Mycobacterium avium and Arcobacter butzlerei. They are discussed in
greater detail in the ``Contaminant Candidate List 3 Microbes: PCCL to
CCL Process'' (USEPA, 2008 f).

        Exhibit 15.--Waterborne Disease Outbreak Scoring Protocol
------------------------------------------------------------------------
                          Category                              Score
------------------------------------------------------------------------
Has caused multiple (2 or more) documented WBDOs in the                5
 U.S. since CDC surveillance initiated in 1973.............
Has caused at least one documented WBDO in the U.S. since              4
 CDC surveillance initiated in 1973........................
Has caused documented WBDOs at any time in the U.S.........            3
Has caused documented WBDOs in countries other than the                2
 U.S.......................................................
Has never caused WBDOs in any country, but has been                    1
 epidemiologically associated with water-related disease...
------------------------------------------------------------------------

b. Occurrence Protocol
    The second attribute of the scoring process evaluates the
occurrence of a pathogen in drinking 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 (Exhibit 16). 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 produce 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. This attribute does not characterize the extent
to which a pathogen's occurrence poses a public health threat from
drinking water exposure. Because viability and infectivity cannot be
determined by non-cultural methods, the public health significance of
non-cultural detections is unknown.

          Exhibit 16.--Occurrence Scoring Protocol for Pathogens
------------------------------------------------------------------------
                          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
------------------------------------------------------------------------

c. Health Effects Protocol
    EPA's health effects protocol evaluates the extent or severity of
human illness produced by a pathogen across a range of potential
endpoints. The seven-level hierarchy developed for this protocol
(Exhibit 17) begins with mild, self-limiting illness and progresses to
death.
    The final outcome of a host-pathogen relationship resulting from
drinking water exposure is a function of viability, infectivity, and
pathogenicity of the microbe to which the host is exposed and the
host's susceptibility and immune response. SDWA directs EPA to consider
subgroups of the population at greater risk of adverse health effects
(i.e., sensitive populations) in the selection of unregulated
contaminants for the CCL. Sensitive populations may have increased
susceptibility and may experience increased severity of symptoms,
compared to the general population. SDWA refers to several categories
of sensitive populations including the following: children and infants,
elderly, pregnant women, and persons with a history of serious illness.
    Health effects for individuals with marked immunosuppression (e.g.,
primary or acquired severe immunodeficiency, transplant recipients,
individuals undergoing potent cytoreductive treatments) are not
included in this health effects scoring. While such populations are
considered sensitive subpopulations, immunosuppressed individuals often
have a higher standard of ongoing health care and protection required
than the other sensitive populations under medical care. More
importantly, nearly all pathogens have very high health effect scores
for the markedly immunosuppressed individuals; therefore there is
little differentiation between pathogens based on health effects for
the immunosuppressed subpopulation.
    This protocol scores the representative or common clinical
presentation for the specific pathogen for the population category
under consideration. EPA used recently published clinical microbiology
manuals as the primary data source for the common clinical
presentation. These manuals take a broad epidemiological view of health
effects rather than focusing on narrow research investigations. The one
exception to this approach was EPA's scoring of health effects for
Helicobacter pylori. H. pylori is discussed in greater detail in
section IV.C as well as in the support document, ``CCL 3 Microbes: PCCL
to CCL Process'' (USEPA, 2008 f).

    To obtain a representative characterization of health effects in
all populations, EPA evaluated separately the general population and
these four sensitive populations 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 subpopulations for an
overall health effects score. The resulting score acknowledges that
sensitive populations have increased risk for waterborne diseases.

                                               Exhibit 17.--Health Effects Scoring Protocol for Pathogens
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Manifestation in population class
         Outcome category              Score    --------------------------------------------------------------------------------------------------------
                                                  General population    Children/infants         Elderly           Pregnant women      Chronic disease
--------------------------------------------------------------------------------------------------------------------------------------------------------
Does the organism cause                       7
 significant mortality (> 1/1,000
 cases)?.
Does the organism cause pneumonia,            6
 meningitis, hepatitis,
 encephalitis, endocarditis,
 cancer, or other severe
 manifestations of illness
 necessitating long term
 hospitalization (> week)?.
Does the illness result in long               5
 term or permanent dysfunction or
 disability (e.g., sequelae)?.
Does the illness require short                4
 term hospitalization? (<  week)?.
Does the illness require physician            3
 intervention?.
Is the illness self-limiting                  2
 within 72 hours (without
 requiring medical intervention)?.
Does the illness result in mild               1
 symptoms with minimal or no
 impact on daily activities?.
--------------------------------------------------------------------------------------------------------------------------------------------------------

d. Combining Protocol Scores to Rank Pathogens
    EPA scored and ranked the PCCL using the three attribute scoring
protocols, occurrence, waterborne disease outbreaks, and health
effects. These protocols are designed in a hierarchical manner so that
each pathogen is evaluated using the same criteria and the criteria
range for each protocol varies from high significance to low
significance. The three attribute scores are then combined into a total
score.
    EPA scored pathogens first using the WBDO and occurrence protocols,
and then selected the highest score. Selection of the higher score from
the WBDO or occurrence protocol elevates pathogens that have been
detected in drinking water or source water in the U.S. (occurrence
score of 2 or 3) above pathogens that have caused WBDOs in other
countries but not in the U.S. (WBDO score of 2).
    The CCL selection process considered pathogens causing recent
waterborne outbreaks more important than pathogens detected in drinking
water without documented disease from that exposure. Direct detection
of pathogens indicates the potential for waterborne transmission of
disease. Documented waterborne disease outbreaks provide an additional
weight of evidence that illness was transmitted and that there was a
waterborne route of exposure. EPA developed protocols to define a
hierarchy of the relevance that each of these types of data provide in
evaluating microbes for the CCL. Combining these two sources of
occurrence information enabled EPA to consider both emerging pathogens,
which are detected in water and should be considered, yet are not
tracked by public health surveillance programs, and those pathogens
with WBDO data. This hierarchy also acknowledges that organisms
identified as agents in WBDO are a higher priority for the CCL.
    Next, pathogens were scored using the Health Effects Protocol. All
five population categories were scored for each pathogen using the most
common clinical presentation for the specific pathogen for the
population category under consideration. Because it is recognized that
pathogens may produce a range of illness from asymptomatic infection to
fulminate illness progressing rapidly to death, scoring decisions are
based upon the more common clinical presentation and clinical course
for the population under consideration, rather than the extremes. The
pathogen's score for the general population is added to the highest
score among the four sensitive populations to produce a sum score
between 2 and 14.
    Finally, EPA normalizes the Health Effects and WBDO/Occurrence
score because the Agency believes they are of equal importance. The
highest possible score for WBDO/Occurrence is 5 and the highest
possible Health Effect score is 14. To equalize this imbalance, the
Agency multiplies the health effects score by \5/14\. Combining health
effects data with the WBDO/occurrence data by adding the scores from
these protocols provides a system that evaluates both the severity of
potential disease and the potential magnitude of exposure through
drinking water.
    Exhibit 18 presents the scores for all the PCCL pathogens with the
exception of Giardia and Cryptosporidium. These two protozoan pathogens
made it through the screening protocol, however, EPA chose not to score
or include them on the PCCL because EPA has recently published a
national primary drinking water regulation that specifically addresses
these pathogens (January 4, 2006, 71 FR 388 (USEPA, 2006 a) and is
discussed in more detail later.

                                       Exhibit 18.--Pathogens on the PCCL
----------------------------------------------------------------------------------------------------------------
                                                                                Normalized     Total\1\
                        Pathogen                              WBDO       Occurrence   health score      score
----------------------------------------------------------------------------------------------------------------
Naegleria fowleri.......................................            4             3           5.0           9.0
Legionella pneumophila..................................            5             3           3.6           8.6
Escherichia coli (0157).................................            5             3           3.2           8.2

Hepatitis A virus.......................................            5             2           3.2           8.2
Shigella sonnei.........................................            5             3           3.2           8.2
Helicobacter pylori.....................................            1             3           5.0           8.0
Campylobacter jejuni....................................            5             3           2.5           7.5
Salmonella enterica.....................................            5             3           2.5           7.5
Caliciviruses...........................................            5             3           2.1           7.1
Entamoeba histolytica...................................            5             3           2.1           7.1
Vibrio cholerae.........................................            5             3           2.1           7.1
Adenovirus..............................................            2             3           3.6           6.6
Enterovirus.............................................            2             3           3.6           6.6
Cyclospora cayetanensis.................................            4             1           2.5           6.5
Mycobacterium avium.....................................            4             3           2.5           6.5
Rotavirus...............................................            4             2           2.5           6.5
Yersinia enterocolitica.................................            5             3           1.4           6.4
Arcobacter butzleri.....................................            4             3           2.1           6.1
Fusarium solani.........................................            1             3           2.9           5.9
Plesiomonas shigelloides................................            4             3           1.8           5.8
Hepatitis E virus.......................................            2             1           3.6           5.6
Toxoplasma gondii.......................................            2             1           3.2           5.2
Aspergillus fumigatus group.............................            1             3           2.1           5.1
Exophiala jeanselmei....................................            1             3           2.1           5.1
Aeromonas hydrophila....................................            1             3           1.8           4.8
Astrovirus..............................................            2             2           1.4           3.4
Microsporidia...........................................            1             2           1.4           3.4
Isospora belli..........................................            2             0           1.1           3.1
Blastocystis hominis....................................            1             0           0.7          1.7
----------------------------------------------------------------------------------------------------------------
1. Total Score = Normalized Health Score + the higher of WBDO or Occurrence scores.

e. Other Criteria Considered for Listing and Scoring Microbes on the
Draft CCL 3
i. Organisms Covered by Existing Regulations
    EPA considered an additional screening criterion based upon
contaminants that might be controlled through drinking water monitoring
requirements under the Total Coliform Rule (TCR) (54 FR 27544, June 29,
1989 (USEPA, 1989b)). Many of the bacteria in the CCL Universe,
including the Enterobacteriaceae and members of the genera
Campylobacter and Vibrio, are associated with fecal contamination and
as such their presence could be signaled by the total coliform
monitoring requirements under current drinking water regulations. In
the TCR, EPA chose to require monitoring for Escherichia coli or fecal
coliform (and total coliforms) in finished drinking water because it
provides a broad indication of the potential presence of fecal
pathogens in drinking water, though more so for bacteria than for
viruses and protozoa.
    EPA chose not to exclude common enteric bacterial pathogens from
the PCCL even though they may be indicated by the TCR. Numerous
waterborne disease outbreaks have occurred in systems that were in
compliance with drinking water monitoring requirements under the TCR.
EPA recognizes the frequency of total coliform monitoring under the TCR
may be limited, especially for smaller systems, thus transitory fecal
contamination could go undetected. The recognition of these bacterial
pathogens on the CCL list will provide additional understanding of the
risks posed by distribution systems.
    The Agency is currently revising the TCR and considering
distribution water quality issues (because of the pathways of potential
fecal contamination). Including these pathogens on the CCL emphasizes
their importance in protecting public health. EPA believes that enteric
pathogens should be included for further specific regulatory
consideration in the CCL.
ii. Organisms Covered by Treatment Technique Regulations
    According to SDWA (section 1412(b)(1), as amended in 1996), 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 (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
(SWTR) (54 FR 27486, June 29, 1989 (USEPA, 1989a)) included MCLGs for
Legionella, Giardia, and viruses at zero because any amount of exposure
to these contaminants represents some public health risk. Since
measuring disease-causing microbes in drinking water is not considered
to be feasible, 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 Surface Water Treatment Rule 1 (67 FR
1813; USEPA, 2002a) and the Long Term Surface Water Treatment Rule 2
(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 (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.
    While Cryptosporidium and Giardia have been implicated in WBDOs,
there is a substantial amount of research regarding health effects and
sensitivity to various treatment control measures. More importantly, as
noted above, EPA has recently published a National Primary Drinking
Water Regulation, The Long Term 2 Surface Water Treatment Rule that
specifically addresses these pathogens (71 FR 654 (USEPA, 2006a)).
Therefore, they are excluded from the CCL.
    EPA did not exclude specific viruses and Legionella from
consideration for the CCL even though they have broad category MCLGs
and treatment technique requirements. Viruses include a wide range of
taxa. The treatment and health effects information for different viral
taxa was very limited when setting the treatment technique requirements
for surface water and ground water systems. Also, different viral taxa
have been implicated in various waterborne disease outbreaks for which
EPA did not have dose response or treatment data when promulgating its
treatment technique requirements. Legionella has recently been
identified in numerous WBDOs (e.g., CDC MMWR reports, 2006).
Additionally EPA received additional information on the occurrence of
Legionella in distribution systems as part of the nominations process
(USEPA 2008g). Therefore EPA included viruses and Legionella on the
draft CCL 3.
iii. Applying Genomic and Proteomic Data to Microbes
    The Agency and NDWAC workgroup evaluated the possibility of using
genomics and proteomics as data to identify emerging waterborne
pathogens, opportunistic microorganisms, and other newly identified
microorganisms. While the application of these data in identifying
genetic properties that may be pathogenic is a powerful tool for the
elucidation of pathogenic mechanisms, the technology is yet largely
unproven and the Agency has decided at this time not to use these
techniques for CCL application. However, the Agency is monitoring the
progress of these technologies and as the data improve and genomics
progresses the Agency may consider them for future CCL development.
4. Selection of the Draft CCL 3 Microbes From the PCCL
    The 29 PCCL pathogens in Exhibit 18 are 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 believes this ranking indicates the most important
pathogens to consider for the draft CCL 3. To determine which of the 29
PCCL pathogens should be the highest priority for EPA's drinking water
program and included on the draft CCL 3, the Agency considered both
scientific and policy factors. The factors included the PCCL scores for
WBDO, occurrence, and health effects; comments and recommendations from
the various expert panels; the specific intent of SDWA; and the need to
focus Agency resources on pathogens to provide the most effective
opportunities to advance public health protection. After consideration
of these factors, EPA has determined that the draft CCL 3 will include
the 11 highest ranked pathogens shown in Exhibit 18.
    Additionally, the Agency notes that, and as can be observed in
Exhibit 18, there are a few ``natural'' break points in the ranked
scores for the 29 pathogens, with the top 11 forming the highest ranked
group of pathogens. EPA does believe that the overall rankings strongly
reflect 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 3.

C. Public Input

1. Nominations and Surveillance
    On October 16, 2006, EPA published a Federal Register notice (71 FR
60704 (USEPA, 2006 b)) requesting the public to submit chemical and
microbial contaminant nominations that should be considered for CCL 3.
EPA evaluated nominated contaminants to identify the data supporting
their nomination. This section describes EPA's request for contaminants
and summarizes the nominations received by EPA. A more detailed
discussion of the contaminants, including a list of the specific
contaminants nominated, can be found in the CCL 3 Nominations Summary
in EPA's Water Docket (USEPA, 2008 g).
    The Agency sought CCL nominations for contaminants by framing the
SDWA requirements in a series of questions to document the anticipated
or known occurrence in PWS(s) and adverse health effects of potential
contaminants. The Agency requested that the public respond to these
questions and provide the documentation and rationale for including a
contaminant for consideration in the CCL process. The questions posed
to the public were:
    --What are the contaminant's name, CAS number, and/or common
synonym (if applicable)?
    --What factors make this contaminant a priority for the CCL 3
process (e.g., widespread occurrence; anticipated toxicity to humans;
potentially harmful effects to susceptible populations (e.g., children,
elderly and immunocompromised); potentially contaminated source water
(surface or ground water), and/or finished water; releases to air,
land, and/or water; contaminants manufactured in large quantities with
a potential to occur in source waters)?
    --What are the significant health effects and occurrence data
available, which you believe supports the CCL requirement(s) that a
contaminant may have an adverse effect on the health of persons and is
known or anticipated to occur in public water systems?
    The Agency compiled the information from the nominations process to
identify the contaminants nominated and the rationale for the
nomination and to compare the supporting data to information already
gathered by EPA.
    The nominations process identified 150 chemical and 24 microbial
contaminants from 11 organizations and individuals. The organizations
that nominated contaminants are:
    --American Society of Microbiology (ASM),
    --American Water Works Association (AWWA),
    --Association of Metropolitan Water Agencies (AMWA),
    --Association of State Drinking Water Administrators (ASDWA),
    --Mothers Against Acanthamoeba Disease,
    --Natural Resources Defense Council, (NRDC),
    --Riverkeepers,
    --State of New Jersey Department of Environmental Protection,
    --State of New York Department of Health, and
    --State of Texas Commission on Environmental Quality.
    Exhibit 19 summarizes the types of nominated contaminants and who
nominated them. The complete list of chemical and microbial
contaminants nominated can be found in EPA's Water Docket. Some of the
nominations identified categories of contaminants that the Agency
should consider for the CCL. There were 23 chemical groups identified
from the 150 chemical contaminants that were nominated. For

example, several organizations identified pesticides that are not
currently regulated under the SDWA as candidates for consideration.
Other groups identified by the public are listed in Exhibit 19.

                Exhibit 19.--Summary of CCL 3 Nominations
------------------------------------------------------------------------
                                    Number of
                                   individual
                                  contaminants
           Nominator               or specific     Types and groups of
                                  examples from        contaminants
                                    nominated
                                     groups
------------------------------------------------------------------------
ASM............................               2  Mimivirus, Naegleria
                                                  fowleri.
AMWA...........................               3  Nitrosoamines and other
                                                  DBPs.
ASDWA..........................              14  Disinfection byproducts
                                                  (DBPs), unregulated
                                                  pesticides, solvents,
                                                  total petroleum
                                                  hydrocarbons,
                                                  cyanotoxins, 3
                                                  perfluorinated
                                                  contaminants (PFCs),
                                                  viruses, phthalates,
                                                  nitrite, nitrate;
                                                  endocrine disruptors.
AWWA...........................              38  DBPs, pesticides, 16
                                                  specific microbes,
                                                  cyanotoxins, radium,
                                                  1,4-dioxane.
Mothers Against Acanthamoeba                  1  Acanthamoeba.
 Disease.
New Jersey DEP.................               4  PFOS, PFOA,
                                                  trichloropropane,
                                                  tertiary butyl
                                                  alcohol.
New York DOH...................              24  Pharmaceuticals,
                                                  personal care
                                                  products, DBPs, fuel
                                                  oxygenates, 1,4-
                                                  dioxane, herbicides,
                                                  bio-monitoring data.
NRDC...........................              26  Alkylphenolpolyethoxyla
                                                  tes (APEs that may be
                                                  endocrine disrupter
                                                  compounds (EDC)), all
                                                  unregulated
                                                  pesticides,
                                                  perchlorate,
                                                  Mycobacterium avium
                                                  complex (MAC),
                                                  phthalates,
                                                  managanese, bisphenol
                                                  A.
Riverkeeper....................              52  Pharmaceuticals,
                                                  sodium, chloride.
Texas DEQ......................               3  Viruses, nitrite,
                                                  nitrate.
------------------------------------------------------------------------

    The Agency evaluated the nominations to identify contaminants not
previously considered for the CCL and new pertinent information
provided by the public. Nominated contaminants were evaluated to
identify and compare supporting information provided to that used in
the CCL process. Of the 174 chemical and microbial contaminants
nominated, 152 contaminants were already being considered by the
Agency. Seven of the nominated contaminants are currently regulated in
PWSs and will not be included in the CCL 3 process. Most of the data
sources cited in the nominations process were already identified for
the CCL 3 process. The nominations process did identify recently
published specialized studies from scientific literature that were
subsequently incorporated in the CCL 3 evaluation process.
    Where new supplemental data was provided for contaminants that had
not been identified for the draft CCL 3, EPA used the supplemental data
to screen the nominated chemicals and score the attributes for those
that passed the screen. EPA then processed the nominated contaminants
through the models and the post-model evaluations. Twenty of the
contaminants identified in the nominations process are on the draft CCL
3.
2. External Expert Review and Input
    EPA actively sought external advice and expert input for the draft
CCL 3. In addition to their own recommendations, the NRC and NDWAC
recommended that the Agency seek opportunities to incorporate
additional expert input in the development of the draft CCL 3. EPA
convened several external expert panels at integral stages during the
development of the draft CCL 3. EPA incorporated expert judgment and
input from the scientific community into the CCL process for both
chemicals and microbes. The Agency has requested a consultation with
the Science Advisory Board that will take place in 2008.
    For each expert panel, EPA sought panel members that provided a
variety of disciplines and expertise. Panel members were encouraged to
provide comments as individuals based upon their expertise and
background, not as representatives of their respective organizational
affiliations. Expert panel members were also encouraged to present
individual comments if consensus comments were not developed. Separate
panels were convened to review the draft chemical and microbial CCL 3
lists and the processes used to develop them. A more detailed
discussion of the chemical and microbial expert review and input is
provided in the support documents in the EPA Water Docket. A brief
overview of the chemical and microbial expert review and stakeholder
involvement follows.
a. Chemical Expert Input Panels
    In September of 2006, EPA formed two external expert panels to
provide specific input into the chemical CCL 3 process. In the first
panel, experts reviewed the data sources and the process used to
identify the chemical universe. EPA convened the second panel for a 3-
day workshop to review the data and information used to develop
screening criteria, the data and methodology for the classification
approach, and to provide overall input into the CCL process. In
summary, the panels recommended that EPA consider additional data
sources in the process. They also commented on ways to improve and
clarify the presentation of EPA efforts, thereby ensuring that the CCL
3 process for chemicals is more transparent. The expert panel reviewing
the classification approach identified additional analyses and
approaches to train and validate the models. The panel specifically
commented on the varied nature of data elements and sources considered
in the classification process. The panel recommended that to account
for these varied data sources, contaminants be flagged based upon data
certainty, and that uncertainty be considered in making a listing
decision. The Agency applied their recommendations in the development
of the draft CCL 3. In addition, the expert panels acknowledged the
Agency's efforts to transparently present a complex process and noted
that many of the questions posed by the panels were previously
considered by EPA. They recommended that additional discussion and
information in the support documents would add to the clarity of the
process.
    In March 2007, EPA convened a panel to review the preliminary draft
CCL 3 list for the chemical contaminants in a two-day workshop.
Panelists provided

comments on a preliminary draft list of contaminants after receiving
supporting materials and presentations from EPA staff. The panel's
review focused mainly on the chemicals on the draft CCL 3. They
provided comments on contaminants considered for the draft CCL 3 and
commented on the supporting data and methods EPA used to identify the
contaminants selected. They also provided general comments on the
classification model output and the processes used to select chemical
contaminants for CCL 3. In addition, they recommended EPA consider a
strong outreach process to highlight the significant modeling and
decision making processes used in its development.
    The panel recognized the level of effort and detail that went into
the development of the modeling process used to create the draft list
and complimented EPA on these efforts. Comments from all the panels
were considered by EPA and appropriate changes were incorporated into
the process/protocols to formulate the draft CCL 3. (Specific
recommendations and comments are further described in USEPA, 2008h.)
b. Microbial Expert Input Panels
    EPA convened three workshops to review, discuss, and comment on the
microbes considered and selected for the draft CCL 3. In December 2005,
a group of expert microbiologists reviewed and commented on the
universe of human pathogens and the screening criteria used to develop
the PCCL. This panel agreed that focusing on human pathogens is a
reasonable and pragmatic way to identify potential drinking water
contaminants. While the panel suggested that animal pathogens may
develop the ability to infect humans, they noted that these emerging
contaminants should not be listed on the CCL based on the theoretical
potential to become zoonotic pathogens. They also identified additional
criteria and methods to apply those criteria to the Microbial Universe,
which EPA incorporated into the CCL process.
    In June 2006, a panel of experts met for three days to review EPA's
implementation of recommendations by NRC and NDWAC to select microbes
for the CCL. EPA implemented the NDWAC recommendation to develop a
process that paralleled the chemical process yet still accounted for
the different types of data and information that are uniquely available
for microbial contaminants. Panel members agreed that health effects
and occurrence of microbes should be evaluated to identify pathogens of
the greatest health importance. The panel recommended that EPA use a
decision tree approach for microbes rather than the classification
approach suggested by NRC and NDWAC.
    The panel further recommended that the Agency consider a different
selection process than the one used for chemical contaminants, related
to the different information available for microbes. Based on this
recommendation, the Agency evaluated options to consolidate the potency
and severity attributes for microbes into a single health effect
attribute, developed a waterborne disease outbreak protocol, and
considered occurrence as a single attribute. The Agency considered
these and other recommendations as it developed the current three
attribute selection process discussed in Section III.B. The panel also
recommended that the Agency consider drinking water treatment and
removing microbes from further consideration if conventional drinking
water treatment protects public health. The Agency's considerations of
these and other recommendations are discussed in the Microbial Expert
Review support document (USEPA, 2008i).
    In March 2007, EPA convened a third workshop to review the
preliminary draft CCL 3 list of microbial contaminants. EPA provided
the panel with background materials and staff presentations. The
panel's review focused mainly on the draft CCL 3 for microbes. The
panel also provided comments on the processes used to select the
microbial contaminants. Panel members commented on specific microbes
considered for the draft CCL 3 and commented on the data and processes
EPA used to identify the contaminants selected. The panel noted that
the Agency considered a comprehensive list of microbes and thought the
draft CCL 3 was reasonable. The panel also recommended that the Agency
consider adding a frequency of disease parameter to the health effects
scoring protocol for future CCLs. For example, while the panel agreed
with EPA that the health effects for Naegleria fowleri are severe, the
health effects scoring protocol should consider the limited occurrence
of disease. The panel also noted that this would help balance the
consideration of less severe adverse health effects such as
gastrointestinal illness that are more prevalent with consideration of
more severe responses that are less prevalent, such as N. fowleri. The
panel recommended that EPA provide further discussion of the rationale
to evaluate waterborne disease and health effects equally in the
protocol. The discussion of the Agency's rationale is included in
Section III.B and addresses the importance of documented waterborne
disease outbreaks to identify potential microbial contaminants for the
CCL. (A more detailed summary of the expert comments is provided in
USEPA, 2008 i.)
3. How are the CCL and UCMR Interrelated for Specific Chemicals and
Groups?
    EPA promulgated UCMR 2 on January 4, 2007 (72 FR 367 (USEPA, 2007
a; see also USEPA, 2007 b and c)). The UCMR program was developed in
coordination with the CCL. Both programs consider the adverse health
effects a contaminant may pose through drinking water exposures.
Sixteen contaminants on the UCMR 2 monitoring list are also on the
draft CCL 3. The draft CCL 3 includes acetochlor and its degradates,
alachlor degradates, dimethoate, 1,3-dinitrobenzene, metolachlor and
its degradates, RDX, terbufos sulfone, and four of the nitrosamines. In
addition to the health effects data and potential occurrence, the UCMR
2 also considers analytical methods, availability of analytical
standards, and laboratory capacity to conduct a nationwide monitoring
program in selecting contaminants. The UCMR 2 includes nine
contaminants that are not on draft CCL 3. The five polybrominated flame
retardants can be measured by the same analytical method used for
terbufos sulfone. The polybrominated flame retardants lacked sufficient
occurrence information to be listed on draft CCL 3 (USEPA 2008 b). The
polybrominated flame retardants are listed on UCMR2 because of recent
concern that these have become more widespread environmental
contaminants (e.g., Darnerud et al., 2001) and this monitoring data
will provide information for future CCLs. Similarly, 2,4,6-
trinitrotoluene (TNT) and two of the nitrosamines also use an
analytical method in the UCMR 2. The Agency will also use the results
from UCMR 2 as a source of occurrence information during the selection
of CCL 4, as well as for CCL 3 regulatory determinations. Alachor was
listed on UCMR 2, but was removed from consideration for CCL 3 because
there is an existing MCL.

IV. Request for Comment

    The purpose of this notice is to present the draft CCL 3 and seek
comment on various aspects of its development. The Agency requests
comment on the approach used to develop the draft CCL 3 and also
requests comments on the contaminants selected, including any
supporting data

that can be utilized in developing the final CCL 3. A number of
contaminants considered for the draft CCL 3 may be of particular
current interest. The following sections provide information for a few
of the contaminants that are of most interest. Data obtained and
evaluated for developing the draft CCL 3 and referred to in the
following sections may be found in the docket for this notice.
Specifically, the Agency is also asking for public comments on
pharmaceuticals and perfluorinated compounds to identify any additional
data and information on their concentrations in finished or ambient
water and requests comment on how they have been considered in the CCL
3 process. The Agency is also seeking additional data and information
on the occurrence and health effects of H. pylori and how this pathogen
was considered in the CCL 3 process. Information and comments submitted
will be considered in determining the final CCL 3, as well as in the
development of future CCLs and in the Agency's efforts to set drinking
water priorities in the future.

A. Pharmaceuticals

    The Agency evaluated data sources to identify pharmaceuticals and
personal care products that have the potential to occur in PWSs. The
primary source of health effects information on pharmaceuticals in the
universe was the Food and Drug Administration Database on Maximum
Recommended Daily Doses (MRDD). This database includes the recommended
adult doses for over 1,200 pharmaceutical agents. Occurrence
information from USGS Toxics Substances Hydrology program's National
Reconnaissance of Emerging Contaminants, and related efforts, provided
ambient water concentration data for 123 contaminants, which include
pharmaceuticals. Other data sources included TRI and high production
volume chemical data. From this analysis, EPA included 287
pharmaceuticals in the Chemical Universe. These pharmaceuticals had
maximum recommended daily dose information that EPA used to evaluate
adverse health effects. EPA considered those pharmaceuticals for which
MRDD values and occurrence information were available and
pharmaceuticals that were in Toxicity Category 1, using the same
criteria discussed in Section III.A.2.a. EPA found that less than two
percent of the pharmaceuticals included in the MRDD database fell into
this category.
    EPA applied the LOAEL screening protocols to contaminants with MRDD
values. The LOAEL protocol was used because pharmaceutical agents,
although used for their beneficial effects, have associated side-
effects that may be adverse. Chemicals evaluated with these data had
similar modal values and distributions to the toxicity values from
IRIS. The range of toxicity values in this database covered 9 orders of
magnitude when evaluated based on their rounded logs. They had the same
modal value as the LOAELs from IRIS and a very similar distribution.
Thirty-five percent of the IRIS LOAELS and 38 percent of the MRDDs had
the modal rounded log. Thirty-three percent of the LOAELs and 19
percent MRDDs had rounded logs that were lower than the mode, while 31
percent of the LOAELs and 44% of the MRDDs had rounded logs that were
above the modal log value.
    The screening process moved approximately 10 percent of the
pharmaceuticals in the Universe to the PCCL. All toxicity data on those
chemicals were included in the screening with the most serious
qualitative or quantitative measure of toxicity determining placement
in a toxicity category. Only one of the PCCL chemicals (diazinon, a
veterinary product as well as a pesticide) had water concentration
data. Two other pharmaceuticals: phenytoin (an anticonvulsant) and
nitroglycerin (treatment of angina), had release data. The remainder
were scored for occurrence based on production information, which meant
that they fell into the low certainty bin for their occurrence
parameters. Nitroglycerin is the only pharmaceutical that is included
on the draft CCL 3. EPA is aware of concerns regarding the potential
presence of pharmaceuticals in water supplies. The Agency is seeking
additional data and information on the concentrations of
pharmaceuticals in finished or ambient water and requests comment on
how pharmaceuticals have been considered in the CCL 3 process.

B. Perfluorooctanoic Acid and Perfluorooctane Sulfonic Acid

    EPA evaluated perfluorinated compounds in the CCL 3 process and
requests comment on its decisions to include perfluorooctanoic acid
(PFOA) and not to include perfluorooctane sulfonic acid (PFOS) on the
draft CCL 3. EPA identified potential health effects and occurrence
information for these compounds from the data sources discussed in
Section III. The data used for these compounds are discussed in the
support documents in more detail. Available analytic methods for these
chemicals limited the occurrence data for these compounds. The Agency
identified data on the annual production from CUS/IUR indicating
limited production and possible release to the environment. Several
organizations nominated PFOS and PFOA for consideration in the CCL
process. The nominations noted that these chemicals are persistent in
the environment and have been detected at varying levels in drinking
water and ambient water in smaller specialized studies. EPA collected
the information cited in the nominations and evaluated each of these
chemicals. The Agency included PFOA on the draft CCL 3 because it met
the criteria for inclusion on draft CCL 3 based on drinking water
occurrence studies in Ohio and West Virginia (Emmett, et al., 2006) and
on health effects data indicated through animal studies (USEPA, 2005
a).
    The Agency did not include PFOS on the draft CCL 3. Occurrence data
for PFOS characterized detections in several States (Boulanger, et al.,
2004, Hansen, et al., 2002, Goeden and Kelly, 2006). These data showed
that levels of detection for PFOS in ambient water ranged from 20 to
approximately 100 parts per trillion. Data identified in the
nominations process detected PFOS at higher concentrations in areas
surrounding landfills known to be contaminated with industrial waste
containing PFOS. The CCL process did not consider occurrence data from
targeted studies of contaminated waste sites, however. Such studies are
usually developed to identify and characterize hazardous waste cleanup
efforts and may not be representative of occurrence in drinking water
not in close proximity to the study site. PFOS was phased out of
production in the U.S. between 2000 and 2002, and regulation limits its
importation to a very small number of controlled, very low release
uses, (67 FR 72854; December 9, 2002 (USEPA, 2002 c)). Based on the
general absence of occurrence data, combined with the phase out,
effectively eliminating most future releases, PFOS did not meet the
criteria for CCL 3.
    The Agency is evaluating data related to PFOA in a formal risk
assessment process under the Toxic Substance Control Act. EPA's Science
Advisory Board (SAB) completed a review of a draft risk assessment in
2006 and SAB made recommendations for the further development of the
risk assessment. A final risk assessment may not be completed for
several years, as a number of important studies are underway. The
Agency is also participating in additional research regarding the
toxicity and persistence of related perfluorochemicals, as well as
research to help identify where these chemicals

are coming from and how people may be exposed to them.

C. Helicobacter pylori

    Helicobacter pylori is a pathogen that causes gastric cancer in
addition to acute gastric ulcers. EPA placed this pathogen on the draft
CCL. However, the analysis for H. pylori differs from the other
pathogens due to the long term and/or chronic nature of its health
effects rather than the more common acute effects of most waterborne
pathogens. This organism is an emerging pathogen whose impact has only
recently begun to be understood. Given the slow development of adverse
health effects due to infection by H. pylori, it is more difficult to
link contamination of drinking water and show a waterborne disease
outbreak. Therefore, given the long timeframe of cancer and ulcer
development (as opposed to the commonly acute gastrointestinal illness
of nearly all the other pathogens on the PCCL) as well as the ongoing
nature of the research, EPA used peer-reviewed scientific papers to
score the health effects of Helicobacter pylori. EPA request comment on
the process of selection of microbial contaminants that cause chronic
rather than acute health effects.

V. EPA's Next Steps

    Between now and the publication of the final CCL, the Agency will
evaluate comments received during the comment period for this notice,
consult with the SAB, and re-evaluate the criteria used to develop the
draft CCL and revise the CCL, as appropriate.

VI. References

Boulanger, B., J. Vargo, J.L. Schnoor and K.C. Hornbuckle. 2004.
Detection of Perfluorooctane Surfactants in Great Lakes Water.
Environmental Science and Technology, Vol. 38, No. 15. pp 4064-4070.
CDC. 2004. Surveillance for Waterborne-Disease Outbreaks Associated
with Drinking Water--United States, 2001-2002. MMWR Surveillance
Summaries, 53(SS08); 23-45.
CDC. 2006. Surveillance for Waterborne-Disease Outbreaks Associated
with Drinking Water--United States, 2003-2004. MMWR Surveillance
Summaries, 55(SS12); 31-58.
Darnerud, P.O., G.S. Erickson, T. Johannesson, P.B. Larson, and M.
Viluksela. 2001. Polybrominated Diphenyl Ethers: Occurrence, Dietary
Exposure, and Toxicology. Environmental Health Perspectives
Supplements. Vol. 109, No. S1. Available on the Internet at: http://ehp.niehs.nih.gov/members/2001/suppl-1/49-68darnerud/darnerud-full.html
.

Emmett, E.A., F.S. Shofer, H. Zhang, D. Freeman, C. Desai, L.M.
Shaw. 2006. Community Exposure to Perfluorooctanoate: Relationships
Between Serum Concentrations and Exposure Sources, Journal of
Occupational and Environmental Medicine, Vol. 48, No. 8, pp. 759-
770.
Goeden, H. and J. Kelly. 2006. Perfluorochemicals in Minnesota,
Minnesota Department of Health, Senate Environment and Natural
Resources Committee, February 27. Available on the Internet at:
http://www.health.state.mn.us/divs/eh/hazardous/sites/washington/pfcsmn.pdf
.

Hansen, K.J., H.O. Johnson, J.S. Eldridge, J.L. Blutenhoff and L.A.
Dick. 2002. Quantitative Characterization of Trace Levels of PFOS
and PFOA in the Tennessee River. Environmental Science and
Technology, Vol. 36, No. 8, pp. 1681-1685.
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). 2001. Classifying Drinking Water
Contaminants for Regulatory Consideration. National Academy Press,
Washington, DC.
NIST. 2006. NIST/SEMATECH e-Handbook of Statistical Methods.
Available on the internet at: http://www.itl.nist.gov/div898/handbook/
, (used on May 3, 2007).

Taylor, L.H., S.M. Latham, and M.E. Woolhouse. 2001. Risk factors
for human disease emergence (Appendix A). Phil. Trans. R. Soc. Lond.
B. Vol. 256, 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. Jour. Infect. Dis. Vol. 189,
No. 9, pp. 1664-75.
USEPA. 1989a. 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.
USEPA. 1989b. Drinking Water; National Primary Drinking Water
Regulations; Total Coliforms (Including Fecal Coliforms and E.
Coli). Federal Register. Vol. 54, No. 124, p. 27544, June 29, 1989.
USEPA. 1992. Drinking Water; National Primary Drinking Water
Regulations--)-Synthetic Organic Chemicals and Inorganic Chemicals;
National Primary Drinking Water Regulations Implementation; Final
Rule. Federal Register. Vol. 57, No. 138, p. 31776, July 17, 1992.
USEPA. 1997. Announcement of the Draft Drinking Water Contaminant
Candidate List; Notice. Federal Register. Vol. 62, No. 193, p.
52193, October 6, 1997.
USEPA. 1998a. Interim Enhanced Surface Water Treatment; Final Rule.
Federal Register. Vol. 63, No 241, p. 69478, December 16, 1998.
USEPA. 1998b. Announcement of the Draft Drinking Water Contaminant
Candidate List; Notice. Federal Register. Vol. 63, No. 40, p. 10273,
March 2, 1998.
USEPA. 1999. Revisions to the Unregulated Contaminant Monitoring
Regulation for Public Water Systems. Federal Register. Vol. 64, No.
180, p. 50556, September 17, 1999.
USEPA. 2002a. Long Term 1 Enhanced Surface Water Treatment Rule;
Final Rule. Federal Register. Vol. 67, No. 9, p. 1813. January 14,
2002.
USEPA. 2002b. Announcement of Preliminary Regulatory Determinations
for Priority Contaminants on the Drinking Water Contaminant
Candidate List. Federal Register. Vol. 67, No. 106, p. 38222, June
3, 2002.
USEPA. 2002c. Perfluoroalkyl Sulfonates; Significant New Use Rule.
Federal Register. Vol 67, No. 236, p. 72854, December 9, 2002.
USEPA. 2003a. Announcement of Regulatory Determinations for Priority
Contaminants on the Drinking Water Contaminant Candidate List.
Federal Register. Vol. 68, No. 138, p. 42898, July 18, 2003.
USEPA. 2004. Drinking Water Contaminant Candidate List 2; Notice.
Federal Register. Vol. 69, No. 64, p. 17406, April 2, 2004.
USEPA. 2005a. Draft Risk Assessment of the Potential Human Health
Effects Associated with Exposure to Perfluorooctanoic Acid and its
Salts. OPPTS, SAB Draft. January 4, 2005.
USEPA. 2005b. Notice--Drinking Water Contaminant Candidate List 2;
Final Notice. Federal Register. Vol. 70, No. 36, p. 9071, February
24, 2005.
USEPA. 2006a. Long Term 2 Enhanced Surface Water Treatment Rule;
Final Rule. Federal Register. Vol. 71, No. 3, p. 654, January 5,
2006.
USEPA. 2006b. Request for Nominations of Drinking Water Contaminants
for the Contaminant Candidate List; Notice. Federal Register. Vol.
71, No. 199, p. 60704, October 16, 2006.
USEPA. 2006c. National Primary Drinking Water Regulations: Ground
Water Rule; Final Rule. Federal Register. Vol. 71, No. 216, p.
65573, November 8, 2006.
USEPA. 2007 a. Unregulated Contaminant Monitoring Regulation (UCMR)
for Public Water Systems Revisions; Final Rule. Federal Register.
Vol. 72, No. 2, p. 367, January 4, 2007.
USEPA. 2007 b. Unregulated Contaminant Monitoring Regulation (UCMR)
for Public Water Systems Revisions; Correction. Federal Register.
Vol. 72, No. 17, p. 3916, January 26, 2007.
USEPA. 2007 c. Unregulated Contaminant Monitoring Regulation (UCMR)
for Public Water Systems Revisions; Correction. Federal Register.
Vol. 72, No. 19, p. 4328, January 30, 2007.
USEPA. 2007 d. Drinking Water: Regulatory Determinations Regarding
Contaminants on the Second Drinking Water Contaminant Candidate
List--

Preliminary Determinations; Proposed Rule. Federal Register. Vol.
72, No. 83, p. 24016, May 1, 2007.
USEPA. 2008 a. Contaminant Candidate List 3 Chemicals: Identifying
the Universe. EPA 815-R-08-002. Draft. February, 2008.
USEPA. 2008 b. Contaminant Candidate List 3 Chemicals: Screening to
a PCCL. EPA 815-R-08-003. Draft. February, 2008.
USEPA. 2008 c. Contaminant Candidate List 3 Chemicals:
Classification of the PCCL to the CCL, EPA 815-R-08-004. Draft.
February, 2008.
USEPA. 2008 d. Contaminant Candidate List 3 Microbes: Identifying
the Universe, EPA 815-R-08-005. Draft. February, 2008.
USEPA. 2008 e. Contaminant Candidate List 3 Microbes: Screening to
the PCCL, EPA 815-R-08-006. Draft. February, 2008.
USEPA. 2008 f. Contaminant Candidate List 3 Microbes: PCCL to CCL
Process, EPA 815-R-08-007. Draft. February, 2008.
USEPA. 2008 g. Summary of Nominations for the Third Contaminants
Candidate List. EPA 815-R-08-008. Draft. February, 2008.
USEPA. 2008 h. Chemical Expert Input and Review for the Third
Contaminant Candidate List, EPA 815-R-08-009. Draft. February, 2008.
USEPA. 2008 i. Microbial Expert Input and Review, EPA 815-R-08-010.
Draft. February, 2008.

    Dated: February 6, 2008.
Benjamin H. Grumbles,
Assistant Administrator, Office of Water.
 [FR Doc. E8-3114 Filed 2-20-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Page 7357]
[FR Doc No: 2019-03766]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL19-47-000]

Notice of Complaint: Independent Market Monitor for PJM v. PJM
Interconnection, LLC

    Take notice that on February 21, 2019, pursuant to Rule 206 of the
Federal Energy Regulatory Commission's (Commission) Rules and Practice
and Procedure, 18 CFR 385.206 (2018), Monitoring Analytics, LLC, acting
in its capacity as the Independent Market Monitor for PJM (Complainant)
filed a formal complaint against PJM Interconnection, L.L.C.
(Respondent) requesting that the Commission direct Respondent to revise
the expected number of Performance Assessment Intervals (PAI) used to
set the default Market Seller Offer Cap in Reliability Pricing Model
(RPM) auctions to a level consistent with a reasonable and supportable
expectation of PAI, as more fully explained in the complaint.
    The Complainant states that copies of the complaint were served on
representatives of the Respondent.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on March 13, 2019.

    Dated: February 25, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-03766 Filed 3-1-19; 8:45 am]
 BILLING CODE 6717-01-P