proteus penneri X MCM-H* Edition Proteus vulgaris X MCM-H* Edition Providencia alcalifaciens X MCM-H^ Edition Providencia rettgeri X MCM-H* Edition Providencia stuartii X MCM-H* Edition Pseudomonas aeruginosa Pseudomonas aeruginosa Pseudomonas alcaligenes X MCM-H* Edition Pseudomonas fluorescens X MCM-H* Edition Page B19 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Pseudomonas pseudoalcaligenes X MCM-H* Edition Pseudomonas putida X MCM-H* Edition Pseudomonas stutzeri X MCM-H* Edition Pseudonocardia autotrophica X MCM-H* Edition Pseudoramibacter alactolyticus X MCM-H* Edition Psychrobacter phenylpyruvicus l X MCM-H* Edition Rahnella aquatilis il X MCM-H^ Edition Ralstonia pickettii Bi X MCM-H* Edition Raoultella ornithinolytica 1 X MCM-H* Edition Rhodococcus equi 11 X MCM-H* Edition Rhodococcus erythropolis 1 X MCM-H* Edition Rhodococcus fascians 111 X MCM-H* Edition Rhodococcus rhodnii il X MCM-H* Edition Rhodococcus rhodochrous i X MCM-H* Edition Rickettsia africae X i MCM-H* Edition Rickettsia akari X Ml MCM-H^ Edition Rickettsia australis X ill MCM-H^ Edition Rickettsia conorii X m MCM-H* Edition Rickettsia felis X m MCM-H* Edition Rickettsia honei X Hi MCM-H^ Edition Rickettsia japonica X MB MCM-H* Edition Rickettsia massiliae X Ml MCM-H* Edition Rickettsia prowazekii X BM MCM-H* Edition Rickettsia rickettsii X BB MCM-H* Edition Page B20 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Rickettsia sibirica X MCM-H* Edition Rickettsia typhi X MCM-H* Edition Rodentibacter pneumotropicus X MCM-H^ Edition Rothia dentocariosa X MCM-H* Edition Saccharomonospora viridis X MCM-H^ Edition Saccharopolyspora rectivirgula X MCM-H* Edition Salmonella bongori X MCM-H* Edition Salmonella choleraesuis X MCM-H* Edition Salmonella enteritidis X MCM-H* Edition Salmonella typhi X MCM-H* Edition Salmonella typhimurium Salmonella enterica Sebaldella termitidis X MCM-H* Edition Selenomonas artemidis X MCM-H* Edition Selenomonas dianae X MCM-H^ Edition Selenomonas flueggei X MCM-H^ Edition Selenomonas infelix X MCM-H* Edition Selenomonas noxia X MCM-H* Edition Serratia ficaria X MCM-H^ Edition Serratia marcescens X MCM-H^ Edition Serratia odorifera X MCM-H* Edition Serratia plymuthica X MCM-H* Edition Serratia proteamaculans X MCM-H* Edition Serratia rubidaea X MCM-H* Edition Shigella boydii X MCM-H* Edition Shigella dysenteriae X MCM-H* Edition Shigella flexneri X MCM-H* Edition Page B21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Shigella sonnei Shigella sonnei Sphingomonas paucimobilis X MCM-H* Edition Spirillum minus X MCM-H* Edition Staphylococcus aureus X MCM-H* Edition Staphylococcus epidermidis X MCM-H^ Edition Staphylococcus haemolyticus X MCM-H* Edition Staphylococcus hyicus X MCM-H* Edition Staphylococcus intermedius X MCM-H* Edition Staphylococcus lugdunensis X MCM-H* Edition Staphylococcus saprophyticus X MCM-H* Edition Staphylococcus warneri X MCM-H* Edition Stenotrophomonas maltophilia X MCM-H* Edition Streptobacillus moniliformis X MCM-H* Edition Streptococcus acidominimus X MCM-H* Edition Streptococcus agalactiae X MCM-H* Edition Streptococcus anginosus X MCM-H* Edition Streptococcus bovis X MCM-H^ Edition Streptococcus canis X MCM-H* Edition Streptococcus constellatus X MCM-H* Edition Page B22 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Streptococcus criceti X MCM-H* Edition Streptococcus equi X MCM-H* Edition Streptococcus gordonii X MCM-H^ Edition Streptococcus intermedius X MCM-H^ Edition Streptococcus milleri X MCM-H^ Edition Streptococcus mitis X MCM-H* Edition Streptococcus mutans X MCM-H* Edition Streptococcus pneumoniae X MCM-H* Edition Streptococcus pyogenes X MCM-H* Edition Streptococcus salivarius X MCM-H* Edition Streptococcus sanguis X HI MCM-H* Edition Streptococcus sobrinus X im MCM-H* Edition Streptococcus suis X MCM-H* Edition Streptococcus uberis X MCM-H* Edition Sutterella wadsworthensis X MCM-H* Edition Suttonella indologenes X MCM-H* Edition Tanerella forsythia X MCM-H* Edition Tatlockia maceachernii X MCM-H^ Edition Tatlockia micdadei X MCM-H^ Edition Tatumella ptyseos X MCM-H* Edition Treponema carateum X MCM-H* Edition Treponema pallidum X MCM-H* Edition Tropheryma whippelii X MCM-H* Edition Trueperella bernardiae X Ml MCM-H* Edition Trueperella pyogenes X MCM-H* Edition Tsukamurella inchonensis X MCM-H^ Edition Page B23 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Tsukamurella paurometabola X MCM-H* Edition Tsukamurella pulmonis X MCM-H* Edition Tsukamurella tyrosinosolvens X MCM-H* Edition Ureaplasma urealyticum X MCM-H^ Edition Veillonella atypica X MCM-H^ Edition Veillonella dispar X MCM-H* Edition Veillonella parvula X MCM-H* Edition Vibrio alginolyticus X MCM-H* Edition Vibrio cholerae BB Vibrio cholerae Vibrio cincinnatiensis 1 X MCM-H* Edition Vibrio fluvialis X MCM-H* Edition Vibrio furnissii MM X MCM-H* Edition Vibrio hollisae X MCM-H* Edition Vibrio mimicus X MCM-H* Edition Vibrio parahaemolyticus X MCM-H* Edition Vibrio vulnificus X MCM-H^ Edition Waddlia chondrophila X Baud, David et al., 2014 Wolinella succinogenes X MCM-H* Edition Yersinia bercovieri X MCM-H* Edition Yersinia enterocolitica Yersinia enterocolitica Yersinia frederiksenii X MCM-H* Edition Yersinia intermedia X MCM-H* Edition Yersinia kristensenii X MCM-H* Edition Yersinia mollaretii X MCM-H* Edition Yersinia pestis X MCM-H* Edition Yersinia pseudotuberculosis X MCM-H* Edition Yersinia rohdei X MCM-H* Edition Page B24 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Bacteria 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Reference Yersinia ruckeri X MCM-H* Edition Viruses 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Andes virus X MCM-H* Edition Apoi vims X Field's Virology, 5th Ed., p. 1153-1158, 1206 Australian bat lyssavirus X Field's Virology, 5th Ed., p. 1364 Bagaza virus X Field's Virology, 5th Ed., p. 1153-1158, 1199 Bangui virus X MCM-H* Edition Banna virus X MCM-H* Edition Banzi virus X MCM-H* Edition Barmah Forest virus X MCM-H^ Edition Batken virus X lUtD://Dhcnc.come. Columbia.cd u/71 h Re do rt/s i t e s/de s c ri d t i o n s/ Orthomvxoviridae/tho eotoviru s.htm Bayou virus X MCM-H* Edition Bebaru virus X Field's Virology, 5th. Ed., p. 1024 Bhanja virus X MCM-H*11 Edition BK virus X MCM-H* Edition Black creek canal virus X MCM-H* Edition Borna disease virus X Field's Virology, 5th Ed., p. 1835 Bovine Ephemeral Fever virus X Field's Virology, 5th Ed., p. 1367 Bovine Papular Stomatitis virus X Field's Virology, 5th Ed., p. 2948, 2955-2956, 2963 Page B25 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Viruses 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Bovine Spongiform Encephalopathy (BSE) agent X MCM-H* Edition Buffalopox vims X Field's Virology, 5th Ed. p. 2955-2956 Bunyamwera vims X MCM-H^ Edition Bussuquara virus X MCM-H* Edition Bwamba virus X MCM-H* Edition California encephalitis virus X MCM-H* Edition Candiru virus complex X MCM-H^ Edition Caraparu virus X MCM-H^ Edition Catu virus X MCM-H* Edition Cercopithecine herpes virus 1 X Field's Virology, 5th Ed., p. 2895-2897 Chandipura virus X MCM-H* Edition Changuinola virus X MCM-H^ Edition Chikungunya virus X MCM-H^ Edition Chim virus X lUtD://Dhcnc.come. Columbia.cd u/ICTVdB/11000000.htm Creutzfeld-Jokob Disease (CJD) agent X Field's Virology, 5th Ed., p. 443-444, 3077-3078 Colorado tick fever virus X MCM-H* Edition Cote d'lvoire Ebola virus X Field's Virology, 5th. Ed., p. 619, 1411-1412, 1432-1434 Cowpox virus X MCM-H* Edition Crimea-Congo Haemorrhagic Fever Virus X MCM-H* Edition Dakar bat virus X Field's Virology, 5th Ed., p. 1158, 1206 Dengue virus X MCM-H^ Edition Page B26 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Viruses 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Dhori vims X MCM-H* Edition Dobrava-Belgrade vims X MCM-H^ Edition Dugbe vims X MCM-H* Edition Duvenhage vims X Field's Virology, 5th Ed., p. 1364 Eastern equine encephalitis vims X MCM-H* Edition Edge Hill vims X MCM-H* Edition Encephalomyocarditis vims X Field's Virology, 5th Ed., p. 796, 840, 858-860 European bat lyssavirus 1 X Field's Virology, 5th Ed., p. 1364 European bat lyssavirus 2 X Field's Virology, 5th Ed., p. 1364 European Tick-borne encephalitis virus X Field's Virology, 5th Ed., p. 1153-1158, 1200-1203 Everglades virus X MCM-12 Eyach virus X Krause et al., p. 87-89 Far eastern Tick-borne encephalitis virus X Field's Virology, 5th Ed., p. 1153-1158, 1200-1203 Foot and mouth disease virus X Field's Virology, 5th Ed., p. 796, 840, 858-860 Ganj am virus X MCM-H* Edition Getah virus X Field's Virology, 5th Ed., p. 1024 Guama virus X MCM-H^ Edition Guanarito virus X MCM-H* Edition Guaroa virus X MCM-H* Edition Hantaan virus X MCM-H* Edition Hendra virus X MCM-H^ Edition Hepatitis A virus Hepatitis A Hepatitis B virus X MCM-H* Edition Page B27 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Viruses 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Hepatitis C vims X MCM-H* Edition Hepatitis delta vims X MCM-H^ Edition Hepatitis E vims Hepatitis E Hepatitis G vims X MCM-H* Edition HU39694 vims X litto ://www .cdc. eov/ncidod/dis eases/hanta/hos/noframes/ohvs/ ecoloev.htm Hughes virus X Field's Virology, 5th Ed., p. 1743-1745 Human adenovirus A Adenovirus Human adenovirus B X MCM-H^ Edition Human adenovirus C X MCM-H* Edition Human adenovirus D X MCM-H* Edition Human adenovirus E X MCM-H* Edition Human adenovirus F X MCM-H^ Edition Human astrovirus Astrovirus Human bocavirus X Allander, T., 2008 Human Coronavirus 229E X MCM-H* Edition Human Coronavirus OC43 X MCM-H* Edition Human coronavirus SARS-CoV-2 X Ciotti, et al., 2019 Human enterovirus 68 X MCM-H^ Edition Human enterovirus 70 X MCM-H* Edition Human enterovirus A Enterovirus Human enterovirus B X MCM-H* Edition Human enterovirus C X MCM-H* Edition Human enterovirus D X MCM-H^ Edition Human Herpesvirus 1 X MCM-H* Edition Human Herpesvirus 2 X MCM-H* Edition Human Herpesvirus 3 X MCM-H* Edition Page B28 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Viruses 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Human Herpesvirus 4 X MCM-H* Edition Human Herpesvirus 5 X MCM-H^ Edition Human Herpesvirus 6 X MCM-H* Edition Human Herpesvirus 7 X MCM-H* Edition Human Herpesvirus 8 X MCM-H* Edition Human Immunodeficiency Virus 1 X MCM-H* Edition Human Immunodeficiency Virus 2 X MCM-H^ Edition Human papillomavirus X MCM-H* Edition Human parainfluenza virus 1 X MCM-H* Edition Human parainfluenza virus 2 X MCM-H* Edition Human parainfluenza virus 3 X MCM-H* Edition Human parainfluenza virus 4 X MCM-H* Edition Human parechovirus type 1 X MCM-H^ Edition Human parechovirus type 2 X MCM-H* Edition Human Respiratory Syncytial virus X MCM-H* Edition Human Rhinovirus A X MCM-H^ Edition Human Rhinovirus B X MCM-H* Edition Human T-Lympho tropic Virus 1 X MCM-H* Edition Igbo-ora virus X Field's Virology, 5th Ed., p. 1024, 1048 Page B29 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Viruses 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Ilheus vims X MCM-H* Edition Influenza A vims X MCM-H^ Edition Influenza B virus X MCM-H* Edition Influenza C virus X MCM-H* Edition Issyk-Kul virus X MCM-H* Edition Japanese encephalitis X MCM-H* Edition virus JC virus X MCM-H* Edition Junin virus X MCM-H^ Edition Juquitiba virus X Field's Virology, 5th Ed., p. 1743-1745 KI polyomavirus X Bofill-Mas, S., et al., 2010 Karshi virus X MCM-H* Edition Kasokero virus X httD://Dhcne.CDinc. Columbia.ed u/ICTVdB/11000000.htm Kedougou virus X Field's Virology, 5th Ed., p. 1153-1158, 1199 Kemerovo virus X MCM-H* Edition Kobuvirus X Ramirez-Castillo et al., 2015 Kokobera virus X MCM-H* Edition Koutango virus X MCM-H* Edition Kyasanur forest disease X MCM-H^ Edition virus Laguna Negra virus X MCM-H* Edition Lanj an virus X httD://Dhcnc.come. Columbia.cd u/ICTVdB/11000000.htm Lassa virus X MCM-H* Edition Lebombo virus X MCM-H* Edition Lechiguanas virus X httD://Dhcne.come. Columbia.ed u/71 h Re do rt/s i t e s/de s c ri d t i o n s/ Bunvaviridae/hantavirus.htm Page B30 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Viruses 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Louping ill virus X MCM-H* Edition Lujo vims X httDS ://www.cdc. eov/vhf/lui o/tr ansmission/index.html Lymphocytic choriomeningitis vims X MCM-H* Edition Machupo vims X MCM-H* Edition Madrid vims X MCM-H* Edition Marburg virus X MCM-H* Edition Marituba virus X MCM-H* Edition Mayaro virus X MCM-H* Edition Measles virus X MCM-H* Edition Menangle virus X litto ://www .cdc. sov/ncidod/eid /vol4no2/ohilbev. htm Mimivirus1 X Field's Virology, 5th Ed., p. 627-628, 637-638 Mokola virus X Field's Virology, 5th Ed., p. 1363-1364 Molluscum contagiosum virus X MCM-H* Edition Monkeypox virus X MCM-H* Edition Monongahela virus X httD://Dhcnc.come. Columbia.cd u/71 h Rc do rt/s i t c s/dc s c ri d t i o n s/ Bunvaviridae/hantavirus.htm Mucambo virus X MCM-H^ Edition Mumps virus X MCM-H* Edition Murray Valley encephalitis virus X MCM-H* Edition New York virus X MCM-H* Edition Newcastle disease virus X Field's Virology, 5th Ed., p. 1497-1498 Nipah virus X MCM-H* Edition Page B31 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Viruses 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Norwalk-like viruses Calicivirus Nyando vims X MCM-H^ Edition Ockelbo vims X MCM-H* Edition Omsk haemorrhagic fever virus X MCM-H* Edition O'nyong-nyong virus X MCM-H* Edition Oran virus X lUtD://Dhcnc.come. Columbia.cd u/71 h Re do rt/s i t e s/de s c ri d t i o n s/ Bunvaviridae/hantavirus.htm Orf virus X MCM-H^ Edition Oriboca virus X MCM-H^ Edition Oropouche virus X MCM-H* Edition Orungo virus X MCM-H* Edition Parvovirus 4 X Sharp, C. P., et al., 2010 Parvovirus B19 X MCM-H* Edition Phnom-Penh bat virus X Field's Virology, 5th Ed., p. 1153-1158, 1206 Picobirnavirus X MCM-H* Edition Piry virus X MCM-H* Edition Poliovirus X MCM-H* Edition Powassan virus X MCM-H^ Edition Pseudocowpox virus X Field's Virology, 5th Ed., p. 2948, 2960, 2963 Punta Toro virus X MCM-H* Edition Puumala virus X MCM-H* Edition Quaranfil Virus X MCM-H* Edition Rabies virus X MCM-H* Edition Reovirus X Field's Virology, 5th Ed., p. 1897-1900 Reston Ebola virus X MCM-H* Edition Rift Valley fever virus X MCM-H* Edition Page B32 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Viruses 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Rio Bravo vims X Field's Virology, 5th Ed., p. 1153-1158, 1206 Rocio virus X MCM-H^ Edition Ross River virus X MCM-H^ Edition Rotavirus A Rotavirus Rotavirus B X MCM-H* Edition Rotavirus C X MCM-H* Edition Rotavirus D X MCM-H* Edition Rotavirus E X MCM-H^ Edition Rotavirus F X MCM-H* Edition Royal Farm virus X Field's Virology, 5th Ed., p. 1153-1158, 1204 Rubella virus X MCM-H* Edition Sabia virus X MCM-H^ Edition Saimiriine herpesvirus 1 X Field's Virology, 4th Ed., p. 2383,2483,2511,2848 Salehabad virus X lUtD://Dhcnc.come. Columbia.cd u/ICTVdB/11041008.htm Sandfly fever Naples virus X MCM-H* Edition Sandfly fever virus group X MCM-H* Edition Saumarez Reef virus X Field's Virology, 5th Ed., p. 1153-1158,1206 Sealpox virus X MCM-H* Edition Semliki Forest virus X MCM-H* Edition Seoul virus X MCM-H* Edition Sepik virus X MCM-H* Edition Sin Nombre virus X MCM-H* Edition Sindbis virus X MCM-H* Edition St. Louis encephalitis virus X MCM-H* Edition Sudan Ebola virus X MCM-H* Edition Page B33 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Viruses 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Suid herpesvirus X Field's Virology, 4th Ed., p. 2385, 2484, 2707 Swine vesicular disease virus X Field's Virology, 5th Ed., p. 963 Tacaiuma virus X MCM-H^ Edition Tamdy virus X MCM-H* Edition Tanapox virus X MCM-H* Edition Tataguine virus X MCM-H* Edition Thogoto virus X MCM-H^ Edition Trubanaman virus X MCM-H^ Edition Tyuleniy virus X Field's Virology, 5th Ed., p. 1153-1158, 1206 Usutu virus X MCM-H* Edition Variola virus X MCM-H* Edition Venezuelan Equine Encephalitis virus X MCM-H^ Edition Vesicular stomatitis virus X MCM-H^ Edition Wad Medani virus X Field's Virology, 5th Ed., p. 1975-1977 Wanowrie virus X MCM-H* Edition Wesselsbron virus X MCM-H* Edition West Nile virus X MCM-H* Edition Western Equine Encephalitis virus X MCM-H^ Edition WU polyomavirus X Bofill-Mas, S., 2010 Wyeomyia virus X MCM-H* Edition Yaba monkey tumor virus X MCM-H* Edition Yellow fever virus X MCM-H* Edition Yogue virus X lUtD://Dhcnc.come. Columbia.cd u/ICTVdB/11000000.htm Zaire Ebola virus X MCM-H* Edition Page B34 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Viruses 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Zika virus X MCM-H* Edition Zinga vims X litto ://www. cdc. eov/mmwr/ore view/mmwrhtml/00001253.ht m Protozoa 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Acanthamoeba astronyxis \ MCM-H* Edition Acanthamoeba castellani \ MCM-H* Edition Acanthamoeba culbertsoni \ MCM-H* Edition Acanthamoeba hatchetti \ MCM-H* Edition Acanthamoeba palestinensis \ MCM-H* Edition Acanthamoeba polyphaga \ MCM-H^ Edition Acanthamoeba rhysodes \ MCM-H^ Edition Babesia bovis \ MCM-H* Edition Babesia divergens \ MCM-H^ Edition Babesia gibsoni \ MCM-H^ Edition Babesia microti \ MCM-H* Edition Balamuthia mandrillaris \ MCM-H* Edition Balantidium coli \ MCM-H* Edition Blastocystis hominis Blastocystis hominis Cryptosporidium parvum1 Page B35 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Protozoa 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Cyclospora cayetanensis Cyclospora cayetanensis Dientamoeba fragilis X MCM-H* Edition Encephalitozoon cuniculi \ MCM-H^ Edition Encephalitozoon hellem \ MCM-H* Edition Encephalitozoon intestinalis Microsporidia Entamoeba chattoni \ litto ://www .its.be/its/Distance Learnins/LectureNotesVanden EndenE/06 AmocbiasisD2.htm #IX 450 Entamoeba histolytica Entamoeba histolytica Entamoeba moshkovskii \ litto ://www .its.be/its/Distance Learnins/LectureNotesVanden EndenE/06 AmocbiasisD2.htm #1X 450 Enterocytozoon bieneusi \ MCM-H* Edition Giardia duodenalis1 Isospora belli Lsospora belli Leishmania aethiopica X MCM-H^ Edition Leishmania amazonensis X MCM-H* Edition Leishmania braziliensis X MCM-H^ Edition Leishmania chagasi X MCM-H^ Edition Leishmania donovani X MCM-H* Edition Leishmania guyanensis X MCM-H* Edition Leishmania infantum X MCM-H* Edition Leishmania lainsoni X MCM-H* Edition Leishmania major X MCM-H* Edition Page B36 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Protozoa 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Leishmania mexicana X MCM-H^ Edition Leishmania naiffi X MCM-H^ Edition Leishmania panamensis X MCM-H* Edition Leishmania peruviana X MCM-H* Edition Leishmania pifanoi X MCM-H* Edition Leishmania shawi X MCM-H* Edition Leishmania tropica X MCM-H* Edition Leishmania venezuelensis X MCM-H* Edition Naegleria fowleri Naegleria fowleri Nosema africanum X MCM-H* Edition Nosema ceylonensis X MCM-H* Edition Nosema connori X MCM-H^ Edition Nosema ocularum X MCM-H^ Edition Pentatrichomonas hominis X MCM-H* Edition Plasmodium falciparum X MCM-H* Edition Plasmodium knowlesi X MCM-H* Edition Plasmodium malariae X MCM-H* Edition Plasmodium ovale X MCM-H* Edition Plasmodium simium X MCM-H* Edition Plasmodium vivax X MCM-H* Edition Retortamonas intestinalis X MCM-H* Edition Sarcocystis hominis X MCM-H* Edition Sarcocystis lindermanni X MCM-H* Edition Sarcocystis suihominis X MCM-H^ Edition Toxoplasma gondii Toxoplasma gondii Trachipleistophora hominis X MCM-H* Edition Page B37 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Protozoa 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Trichomonas tenax X MCM-H^ Edition Trichomonas vaginalis X MCM-H^ Edition Trypanosoma brucei X MCM-H* Edition Trypanosoma cruzi X MCM-H* Edition Vittaforma corneae X MCM-H* Edition Helminths 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Acanthocephalus rauschi x Ashford and Crewe, 2003 Achillurbainia nouveli X Ashford and Crewe, 2003 Achillurbainia recondita X Ashford and Crewe, 2003 Alaria americana X Ashford and Crewe, 2003 Alaria marcianae X Ashford and Crewe, 2003 Amphimerus pseudofelineus X Ashford and Crewe, 2003 Anatrichosoma cutaneum X Ashford and Crewe, 2003 Ancylostoma braziliense X Ashford and Crewe, 2003 Ancylostoma caninum X Ashford and Crewe, 2003 Ancylostoma ceylanicum X Ashford and Crewe, 2003 Ancylostoma duodenale X Ashford and Crewe, 2003 Ancylostoma malayanum X Ashford and Crewe, 2003 Anisakis physeteris X Ashford and Crewe, 2003 Anisakis simplex X Ashford and Crewe, 2003 Aonchotheca philippinensis X Ashford and Crewe, 2003 Apophallus donicus X Ashford and Crewe, 2003 Page B38 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Helminths 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Artyfechinostomum mehrai X Ashford and Crewe, 2003 Ascaris lumbricoides \ Ashford and Crewe, 2003 Ascaris suum \ Ashford and Crewe, 2003 Ascocotyle sp. \ Ashford and Crewe, 2003 Australobilharzia terrigalensis X Ashford and Crewe, 2003 Baylisascaris procyonis \ Ashford and Crewe, 2003 Bertiella mucronata \ Ashford and Crewe, 2003 Bertiella studeri X Ashford and Crewe, 2003 Bilharziella polonica X Ashford and Crewe, 2003 Bolbosoma sp. X Ashford and Crewe, 2003 Brugia beaveri \ Ashford and Crewe, 2003 Brugia guyanensis \ Ashford and Crewe, 2003 Brugia malayi \ Ashford and Crewe, 2003 Brugia pahangi \ Ashford and Crewe, 2003 Brugia timori \ Ashford and Crewe, 2003 Bunostomum phlebotomum \ Ashford and Crewe, 2003 Calodium hepaticum \ Ashford and Crewe, 2003 Carneocephallus brevicaea X Ashford and Crewe, 2003 Cathaemasia cabrerai X Ashford and Crewe, 2003 Centrocestus armatus X Ashford and Crewe, 2003 Centrocestus formosanus X Ashford and Crewe, 2003 Cheilospirura sp. X Ashford and Crewe, 2003 Clinostomum complanatum X Ashford and Crewe, 2003 Contracaecum osculatum X Ashford and Crewe, 2003 Page B39 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Helminths 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Corynosoma strumosum \ Ashford and Crewe, 2003 Cryptocotyle lingua X Ashford and Crewe, 2003 Cyclodontostomum X Ashford and Crewe, 2003 purvisi Dicrocoelium dendriticum \ Ashford and Crewe, 2003 Dicrocoelium hospes X Ashford and Crewe, 2003 Dioctophyme renale \ Ashford and Crewe, 2003 Dipetalonema arbuta \ Ashford and Crewe, 2003 Dipetalonema reconditum \ MCM-8, p. 634, 1209 Diphyllobothrium X Ashford and Crewe, 2003 cameroni Diphyllobothrium cordatum \ Ashford and Crewe, 2003 Diphyllobothrium dalliae \ Ashford and Crewe, 2003 Diphyllobothrium dendriticum \ Ashford and Crewe, 2003 Diphyllobothrium elegans X Ashford and Crewe, 2003 Diphyllobothrium X Ashford and Crewe, 2003 erinaceieuropaei Diphyllobothrium hians X Ashford and Crewe, 2003 Diphyllobothrium houghtoni X Ashford and Crewe, 2003 Diphyllobothrium nihonkaiense X Ashford and Crewe, 2003 Diphyllobothrium lanceolatum \ Ashford and Crewe, 2003 Dibothriocephalus latus \ Ashford and Crewe, 2003 Page B40 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Helminths 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Diphyllobothrium mansonoides \ Ashford and Crewe, 2003 Diphyllobothrium klebanovskii X Ashford and Crewe, 2003 Diphyllobothrium orcini X Ashford and Crewe, 2003 Adenocephalus pacificus X Ashford and Crewe, 2003 Diphyllobothrium scoticum X Ashford and Crewe, 2003 Diphyllobothrium stemmacephalum \ Ashford and Crewe, 2003 Diphyllobothrium theileri X Ashford and Crewe, 2003 Diplogonoporus balaenopterae X Ashford and Crewe, 2003 Diplogonoporus brauni X Ashford and Crewe, 2003 Diplogonoporus balaenopterae X Ashford and Crewe, 2003 Diplostomum spathaceum X Ashford and Crewe, 2003 Dipylidium caninum \ Ashford and Crewe, 2003 Dirofilaria immitis \ Ashford and Crewe, 2003 Dirofilaria repens \ Ashford and Crewe, 2003 Dirofilaria striata \ Ashford and Crewe, 2003 Dirofilaria subdermata \ Ashford and Crewe, 2003 Dirofilaria tenuis \ Ashford and Crewe, 2003 Dirofilaria ursi \ Ashford and Crewe, 2003 Dracunculus insignis X Ashford and Crewe, 2003 Dracunculus medinensis X Ashford and Crewe, 2003 Drepanidotaenia lanceolata \ Ashford and Crewe, 2003 Page B41 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Helminths 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Echinochasmus japonicus X Ashford and Crewe, 2003 Echinochasmus jiufoensis X Ashford and Crewe, 2003 Echinochasmus perfoliatus X Ashford and Crewe, 2003 Echinococcus granulosus \ Ashford and Crewe, 2003 Echinococcus multilocularis \ Ashford and Crewe, 2003 Echinococcus oligarthus X Ashford and Crewe, 2003 Echinococcus vogeli X Ashford and Crewe, 2003 Echinoparyphium recurvatum X Ashford and Crewe, 2003 Echinostoma cinetorchis X Ashford and Crewe, 2003 Echinostoma echinatum X Ashford and Crewe, 2003 Echinostoma hortense X Ashford and Crewe, 2003 Echinostoma ilocanum X Ashford and Crewe, 2003 Echinostoma jassyense X Ashford and Crewe, 2003 Echinostoma macrorchis X Ashford and Crewe, 2003 Echinostoma malayanum X Ashford and Crewe, 2003 Echinostoma revolutum X Ashford and Crewe, 2003 Enterobius gregorii \ Ashford and Crewe, 2003 Enterobius vermicularis \ Ashford and Crewe, 2003 Episthmium caninum X Ashford and Crewe, 2003 Eucoleus aerophilus \ Ashford and Crewe, 2003 Eurytrema pancreaticum \ Ashford and Crewe, 2003 Eustrongylides sp. \ Ashford and Crewe, 2003 Fasciola indica \ Ashford and Crewe, 2003 Page B42 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Helminths 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Fasciola hepatica \ Ashford and Crewe, 2003 Fasciola indica \ Ashford and Crewe, 2003 Fasciolopsis buski X Ashford and Crewe, 2003 Neodiplostomum seoulense X Ashford and Crewe, 2003 Gastrodiscoides hominis X Ashford and Crewe, 2003 Gigantobilharzia huttoni \ Ashford and Crewe, 2003 Gigantobilharzia sturniae X Ashford and Crewe, 2003 Gnathostoma doloresi X Ashford and Crewe, 2003 Gnathostoma hispidum X Ashford and Crewe, 2003 Gnathostoma nipponicum X Ashford and Crewe, 2003 Gnathostoma spinigerum \ Ashford and Crewe, 2003 Gongylonema pulchrum \ Ashford and Crewe, 2003 Gymnophalloides sp. X Ashford and Crewe, 2003 Haemonchus contortus X Ashford and Crewe, 2003 Haplorchis pumilo X Ashford and Crewe, 2003 Haplorchis taichui X Ashford and Crewe, 2003 Haplorchis vanissima \ Ashford and Crewe, 2003 Haplorchis yokogawai \ Ashford and Crewe, 2003 Heterobilharzia americana \ Ashford and Crewe, 2003 Heterophyes dispar X Ashford and Crewe, 2003 Heterophyes heterophyes X Ashford and Crewe, 2003 Heterophyes nocens X Ashford and Crewe, 2003 Heterophyopsis continua X Ashford and Crewe, 2003 Page B43 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Helminths 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Himasthala muehlensi \ Ashford and Crewe, 2003 Hymenolepis diminuta \ Ashford and Crewe, 2003 Hymenolepis nana \ Ashford and Crewe, 2003 Hypoderaeum conoideum X Ashford and Crewe, 2003 Inermicapsifer madagascariensis X Ashford and Crewe, 2003 Isoparorchis hypselobagri X Ashford and Crewe, 2003 Lagochilascaris minor \ Ashford and Crewe, 2003 Ligula intestinalis X Ashford and Crewe, 2003 Loa loa \ Ashford and Crewe, 2003 Macracanthorhynchus hirudinaceus X Ashford and Crewe, 2003 Macracanthorhynchus ingens \ Ashford and Crewe, 2003 Mammomonogamus laryngeus X Ashford and Crewe, 2003 Mammomonogamus nasicola X Ashford and Crewe, 2003 Mansonella ozzardi \ Ashford and Crewe, 2003 Mansonella perstans \ Ashford and Crewe, 2003 Mansonella rodhaini \ Ashford and Crewe, 2003 Mansonella semiclarum \ Ashford and Crewe, 2003 Mansonella streptocerca \ Ashford and Crewe, 2003 Marshallagia marshalli X Ashford and Crewe, 2003 Mathevotaenia symmetrica X Ashford and Crewe, 2003 Mecistocirrus digitatus \ Ashford and Crewe, 2003 Meningonema peruzzii X Ashford and Crewe, 2003 Mesocestoides lineatus X Ashford and Crewe, 2003 Page B44 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Helminths 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Mesocestoides variabilis \ Ashford and Crewe, 2003 Metagonimus minutus X Ashford and Crewe, 2003 Metagonimus yokogawai X Ashford and Crewe, 2003 Metastrongylus apri \ Ashford and Crewe, 2003 Metorchis albidus \ Ashford and Crewe, 2003 Metorchis conjunctus \ Ashford and Crewe, 2003 Microfilaria bolivarensis \ Ashford and Crewe, 2003 Micronema deletrix \ Ashford and Crewe, 2003 Moniezia expansa \ Ashford and Crewe, 2003 Moniliformis moniliformis \ Ashford and Crewe, 2003 Multiceps brauni X Ashford and Crewe, 2003 Taenia glomeratus X Ashford and Crewe, 2003 Multiceps longihamatus X Ashford and Crewe, 2003 Multiceps multiceps \ Ashford and Crewe, 2003 Taenia serialis \ Ashford and Crewe, 2003 Nanophyetus salmincola \ Ashford and Crewe, 2003 Necator americanus \ Ashford and Crewe, 2003 Nematodirus abnormalis \ Ashford and Crewe, 2003 Neodiplostomum sp. X Ashford and Crewe, 2003 Oesophagostomum aculeatum X Ashford and Crewe, 2003 Oesophagostomum bifurcum X Ashford and Crewe, 2003 Oesophagostomum stephanostomum \ Ashford and Crewe, 2003 Onchocerca volvulus \ Ashford and Crewe, 2003 Opisthorchis (Chlonorchis) sinensis X Ashford and Crewe, 2003 Page B45 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Helminths 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Opisthorchis felineus X Ashford and Crewe, 2003 Opisthorchis noverca \ Ashford and Crewe, 2003 Opisthorchis viverrini X Ashford and Crewe, 2003 Orientobilharzia turkestanica X Ashford and Crewe, 2003 Ornithobilharzia sp. X Kolarova, 2007 Ostertagia ostertagi X Ashford and Crewe, 2003 Paragonimus africanus X Ashford and Crewe, 2003 Paragonimus bankokensis \ Ashford and Crewe, 2003 Paragonimus caliensis \ Ashford and Crewe, 2003 Paragonimus heterotremus X Ashford and Crewe, 2003 Paragonimus hueitungensis X Ashford and Crewe, 2003 Paragonimus kellicotti \ Ashford and Crewe, 2003 Paragonimus mexicanus \ Ashford and Crewe, 2003 Paragonimus miyazakii X Ashford and Crewe, 2003 Paragonimus ohirai X Ashford and Crewe, 2003 Paragonimus phillipinensis X Ashford and Crewe, 2003 Paragonimus sadoensis X Ashford and Crewe, 2003 Paragonimus siamensis X Palmer et al., 1998, p. 736 Paragonimus skrjabini X Ashford and Crewe, 2003 Paragonimus uterobilateralis X Ashford and Crewe, 2003 Paragonimus westermani X Ashford and Crewe, 2003 Parascaris equorum \ Ashford and Crewe, 2003 Page B46 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Helminths 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Parastrongylus cantonensis X Ashford and Crewe, 2003 Parastrongylus costaricensis \ Ashford and Crewe, 2003 Pearsonema plica \ MCM-8, p. 1134 Pelodera strongyloides X Ashford and Crewe, 2003 Phaneropsolus bonnei X Ashford and Crewe, 2003 Philophthalmus lacrymosus X Ashford and Crewe, 2003 Pseudoterranova decipiens \ Ashford and Crewe, 2003 Physaloptera caucasica \ Ashford and Crewe, 2003 Physaloptera transfuga X Ashford and Crewe, 2003 Plagiorchis harinasutai X Ashford and Crewe, 2003 Plagiorchis javensis X Ashford and Crewe, 2003 Plagiorchis muris X Ashford and Crewe, 2003 Plagiorchis philippinensis X Ashford and Crewe, 2003 Poikilorchis congolensis X Ashford and Crewe, 2003 Procerovum calderoni X Ashford and Crewe, 2003 Prohemistomum vivax X Ashford and Crewe, 2003 Prosthodendrium molenkampi X Ashford and Crewe, 2003 Pseudamphistomum aethiopicum X Ashford and Crewe, 2003 Pseudamphistomum truncatum X Ashford and Crewe, 2003 Psilorchis hominis \ Ashford and Crewe, 2003 Pygidiopsis summa X Ashford and Crewe, 2003 Pyramicocephalus anthrocephalus \ Ashford and Crewe, 2003 Page B47 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Helminths 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Raillietina celebensis X Ashford and Crewe, 2003 Raillietina demerariensis \ Ashford and Crewe, 2003 Rhabditis elongata X Ashford and Crewe, 2003 Rhabditis inermis X Ashford and Crewe, 2003 Rhabditis niellyi \ Ashford and Crewe, 2003 Rhabditis pellioditis \ Ashford and Crewe, 2003 Rictularia sp. \ Ashford and Crewe, 2003 Schistocephalus solidus \ Ashford and Crewe, 2003 Schistosoma bovis X Ashford and Crewe, 2003 Schistosoma haematobium X Ashford and Crewe, 2003 Schistosoma intercalatum X Ashford and Crewe, 2003 Schistosoma japonicum X Ashford and Crewe, 2003 Schistosoma malayensis X Ashford and Crewe, 2003 Schistosoma mansoni \ Ashford and Crewe, 2003 Schistosoma mattheei X Ashford and Crewe, 2003 Schistosoma mekongi X Ashford and Crewe, 2003 Schistosoma rodhaini X Ashford and Crewe, 2003 Schistosoma spindale X Ashford and Crewe, 2003 Schistosomatium douthitti \ Ashford and Crewe, 2003 Setaria equina \ Ashford and Crewe, 2003 Spirocerca lupi X Ashford and Crewe, 2003 Stellantchasmus falcatus \ Ashford and Crewe, 2003 Stictodora fuscata X Ashford and Crewe, 2003 Strongyloides fuelleborni X Ashford and Crewe, 2003 Page B48 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Helminths 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Strongyloides papillosus \ Ashford and Crewe, 2003 Strongyloides ransomi \ Ashford and Crewe, 2003 Strongyloides stercoralis \ Ashford and Crewe, 2003 Strongyloides westeri \ Ashford and Crewe, 2003 Syphacea obvelata X Ashford and Crewe, 2003 Taenia crassiceps \ Ashford and Crewe, 2003 Taenia saginata \ Ashford and Crewe, 2003 Taenia solium \ Ashford and Crewe, 2003 Taenia taeniaeformis X Ashford and Crewe, 2003 Teladorsagia circumcincta X Ashford and Crewe, 2003 Ternidens deminutus X Ashford and Crewe, 2003 Thelazia californiensis \ Ashford and Crewe, 2003 Thelazia callipaeda X Ashford and Crewe, 2003 Thelazia rhodesi X MCM-8, p. 363 Toxascaris leonina \ Ashford and Crewe, 2003 Toxocara canis \ Ashford and Crewe, 2003 Toxocara cati \ Ashford and Crewe, 2003 Trichinella britovi X Ashford and Crewe, 2003 Trichinella nativa \ Ashford and Crewe, 2003 Trichinella nelsoni X Ashford and Crewe, 2003 Trichinella pseudospiralis X Ashford and Crewe, 2003 Trichinella spiralis \ Ashford and Crewe, 2003 Trichinella T5 \ Ashford and Crewe, 2003 Trichobilharzia brevis X Ashford and Crewe, 2003 Trichobilharzia ocellata \ Ashford and Crewe, 2003 Trichobilharzia stagnicolae \ Ashford and Crewe, 2003 Trichostrongylus affinis \ Ashford and Crewe, 2003 Page B49 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Helminths 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Trichostrongylus axei \ Ashford and Crewe, 2003 Trichostrongylus brevis X Ashford and Crewe, 2003 Trichostrongylus calcaratus X Ashford and Crewe, 2003 Trichostrongylus capricola X Ashford and Crewe, 2003 Trichostrongylus colubriformis \ Ashford and Crewe, 2003 Trichostrongylus instabilis X Ashford and Crewe, 2003 Trichostrongylus lerouxi X Ashford and Crewe, 2003 Trichostrongylus orientalis X Ashford and Crewe, 2003 Trichostrongylus probolurus X Ashford and Crewe, 2003 Trichostrongylus skrjabini X Ashford and Crewe, 2003 Trichostrongylus vitrinus X Ashford and Crewe, 2003 Trichuris suis \ Ashford and Crewe, 2003 Trichuris trichiura \ Ashford and Crewe, 2003 Trichuris vulpis \ Ashford and Crewe, 2003 Uncinaria stenocephala \ Ashford and Crewe, 2003 Watsonius macaci X Ashford and Crewe, 2003 Wuchereria bancrofti \ Ashford and Crewe, 2003 Wuchereria lewisi \ Ashford and Crewe, 2003 Page B50 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fungi 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Absidia corymbifera X MCM-H* Edition Acremonium kiliense X MCM-H* Edition Acremonium potronii X MCM-H^ Edition Acremonium recifei X MCM-H^ Edition Acremonium strictum X MCM-H* Edition Acrophialophora fusispora X MCM-H* Edition Actinomadura madurae X MCM-H* Edition Actinomadura pelletieri X MCM-H* Edition Alternaria alternata X MCM-H* Edition Alternaria caespitosa X Howard p. 575 Alternaria chlamydospora X MCM-H* Edition Alternaria dianthicola X MCM-H* Edition Alternaria infectoria X MCM-H* Edition Alternaria longipes X MCM-H^ Edition Alternaria stemphyloides X htto://www.doctorfuneus.ore/t hefunei/ Alternaria. htm Alternaria tenuissima X MCM-H^ Edition Aphanoascus fulvescens X MCM-H^ Edition Apophysomyces elegans X MCM-H^ Edition Arachnomyces nodosetosus X MCM-H* Edition Arthrinium phaeospermum X h 11 d : // w w w. doc t o rfu n e u s. o r e/t hefunei/ Arthrinium. htm Arthroderma uncinatum X MCM-H* Edition Arthrographis kelrae* X Warris et al., 2001 Aspergillus candidus X MCM-H* Edition Aspergillus clavatus X MCM-H* Edition Page B51 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fungi 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Aspergillus fisherianus X MCM-H* Edition Aspergillus flavipes X MCM-H* Edition Aspergillus flavus group X MCM-H^ Edition Aspergillus fumigatus group Aspergillus fumigatus Aspergillus glaucus X MCM-H* Edition Aspergillus nidulans group X MCM-H* Edition Aspergillus niger X MCM-H* Edition Aspergillus oryzae X MCM-H* Edition Aspergillus terreus group X MCM-H* Edition Aspergillus versicolor X MCM-H^ Edition Aspergillus wentii X MCM-H^ Edition Aureobasidium pullulans X MCM-H* Edition Basidiobolus ranarum X MCM-H* Edition Beauveria bassiana X MCM-H* Edition Bipolaris australiensis X MCM-H* Edition Blastomyces dermatitidis X MCM-H* Edition Botryosphaeria subglobosa X litto ://newoortal. sbif. ore/soecie s/14373513 and litto ://www .cabri. ors/C ABRI/s rs-bin/weetz?-newld+-e+- Daac+ciRcsult+ICABI FIL- id:'IMI%20287616'l Botrytsis cinerea X Hashimoto et al., 2017 Byssochlamys spectabilis X MCM-H* Edition Page B52 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Fungi 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Candida acidothermophilum X MCM-H* Edition Candida albicans X MCM-H* Edition Candida catenulata X MCM-H* Edition Candida famata X MCM-H* Edition Candida fimetaria var. fimetaria X MCM-H^ Edition Candida glabrata X MCM-H* Edition Candida haemulonis X MCM-H* Edition Candida intermedia X htto://www.doctorfuneus.ore/t hefunei/Candida smhtm Candida lodderae X MCM-H* Edition Candida mycoderma var. annulata X MCM-H* Edition Candida parapsilosis X MCM-H* Edition Candida tropicalis X MCM-H* Edition Cephaliophora irregularis X htto://www.doctorfuneus.ore/i maacban/sv nonvms/CcDhalioD hora.htm Cerinosterus cyanescens X 1iUd://w w w .doctorfunaus.ora/t hefunei/Soorothrix.htm Chaetomium atrobrunneum X MCM-H* Edition Chaetomium funicola X 1111 d : //www. doc t o ifu n a u s. o r a/t hefunsi/Chaetomium.htm Chaetomium globosum X MCM-H*1 Edition Chaetomium perpulchrum X h 11 d : //www. doc t o ifu n a ii s. o r a/t hefunsi/Chaetomium.htm Chaetomium strumarium X MCM-H*1 Edition Page B53 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fungi 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Chaetophoma dermo- unguis X htto://www.doctorfuneus.ore/i ma acban/sv nonv ms/ChactoDlio ma.htm Chlamydoabsidia padenii X htto://www.doctorfuneus.ore/i maeeban/svnonvms/Chlamvdo absidia.htm Chlorella protothecoides X htto://t)caoxfordiournals.ore/c ei/content/abstract/9/1/87 Chrysosporium zonatum* X Arvanitidou et al., 1999 Cladophialophora arxii X MCM-H* Edition Cladophialophora bantiana X MCM-H* Edition Cladophialophora boppii X MCM-H* Edition Cladophialophora carrionii X MCM-H* Edition Cladophialophora devriesii X MCM-H* Edition Cladorrhinum bulbillosum X littD ://uwadmnweb .uwvo .edu/b otanv/Soil%20Microfuneal%2 0Collection/RMF%20collectio n%20(Rockv%20Mountain%2 OFunai )oartI Ilitm Cladosporium cladosporioides X MCM-H* Edition Cladosporium elatum X htto://www.doctorfuneus.ore/t hefunsi/CladosBorium.htm Cladosporium oxysporum X htto://www.doctorfuneus.ore/t hefunsi/CladosDorium.htm Cladosporium sphaerosphermum X MCM-H^ Edition Page B54 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fungi 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Clavispora lusitaniae X MCM-H* Edition Coccidioides immitis X MCM-H* Edition Cochliobolus pallescens X Howard p. 584-586 Cokeromyces recurvartus X MCM-H^ Edition Colletotrichum coccodes X Howard p. 662-664 Colletotrichum gloeosporioides X Howard p. 662-664 Conidiobolus coronatus X MCM-H* Edition Conidiobolus incongruus X MCM-H* Edition Conidiobolus lamprauges X Howard p. 133-137 Coniochaeta hoffinannii X MCM-H* Edition Coniochaeta mutabilis X MCM-H* Edition Coniothyrium fuckelii X htto://www.doctorfuneus.ore/i maeeban/svnonvms/Coniothvri um.htm Coprinopsis cinerea X MCM-H* Edition Cryptococcus neoformans X MCM-H^ Edition Cunninghamella bertholletiae X MCM-H* Edition Curvularia brachyspora X Howard p. 584-586 Curvularia clavata X Howard p. 584-586 Curvularia geniculata X MCM-H^ Edition Curvularia hawaiiensis X MCM-H^ Edition Curvularia lunata X MCM-H* Edition Curvularia senegalensis X Howard p. 584-586 Curvularia spicifera X MCM-H* Edition Page B55 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fungi 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Curvularia verucculosa X Howard p. 584-586 Dichotomophthora portulacae X htto://www.doctorfuneus.ore/i maeeban/svnonvms/Dichotom ODhthora.htm Dichotomophthoropsis nymphaerum X htto://www.doctorfuneus.ore/i maeeban/svnonvms/Dichotom ODhthoroDsis.htm Dissitimurus exedrus X Howard p. 588 Diutina rugosa X MCM-12 Doratomyces stemonitis X htto://www.doctorfuneus.ore/i maeeban/svnonvms/Doratomvc es.htm Emmonsia crescens X MCM-12111 Edition Emmonsia parva X MCM-12111 Edition Epiccocum purpurascens X lUtDs://\Yww.insDa.ac.ca/cn/mo ulds/fact-sheets/emcoccum- DiirDiirasccns Epidermophyton floccosum X MCM-12111 Edition Exophiala dermatitidis X MCM-12111 Edition Exophiala jeanselmei Exophiala jeanselmei Exophiala moniliae X Howard p. 590-596 Exophiala pisciphila X Howard p. 590-596 Exophiala psychrophila X htto://www.doctorfuneus.ore/t hefunei/exoohiala. htm Exophiala salmonis X Howard p. 590-596 Exophiala spinifera X MCM-12111 Edition Exosporium dematium X Howard p. 662-664 Exserohilum longirostratum X MCM-12111 Edition Page B56 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fungi 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Exserohilum macginnisii X Howard p. 596-597 Falciformispora senegalensis X MCM-H* Edition Falciformispora tompkinsii X MCM-H^ Edition Fonsecaea compacta X htto://www.doctorfuneus.ore/t hefunei/Fonsecaea.htm Fusarium aquaeductuum X Howard p. 402 Fusarium chlamydosporum X MCM-H^ Edition Fusarium dimerum X MCM-H^ Edition Fusarium falciforme X MCM-H* Edition Fusarium moniliforme X MCM-H* Edition Fusarium napiforme X MCM-H* Edition Fusarium neocosmosporiellum X Howard p. 434-436 Fusarium nivale X Howard p. 431 Fusarium oxysporum X MCM-H* Edition Fusarium pallidoroseum X Howard p. 320,418-421 Fusarium proliferatum X MCM-H* Edition Fusarium sacchari X MCM-H^ Edition Fusarium solani Fusarium solani Fusarium subglutinans X MCM-H* Edition Fusarium ventricosum X htto://www.doctorfuneus.ore/t hefunei/fusarium. htm Fusarium verticillioides X MCM-H* Edition Geotrichum candidum * X Rosenzweig et al, 1986 Gliomastix roseogrisea X Howard, p. 384 Hansenula anomala X MCM-H* Edition Page B57 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fungi 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Histoplasma capsulatum X MCM-H* Edition Hortaea werneckii X MCM-H* Edition Humicola lanuginosa X Howard p. 623 Hypocrea pseudokoningii X MCM-H* Edition Kiflimonium curvulum X MCM-H* Edition Kluyveromyces marxianus X MCM-H* Edition Lasiodiplodia theobromae X MCM-H* Edition Lophophyton gallinae X MCM-H* Edition Madurella ikedae X MCM-H* Edition Magnusiomyces capitatus X MCM-H* Edition Malassezia globosa X MCM-H* Edition Malassezia obtusa X MCM-H* Edition Malassezia pachydermatis X MCM-H* Edition Malassezia restricta X MCM-H* Edition Malassezia sloofiae X MCM-H^ Edition Malassezia sympodialis X MCM-H* Edition Meyerozyma guilliermondii X MCM-H* Edition Microascus cinereus X MCM-H* Edition Microascus cirrosus X MCM-H* Edition Microsporum audouinii X MCM-H^ Edition Microsporum canis X MCM-H* Edition Microsporum equinum X MCM-H* Edition Microsporum ferrugineum X MCM-H* Edition Page B58 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fungi 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Microsporum nanum X MCM-H* Edition Microsporum praecox X MCM-H* Edition Moniliella suaveolens X htto://www.doctorfuneus.ore/i maeeban/svnonvms/Moniliella. htm Mucor circinelloides X MCM-H* Edition Mucor hiemalis X MCM-H* Edition Mucor indicus X Howard p. 70, 98-99, 101 Mucor racemosus X MCM-H* Edition Mucor ramosissimus X MCM-H* Edition Myceliophthora thermophila X MCM-H* Edition Mycocentrospora acerina X Howard p. 602-603 Mycoleptodiscus indicus X Howard p. 602-603 Myriodontium keratinophilum X MCM-H* Edition Nannizzia cajetani X Howard p. 155 Nannizzia fulva X MCM-H* Edition Nannizzia gypsea X MCM-H* Edition Nannizzia persicolor X MCM-H^ Edition Nannizzia racemosa X MCM-H* Edition Nattrassia mangiferae X MCM-H* Edition Neocosmospora cyanescens X MCM-H* Edition Neocosmospora keratoplastica X Howard p. 394 Neocosmospora lichenicola X MCM-H* Edition Page B59 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fungi 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Neoscytalidium hyalinum X MCM-H* Edition Neotestudina rosatii X MCM-H* Edition Neurospora sitophila X htto://www.doctorfuneus.ore/i maeeban/svnonvms/Chrvsonili a. htm Nigrospora sphaerica X htto://www.doctorfuneus.ore/t hefunei/Nierosoora.htm Ochroconis gallopava X MCM-H* Edition Ochroconis tshawytschae X Howard p. 617 Oidiodendron cereale X htto://www.doctorfuneus.ore/i maeeban/svnonvms/Oidiodend ron.htm Oidium chartarum X Doggett, 2000 Oospora sulphureo- ochracea X Howard p. 230-232 Ovadendron ochraceum X litto ://www .catalo eueoflife .ore/ show soccics details.Dho?rcco rd id=3330913 Paecilomyces farinosus X htto://www.doctorfuneus.ore/t hefunei/Paecilomvces.htm Paecilomyces fumerosoreus X Howard p. 361-362 Paecilomyces javanicus X MCM-H^ Edition Paecilomyces lilacinus X MCM-H* Edition Paecilomyces marquandii X MCM-H* Edition Paecilomyces viridis X Howard p. 357-359 Paracoccidioides brasiliensis X lUtD ://w\vw. docto rlli naus. ora/t hefunsi/Lacazia.htm Page B60 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fungi 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Paracoccidioides brasiliensis X MCM-H* Edition Parendomyces zeylanoides X MCM-H* Edition Parengyodontium album X MCM-H^ Edition Penicillium chrysogenum X MCM-H* Edition Penicillium citrinum X MCM-H* Edition Penicillium commune X MCM-H* Edition Penicillium decumbens X MCM-H^ Edition Penicillium expansum X MCM-H* Edition Penicillium marneffei X MCM-H* Edition Penicillium purpurogenum X MCM-H* Edition Phaeoanellomyces elegans X Howard p. 605-606 Phaeoanellomyces werneckii X MCM-H* Edition Phaeosclera dematioides X htto://www.doctorfuneus.ore/i maeeban/svnonvms/Phaeoscler a. htm Phaeotrichoconis crotalariae X Howard p. 606-607 Phanerochaete chrysosporium X Doggett, 2000 Phialemoniopsis curvata X MCM-H* Edition Phialemonium obovatum X MCM-H* Edition Phialophora bubakii X Howard p. 607-612 Page B61 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fungi 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Phialophora pedrosoi X lUtD ://\vw\v.docto rfii naus. ora/t hefunei/Fonsecaea.htm Phialophora richardsiae X MCM-H^ Edition Phialophora verrucosa X MCM-H* Edition Phoma cava X htto://www.doctorfuneus.ore/t hefunei/ohoma.htm Phoma cruris-hominis X Howard p. 666-668 Phoma eupyrena X Howard p. 666-668 Phoma glomerata X Howard p. 666-668 Phoma herbarum X htto://www.doctorfuneus.ore/t hefunei/ohoma.htm Phoma hibernica X Howard p. 666-668 Phoma minutella X Howard p. 666-668 Phoma oculo-hominis X Howard p. 666-668 Phyllosticta citricarpa X lUtD ://w\vw. docto rlli naus. ora/t hefunei/ohoma.htm Piedraia hortae X MCM-H* Edition Pityrosporum orbiculare X MCM-H^ Edition Pleurophoma pleurospora X Howard p. 666-668 Pleurostoma repens X MCM-H^ Edition Pneumocystis carinii X MCM-H* Edition Prototheca wickerhamii X MCM-H* Edition Prototheca zopfii X MCM-H* Edition Pseudoallescheria boydii X MCM-H* Edition P seudomicrodochium suttonii X MCM-H* Edition Pyrenochaeta mackinnonii X MCM-H* Edition Pyrenochaeta romeroi X MCM-H* Edition Page B62 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fungi 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Pyrenochaeta unguis- hominis X Howard p. 666-668 Pyrenophora biseptata X Howard p. 588-589 Pythium insidiosum X MCM-H* Edition Ramichloridium obovoidea X htto://www.doctorfuneus.ore/i maeeban/svnonvms/Ramichlor idium.htm Rhinocladiella aquaspersa X MCM-H* Edition Rhinocladiella schulzeri X htto://www.doctorfuneus.ore/i maeeban/svnonvms/Ramichlor idium.htm Rhinosporidium seeberi X MCM-H* Edition Rhizomucor miehei X MCM-H* Edition Rhizomucor pusillus X MCM-H* Edition Rhizopus azygosporus X MCM-H* Edition Rhizopus microsporias X MCM-H^ Edition Rhizopus oryzae X MCM-H* Edition Rhizopus stolonifer X MCM-H* Edition Rhodotorula glutinis X MCM-H^ Edition Rhodotorula minuta X MCM-H^ Edition Rhodotorula mucilaginosa X MCM-H* Edition Rhodotorula rubra X MCM-H* Edition Saccharomyces cerevisiae X MCM-H* Edition Saksenaea vasiformis X MCM-H* Edition Sarcinomyces phaeomuriformis X MCM-H* Edition Scedosporium prolificans X MCM-H* Edition Page B63 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fungi 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Schizophyllum commune X MCM-H* Edition Scolecobasidium humicola X Howard p. 617 Scopulariopsis acremonium X MCM-H^ Edition Scopulariopsis asperula X MCM-H* Edition Scopulariopsis brevicaulis X MCM-H^ Edition Scopulariopsis brumptii X MCM-H* Edition Scopulariopsis Candida X MCM-H^ Edition Scopulariopsis flava X MCM-H* Edition Scopulariopsis fusca X MCM-H* Edition Scytalidium infestans X litto ://www. scielo .br/scielo ,v\m '.'scriDt=sci arttext&md=S0036 46651999000500009&lne=r>t& nrm=iso&tlna=Dt Septonema exile X Howard p. 621 Setosphaeria rostrata X MCM-H* Edition Sporothrix schenckii X MCM-H^ Edition Stemphylium macrosporoideum * X West 1986 Stenella araguata X htto://www.doctorfuneus.ore/i maeeban/svnonvms/Stenella.ht m Streptomyces somaliensis X MCM-H^ Edition Taeniolella stilbaspora X Howard p. 621 Tetraploa aristata X Howard p. 621-623 Thermomyces dupontii X Howard p. 340-346 Page B64 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fungi 1 2 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Thielavia terrestris X MCM-H* Edition Torulopsis magnoliae X htto://www.doctorfuneus.ore/i maeeban/svnonvms/T oailoosis .htm Trematosphaeria grisea X MCM-H* Edition Trichoderma viride X MCM-H* Edition Trichomaris invadens X htto ://www .rac .dfo- m do . sc .ca/sci/shelldis/raees/ch itfdcb e.htm Trichophyton concentricum X MCM-H* Edition Trichophyton equinum X MCM-H* Edition Trichophyton gallinae X MCM-H* Edition Trichophyton gourvilii X MCM-H* Edition Trichophyton megninii X MCM-H* Edition Trichophyton mentagrophytes X MCM-H* Edition Trichophyton rubrum X MCM-H* Edition Trichophyton schoenleinii X MCM-H* Edition Trichophyton simii X MCM-H* Edition Trichophyton soudanense X MCM-H* Edition Trichophyton tonsurans X MCM-H* Edition Trichophyton verrucosum X MCM-H* Edition Trichophyton violaceum X MCM-H* Edition Trichosporon asahii X MCM-H* Edition Trichosporon beigelii X MCM-H* Edition Trichosporon cutaneum X MCM-H* Edition Trichosporon inkin X MCM-H* Edition Page B65 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Fungi 12 3 4 5 6 7 8 9 10 11 12 PCCL Page Reference Trichosporon mucoides X MCM-H* Edition Trichosporon ovoides X MCM-H* Edition Tritirachium oryzae X htto://www.doctorfuneus.ore/i maeeban/svnonvms/T ritirachiu m.htm Tubercularia vulgaris X Howard p. 448-449 Ulocladium chartarum X Howard p. 623-624 Veronaea botryosa X htto://www.doctorfuneus.ore/i maucban/sv nonv ms/V eronaea. htm Verticillium nigrescens X Howard p. 449-450 Volutella cinerescens X Howard p. 451 Yarrowia lipolytica X MCM-H* Edition Page B66 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Appendix C: PCCL 5 Pathogen Scores Pathogen WBDO Occurrence Normalized health score Total score Naegleria fowleri 5 3 5.0 10.0 Legionella pneumophila 5 3 3.6 8.6 Escherichia coli (0157) 5 3 3.2 8.2 Pseudomonas aeruginosa 5 3 3.2 8.2 Helicobacter pylori 1 3 5.0 8.0 Campylobacter jejuni 5 3 2.5 7.5 Mycobacterium abcessus 4 3 3.2 7.2 Shigella sonnei 4 3 3.2 7.2 Caliciviruses 5 3 2.1 7.1 Mycobacterium avium 4 3 2.9 6.9 Adenovirus 2 3 3.6 6.6 Enterovirus 2 3 3.6 6.6 Pantoea agglomerans 4 3 2.5 6.5 Hepatitis A virus 3 2 3.2 6.2 Fusarium solani 1 3 2.9 5.9 Nontuberculous Mycobacteria (NTM) 3 3 2.9 5.9 Hepatitis E virus 2 1 3.6 5.6 Cyclospora cayetanensis 3 3 2.5 5.5 Rotavirus 2 3 2.5 5.5 Salmonella enterica 3 3 2.5 5.5 Toxoplasma gondii 2 1 3.2 5.2 Aspergillus fumigatus group 1 3 2.1 5.1 Entamoeba histolytica 3 3 2.1 5.1 Exophiala jeanselmei 1 3 2.1 5.1 Vibrio cholerae 3 3 2.1 5.1 Aeromonas hydrophila 1 3 1.8 4.8 Plesiomonas shigelloides 3 3 1.8 4.8 Blastocystis hominis 4 1 0.7 4.7 Acinetobacter baumannii 1 2 2.5 4.5 Comanonas testosteroni 1 2 2.5 4.5 Yersinia enterocolitica 3 3 1.4 4.4 Astrovirus 2 2 1.4 3.4 Microsporidia 1 2 1.4 3.4 Isospora belli 2 1 1.1 3.1 Page CI ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Appendix D: The Draft CCL 5 for Microbes Microbe Final CCL 3 Final CCL 4 Draft CCL 51 Adenovirus X X X Caliciviruses X X X Campylobacter jejuni X X X Enterovirus X X X Escherichia coli (0157) X X X Helicobacter pylori X X X Legionella pneumophila X X X Mycobacterium abcessus X Mycobacterium avium X X X Naegleria fowleri X X X Pseudomonas aerugionosa X Shigella sonnei X X X hepatitis A and Salmonella enterica were listed on CCL 3 and CCL 4 but are not listed on CCL 5. Page D1 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Appendix E: Microbial Contaminant Information Sheets (CISs) Microbes Infographics Selection of microbes from the CCL Universe for placement on the PCCL is based upon exclusionary screening criteria that assess the potential of water-related transmission (occurrence) and the plausibility of causing waterborne disease by ingestion, inhalation, or dermal contact (health effects). Microbes that met any of the exclusionary criteria were not included on the PCCL. The pages below provide examples of the CCL decision making process Adenovirus, which was included on the CCL 5. Following the example are CISs for each of the PCCL 5 and nominated microbes. Page El ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 This infographic shows Adenovirus as an example of a contaminant that was listed on the CCL 5. The graphic shows a box for each of the three attributes (Occurrence, WBDO, and Health Effects) that serve as input to the scoring model. The attribute boxes show: • The data used for scoring each attribute, in bold, and indicated by a "yes" in the right hand column. • The score the contaminant received for that particular attribute (in the left hand column). • The occurrence score (of 3) for Adenovirus was chosen, as shown in the upper left hand corner, because it is greater than the WBDO score (of 2). • The health effects scores for the general population (of 6) and the sensitive population (of 4) are added together (equaling 10) and multiplied by 5/14 (the health effects score equalizing value), which equals 3.6. • The occurrence score is added to the adjusted health effects score for a total score for Adenovirus of 6.6, Pathogen _ Highest Score Total Score " between WBDO and Occurrence i ,j- General Population *1 \ t ? asr- \ •*» :• \ % Population / , Example: Calculation of Adenovirus Total Score Adenovirus Total Score = 3 (Occurrence Score) + ((6 (General Population Score) + 4 (Children/CD) x 5/14); Adenovirus Total Score = 3 + 3.6; Adenovirus Total Score = 6.6 Page E2 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Adenovirus: Microbe Included on the CCL 5 Scoring Summary Adenovirus Occurrence 3 Total Score: 6.6 Health Effects General population 6 Waterborne Disease Outbreaks Sensitive population 4 Score Data Element Scoring Data Occurrence 5 Multiple WBDOs in US (2009-2017) Score Data Element Scoring Data 4 At least one WBDOs in US (2009-2017) 3 Detected in drinking water in the US Yes23 3 Caused WBDOs at any time in US 2 Detected in Source water in the US 2 Caused WBDOs in countries other than US Yes: Europe1 1 Not detected in the US 1 Never caused WBDOs, associated w/ water related disease Health Effects Score Data Element Scoring Data 7 Does the organism cause significant mortality (> 1/1,000 cases) 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? [General population] A frequent cause of pneumonia among (unvaccinated) military recruits. Two deaths in previously-healthy adults.4 ARD is still significant problem in military. Less common 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? 4 Does the illness require short term hospitalization (< week) ? [Chronic Disease] Children with chronic disease required respiratory ventilation.6 fChildren/ Young adults mav contract acute respiratory disease.7 3 Does the illness require physician intervention? 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? Pathogen Total Score = Highest Score between WBDO and Occurrence + ((General Population Score + Highest Sensitive population Score) x 5/14) Adenovirus Total Score = 3 (Occurrence Score) + ((6 (General Population Score) + 4 (Children/CD) x 5/14); Adenovirus Total Score = 3 + 3.6 = 6.6 1 Kukkula, M., Arstila P., Klossner M.L., Maunula L., Bonsdorff C.H., and P. Jaatinen. 1997. Scandinavian Journal of Infectious Disease, 29(4): 415-418. 2 O'Reilly, C.E., A.B. Bowen, E.P. Nytzia, J.P. Sarisky, C.A. Shepherd, M.D. Miller, B.C. Hubbard, M. Herring, S.D. Buchanan, C.C. Fitzgerald, V. Hill, M.J. Arrowood, L.X. Xiao, R.M. Hoekstra, E.D. Mintz, M.F. Lynch, and the Outbreak Working Group. 2007. A Waterborne Outbreak of Gastroenteritis with Multiple Etiologies among Resort Island Visitors and Residents: Ohio, 2004. Clinical Infectious Diseases, 44:506-512. 3 Fong, T., L. Mansfield, D. Wilson, D. Schwab, S. Molloy and J. Rose. 2007. Massive Microbiological Groundwater Contamination Associated with a Waterborne Outbreak in Lake Erie, South Bass Island, OH. Environmental Health Perspectives. 115(6): 856-864. 4 Gray, G.C., P.R. Goswami, M.D. Malasig, A.W. Hawksworth, D.H. Trump, M.A. Ryan and D.P. Schnurr. 2001. Adult Adenovirus Infections: Loss of Orphaned Vaccines Precipitates Military Respiratory Disease Epidemics. Clinical Infectious Diseases, 31: 663-70. 5 Robinson, C. and M. Echavarria. 2007. Adenoviruses. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology, Washington, DC. Vol. 2: p. 1592. 6 CDC, 1983. Adenovirus type 7 outbreak in a pediatric chronic-care facility - Pennsylvania. 1972. MMWR, 1983:32;258-60. 7 CDC, 1998. Surveillance for Waterborne-Disease Outbreaks Associated with Drinking Water — United States, 1995—1996. MMWR Surveillance Summaries, 47(SS-5); 1-33. Page E3 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Acinetobacter baumannii Scoring Data Scoring Summary1'2 Occurrence 2 Health Effects General population 1 Sensitive subpopulation(s) [CD, P] 6 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Yes. Outbreaks occur most commonly in hospitals to very ill patients by person to person contact or via contaminated surfaces. However, it is still can occur and be transmitted in water. CDC, 2010 Page E4 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 Occurrence 3 Detected in drinking water in the U.S.? 2 Detected in source water in the U.S.? Yes. It was detected in untreated groundwater used as drinking water in Preston County, W. VA. Bifulco, 1989 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases) 6 [CD, P] Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? People with weakened immune systems due to chronic diseases or serious illnesses are the most susceptible. It causes various diseases including pneumonia and serious blood or wound infections. Acinetobacter baumannii infection during pregnancy can lead to premature contractions and chorioamnionitis. it can also cause septic complications in the puerperium associated with long duration of hospitalization. CDC, 2010 Aivazova, 2009 Cools et al., in MCM, 2019 Page E5 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? 4 Does the illness require short term hospitalization (< week)? 3 Does the illness require physician intervention? 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 1 [G, C, E] Does the illness result in mild symptoms with minimal or no impact on daily activities? [G, C, E] Acinetobacter baumannii poses a very limited health threat to individuals without a health condition. Most studies only report outbreaks in hospitals with patients that have a health condition. CDC, 2010 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Aivazova, V., Kainer, F., Friese, K., & Mylonas, I., 2010. Acinetobacter baumannii infection during pregnancy and puerperium. Archives of gynecology and obstetrics, 257(1), 171-174. Page E6 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Bifulco, J. M., Shirey, J. J., & Bissonnette, G. K., 1989. Detection of Acinetobacter spp. in rural drinking water supplies. Applied and Environmental Microbiology, 55(9), 2214-2219. Centers for Disease Control and Prevention (CDC)., 2010. Acinetobacter in Healthcare Settings. (2010, November 24). Retrieved from https://www.cdc.gov/hai/organisms/acinetobacter.html. CDC, 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Coots et al., Acinetobacter, Chryseobacterium, Moraxella, and Other Nonfermaentive Gram- Negative Rods. Chapter 46 in Carroll, K.C., Pfaller, M.A., Landry, M. L., McAdam, A.J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Page E7 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Adenovirus Scoring Data Scoring Summary1'2 Occurrence 3 Health Effects General population 6 Sensitive subpopulation(s) [CD, C] 4 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? 2 Has caused WBDOs in countries other than the U.S.? Yes Europe; S. Korea Kukkula et al., 1997 Lee et al., 2002 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Occurrence 3 Detected in drinking water in the U.S.? Yes O'Reilly et al., 2007 Fong et al., 2007 Page E8 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 PCR in connection with an outbreak. 2 Detected in source water in the U.S.? Yes 38% of surface water samples collected as part of the Information Collection Rule contained Adenovirus 40 and Adenovirus 41. USEPA, 2007 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? 6 [G] Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? [G] A frequent cause of pneumonia among (unvaccinated) military recruits. Two deaths in previously-healthy adults. ARD is still a significant problem in military. Less common manifestations include fatal neonatal disease, meningoencephalitis and myocarditis. Gray et al., 2001 Robinson in Murray, 2010 Heim in Carroll, 2019 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? None reported Page E9 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 4[C, CD] Does the illness require short term hospitalization (< week)? [CD] Children with chronic disease required respiratory ventilation. [C] Young adults may contract acute respiratory disease. CDC, 1983 CDC, 1998 3 Does the illness require physician intervention? Physician office visits are indicated for ocular infections. Robinson in Murray, 2010 2 [E, P] Is the illness self-limiting within 72 hours (without requiring medical intervention)? [E, P] Approximately 50% of cases are asymptomatic, symptomatic cases usually present as upper respiratory infections similar to the common cold. Robinson in Murray, 2010 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text indicates the highest score for that particular protocol. For the hea th effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Centers for Disease Control and Prevention (CDC). 1983. Adenovirus type 7 outbreak in a pediatric chronic-care facility - Pennsylvania. 1972. MMWR, 1983: 32; 258-60. CDC. 1998. Civilian Outbreak of Adenovirus Acute Respiratory Disease - South Dakota, 1997. MMWR 1998: 47(27); 567-570. CDC. 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Page E10 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fong, T., L. Mansfield, D. Wilson, D. Schwab, S. Molloy and J. Rose. 2007. Massive Microbiological Groundwater Contamination Associated with a Waterborne Outbreak in Lake Erie, South Bass Island, OH. Environmental health perspectives, 115(6), 856-864. Gray, G.C., P.R. Goswami, M.D. Malasig, A.W. Hawksworth, D.H. Trump, M.A. Ryan and D.P. Schnurr. 2001. Adult Adenovirus Infections: Loss of Orphaned Vaccines Precipitates Military Respiratory Disease Epidemics. Clinical Infectious Diseases, 31: 663-70. Heim et al., in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A.J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Kukkula, M., Arstila P., Klossner M.L., Maunula L., Bonsdorff C.H., and P. Jaatinen. 1997. Waterborne outbreak of viral gastroenteritis. Scandinavian Journal of Infectious Disease, 29(4): 415-8. Lee, S. & Kim, S. 2002. Detection of infectious enteroviruses and adenoviruses in tap water in urban areas in Korea. Water research. 36. 248-56. 10.1016/S0043-1354(01)00199-3. O'Reilly, C.E., A.B. Bowen, E.P. Nytzia, J.P. Sarisky, C.A. Shepherd, M.D. Miller, B.C. Hubbard, M. Herring, S.D. Buchanan, C.C. Fitzgerald, V. Hill, M.J. Arrowood, L.X. Xiao, R.M. Hoekstra, E.D. Mintz, M.F. Lynch, and the Outbreak Working Group. 2007. A Waterborne Outbreak of Gastroenteritis with Multiple Etiologies among Resort Island Visitors and Residents: Ohio, 2004. Clinical Infectious Diseases, 44: 506-512. Robinson, C. and M. Echavarria. 2010. Adenoviruses. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 10th. edition, American Society for Microbiology, Washington, DC. Vol. 2: p. 1600. United States Environmental Protection Agency. 2007. Adenovirus Health and Criteria Document (Draft). Page Ell ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Aeromonas hydrophila Scoring Data Scoring Summary1'2 Occurrence 3 Health Effects General population 2 Sensitive subpopulation(s) [C] 3 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC, 1991 - CDC, 2017 3 Has caused documented WBDOs at any time in the U.S.? No 2 Has caused WBDOs in countries other than the U.S.? No 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Yes Gavriel et al., 1998 Occurrence 3 Detected in drinking water in the U.S.? Yes Page E12 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 EPA found A. hydrophila in the distribution systems of 42 public water systems out of 293 systems tested. EPA, 2006 and EPA, 2003 2 Detected in source water in the U.S.? Yes Holmes et al., 1996 EPA, 2006 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? Wound infections are usually preceded by injury that occurs in contact with water. These infections range from cellulitis to myronecrotic infections with a poor prognosis. Horneman et al. in Murray, 2010 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? Septicemia occurs rarely in immunocompetent hosts. Can cause HUS. Horneman et al. in Murray, 2010 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? 4 Does the illness require short term hospitalization (< week)? 3 [C] Does the illness require physician intervention? [C] Children may require hospitalization due to dehydration. Horneman and Ali in Murray, 2010 Page E13 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 2 [G, P, E, CD] Is the illness self-limiting within 72 hours (without requiring medical intervention)? [G, P, E, CD] Acute watery disease is the most common form as well as abdominal pain, vomiting, fever. Horneman and Ali in Murray, 2010 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Gavriel, A.A., J.P.B. Landre, and A.J. Lamb. 1998. Incidence of mesophilic Aeromonas within a public drinking water supply in northeast Scotland. Journal of Applied Bacteriology, 84: 383- 392. Holmes, P., L.M. Niccolls, and D.P. Sartory. 1996. The ecology of mesophilic Aeromonas in the aquatic environment. In Austin, B., M. Altwegg, P.J. Gosling, and S. Joseph, (ed.) The Genus Aeromonas. John Wiley & Sons, Chichester, UK. Horneman, A., A. Al. 2010. Aeromonas. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 10th. edition, American Society for Microbiology, Washington, DC. Vol. 1: p. 658. United States Environmental Protection Agency (USEPA). 2003. Unpublished data on occurrence results from the Unregulated Contaminant Monitoring Rule. http://www.epa.gov/safewater/ucmr/data.html. See 70 FR 49094, August 22, 2005 for more information. USEPA. 2006. Aeromonas: Human Health Criteria Document. http://www.epa.gov/waterscience/criteria/humanhealth/microbial/aeromonas-200603.pdf. Page El4 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Arcobacter butzleri Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 4 Health Effects General population 3 Sensitive subpopulation(s) [CD, C, P, E] 3 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 Yes Not listed in CDC's MMWR, however, linked to outbreak and drinking water. Symptom severity also suggests Arcobacter. Fong et al., 2007 3 Has caused documented WBDOs at any time in the U.S.? 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any country, but has been epidemiologically Page El5 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 associated with water related disease? Occurrence 3 Detected in drinking water in the U.S.? Yes Fong et al., 2007 2 Detected in source water in the U.S.? Yes Arcobacter butzleri was isolated from ground water in Idaho after a WBDO. Rice et al., 1999 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? Unknown 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? Persons with underlying disease such as liver disease, cirrhosis, or alcoholism may be at increased risk of complications. Has been isolated from patients with bacteremia, endocarditis, peritonitis and diarrhea. Clinical significance unknown. Hsueh et al., 1997 Lerner et al., 1994 Yan et al., 2000 Fitzgerald in Murray, 2010 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? Page El6 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 4 Does the illness require short term hospitalization (< week)? 3 [G, C, P, E, CD] Does the illness require physician intervention? [All populations] Displays clinical features similar to Campylobacter jejuni, however is more frequently associated with a persistent diarrhea. Twenty-six percent of Belgian patients required antibiotics. Vandenberg et al., 2004 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? Usual symptoms are diarrhea, abdominal pain, vomiting, and nausea resolving in < 3 days. Wybo et al., 2004 Rice et al., 1999 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Centers for Disease Control and Prevention (CDC), 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Fitzgerald, C. and I. Nachamkin. 2010. Campylobacter and Arcobacter. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 10th. edition, American Society for Microbiology, Washington, DC. Vol. 1: p. 885. Page El7 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Fong, T., L. Mansfield, D. Wilson, D. Schwab, S. Molloy and J. Rose. 2007. Massive Microbiological Groundwater Contamination Associated with a Waterborne Outbreak in Lake Erie, South Bass Island, OH. Environmental health perspectives, 115(6), 856-864. Houf, K., L.A. Devriese, et al. 2001. Susceptibility of Arcobacter butzleri, Arcobacter cryaerophilus, and Arcobacter skirrowii to antimicrobial agents used in selective media. Journal of Clinical Microbiology, 39(4): 1654-1656. Hsueh, P.R., L.J. Teng, et al. 1997. Bacteremia caused by Arcobacter cryaerophilus IB. Journal of Clinical Microbiology, 35(2): 489-491. Nachamkin. 2019. Campylobacter and Arcobacter In Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A. J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Lerner, J., V. Brumberger, et al. 1994. Severe diarrhea associated with Arcobacter butzleri. European Journal of Clinical Microbiology & Infectious Diseases, 13(8): 660-662. Rice, E.W., M.R. Rodgers, I.V. Wesley, C.H. Johnson, and S.A. Tanner. 1999. Isolation of Arcobacter butzleri from ground water. Letters in applied microbiology, 28: 31-35. Vandenberg, O., A. Dediste, K. Houg, S. Ibekwen, H. Souayah, S. Cadranel, N. Douat, G. Zissis, J. Butzler and P. Vandamme. 2004. Arcobacter Species in Humans. Emerging Infectious Diseases. Vol. 10, No. 10, page 1863, October 2004. Wybo, I., J. Breynaert, et al.. (2004). Isolation of Arcobacter skirrowii from a patient with chronic diarrhea. Journal of Clinical Microbiology, 42(4): 1851-1852. Yan, J.J., W.C. Ko, et al. (2000). Arcobacter butzleri bacteremia in a patient with liver cirrhosis. Journal of the Formosan Medical Association, 99(2): 166-169. Page El8 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Aspergillus fumigatus Scoring Data Scoring Summary1'2 Occurrence 3 Health Effects General population 3 Sensitive subpopulation(s) [C, P, E, CD] 3 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC, 1991 - CDC, 2017 3 Has caused documented WBDOs at any time in the U.S.? No 2 Has caused WBDOs in countries other than the U.S.? No 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Yes Study on two bone marrow transplantation units at a Little Rock, AR hospital. Anaissie et al., 2002 Anaissie et al., 2003 Warris et al., 2003 Occurrence Page El9 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 Detected in drinking water in the U.S.? Yes Anaissie et al., 2002 Anaissie et al., 2003 1 Nagy and Olson, 1982 O Rosenzweig et al., 1986 Doggett, 2000 Vesper et al., 2007 2 Detected in source water in the U.S.? Yes Nagy and Olson, 1982 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? Invasive infections caused by Aspergillus species are associated with high rates of morbidity and mortality, especially in immunosuppressed patients. Verweij and Brandt in Murray, 2010 Chen in Carroll, 2019 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? Sporadic cases of invasive aspergillosis have been reported in immunocompetent hosts (chronic meningitis, endocarditis, pericarditis, osteomyelitys). Bodey and Vartivarian, 1989 6 Invasive aspergillosis is primarily an infection of severely immunocompromi sed patients. Serious infection can also occur in patients with Page E20 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 more modest impairments of host immune system such as diabetics. Nagy and Olson, 1982 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? None reported. 4 Does the illness require short term hospitalization (< week)? Requirement for hospitalization depends upon the manifestation of disease (e.g., superficial skin and ear infections do not require hospitalization). Bodey and Vartivarian, 1989 3 [G, C, P, E, CD] Does the illness require physician intervention? [All populations] Most infections and allergies caused by this organism require physician intervention. Bodey and Vartivarian, 1989 CDC, 2019 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? Aspergillus spores are allergens and persons who become sensitized experience symptoms of allergy and asthma. Horner et al., 1995 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. Page E21 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Anaissie, E.J., S.L. Stratton, M.C. Dignani, R.C. Summerbell, J.H. Rex, T.P. Monson, T. Spencer, M. Kasai, A. Francesconi, and T.J. Walsh. 2002. Pathogenic Aspergillus species recovered from a hospital water system: a 3-year prospectie study. Clinical Infectious Diseases, 34: 780-789. Anaissie, E.J., S.L. Stratton, M.C. Dignani, C. Lee, R.C. Summerbell, J.H. Rex, T.P. Monson, and T.J. Walsh. 2003. Pathogenic molds (including Aspergillus species) in hospital water distribution systems: a 3-year prospective study and clinical implications for patients with hematologic malignancies. Blood, 101(7): 2542-2546. Bodey, G.P. and S. Vartivarian. 1989. Aspergillosis. European Journal of Clinical Microbiology and infectious diseases, 8(5): 413-437. Centers for Disease Control and Prevention (CDC). 2019. Aspergillus home page. www.cdc.gov/fungal/diseases/aspergillosis/index.html CDC, 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Chen. Apergillus, Talarmyces, and Penicillium. in Carroll, K.C., Pfaller, M.A., Landry, M. L., McAdam, A. J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Doggett, M.S. 2000. Characterization of fungal biofilms within a municipal water distribution system. AppliedandEnvironmentalMicrobiology, 66(3): 1249-1251. Horner, W.E., A. Helbling, J.E. Salvaggio, and S.B. Lehrer. 1995. Fungal allergens. ClinicalMicrobiology. Reviews, 8(2): 161-179. Nagy, L.A. and B.H. Olson. 1982. The occurrence of filamentous fungi in drinking water distribution systems. Canadian Journal of Microbiology, 28: 667-671. Rosenzweig W.D., H. Minnigh, and W.O. Pipes. 1986. Fungi in potable water distribution systems. JAWWA 78(1): 53-55. Verweij, P.E. and M.E. Brandt. 2010. Aspergillus, Fusarium, and Other Opportunistic Moniliaceous Fungi. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry and M.A. Pfaller (ed.) Manual of Clinical Microbiology, 10th. edition, American Society for Microbiology, Washington, DC (Vol. 2). p. 1836. Vesper, S.J., M.E. Rogers, A.N. Neely andR.A. Haugland. 2007. Opportunistic Aspergillus pathogens measured in home and hospital tap water by quantitative PCR (QPCR). Journal of Water and Health, 5(3): 427-431. Warris, A., C.H. W. Klassen, J.F.G.M. Meis, M.T. de Ruiter, H.A. de Valk, T.G. Abrahamsen, P. Gaustaad, and P.E. Verweij. 2003. Molecular epidemiology of Aspergillus fumigatus isolates Page E22 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 recovered from water, air, and patients shows two clusters of genetically distinct strains. Journal of Clinical Microbiology. 41(9): 4101-4106. Page E23 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Astrovirus Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 2 Health Effects General population 2 Sensitive subpopulation(s) [C, P, E, CD] 2 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC, 1991 - CDC, 2017 3 Has caused documented WBDOs at any time in the U.S.? No 2 Has caused WBDOs in countries other than the U.S.? Yes England and Wales Smith et al., 2006 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Yes Gofti-Laroche et al., 2003 Occurrence 3 Detected in drinking water in the U.S.? No Page E24 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 2 Detected in source water in the U.S.? Yes Astrovirus was detected in 15 of 29 samples collected under the Information Collection Rule. Chapron et al., 2000 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? No 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? No 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? No 4 Does the illness require short term hospitalization (< week)? No 3 Does the illness require physician intervention? No 2 [G, C, P, E, CD] Is the illness self-limiting within 72 hours (without requiring medical intervention)? [All populations] Asymptomatic infections common. Moderate self- limiting gastroenteritis (vomiting and diarrhea). Farkas in Murray, 2010 Page E25 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Chapron, C.D., N.A. Ballester, J.H. Fontaine, C.N. Frades, and A.B. Margolin. 2000. Detection of astroviruses, enteroviruses, and adnovirus types 40 and 41 in surface waters collected and evaluated by the information collection rule and an integrated cell culture-nested PCR procedure. Applied and Environmental. Microbiology, 66(6): 2520-2525. Farkas, T. and X. Jiang. 2010. Rotaviruses, Caliciviruses, Astroviruses, Enteric Adenoviruses, and Other Diarrheic Viruses. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.A. Pfaller, and R.H. Yolken (ed.) The Manual of Clinical Microbiology, 10th edition, American Society for Microbiology, Washington, DC Vol. 2; p. 1456. Gofti-Laroche, L., B. Gratacap-Cavallier, D. Demanse, O. Genoulaz, J-M. Segneurin, andD. Zmirou. 2003. Are waterborne astrovirus implicated in acute digestive morbidity (E.M.I.R.A. study)? J. Clin. Virol. 27: 74-82. Pang and Smieja. Gastroenteritis Viruses in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A. J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Smith, A., M. Reacher, W. Smerdon, G.K. Adak, G. Nichols and R.M. Chalmers. 2006. Outbreaks of waterborne infectious intestinal disease in England and Wales, 1992-2003. Epidemiology & Infection, 134(6): 1141-1149. Page E26 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Blastocystis hominis Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 4 Health Effects General population 1 Sensitive subpopulation(s) [C, P, E, CD] 1 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 Yes 2012: 1 Transient noncommunity (suspected) CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? No 2 Has caused WBDOs in countries other than the U.S.? No 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Yes Drinking untreated water has been associated with infection. Leelayoova et al., 2004 Stenzel and Boreham, 1996 Taamasri et al., 2000 Page E27 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 Occurrence 3 Detected in drinking water in the U.S.? No 2 Detected in source water in the U.S.? No 1 Not detected in the U.S.? Yes Karanis, 2006 Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? No 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? No 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? No 4 Does the illness require short term hospitalization (< week)? No 3 Does the illness require physician intervention? No 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? Symptoms may be more pronounced and prolonged in immunocompromised; neoplasia and abnormal intestinal tract function. Leber in Murray, 2010 1[G, C, P, E, CD] Does the illness result in mild symptoms with minimal or no impact on daily activities? [All populations] Pathogenicity of B. hominis is controversial. Symptoms may include Leber in Murray, 2010; Novak- Weekly, 2019 Page E28 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 diarrhea, vomiting and abdominal pain. 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Centers for Disease Control and Prevention (CDC), 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Karanis P. 2006. A review of an emerging waterborne medical important parasitic protozoan. Japanese Journal of Protozoology, 39(1): 5-19. Leber, A. and S. Novak-Weekley. 2010. Intestinal and Urogenital Amebae, Flagellates, and Ciliates. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 10th. edition, American Society for Microbiology, Washington, DC. Vol. 2: pp. 2149. Leelayoova, S., R. Rangsin, P. Taamasri, T. Naaglor, U. Thathaisong, and M. Mungthin. 2004. Evidence of waterborne transmission of Blastocystis hominis. American Journal of Tropical Medicine & Hygiene, 70(6): 658-662. Novak-Weekly and Leber. Intestinal and Urogenital Amebae, Flagellates, and Ciliates. in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A.J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Stenzel, D.J., and P.F. Boreham. 1996. Blastocystis hominis revisited. Clinical Microbiology Reviews, 9(4): 563-584. Taamasri, P., M. Mungthin, R. Rangsin, B. Tongupprakarn, W. Areekul, and S. Leelayoova. 2000. Transmission of intestinal blastocystosis related to the quality of drinking water. Southeast Asian Journal of Tropical Medicine & Public Health, 31(1): 112-117. Page E29 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Calicivirus Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 5 Health Effects General population 2 Sensitive subpopulation(s) [C, E, CD] 4 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 Yes 2010: 1 Nontransient noncommunity 2012: 1 Transient noncommunity 2014: 2 Transient noncommunity 2015: 1 community CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 3 Has caused documented WBDOs at any time in the U.S.? 1971-2008: 11 Community 30 Noncommunity CDC-NORS, 2020 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any Page E30 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 country, but has been epidemiologically associated with water related disease? Occurrence 3 Detected in drinking water in the U.S.? Yes Detection by PCR. Huffman et al., 2003 2 Detected in source water in the U.S.? Yes Detected in ground water by PCR. Borchardt et al., 2003 Fout et al., 2003 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? No long term sequelae have been reported. CDC, 2001 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? No CDC, 2001 4 [C, E, CD] Does the illness require short term [E, CD] (Norovirus) Although rare, severe dehydration can be fatal, with this outcome CDC, 2019 Page E31 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 hospitalization (< week)? occurring among susceptible persons (e.g., older persons with debilitating health conditions). [C] Sappoviruses cause disease mainly in children. Farkas in Murray, 2007 3 Does the illness require physician intervention? 2[G, P] Is the illness self- limiting within 72 hours (without requiring medical intervention)? [G, P] Acute gastroenteritis. Highly contagious, able to cause large outbreaks and environmentally stable. Farkas in Murray, 2007 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text inc icates the highest score for t lat particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Borchardt, M.A., P.D. Bertz, S.K. Spencer, and D.A. Battigelli. 2003. Incidence of enteric viruses in groundwater from household wells in Wisconsin. Applied and Environmental. Microbiology, 69: 1172-1180. Centers for Disease Control and Prevention (CDC). 2001 Norwalk-like viruses: Public health consequences and outbreak management. MMWR 50(RR-9):1-18. CDC. 2003. Managing acute gastroenteritis among children. MMWR 52(RR-16):1-16. Page E32 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 CDC. 2019. Norovirus home page, https://www.cdc.gov/norovirus/index.html CDC. 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Farkas, T. and X. Jiang. 2007. Rotaviruses, Caliciviruses, Astroviruses, Enteric Adenoviruses, and Other Diarrheic Viruses. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.A. Pfaller, and R.H. Yolken (ed.) The Manual of Clinical Microbiology, 9th edition, American Society for Microbiology, Washington, DC Vol. 2; pp. 1454-1457. Fout, G.S., B.C. Martinson, M.W. Moyer, and D.R. Dahling. 2003. A multiplex reverse transcription-PCR method for detection of human enteric viruses in groundwater. Applied and Environmental Microbiology, 69: 3158-3164. Huffman, D.E., K.L. Nelson, and J.B. Rose. 2003. Calicivirus - an emerging contaminant in water: state of the art. Environmental engineering science, 20: 503-515. Pang and Smieja. Gastroenteritis Viruses in Carroll, K.C., Pfaller, M.A., Landry, M. L., McAdam, A. J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Page E33 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Campylobacter jejuni Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 5 Health Effects General population 3 Sensitive subpopulation(s) [C, E] 4 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 Yes 2009: 1 Community 2010: 3 Community 1 Nontransient Noncommunity 2012: 1 Community (Campylobacter unknown) 2015: 2 Community 2017: 1 Community CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 3 Has caused documented WBDOs at any time in the U.S.? Yes 1971-2008: 13 Community and 15 Noncommunity CDC-NORS, 2020 Page E34 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 2 Has caused WBDOs in countries other than the U.S.? Yes Finland, New Zealand Kuusi, 2005; waterandhealth. org 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Occurrence 3 Detected in drinking water in the U.S.? Yes Sacks et al., 1986 O'Reilly, 2007 2 Detected in source water in the U.S.? Yes Carter et al., 1987 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? Death is uncommon. Fitzgerald in Murray, 2007 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? Complications include hepatitis, bacteremia cholecystitis, pancreatitis, nephritis, abortion and neonatal sepsis, urinary tract infection, meningitis and septic arthritis. Bacteremia occurs in 0.15% of intestinal infections with elderly mostly affected. Fitzgerald in Murray, 2007 5 Does the illness result in long term or permanent dysfunction Page E35 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 or disability, i.e. sequelae? Does the illness require short term hospitalization (< week)? [C, E] Most cases do not require hospitalization, pediatric cases and elderly are more likely to require hospitalization than normal adult cases. Fitzgerald in Murray, 2007 4[C, E] The highest incidence is in children and infants. Bacteremia occurs at 1.5 per 1,000 cases with the highest rate occurring in the elderly. Does the illness require physician intervention? [G, P, CD] Guillain-Barre syndrome, reactive arthritis. Fitzgerald in Murray, 2007 3 [G, P, CD] Guillain-Barre 1/1000 cases. Reactive arthritis 1/100 cases. Altekruse et al., 1999 2 Is the illness self- limiting within 72 hours (without requiring medical intervention)? Duration 2-5 days, usually self-limiting. Several days to more than 1 week, self-limiting, relapse in 5-10% cases. Heymann, 2005 Fitzgerald in Murray, 2007 CDC,2019 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? Asymptomatic to acute diarrhea, abdominal pain, malaise, and fever. Fitzgerald in Murray, 2007 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The Page E36 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC NORS reports from 1971 - 2017 and then collected occurrence citations if there were no CDC WBDOs. References Altekruse, S.F., N.J. Stern, P.I. Fields, and D.L. Swerdlow. 1999. Campylobacter jejuni - An Emerging Foodborne Pathogen. Emerging Infectious Diseases, 5(1): 28-35. Carter, A.M., R. E. Pacha, G.W. Colark, and E.A. Williams. 1987. Seasonal occurrence of Campylobacter spp. in surface waters and their correlation with standard indicator bacteria. Applied and Environmental. Microbiology, 53(3): 523-526. Centers for Disease Control and Prevention (CDC), 2019. Campylobacter home page. https://www.cdc.gov/campylobacter/index.html CDC, 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public Health Association, Washington, DC. Kuusi, M., J.P. Nuorti, M.L. Hanninen, M. Koskela, V. Jussila, E. Kela, I. Miettinen, P. Ruutu. A large outbreak of campylobacteriosis associated with a municipal water supply in Finland. Epidemiology & Infection, 2005 Aug; 133(4): 593-601 Fitzgerald, C. and I. Nachamkin. 2007. Campylobacter and Arcobacter. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology, Washington, DC. Vol. 1: pp. 933 -935. Nachamkin. 2019. Campylobacter and Arcobacter in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A. J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. O'Reilly, C.E., A.B. Bowen, N.E. Perez, J.P. Sarisky, C.A. Shepherd, M.D. Miller, B.C. Hubbard, M. Herring, S.D. Buchanan, C.C. Fitzgerald, V. Hill, M.J. Arrowood, L.X. Xiao, R.M. Hoekstra, E.D. Mintz, F. Lynch, and Outbreak Working Group. 2007. A Waterborne Outbreak of Gastroenteritis with Multiple Etiologies among Resort Island Visitors and Residents: Ohio, 2004. Clinical Infectious Diseases, 44(4): 506-512. Sacks, J.J., S. Lieb, L.M. Baldy, S. Berta, C.M. Patton, M.C. White, W.J. Bigler, and J.J. Witte. 1986. Epidemic campylobacteriosis associated with a community water supply. American Journal of Public Health, 76(4): 424-429. Waterandhealth.org, 2017. https://waterandhealth.org/safe-drinking-water/update-new-zealands- largest-drinking-water-outbreak-2. Page E37 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Comamonas testosteroni Scoring Data Scoring Summary1'2 Occurrence 2 Health Effects General population 1 Sensitive subpopulation(s) [CD] 6 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Occurrence Page E38 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 3 Detected in drinking water in the U.S.? 2 Detected in source water in the U.S.? Comamonas testosteroni is often found in freshwater, soil, plants, and in hospital devices such as intravenous lines and the reservoir water in the humidifiers of respiratory therapy equipment. Tiwari and Nanda, 2019 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? 6 [CD, G] Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? Comamonas testosteroni has been shown to cause pneumonia in patients with AIDS. (Franzetti et al., 1992). It has also been documented causing meningitis in a patient that had recurrent cholesteatoma (Arda et al., 2008). It also been shown to infect those who were previously healthy. Franzetti et al., 1992 Arda et al., 2008 Arda et al., in MCM, 2019 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? Page E39 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 4 Does the illness require short term hospitalization (< week)? 3 Does the illness require physician intervention? 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 1 [G] Does the illness result in mild symptoms with minimal or no impact on daily activities? Infrequently cause human infections on healthy individuals Arda et al., in MCM, 2019 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Arda, B., Aydemir, S., Yamazhan, T., Hassan, A., Tiinger, A., & Serter, D. 2003. Comamonas testosteroni meningitis in a patient with recurrent cholesteatoma: Case report. Apmis, 111(4), 474-476. Franzetti, F., Cernuschi, M., Esposito, R., & Moroni, M. 1992. Pseudomonas infections in patients with AIDS and AIDS-related complex. Journal of internal medicine, 231(4), 437-443. Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. LaPuma et al., Burkholderia, Stenotrophomonas, Ralstonia, Cupriavidus, Pandoraea, Brevundimonas, Comamonas, Delftia, and Acidovorax. Chapter 45 in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A.J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Tiwari, S., & Nanda, M. 2019. Bacteremia caused by Comamonas testosteroni an unusual pathogen. Journal of laboratory physicians, 11(1), 87. Page E40 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Cyclospora cayetanensis Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 3 Health Effects General population 3 Sensitive subpopulation(s) [C] 4 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? Yes 1971-2008:2 Community CDC-NORS, 2020 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Yes Huang et al., 1995 Occurrence Page E41 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 3 Detected in drinking water in the U.S.? Yes CDC, 2011 2 Detected in source water in the U.S.? No 1 Not detected in the U.S.? Detected in drinking water in Guatemala. Dowd et al., 2003 Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? No 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? No 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? Guillain-Barre and Reiter' s syndromes have been reported. Connor et al., 2001 4 [C] Does the illness require short term hospitalization (< week)? [C] Most cases do not required hospitalization, infants may require hospitalization for rehydration therapy. Fisk et al., 2005 3 [G, P, E, C, CD] Does the illness require physician intervention? [All populations] Can cause diarrhea and biliary disease. In patients not treated, illness can be protracted with relapsing symptoms. Lindsay in Murray, 2010 Heymann, 2005 CDC, 2019 2 Is the illness self-limiting within 72 hours (without Page E42 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 requiring medical intervention)? 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Centers for Disease Control and Prevention (CDC). 2019. Cyclospora home page. https://www.cdc.gov/parasites/cyclosporiasis/index.html CDC, 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Connor, B.A., E. Johnson and R. Soave. 2001. Reiter syndrome following protracted symptoms of Cyclospora infection. Emerging infectious diseases, 7: 453-454. Dowd, E.S., D. John, J. Eliopolus, C.P. Gerba, J. Naranjo, R. Klein, B. Lopez, M. de Mejia, C.E. Mndoza and I. Pepper. 2003. Confirmed detection of Cyclospora cayetanesis, Encepalitozoon intestinalis and Cryptosporidium parvum in water used for drinking. Journal of Water and Health, 01 (3): 117-123. Fisk, T.L., J.S. Keystone, and P. Kozarsky. 2005. In Mandel, G.L., J.E. Bennett, and R. Dolin Ed. Mandel, Douglas and Bennett's Principles and Practice of Infectious Diseases, 6th Ed., Elsevier, Philadelphia. Heymann, D.(ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public Health Association, Washington, DC. Huang, P., J.T. Weber, D.M. Sosin, P.M. Griffin, E.G. Long, J.J. Murphy, F. Kocka, C. Peters, C. Kallick. 1995. The first reported outbreak of diarrheal illness associated with Cyclospora in the United States. Annals of internal medicine, 123: 409-414. Lindsay, D., S. Upton and L. Weiss. 2010. Isospora, Cyclospora and Sarcocystis. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.A. Pfaller, and R.H. Yolken (ed.) The Manual of Clinical Microbiology, 10th edition, American Society for Microbiology, Washington, DC Vol. 2; p. 2172. Page E43 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Entamoeba histolytica Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 3 Health Effects General population 3 Sensitive subpopulation(s) [C, P, E, CD] 3 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? 1971-2008:3 Community (one is "Entamoeba unknown') 1 Noncommunity CDC-NORS, 2020 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Occurrence Page E44 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 3 Detected in drinking water in the U.S.? Found during WBDO. CDC, 2006 2 Detected in source water in the U.S.? 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? 500 million infected (E. dispar and E. histolytica) each year with approximately 50 million cases of colitis and liver abscess and 100,000 deaths worldwide. Leber in Murray, 2010 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? Infections in the U.S. rarely progress to complications, amoebic colitis may result in perforation of the intestinal wall, resulting in peritonitis; dissemination to extraintestinal sites may involve the liver, lungs, or brain. Liver abscess is the most common complication. Heymann, 2005 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? Abdominal perforations and peritonitis are rare complications. Up to 5% develop liver abscess. Leber in Murray, 2010 Page E45 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 4 Does the illness require short term hospitalization (< week)? Intestinal invasion can lead to lesions, ulcers. Leber in Murray, 2010 3 [G, C, P, E, CD] Does the illness require physician intervention? [All populations] Clinical symptoms are dysentery, colitis or rarely amoeboma). Fulminant colitis occurs most often in children who present with diffuse abdominal pain, profuse bloody diarrhea and fever. Leber in Murray, 2010 Marshall, 1997 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? Most human infections (90%) are asymptomatic, symptomatic non- invasive strains cause gastrointestinal symptoms such as cramping and increased frequency of bowel movements, constipation may alternate with diarrhea, invasive strains may cause amoebic dysentery. Heymann, 2005 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text inc icates the highest score for that particular protocol. For the healt i effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. Page E46 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public Health Association, Washington, DC. Leber, A. and S. Novak-Weekley. 2010. Intestinal and Urogenital Amebae, Flagellates, and Ciliates. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 10th. edition, American Society for Microbiology, Washington, DC. Vol. 2: p. 2149. Marshall, M., D. Naumovitz, Y. Ortega and C. Sterling. 1997. Clinical Microbiology Reviews, Jan. 1997, p. 73. Page E47 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Enterovirus Scoring Data Scoring Summary1'2 Occurrence 3 Health Effects General population 4 Sensitive subpopulation(s) [C] 6 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 1990-2009 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? No 2 Has caused WBDOs in countries other than the U.S.? Yes Switzerland and others. Hafliger et al., 2000 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Occurrence Page E48 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 Detected in drinking Yes Mack et al., 1972 water in the U.S.? Lieberman et al., 3 2003 Keswick et al., 1984 O Detected in source water Yes Borchardt et al., 2003 L in the U.S.? 1 Not detected in the U.S.? Health Effects Does the organism cause 7 significant mortality (> 1/1,000 cases)? Does the organism cause [C] Aseptic meningitis Heymann, 2005 pneumonia, meningitis, and neonatal sepsis are hepatitis, encephalitis, the most common endocarditis, cancer, or complications. other severe manifestations of illness necessitating long term EVs are the most hospitalization (> common cause of Romero in Murray, week)? meningitis in the U.S., 2007 over 80% of all viral meningitides (estimated 30,000 to 50,000 hospitalizations for non- 6 [C] polio EV each year (principally echo and coxsackie)). Enterovirus causes myocarditis, viral meningitis, encephalitis and meningioencephalitis. Khetsuriani et al., 2002 Widespread illness in Kim et al., 2001 children with asthma. Khetsuriani, 2003 Page E49 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 Midgely at al, 2015 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? Diabetes has been associated with enterovirus infection. Heymann, 2005 4 [G] Does the illness require short term hospitalization (< week)? [G] Hospitalization may be required for severe manifestations of disease. Approximately 20-30% of meningitis outbreak cases in young adults require hospitalization. During the summer and fall, responsible for 50 - 60% of hospital admissions for evaluation of febrile illnesses for infants and children. Sawyer, 2002 Romero in Murray, 2007 3 Does the illness require physician intervention? Children with acute pharyngitis may be taken to a physician to differentiate between streptococcal and viral sore throat. Upper respiratory illness lasts 4- 6 days, lower respiratory illness lasts 5-7 days, and meningitis lasts 7-10 days. Romero in Murray, 2007 Heymann, 2005 2 [E, P, CD] Is the illness self-limiting within 72 hours (without requiring medical intervention)? [E, P, CD] Most cases are asymptomatic. Most common symptoms are acute nonspecific febrile illness. Romero in Murray, 2007 1 Does the illness result in mild symptoms with Page E50 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 minimal or no impact on daily activities? 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Borchardt, M.A., P.D. Bertz, S.K. Spencer, and D.A. Battigelli. 2003. Incidence of enteric viruses in groundwater from household wells in Wisconsin. Applied and Environmental Microbiology, 69(2): 1172-1180. Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Hafliger D., P. Hubner and J. Luthy. 2000. Outbreak of viral gastroenteritis due to sewage- contaminated drinking water, International Journal of Food Microbiology, 54(1-2): 123 - 126. Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public Health Association, Washington, DC. Keswick, B., C. Gerba, H. DuPont, and J. Rose. 1984. Detection of Enteric Viruses in Treated Drinking Water. Applied and Environmental Microbiology, June 1984, 1290- 1294. Khetsuriani N., R. Holman, and L. Anderson. 2002. Burden of Encephalitis-Associated Hospitalizations in the United States, 1988-1997. Clinical Infectious Diseases. 35(2): 175-182. Khetsuriani, N., E.S. Quiroz, R.C. Holman and L.J. Anderson. 2003. Viral meningitis-associated hospitalizations in the United States, 1988-1999. Neuroepidemiology, 22(6): 345-352. Kim, K-S., G. Hufnagel, N.M. Chapman, S. Tracy. 2001. The group B coxsackieviruses and myocarditis. Reviews in Medical Virology, 11(6): 355-368. Lieberman, R.J., L.C. Shadix, B.S. Newport, C.P. Frebis, M.W.N. Moyer, R.S. Safferman, R.E. Stetler, D. Lye, G.S. Fout and D. Dahling. 2002 "Microbial monitoring of vulnerable public ground water supplies." AWWA Research Foundation and AWWA, p. 142. Mack, W.N., L. Yue-Shoung, and D.B. Coohon. 1972 "Isolation of poliomyelitis virus from a contaminated wellHealth Services Report, 87(3): 271-274. Midgley, C.M., Watson, J.T., Nix, W.A., Curns, A.T., Rogers, S.L., Brown, B.A., Conover, C., Dominguez, S.R., Feikin, D.R., Gray, S. and Hassan, F., 2015. Severe respiratory illness Page E51 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 associated with a nationwide outbreak of enterovirus D68 in the USA (2014): a descriptive epidemiological investigation. The Lancet Respiratory medicine, 3(11), 879-887. Romero, J. 2007. Enteroviruses and Parechoviruses. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M. A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology, Washington, DC. Vol. 2: p. 1394. Sawyer, M.H. 2002. Enterovirus infections: diagnosis and treatment. Seminars in Pediatric Infectious Diseases 13(1): 40-47. Page E52 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Escherichia coli (0157)' Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 5 Health Effects General population 3 Sensitive subpopulation(s) [C, E] 6 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 Yes 2010: 1 Community 2011: 1 Transient Noncommunity CDC-NORS, 2020 5 2013: 1 Transient Noncommunity 2014: 1 Nontransient Noncommunity 2016: 1 Community 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 3 Has caused documented WBDOs at any time in the U.S.? 1971-2008: 5 Community 5 Noncommunity CDC-NORS, 2020 2 Has caused WBDOs in countries other than the U.S.? Page E53 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Occurrence 3 Detected in drinking water in the U.S.? Yes Bopp et al., 2003 2 Detected in source water in the U.S.? Yes As a result of animal fecal contamination. Kramer etal., 1996 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? No Approximately 60 deaths per 73,000 cases per year (nearly >1/1,000) are reported due to E. coli (0157). A case fatality rate of 0.5 has been reported for outbreak- related cases caused by E. coli 0157:H7 Nataro in Murray, 2007 Rangel et al., 2005 Buchan in Carroll, 2019 6 [C, E] Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? [C, E] Patients at extremes of age have an increased risk for infection and associated complications. Children under 5 are most frequently diagnosed with infection and are at greatest risk of developing HUS. The elderly also appear to be an increased risk of complications. Chinyu, 1995 Page E54 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 HUS develops in 10% of patients under the age of 10. Nataro and Kaper, 1998 Heymann, 2005 CDC, 2019 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? 25% of HUS survivors develop long term renal sequelae. Garg et al., 2003 5 3.2% of children with diarrhea plus HUS develop diabetes. Adults have a greater likelihood of hypertension and reduced renal function. Suri et al., 2005 Garg et al., 2005 4 Does the illness require short term hospitalization (< week)? 3 [G, P, CD] Does the illness require physician intervention? [G, P, CD] Fluid replacement is the cornerstone of treatment for EHEC diarrhea; some clinicians choose to hospitalize all patients with E. coli 0157:H7 for hydration to prevent HUS. Heymann, 2005 2 Is the illness self-limiting within 72 hours (without Page E55 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 requiring medical intervention)? 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? Can present as mild nonbloody diarrhea. Nataro in Murray, 2007 "The names E. coli 0157 and E. coli 0157:H7 are used interchangeably for CCL 5 due to ongoing taxonomical debate in the scientific literature. 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Bopp, D.J., B.D. Sauders, A.L. Waring, J. Ackelsberg, N. Dumas, E. Braun-Howland, D. Dziewulski, B.J. Wallace, M. Kelly, T. Halse, K. ArudaMusser, P.F. Smith, D.L. Morse, and R.J. Limberger. 2003. Detection, Isolation, and Molecular Subtyping of Escherichia coli 0157:H7 and Campylobacter jejuni Associated with a Large Waterborne Outbreak. Journal of Clinical Microbiology. 41(1): 174-180. Buchan. Escherichia, Shigella and Salmonella in in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A. J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Chinyu S., and L.J. Brandt. Escherichia coli: H7 Infection in Humans. 1995. Annals of Internal Medicine. 123 (9): 698-707. Centers for Disease Control and Prevention (CDC). 2019. E. coli home page. https://www.cdc.gov/ecoli/index.html. CDC, 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Garg, A.X., L. Moist, D. Matsel, H.R. Thiessen-Philbrook, R.B. Haynes, R.S. Suri, M. Salvadori, J. Ray, and W.F. Clark. 2005. Risk of hypertension and reduced kidney function after acute gastroenteritis from bacteria-contaminated drinking water. CMAJ August 2, 2005: 173 (3). Garg, A.X., R.S. Suri, N. Barrowman, F. Rehman, D. Matsell, M.P. Rosas-Arellano, M. Salvadori, R.B. Haynes, and W.F. Clark. 2003. Long-term Renal Prognosis of Diarrhea- Associated Hemolytic Uremic Syndrome. JAMA; 290 (10): 1360 -1370. Page E56 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public Health Association, Washington, DC. Karch, H., P.I. Tarr and M. Bielaszewska. 2005. Enterohaemorrhagic Eschericia coli in human medicine. International Journal of Medical Microbiology, 295: 405-418. Kramer, M.H., B.L. Herwaldt, G.F. Craun, R.L. Calderon, and D.D. Juranek. 1996. Surveillance for waterborne-disease outbreaks - United States, 1993-1994. MMWR45(SS-): 1-33. Nataro, J., C. Bopp, P. Fields, J. Kaper and N. Strockbine. 2007. Escherichia, Shigella and Salmonella. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology, Washington, DC. Vol. 1: pp. 670 - 672. Nataro, J.P. and J.B. Kaper. 1998. Diarrheagenic Escherichia coli. Clinical microbiology reviews, 11(1): 142-201. Rangel, J.M., P.H. Sparling, C. Crowe, P.M. Griffin, and D.L. Swerdlow. 2005. Epidemiology of Escherichia coli 0157:H7 outbreaks, United States, 1982-2002. Emerging infectious diseases, 11(4): 603-609. Suri, R.S., W.F. Clark, N. Barrowman, J.L. Mahon, H.R. Thiessen-Philbrook, M.P. Rosas- Arellano, K. Zarnke, J.S. Garland, and A.X. Garg. 2005. Diabetes during diarrhea-associated hemolytic uremic syndrome: a systematic review and meta-analysis. Diabetes Care, 2005 October, 28(10): 2556-2562. Page E57 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Exophiala jeanselmei Scoring Data Scoring Summary1 Occurrence 3 Health Effects General population 3 Sensitive subpopulation(s) [C, P, E, CD] 3 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? No 2 Has caused WBDOs in countries other than the U.S.? No 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Yes Nucci et al., 2002 Occurrence 3 Detected in drinking water in the U.S.? Yes West, 1986 Page E58 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 2 Detected in source water in the U.S.? Yes Nucci et al., 2001 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? No 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? Infections increase in severity in patients with impaired immunity and metabolic diseases such as diabetes. De Hoog in Murray, 2007 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? No 4 Does the illness require short term hospitalization (< week)? No 3 [G, C, P, E, CD] Does the illness require physician intervention? [All populations] A chronic spreading mycosis. The frequency of infection is low, yet potential severe outcome and high degrees of resistance to antifungal drugs requires medical attention. Heymann, 2005 De Hoog in Murray, 2007 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? Page E59 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public Health Association, Washington, DC. Nucci, M.T. Akiti, G. Barreiros, F. Silveira, S.G. Revankar, D.A. Sutton, and T.F. Patterson. 2001. Nosocomial fungemia due to Exophiala jeanselmei var. jeanselmei and a Rhinocladiella species: newly described causes of bloodstream infection. Journal of Clinical. Microbiology, 39(2): 514-518. Nucci, M.T., T. Akiti, G. Barreiros, F. Silveira, S.G. Revankar, B.L. Wickes, D.A. Sutton, and T.F. Patterson. 2002. Nosocomial outbreak of Exophiala jeanselmei fungemia associated with contamination of hospital water. Clinical infectious diseases, 34: 1475-1480. De Hoog, G. and R. Vitale. 2007. Bipolaris, Exophiala, Scedosporium, Sporothrix, and Other Dematiaceous Fungi. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology, Washington, DC. Vol. 2: pp. 1908 and 1918. West, P.R. 1986. Isolation rates and characterization of fungi in drinking water distribution systems. Proceedings of the Water Quality Technology Conference, American Water Works Association, Denver, CO. Page E60 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 l usarinm solani Scoring Data Scoring Summary1'2 Occurrence 3 Health Effects General population 4 Sensitive subpopulation(s) [C, P, E, CD] 4 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? No 2 Has caused WBDOs in countries other than the U.S.? No 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Yes Houston TX Annaissie et al., 2001 Occurrence 3 Detected in drinking water in the U.S.? Yes Nagy and Olson, 1982 Annaissie et al., 2001 Page E61 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 2 Detected in source water in the U.S.? Yes 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? Mortality associated with cutaneous Fusarium infection is high in immunocompromi sed patients but low for immunocompetent hosts. Nucci and Annaissie, 2002 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? Most severe disease occurs in severely immunocompromised. Fusarium has been associated with pneumonia and disseminated infections Fridkin and Jarvis, 1996; Annaissie et al., 2001 Sutton and Brandt, in Murray, 2010 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? 4 [G, C, P, E, CD] Does the illness require short term hospitalization (< week)? [All populations] Can cause infections that may require hospitalization, particularly in immunocompromised patients (endophthalmitis, central nervous system infections, endocarditis) Dignani and Anaissie, 2004 3 Does the illness require physician intervention? Treatment and/or removal of the foreign body is usually Dignani and Anaissie, 2004 Page E62 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 required as well as antifungal therapy. In immunocompetent patients manifestations include keratitis, localized skin lesions, onychomycosis, and occasionally cellulitis and peritonitis. 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Anaissie, E.J., R.T. Kuchar, J.H. Rex, A. Francesconi, M. Kasai, F-M.C. Muller, M. Lozano- Chiu, R.C. Summerbell, M.C. Dignani, S.J. Chanock, and T.J. Walsh. 2001. Fusariosis Associated with Pathogenic Fusarium Species Colonization of a Hospital Water System: A New Paradigm for the Epidemiology of Opportunistic Mold Infections. Clinical Infectious diseases, 33: 1871-1878. Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Dignani, M. and E. Anaissie. 2004. Human Fusariosis. Clinical and Infection Microbiology, 1: 67-75. Fridkin, S. and W. Jarvis. 1996. Epidemiology of Nosocomial Fungal Infections. Clinical microbiology reviews, 9(4): 499-511. Page E63 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Nagy L., and Olson B. 1982. The occurrence of filamentous fungi in drinking water distribution systems. Canadian Journal of Microbiology. 1982 Jun; 28(6): 667-71 Nucci, M. and E. Anaissie. 2002. Cutaneous infection by Fusarium species in health and immunocompromised hosts: implications for diagnosis and management. Clinical Infectious diseases,35: 909-920. Sutton, D. and M. Brandt. 2007. Fusarium, and Other Opportunistic Hyaline Fungi. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry and M. A. Pfaller (ed.) Manual of Clinical Microbiology, 10th. Edition, American Society for Microbiology, Washington, DC (Vol. 2). p: 1853. Page E64 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Helicobacter pylori Scoring Data Scoring Summary1'2 Occurrence 3 Health Effects General population 7 Sensitive subpopulation(s) [E] 7 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017. No CDC, 1991 - CDC, 2017 3 Has caused documented WBDOs at any time in the U.S.? No 2 Has caused WBDOs in countries other than the U.S.? No 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Yes Klein and Graham, 1991 Hulten et al., 1996 Rolle-Kampczyk, 2004 Aziz et al., 2015 Page E65 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 Occurrence 3 Detected in drinking water in the U.S.? Yes Hegarty and Baker, 1999 2 Detected in source water in the U.S.? 1 Not detected in the U.S.? Health Effects 7 [G, E] Does the organism cause significant mortality (> 1/1,000 cases)? [G, E] 6500 deaths per year. 1.2 Million acute cases per year (>1/1,000 deaths). 46% of deaths occur before age of 64. CDC, 1997 Stratton et al., 2000 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? 40 - 50% infection rates in the elderly. More likely to suffer from gastric ulcer, gastric adenocarcinomas and MALT. Fox in Murray, 2007 Couturier in Carroll, 2019 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? Main cause for peptic ulcers and a major risk factor for gastric cancer. Fox in Murray, 2007 4 Does the illness require short term hospitalization (< week)? 3 [C, P, CD] Does the illness require physician intervention? [C, P, CD] Many patients have recurrent abdominal symptoms; 16% develop duodenal ulcers. NIH( 1994) recommends diagnosis and antimicrobial Fox in Murray, 2007 Page E66 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 treatment for anyone with peptic ulcers. 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? No Infection persists lifelong without treatment. Fox in Murray, 2007 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Aziz, R.K., Khalifa, M.M., and Sharaf, R. R. (2013). Contaminated water as a source of Helicobacter pylori infection: A review. Journal of advanced research, 6(4): 539-547. doi:10.1016/j.jare.2013.07.007. Centers for Disease Control and Prevention (CDC). 1997. Knowledge About Causes of Peptic Ulcer Disease — United States, March-April 1997, October 24, 1997 / 46(42): 985-987 CDC. 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Couturier Helicobacter in in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A. J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Fox, G. and F. Megraud. 2007. Helicobacter. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M. A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology, Washington, DC. Vol. 1: p. 950. Hegarty, J.P. and K.H. Baker. 1999. Occurrence of Helicobacter pylori in surface water in the United States. Journal of Applied Microbiology, 87: 697-701. Hulten, K., S.W. Han, H. Enroth, P.D. Klein, A.R. Opekun, R.H. Gilman D.G. Evans, L. Engstrand, D.Y. Graham, and F.A.K. El-Zaatari. 1996. Helicobacter pylori in the drinking water in Peru. Gastroenterology, 110: 1031-1035. Page E67 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Klein, P.D, D.Y. Graham, Gaillour, A, Opekun, A.R. and Smith, E.0.1991. Water source as risk factor for Helicobacter pylori infection in Peruvian children. Lancet, 337(8756): 1503-1506. Rolle-Kampczyk, U.E., G.J. Fritz, U. Diez, I. Lehman, M. Richter, and O. Herbarth. 2004. Well water - one source for Helicobacter pylori colonization. International Journal of Hygiene and Environmental Health, 207: 363-368. Stratton, K., J. Durch, and R. Lawrence (Editors). 2000. Vaccines for the 21st Century. National Academy of Sciences, National Academy of Press: 181-187. Page E68 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Hepatitis A Virus Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 3 Health Effects General population 3 Sensitive subpopulation(s) [E] 6 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No 3 Has caused documented WBDOs at any time in the U.S.? Yes 1 Community 1 Noncommunity (Previously unreported)/A 1971-2008: 10 Community 9 Noncommunity CDC-NORS, 2020 2 Has caused WBDOs in countries other than the U.S.? Page E69 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Occurrence 3 Detected in drinking water in the U.S.? 2 Detected in source water in the U.S.? Yes Abbaszadegan et al., 2003 Borchardt et al., 2004 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? Reported case fatality is normally low, 0.1% - 0.3%; it can reach 1.8% for adults over 50. Heymann, 2005 6[E] Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? [E] Fulminant hepatitis may develop. Disease severity shows a general increase with age. Anderson in Murray, 2007 CDC, 2019 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? 4 Does the illness require short term Page E70 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 hospitalization (< week)? 3 [G, C, P, CD] Does the illness require physician intervention? [G, C, P, CD] Commonly begins with "flu-like" symptoms. May develop jaundice. Physician office visit is common for diagnosis and/or vaccination. Anderson in Murray, 2007 2 Is the illness self- limiting within 72 hours (without requiring medical intervention)? 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text inc icates the highest score for that particular protocol. For the lealth effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Abbaszadegan, M., M. LeChevallier, and C. P. Gerba, 2003. Occurrence of viruses in U. S. groundwaters. JAWWA95: 107-120. Anderson, D. 2007. Hepatitis A and E Viruses. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M. A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology, Washington, DC. Vol. 2: pp. 1428 - 1429. Borchardt, M.A., N.L. Haas and R.L. Hunt. 2004. Vulnerability of drinking-water wells in La Crosse, Wisconsin to enteric-virus contamination from surface water contributions. Applied and Environmental Microbiology, 10: 5937-5946. Centers for Disease Control and Prevention (CDC). 2019. Hepatitis A home page. https://www.cdc.gov/hepatitis/hav/index.htm. CDC. 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Page E71 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public Health Association, Washington, DC. Page E72 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Hepatitis E Virus Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 2 Health Effects General population 3 Sensitive subpopulation(s) [P] 7 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? No 2 Has caused WBDOs in countries other than the U.S.? Yes Waterborne outbreaks have occurred in Asia and Africa. Guthmann et al., 2006 Panda et al., 2006 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Yes California camping. Tsang et al., 2000 Occurrence Page E73 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 3 Detected in drinking water in the U.S.? No 2 Detected in source water in the U.S.? No 1 Not detected in the U.S.? Yes India Jothikumar et al., 2000 Health Effects 7[P] Does the organism cause significant mortality (> 1/1,000 cases)? [P] May progress to fulminant disease in pregnant women when infection occurs during the third trimester. High mortality (for fetus) when infection occurs during pregnancy. The case-fatality rate is similar to that of hepatitis A except in pregnant women, where it may reach 20% among those infected during the third trimester of pregnancy. Anderson in Murray, 2010; Isopet and Kamar in MCM 2019 Heymann, 2005 6 [E] Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? [E] Fulminant hepatitis may develop. Disease severity shows a general increase with age. Anderson in Murray, 2010 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? Page E74 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 4 Does the illness require short term hospitalization (< week)? 3 [G, C] Does the illness require physician intervention? [G, C] Commonly begins with "flu-like" symptoms. May develop jaundice. Physician office visit is common for diagnosis and/or vaccination. Anderson in Murray, 2010 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Anderson, D., and N. Counahan. 2010. Hepatitis A and E Viruses. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 10th. edition, American Society for Microbiology, Washington, DC. Vol. 2: pp. 1423. Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Guthmann, J-P., H. Klovstad, D. Boccia, N. Hamid, L. Pinoges, J-Y. Nizou, M. Tatay, F. Diaz, A. Moren, R.F. Grais, I. Ciglenecki, E. Nicand, and P.J. Guerin. 2006. A large outbreak of hepatitis E among a displaced population in Darfur, Sudan, 2004: the role of water treatment methods. Clinical Infectious Diseases, 42: 1685-1691. Page E75 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public Health Association, Washington, DC. Isopet and Kamar. Hepatitis A and E Viruses in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A. J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Jothikumar N., R. Paulmurugan, P. Padmanabhan, R.B. Sundari, S. Kamatchiammal, andK.S. Rao. 2000. Duplex RT-PCR for simultaneous detection of hepatitis A and hepatitis E virus isolated from drinking water samples. Journal of Environmental Monitoring. 2(6): 587-90. Panda, S.K., D. Thakral, and S. Rehman. 2007. Hepatitis E virus. Reviews in medical virology, 17(3): 151-180. Tsang, T.H., E.K. Denison, H.V. Williams, L.V. Venczel, M.M. Ginsberg, and D.J. Vugia. Acute Hepatitis E Infection Acquired in California. Clinical Infectious Diseases, 30: 618-9. Page E76 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Isospora belli Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 2 Health Effects General population 1 Sensitive subpopulation(s) [C] 2 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? No 2 Has caused WBDOs in countries other than the U.S.? Yes Karanis, 2006 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Yes Occurrence Page E77 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 3 Detected in drinking water in the U.S.? No 2 Detected in source water in the U.S.? No 1 Not detected in the U.S.? No Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? 4 Does the illness require short term hospitalization (< week)? 3 Does the illness require physician intervention? Can cause serious and sometimes fatal disease in immunocompetent humans, more severe in immunocompromi sed patients. Lindsay in Murray, 2010 2 [C] Is the illness self-limiting within 72 hours (without requiring medical intervention)? [C] Symptoms are more severe in infants and children. Lindsay in Murray, 2010 1 [G] Does the illness result in mild symptoms with [G] Symptoms include diarrhea, steatorrhea, headache, fever, Lindsay in Murray, 2010 Page E78 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 minimal or no impact on daily activities? malaise, abdominal pain, vomiting, dehydration, and weight loss. 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Karanis P. 2006 A review of an emerging waterborne medical important parasitic protozoan. Japanese Journal of Protozoology, 39(1): 5-19. Lindsay, D., S. Upton and L. Weiss. 2010. Isospora, Cyclospora and Sarcocystis. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.A. Pfaller, and R.H. Yolken (ed.) The Manual of Clinical Microbiology, 10th edition, American Society for Microbiology, Washington, DC Vol. 2; p. 2172. Page E79 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Legionella pneumophila Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 5 Health Effects General population 4 Sensitive subpopulation(s) [E, CD] 6 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 Yes 9 Community (2009) 12 Community (2010) 11 Community (2011) 12 Community (2012) CDC-NORS, 2020 5 6 Community (2013) 17 Community (2014) 13 Community (2015) 24 Community (2016) 21 Community (2017) 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 Page E80 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 3 Has caused documented WBDOs at any time in the U.S.? 1971-2008: 30 Community 25 Noncommunity CDC-NORS, 2020 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Occurrence 3 Detected in drinking water in the U.S.? Yes AwwaRF, 2004 Lin et al., 1998 Maier et al., 2000 2 Detected in source water in the U.S.? Yes Maier et al., 2000 1 Not detected in the U.S.? Health Effects Does the organism cause significant mortality (> 1/1,000 cases)? Avg. 12% fatality rate; death rates of 15% (general pop.) up to 75% (immunocompromised) if untreated. Edel stein in Murray, 2007 7 Avg. 25% death rate (between 20-40% during an outbreak. 10-15%) death rate. Fatality rate has been as high as 39%) in hospitalized cases; it is generally higher in those AWWARF, 2004 CDC, 2005 Heymann, 2005 Page E81 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 with compromised immunity. 6 [E, CD] Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? [E, CD] Acute pneumonia may progress to respiratory collapse and death if diagnosis and effective antibiotic therapy are delayed. The elderly and individuals with chronic diseases are at higher risk. Edelstein in Murray, 2007; Carroll. 2019 CDC, 2005 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? No 4 [G, C, P] Does the illness require short term hospitalization (< week)? [G, C, P] Hospitalization is required for treatment of acute pneumonia. Edelstein in Murray, 2007 3 Does the illness require physician intervention? 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? Pontiac fever resolves without treatment and has flu-like symptoms. Edelstein in Murray, 2007 Heymann, 2005 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text indicates the highest score for that particular protocol. For the health e Tccts protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. Page E82 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 References Centers for Disease Control and Prevention (CDC). 2005. Legionellosis: Legionnaires' Disease (LD) and Pontiac Fever. Disease Listing. October 12, 2005. http://www.cdc.gov/ncidod/dbmd/diseaseinfo/legionellosis t.htm CDC. 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Edelstein, P. 2007. Legionella. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology, Washington, DC. Vol. 1: p. 837. Edelstein, P. 2007. Legionella, in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A.J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Heymann, D.(ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public Health Association, Washington, DC. Lin, Y.S., J.E. Stout, V.L. Yu, and R.D. Vidic. 1998. Disinfection of water distribution systems for Legionella. Seminars in Respiratory Infections, 13: 147-159. Maier, R.M., I.L. Pepper, C.P. Gerba. 2000. Environmental Microbiology. Academic Press, pp. 454-455, 539. Riffard, S., Springthorpe, S., Filion, L. and Sattar, S., 2002. Occurrence of Legionella in Groundwater (AWWA Research Foundation Reports). American Water Works Association publisher. Page E83 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Microsporidia Scoring Data Scoring Summary1'2 Occurrence 2 Health Effects General population 2 Sensitive subpopulation(s) [CD, C, P, E] 2 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? No 2 Has caused WBDOs in countries other than the U.S.? No 1 Has never caused WBDOs in any country, but has been epidemiologically Yes Cotte, et al., 1999 Enriquez et al., 1998 Hutin et al., 1998 Page E84 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 associated with water related disease? Occurrence 3 Detected in drinking water in the U.S.? No 2 Detected in source water in the U.S.? Yes Didier et al., 2004 Dowd et al., 1998 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? 4 Does the illness require short term hospitalization (< week)? 3 Does the illness require physician intervention? Antimicrobial therapy available for immunodeficient patients. Weber in Murray, 2010 2[G, C, P, E, CD] Is the illness self-limiting within 72 hours (without requiring medical intervention)? [All populations] Diarrhea and weight loss lasting in up to 2 - 3 weeks in Weber in Murray, 2010 Page E85 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 immunocompetent hosts. Has been identified among elderly persons with acute or chronic diarrhea. 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Cotte, L., M. Rabondonira, F. Chapuis, F. Bailly, F. Bissuel. C. Raynal. 1999. Waterborne outbreak of intestinal microsporidiosis in persons with and without human immunodeficiency virus infection. Journal of Infectious Diseases, 180: 2003-2008. Didier, E.S., M.E. Stovall, L.C. Green, P.J. Brindley, K. Sestak, and P.J. Didier. 2004. Veterinary parasitology, 126: 145-166. Dowd, S.E., C.P. Gerba, I.L. Pepper. 1998. Confirmation of the human-pathogenic microsporidia Enterocytozoon bieneusi, Encephalitozoon intestinalis, and Vittaforma corneae in water. Applied and Environmental. Microbiology, 64(9): 3332-3335. Enriquez, F.J., D. Taren, A. Cruz-Lopez, M. Muramoto, J.D. Palting, P. Cruz. 1998. Prevalence of intestinal encephalitozoonosis in Mexico. Clinical Infectious Diseases, 26: 1227-1229. Hutin, Y.J.F., M.N. Sombardier, O. Ligoury, C. Sarfati, F. Derouin, J. Modai, J.M. Molina. 1998. Risk factors for intestinal micorspooridiosis in patients with human immunodeficiency virus infection.: a case control study. Journal of Infectious Diseases, 178: 904-907. Weber R., A. Mathis and P. Deplazes. 2010. Microsporidia. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.A. Pfaller, and R.H. Yolken (ed.) The Manual of Clinical Microbiology, 10th edition, American Society for Microbiology, Washington, DC Vol. 2; p. 2190. Page E86 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Mycobacterium abscessus Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 4 Health Effects General population 4 Sensitive subpopulation(s) [CD] 5 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 2014: 1 Hospital CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Occurrence 3 Detected in drinking water in the U.S.? Yes. Idaho public health officials and pediatric infectious Baker et al., 2017 Page E87 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 disease physicians investigated a US documented outbreak of Mycobacterium abscessus skin infections in children whose only common exposure was an indoor wading pool (Carter et al., 2019). Another outbreak occurred in the Duke University Hospital linked to the hospital tap water (Baker et al., 2017). Carter et al., 2019 2 Detected in source water in the U.S.? 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? 5 [CD] Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? [CD] M. abscessus complex can cause pulmonary disease, especially in vulnerable hosts with underlying structural lung disease, such as cystic fibrosis, Griffith, 2007 Page E88 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 bronchiectasis, and prior tuberculosis. 4 [G] Does the illness require short term hospitalization (< week)? Yes. Prolonged intravenous (IV) therapy and side effects are often necessary to treat Mycobacterium abscessus infections. Novosad, 2016 3 Does the illness require physician intervention? 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Baker, A.W., Lewis, S.S., Alexander, B.D., Chen, L.F., Wallace Jr, R.J., Brown-Elliott, B.A., and Reynolds, J.M. 2017. Two-phase hospital-associated outbreak of Mycobacterium abscessus: investigation and mitigation. Clinical Infectious Diseases, 64(7), 902-911. Carter, K.K., Lundgren, I., Correll, S., Schmalz, T., McCarter, T., Stroud, J., and Hahn, C.G. 2018. First United States outbreak of Mycobacterium abscessus hand and foot disease among children associated with a wading pool. Journal of the Pediatric Infectious Diseases Society. Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Page E89 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Griffith, D.E., Aksamit, T., Brown-Elliott, B.A., Catanzaro, A., Daley, C., Gordin, F., and Iseman, M. 2007. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. American journal of respiratory and critical care medicine, 775(4), 367-416. Novosad, S.A., Beekmann, S.E., Polgreen, P.M., Mackey, K., and Winthrop, K.L. 2016. Treatment of Mycobacterium abscessus infection. Emerging infectious diseases, 22(3), 511. Page E90 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Mycobacterium avium Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 4 Health Effects General population 3 Sensitive subpopulation(s) [E] 5 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 Yes 2016: 1 Community (Mycobacterium "other") CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? Yes Not listed in CDC's NORS however, data linking patient, outbreak and drinking water. Tobin-D' Angelo et al., 2004 2 Has caused WBDOs in countries other than the U.S.? No 1 Has never caused WBDOs in any country, but has been Yes Glover et al., 1994 Aronson et al., 1999 Page E91 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 epidemiologically associated with water related disease? von Reyn et al., 1994 Occurrence 3 Detected in drinking water in the U.S.? Yes Glover et al., 1994 Covert et al., 1999 Falkinham et al., 2001 2 Detected in source water in the U.S.? Yes Covert etal., 1999 Falkinham et al., 2004 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? Disseminated MAC infections are a major problem in HIV- infected individuals. Heymann, 2005 5[E] Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? [E] Most commonly immunocompetent patients develop a slowly evolving cavitary disease that resembles tuberculosis. Elderly non-smoking females, can develop "Lady Windermere's syndrome" which has been associated with significant morbidity and mortality. Murray et al., 2005 Carroll et al., 2019 Page E92 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 4 [CD] Does the illness require short term hospitalization (< week)? [CD] Tuberculosis-like upper lobe fibrocavitary disease occurs typically in men 45 - 60 who have preexi siting lung disease. Pfyffer in Murray, 2007 3 [G] Does the illness require physician intervention? [G] Symptoms of infection include pulmonary disease, lymphadenitis, post- traumatic wound infection. Diagnosis of disease and treatment requires physician intervention. Pfyffer in Murray, 2007 Heymann, 2005 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Aronson, T., A. Holtzman, N. Glover, M. Boian, S. Froman, O.G.W. Berlin, H. Hill, and G. Stelma, Jr. 1999. Comparison of large restriction fragments of Mycobacterium avium isolates recovered from AIDS and non-AIDS patients with those of isolates from potable water. J. Clin. Microbiol. 37: 1008-1012. Page E93 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A.J., Patel, R., Richter, S.S. and Warnock, D.W.(ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Falkinham, J.O., III, C.D. Norton, and M.W. LeChevallier. 2001. Factors influencing numbers of Mycobacterium avium, Mycobacterium intracellulare, and other mycobacteria in drinking water distribution systems. Applied and Environmental Microbiology, 67: 1225-1231. Falkinham, J.O., G. Nichols, J. Bartram, A. Dufour, and F. Portaels. 2004. Natural ecology and survival in water of mycobacteria of potential public health importance. In Pedley, S., J. Bartram, G. Rees, A. Dufour, and J. A. Cotruvo (Eds.) Pathogenic mycobacteria in water: a guide to public health consequences, monitoring and management. IWA Publishing, London, UK. Glover, N., A. Holtzman, T. Aronson, S. Froman, O.G.W. Berlin, P. Dominguez, K.A. Kunkel, G. Overturf, G. Stelma, Jr., C. Smith, and M. Yakrus. 1994. The isolation and identification of Mycobacterium avium complex (MAC) recovered from Los Angeles potable water, a possible source of infection in AIDS patients. International Journal of Environmental Health Research,-4: 63-72. Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public Health Association, Washington, DC. Murray, P.R., K.S. Rosenthal and M.A. Pfaller. 2005. Medical Microbiology, 5th edition. Elsevier Mosby. p. 304. Pfyffer, G. 2007. Mycobacterium: General Characterises, Laboratory Detection, and Staining Procedures. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology, Washington, DC. Vol. 1: pp. 547- 548. Tobin-D'Angelo, M.J., M. A. Blass, C. del Rio, J.S. Halvosa, H.M. Blumberg, and C.R. Horsburgh, Jr. 2004. Hospital water as a source of Mycobacterium avium complex isolates in respiratory specimens. Journal of Infectious Diseases, 189: 98-104. von Reyn, C.F., J.N. Maslow, T.W. Barber, J.O. Falkinham, III, and R.D. Arbeit. 1994. Persistent colonization of potable water as a source of Mycobacterium avium infection in AIDS. Lancet. 343: 1137-1141. Page E94 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Naegleria fowleri Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 5 Health Effects General population 7 Sensitive subpopulation(s) [C, P, E, CD] 7 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 Yes, 1 Community (note an outbreak is only one case for Naegleria) CDC, 2017 4 Has caused at least one documented WBDOs in the U.S. as reported by CDC surveillance between 1990 and 2014? 3 Has caused documented WBDOs at any time in the U.S.? 1971-2008: 1 Community CDC-NORS, 2020 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Page E95 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 Occurrence 3 Detected in drinking water in the U.S.? Yes Arizona storage - Sampled pre-treatment multiple-well study in Arizona. Louisiana Gerba et al., 2007 Marciano-Cabral et al., 2003 LA, 2013 2 Detected in source water in the U.S.? Yes Schuster and Visvesvara, 2004 1 Not detected in the U.S.? Health Effects 7[G, C, P, E, CD] Does the organism cause significant mortality (> 1/1,000 cases)? [All populations] Recovery from primary amoebic meningoencephalitis is rare. Heymann, 2005 Cope and Ali, 2016. 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? Acute fulminating disease. Only a few patients have survived. Visvesvara in Murray, 2010 Cope et al, in Carroll, 2019 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? No Page E96 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 4 Does the illness require short term hospitalization (< week)? All cases are hospitalized for diagnosis and treatment. Visvesvara in Murray, 2010 3 Does the illness require physician intervention? 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Centers for Disease Control and Prevention (CDC). 2017. Naegleria fowleri in Louisiana Public Water Systems, https://www.cdc.gov/parasites/naegleria/public-water-systems-louisiana.html Cope, J.R., & Ali, I.K. 2016. Primary Amebic Meningoencephalitis: What Have We Learned in the Last 5 Years?. Current infectious disease reports, 18(10), 31. https://doi.org/10.10Q7/sl 1908- 016-0539-4 Cope J.R., Pathogenic and Opportunistic Free-Living Amebae in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A.J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Gerba, C., B. Blair, P. Sarkar, and K. Bright. 2007. Occurrence and Control of Naegleria fowleri in Well Water and Chlorine Resistance. Proceedings, Water Quality Technology Conference, American Water Works Association, November 5-8, 2007. Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public Health Association, Washington, DC. pp. 417-419. Louisiana Department of Health, 2013. http://ldh.la.gov/index.cfm/newsroom/detail/2906 Page E97 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Marciano-Cabral, F., R. MacLean, A. Mensah, and L. LaPat-Polasko. 2003. Identification of Naegleria fowleri in domestic water source by nested PCR. Applied and Environmental Microbiology, 69 (10): 5864-5869. Schuster, F.L. and G.S. Visvesvara. 2004. Free-living amoebae as opportunistic and non- opportunistic pathogens of humans and animals. International Journal for Parasitology, 34: 1001-1027. Visvesvara, G. 2007. Pathogenic and Opportunistic Free-Living Amebae. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.A. Pfaller, and R.H. Yolken (ed.) The Manual of Clinical Microbiology, 10th edition, American Society for Microbiology, Washington, DC Vol. 2; p. 3129. Page E98 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Nontuberculous Mycobacteria (NTM) Scoring Data Scoring Summary1'2 Occurrence 3 Health Effects General population 3 Sensitive subpopulation(s) [E] 5 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? No 2 Has caused WBDOs in countries other than the U.S.? No 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Yes Johnson and Odell, 1994 Occurrence 3 Detected in drinking water in the U.S.? Yes Falkinham et al., 2011 Page E99 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 2 Detected in source water in the U.S.? Yes Covert etal., 1999 Falkinham et al., 2004 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? Disseminated MAC infections are a major problem in HIV- infected individuals. Heymann, 2005 5[E] Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? [E] Most commonly immunocompetent patients develop a slowly evolving pulmonary disease. Murray et al., 2005 4 Does the illness require short term hospitalization (< week)? 3 [G] Does the illness require physician intervention? [G] Symptoms of infection include pulmonary disease; diagnosis of disease and treatment requires physician intervention. Pfyffer in Murray, 2007 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 1 Does the illness result in mild symptoms with minimal Page E100 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 or no impact on daily activities? 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Falkinham J.O. III. 2011. Nontuberculous mycobacteria from household plumbing of patients with nontuberculous mycobacteria disease. Emerging Infectious Diseases, 17:419-424 Hernandez-Garduno, E., & Elwood, K. 2012. Nontuberculous mycobacteria in tap water. Emerging Infectious Diseases, 18(2), 353. Johnson, M.M., & Odell, J.A. 2014. Nontuberculous mycobacterial pulmonary infections. Journal of Thoracic Disease, 6(3), 210-220. Murray, P.R., K.S. Rosenthal and M.A. Pfaller. 2005. Medical Microbiology, 5th edition. Elsevier Mosby. p. 304. Pfyffer, G. 2007. Mycobacterium: General Characterises, Laboratory Detection, and Staining Procedures. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology, Washington, DC. Vol. 1: pp. 547- 548. Page E101 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Pantoea agglomerans Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 4 Health Effects General population 1 Sensitive subpopulation(s) [C, CD] 6 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 Yes. 2012: 1 Community Outbreak of Pantoea agglomerans bloodstream infection occurred in a health care facility linked to the drinking water system. CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any country, but has been Page E102 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 epidemiologically associated with water related disease? Occurrence 3 Detected in drinking water in the U.S.? Yes. Outbreak of Pantoea agglomerans bloodstream infection occurred in a health care facility linked to the drinking water system. CDC, 2015 2 Detected in source water in the U.S.? 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? 6 [C, CD] Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? [C, CD] Yes. There are documented cases of long-term hospitalization and death in children with pneumonia Biiyiikcam (2018). It can also cause infections in cuts and in immunocompromised individuals in health care settings. Septic arthritis or synovitis appears as a common clinical outcome of exogenous infection with P. agglomerans, others include endophthalmitis, periostitis, endocarditis and osteomyelitis Biiviikcam, 2018 Dutkiewicz J, et al., 2016 Forsythe et al., in MCM, 2019 Page E103 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 (Dutkiewicz J, et al. 2016). 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? 4 Does the illness require short term hospitalization (< week)? 3 Does the illness require physician intervention? 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 1 [G] Does the illness result in mild symptoms with minimal or no impact on daily activities? Pantoea agglomerans is not generally an infections agent in healthy humans (Dutkiewicz J, et al. 2016). Dutkiewicz J, et al., 2016 1 Bolded text inc icates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Buyiikcam, A., Tuncer, O., Giir, D., Sancak, B., Ceyhan, M., Cengiz, A.B., & Kara, A. 2018. Clinical and microbiological characteristics of Pantoea agglomerans infection in children. Journal of infection and public health, 11(3), 304-309. Dutkiewicz, J., Mackiewicz, B., Lemieszek, M.K., Golec, M., & Milanowski, J. 2016. Pantoea agglomerans: a mysterious bacterium of evil and good. Part III. Deleterious effects: infections of humans, animals and plants. Annals of Agricultural and Environmental Medicine, 23(2). Page E104 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Forsythe et al., Klebsiella and Selected Enterobacterales. Chapter 40 in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A.J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Page E105 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Plesiomonas shigelloides Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 3 Health Effects General population 2 Sensitive subpopulation(s) [C, E] 3 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? 1971-2008:2 Noncommunity CDC-NORS, 2020 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Page E106 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 Occurrence 3 Detected in drinking water in the U.S.? Yes CDC, 1998(a) Detected in source water in the U.S.? Yes Abbott in Murray, 2010 2 Holmberg and Farmer, 1984 Holmberg et al., 1986 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? No 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? No 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? No 4 Does the illness require short term hospitalization (< week)? Hospitalization may be required for severe infections and/or underlying diseases. Abbott in Murray, 2010 3 [C, E] Does the illness require physician intervention? [C, E] Physician office visit may be required for diagnosis and treatment of dysenteric form of the disease in children or the Abbott in Murray, 2010 Page E107 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 elderly. Bacteremia more common with advanced age. 2 [G] Is the illness self- limiting within 72 hours (without requiring medical intervention)? [G] Diarrhea may persist up to two weeks. Abbott in Murray, 2010; Forsythe in MCM, 2019 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? Plesiomonas is associated with travelers' diarrhea or a history of seafood consumption, most infections are self- limiting. Abbott in Murray, 2010 1 Bolded text indicates the highest score for that particular protocol. For the hea th effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Abbott, S.L. 2007. Klebsiella, Enterobacter, Citrobacter, Serratia, Plesiomonas, and other Enterobacteriaceae. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.A. Pfaller, and R.H. Yolken (ed.) The Manual of Clinical Microbiology, 10th edition, American Society for Microbiology, Washington, DC Vol. 1; p. 639. Centers for Disease Control and Prevention (CDC). 1998. Plesiomonas shigelloides and Salmonella serotype Hartford infections associated with a contaminated water supply - Livingston County, New York, 1996. MMWR 47(19):394-396. CDC, 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Forsythe et al., Klebsiella and Selected Enterobacterales. Chapter 40 in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A.J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Holmberg, S.D. and J.J. Farmer. 1984. Aeromonas hydrophila and Plesiomonas shigelloides as causes of intestinal infections. Rev. Infect. Dis. 6: 633-639. Page E108 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Holmberg, S.D., K. Wachsmith, F.W. Hickman-Brenner, P.A. Blake, and J.J. Farmer. 1986. Plesiomonas enteric infections in the United States. Annals of Internal Medicine, 105(5): 690- 694. Page E109 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Pseudomonas Aeruginosa Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 5 Health Effects General population 3 Sensitive subpopulation(s) [C, CD] 6 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 Yes 2013: 1 Community 2016: 1 Community CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? Yes; tap water in NICU Kinsey et al., 2017 2 Has caused WBDOs in countries other than the U.S.? NA 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? NA Occurrence Page El10 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 3 Detected in drinking water in the U.S.? Yes Kinsey et al., 2017 2 Detected in source water in the U.S.? 1 Not detected in the U.S.? Health Effects 7 [C] Does the organism cause significant mortality (> 1/1,000 cases)? Nosocomial pneumonia. Henry and Speert in Murray, 2010 6 [C, CD] Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? Septicemia and meningitis occur rarely in immunocompetent hosts, but can occur in neonates and cystic fibrosis patients. Henry and Speert et al. in Murray, 2010 CDC, 2019 Hoiby et al., in MCM, 2019 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? 4 Does the illness require short term hospitalization (< week)? 3 [G] Does the illness require physician intervention? Antibiotics Henry and Speert in Murray, 2010 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The Page El11 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Centers for Disease Control and Prevention (CDC). 2019. Pseudomonas aeruginosa home page. https://www.cdc.gov/hai/organisms/pseudomonas.html CDC, 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Henry, D. and D. Speert. 2010. Pseudomonas. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.A. Pfaller, and R.H. Yolken (ed.) The Manual of Clinical Microbiology, 8th. edition, American Society for Microbiology, Washington, DC. Vol. 1: p. 666. Hoiby et al., Pseudomonas. Chapter 46 in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A.J., Patel, R., Richter, S.S. and Warnock, D.W. (ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Kinsey C.B., et al. P. aeruginosa outbreak in NICU linked to contaminated tap water. 2017. Infection control & hospital epidemiology, 38(7), 801-808. Page El12 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Rotavirus Scoring Data Scoring Summary1'2 Occurrence 3 Health Effects General population 1 Sensitive subpopulation(s) [C] 6 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009- 2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009- 2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? Yes 1971-2008: 1 Community CDC-NORS,2020 2 Has caused WBDOs in countries other than the U.S.? Yes China and Sweden. Hardy, 1987 Gerba et al., 1996 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Occurrence Page El13 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 3 Detected in drinking water in the U.S.? Yes USGS, 2001 Gerba et al., 1996 2 Detected in source water in the U.S.? Yes Abbaszadegan et al., 2003 Gerba etal., 1996 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? No For children under 5 years of age: Estimated 37 deaths in 60,000 hospitalized cases per year in U.S.(1/1621 hospitalizations). Fischer et al., 2007 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? [C] Rotavirus infects all children; causes severe gastroenteritis in infants. Significant numbers of physician visits and hospitalizations and high medical and societal costs. Pang in Murray, 2010; Carroll, 2019 CDC, 2019 6 [C] A sporadic, seasonal, often severe gastroenteritis of infants and young children, characterized by vomiting, fever and watery diarrhea. Rotaviral enteritis is occasionally associated with severe dehydration Page El14 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 and death in young children. In developing countries, an estimated 600,000- 870,000 diarrheal deaths each year. Heymann, 2005 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? 4 Does the illness require short term hospitalization (< week)? 3 Does the illness require physician intervention? 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 1[G, P, E, CD] Does the illness result in mild symptoms with minimal or no impact on daily activities? [G, E, P, CD] Self-limiting acute watery diarrhea, vomiting, fever. Heymann, 2005 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Abbaszadegan, M., M. LeChevallier, and C.P. Gerba. 2003. Occurrence of viruses in U. S. groundwaters, JAWWA 95: 107-120. Centers for Disease Control and Prevention (CDC). 2019. Rotavirus home page. https://www.cdc.gov/rotavirus/index.html CDC, 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Page El15 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Pang, X. and X. Jiang. 2010. Gastroenteritis Viruses. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.A. Pfaller, and R.H. Yolken (ed.) The Manual of Clinical Microbiology, 10th edition, American Society for Microbiology, Washington, DC Vol. 2; 1454-1457. Pang and Smieja. Gastroenteritis Viruses in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A. J., Patel, R., Richter, S.S. and Warnock, D.W.(ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. United States Geological Service (USGS). 2001. W.S.L. Banks, C.A. Klohe and D.A. Battigelli. Occurrence and Distribution of Enteric Viruses in Shallow Ground Water and Factors Affecting Well Vulnerability to Microbiological Contamination in Worcester and Wicomico Counties, Maryland. Water-Resources Investigations Report 01-4147: 14, 21. Page El16 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Salmonella enterica Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 3 Health Effects General population 3 Sensitive subpopulation(s) [C, E] 4 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No 3 Has caused documented WBDOs at any time in the U.S.? Yes 1971-2008: 13 Community 7 Noncommunity CDC-NORS, 2020 (some are "Salmonella unknown") 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Occurrence Page El17 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 3 Detected in drinking water in the U.S.? Yes Angulo et al., 1997 CDC, 1998(a). 2 Detected in source water in the U.S.? 1 Not detected in the U.S.? Health Effects Does the organism cause significant mortality (> 1/1,000 cases)? Each year, 1.4 M cases of illness and 600 deaths are caused by non- typhoidal salmonellosis in the U.S. Nataro et al. in Murray, 2007 Buchan in Carroll, 2019 7 Estimated 800 cases per year of typhoid fever in the U.S., with fewer than 5 deaths/yr.; >70% of U.S. cases related to foreign travel. 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? Nontyphoidal salmonellosis usually causes intestinal infection; can cause extraintestinal infections in rare cases (bacteremia, urinary tract infection, osteomyelitis), especially in immunocompromised persons. Nataro et al. in Murray, 2007 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? None reported. Page El18 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 Does the illness require short term hospitalization (< week)? [C] Extra-intestinal infections highest in infants and young children. Nataro et al. in Murray, 2007 4[C, E] [E] Dehydration, especially among infants or in the elderly, may be severe. Deaths are uncommon, except in the young and old, the debilitated and immunosuppressed. Heymann, 2005 CDC, 2019. 3 [G, P, CD] Does the illness require physician intervention? [G, P, CD] Antibiotic and rehydration may be necessary. Heymann, 2005 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? Non-typhoidal Salmonella usually cause intestinal infection that often lasts 1 week or longer. Nataro et al. in Murray, 2007 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Angulo, F.J., S. Tippen, D. J. Sharp, B.J. Payne, C. Collier, J.E. Hill, T.J. Barrett, R.H. Clark, E.E. Geldreich, H.D. Donnell, Jr., D.L. Swerdlow. 1997. A community waterborne outbreak of salmonellosis and the effectiveness of a boil water order. American Journal of Public Health, 87(4): 580-584. Page El19 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Buchan. Escherichia, Shigella and Salmonella in in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A. J., Patel, R., Richter, S.S. and Warnock, D.W.(ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Centers for Disease Control and Prevention (CDC). 1998. Plesiomonas shigelloides and Salmonella serotype Hartford infections associated with a contaminated water supply - Livingston County, New York, 1996. MMWR 47(19): 394-396. CDC, 2019. Salmonella home page, https://www.cdc.gov/salmonella/index.html CDC, 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Heyman, D. (ed.). 2005. Control of Communicable Diseases Manual, 18ed. American Public Health Association, Washington, DC. Nataro, J.P., C.A. Bopp, P.I. Fields, J.B. Kaper, andN.A. Strockbine. 2007. Escherichia, Shigella, and Salmonella. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology, Washington, DC. Vol. 1: 680-687. Page E120 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Shigella sonnei Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 4 Health Effects General population 3 Sensitive subpopulation(s) [C, E] 6 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 Yes 2015: 1 Community (suspected, not confirmed) CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? 1971-2008:15 Community 23 Noncommunity (some unknown) CDC-NORS, 2020 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Occurrence 3 Detected in drinking water in the U.S.? Yes Craun, 2003 Page E121 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 2 Detected in source water in the U.S.? Yes Black et al., 1978 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? In U.S. approximately 450,000 cases occur each year with 70 deaths. Nataro in Murray, 2007 Buchan in Carroll, 2019 6 [C, E] Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? [C, E] S. dysentariae is associated with more serious symptoms than other species with complications such as toxic megacolon, hemolytic uremic syndrome and intestinal perforation. Cases may be severe in infants and the elderly and convulsions may occur in young children. Heymann, 2005 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? Reiter's syndrome. Heymann, 2005 4 Does the illness require short term hospitalization (< week)? Hospitalization is usually required for intravenous antibiotic therapy due to bacteremia, which is uncommon. Heymann, 2005 3 [G] Does the illness require physician intervention? [G] Most cases occur in children under 10 years, infants under 6 months rarely infected, increased severity in children and elderly, high secondary case rate in outbreaks, Heymann, 2005 Page E122 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 outbreaks occur in daycare centers, institutions, refugee camps, among homosexual men, 20% of U.S. cases result from international travel, specific antibiotic therapy available for prolonged or severe cases, multi- antibiotic resistance occurs. 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? Acute diarrhea, fever, nausea, vomiting, cramps and tenesmus, stools contain blood and mucus (dysentery), usually self-limiting in 4- 7 days without treatment. Heymann, 2005 CDC, 2019 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? S. sonnei causes most of the shigellosis cases in the U.S., cases may be asymptomatic or mildly symptomatic, but they are frequently acute. Heymann, 2005 1 Bolded text indicates the highest score for that particular protocol. For the healt i effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Black, R.E., G.F. Craun, and P. A. Blake. 1978. Epidemiology of common-source outbreaks of shigellosis in the United States, 1961-1975. American journal of epidemiology, 108: 47-52. Page E123 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Buchan. Escherichia, Shigella and Salmonella in in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A. J., Patel, R., Richter, S.S. and Warnock, D.W.(ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Centers for Disease Control and Prevention (CDC). 2019. Shigella home page. https://www.cdc.gov/shigella/index.html. CDC. 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Craun, G., R. Calderon, and M. Craun. 2003. Waterborne Outbreaks in the United States, 1971- 2000, in Drinking Water Regulation and Health. F. Pontius (ed.): pp. 45 - 60. Heymann, D. (ed.). 2005. Control of communicable diseases manual. 18th edition. American Public Health Association, Washington, DC. Nataro, J., C. Bopp, P. Fields, J. Kaper and N. Strockbine. 2007. Escherichia, Shigella, and Salmonella. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.A. Pfaller, and R.H. Yolken (ed.) The Manual of Clinical Microbiology, 9th edition, American Society for Microbiology, Washington, DC. Vol. 1: pp. 670, 677 - 678. Page E124 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Toxoplasma gondii Scoring Data Scoring Summary1 Waterborne Disease Outbreak 2 Health Effects General population 2 Sensitive subpopulation(s) [P] 7 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (1 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009- 2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? No 2 Has caused WBDOs in countries other than the U.S.? Yes Canada and Brazil. Bowie et al., 1997 de Moura, 2006 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Page E125 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 Occurrence 3 Detected in drinking water in the U.S.? No 2 Detected in source water in the U.S.? No 1 Not detected in the U.S.? Yes Groundwater in Poland and Canada. Sroka et al., 2006 Isaac-Renton et al., 1998 Health Effects 7[P] Does the organism cause significant mortality (> 1/1,000 cases)? [P] Congenital infection of neonates severe. Infection during early pregnancy may lead to fetal infection with death of the fetus or other severe manifestations. Later in pregnancy, maternal infection results in mild or subclinical fetal disease. Wilson in Murray, 2007; McAuley and Singh in MCM, 2019 Heymann, 2005 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? Immunocompromi sed hosts may experience CNS, pneumonitis, and myocarditis. Wilson in Murray, 2007 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? Page E126 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 4 Does the illness require short term hospitalization (< week)? 3 Does the illness require physician intervention? Treatment is indicated only for pregnant women, infants and immunocompromi sed hosts. Wilson in Murray, 2007 2 [G, C, E, CD] Is the illness self- limiting within 72 hours (without requiring medical intervention)? [G, C, E, CD] Infection is generally asymptomatic; however, 10 - 20% of patients with acute infection may develop cervical lymphadenopathy and/or flu-like symptoms. Wilson in Murray, 2007 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Bowie, W.R., S.A. King, D.H. Werker, J.L. Isaac-Renton, A. Bell, S.B. Eng, and S.A. Marion. 1997. Outbreak of toxoplasmosis associated with municipal drinking water. Lancet, 350: 173- 177. Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public Health Association, Washington, DC. Page E127 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Isaac-Renton, J., W.R. Bowie, A. King, G.S. Irwin, C.S. Ong, C.P. Fung, M.O. Shokeir and J.P. Dubey. 1998. Detection of Toxoplasma gondii Oocysts in Drinking Water. Applied and Environmental Microbiology, 64(6): 2278-2280. de Moura L., L.M. Bahia-Oliveira, M.Y. Wada, J.L. Jones, S.H. Tuboi, E.H. Carmo, W.M. Ramalho, N.J. Camargo, R. Trevisan, R.M. Graca, A.J. da Silva, I. Moura, J.P. Dubey, and D.O. Garrett. 2006. Waterborne toxoplasmosis, Brazil, from field to gene. Emerging Infectious Diseases, 12(2): 326-9. McAuley and Singh. Toxoplasma in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A. J., Patel, R., Richter, S.S. and Warnock, D.W.(ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Sroka J., A. Wojcik-Fatla, J. Dutkiewicz. 2006. Occurrence of Toxoplasma Gondii in Water from Wells Located on Farms. Annals of Agricultural and Environmental Medicine ,13: 169-175. Wilson, M., J. Jones and J. McAuley. 2007. Toxoplasma. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M. A. Pfaller (ed.) The Manual of Clinical Microbiology, 9th. edition, American Society for Microbiology, Washington, DC. Vol. 2: p. 2070. Page E128 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Vibrio cholerae Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 3 Health Effects General population 3 Sensitive subpopulation(s) [C, E, P, CD] 3 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? 1971-2008: 1 Bulk Water Purchase CDC-NORS, 2020 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Occurrence 3 Detected in drinking water in the U.S.? Yes (outbreak data) CDC, 1996 Page E129 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 2 Detected in source water in the U.S.? Yes Rhodes et al., 1986 Kaper et al., 1982 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? V cholerae Non-01: third most commonly isolated in U.S. - Septicemia case fatality rate from 47-65%. Abbott in Murray, 2010; Tarr et al., in MCM 2019 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? V. cholerae 01: Extremely rare cases cause severe extraintestinal infection. If untreated, V. cholerae 01 infection causes severe dehydration which leads to hypovolemic shock, acidosis, circulatory collapse, and death. Unlike 01 strains, non-01 isolates are commonly associated with extrainstestinal infections such as septicemia. Abbott in Murray, 2010 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? Page E130 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 4 Does the illness require short term hospitalization (< week)? In severely dehydrated cases (cholera gravis), death may occur within a few hours, and the case- fatality rate may exceed 50%. With proper and timely rehydration, this can be less than 1%. Heymann, 2005 3 [G, C, P, E, CD] Does the illness require physician intervention? [All populations] In most cases infection is asymptomatic or causes self-limiting diarrhea. Treatment consists of fluid replacement by oral rehydration therapy and/or intravenous fluids. Abbott in Murray, 2010 2 Is the illness self-limiting within 72 hours (without requiring medical intervention)? 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text indicates the highest score for that particular protocol. For the hea th effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Abbott, S.L., J.M. Janda, and J.J. Farmer. 2010. Vibrio and Related Organisms. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.A. Pfaller, and R.H. Yolken (ed.) The Manual of Clinical Microbiology, 8th. edition, American Society for Microbiology, Washington, DC. Vol. 1: p. 666. Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Page E131 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public Health Association, Washington, DC. pp. 113-127. Kaper, J.B., H.B. Bradford, N.C. Roberts, and S. Falkow. 1982. Molecular epidemiology of Vibrio cholerae in the U.S. Gulf Coast. Journal of Clinical Microbiology, 16(1): 129-134. Rhodes, J.B., H.L. Smith Jr., and J.E. Ogg. 1986. Isolation of Non-01 Vibrio cholerae Serovars from Surface Waters in Western Colorado. Applied and Environmental Microbiology, 51(6): 1216-1219. Tarr et al., Vibrio and Related Organisms in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A. J., Patel, R., Richter, S.S. and Warnock, D.W.(ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Page E132 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Yersinia enterocolitica Scoring Data Scoring Summary1'2 Waterborne Disease Outbreak 3 Health Effects General population 2 Sensitive subpopulation(s) [C] 2 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease Score2 Data Element Scoring Data Reference3 Waterborne Disease Outbreaks 5 Has caused multiple (2 or more) documented WBDOs in the U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 4 Has caused at least one documented WBDOs in U.S. reported by CDC between 2009-2017 No CDC-NORS, 2020 3 Has caused documented WBDOs at any time in the U.S.? 1971-2008: 1 Noncommunity CDC-NORS, 2020 2 Has caused WBDOs in countries other than the U.S.? 1 Has never caused WBDOs in any country, but has been epidemiologically associated with water related disease? Occurrence Page E133 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 3 Detected in drinking water in the U.S.? Yes Highsmith et al., 1977 Eden et al., 1977 2 Detected in source water in the U.S.? Yes Meadows and Snudden, 1982 1 Not detected in the U.S.? Health Effects 7 Does the organism cause significant mortality (> 1/1,000 cases)? No 6 Does the organism cause pneumonia, meningitis, hepatitis, encephalitis, endocarditis, cancer, or other severe manifestations of illness necessitating long term hospitalization (> week)? An uncommon complication of gastroenteritis is septicemia for which the elderly and immunocompromised are at higher risk, particularly those with metabolic diseases associated with iron overload (hemochromatosis), cancer, liver disease and steroid therapy. Wanger in Murray, 2010; Kingry et al, in MCM 2019 5 Does the illness result in long term or permanent dysfunction or disability, i.e. sequelae? Uncommon sequelae include: reactive arthritis, inflammatory bowel disease, autoimmune thyroid disorders. Wanger in Murray, 2010 4 Does the illness require short term hospitalization (< week)? 3 Does the illness require physician intervention? The elderly are at greater risk for septicemia. Wanger in Murray, 2010 Page E134 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Score2 Data Element Scoring Data Reference3 Is the illness self- [G, C] (No information Wanger in Murray, limiting within 72 available for other 2010 hours (without populations) Young requiring medical children most intervention)? commonly develop gastroenteritis and present with fever, diarrhea, and abdominal pain. 2 [G, C] Symptoms typically resolve within 7 days. Infection typically manifested by acute febrile diarrhea with abdominal pain (especially in young Heymann, 2005 children). Diarrhea may be absent in up to a third of Y. enterocolitica infections. 1 Does the illness result in mild symptoms with minimal or no impact on daily activities? 1 Bolded text indicates the highest score for that particular protocol. For the health effects protocol two scores were selected: the general population [G] and the highest score for a sensitive subpopulation. These 2 scores were added and normalized by multiplying by 5/14 for a final health effects score. The higher score between the WBDO and Occurrence protocols was used for total pathogen score calculation. Health Effects protocol: G - General, C - Child, E - Elderly, P - Pregnant Women, CD - Chronic Disease. 2See Final Contaminant Candidate List 3 Microbes: PCCL to CCL Process. EPA 815-R-09-009. Final. August 2009 for a detailed description on how to calculate the total pathogen score. 3EPA based the WBDO scores on the CDC MMWR reports from 1991 -2017 and then collected occurrence citations if there were no CDC WBDOs. References Centers for Disease Control and Prevention (CDC). 2020. National Outbreak Reporting System (NORS). https://wwwn.cdc.gov/norsdashboard/ Accessed August 31, 2020. Eden, K.V., M.L. Rosenberg, M. Stoopler, B.T. Wood, A.K. Highsmith, P. Skaliy, J.G. Wells, J.C. Feeley. Waterborne gastrointestinal illness at a ski resort. Isolation of Yersinia enterocolitica from drinking water. Public Health Report 1977, May - June. 92(3): 245-50. Page E135 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Heymann, D. (ed.). 2005. Control of Communicable Diseases Manual, 18th ed. American Public Health Association, Washington, DC. Highsmith, A.K., J.C. Feeley, P. Skaliy, J.G. Wells, and B.T. Wood. 1977. Isolation of Yersinia enterocolitica from well water and growth in distilled water. Applied and Environmental Microbiology, 34: 745-750. Kingry et al., Yersinia., in Carroll, K.C., Pfaller, M.A., Landry, M.L., McAdam, A.J., Patel, R., Richter, S.S. and Warnock, D.W.(ed). 2019. Manual of Clinical Microbiology, Twelfth Edition. Meadows, C.A. and B.H. Snudden. 1982. Prevalence of Yersinia enterocolitica in waters of the lower Chippewa river basin, Wisconsin. Applied and Environmental Microbiology, 43: 953-954. Schriefer, M. and J. Petersen. 2007. Yersinia. In Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller (ed.) The Manual of Clinical Microbiology, 10th. edition, American Society for Microbiology, Washington, DC. Vol. 1: 627. Page E136 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 Appendix F. CCL 5 Data Source Descriptions Data Sources for Microbial Contaminants Data Source Name Data Source Description The National Outbreak Reporting System (NORS) Launched in 2009 for Health Departments to report to CDC cases of enteric disease outbreaks caused by bacterial, viral, parasitic, chemical, toxin, and unknown agents, as well as foodborne and waterborne outbreaks of non-enteric disease. NORS was designed to integrate data on waterborne as well as foodborne outbreaks, but for CCL only the waterborne data were used. Proprietor Contact Information CDC CDC, 1600 Clifton Road, N.E., MS C-9, Atlanta, GA 30333. Telephone: 404-639-1700; E-mail: healthywater@cdc.gov Type of Data Elements Relevance Explanation Completeness Explanation Redundancy Explanation Retrievability Explanation Source URL Waterborne outbreak data This source is considered relevant for the CCL process because it contains information on drinking water outbreaks caused by microbial contaminants which is a major component of the scoring process. It meets considerations because it is peer reviewed. This source is not redundant. This source meets retrievability criteria because it is in tabular format. https://www.cdc.gov/nors/index.html Data Source Name Center for Disease Control and Prevention's Morbidity and Mortality Weekly Reports (MMWR) Data Source Description Since 1971, CDC, EPA and the Council of State and Territorial Epidemiologists (CSTE) have maintained a collaborative surveillance system for collecting and periodically reporting data related to occurrences and causes of Water Borne Disease Outbreaks (WBDOs). These reports from the CDC are published periodically in the MMWR. For CCL EPA used CDC's MMWR summaries as the source for the WBDO scoring protocol. The summaries include data on outbreaks associated with drinking water, recreational water, water not intended for drinking Page F1 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List (CCL 5)-Microbiai Contaminants EPA 815-R-21-007 July 2021 (excluding recreational water) and water use of unknown intent. Public health agencies are responsible for investigating outbreaks and reporting them voluntarily to CDC using a standard form. Only data on outbreaks associated with drinking water, water not intended for drinking (excluding recreational water) and water use of unknown intent are summarized in this report. CDC and EPA acknowledge that the WBDOs reported in the surveillance system represent only a portion of the burden of illness associated with drinking water exposure. The surveillance information does not include endemic waterborne disease risks. (Description adapted from website.) Proprietor Contact Information CDC Division of Foodborne, Waterborne, and Environmental Diseases, National Center for Emerging and Zoonotic Infectious Diseases, CDC, 1600 Clifton Road, N.E., MS C-9, Atlanta, GA 30333. Telephone: 404-639-1700; E-mail: healthywater@cdc.gov Type of Data Elements Relevance Explanation Completeness Explanation Redundancy Explanation Retrievability Explanation Source URL Waterborne outbreak data This source is considered relevant for the CCL process because it contains information on drinking water outbreaks caused by microbial contaminants which is a major component of the scoring process. It meets considerations because it is peer reviewed. This source is not redundant. This source meets retrievability criteria because it is in tabular format. http://www.cdc.gov/mmwr/indss 2011.html Data Source Name Data Source Description Proprietor Contact Information EPA Literature Search for Supplemental Data for Microbial Contaminants As part of its ongoing assessment of microbes in drinking water, EPA conducted a literature review of peer-reviewed, published journal literature for health effects and occurrence data for nominated microbes from 2016-2019. EPA reviewed all relevant research reports found to identify papers that might present data for the nominated microbes that might help inform CCL 5. EPA also reviewed studies submitted and referenced by nominators. U.S. EPA Nicole Tucker Page F2 ------- EPA-OGWDW Technical Support Document for the Draft Fifth Contaminant Candidate List EPA 815-R-21-007 (CCL 5)-Microbiai Contaminants July 2021 Email: Tucker.Nicole@epa.gov Type of Data Elements Relevance Explanation Completeness Explanation Redundancy Explanation Retrievability Explanation Source URL Health effects, drinking water occurrence data elements This source is considered relevant for the CCL process because it contains information on health effects and occurrence in water. It meets considerations because the studies were peer-reviewed. This source is not redundant (though some, but not all, data may overlap among papers by the same authors). Data not retrievable. This source contains written and tabulated data that can be copied and formatted. Not applicable Data Source Name Data Source Description Proprietor Contact Information Type of Data Elements Relevance Explanation Completeness Explanation Redundancy Explanation Retrievability Explanation Source URL Manual of Clinical Microbiology (MCM), 12th Edition The 12th edition of the MCM is the result of collaborative efforts of 22 editors and more than 267 authors from around the world, all experienced researchers and practitioners in medical and diagnostic microbiology. The manual has been brought fully up to date, resulting in 149 chapters containing the latest research findings, infectious agents, methods, practices and safety guidelines. Now entering its fifth decade the Manual strives to continue to be the leading, most authoritative reference for the "real-world" practice of clinical microbiology. This publication builds on the content of past editions. The process requires about 3 years of careful planning, design, writing and review of chapters before the final phases of copyediting, composition, printing and binding. (Description adapted from website.) ASM Press, Washington, DC James Versalovic Microbiology Laboratories Texas Children's Hospital Houston, Texas Production Volume This source is considered relevant for the CCL Universe because it contains health effects and occurrence information on microbial pathogens. It meets considerations because it is peer reviewed. This source is not redundant. This source is not automatically retrievable. It is a book available for purchase. Not applicable Page F3 ------- |